Angioplasty, Bypass and Invasive Procedures

Abou-Zamzam AM, Moneta GL, Lee RW, Nehler MR, Taylor LM and Porter JM: Peroneal bypass is equivalent to inframalleolar bypass for ischemic pedal gangrene. Arch Surg 131:894-899, 1966. Peroneal bypasses (159 patients) had similar intermediate-term survival, limb salvage and wound healing as inframalleolar bypasses (57 patients).
Abularrage CJ, Conrad MF, Hackney LA et al.: Long-term outcomes of diabetic patients undergoing endovascular infrainguinal interventions. J Vasc Surg 52:314-22, 2010. Abstract: OBJECTIVE: Diabetes mellitus (DM) has traditionally predicted poor outcomes after lower extremity revascularization for peripheral vascular disease (PVD). This study assessed the influence of DM on long-term outcomes of percutaneous transluminal angioplasty, with or without stenting (PTA/stent), in patients with PVD. METHODS: From January 2002 to December 2007, 920 patients underwent 1075 PTA/stent procedures. Patients were stratified into DM and non-DM cohorts. Study end points included primary patency (PP), assisted patency (AP), limb salvage, and survival and were evaluated using Kaplan-Meier and Cox regression analyses. RESULTS: There were 533 DM and 542 non-DM limbs. Median follow-up was 34 months. Overall, the 5-year actuarial PP was 42% +/- 2.4%, AP was 81% +/- 2.0%, limb salvage was 89% +/- 1.6%, and survival was 60% +/- 2.4%. On univariate analysis, DM vs non-DM was associated with inferior 5-year PP (37% +/- 3.4% vs 46% +/- 3.3%; P = .009), limb salvage (84% +/- 2.6% vs 93% +/- 1.8%, P < .0001), and survival (52% +/- 3.5% vs 68% +/- 3.1%, P = .0001). AP did not differ between DM and non-DM patients (P = .18). In the entire cohort, DM (hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.01-1.54; P = .04), single-vessel peroneal runoff (HR, 1.54; 95% CI, 1.16-2.08; P = .003), and dialysis (HR, 1.59; 95% CI, 1.10-2.33; P = .02) were associated with decreased PP on multivariate analysis. The only variables on multivariate analysis to predict limb loss and death were critical limb ischemia (HR, 9.09; 95% CI, 4.17-20.00; P < . 0001; HR, 2.99; 95% CI, 2.01-4.44; P < .0001, respectively) and dialysis (HR, 2.94; 95% CI, 1.39-5.00; P = .003; HR, 4.24; 95% CI 2.80-6.45; P < .0001, respectively). CONCLUSIONS: DM is an independent predictor of decreased long-term primary patency after PTA/stent. Although acceptable assisted patency rates can be achieved with close surveillance and reintervention, long-term limb salvage remains inferior in diabetic patients compared with non-diabetic patients due to a more severe clinical presentation and poor runoff. Comments: An interesing report of the experience of the vascular sevice at the Massachusetts General Hospital...not a prospective controlled trial... no conrols...decision to operate left to the whims of the operator.... multiple exemptions from the report: those with aortoiliac endovascular procedures; those having had an atherectomy, cryoplasty, multivessel thrombectomy, extended thrombolysis, procedures for failed bypass, acute critical limb ischemia, or a leg thought to be functionably unsalvageable.
Albers M, Fratezi AC, De Luccia N: Assessment of quality of life of patients with severe ischemia as a result of infrainguinal arterial occlusive disease. J Vasc Surg 16:54-9, 1992. The purpose of this cohort study was to assess the quality of life of patients with severe ischemia as a result of infrainguinal arterial occlusive disease. Spitzer's QL-INDEX was selected to measure quality of life at baseline and at 3, 6, and 12 months. On the basis of initial treatment, 61 patients were grouped as follows: IC (conservative, n = 31), IR (arterial reconstruction, n = 14), and IA (major amputation, n = 16). After 12 months of follow-up, 48 patients were similarly regrouped according to ultimate treatment as follows: UC (n = 19), UR (n = 9), and UA (n = 20). At 12 months the mean score was significantly higher than the baseline in IC (6.43 vs 3.84, p less than 0.0001) as well as IR (5.64 vs 3.57, p less than 0.01), but not in IA (4.43 vs 3.62). The QL-INDEX mean score was lower in UA than in UC (4.15 vs 6.58, p less than 0.01) or UR (4.15 vs 7.11, p less than 0.0001). The correlation between QL-INDEX and an arbitrary scale was also high (r = 0.726, p less than 0.001). In conclusion, quality of life of patients with limb ischemia can be confidently assessed, improves during the first year of follow-up if major amputation is avoided, and improves and is sustained by a functioning graft. At baseline the mean QL-Index of 3.31 always close to the value of 3.31 achieved by 78 patients in critical or even terminal stages of cancer. 12 0f the 31 conservatively treated patients survived at least one year and 12 remained free of surgery. IC 3.84 to 5.15 to 6.32 to 6.43 (0, 3mo, 6mo, 12mo) IR 3.57 to 4.64 to 5.91 to 5.64 IA 3.62 to 3.62 to 4.13 to 4.43. Comments: It is to be appreciated that the conservatively-treated (a placebo-treated group from a surgical viewpoint) had a higher quality of life than the other groups at all time points throughout the study while the surgical group ended with the highest mean score. Something to be said for placebo care. Ideally, control-placebo groups should be included in all studies when feasible.
Allie DE, Hebert CJ et al:Critical limb ischemia: a global epidemic.A critical analysis of current treatment unmasks the clinical and economic costs of CLI. EuroIntervention 1(1):75-84, 2005. Abstract: Background: Multiple reports document the higher costs of primary amputation (PA) compared to infrainguinal bypass surgery (IBS). Recent reports document 40-50% cost-effectiveness for percutaneous transluminal angioplasty (PTA) compared to IBS. The literature suggests appropriate initial treatment for critical limb ischemia (CLI) to be IBS = 38%, PTA = 28%, and PA = 16%. The encouraging 6-month Laser Angioplasty for Critical Limb Ischemia (LACI) 93% limb salvage rate prompted an independent CLI and LACI clinical and economic analysis. Methods: Between 1999-2001 a reference amputation population (RAP) of 417 patients with at least one infrainguinal amputation were identified from a 2.5 million patients Medicare/insurance dataset. Clinical data and all medical cost claims for 18 continuous months, 12-month prior and 6-month post-amputation, were analyzed for PTA, IBS, and PA treatment pathways. Based on multiple assumptions and the LACI phase II results, economic outcomes were used for a LACI pathway analysis compared to PTA, IBS and PA pathways by substituting the LACI trial pathway as the initial treatment in lieu of the RAP actual treatment. Results: Initial treatments for CLI RAP were PA = 67%, IBS = 23%, PTA = 10%; A majority of wound complications (80%) and myocardial infarction 7/9 (77.7%), stroke 13/16 (81.2%), and death 2/2 (100%) occurred in the PA RAP. Only 35% of the RAP had an ankle brachial index (ABI) and only 16% angiography before PA. 227/417 (56%) of the RAP had multiple procedures. Average total costs / patient = $31,638 without LACI and $25,373 with LACI. Average savings/patient with LACI = $6,265. Conclusion: The most common current treatments in the US for CLI are still characterized by high rates of primary amputations, multiple procedures, and high rates of procedure-related complications. Despite the limitations and assumptions of this analysis, the utilization of a LACI pathway first revascularization treatment strategy may provide clinical and economic cost savings in treating patients with CLI.
Adam DJ, Beard JD, Cleveland T et al: Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 366: 1925-34, 2005. BACKGROUND: The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients. METHODS: We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889. FINDINGS: The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy. INTERPRETATION: In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty.
Akbari CM, Pomposelli FB Jr, Gibbons GW, Campbell DR, Pulling MC, Mydlarz D, LoGerfo FW. Lower extremity revascularization in diabetes: late observations. Arch Surg 135: 452-6, 2000. HYPOTHESIS: Despite the success of infrainguinal arterial bypass in diabetic limb and foot salvage, optimism remains guarded because of purported high late mortality and limb loss in patients with diabetes. DESIGN: Inception cohort, with minimum 5-year follow-up. SETTING: Tertiary referral center. PATIENTS: Eight hundred forty-three consecutive patients undergoing lower extremity arterial reconstruction from July 1, 1990, through July 31, 1993. INTERVENTION: Infrainguinal arterial bypass with vein graft. MAIN OUTCOME MEASURES: Graft patency, limb salvage, and survival. RESULTS: A total of 962 vein grafts (843 patients) were performed; 795 grafts (82.6%) were performed in patients with diabetes (DM group) and 167 (17.4%) in nondiabetic patients (NDM group). Average age was 68.4 years, and was lower in the DM group (66.2 [range, 27-92 years] vs. 70.5 years [range, 37-96 years]) (P = .005). Inhospital 30-day perioperative mortality was 1.4%, lower in the DM group (0.9% vs. 4.2%) (P = .005). The target vessel was more frequently infrageniculate in the DM group (87% vs. 77%; P = .002). Five-year primary and secondary graft patencies were 74.7% (DM group, 75.6%; NDM group, 71.9%; P = .80) and 76.2% (DM group, 77.0%; NDM group, 73.6%; P = .90), respectively. The 5-year overall limb salvage rate was 87.1%, also unaffected by diabetes (DM group, 87.3%; NDM group, 85.4%; P = .80). Survival at 5 years was 58.1% overall and virtually identical in the DM (58.2%) and NDM groups (58.0%). CONCLUSIONS: Diabetes mellitus does not influence late mortality, graft patency, or limb salvage rates after lower extremity arterial reconstruction. Concern for longterm mortality and limb loss in diabetic patients is unwarranted and should not prevent aggressive attempts at limb salvage. See Voisine et al for gene differences in diabetics and non-diabetics undergoing cardiac surgery.
Arora S, Pomposelli F, LoGerfo FW, Veves A: Cutaneous microcirculation in the neuropathic diabetic foot improves significantly but not completely after successful lower extremity revascularization. J Vasc Surg 35:501-5, 2002. OBJECTIVE: The purpose of this study was the examination of the effect of successful large vessel revascularization on the microcirculation of the neuroischemic diabetic foot. RESEARCH DESIGN AND METHODS: We measured the cutaneous microvascular reactivity in the foot in 13 patients with diabetes with peripheral arterial disease and neuropathy (group DI) before and 4 to 6 weeks after successful lower extremity arterial revascularization. We also compared them with age-matched and sex-matched groups of 15 patients with diabetes and neuropathy, seven patients without neuropathy, and 12 healthy patients for control. We used single-point and laser Doppler scan imaging for the measurement of the foot skin vasodilatation in response to heating to 44 degrees C and to iontophoresis of 1% acetylcholine (endothelial-dependent response) and 1% sodium nitroprusside (endothelial-independent response). RESULTS: The group DI response to heat increased from 289% +/- 90% before surgery (percent increase over baseline measured in volts) to 427% +/- 61% (P <.05) after surgery but was still comparable with the response of the patients with diabetes and neuropathy (318% +/- 51%) and lower than the responses of the patients without neuropathy (766% +/- 220%) and the healthy patients for control (891% +/- 121%; P <.0001). The group DI acetylcholine response also improved from 6% +/- 4% before surgery to 26% +/- 8% after surgery (P <.05) and was similar to the responses of patients with diabetes and neuropathy (18% +/- 3%) and patients without neuropathy (38% +/- 8%) but still lower when compared with the response of the patients for control (48% +/- 9%; P <.001). The sodium nitroprusside response for group DI improved from 10% +/- 4% to 29% +/- 9% (P <.05) and was similar to the responses of the neuropathic (25% +/- 9%), nonneuropathic (32% plus minus 6%), and control (40% +/- 5%) groups. The group DI neurovascular response, which depends on the healthy function of the C-fiber nociceptors, was similar at baseline (5% +/- 9%) and after surgery (14% +/- %10) and in the neuropathic group (33% +/- 21%), but it was dramatically reduced when compared with the nonneuropathic (110% +/- 40%) and control (198% +/- 54%) groups (P <.001). CONCLUSION: Impaired vasodilation in the diabetic neuropathic lower extremity leads to functional ischemia, which improves considerably but is not completely corrected with successful bypass grafting surgery. Therefore, patients with diabetes and neuropathy may still be at high risk for the development of foot ulceration or the failure to have an existing ulcer heal despite adequate correction of large vessel blood flow.
Arafa OE, Pedersen TH, Svennevig JL, Fosse E, Geiran OR: Vascular complications of the intraaortic balloon pump in patients undergoing open heart operations: 15-year experience. Ann Thorac Surg 67: 645-51, 1999. Background. The beneficial effects of the intraaortic balloon pump (IABP) in providing circulatory support must be weighed against its complications, particularly its vascular trauma. Methods. Five hundred nine patients who underwent open heart operations at our institution and who were treated with the IABP from January 1980 through December 1994 were studied retrospectively to assess IABP-related vascular complications and their independent preoperative predictors and the implications of IABP-related vascular complications on the patients’ mortality, morbidity (clinical sepsis and organ failure), and long-term survival. Results. Early vascular complications occurred in 56 patients (11%) and major complications occurred in 41 patients (8%). The latter consisted of aortic perforation in 1 patient, aortoiliac dissection in 2 patients, and limb ischemia in 38 patients. Logistic regression analysis identified concomitant peripheral vascular disease (p < 0.001), elevated preoperative end-diastolic pressure, small body surface area, and large catheter size (p < 0.05) as independent risk factors for IABP-related major vascular complications in patients who survived the day of operation. Late IABP-related sequelae occurred in 10 patients, 9 of whom had had early vascular complications. The presence of vascular complications per se was not a significant independent factor among other risk factors for mortality, morbidity, or long-term survival. Conclusions. Careful clinical assessment of the aortofemoral vascular tree is a cornerstone of early diagnosis and early intervention and usually prevents limb loss. The significant decrease in major vascular complications that has occurred over the last 5 years can be explained by the increased use of catheters with smaller diameters. The timing of IABP insertion in relation to operation and the duration of IABP use were the only device-related risk factors identified for morbidity and survival.
Arvela E, Söderström M, Albäck A et al: Arm vein conduit vs prosthetic graft in infrainguinal revascularization for critical leg ischemia. J Vasc Surg:52:616-23, 2010. Abstract: BACKGROUND: One-piece great saphenous vein (GSV) is the conduit of choice in infrainguinal revascularizations for critical limb ischemia (CLI). Unfortunately, adequate length of usable GSV is not always available. Despite inferior patency rates compared with GSV, prosthetic and arm vein conduits are generally considered usable. The purpose of this study was to compare the outcome of infrainguinal arm vein and prosthetic bypass. MATERIAL AND METHODS: We retrospectively reviewed 290 consecutive infrainguinal bypasses for CLI using arm vein conduit (n = 130) or prosthetic graft (n = 160) during January 2000 and December 2006 at our institution. The groups were compared for risk factors, indication for surgery, and runoff score. Survival, leg salvage, and patency rates were calculated with the Kaplan-Meier method. RESULTS: Median surveillance time was 35 months (range 0-118 months). The age, gender, and usual risk factors were similar in arm vein and prosthetic groups, except cerebrovascular disease that was more common in the prosthetic group (P = .011). Indication for surgery was CLI. In the arm vein group, more than two-thirds (70.2%) of the procedures were for ischemic ulcer or gangrene, whereas in the prosthetic group the main indication was ischemic rest pain (51.3%). When the outcome of femoropopliteal bypasses was analyzed, the difference between groups was not statistically significant. However, in infrapopliteal revascularizations primary patency, assisted primary patency, and secondary patency rates at 3 years were significantly better in the arm vein group: 28.3% (SE +/- 6.3%) vs 9.6% (SE +/- 8.1%) (P = .031), 56.8% (SE +/- 6.6%) vs 10.4% (SE +/- 8.7%) (P = .000), and 57.4% (SE +/- 6.6) vs 11.2% (SE +/- 9.3%) (P = .000), respectively. Leg salvage and survival at 3 years were 75.0% (SE +/- 4.9%) vs 57.1% (SE +/- 8.8%) (P = .005) and 58.8% (SE +/- 5.1%) vs 39.5% (SE +/- 7.7%) (P = .007), respectively. CONCLUSION: Arm vein conduits, even when spliced, are superior to prosthetic grafts in terms of midterm assisted primary patency, secondary patency, and leg salvage in infrapopliteal bypasses for CLI.
Axelrod DA, Stanley JC et al: Risk for stroke after elective noncarotid vascular surgery. J Vasc Surg 39: 67-72, 2004. Introduction: Patients undergoing operations to treat peripheral vascular disease have systemic atherosclerosis and are at risk for stroke. However, the incidence and effect of cerebrovascular events on noncarotid vascular surgical outcomes are not well-defined. Methods: Patients undergoing common operations for vascular disease from 1997 to 2000 were examined with data from the Veterans Affairs (VA) National Surgery Quality Improvement Project and the VA patient treatment files. Operations studied included abdominal aortic aneurysmectomy (n = 2551), aortobifemoral bypass (n = 2616), lower extremity bypass (n = 6866), and major lower extremity amputation (n = 7442). The incidence of perioperative stroke was determined, and logistic regression analysis was used to identify independent risk factors for stroke. Logistic and linear regression analyses were used to quantify the effect of postoperative stroke on adjusted mortality and length of stay. Odds ratio (OR) and 95% confidence interval (CI) were defined. P <.05 was considered significant. Results: Stroke was uncommon after noncarotid vascular procedures, occurring in only 0.4% to 0.6% of patients. Independent risk factors for stroke include preoperative ventilation (OR, 11; 95% CI, 5.0-22.3; P <.001), previous stroke or transient ischemic attack (OR, 4.2; 95% CI, 2.7-6.4; P <.001), postoperative myocardial infarction (OR, 3.3; 95% CI, 1.3-8.7; P =.009), and need to return to the operating room (OR, 2.2; 95% CI, 1.4-3.5; P =.001). Factors that did not appear to be associated with stroke risk included procedure type, diabetes, renal failure, dialysis dependence, number of transfused units of blood, and hypertension. After controlling for other postoperative complications and comorbid conditions, postoperative stroke significantly increased the risk for perioperative mortality (OR, 6.3; 95% CI, 3.4-11.4; P <.001), with similar magnitude as postoperative myocardial infarction (OR, 6.3; 95% CI, 3.9-10.1; P < .001). Stroke was also associated with a 48% increase in overall length of stay. Conclusions: Stroke after noncarotid peripheral vascular surgery is uncommon, but results in markedly increased mortality and length of stay. Stroke risk is most strongly associated with previous stroke history and greater degree of illness. Patients with these associated conditions deserve particular attention to assessing and medically managing modifiable risk factors.
Ballard JL, Sparks SR, Taylor FC, Bergan JJ, Smith DC, Bunt TJ, Killeen JD: Complications of iliac artery stent deployment. J Vasc Surg 24(4):545-53, 1996; discussion 553-5. PURPOSE: This study was performed to determine the primary patency, foot salvage, and complication rates associated with iliac artery stent deployment. METHODS: From March 1992 to May 1995, 147 iliac artery stents were deployed in 98 limbs of 72 patients for disabling claudication or limb-threatening ischemia. Procedure-related and late (> 30 days) complications, as well as adjunctive maneuvers required to correct a complication, were tabulated. Stented iliac artery cumulative primary patency and foot salvage rates were calculated with life-table analysis. Factors that impacted early complications, late complications, foot salvage rates, and stented iliac artery primary patency rates were identified with stepwise logistic regression analysis. RESULTS: A procedure-related complication occurred in 19 (19.4%) limbs. Initial technical success, however, was achieved in all but three of 98 limbs (96.9%). Stented iliac artery cumulative primary patency rates were 87.6%, 61.9%, 55.3%, and foot salvage rates were 97.7%, 85.1%, 76.1%, at 12, 18, and 24 months, respectively. External iliac artery stent deployment, superficial femoral artery occlusion before treatment, and single-vessel tibial runoff before treatment negatively affected stented iliac artery cumulative primary patency rates. Stented iliac artery primary patency rates were not significantly affected by age, smoking, coronary artery disease, diabetes, hypercholesterolemia, hypertension, presenting symptom, early complication, number of stents deployed, type of stent deployed, or stent deployment for stenosis versus occlusion. CONCLUSIONS: Limb-threatening and life-threatening complications can be associated with iliac artery stent deployment. Stented iliac artery primary patency rates are affected by distal atherosclerotic occlusive disease and the position of the deployed stent within the iliac system. Stent reconstruction of severe iliac artery occlusive disease is feasible but should be thoughtfully selected. Comments: Angioplasty and stents do cause complications. Collateral flow develops with time in many patients and may be hastened with boot therapy (left photograph below). The plaque material, of course, is impacted into the vessel wall with the balloon procedure occasionally leaving the patient with a patent vessel that has lost its nutrient vessels to the adjacent tissue (second photograph); this patient was left with a painful thigh. Other patients in our case history section were referred for boot therapy after having suffered peripheral embolization after the placement of stents.
BARI 2D Study Group, Frye RL, August P et al A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med.360:2503-15, 2009. BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. METHODS: We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. RESULTS: At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). CONCLUSIONS: Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision.Comments: By October, the New England Journal had published 9 articles in 2009 on coronary angioplasty. Clearly, everyone is doing it. This article and that by Mark et al below show it expensive and not always beneficial.
Barner HB, Kaiser GC and Willman VL: Blood flow in diabetic leg. Circulation 43:391, 1971. Reconstruction and repair of diabetic lesion should not be withheld on basis of arteriolar-capillary disease.
Bartlett FR, Gibbon GW and Wheelock FC: Aortic reconstruction for occlusive disease. Comparable results in diabetics. Arch Surg 121:1150-1153, 1986. 57 diabetic (68% for limb salvage) and 43 nondiabetics (47% for limb salvage). Both groups left hospital with open grafts but had 9% late graft occlusion. 33% diabetics dead at 4 years vs 16% for nondiabetics.
Becquemin J-P for the Etude de la Ticlopidine apres pontage femoro-poplite and the Association Universitaire de Recherche en Chirurgie: Effect of ticlopidine on the long-term patency of saphenous-vein bypass grafts in the legs. N Engl J Med 337:1726-31, 1997. Abstract results: After two years, 66.4% of patients were alive with a patent graft in the ticlopidine group, as compared with 51.2% in the placebo group (95% confidence interval for the difference between the two groups, 2.9 to 27.4%; P=0.02). The two-year cumulative patency rate was 82% in the ticlopidine group and 63% in the placebo group (P=0.002). There was no significant difference between the groups in overall mortality or major ischemic events. Comments: Perhaps, we should give our boot patents ticlopidine also. The authors note that ticlopidine, presumably by its inhibition of platelet aggregation, has been reported to be effective in increasing walking distance and decreasing need for bypass surgery in claudicators and in reducing death rate, myocardial infarction and stroke.
Berlauk JF, Abrams JH, Gilmour IJ et al: Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery. A prospective, randomized clinical trial. Ann Surg 214: 289-299, 1991. Abstract: The hypothesis that optimizing hemodynamics using pulmonary artery (PA) catheter (preoperative 'tune-up') would improve outcome in patients undergoing limb-salvage arterial surgery was tested. Eighty-nine patients were randomized to preoperative tune-up either in the surgical intensive care unit (SICU) (group 1) or the preinduction room (group 2) or to control (group 3). The tune-up consisted of fluid loading, afterload reduction, and/or inotropic support to achieve predetermined endpoints. Patients with a PA catheter had significantly fewer adverse intraoperative events (p less than 0.05), less postoperative cardiac morbidity (p less than 0.05), and less early graft thrombosis (p less than 0.05) than the control group. The overall study mortality rate was 3.4%, with a mortality rate of 9.5% in the control group and 1.5% in the PA catheter groups. There were no differences in ICU length of stay (LOS), hospital LOS, or total hospital costs, although the percentage of cost from complications was higher in group 3 (p greater than 0.05). In this group of patients, preoperative cardiac assessment and optimization is associated with improved outcome.
Biancari F, Railo M, Lundin J et al: Redo bypass surgery to the infrapopliteal arteries for critical leg ischaemia. Eur J Vasc Endovasc Surg 21:137-42, 2001. OBJECTIVES: to evaluate the results of redo bypass surgery to the infrapopliteal artery and the value of adjuvant arteriovenous fistula (AVF) in this setting. DESIGN: retrospective study. MATERIALS: fifty-one redo reconstructions to the infrapopliteal arteries were done for critical leg ischaemia in 45 patients who have had primary infrainguinal reconstructions to the popliteal artery in 20 cases (39%), the crural arteries in 18 (35%), and the pedal arteries in 13 (25%). METHODS: a PTFE prosthesis was used in 21 cases (41%). A Miller cuff was used in 16 prosthetic grafts. Adjuvant AVF was added to three autogenous vein and 12 prosthetic grafts. RESULTS: at 2 years, the primary patency rate was 42%, the secondary patency was 43%, the limb salvage was 67%, the survival was 77%, and 53% of patients were alive with salvaged leg. The primary patency rate with a vein graft was 44% at 1 year, with prosthesis plus AVF 67%, but with prosthesis without AVF only 19%. Secondary patency rates were similar. Prosthetic graft with AVF and those without AVF achieved a 1-year leg salvage rate of 100% and 51%, respectively (p =0.01). Patients with adjuvant AVF had a worse 2-year survival rate that those without AVF (31% vs 89%) (p =0.007; RR: 8.87, CI 95%: 1.62-48.42). CONCLUSIONS: redo bypass surgery using autogenous vein graft may achieve satisfactory long-term results. The use of adjuvant AVF may improve patency of redo infrapopliteal prosthetic bypass grafts. Comments: Redo surgery, of course, adds to the expense of limb salvage but is better than limb loss.
Bjerre-Jepsen K, Faris I et al: Effect of therapy on 24-h subcutaneous blood flow in the leg in patients with severe ischemia. Eur J Nucl Med 9:413-5, 1984. The effect of vascular surgical reconstruction or Buerger's exercises upon average subcutaneous blood flow for a 24-h period was studied in 14 patients with severe leg ischemia due to occlusive arterial disease. Blood flow was estimated proximally in the calf and in the foot by a 133Xe washout technique. Seven patients underwent vascular surgery. Postoperatively subcutaneous blood flow increased in the calf and the foot in all patients except one in whom a decrease in blood flow in the foot was seen. In this case a decrease in systolic blood pressure occurred following the operation. Buerger's exercises did not alter subcutaneous blood flow either in the calf or in the foot in the seven patients studied. Buerger's exercises seem to be of no value for these patients. The measurement of blood flow in subcutaneous tissue over a period of 24 h seems to be a useful test of the effect of different treatments. Comments: While Buerger's exercises may not help patients with severe PVD, a rocking bed in providing untiring treatments and a tilt of the entire body has had some benefit historically both in patients with PVD and pulmonary insufficiency. See Arch Phys Med Rehabil 37(10): 637-42, 1956 and (Influence of an oscillating bed on cutaneous temperature and oxygen tension of ischemic toes) Circulation 17:277-83, 1958.
Blair JM, Gewertz BL, Moosa H, Lu CT, Zarins CK: Percutaneous transluminal angioplasty versus surgery for limb-threatening ischemia. J Vasc Surg 9:698-703. 1989. This retrospective study compared the results of percutaneous transluminal angioplasty (PTA) with those of infrainguinal bypass procedures in patients with critical arterial ischemia to determine which procedure had superior patency, limb salvage, and durability. The records of 54 patients who underwent 54 PTAs and 56 patients who underwent 63 infrainguinal bypasses (29 femoropopliteal and 34 femorodistal) from 1981 to 1987 were reviewed. In each patient PTA or bypass was the initial vascular procedure. Patients in both groups were comparable with respect to age, sex, and the presence of diabetes, hypertension, obesity, hypercholesterolemia, and smoking. Mean follow-up was 40 months (4 to 88 months) for the PTA group and 28 months (6 to 78 months) for the surgery group. Thirty-nine of the 54 patients (72%) were initially improved after PTA, whereas 15 patients (28%) showed no improvement. During follow-up, 20 initially successful PTAs reoccluded. Thirty-two of 54 patients (59%) underwent subsequent procedures, which included repeat PTA (10) and distal bypass (14). Patency determined by noninvasive Doppler studies was 18% at 2 years. Limb salvage, which included such secondary procedures, was 78%. Two-year patency for femoropopliteal bypasses was 68% with a limb salvage of 90%. Femorodistal bypasses had a 2-year patency of 47% and a limb salvage of 74%. No perioperative deaths occurred. Twenty-one of the 63 patients (33%) had subsequent procedures, which included thrombectomy (5) and bypass revision (9). In patients treated for limb-threatening ischemia the 2-year patency after femoropopliteal bypass (68%) or femorodistal bypass (47%) is significantly better than that from PTA (18%, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Bloom RJ and Stevick CA: Amputation level and distal bypass salvage of the limb. Surg Gynecol Obstet 166:1-5, 1988. From Stanford...59% salvage rate... failure of the graft did not predispose to a subsequent amputation.
Bode RH Jr, Lewis KP, Zarich SW, Pierce ET, Roberts M, Kowalchuk GJ, Satwicz PR, Gibbons GW, Hunter JA, Espanola CC: Cardiac outcome after peripheral vascular surgery. Comparison of general and regional anesthesia. Anesthesiology 84: 3-13, 1996. BACKGROUND: Despite evidence that regional anesthesia may be associated with fewer perioperative complications than general anesthesia, most studies that have compared cardiac outcome after general or regional anesthesia alone have not shown major differences. This study examines the impact of anesthetic choice on cardiac outcome in patients undergoing peripheral vascular surgery who have a high likelihood of associated coronary artery disease. METHODS: Four hundred twenty-three patients, between 1988 and 1991, were randomly assigned to receive general (n = 138), epidural (n = 149), or spinal anesthesia (n = 136) for femoral to distal artery bypass surgery. All patients were monitored with radial artery and pulmonary artery catheters. Postoperatively, patients were in a monitored setting for 48-72 h and had daily electrocardiograms for 4-5 days and creatine phosphokinase/isoenzymes every 8 h x 3, then daily for 4 days. Cardiac outcomes recorded were myocardial infarction, angina, and congestive heart failure. RESULTS: Baseline clinical characteristics were not different between anesthetic groups. Overall, the patient population included 86% who were diabetic, 69% with hypertension, 36% with a history of a prior myocardial infarction, and 41% with a history of smoking. Cardiovascular morbidity and overall mortality were not significantly different between groups when analyzed by either intention to treat or type of anesthesia received. In the intention to treat analysis, incidences of cardiac event or death for general, spinal, and epidural groups were 16.7%, 21.3%, and 15.4%, respectively. The absolute risk difference observed between general and all regional anesthesia groups for cardiac event or death was -1.6% (95% confidence interval -9.2%, 6.1%) This reflected a nonsignificant trend for lower risk of postoperative events with general anesthesia. CONCLUSIONS: The choice of anesthesia, when delivered as described, does not significantly influence cardiac morbidity and overall mortality in patients undergoing peripheral vascular surgery. Comments: The kind of anesthesia may not influence outcome, but the risks of the surgery and anesthesia remain impressive even in good hands: incidences of cardiac event or death for general, spinal, and epidural groups were 16.7%, 21.3%, and 15.4%, respectively.
Boden WE, O'Rourke RA, Teo KK et al: Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 356:1503-16, 2007. BACKGROUND: In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events. METHODS: We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6). RESULTS: There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33). CONCLUSIONS: As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. Comments: The Nobel Prize award to Daniel Kahneman in 2002 is perhaps relevant and a good way to begin a review of this article. He was recognized for his work on “availability bias”…. roughly the idea that people judge the validity of a method by how easily it comes to mind. Or stated another way, if everybody is doing it, the common belief is that it must be based on good science. Conversely, if few are doing it, it must have little real value. Again, it is commonly thought that a procedure must be valid if it is widely used and reimbursed. However, it has been shown that the major indication for some procedures is the fact that they are reimbursed. Finally, there are obvious biases in the publication of therapies: editors approve the familiar and work that supports their own activities. Today, most doctors assume that the procedures commonly practiced in their hospitals are based on appropriate “evidence-based medicine”. The gold standard of the latter, of course, is the prospective randomized placebo-controlled study. Unfortunately, few vascular procedures practiced in American hospitals have ever been justified by such studies.
Boucher CA, Brewster DC, Darling RC et al: Determination of cardiac risk by dipyridamole-thallium imaging before peripheral vascular surgery. N Engl J Med 312: 389-394, 1985. Abstract: To evaluate the severity of coronary artery disease in patients with severe peripheral vascular disease requiring operation, we performed preoperative dipyridamole-thallium imaging in 54 stable patients with suspected coronary artery disease. Of the 54 patients, 48 had peripheral vascular surgery as scheduled without coronary angiography, of whom 8 (17 per cent) had postoperative cardiac ischemic events. The occurrence of these eight cardiac events could not have been predicted preoperatively by any clinical factors but did correlate with the presence of thallium redistribution. Eight of 16 patients with thallium redistribution had cardiac events, whereas there were no such events in 32 patients whose thallium scan either was normal or showed only persistent defects (P less than 0.0001). Six other patients also had thallium redistribution but underwent coronary angiography before vascular surgery. All had severe multivessel coronary artery disease, and four underwent coronary bypass surgery followed by uncomplicated peripheral vascular surgery. These data suggest that patients without thallium redistribution are at a low risk for postoperative ischemic events and may proceed to have vascular surgery. Patients with redistribution have a high incidence of postoperative ischemic events and should be considered for preoperative coronary angiography and myocardial revascularization in an effort to avoid postoperative myocardial ischemia and to improve survival. Dipyridamole-thallium imaging is superior to clinical assessment and is safer and less expensive than coronary angiography for the determination of cardiac risk.
Bradbury AW, Adam DJ et al (colaborators (140). Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 51(5 Suppl):5S-17S, 2010. Abstract: BACKGROUND: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). METHODS: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. RESULTS: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). CONCLUSIONS: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS. Comments: A lot of contributors to a study involving lots of hospitals for a relatively few patients and showing little difference between results. Such a study is hard to manage and to achieve uniform treatment protocols. Again, the study is not a controlled trial showing either bypass or angioplasty benefit patients... rather it shows modality produces similar results. The group has generated several other reports from this material.
Bursi1 F, Babuin L, Barbieri1 A et al: Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation. European Heart Journal 26: 2448-2456, 2005. Aims The objectives of this study are to evaluate the prognostic role of pre-operative stratification in patients undergoing elective major vascular surgery, the timing of adverse outcomes, and the predictive role of troponin (cTn). Methods and results Consecutive vascular surgery candidates (n=391) were prospectively stratified and treated according to the ACC/AHA guidelines. The patients were categorized into three groups: (1) with coronary revascularization in the past 5 years, (2) with intermediate clinical risk predictors, and (3) with minor or no clinical risk predictors. cTnI was measured post-operatively. By 18 months, 18.7% of subjects had experienced death or acute myocardial infarction (MI) (by the ACC/ESC criteria). The hazard ratio (HR) was 5.21 (95% CI=2.60-10.43; P<0.0001) in group 1 and 2.58 (95% CI=1.27-4.38; P=0.004) in group 2 when compared with group 3. Most events occurred within 30 days. Elevations of cTnI were associated with adverse outcomes even after multivariable adjustment at long-term (adjusted overall HR=4.73, 95% CI=2.92-7.65; P<0.0001) and at 30 days (adjusted HR=5.52, 95%CI=3.23-9.42; P<0.0001). Conclusion After pre-operative stratification, patients undergoing elective major vascular surgery remain at high risk of MI and death. Events occur mainly early after surgery. cTnI elevations are frequent and independently associated with increased risk. These findings suggest the need for a major re-evaluation of our approach to these patients.
Claesson K, Kölbel T, Acosta S.Role of endovascular intervention in patients with diabetic foot ulcer and concomitant peripheral arterial disease. Int Angiol 30:349-58, 2011. Abstract: AIM:The aim of this study was to evaluate wound healing, major amputation and mortality in patients with diabetic foot ulcer and peripheral arterial disease (PAD), and to compare the group decided to have an endovascular intervention with groups referred to conservative treatment or to those judged as unreconstructable. METHODS:A retrospective two-year review of all patients with diabetic foot ulcers and PAD presented at an interdisciplinary diabetic foot round 2006-2007 at Malmö University Hospital, Sweden, was performed. Independent predictive factors of insufficient ulcer healing, amputation and mortality during follow-up were analysed according to treatment decisions at the diabetic foot round. RESULTS:A total of 135 limbs in 115 consecutive diabetic patients with foot ulcers were included. Median age was 73 years and 41% were women. During a median follow-up time of 17 months, 44% of the ulcers did not heal, 15% of the limbs underwent major amputation and 42% died. Ulcer depth with a Wagner grade =3 (hazard ratio [HR] 5.8; 95% confidence interval [CI] 2.6-12.9), CRP (HR 1.007; 95% CI 1.002-1.012, and impaired run-off (HR 3.0; 95% CI 1.03-8.9) were independent risk factors for incomplete wound healing. The three treatment decision groups: attempt for endovascular leg revascularization (N.=75), conservative (N.=42) and unreconstructable (N.=18) showed no significant difference in terms of wound healing, major amputation or death. CONCLUSION: Patients with diabetic foot ulcers and concomitant PAD are at high risk for limb loss and premature death. Ulcer depth, CRP and impaired run-off are independent risk factors for incomplete wound healing. There is an apparent need for prospective controlled studies to better define the role of endovascular therapy in this subset of diabetic foot ulcer patients.
Collins TC, Souchek J, Beyth RJ: Benefits of antithrombotic therapy after infrainguinal bypass grafting: a meta-analysis. Am J Med 117: 93-9, 2004. PURPOSE: We performed a meta-analysis to ascertain the benefits of antithrombotic therapy for maintaining the patency of vascular grafts following lower extremity bypass operations. METHODS: We identified articles using MEDLINE and hand searches of relevant journals for randomized clinical trials that compared the use of antithrombotic therapy with control or placebo therapy. Random-effects (DerSimonian and Laird) analyses were used to determine the risk of graft occlusion following lower extremity bypass operations. We also assessed the odds of secondary outcomes, such as myocardial infarction, cerebrovascular accident, all-cause mortality, and bleeding. RESULTS: Sixteen articles met the inclusion criteria of a randomized trial of antithrombotic therapy for the patency of vascular grafts; six were excluded because the analyses involved repeat surgeries or lacked a control group. Of the 10 studies included in the final analysis, seven compared antiplatelet agents with placebo or control, and three compared anticoagulant agents with placebo or control. The 10 studies were homogeneous in spite of differing durations of follow-up. The odds of graft occlusion in the treated group was half that in the placebo or control group. The odds ratio was 0.46 (95% confidence interval [CI]: 0.32 to 0.66) for the 10 studies that reported outcomes at 12 months or longer, 0.50 (95% CI: 0.29 to 0.87) in the five studies with 12-month rates; and 0.58 (95% CI: 0.39 to 0.88) at 24 months. CONCLUSION: Antithrombotic therapy decreases the risk of graft occlusion after a vascular operation by about 50% at 12 months and is still protective at 24 months after the operation. Comments: A choice of the risk of anticoagulation therapy versus the risk of graft occlusion.
Conrad MF, Kang J, Cambria RP et al:, Brewster DC, Watkins MT, Kwolek CJ, LaMuraglia GM. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease. J Vasc Surg 50:799-805, 2009. OBJECTIVE: There is little documentation of the effectiveness of percutaneous balloon angioplasty (PTA) of infrapopliteal vessels for the treatment of chronic lower extremity ischemia. This study reviewed our recent experience with infrapopliteal PTA in a large series of patients to determine its effectiveness as a treatment modality. METHODS: All patients undergoing primary infrapopliteal PTA from March 2002 to June 2006 were included. Primary study end points were primary patency, assisted patency, limb salvage, and patient survival assessed by Kaplan-Meier life-table analysis. Factors predictive of PTA failure and patient longevity were evaluated by multivariate methods. RESULTS: There were 155 PTAs undertaken in 144 patients (70% men; mean age, 74 years), with critical limb ischemia (86%), diabetes (66%), and renal insufficiency (45%). Infrapopliteal lesions were classified as TransAtlantic Inter-Society Consensus A (7%), B (18%), C (39%), and D (35%). PTA was confined to the infrapopliteal segment in 40 (26%), and 115 (74%) underwent multilevel treatment. Five patients (3%) received stents. Technical success was 95%. The 30-day mortality was 2%, and major morbidity was 3%. The mean follow-up was 22 months (range, 0-54 months). The 40-month actuarial primary patency was 62% (standard error, 5%), with assisted patency (infrapopliteal re-PTA, 25 [16%]) of 90%. Interval conversion to bypass surgery occurred in seven (5%). Nonhealing ulcers occurred in 118 patients (76%), of which 76 (64%) healed during follow-up. Of the 42 unhealed ulcers, 15 (13%) required major amputations for a 40-month limb salvage of 86.2%. Multivariate predictors that were negative for primary patency included 0/1 vessel runoff (P = .01), critical limb ischemia (P = .002), and dialysis (P = .03). Negative predictors of limb salvage included dialysis (P = .007) and failure to improve runoff to the foot (P = .006). At 40-months, patient survival was 54%, with negative predictors including severe pulmonary disease (P = .01), coronary artery disease (P = .04), and renal insufficiency (P < .001). CONCLUSIONS: Infrapopliteal angioplasty can be performed safely with favorable results in patients with limited longevity. Primary patency is related to disease extent. Secondary interventions may be necessary to maintain clinical success. These data indicate that PTA should be considered as initial therapy for infrapopliteal occlusive disease in patients with lower extremity ischemia. Comments: The bulk of the 124 patients with critical leg ischemia, apparently had nonhealing ulcers (118 patients). Of the latter, 35.5% (42) did not heal during follow-up presumably in spite of needed follow-up procedures. Looks like these folks need the Circulator Boot.
Crescenzia G, Bovea T, Pappalardoa F et al: Clinical significance of a new Q wave after cardiac surgery. Eur J Cardiothorac Surg 25: 1001-1005, 2004. Objective: The appearance of new Q waves on the electrocardiogram (ECG) after cardiac surgery has been traditionally considered a sign of major myocardial tissue damage. The aim of this study was to investigate the clinical significance of new Q waves appearing following cardiac surgery and to correlate them with the release of myocardial cell damage biomarkers. Methods: 206 consecutive patients undergoing cardiac surgery were prospectively evaluated. A 12 lead ECG was recorded and cardiac troponin I and creatinekinase subfraction MB assayed the day before surgery, on arrival at the intensive care Unit. 4 and 18 h postoperatively and every morning until the fifth postoperative day. Results: The incidence of new Q waves was 7.3%. Patients with isolated ECG findings had an uneventful postoperative course; on the contrary, when ECG changes were coupled with the release of myocardial necrosis biomarkers, patients had a complicated postoperative course. Conclusions: The association of a new Q wave and high levels of myocardial necrosis biomarkers is strongly associated with postoperative cardiac events. On the contrary, the isolated appearance of a new Q wave has no impact on the postoperative cardiac outcome. Comments: Patients undergoing angioplasty for coronary heart disease or peripheral vascular disease are frightened as are their families. Perhaps, because they need reassurance that they will do well or because the physician believes the occurence of a small heart defect due to the procedure is a necessary complication of the procedure and worth the price for having possibly avoided much larger heart damage, the occurrence of the procedure-related damage is commonly not brought to the attention of the patient or their family and may not be mentioned in the discharge summary or the discharge list of diagnoses.
Davies MG, Saad We, Peden Ek et al: Percutaneous superficial femoral artery interventions for claudication--does runoff matter? Ann Vasc Surg 22:790-8, 2008. Endoluminal therapy for superficial femoral artery (SFA) occlusive disease for claudication is commonplace, but the implications of tibial vessel runoff on long-term outcomes of these interventions in patients with claudication are unclear. Runoff is known to negatively affect graft patency, but no data are available on the impact of runoff on percutaneous SFA interventions and their implications during follow-up. We examined the impact of distal popliteal and tibial runoff on long-term outcomes of SFA interventions for claudication. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classifications 1, 2, and 3 were selected; those with concomitant tibial interventions were excluded. Angiograms were reviewed preoperatively in all cases to assess distal popliteal and tibial runoff and scored according to modified Society for Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1, maximum 19). Three run-off score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. There were 481 limbs in 347 patients (70% male, average age 66 years) that underwent endovascular SFA treatment for claudication: 87% had hypertension, 51% had diabetes mellitus, 67% had hyperlipidemia, and 16% had chronic renal insufficiency (1% on hemodialysis). Technical success was 92%, with 63% SFA undergoing angioplasty, 26% SFA undergoing primary stenting, and 3% SFA undergoing atherectomy. Overall mortality was 1.1% and overall morbidity was 17% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly lower freedom from recurrent symptoms and lower freedom from restenosis. Primary and assisted primary patency rates were significantly worse in patients with poor runoff. However, secondary patency was equivalent between the groups. Compromised or poor runoff was associated with incremental lower limb salvage. Following SFA percutaneous interventions for claudication, runoff can identify patients more likely to develop restenosis and recurrent symptoms and, more importantly, those at higher risk of limb loss. Defining such subgroups allows a clear risk stratification of patients with claudication and can guide the intensity of surveillance in the outpatient setting. Comments: An observational prospective uncontrolled study of the effects of lower leg runoff on PTA of the femoral artery for claudication. Runoff was related to lower limb salvage rates in this study; however, we are not told how many limbs were lost. It is to be appreciated that the natural history of claudication reveals only 1% to 3% of claudicants require a major amputation over 5 years (Dormandy 1999). Here also worth noting is the 19% morbidity rate at 90 days. Finally, the benefits of boot therapy should be considered: the FDA approves the Circulator Boot to improve runoff both before and after invasive reconstruction procedures.
De Luca G, Ernst N, van't Hof AW, Ottervanger JP, Hoorntje JC, Gosselink AT, Dambrink JH, de Boer MJ, Suryapranata H: Predictors and clinical implications of early reinfarction after primary angioplasty for ST-segment elevation myocardial infarction. Am Heart J 151:1256-9, 2006. BACKGROUND: Recurrent infarction after fibrinolytic therapy has been shown to be associated with increased mortality. The aim of this study was to analyze predictors and outcome of reinfarction in a consecutive series of patients undergoing primary angioplasty. METHODS: Our population is represented by a total of 1955 patients with ST-segment elevation myocardial infarction treated by primary angioplasty between 1997 to 2002. All clinical, angiographic, and follow-up data were prospectively collected. Early reinfarction was defined when two clinical criteria were satisfied within 30 days after the procedure: (1) recurrent ischemic symptoms for >15 minutes after resolution of symptoms from initial MI; (2) new ST-T-wave changes or new Q waves; (3) reelevation in creatine kinase (CK) or CK-MB to higher levels than normal (or by another 20% if already higher than normal). RESULTS: Early reinfarction was observed in 75 (3.8%) patients. At multivariate analysis, advanced Killip class (P = .002), poor preprocedural TIMI flow (P = .014), administration of IIb-IIIa inhibitors (P = .02), and diabetes (P = .038) were independent predictors of 30-day reinfarction. A total of 107 (5.6%) patients had died. Early reinfarction was associated with a significantly higher mortality (22.7% vs 4.9%, P < .001), even after adjustment for confounding factors (blood pressure, diabetes, Killip class, preprocedural TIMI flow, coronary stenting, multivessel disease, anterior infarct location, preprocedural stenosis, and administration of IIb-IIIa inhibitors) (HR 3.32, 95% CI 1.88-5.84, P < .0001). CONCLUSIONS: This study showed that, among patients undergoing primary angioplasty for ST-segment elevation myocardial infarction, advanced Killip class at presentation, poor preprocedural TIMI flow, the use of IIb-IIIa inhibitors, and diabetes are independently associated with 30-day reinfarction. Early reinfarction is an independent predictor of 1-year mortality. Comments: A report of a natural early progression of disease, of a complication of therapy (impaction of plaque into small arteries by the angioplasty procedure or both?
de Virgilio C, Pak S et al: Cardiac assessment prior to vascular surgery: is dipyridamole-sestamibi necessary? Ann Vasc Surg 10:325-9, 1996. Dipyridamole-sestamibi (PMIBI) is recommended prior to vascular surgery in patients with > or = 1 Eagle criteria (Q waves, history of ventricular ectopy, diabetes, advanced age, and/or angina). To review our cardiac morbidity and mortality and the need for preoperative PMIBI, we reviewed 109 consecutive patients with a mean age of 59 years who underwent 145 elective major vascular procedures over a 1-year period. Seventy patients (with a mean of 0.8 Eagle criteria) underwent 92 vascular procedures without preoperative PMIBI and without coronary revascularization. Thirty-one patients (with a mean of 1.1 Eagle criteria) underwent 39 procedures without coronary revascularization following PMIBI, which showed reversible ischemia in seven and a fixed defect in 10; findings were normal in 14. Preoperative coronary bypass or angioplasty was limited to eight patients (14 procedures, mean of 1.6 Eagle criteria) who had unstable angina with (2 patients) or without (6 patients) acute myocardial infarction. There were four perioperative myocardial infarctions (2.8%), seven cardiac events overall (4.8%), and one cardiac death (0.7%). Three (43%) of the seven cardiac events occurred in patients with a normal scan or fixed defect on PMIBI imaging. In the absence of unstable angina, PMIBI had a sensitivity of only 25% and a specificity of 80% for cardiac events. We conclude that among patients without severe cardiac symptoms (1) PMIBI has a very limited ability to identify patients at risk for cardiac complications, and (2) preoperative PMIBI is neither necessary nor cost-effective.
Clark TW, Groffsky JL, Soulen MC: Predictors of long-term patency after femoropopliteal angioplasty: results from the STAR registry. J Vasc Interv Radiol 12(8):923-33, 2001. PURPOSE: To identify variables predictive of long-term patency after femoropopliteal angioplasty. MATERIALS AND METHODS: The primary patency of 219 limbs in 205 patients from a multicenter registry who underwent femoropopliteal angioplasty between January 1, 1992, and December 31, 1994, was prospectively monitored with a combination of angiography, noninvasive hemodynamic testing, and clinical outcome. Patient demographic, angiographic, and hemodynamic variables were examined alone and in combination to determine effect on long-term primary patency. Each limb was graded as Category 1-4 according to the American Heart Association (AHA) criteria for arterial lesions, and differences in outcome for each category were examined. Primary patency and intergroup analysis were determined with use of the Kaplan-Meier method and log-rank test, respectively. Cox proportional hazards models were used to calculate relative risks for predictive variables. RESULTS: Primary patency rates for all limbs (on an intent-to-treat basis) at 12, 24, and 36 months were 87% +/- 3%, 80% +/- 3%, and 69% +/- 5%, respectively. Primary patency at 48 and 60 months was 55% +/- 7%. Poor tibial runoff (single tibial vessel with 50%-99% stenosis or occlusion) was most predictive of occlusion (relative risk 8.5, P <.0001). The presence of diabetes or renal failure was associated with lower long-term patency (relative risk 5.5 and 4.0, P <.0001 and.0002, respectively). Long-term patency was higher with AHA Category 1 lesions (P =.006), and no significant difference in patency was observed between Category 2 and 3 lesions (P =.65). A multivariate Cox proportional hazards model showed only the stratified runoff score and the presence of diabetes to be significant determinants of long-term patency. CONCLUSION: Poor tibial runoff is most predictive of lower long-term patency rates. Diabetes is also independently associated with lower long-term patency rates. The criteria that distinguish Category 2 and 3 lesions do not predict differences in long-term patency, nor do they serve to identify lesions best treated with surgical bypass. This suggests that indications for femoral angioplasty can be extended to include longer and more complex Category 3 lesions.
DeFrang RD, Edwards JM, Moneta GL, Yeager RA, Taylor LM and Porter JM: Repeat leg bypass after multiple prior bypass failures. J Vasc Surg 19:268-77, 1994. From 1980 to 1992, 81 patients had 85 procedures having had 3 previous procedures in 72, 4 previous procedures in 6 and 5 previous procedures in 7 patients. Twenty percent had diabetes, 83% had a history of smoking and none had kidney failure or renal insufficiency. Fifteen percent of the patients screened after 1987 had a hypercoagulable state due to anticardiolipin antibodies and were largely later maintained on warfarin. Thirty percent of the repeat bypasses were revisions of grafts found to be failing by routine surveillance methods and 69% of the repeat grafts were replacements of thrombosed grafts. Three patients died within 30 days of surgery and 15 were dead at a men interval of 24 months. Ten limbs were amputated at a mean interval of 9.8 months. Mean follow-up after the most recent operation was 17 months. The primary patency rate at 4 years was 79.8% and the limb salvage rate at 4 years was 69.6%. The authors conclude that their results justify an aggressive policy of limb revascularization after multiple failed prior bypasses. Comments: Lots of surgery here... 360 bypass procedures (past and present) among 81 patients on one leg. In their introduction, the authors quote previous literature showing a 30-52% limb salvage rate in patients undergoing repeat operations. In our experience, the risk of amputation increases with the number of failed bypasses. These patients did well and were relatively young (average age 68). Most were smokers. How many stopped smoking?
Desgranges P, Kobeiter K, d'Audiffret A, Melliere D, Mathieu D, Becquemin JP. Acute occlusion of popliteal and/or tibial arteries: the value of percutaneous treatment. Eur J Vasc Endovasc Surg 20(2):138-45, 2000. OBJECTIVES: to describe early and mid-term results with a percutaneous therapeutic protocol including thromboaspiration, thrombolysis, and correction of the underlying lesion by PTA. METHODS: thirty-three consecutive selected patients with recent (<1 month) reversible acute ischaemia associated with popliteal and/or tibial occlusion were studied. The primary endpoints were technical success (defined as residual mural thrombus less than 20% of the lumen and the presence of at least one tibial artery on angiogram), patient survival and limb salvage at 1 and 12 months. Secondary endpoints included complications, primary, assisted primary and secondary patency determined by duplex scan at 1, 6 and 12 months. RESULTS: technical success was achieved in 27 patients (82%). Twenty patients were treated by thrombo- aspiration+/-thrombolysis only, and seven required additional PTA (26%). In six patients (18%), percutaneous techniques failed, and embolectomy was performed in two, bypass in one and major amputations in three (9%). For the entire series, the survival rate was 100% at 1 month and 94% at 1 year. The limb salvage rate was 91% at 1 month and 1 year. The cumulative primary patency, assisted primary patency and secondary patency rates were 81%, 81% and 86% respectively at 1 month and 66%, 72% and 77%, respectively, at 12 months. Early complications occurred in 10 patients (30%): five groin haematomas (15%), four compartment syndromes (12%) and one haemoglobinuria (3%). CONCLUSION: percutaneous techniques offer excellent early and mid-term results in selected patients presenting with acute ischaemia with popliteal and/or tibial arteries occlusion
Domenig CM, Aspalter M, Umathum M, Holzenbein TJ: Redo pedal bypass surgery after pedal graft failure: gain or gadget? Ann Vasc Surg 21:713-8, 2007. Pedal bypass failure is not always associated with limb loss. Management of critical limb ischemia after failure is controversial. The aim of this study is to evaluate the results of redo bypass procedures to foot arteries in the absence of alternative tibial outflow arteries. Data of patients undergoing redo pedal bypass within a 14-year period were reviewed. The outcome after redo pedal bypass in patients whose original pedal bypass failed within 30 days versus those in patients whose original pedal bypass failed more than 30 days after the original pedal bypass were reviewed. Society for Vascular Surgery reporting standards were applied. Out of 335 pedal bypass grafts, 22 (6.6%) pedal redo bypass procedures were identified in 20 patients performed after previous pedal graft failure: 64% were male, mean age 67.7 +/- 9.5 years, diabetes 90.9%, hypertension 90.9%, coronary disease 68.2%, renal disease 18.2%. Seven patients were operated for early failure and 15 for late failure (median 193 days). The graft conduit at the first operation was ipsilateral greater saphenous vein (GSV) in 18 (81.8%), alternative vein in three (13.6%), and one expanded polytetrafluoroethylene. Redo graft conduits were as follows: ipsilateral GSV in nine (40.9%), arm vein in six (27.3%), contralateral GSV in two (9.1%), "other veins" in two (9.1%), and homologous artery in three (13.6%). The same target artery was used in 81.8%, at the initial site in 54.5% and more distally in 27.3%. Redo revascularization for early failure was successful only once. Median follow-up after late redo was 23.7 months. Seven redo grafts performed after late pedal graft failure failed after a median of 115 days. The availability of adequate autologous conduit is the limiting factor for redo procedures. Lack of alternative outflow sites adds to the difficulty of target artery dissection. Redo pedal bypass surgery after early pedal bypass failure is associated with very poor patency and limb salvage. Acceptable patency and extension of limb salvage can be achieved with redo procedures for late pedal bypass failure. Comments: All these patients are candidates for boot therapy in place of the redo procedures.
Dorros G, Jaff MR, Dorros AM, Mathiak LM, He T: Tibioperoneal (outflow lesion) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia: five-year follow-up. Circulation 104(17):2057-62, 2001. BACKGROUND: In a prospective, nonrandomized, consecutive series of tibioperoneal vessel angioplasty (TPVA), critical limb ischemia (CLI) patients' data were analyzed with regard to immediate and follow-up success. METHODS AND RESULTS: TPVA was successful in 270 of 284 critically ischemic limbs (95%), with 167 limbs (59%) requiring dilatation of 333 ipsilateral inflow obstructions to access and successfully dilate 486 of 529 (92%) tibioperoneal lesions. A clinical success (relief of rest pain or improvement of lower-extremity blood flow) was attained in 270 limbs at risk (95%). Clinical 5-year follow-up of 215 of 221 successful CLI patients (97%) with 266 successfully revascularized limbs revealed that bypass surgery occurred in 8% and significant amputations in 9% of limbs; 91% of the limbs were salvaged. The cohort's probability of survival was 56%: 58% for Fontaine class III and 33% for class IV patients. Class III compared with class IV patients had significantly (P<0.05) fewer surgical bypasses (3% versus 16%) and amputations: above-knee, 1% versus 4%; below-knee, 3% versus 12%; and transmetatarsal, <1% versus 21%. CONCLUSIONS: TPVA, often in combination with inflow lesions, is an effective primary treatment for critical limb ischemia. The poor cumulative survival reflects the existence of severe comorbidities, which could potentially be affected by aggressive and effective cardiovascular diagnostic and therapeutic strategies. Comments: Patients failing angioplasty are commonly referred for boot therapy and present in sufficient numbers to give us the impression that angioplasty and stenting below the knee is to be avoided. We are including this and other articles to show some are reporting favorable experience.
Eagleton MJ, Erez O, Srivastava SD et al: Outcome of Surgical and Endoluminal Intervention for Infrainguinal Bypass Anastomotic Strictures. Vasc and Endovasc Surgery 40:11-22, 2006. The objective of this study was to compare the outcomes of percutaneous transluminal angioplasty (PTA) versus open surgical repair of anastomotic strictures affecting infrainguinal bypasses. Anastomotic strictures affecting 39 bypasses in 36 patients were identified among 593 consecutive infrainguinal arterial reconstructions performed between 1994 and 2004. The mean age of affected patients was 65 ±2 years (range: 61 to 101 years). The original bypasses, with vein grafts outnumbering prosthetic grafts 2 to 1, were performed for acute (5%) and chronic (54%) limb-threatening ischemia, disabling claudication (28%), or popliteal aneurysms (13%). Anastomotic strictures were first recognized an average of 16 ±3 months (range 2 to 92 months) postoperatively. Strictures affected the distal anastomosis in 62% of cases and the proximal anastomosis in 38%. Primary patency, assisted primary patency, secondary patency, and limb salvage were assessed following PTA or open surgical repair of the strictures. Anastomotic strictures were detected following acute (41%) and chronic (18%) limbthreatening ischemia, claudication (13%), or during routine graft surveillance (28%) in asymptomatic patients. Graft thrombosis, occurring in 51% of patients at the time of presentation, was not affected by the site of anastomotic stricture, although prosthetic grafts were affected more than vein grafts (92% vs 31%). Interventions included PTA (67%) and conventional open procedures (33%). The latter included vein patch angioplasty, short interposition grafts, and redo bypasses. The stricture site and bypass material used in the original revascularization did not affect reintervention patency rates. Sixteen (62%) of the endovascular procedures were performed on a graft presenting with thrombosis, while only 4 (31%) were initially treated with operative therapy. Treatment of thrombosed grafts resulted in an 18-month patency of 32% compared to an 80% patency in treating grafts that were not occluded at the time of presentation (p <0.05). No anastomotic stricture repaired operatively required reintervention, whereas 42% of those treated by PTA required a mean of 1.3 additional reinterventions (p <0.03). Anastomotic strictures affecting infrainguinal bypass grafts contribute to low patency rates. Outcomes can be significantly improved if these strictures are identified before graft thrombosis. Open surgical repair, compared to PTA, provides improved graft function as evident by fewer subsequent interventions required to maintain graft patency. Patients coming to the attention of the surgeons during follow-up do better with redo surgery.
Eickhoff HJ, Hanson B, Lorentzen JE: The effect of arterial reconstruction on lower limb amputation rate. Acta Chir Scand 502:181-187, 1980. During the period 1 April-31 December 1976, the incidence rates of admission, of amputation and of arterial reconstruction for arteriosclerosis of the lower limbs were calculated from information in the Danish National Patient Register. Admissions increased with age (from 4.3 per 100,000 persons under 40 years of age per year to 1603 per 100.000 persons over 80 years per year). Similarly, lower limb amputations varied with age (from 0.3 to 226 per 100.000 persons per year). Arterial reconstructions, however, did not vary with age, but remained rather constant at about 50 per 100.000 persons per year, in persons over 50 years. The incidence rates of admissions, amputations and arterial reconstructions in men were 1.5 x the incidence rates in women. Both amputation and arterial reconstruction showed a significant regional variation from county to county. However, the rates were not correlated, and the expected amputation-preventing-effect of arterial reconstructions could not be demonstrated. The most probable cause for this was the inadequate capacity for vascular surgery in Denmark. An estimation shows that of the 1100 operated on for severe lower limb ischemia during the period studied, only 290 were offered arterial reconstruction.
Eskelinen E, Lepantalo M: Role of infrainguinal angioplasty in the treatment of critical limb ischaemia. Scand J Surg 96: 11-6, 2007. OBJECTIVE: To review the published papers reporting on the use of infrainguinal angioplasty in the treatment of critical limb ischaemia (CLI). METHODS: A MEDLINE (1966-2005) and Cochrane library search for articles relating to the use of infrainguinal angioplasty in the treatment of CLI. RESULTS: Recent papers reporting on the results of infrainguinal angioplasty as treatment for CLI patients show excellent limb salvage rates regardless of the patency rates. The Cochrane Database of systematic reviews has accepted two prospective randomised trials comparing bypass operations and angioplasty among CLI patients. Pooling both trials showed no overall significant difference in amputation rates between the surgery and PTA groups. A multicentre, randomised controlled trial, the BASIL (Bypass versus Angioplasty in Severe Ischaemia of the Leg) trial showed that in the medium term (after six months), the outcomes after angioplasty or surgery among CLI patients did not differ significantly with respect to amputation-free survival, all-cause mortality and quality of life. CONCLUSIONS: Infrainguinal PTA is feasible in CLI patients. Data from the BASIL trial show the similar ability of bypass surgery and balloon angioplasty in preserving both life and limb in short term. These results are, however, not applicable for the majority of CLI patients as only 15% (70/456) of the patients with severe limb ischaemia were considered candidates for the trial. Comments: Italics added by CBC editor not authors of article.
Faglia E, Dalla Paola L, Clerici G et al: Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc 29:620-7, 2005. OBJECTIVE: To evaluate the effectiveness of peripheral angioplasty (PTA) as the first-choice revascularisation procedure in diabetic patients with critical limb ischemia (CLI). DESIGN: Prospective study. METHODS: PTA was employed as first choice revascularisation in a consecutive series of diabetic patients hospitalized for CLI between January 1999 and December 2003. RESULTS: PTA was successful performed in 993 patients. Seventeen (1.7%) major amputations were carried out. One death and 33 non-fatal complications were observed. Mean follow-up was 26+/-15 months. Clinical restenosis was observed in 87 patients. The 5 years primary patency was 88%, 95% CI 86-91%. During follow-up 119 (12.0%) patients died at a rate of 6.7% per year. CONCLUSIONS: PTA as the first choice revascularisation procedure is feasible, safe and effective for limb salvage in a high percentage of diabetic patients. Clinical restenosis was an infrequent event and PTA could successfully be repeated in most cases.Comments: For Dr. Faglia's view of hyperbaric oxygen see www.circulatorboot.com/literature/cellulit.html. This current report is large (993 patients) and limited to diabetics (rare for PTA studies), but uncontrolled. The degree of ischemia in their patients is uncertain. The study population had at least one missing or reduced pedal pulse, a TcPO2 under 50 mmHg on the dorsum of the foot and a duplex scan showing one or more stenoses >50% of vessel diameter. As found in our library on vascular tests, many people may heal with TcPO2's in the 20-50 range and over 40 is considered normal. The presence of one pedal pulse may adequately supply distal blood flow (as might a successful bypass). Success was defined essentially by the absence of above-the-ankle amputations. More from the same group below.
Faglia E, Clerici G et al: Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort study of 564 patients. Eur J Vasc Endovasc Surg 32(5):484-90, 2006.OBJECTIVE: To evaluate the early and late major amputation and survival rates and related risk factors in diabetic patients with critical limb ischemia (CLI). DESIGN: Retrospective study. METHODS: Revascularization feasibility, major amputation, survival rate and related risk factors were recorded in 564 diabetic patients consecutively hospitalized for CLI from 1999 to 2003 and followed until June 2005. RESULTS: Peripheral angioplasty (PTA) was carried out in 420 (74.5%), bypass graft (BPG) in 117 (20.7%) patients. In 27 (4.8%) patients both PTA and BPG were not possible. Twenty-three above-the-ankle amputations (4.1%) were performed at 30 days: 6 in PTA patients, 3 in BPG patients, 14 in non revascularized patients. In the follow-up of 558 patients (98.9%), 62 repeated PTAs and 9 new BPGs, 32 new major amputations (16 in PTA patients, 14 in BPG patients and 2 in non-revascularized patients) were performed. Major amputation was associated with absence of revascularization (OR 35.9, p < 0.001, CI 12.9-99.7), occlusion of each of the three crural arteries (OR 8.20, p = 0.022, CI 1.35-49.6), wound infection (OR 2.1, p = 0.004 CI 1.3-3.6), dialysis (OR 4.7, p = 0.001 CI 1.9-11.7) increase in TcPO2 after revascularization (OR 0.80, p < 0.001 CI 0.74-0.87). One hundred seventy three patients died during follow-up and this was associated with age (HR 1.05, p < 0.001 CI 1.03-1.07), history of cardiac disease (HR 2.16, p < 0.001 CI 1.53-3.06), dialysis (HR 3.52, p < 0.001 CI 2.08-5.97), absence of revascularization (HR 1.68, p < 0.001, CI 1.29-2.19) and impaired ejection fraction (HR 1.08, p < 0.001, CI 1.05-1.09). CONCLUSIONS: In diabetic patients with CLI the revascularization is feasible in most cases and allows a low rate of early major amputation. This rate is higher in the follow-up period. Major amputation is very high in patients where revascularization is not feasible while the high mortality rate is due to the serious comorbidities Comments: One must first ask what these authors mean by CLI. They write: “Peripheral arterial disease was suspected if one foot pulse was reduced or absent, ankle-pressure was <70 mmHg when assessable, transcutaneous oxygen tension (TcPO2) at the dorsum of the foot was <50 mmHg, and significant obstructions were present at duplex scanning.” It may be noted that normal TcPO2 levels are over 40 mmHg. Again, of their 567 CLI patients, ankle blood pressures were not included because of arterial calcifications in 192 and absent vessels in 105 (In such patients, the presence of ischemia can be further investigated/documented with the Pole test and/or toe blood pressures). For definitions of CLI see http://www.circulatorboot.com/Newsletter/vol2numb9.html. In summary, of their 564 pts, 420 (74.5%) have PTA requiring 6 above ankle amps by 30 days (1.4%), 62 later PTA’s (14.8%) and 16 later amputations (3.8%). 117 (20.7%) had bypass graphs requiring 3 above ankls amps by 30 days (2.6%), 9 later bypasses (7.7%) and 14 later amps (12%). Of the 27 receiving no vascular procedure, 14 (52%) had above ankle amps by 30 days and 2 more (7.4%) had amps during follow-up. Overall 55 (9.8%) had amputations and 173 (30.7%) died.
Fine MJ, Kapoor W, Falanga V: Cholesterol crystal embolization: a review of 221 cases in the English literature. Angiology 38:769-84, 1987. Cholesterol crystal embolization (CCE) frequently presents with nonspecific manifestations that mimic other systemic diseases. The authors reviewed 221 cases of histologically proven CCE in the English literature to define the clinical, laboratory, and pathologic characteristics of this disorder. CCE affected predominantly elderly males (mean age sixty-six) with a frequent history of hypertension (61%), atherosclerotic cardiovascular disease (44%), renal failure (34%), and aortic aneurysms (25%) at presentation. At least one possible predisposing factor was present in 31% and included operative and radiological vascular procedures and the use of anticoagulants. Cutaneous findings (34%) and renal failure (50%) were two of the most common clinical findings throughout the course of CCE. The nonspecific signs and symptoms included: fever (7%), weight loss (7%), myalgias (4%), and headache (3%). Premortem diagnoses were established in 31% of patients most commonly by biopsy of the muscle, skin, and kidney. Mortality was high (81%) and was most commonly due to multifactorial, cardiac, and renal etiologies. The authors conclude that CCE should be strongly considered in elderly patients with atherosclerotic vascular disease who have the onset of renal insufficiency and cutaneous manifestations. CCE may be confirmed by a skin or muscle biopsy.
Fukumoto Y, Tsutsui H, Tsuchihashi M, Masumoto A, Takeshita A: The incidence and risk factors of cholesterol embolization syndrome, a complication of cardiac catheterization: a prospective study. J Am Coll Cardiol 42:217-8, 2003. BACKGROUND: Cholesterol embolization syndrome is a systemic disease caused by distal showering of cholesterol crystals after angiography, major vessel surgery, or thrombolysis. METHODS: We prospectively evaluated a total of 1,786 consecutive patients 40 years of age and older, who underwent left-heart catheterization at 11 participating hospitals. The diagnosis of CES was made when patients had peripheral cutaneous involvement (livedo reticularis, blue toe syndrome, and digital gangrene) or renal dysfunction. RESULTS: Twenty-five patients (1.4%) were diagnosed as having CES. Twelve patients (48%) had cutaneous signs, and 16 patients (64%) had renal insufficiency. Eosinophil counts were significantly higher in CES patients than in non-CES patients before and after cardiac catheterization. The in-hospital mortality rate was 16.0% (4 patients), which was significantly higher than that without CES (0.5%, p < 0.01). All four patients with CES who died after cardiac catheterization had progressive renal dysfunction. The incidence of CES increased in patients with atherosclerotic disease, hypertension, a history of smoking, and the elevation of baseline plasma C-reactive protein (CRP) by univariate analysis. The femoral approach did not increase the incidence, suggesting a possibility that the ascending aorta may be a potential embolic source. As an independent predictor of CES, multivariate regression analysis identified only the elevation of pre-procedural CRP levels (odds ratio 4.6, P = 0.01). CONCLUSIONS: Cholesterol embolization syndrome is a relatively rare but serious complication after cardiac catheterization. Elevated plasma levels of pre-procedural CRP are associated with subsequent CES in patients who undergo vascular procedures. Comments: A 1.4% incidence of clinically apparent disease.
George SM Jr, Klamer TW, Lambert GE Jr: Value of continued efforts at limb salvage despite multiple graft failures. Ann Vasc Surg 8(4):332-6, 1994. Treatment of patients with limb-threatening ischemia after multiple failed bypasses remains difficult and controversial. Further revascularization procedures despite failure of the original procedure may be viewed as futile. The purpose of this report is to determine the efficacy of third or fourth revascularization procedures after the original and second procedures fail. Over a 10-year period from January 1, 1983, to December 31, 1992, 312 infrainguinal bypasses were performed on 271 consecutive patients for foot salvage. The overall limb salvage rate was 84%, and the operative mortality rate was 3.7% (10 patients). Sixteen patients (5.8%) had repeat infrainguinal bypasses performed after failure of two or more prior bypass procedures in the same leg. Twenty-three reconstructions were performed in these 16 patients. There were no operative deaths. One half of these patients had major amputations performed within the first year following their tertiary or fourth reconstructive procedure. Sixty-two percent of patients have survived longer than 3 years after their third or fourth procedure. One half of these patients have maintained graft patency and an excellent quality of life. Only 22% of the patients requiring amputation ambulated with a prosthesis, whereas all revascularized patients ambulated. Although this subset of patients is known to have an increased risk of repeated graft failure and limb loss, we believe continued efforts at limb salvage despite multiple previous graft failures is justified.
Glass H, Rowe VL, Hood DB, Yellin AE, Weaver FA: Influence of transmetatarsal amputation in patients requiring lower extremity distal revascularization. Am Surg.70(10):845-9, 2004. When a transmetatarsal amputation (TMA) is required, successful long-term limb salvage is questioned. We evaluated the influence of TMA on limb salvage in patients undergoing lower extremity revascularization. Patients who had distal bypasses extending to the infrapopliteal arterial tree and adjunctive TMA were retrospectively reviewed. Limb salvage was determined with life-table analysis. Twenty-four patients (29 limbs) were evaluated: 15 male and 9 female. Average age was 64.2 years old. Gangrene was the indication for bypass and TMA in 25 (86.2%) patients. Seven limbs were lost to follow-up. Nine of the remaining 22 limbs required below-knee (8) or above-knee (1) amputations, seven limbs within the first 3 months. In the group of patients who had major amputations within the first 3 months, graft thrombosis was the cause of leg amputation in six (85.7%) cases. No significant predictors of early major amputation were identified. Limb salvage was 62 per cent at 1 year in the TMA group. In comparison, among historical controls requiring distal revascularization and no adjunctive toe or foot amputations, limb salvage was 76.5 per cent (P = NS). Long-term limb salvage is dependent on successful lower extremity revascularization. Requirement for TMA should not influence the decision for limb salvage.
Goldman RJ, Brewley BI, Golden MA: Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care 15(3):112-20, 2002. OBJECTIVE: To retrospectively evaluate the ability of high voltage pulsed current (HVPC) to increase microcirculation in critically ischemic wounds (transcutaneous oxygen [TcPO(2)] less than 10 mm Hg) and, as a result, to improve wound healing. DESIGN AND METHODS: Clinical case series with successive adult diabetic subjects (3 men and 3 women) with nonsurgical ischemic malleolar or inframalleolar skin lesions, each subject serving as his or her own control. Wound area and TcPO(2) were measured periodically. Presence of distal arteriosclerosis was assessed on 5 patients by 2-dimensional, time-of-flight magnetic resonance angiography. End point was either complete wound closure or leg amputation. RESULTS: Maximum mean TcPO(2) was 2 +/- 2 mm Hg at the wound edge before the start of electrotherapy. After electrotherapy began, maximum TcPO(2) was 33 +/- 18 mm Hg (N=6; P<.05, Wilcoxon signed rank test). After treatment with HVPC, 4 patients' wounds healed and 2 patients underwent amputation. As expected, healed patients initially deteriorated after the start of treatment, but their wounds began healing when the perilesion TcPO(2) measurement exceeded 20 mm Hg. Thereafter, the wounds closed at a predictable rate. Complete closure occurred for patients who had a relatively low atherosclerotic burden. CONCLUSION: The results of this clinical case series suggest that electrotherapy can improve periwound microcirculation of ischemic inframalleolar skin lesions. Comments: TcPO(2) reflects indirectly the adequacy of the microcirculation. Very low values are seen also with cellulitis due to aerobic infections. Improved healing might be expected if electrotherapy helped sterilize the ulcers. It is hard to imagine how the application of electrodes around a distal ulcer might affect the blood flow through a critical stenosis in the mid-calf or thigh. In keeping with these thoughts is the observation of the authors that healing occurred in patients with a low atherosclerotic burden.
Golledge J, Ferguson K, Ellis M, Sabharwal T, Davies AH, Greenhalgh, Powell JT: Outcome of femoropopliteal angioplasty. Annals of Surgery 229(1): 146-53, 1999. Author's abstract: Objective: To assess prospectively the outcome of femoropopliteal angioplasty and investigate prognostic indicators of success. Background: Percutaneous transluminal angioplasty is commonly used to treat symptomatic femoropopliteal stenoses or occlusions, but the durability of the procedure is uncertain. Methods: Seventy-four consecutive patients treated by femoropopliteal angioplasty for intermittent claudication (43), rest pain (4), and tissue loss (27) were followed by assessment of symptoms, ankle-brachial pressure index (ABPI) to measure hemodynamic outcome, and duplex monitoring of velocity gradient at the angioplasty site to identify restenosis at 1 day and 3,6,9, and 12 months. Univariate comparisons, life table analysis, and backward stepwise regression were used to investigate factors predicting the symptomatic and hemodynamic outcome and restenosis. Results: Technical success was obtained in 67 patients (91%); failure occurred in 7 patients. At 1 year, a successful symptomatic outcome was achieved in 35 patients (51%), hemodynamic success was achieved in 41 patients (58%), and restenosis developed in 39%. ABPI at 24 hours after angioplasty was the most significant variable predicting a symptomatic outcome, hemodynamic outcome, and restenosis at 12 months. Life table analysis demonstrated that in 24% of patients with a 24-hour ABPI > or = 0.9, restenosis developed by 12 months, compared with 64% of patients with a 24-hour ABPI <0.9. Conclusion: Only half of the patients treated by femoropopliteal angioplasty had symptomatic improvement at 1 year, raising concern about the cost-benefit ratio of this procedure. Restoration of ABPI to >0.9 predicted a favorable outcome. Comments: For more on angioplasty success rates, see our section of claudication.
Gordon IL, Conroy RM, Arefi M, Tobis JM, Stemmer EA, Wilson SE: Three-year outcome of endovascular treatment of superficial femoral artery occlusion. Arch Surg 136(2):221-8, 2001. HYPOTHESIS: Patency after primary percutaneous transluminal angioplasty (PTA) and stenting of superficial femoral artery (SFA) occlusions is better than historical experience with PTA alone. DESIGN: Consecutive case series of primary PTA with stenting, and follow-up with duplex imaging every 6 months (mean +/- SD follow-up, 32 +/- 15 months). SETTING: Veterans Affairs medical center. PATIENTS AND METHODS: Patients were 57 previously untreated men with 71 limbs having chronic atherosclerotic SFA occlusion with suprageniculate reconstitution and patent tibial runoff. Critical ischemia (Society for Vascular Surgery [SVS] category, 4-6) was present in 7 (10%), the remainder had intermittent claudication only (SVS, 1-3). INTERVENTIONS: Guidewire recanalization followed by PTA, Wallstent deployment, and adjunctive thrombolysis as necessary; 19 limbs (27%) required thrombolysis to manage periprocedural thrombosis. MAIN OUTCOME MEASURES: Cumulative patency, limb salvage, and complications. RESULTS: Length (mean +/- SD) of occlusion was 14.4 +/- 9.9 cm. Length of stented artery was 24.3 +/- 11.1 cm. Ankle brachial index increased from 0.59 +/- 0.14 to 0.86 +/- 0.16 (P<.001) after stenting. One- and 3-year patencies were as follows: primary, 54.6% +/- 6.3% and 29.9% +/- 6.6%; assisted primary, 72.3% +/- 5.6% and 59.0% +/- 6.8%; and secondary, 81.6% +/- 4.8% and 68.3% +/- 6.5%. Three-year secondary patency when periprocedural thrombolysis was required was 35.7% +/- 12.5% compared with 70.6% +/- 7.4% for limbs not requiring periprocedural thrombolysis (P=.02); the differences in occlusion length and severity of ischemia were not significant between these 2 groups. Limbs undergoing adjunctive PTA during angiography 6 to 12 months after initial stenting had 63.0% +/- 13.3% patency at 3 years compared with 100% patency in limbs not requiring PTA at 6 to 12 months angiography (P=.046). Periprocedural mortality and morbidity were 2.8% and 15.5%, respectively. Three of the 7 limbs with critical ischemia underwent amputation during follow-up compared with 2 (3%) of 64 limbs with functional ischemia (chi(2) test, P<.006). A mean of 1.8 endovascular interventions per limb were performed. CONCLUSIONS: Percutaneous transluminal angioplasty and stenting yielded higher patency rates than historical controls undergoing PTA alone. When periprocedural thrombolysis is required, subsequent patency appears to be significantly worse. Poor results after PTA and stenting of limbs with critical ischemia and the need for additional endovascular therapy limit the technique's utility.
Goshima KR, Mills JL, Hughes JD: A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 39(2):330-5, 2004. BACKGROUND: Graft patency, limb salvage, and mortality are the traditional means of assessing the outcome of infrainguinal bypass surgery (IBS). However, these measures underestimate patient morbidity and fail to consider the entire spectrum of treatment required to restore the patients to their premorbid state. The aim of this study was to quantify the efforts required to achieve limb salvage by assessing three nontraditional outcomes: (1). index limb reoperation rate in 3 months, (2). hospital readmission rate in the first 6 months after IBS, and (3). wound-healing time. METHODS: We retrospectively analyzed 318 IBSs performed at a single institution. Repeat operations for limb or graft-related problems and readmissions within 6 months of the initial operation were recorded. When available, wound-healing time was determined. Pertinent demographics and comorbidities were subjected to univariate and multivariate analysis to determine risk factors for adverse outcomes. RESULTS: Seventy-two percent of patients underwent IBS for critical limb ischemia (CLI), and 84% had below-knee popliteal or distal bypasses. Among those who underwent IBS for CLI, 48.9% of patients required at least one reoperation within 3 months. Within 6 months, 49.3% of patients required hospital readmission. Time to heal exceeded 3 months in 54% of patients. After multivariate analysis, tissue loss and minority status were significant risk factors for reoperation within 3 months. Tissue loss and renal failure increased the odds for readmission within 6 months. Diabetes was the sole risk factor for prolonged wound healing. CONCLUSIONS: IBS for limb salvage is often complicated by prolonged recovery and multiple reoperations and readmissions. Traditional reporting standards for limb salvage operations need modification to reflect the true outcome of such procedures.
Grüntzig A, Schneider HJ: [The percutaneous dilatation of chronic coronary stenoses--experiments and morphology] [Article in German] Schweiz Med Wochenschr 107:1588, 1977. Since 1971, percutaneous transluminal angioplasty of peripheral arteries has been performed in 225 patients. There was an overall patency rate of 70-80% after 2 years. Our technique was then adapted and modified to perform coronary dilatation. This was performed successfully in 8 dogs in which selective coronary artery stenosis war induced by silk ligature and secondary inflammatory changes. The technique was then applied to the coronary lesions in postmortal humans and tested in the operating room during A-C bypass to evaluate vessel patency, peripheral debris etc.
Haider SN, Kavanagh EG et al: Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg 43:504-12, 2006. OBJECTIVE: Infrainguinal angioplasty provides a minimally invasive alternative to bypass surgery in patients with critical ischemia. This study aimed to determine the 2-year patency, limb salvage, and survival rates in patients who underwent infrainguinal angioplasty in a unit where angioplasty is used preferentially whenever possible for critical ischemia. METHODS: A total of 333 consecutive patients who presented with rest pain, tissue loss, or both and who underwent an infrainguinal intervention in the 4-year period between January 1998 and January 2002 were divided into femoropopliteal and femorodistal groups. The TransAtlantic Inter-Society Consensus angiogram scoring system was used to classify the lesions. Angioplasty was the preferred procedure in all patients for whom a stump or portion of a superficial femoral artery was patent. Exclusion criteria included the concomitant or sequential treatment of iliac lesions. Patients were followed up after surgery with ankle-brachial indices and duplex ultrasonography. RESULTS: A total of 180 patients underwent 198 angioplasties. Primary cumulative patency, limb salvage, and survival for femoropopliteal angioplasty (n = 166) at 2 years were 75%, 90%, and 88%, respectively, and 60%, 76%, and 82% for infrapopliteal angioplasty (n = 32). At 30 days, mortality was 2.7%, and the complication rate was 8.3%. There was a restenosis rate (>50%) of 68% and 65% at 2 years for the femoropopliteal and infrapopliteal angioplasty groups, respectively. Seven patients required repeat angioplasty of the same site, 30 underwent subsequent bypass, and 16 of 43 occluded limbs were amputated. A total of 153 comparative control patients underwent 162 bypass procedures during the same period. Primary cumulative patency, limb salvage, and survival for femoropopliteal bypass (n = 80) at 2 years were 69%, 87%, and 76%, respectively, and were 53%, 57%, and 64% for infrapopliteal bypass (n = 82). The 30-day mortality for bypass was 5.2%, the complication rate was 35%, and 31 limbs were amputated. CONCLUSIONS: The results of this study on the intermediate-term outcome of angioplasty suggest that angioplasty, when used preferentially for critical ischemia, in anatomically suitable patients provides very acceptable limb salvage and survival despite a relatively high restenosis rate.
Hanna GP, Fujise K, Kjellgren O, Felf S, Fife C, Schroth G, Clanton T, Anderson V, Smalling RW: Infrapopliteal transcatheter interventions for limb salvage in diabetic patients: Importance of aggressive interventional approach and role of transcutaneous oximetry. J Am Coll Cardiol 30: 664-9, 1997. Abstract: Methods: Percutaneous interventions were performed were performed in 29 consecutive diabetic patients in need of limb salvage. Technical success was defined as <20% residual vessel stenosis. Clinical success was defined as avoidance of amputation and achievement of wound healing. At hospital discharge, patients were treated with Coumadin and aspirin. Ankle-brachial index (ABI) and TcO2 measurements were obtained before and after the intervention. Results: After 12-month follow-up, six patients had persistent wounds, whereas 23 experienced wound healing. Forty of the 50 infrapopliteal arteries successfully dilated were occluded, with a mean lesion length of 18.0 ± 3.5 cm. After the procedure, TcO2 improved from 27.82 ± 9.97 mm Hg (95% confidence interval [CI] 23.95 to 31.69) to 54.5 ± 14.73 mm Hg (95% CI 48.79 to 60.21, p>< 0.0001), whereas the ABI did not (p>0.2). Tc O2 predicted procedural and clinical success (p < 0.0182). Conclusions: Infrapopliteal transcatheter interventions in diabetic patients may salvage the majority of limbs doomed to amputation. Although TcO2 measurements are valuable in predicting wound healing and success after interventions, ABI measurements are not. Comments: This paper described much greater success than we have experienced with angioplasties below the knee, which have usually failed within a few weeks time. One is not sure why these legs were considered "doomed". The average baseline TcPO2 was not so low that healing was out of the question (see Vascular testing section of our library). Again, 65% of their patients apparently had hyperbaric therapy after the procedure. Finally, we are not told how much effort had been expended in trying to heal these patients before they were offered angioplasty.
Harmon JW and Hoar CS Jr: Cloth femoral popliteal bypass grafts in 29 diabetics. Arch Surg 106:282, 1973. Major amputation common if graft closes.
Hertzer NR, Beven EG, Young JR et al: Coronary artery disease in peripheral vascular patients. A classification of 1000 coronary angiograms and results of surgical management. Ann Surg 199: 223-233, 1984. Abstract: In an attempt to reduce early and late mortality caused by myocardial infarction, coronary angiography was performed in 1000 patients (mean age, 64 years) under consideration for elective peripheral vascular reconstruction since 1978. Those found to have severe, surgically correctable coronary artery disease (CAD) were advised to undergo myocardial revascularization (CABG), usually preceding other vascular procedures. The primary vascular diagnosis was abdominal aortic aneurysm (AAA) in 263 patients (mean age, 67 years), cerebrovascular disease (CVD) in 295 (mean age, 64 years), and lower extremity ischemia (ASO) in 381 (mean age, 61 years). Severe correctable CAD was identified in 25% of the entire series (AAA, 31%; CVD, 26%; and ASO, 21%). Surgical CAD was documented in 34% of patients suspected to have CAD by clinical criteria (AAA, 44%; CVD, 33%; and ASO, 30%) and in 14% of those without previous indications of CAD (AAA, 18%; CVD, 17%; and ASO, 8%). Cardiac procedures (216 CABG) were performed in 226 patients (AAA, 30%; CVD, 22%; and ASO, 19%), with 12 (5.3%) postoperative deaths. A total of 796 patients underwent 1066 peripheral vascular operations with an early mortality of 2.0% (AAA, 3.4%; ASO, 1.9%; and CVD, 0.3%), but only one death (0.8%) occurred in the group of 130 patients having preliminary CABG. The overall operative mortality for 1292 cardiac and peripheral vascular procedures was 2.6%.
Humphrey LL, Ballard DJ, Butters MA, Palumbo PJ and Hallett JW: The epidemiology of lower extremity amputation in diabetes: a population based study in Rochester, Minnesota. Diabetes 1989, 38 Suppl 2:33A. Between 1945 and 1984 the incidence rate of amputation increased for both male and female diabetics. Each 10 year increase in age at the time of diagnosis is the most significant risk factor for amputation. Despite advances in therapy, amputation will continue to be an important public health problem particularly as the population ages.
Ihnat DM, Duong ST, Taylor ZC et al: Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg 47(5):967-74, 2008. OBJECTIVE: A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff. METHODS: A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. RESULTS: Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. CONCLUSIONS: Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed. Comments: Poor runoff either before or after revascularization procedures is an approved FDA indication for boot therapy.
Ihnat DM, Mills JL Sr: Current assessment of endovascular therapy for infrainguinal arterial occlusive disease in patients with diabetes. J Vasc Surg 52(3 Suppl):92S-95S, 2010. Abstract: Endovascular therapy (EVT) has increasingly become the initial clinical option for treatment of lower extremity peripheral arterial disease (PAD), not only for patients with claudication, but also for those with critical limb ischemia. Despite this major clinical practice paradigm shift, the outcomes of EVT for PAD are difficult to evaluate and compare with established surgical benchmarks because of the lack of prospective, randomized trials, incomplete characterization of indications for intervention, mixing of arterial segments and extent of disease treated, the multiplicity of EVT techniques used, the exclusion of early treatment failures, crossover to open bypass during follow-up, and the frequent lack of intermediate and long-term patency and limb salvage rates in life-table format. These data limitations are especially problematic when one tries to assess the outcome of EVT in patients with diabetes. The purpose of the present report is to succinctly review and objectively analyze available data regarding the results of EVT in patients with diabetes.
Indes JE, Shah HJ et al:Subintimal angioplasty is superior to SilverHawk atherectomy for the treatment of occlusive lesions of the lower extremities. J Endovasc Ther 17(2):243-50, 2010. PURPOSE: To evaluate the outcomes of atherectomy versus subintimal angioplasty (SIA) in patients with lower extremity arterial occlusive disease. METHODS: From September 2005 through July 2006, 27 patients (17 women; mean age 65 years, range 37-85) underwent atherectomy of 46 lesions (11 TASC C/D occlusions) with the SilverHawk device. Results were compared to 67 patients (34 men; mean age 69 years, range 46-92) undergoing SIA for 67 lower extremity arterial occlusions from July 1999 through June 2004. RESULTS: Technical success in the atherectomy cohort was 100%. In the 11 patients with occlusions, symptoms improved in 10 and worsened in 1, but 9 (82.0%) of the 11 patients required reintervention, and 8 (72.7%) patients with occlusive lesions re-occluded. Endovascular reintervention was required to maintain primary patency in only 2 (12.5%) of 16 patients treated for stenotic lesions. At 1 year, the assisted primary patency was 37.7% in the atherectomy group. In the 11 patients with occlusive lesions, the patency rates were 36.8% and 12.3% at 6 and 9 months, respectively, versus 100% and 83.3% at the same time intervals in patients with stenotic lesions. SIA was technically successful in 56 (83.6%) of 67 occlusions. The assisted primary patency and limb salvage rates of the entire group (intention-to-treat) at 12 and 24 months were 59.2% and 45.0%, respectively, while the assisted primary patency of the 56 technically successful SIAs at 12 and 24 months were 70.7% and 53.8%, respectively. Limb salvage for the entire group (intention-to-treat) was 90.6% and 87.9% at 12 and 24 months, respectively. CONCLUSION: Atherectomy may yield acceptable primary patency and limb salvage in patients with stenotic lesions. Many of the patients treated for occlusive lesions require reintervention. Based on patency and limb salvage, SIA appears superior to atherectomy for the treatment of lower extremity occlusive disease.
Jämsén T, Manninen H, Tulla H and Matsi P: The Final Outcome of Primary Infrainguinal Percutaneous Transluminal Angioplasty in 100 Consecutive Patients with Chronic Critical Limb Ischemia. Journal of Vascular and Interventional Radiology 13:455-463, 2002. PURPOSE: This study was performed to determine final outcomes in patients treated with infrainguinal percutaneous transluminal angioplasty (PTA) for chronic critical limb ischemia (CLI). MATERIALS AND METHODS: The study population consisted of 100 consecutive patients (mean age, 72 y; range, 38–90 y; 40 men and 60 women) with 116 treated limbs. CLI was defined as rest pain or ischemic tissue defect combined with an ankle systolic pressure <= 50 mm Hg. Indication for treatment was rest pain in 23 limbs (20%), ischemic ulcer in 50 (43%), and gangrene in 43 (37%). All patients were followed until they had met the study endpoints: major amputation or death. The mean follow-up period was 38 months (1–119 mo). Limb salvage, survival, and life with limb rates were determined along with their determinants. RESULTS: On average, 1.9 invasive procedures were required during the lifespan of a critically ischemic limb, including primary PTA and 32 repeat PTA procedures, 11 surgical revascularizations, and 51 amputations. The major amputation rate was 32% (n = 37). Limb salvage for endovascular treatments at 3, 5, and 8 years was 65%, 60%, and 60%, respectively (SE of estimate [SEE] <= 0.06), and the corresponding life with limb rates were 29%, 18%, and 6% (SEE <= 0.05). A greater number of diseased vessels in the treated limb was associated with poorer limb salvage (P = .004). Survival rates were 41%, 26%, and 14% (SEE <= 0.05) at 3, 5, and 10 years. The 10-year survival rate was markedly poorer than that in the age- and sex-matched control population. Coronary artery disease (P = .001) and poor peripheral runoff (P = .02) were associated with decreased survival. CONCLUSIONS: Infrainguinal PTA in patients with CLI results in acceptable limb salvage with a low number of additional revascularization treatments, but patient survival is poor. Comments: Not really a randomized controlled study.... All patients suitable for PTA got it.... Compared with patients not suitable who were bypassed.
Jonson BL, Glickman MH, Bandyk DF and Esses GE: Failure of foot salvage in patients with end-stage renal disease after surgical revascularization. J Vasc Surg 22:280-5, 1995. PURPOSE: This report ascertained factors responsible for for failure of foot salvage in patients with end-stage renal disease (ESRD) after undergoing infrainguinal bypass for critical ischemia. METHODS: A retrospective review of 69 distal arterial reconstructions performed in 53 patients with ESRD (hemodialysis [n = 37], kidney transplantation [n = 10], peritoneal dialysis [n = 6]) for foot gangrene (n = 28), nonhealing ulcer (n = 25), or ischemic rest pain (n = 16) was conducted. Endpoints of surgical morbidity, limb loss, and graft patency were correlated with extent of preoperative tissue loss and presence of diabetes mellitus. RESULTS: The 30-day operative mortality rate was 10%, and the patient survival rate at 2 years was 38%. The primary graft patency rate was 96% at 30 days, 72% at 1 year, and 68% at 2 years. Eleven of 22 foot amputations performed during the mean follow-up period of 14 months (range 3 to 96 months) occurred within 2 months of revascularization. Mechanisms responsible for limb loss included graft failure (n = 9), foot ischemia despite a patent bypass (n = 8), and uncontrolled infection (n = 5). Overall, 59% of amputations were performed in limbs with a patent bypass to popliteal or tibial arteries. Healing of forefoot amputations was prolonged, but all limb loss beyond 9 months of revascularization was due to graft failure. The limb salvage rate at 1 year decreased (p = 0.13) from 74% to 51% in patients admitted with gangrene. Only two of seven patients admitted with forefoot gangrene experienced foot salvage. CONCLUSION: Failure of foot salvage in patients with ESRD and critical ischemia was due to wound healing problems rather than graft thrombosis. Earlier referral for revascularization, before development of extensive tissue ischemia and infection, is recommended. Primary amputation should be considered in patients admitted with forefoot gangrene, particularly if it is complicated by infection. Comments: Patients with ESRD have long been known to have an increased risk for foot gangrene. Besides generalized ASCVD, their hemodialysis itself poses significant risk. Large fluid volumes may be dialyzed from the body causing hypotension and faintness. The dialysis chair is commonly then flattened and the feet raised potentially leaving the feet without arterial flow for minutes to hours. In a more recent study, Boufi et al (Foot Gangrene in Patients with End-Stage Renal Disease: A Case Control Study. Angiology 57:355-61, 2006) compared patients with foot gangrene and ESR to controls with foot gangrene and no ESR; the ESR patients had a higher mortality 68.7% vs 12.5% and major amputation rate 31% vs 8% along with more extensive arterial calcification and a higher calcium-phosphorus product. The latter raises the problem of calciphylaxis which has in ESR patients been associated not only with foot gangrene but gangrene of other tissues such as the penis (Guvel S et al: Penile Necrosis. J of Andrology 25, 2004).
Johnson KW et al: 5-year results of a prospective study of percutaneous transluminal angioplasty. Ann Surg 26:403-413, 1987. 984 consecutive PTA's...initial success rate 88.6% and at five years 48.2%. Success more likely if done for claudication vs salvage, if site common iliac vs other, if a stenotic lesion vs occlusion, and if good runoff - Comment: No controls and question of desirability of a procedure for claudication.
Kalbaugh CA, Taylor SM, Blackhurst DW et al: One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease. J Vasc Surg 44(2): 296-302, 2006. BACKGROUND: Despite lower reported patency rates than open bypass, percutaneous transluminal angioplasty (PTA) may result in symptom relief, limb salvage, maintenance of ambulation and independent living, and overall improved quality of life. The goal of this study was to prospectively assess quality of life and functional outcomes after angioplasty and stenting in patients with chronic leg ischemia. METHODS: From August to December 2002, 84 patients with 118 chronically ischemic limbs underwent PTA with or without stenting as part of an ongoing prospective project performed to examine management of symptomatic peripheral arterial disease. All patients completed a preprocedure health questionnaire (Short Form 36) to provide adequate baseline data. Each patient was followed up every 3 months after treatment for 1 year to determine traditional outcomes of arterial patency, limb salvage, survival and amputation-free survival, and functional outcomes assessed according to improvement in quality of life, maintenance of ambulatory status, and maintenance of independent living status. The entire cohort was analyzed, as were subgroups of patients with lifestyle-limiting claudication and those with critical limb ischemia. Outcomes were analyzed by using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome. RESULTS: Of the 84 patients, 54 (64.3%) were treated for claudication (34 aortoiliac occlusive disease and 20 infrainguinal disease), and 30 (35.7%) were treated for critical limb ischemia (11 aortoiliac occlusive disease and 19 infrainguinal disease). One-year results for the 54 patients with claudication were as follows: primary patency, 78.5%; limb salvage, 100%; amputation-free survival, 96.3%; survival, 96.3%; maintenance of ambulation status, 100%; and maintenance of independence, 100%. There was statistical improvement in all physical function categories, including physical function (29.4 +/- 8.9 vs 37.1 +/- 11.3; P < .0001), role-physical (32.5 +/- 11.3 vs 39.5 +/- 13.0; P = .0001), bodily pain (35.8 +/- 8.5 vs 42.9 +/- 10.9; P < .0001), and aggregate physical scoring (31.1 +/- 9.7 vs 38.1 +/- 11.5; P < .0001). One-year results for the 30 patients with critical limb ischemia were as follows: primary patency, 35.2%; limb salvage, 77.2%; amputation-free survival, 50.0%; survival, 60.0%; maintenance of ambulation status, 75.8%; and maintenance of independence, 92.8%. There was statistical improvement in bodily pain resolution (35.3 +/- 12.0 vs 46.6 +/- 12.0; P = .0009). Cox models with hazard ratios (HRs) revealed that presentation was a significant predictor for outcomes of primary patency (HR, 4.2; P= .0002), secondary patency (HR, 6.0; P < .0001), limb salvage (HR, 20.2; P = .0047), survival (HR, 10.9; P = .0002), and amputation-free survival (HR, 11.2; P < .0001). Conversely, the level of disease was predictive of outcome only for primary patency (HR, 1.8; P = .00289). CONCLUSIONS: Despite inferior reconstruction patency rates when compared with the historical results of open bypass, PTA provides excellent functional outcomes with good patient satisfaction, especially for treating claudication. These findings support a more liberal use of PTA intervention for patients with vasculogenic claudication. Comments: No control group. See Albers et al above.
Karnabatidis D, Katsanos K, Kagadis GC, et al: Distal embolism during percutaneous revascularization of infra-aortic arterial occlusive disease: an underestimated phenomenon. J Endovasc Ther.13:269-80, 2006.PURPOSE: To investigate distal embolism during endovascular procedures of the infra-aortic arteries by utilizing a commercial filter basket and unveil any correlation between the baseline clinical and procedural variables and the histopathological findings of the collected particles. METHODS: In a prospective study, 48 patients (37 men; mean age 70.8+/-7.8 years, range 50- 83) underwent endoluminal therapy of infra-aortic lesions (stenosis >75% or occlusion; mean lesion length 52.2+/-38.0 mm) with standard endovascular procedures. A nitinol filter basket (n=50) was employed for distal protection. The collected particles were histopathologically analyzed. The harvested specimens were quantified after digital image post processing. RESULTS: Procedural success of filter-protected revascularization was 93.8%. Three failures included 1 vasospasm, 1 distal embolus, and 1 side-branch occlusion. The total area of retrieved particles per basket was 2.76+/-6.49 mm(2) (range 0.0-40.3). Particles with a major axis >1 and >3 mm were detected in 29 (58.0%) and 6 (12.0%), respectively, of the examined filters. Collected particles consisted primarily of platelets and fibrin conglomerates, trapped erythrocytes, inflammatory cells, and extracellular matrix. Increased lesion length, increased reference vessel diameter, acute thromboses, and total occlusions were positively correlated with higher amounts of captured particles (p<0.05). Multivariate analysis incriminated declotting procedures as the only independent predictor of increased embolic burden (p<0.05). CONCLUSION: The embolism phenomenon during infra-aortic interventions is frequent and underestimated. The liberated particles consisted primarily of atheromatous plaque elements and thrombus. The reported data might support the application of a protective filter basket in selected subsets of lesions with a riskier embolic profile and whenever declotting procedures are performed.
Khan AM, Jacobs S: Trash feet after coronary angiography. Heart 89: e17, 2003. Cholesterol crystal embolisation is a frequently underdiagnosed condition. While coronary catheterisation is safe and commonly performed, the reported patient developed very painful trash feet after undergoing this routine procedure. Ulceration and gangrene occurred after catheter manipulation during cardiac angiography, which caused occlusion of the small arteries in his feet. The triad of pain, livedo reticularis, and intact peripheral pulses is pathognomonic for cholesterol embolisation. The prognosis depends on the extent of the systemic disease and a high rate of mortality (75-80%) is observed. Prognosis is poor and the treatment is only supportive. It is suggested that while cardiac catheterisation is largely safe and a very commonly performed procedure, it can still lead to complications with serious side effects and can even prove fatal.
Keen RR, McCarthy WJ, Shireman PK et al: Surgical management of atheroembolization. J Vasc Surg 21:773-781, 1995. The atheroembolic source is the aorta or iliac arteries in 2/3 of patients who underwent operation. CAT scan useful diagnostic techniques. Natural history includes 80% recurrence rate of emboli and 60% incidence of tissue loss. Precipitation events: use of warfarin (21), arteriography (17), percutaneous transluminal arteriography (5), trauma (5), and laparotomy (3 patients).
Keeley EC, Velez CA, O'Neill WW, Safian RD: Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts. J Am Coll Cardiol 38:659-65, 2001. Abstract: OBJECTIVES: The purpose of this study was to examine the long-term clinical outcome after percutaneous intervention of saphenous vein grafts (SVG) and to identify the predictors of major adverse cardiac events (MACE). BACKGROUND: Percutaneous interventions of SVGs have been associated with more procedural complications and higher restenosis rates compared with interventions on native vessels. METHODS: From 1993 to 1997, 1,062 patients underwent percutaneous intervention on 1,142 SVG lesions. Procedural, in-hospital and long-term clinical outcomes were recorded in a database and analyzed. RESULTS: In-hospital MACE occurred in 137 patients (13%) including death (8%), Q-wave myocardial infarction (MI) (2%) and coronary artery bypass surgery (3%). Late MACE occurred in 565 patients (54%) including death (9%), Q-wave MI (9%) and target vessel revascularization (36%). Any MACE occurred in 457 (43%) patients. Follow-up was available in 1,056 (99%) patients at 3 +/- 1 year. Univariate predictors were restenotic lesion (odds ratio [OR]: 2.47, confidence interval [CI]: 1.13 to 3.85, p = 0.0003), unstable angina (OR: 1.99, CI: 1.27 to 2.91, p = 0.04) and congestive heart failure (CHF) (OR: 1.97, CI: 1.14 to 3.24, p = 0.02) for in-hospital MACE, and peripheral vascular disease (PVD) (OR: 2.18, CI: 1.34 to 3.44, p = 0.002), intra-aortic balloon pump placement (OR: 2.08, CI: 1.13 to 3.85, p = 0.02) and previous MI (OR: 1.97, CI: 1.14 to 3.25, p = 0.007) for late MACE. Independent multivariate predictors for late MACE were restenotic lesion (relative risk [RR] 1.33, p = 0.02), PVD (RR: 1.31, p = 0.01), CHF (RR: 1.42, p = 0.01) and multiple stents (RR: 1.47, p = 0.004). Angiographic follow-up was available for 422 patients. Angiographic restenosis occurred in 122 (29%) of stented SVGs and 181 (43%) of nonstented SVGs (p = 0.04). Stent implantation did not confer a survival benefit. CONCLUSIONS: Despite the use of new interventional devices, SVG interventions are associated with significant morbidity and mortality; SVG stenting is not associated with better three-year event-free survival. This may be due to progressive disease at nonstented sites. Comments: We have had no such morbidity in booting such patients
Kirwin JD, Ascer E, Gennaro M, Mohan C et al: Silent myocardial ischemia is not predictive of myocardial infarction in peripheral vascular surgery patients. Ann Vasc Surg 7:27-32, 1993. Continuous ambulatory ECG (CAECG) monitoring has been advocated as an effective low-cost preoperative method for detecting silent myocardial ischemia in patients undergoing peripheral vascular surgery. In addition, silent ischemic events are associated with an increased incidence of postoperative myocardial infarctions. Ninety-six patients (mean age 73 years) admitted for elective aortic (24) or infrainguinal (72) operations over a 2-year period underwent 24-hour two- or three-lead CAECG monitoring. Results were reviewed by a single cardiologist blinded to the study. The criterion for ischemia was ST segment depressions of 1 mm or greater for 40 seconds or more 60 msec after the J point. Postoperative myocardial infarction was determined by ECG changes and/or elevated serum creatinine phosphokinase with positive MB isoenzymes. Risk factors included hypertension (71%), history of coronary artery disease (66%), smoking (61%), and diabetes mellitus (47%). Nine out of 96 patients (9.4%) had a positive CAECG test for silent myocardial ischemia. Only one patient (11.1%) developed postoperative myocardial infarction and there were no deaths in this group. The incidence of postoperative myocardial infarction in the nonischemic group was 16.1% (14/87). However, the mortality in this group was 6.9% (6/87). New and malignant arrhythmias requiring preoperative medical intervention were observed in seven patients (7.4%): two cases of ventricular tachycardia and five cases of atrial flutter/fibrillation. Contrary to previous reports, CAECG monitoring for silent ischemia was not a significant predictor of postoperative myocardial infarction or mortality in our patient population. However, we continue to recommend the preoperative use of CAECG monitoring as a diagnostic tool for unsuspected malignant arrhythmias.
Krupski WC, Nehler NR, Whitehill TA, Lawson RC, Strecker PK, Hiatt WR: Negative impact of cardiac evaluation before vascular surgery. Vascular Medicine 5:3-9, 2000. The optimal preoperative evaluation of cardiac risk in patients with peripheral vascular disease is controversial. In developing a paradigm for preoperative cardiac workup, potential adverse effects of evaluation and cardiac intervention must be considered. This study analyzed the deleterious outcomes of extensive, comprehensive cardiac evaluation and intervention before planned vascular surgery in patients treated at the Denver Department of Veterans Affairs Medical Center. Over a 12-month period between 1994 and 1995, 161 patients were scheduled to undergo major vascular operations; 153 patients came to operation. The decision to pursue a cardiac evaluation was variously made by a combination of surgeons, cardiologists, and anesthesiologists. No defined protocol was followed. Cardiac history, chest X-rays and ECGs were obtained for all patients. Extendedcardiac evaluation included these studies plus special tests, including echocardiography (echo), radionuclide ventriculography (RNVG), dipyridamole thallium scintigraphy (DTS), and cardiac catheterization (CC). Extended cardiac evaluations were undertaken in 42 patients. Complications related to percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG) were also recorded. Cardiac mortality and morbidity after vascular interventions were itemized in all 153 patients. Forty-two male patients, aged 68 6 9 years, underwent extended cardiac evaluations before planned vascular operations. The median elapsed time for cardiac workup was 14 days (mean 30 6 59 days). The median and mean times from cardiac workup to vascular surgery were 25 days and 76 6 142 days, respectively. Eighteen (43%) patients had echo or RNVG; 22 (52%) patients had DTS; 27 (64%) had CC; 9 (21%) had PTCA; 7 (17%) had CABG. Sixteen (38%) patients had untoward events related to cardiac evaluation. Eight patients (19%: one with cerebrovascular disease, and seven with aortic aneurysms) refused vascular surgery after extended cardiac workup. Complications attributable to CC, PTCA, and CABG included prosthetic graft infection, pseudoaneurysms (two), sternal wound infections (two), renal failure and brain anoxia. Two patients with severe limb ischemia who were candidates for revascularization ultimately required amputations because of delay due to cardiac evaluations. Extensive cardiac evaluation prior to vascular operations can result in morbidity, delays, and refusal to undergo vascular surgery. The underlying indication for vascular operations and the local iatrogenic cardiac complication rates must be considered before ordering special studies.
Kudo T, Chandra FA, Ahn SS: The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg 41:423-35, 2005. OBJECTIVE: To determine the efficacy, safety, and long-term results, including continued clinical improvement and limb salvage, of percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI). METHODS: From August 1993 to March 2004, 138 limbs in 111 patients with CLI (rest pain in 62 [45%] and ulcer/gangrene in 76 [55%]) were treated by PTA. In iliac lesions, stents were placed selectively for primary PTA failure: residual stenosis (>30%) or pressure gradient (>5 mm Hg). Stent placement was limited in infrainguinal lesions. The most distal affected arteries treated with angioplasty were the iliac artery in 45 limbs (33%; iliac group), the femoropopliteal artery in 41 limbs (30%; FP group), and tibial arteries in 52 limbs (37%; BK group). All analysis was performed according to an intent-to-treat basis. Reporting standards of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery were followed to evaluate initial success, and late follow-up status was evaluated with the Kaplan-Meier method. Patency was evaluated by using ultrasound scanning and ankle-brachial pressure index measurement. RESULTS: There was one (0.9%) perioperative death. Twenty stents were placed selectively in 14 iliac arteries. Mean follow-up was 14.7 months (range, 1-75 months). Overall, initial technical and clinical success rates were 96.4% and 92.8%, respectively. The cumulative primary, assisted primary, and secondary patency; continued clinical improvement; and limb salvage rates +/- SE at 5 years were 31.4% +/- 10.4%, 75.5% +/- 5.7%, 79.6% +/- 5.5%, 36.1% +/- 10.0%, and 89.1% +/- 4.0%, respectively. In each subgroup, the primary, assisted primary, and secondary patency; continued clinical improvement; and limb salvage rates at 3 years were 51.6%, 94.7%, 97.8%, 65.1%, and 95.0%, respectively, in the iliac group; 49.4%, 72.2%, 76.4%, 57.4%, and 92.7%, respectively, in the FP group; and 23.5%, 41.8%, 46.1%, 51.1%, and 77.3%, respectively, in the BK group. Of the 12 predictable variables, hypertension, multiple segment lesions, more distal lesions, and TransAtlantic Inter-Society Consensus classification type D were significant independent risk factors for the outcomes ( P < .05; univariate log-rank test and Cox regression multivariate analysis). CONCLUSIONS: PTA is a feasible, safe, and effective procedure for the treatment of CLI. The high limb salvage rate is attributed to the high assisted primary and secondary patency rates despite the low primary patency rate. Angioplasty can be the primary choice for the treatment of CLI due to iliac and infrainguinal arterial occlusive disease. Comments: An impressive "observational" study. For those who require studies to be "controlled" and "prospective" to be considered evidence of efficacy, we might ask them how they would have accomplished the feat. See Hobbs and Bradbury in our Claudication library. Kudo et al report on more data generated by a single surgeon (J Vasc Surg 44:304-13, 2006) again supporting the use of PTA in treating CLI when possible. An increase in clinical success was gained at the expense of an increase in follow-up procedures.
Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD: Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol 16:1051-4, 2005. PURPOSE: Despite suboptimal results (italics added by website editor), angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease. MATERIALS AND METHODS: One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. RESULTS: A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. CONCLUSIONS: Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty.
Landesberg G, Mosseri M, Zahger D, Wolf Y et al: Myocardial infarction after vascular surgery: the role of prolonged stress-induced, ST depression-type ischemia. J Am Coll Cardiol 37:1839-45, 2001. OBJECTIVES: The goal of this study was to investigate the nature of the association between silent ischemia and postoperative myocardial infarction (PMI). BACKGROUND: Silent ischemia predicts cardiac morbidity and mortality in both ambulatory and postoperative patients. Whether silent stress-induced ischemia is merely a marker of extensive coronary artery disease or has a closer association with infarction has not been determined. METHODS: In 185 consecutive patients undergoing vascular surgery, we correlated ischemia duration, as detected on a continuous 12-lead ST-trend monitoring during the period 48 h to 72 h after surgery, with cardiac troponin-I (cTn-I) measured in the first three postoperative days and with postoperative cardiac outcome. Postoperative myocardial infarction was defined as cTn-I >3.1 ng/ml accompanied by either typical symptoms or new ischemic electrocardiogram (ECG) findings. RESULTS: During 11,132 patient-hours of monitoring, 38 patients (20.5%) had 66 transient ischemic events, all but one denoted by ST-segment depression. Twelve patients (6.5%) sustained PMI; one of those patients died. All infarctions were non-Q-wave and were detected by a rise in cTn-I during or immediately after prolonged, ST depression-type ischemia. The average duration ofischemia in patients with PMI was 226+/-164 min (range: 29 to 625), compared with 38+/-26 min (p = 0.0000) in 26 patients with ischemia but not infarction. Peak cTn-I strongly correlated with the longest, as well as cumulative, ischemia duration (r = 0.83 and r = 0.78, respectively). Ischemic ECG changes were completely reversible in all but one patient who had persistent new T wave inversion. All ischemic events culminating in PMI were preceded by an increase in heart rate (delta heart rate = 32+/-15 beats/min), and most (67%) of them began at the end of surgery and emergence from anesthesia. CONCLUSIONS: Prolonged, ST depression-type ischemia progresses to MI and is strongly associated with the majority of cardiac complications after vascular surgery.
Lee ES, Santilli SM, Olson MH, Kuskowski MA, Lee JT: Wound Infection After Infrainguinal Bypass Operations: Multivariate Analysis of Putative Risk Factors. Surgical Infections 1: 257-263, 2000. Reported wound infection rates for infrainguinal bypass operations range from 17% to 44%, but there is limited appreciation of which characteristics of patients or operations are reliable markers of increased wound infection risk. The purpose of the present study was to analyze all wound infections observed after infrainguinal bypass operations during 20 years of practice in a large teaching institution. Independent risk factors for wound infection development were identified. During the 20-year period ending 31 December, 1997, 978 male patients underwent infrainguinal bypass operations at the Minneapolis Department of Veterans Affairs Medical Center. Wound infections complicated the recovery of 129 of these patients during a 30-day postoperative surveillance interval. Multivariate logistic regression analysis was used to test the association between wound infection occurrence and putative risk factors that were either features of patients or characteristics of the operations. The following variables were examined: obesity, prosthetic graft placement, diabetes mellitus, steroid use, anticoagulation use, length of preoperative hospital stay, development of incisional hematoma, duration of operation, and the preoperative presence of a non-healing wound in the extremity being revascularized. The overall wound infection rate was 13.2% (129/978). In a final logistic regression model, obesity was a significant and independent predictor of wound infection (Relative Risk 2.6, 95% confidence interval, 1.35-4.90), as was development of a post-operative incisional hematoma (Relative Risk 6.44, 95% confidence interval, 2.95-14.08). No other explanatory variable was significantly associated with wound infection development.
Leng GC, Davis M, Baker D: Bypass surgery for chronic lower limb ischemia. Cochrane Database Syst Rev. 2000; (3):CD002000. BACKGROUND: Surgical bypass of an occluded arterial segment is the mainstay of treatment for patients with critical limb ischaemia. As with many surgical interventions, however, it was introduced without formal evaluation. OBJECTIVES: The objective of this review was to determine the effects of bypass surgery in patients with chronic lower limb ischaemia. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register, MEDLINE, EMBASE, reference lists of relevant articles, and contacted principal trial investigators. SELECTION CRITERIA: All randomised controlled trials of bypass surgery versus control, or versus any other form of treatment. DATA COLLECTION AND ANALYSIS: At least two reviewers extracted data and assessed trial quality independently. The reviewers contacted investigators to obtain information or data needed for the review that could not be found in published reports. Dichotomous data were analysed using the Peto odds ratio (OR), and continuous data with the weighted mean difference (fixed effect and random effects models). MAIN RESULTS: Eight trials were identified which appeared to meet the inclusion criteria, but two were subsequently excluded. The remaining six trials involved a total of just over 700 patients, two trials comparing bypass surgery with angioplasty (PTA), and one with each of thromboendarterectomy, thrombolysis, exercise, and spinal cord stimulation. Four trials included patients with a range of disease severity (intermittent claudication and critical limb ischaemia), one was restricted to claudicants only and another to only critical limb ischaemia. The type of bypass procedure performed in each trial was similar: vein grafts for distal reconstructions; synthetic prostheses for aorto-iliac or ilio-femoral bypasses. The outcome measures varied, but four of the six trials included mortality and operative failure. In general the quality of the trials was good, but none was blinded because of the nature of the intervention. There were no clear differences between bypass surgery and PTA. Mortality and amputation rates did not differ significantly, although primary patency was significantly higher in the bypass group after 12 months (Peto OR 1. 6, 95% CI 1.0, 2.6) but not after four years (p=0.14). Compared with thrombolysis, amputation rates were significantly lower in the bypass group (Peto OR 0.2, 95% CI 0.1, 0.6), but mortality rates did not differ. Compared with thromboendarterectomy, restoration of blood flow was significantly greater in the bypass patients (Peto OR 9.2, 95% CI 1.7, 50.6), but mortality and amputation rates did not differ. Bypass did not differ significantly from exercise or spinal cord stimulation. REVIEWER'S CONCLUSIONS: There is limited evidence for the effectiveness of bypass surgery and further large trials are required.
Lette J, Waters D, Lassonde J et al: Postoperative myocardial infarction and cardiac death. Predictive value of dipyridamole-thallium imaging and five clinical scoring systems based on multifactorial analysis. Ann Surg 211:84-90, 1990. Abstract: Sixty-six patients unable to complete a standard preoperative exercise test because of physical limitations were studied to determine the predictive value of individual clinical parameters, of clinical scoring systems based on multifactorial analysis, and of dipyridamole-thallium imaging before major general and vascular surgery. Study endpoints were limited to postoperative myocardial infarction or cardiac death before hospital discharge. There were nine postoperative cardiac events (seven deaths and two nonfatal infarctions). There was no statistical correlation between cardiac events and preoperative clinical descriptors, including individual clinical parameters, the Dripps-American Surgical Association score, the Goldman Cardiac Risk Index score, the Detsky Modified Cardiac Risk Index score, Eagle's clinical markers of low surgical risk, and the probability of postoperative events as determined by Cooperman's equation. There were no cardiac events in 30 patients with normal dipyridamole-thallium scans or in nine patients with fixed myocardial perfusion defects. Of 21 patients with reversible perfusion defects who underwent surgery, nine had a postoperative cardiac event (sensitivity, 100%; specificity, 43%). In the six other patients with reversible defects, preoperative angiography showed severe coronary disease or cardiomyopathy. Thus in patients unable to complete a standard exercise stress test, postoperative outcome cannot be predicted clinically before major general and vascular surgery, whereas dipyridamole-thallium imaging successfully identified all patients who sustained a postoperative cardiac event.
Lin PH, Bush RL, Conklin BS, Chen C, Weiss VJ, Chaikof EL, Lumsden AB. Late complication of aortoiliac stent placement - atheroembolization of the lower extremities. J Surg Res 103:153-9, 2002. BACKGROUND: Atheroembolization following aortoiliac stent placement is uncommon. The purpose of this study was to examine the management and risk factors of lower extremity atheroembolization following aortoiliac stent placement for occlusive disease. MATERIALS AND METHODS: From March 1993 to February 2001, the hospital records of all patients who developed thromboembolic events following aortoiliac stent placement were reviewed. Risk factor analysis was performed by comparing with the control group, which consisted of 493 patients treated with aortoiliac stents during the study period who did not develop atheroembolic complications. Patients with cardiac etiologies or aortic aneurysms as the source of embolization as well as those who developed acute embolization following stent deployment (<30 days) were excluded. RESULTS: Atheroembolization occurred in eight patients (12 iliac artery stents and 1 aortic stent) at intervals ranging from 9 to 43 months (mean 22 months) following aortoiliac stent placement. Arteriography in all patients implicated the stented artery as the source of atheroembolism. Five corrective operations (two aorto-bifemoral bypasses, one ileofemoral bypass, and two aortoiliac endarterectomies) along with two concomitant femoropopliteal thrombectomies were performed successfully in five patients. The remaining three patients were treated with either thrombolysis and/or additional stent placement, which resulted in either iliac occlusion or recurrent embolic symptoms (P < 0.05). All 3 patients subsequently underwent bypass procedures (one ileofemoral and two femorofemoral bypasses). There was no perioperative mortality. During a mean follow-up of 16 months (range 3 to 45 months), two patients required minor amputations, whereas one required major leg amputation. No further episodes of atheroembolism occurred in the involved limbs following surgical bypass procedures. Risk factor analysis failed to identify potential variables that correlated with atheroembolism following aortoiliac stent placement. CONCLUSION: Patients with atheromatous embolization following aortoiliac stent placement should be evaluated aggressively. The treatment of choice is surgical correction or bypass with exclusion of the offending embolic source. Although intra-arterial stent placement in the atheroembolic stented iliac artery is feasible, it may provide a less durable result.
Littooy FN, Steffan G, Steinam S, Saletta C and Greisler HP: An 11-year experience with aortofemoral bypass grafting. Cardiovasc Surgery 1:232-238, 1993. Abstract: Over the past 11 years, 224 patients (440 limbs) underwent aortofemoral bypass grafting for claudication (63%), or limb-threatening ischemia (37%). The distal anastomosis included the profunda femoris artery directly or only as a profundoplasty in 163 limbs (37.0%). Concomitant distal bypasses were carried out in 19 limbs (4.3%). The perioperative mortality rate was 4.9%; over half of the deaths (six) were from myocardial infarction. There were ten early graft limb occlusions (2.3%). Only five major amputations (1.1%) occurred. Long-term follow-up of 416 limbs averaged 58.5 (range 2-142) months. Cumulative primary and secondary patency rates were 88 and 93% respectively at 5 years, and 73% and 89% respectively at 10 years. The cumulative limb salvage rate was 95% at 5 years and 91% at 10 years. Improvement of claudication or relief from limb-threatening ischemia occurred in 90% of limbs early after treatment. Only 5.9% of limbs were worse after operation. During follow-up, 55 patients (38.5%) died, over half from cardiac causes. Long-term graft-related complications included pseudoaneurysm in 16 limbs (3.8%) and graft limb thrombosis in 33 (7.9%), occurring at a mean of 57.8 and 24.8 months respectively. Graft infection occurred in four patients (1.9%). Excluding operations for graft infection, the operative mortality rate in 72 reoperations on 45 patients was 5.5%. In summary, aortofemoral bypass grafting can be performed safely with long-term patency and limb salvage rates. Improvements in the perioperative mortality rate could best be addressed by improvements in cardiac evaluation and perioperative monitoring. Long-term graft limb complications do occur and, therefore, these patients require lifetime surveillance. Comments: Indications for operation in these patients were claudication 62.9%, rest pain 23.7%, non-healing ulcers 9.4% and gangrene 4%. The latter three categories generally signify more ischemia than the claudication group, but still did well.
Lofberg AM, Karacagil S, Ljungman C et al: Percutaneous transluminal angioplasty of the femoropopliteal arteries in limbs with chronic critical lower limb ischemia. J Vasc Surg 34: 114-21, 2001. PURPOSE: The aim of the study was to evaluate the results of percutaneous transluminal angioplasty (PTA) of femoropopliteal arteries in patients with subcritical or critical lower limb ischemia. Materials and Methods: Ninety-two patients underwent 121 PTA procedures, 68 were of the superficial femoral artery (SFA), 13 of the popliteal and 40 of both arteries. Fifty-seven procedures were performed for treatment of occlusions. Eighty-four patients (94 procedures) were monitored with duplex scanning. RESULTS: Technical success rate was 88%. Primary success rates at 12 and 60 months in the whole series were 40% and 27%, respectively. The primary success rate in limbs with SFA occlusion of longer than 5 cm was only 12% after 5 years compared with 32% if the occlusion was less than/equal to 5 cm in length (P <.01). The primary success rate at 60 months was 53% in limbs with single SFA stenosis and 42% in those with multiple stenoses (P = NS). Limb salvage rate for combined endovascular and vascular interventions was 86% at 5 years. The overall survival rate was 51% at 5 years. CONCLUSION: The results of femoropopliteal PTA performed for treatment of subcritical or critical lower limb ischemia seemed to be inferior to the results of infrainguinal bypass grafting reported in literature. However, because the PTA procedure does not preclude the performance of bypass grafting, it might be an alternative to surgical intervention in limbs with stenotic femoropopliteal lesions. PTA might also be considered in patients with high surgical risk and limited life expectancy, having short occlusive lesions (< 5 cm).
Lopez-Galarza LA, Ray LI, Rodriguez-Lopez J and Diethrich EB: Combined percutaneous transluminal angioplasty, iliac stent deployment, and femorofemoral bypass for bilateral aortoiliac occlusive disease. In their title, the authors describe their option for treating iliac occlusion and contralateral iliac stenosis of less than 3cm in length when other circumstances make the avoidance of an abdominal incision desirable. Comments: We are sometimes asked to boot patients with iliac disease who are inoperable because of age, severe heart disease or other problems. Booting rarely has an impact on disease in the iliacs or common femoral vessels. Procedures as described by these authors may be necessary.
Lundell A, Bergqvist D and Cederholm C: Patency of the plantar arch as a prognostic indicator in patients with critical leg ischemia; a retrospective study. Eur J Surg 159: 625-629, 1993. Patients with patent plantar arches on angiograms had higher cumulative patency after vascular intervention (P < 0.05), leg salvage (P < 0.01) and longer survival (P < 0.01).
Mamode N, Scott RN, McLaughlin SC, McLelland A, Pollock JG: Perioperative myocardial infarction in peripheral vascular surgery. BMJ 312:1396-1397, 1996. The commonest major complication in patients undergoing peripheral vascular surgery is perioperative myocardial infarction.1 No study in Britain has prospectively assessed this risk, but a recent retrospective study found an incidence of 6.3% in patients undergoing aortic surgery.2 We report the incidence of perioperative myocardial infarction in our unit, which is a regional centre for peripheral vascular surgery. Patients, methods, and results We studied consecutive patients undergoing peripheral vascular surgery after excluding those who were undergoing surgery for trauma, venous surgery, and minor procedures. Patients thought to be at high risk of perioperative myocardial infarction were referred to a cardiologist for further preoperative assessment. Concentrations of creatinine kinase MB isoenzymes were measured (by Imx STAT) for the first three days after surgery, and electrocardiograms were recorded on admission, on discharge from hospital, and at doctors' discretion. Because the concentration of creatinine kinase MB isoenzyme may be raised by skeletal muscle ischaemia, myocardial infarction was diagnosed only when a raised total creatinine kinase concentration was associated with an MB subunit concentration of > 10 ng/ml and a ratio of MB subunit to total creatinine kinase of >/=5%. Cardiac death was defined as death unequivocally related to myocardial infarction, heart failure, or arrhythmia. The primary end points of our study were myocardial infarction or cardiac death within 30 days of surgery. We performed statistical analysis with the {chi}2 test or, when appropriate, Fisher's exact test. The 191 patients included in our study (128 men, median age 65, and 63 women, median age 70) underwent 204 operations, of which 100 were elective procedures, 70 were urgent (requiring surgery within the same hospital admission), and 34 were emergency (requiring surgery within 24 hours). Ninety one of the operations were carried out for critical ischaemia, 32 were aortic procedures, and 120 patients (of the 182 in whom data were available) had preoperative evidence of ischaemic heart disease. The overall incidence of perioperative myocardial infarction and cardiac death was 7.3%--6% for those undergoing elective or urgent procedures and 12% for those undergoing emergency surgery. Table 1 gives details of the six myocardial infarctions and eight cardiac deaths that occurred. Four of the non-fatal infarctions were clinically silent. Two patients had surgery performed under regional anaesthesia (amputation and brachial embolectomy), while the rest had a general anaesthetic. Three patients were submitted to necropsy, which showed subendocardial infarction in two patients and transmural infarction (probably preceding surgery) in the other. The factors associated with perioperative myocardial infarction were age over 70 {chi}2=4.642, P=0.03), sex ({chi}2=3.989, P=.05), perioperative shock (Fisher's exact test {chi}2=6.949, P=0.05), and angina (Fisher's exact test {chi}2=7.317, P=0.008). Comment: This is the first prospective study in Britain to assess the incidence of perioperative myocardial infarction in patients undergoing peripheral vascular surgery. Infarction is clinically silent in about 30% of patients,3 as we found, and is fatal in 50%.4 Perioperative cardiac events were not restricted to patients obviously at high risk: myocardial infarctions occurred in patients undergoing elective non-aortic surgery as well as in those undergoing repair of ruptured aortic aneurysm. We found angina to be a strong predictor of risk, but previous myocardial infarction was not. Reviews have confirmed age, diabetes, and heart failure at operation as the only consistent predictors of risk,5 but larger studies with better design might shed more light on this. We found an overall rate of perioperative myocardial infarction of 7.3%, which remained substantial at 6% if we excluded patients undergoing emergency surgery. This implies that further attempts at risk stratification are justified. We urgently require studies to ascertain the best methods of preoperative stratification in order to minimise the risks of vascular surgery.
Mand' ak J, Lonsky V, Dominik J, Zacek P: Vascular complications of the intra-aortic balloon counterpulsation. Angiology 56: 69-74, 2005. From September 1994 to December 2002, 6,274 cardiosurgery operations were performed at the Department of Cardiac Surgery, University Hospital, Hradec Kralove, Czech Republic. Intra-aortic balloon counterpulsation (IABP) was applied in 192 cases (3.1%). From this group of 192 counterpulsated patients 103 were successfully treated (53.6%); 89 counterpulsated patients (46.4%) died from the surgical procedure (30-day mortality rate). In 5 cases (2.6%) from the group of 192, the IABP was introduced before the operation. Ischemic changes of the limb were observed in 11 cases (5.7%). Significant bleeding occurred at the site of puncture in 6 cases (3.1%). Dissection of the femoral and iliac arteries was found in 2 patients (1.0%), perforation of the iliac artery in 1 case (0.5%). In 2 cases (1.0%) the balloon was led into the venous system. In case report No. 1 an introduction of the balloon under a sclerotic plaque of the descending aorta and iliac artery is described. In case report No. 2 a placement of the balloon in the venous bloodstream is reported.
Mansell PI, Gregson R, Allison SP: An audit of lower limb arteriography in diabetic patients. Diabet Med 9(1):84-90, 1992. The outcome of 83 diabetic patients with peripheral vascular disease who underwent arteriography between 1984 and 1988 was reviewed. Angioplasty was possible in 42 legs and was technically successful in 31 but led directly to clinical improvement in only 15. Five of 20 patients referred for vascular surgery also improved. Factors associated with a clinically successful outcome were presentation with claudication, palpable pulses in the contralateral foot, and radiographic evidence of either a short proximal lesion or 2-3 vessel run-off. Median life expectancy following arteriography was 36 months. The median time to amputation was 21 months and median survival with both life and limb intact was only 13 months.
Mark DB, Pan W, Clapp-Channing NE et al: Quality of life after late invasive therapy for occluded arteries. N Engl J Med 360:774-83. 2009. BACKGROUND: The open-artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction will improve clinical outcomes. We evaluated the quality-of-life and economic outcomes associated with the use of this strategy. METHODS: We compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in high-risk patients in stable condition who had a totally occluded infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44% of those eligible), we assessed quality of life by means of a battery of tests that included two principal outcome measures, the Duke Activity Status Index (DASI) (which measures cardiac physical function on a scale from 0 to 58, with higher scores indicating better function) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being). Structured quality-of-life interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment were assessed for 458 of 469 patients in the United States (98%), and 2-year cost-effectiveness was estimated. RESULTS: At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically marginal decrease of 3.4 points in the DASI score (P=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. For the 469 patients in the United States, cumulative 2-year costs were approximately $7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival was marginally longer in the medical-therapy group. CONCLUSIONS: PCI was associated with a marginal advantage in cardiac physical function at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and was associated with marginally longer quality-adjusted survival.
Marzelle J, Raffoul R, Mekouar T, Laridon D, Cormier F, Fichelle JM, Guez D, Cormier JM: Long-term outcome of infra-inguinal endovascular surgery for critical ischemia. Chirurgie 123(2):162-7, 1998. STUDY AIM: Endovascular surgery can be proposed as an alternative to infrainguinal conventional surgery in critical ischemia. The aim of this study was to report the latest results of our series of 186 patients. MATERIALS AND METHODS: One hundred and eighty-six patients (100 women and 86 men; mean age 74.5 +/- 13 years) were treated for pain during rest (31.5%), gangrene (58%), or ischemic ulcer (10.5%). The lesions were unilateral (n = 172) or bilateral (n = 14). Two hundred eighty-seven target lesions were treated: for stenosis (n = 168) or occlusion (n = 119): of superficial femoral artery (31.7%), popliteal artery (40%) or tibial arteries (28.3%). RESULTS: Technical success was achieved in 81% (15% amputations). The in-hospital mortality rate was 6.5%. The cumulative patency rate was 61 +/- 3% at 12 months, and 52 +/- 6% at 48 months. The limb salvage rate was 87 +/- 3% at 12 months and 82 +/- 4% at 48 months. Thirteen potential factors of patency were analyzed: the only predictive factors affecting patency were occlusion versus stenosis, and the use of atherectomy (Log rank test: P < 0.001 and P < 0.0001). CONCLUSION: Despite a risk of technical failure and of mid-term restenosis, endovascular surgery for critical ischemia provides a fair long-term limb salvage rate.
McCarthy RJ, Neary W, Roobottom C, Tottle A, Ashley S: Short-term results of femoropopliteal subintimal angioplasty. Br J Surg 88:887-8, 2001. BACKGROUND: Subintimal angioplasty may be more successful than conventional (intraluminal) angioplasty for treatment of long femoropopliteal occlusions. This study assessed the clinical and haemodynamic outcome of subintimal angioplasty. METHODS: All patients with femoropopliteal occlusions treated by subintimal angioplasty over a 3-year period at two centres were reviewed. Clinical assessment and colour duplex imaging were carried out. RESULTS: Sixty-nine procedures were performed in 33 men and 33 women of median age 74 (range 47-92) years. Indications for treatment were intermittent claudication in 26 (38 per cent) and critical limb ischaemia in 43 (62 per cent). Median occlusion length was 10 (range 2-50) cm. Primary technical success was achieved in 51 occlusions (74 per cent). There were 11 complications (16 per cent); the majority were minor but surgical intervention was required in two patients (3 per cent). At 6 months the cumulative symptomatic and haemodynamic primary patency rates were 60 and 51 per cent respectively, analysed on an intention-to-treat basis. The symptomatic and haemodynamic patency rates for technically successful procedures were 80 and 77 per cent respectively. CONCLUSION: In this series the short-term clinical success of subintimal angioplasty was poor because of a high incidence of reocclusion and restenosis, despite a relatively high initial technical success rate.
McFalls EO, Ward HB, Moritz TE, Goldman S, Krupski WC et al: Coronary-Artery Revascularization before Elective Major Vascular Surgery. New Engl J Med 351:2795-2804, 2004. ABSTRACT: Background The benefit of coronary-artery revascularization before elective major vascular surgery is unclear. Methods We randomly assigned patients at increased risk for perioperative cardiac complications and clinically significant coronary artery disease to undergo either revascularization or no revascularization before elective major vascular surgery. The primary end point was long-term mortality. Results Of 5859 patients scheduled for vascular operations at 18 Veterans Affairs medical centers, 510 (9 percent) were eligible for the study and were randomly assigned to either coronary-artery revascularization before surgery or no revascularization before surgery. The indications for a vascular operation were an expanding abdominal aortic aneurysm (33 percent) or arterial occlusive disease of the legs (67 percent). Among the patients assigned to preoperative coronary-artery revascularization, percutaneous coronary intervention was performed in 59 percent, and bypass surgery was performed in 41 percent. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the group not undergoing revascularization (P<0.001). At 2.7 years after randomization, mortality in the revascularization group was 22 percent and in the no-revascularization group 23 percent (relative risk, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.92). Within 30 days after the vascular operation, a postoperative myocardial infarction, defined by elevated troponin levels, occurred in 12 percent of the revascularization group and 14 percent of the no-revascularization group (P=0.37). Conclusions Coronary-artery revascularization before elective vascular surgery does not significantly alter the long-term outcome. On the basis of these data, a strategy of coronary-artery revascularization before elective vascular surgery among patients with stable cardiac symptoms cannot be recommended. Comments: Perhaps a key phrase here is among patients with stable cardiac symptoms.
Miller JS, Dodson TF, Salam AA, Smith RB 3rd: Vascular complications following intra-aortic balloon pump insertion. Am Surg 58: 332-8, 1992. The intra-aortic balloon pump (IABP) has been used for 23 years to treat cardiogenic shock from various causes. A retrospective review was conducted to evaluate the morbidity, mortality, and risk factors associated with insertion of this device. Over a recent 3-year period, 415 such pumps were inserted either by percutaneous (323) or cut-down (92) technique in 404 patients. Indications for placement included intraoperative pump failure (46%), cardiac instability before coronary artery bypass grafting (28%), perioperative support (13%), cardiac transplantation (7%), and cardiogenic shock (6%). Noncardiac vascular complications occurred in 67 patients, 55 per cent of whom required surgical correction. Operative procedures included femoral artery thrombectomy, bypass grafting, fasciotomy, and amputation. Major risk factors for vascular complications included diminished or absent femoral pulses on initial examination, being a woman, and obesity. In patients with known peripheral vascular disease, the risk of a vascular complication was 17.9 per cent when a surgical cut-down technique was used to insert the IABP, and 38.9 per cent when a percutaneous insertion was performed. The mortality doubled in those patients who had a vascular complication as compared to those who did not (34% vs 17%). A more liberal use of an open surgical technique in those patients with peripheral vascular disease, obesity, and who are women may help to reduce complications after the insertion of the intra-aortic balloon pump. Comments: Why the interest in balloon pumps on our website? We have used the Circulator Boot to support the circulation in patients with cardiac and septic shock with no complications. It may be applied quickly and removed quickly without harmful sequelae.
Miller VM: Femoropopliteal bypass graft patency: analysis of 156 cases. Ann Surg 180:35, 1974. 84% at one year and 65% at five years.
Moawad MR, Masannat YA, Alhamdani A, Gibbons CP: Nerve injury in lower limb vscular surgery. The Surgeon 6:32-35, 2008. Objective: Nerve injury is one of the most common complications of varicose vein surgery and is a frequent cause for litigation but its incidence following lower limb arterial surgery has not been well documented. This study was undertaken to determine the incidence of nerve injury following lower limb arterial surgery. This was addressed in relation to long saphenous or femoral vein harvesting, or re-operative surgery. Materials and Methods: A total of one hundred patients who had undergone lower limb arterial reconstruction in the previous five years were invited to participate in this study. Seventy-eight patients responded, of which 44 patients (66 operated legs) agreed to participate. They underwent neurological assessment of the lower limbs. Results: 66.7% of limbs had objective evidence of sensory deficit following lower limb arterial surgery but none had motor deficit. Redo surgery or superficial femoral vein harvest had no influence on the incidence of nerve injury. Below knee incisions had a higher incidence of nerve injury than other approaches. Long saphenous vein harvest significantly increased the rate of nerve injury. Conclusions: There is a high incidence of sensory nerve damage following lower limb arterial surgery. In the present climate of increasing litigation it is important to know the likely incidence of post-operative nerve damage so that patients can be counselled appropriately during the process of obtaining informed consent.
Morris PE, Hessel SJ, Couch NP and Adams DP: Surgery and the progression of the occlusive process in patients with peripheral vascular disease. Radiology 124:343-348, 1977. Repeat angiograms done on 42 patients with ASO. Occlusive disease progressed significantly faster in operated limbs (77%) than in nonoperated limbs (44%). When progression occurred, it was more likely to take the form of occlusion in operated limbs (85%) than in nonoperated limbs (61%). Graft closure was associated with a 93% incidence of disease progression, but even limbs with patent grafts had a more rapid progression than nonoperated limbs (62 vs 44%). There was good correlation between symptoms and the angiographic process.
Movahed MR, Butman SM: The pathogenesis and treatment of no-reflow occurring during percutaneous coronary intervention. Cardiovasc Revasc Med 9(1): 56-61, 2008. No-reflow is one of the major causes of postinterventional rise of cardiac enzyme and myocardial infarction (MI). This complication is associated with substantial morbidity and mortality after percutaneous coronary intervention (PCI). During and after a no-reflow episode, the patient can suffer from severe chest pain, hypotension, bradycardia, hemodynamic collapse, MI, congestive heart failure, and death. Every effort should be taken to reduce the incidence of this complication. The distal embolic protection device has been shown to decrease this risk in saphenous vein graft (SVG) interventions but not in native coronaries. On the other hand, the use of glycoprotein IIb/IIIa receptor antagonists have been effective in reducing the occurrence of no-reflow during PCI of native coronaries but not during SVG interventions. The treatment of no-reflow is based on the intracoronary administrations of medications that induce maximal vasodilatation in small distal coronary vasculature. The most commonly used drugs in this setting are adenosine, nitroprusside, and verapamil. The goal of this study was to review the pathogenesis and treatment of no-reflow in patients undergoing PCI.Comments: And also a problem in the leg after either/or angioplasty or stent placement. And in both areas Long Boot therapy potentially beneficial.
Myers SI, Myers DJ, Ahmend A, Ramakrishnan V: Preliminary results of subintimal angioplasty for limb salvage in lower extremities with severe chronic ischemia and limb-threatening ischemia.. J Vasc Surg 44(6): 1239-46, 2006. OBJECTIVE: This study examined the hypothesis that superficial femoral artery (SFA) subintimal angioplasty (SI-PTA) can maintain limb salvage with minimal complications in patients with symptomatic occlusive arterial disease. METHODS: From March 1, 2004, until April 28, 2006, 78 patients with rest pain (62.2%), gangrene (25.6%), or severe progressive claudication (12.2%) were treated consecutively with 82 SFA SI-PTAs (4 bilateral). The mean age was 59 +/- 1.2 years, and 21 (27%) of the patients were female. All patients were treated in the operating room under local anesthesia by using fluoroscopic guidance, and the percentage SFA that was occluded was measured during the diagnostic portion of the procedure. Selective stent placement was performed after successful recanalization of the occluded arterial segments. Patients were treated with chronic aspirin and clopidogrel bisulfate for 3 months and followed up at 30 days and then every 3 months with physical examination and arterial duplex scan. RESULTS: Of the 82 SFA SI-PTA attempts, 76 (92%) were initially successful, with an increase in the ankle-brachial index from 0.46 +/- 0.02 to 0.88 +/- 0.01 (P < .001). Five of the six patients with a failed SFA SI-PTA were female, two of the six had had previous bypass attempts, and one of the six had had a previous SFA SI-PTA attempt by another physician. Forty-nine (64%) of the 76 initially successful SFA SI-PTAs required placement of a stent, and 43 (56.5%) of the successful 76 SFA SI-PTAs required additional PTA of 1 or more arterial segments. The group treated with a successful SFA SI-PTA had 42.5% +/- 3.5% SFA occlusion, compared with 82% +/- 10% (P < .05) in the group with a failed attempt at SFA SI-PTA. Two of the six patients with initial SI-PTA failure underwent leg amputation within 30 days, three were treated with successful leg bypass surgery, and one was lost to follow-up. Of the 76 successful SFA SI-PTAs, 5 (6.5%) failed within 90 days, and the patients were treated successfully with leg bypass surgery. Of the 71 limbs with patent SI-PTAs at 90 days, 68 have remained patent with a mean follow-up 10.4 +/- 0.7 months (range, 2-24 months). Three of the 71 SFA SI-PTAs failed between 4 and 7 months (mean, 5 +/- 0.7 months): 1 patient was treated with successful bypass surgery, 1 patient is currently considering further intervention, and 1 patient was treated with amputation. Ten (14%) of the 71 successful SFA SI-PTAs required limited PTA for asymptomatic restenosis, as identified by the arterial duplex scan (7.4 +/- 1.4 months; range, 2-16 months). There were no perioperative deaths, and three patients have died during follow-up with patent SFA SI-PTAs (9.3 +/- 1.4 months). CONCLUSIONS: These data suggest that SFA SI-PTA can be successfully used for limb salvage with minimal morbidity and mortality in a group of patients with severe lower extremity occlusive vascular disease. Comments: An observational report of the experience of these authors. No controls. Those capable of a procedure had PTA. The superficial femoral was the target artery and is more likely to benefit from the procedure than tibial vessels. The greater the occlusion the more likely failure.
Nguyen LL, Moneta GL, Conte MS, Bandyk DF, Clowes AW, Seely BL; PREVENT III Investigators. Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia. J Vasc Surg 44(5):977-83, 2006. BACKGROUND: Patients with critical limb ischemia (CLI) have multiple comorbidities and limited life spans. The ability of infrainguinal vein bypass to improve quality of life (QoL) in patients with CLI has therefore been questioned. Prospective preoperative and postoperative QoL data for patients undergoing lower extremity vein bypass for CLI are presented. METHODS: A validated, disease-specific QoL questionnaire (VascuQoL) with activity, symptom, pain, emotional, and social domains and responses scored 1 (lowest QoL) to 7 (best QoL) was administered before surgery and at 3 and 12 months after lower extremity vein bypass for CLI. Changes in QoL at 3 and 12 months after lower extremity vein bypass and multiple predetermined variables potentially influencing QoL after lower extremity vein bypass were analyzed to determine the effect of lower extremity vein bypass on QoL in CLI patients. RESULTS: A total of 1404 patients had lower extremity vein bypass for CLI at 83 centers in the United States and Canada as part of the PREVENT III clinical trial. Surveys were completed in 1296 patients at baseline, 862 patients at 3 months, and 732 patients at 12 months. The global QoL score (mean +/- SD) was 2.8 +/- 1.1 at baseline and was 4.7 +/- 1.4 and 5.1 +/- 1.4 at 3 and 12 months, respectively. Mean changes from baseline at 3 and 12 months were statistically significant (P < .0001). Improved QoL scores extended across all domains. Diabetes and the development of graft-related events were associated with decreased improvement in QoL scores, though the mean relative change from baseline remained positive. CONCLUSIONS: Patients with CLI have a low QoL at baseline that is improved at 3 and 12 months after lower extremity vein bypass. QoL improvements are lower in diabetic patients and those who develop graft-related events. Successful revascularization can be expected to improve QoL in patients with CLI, with benefits that are sustained to at least 1 year.
Ouriel K, Veith FJ, and Sasahara AA: A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. N Engl J Med 338: 1105-11, 1998. Authors' abstract: Background: Recent controlled trials suggest that thrombolytic therapy may be an effective initial treatment for acute arterial occlusion of the legs. A major potential benefit of initial thrombolytic therapy is that limb ischemia can be managed with less invasive interventions. Methods: In this randomized, multicenter trial conducted at 113 North American and European sites, we compared vascular surgery (e.g., thrombectomy or bypass surgery) with thrombolysis by catheter-directed intraarterial recombinant urokinase; all patients (272 per group) had had acute arterial occlusion of the legs for 14 days or less. Infusions were limited to a period of 48 hours (mean [( SE], 24.4(0.86), after which lesions were corrected by surgery or angioplasty if needed. The primary end point was the amputation-free survival rate at six months. Results: Final angiograms, which were available for 246 patients treated with urokinase, revealed recanalization in 196 (79.7 percent) and complete dissolution of thrombus in 167 (67.9 percent). Both treatment groups had similar significant improvements in mean ankle-brachial pressure index. Amputation-free survival rates in the urokinase group were 71.8 percent at six months and 65.0 percent at one year, as compared with respective rates of 74.8 percent and 69.9 percent in the surgery group; the 95 percent confidence intervals for the differences were -10.5 to 4.5 percentage points at six months (P=0.43) and -12.9 to 3.1 percentage points at one year (P=0.23). At six months the surgery group had undergone 551 open operative procedures (excluding amputations), as compared with 315 in the thrombolysis group. Major hemorrhage occurred in 32 patients in the urokinase group (12.5 percent) as compared with 14 in the surgery group (5.5 percent)(P=0.005). There were four episodes of intracranial hemorrhage in the urokinase group (1.6 percent), one of which was fatal. By contrast, there were no episodes of intracranial hemorrhage in the surgery group. Conclusions: Despite its association with a higher frequency of hemorrhagic complications, intraarterial infusion of urokinase reduced the need for open surgical procedures, with no significant risk of amputations or death. Comments: See excerpts of the editorial comments of JAM. Porter regarding this article below. Of the 272 patients in the urokinase group, 48 had a major amputation at six months and 58 had had a major amputation at one year. For the 272 patients in the surgical group, 41 had a major amputation at six months and 51 had had a major amputation at one year. With boot therapy, we have not seen such high amputation rates except among the Wagner 5 class (those presenting with gangrene of most of the foot). Further, booting has none of the complications these authors describe... and many of the patients are treated as outpatients. See our Pneumatic Boot section and Dillon, Angiology 1997. It should be understood that Circulator Boot therapy is not designed for all patients with acute arterial insufficiency of the legs. A patient, for example with a saddle embolus blocking both iliac arteries is not a candidate for boot therapy; the embolus must be removed. The physician does well to remember the analogy of the sponge: squeezing a half-wetted sponge will disseminate the water through the whole sponge while squeezing a dry sponge does nothing. A leg with little or no inflow of arterial blood at the groin is generally not a leg for boot treatment. On the other hand, we have treated some such patients placing them in high reverse Trendelenburg and pumping them at 20 to 30 compressions a minute in the "automatic mode" to maintain the patency and integrity of the leg vessels while awaiting a decision for vascular surgery.
Pell JP, Whyman MR, Fowkes FG, Gillespie I, Ruckley CV: Trends in vascular surgery since the introduction of percutaneous transluminal angioplasty. Br J Surg 81(6):832-5, 1994. Lower-limb percutaneous transluminal angioplasty (PTA) has been used increasingly over the past decade, either alone or in conjunction with arterial reconstructive surgery. However, its impact on operation rates has not been evaluated properly. Rates of vascular operations and PTAs performed per referral for peripheral arterial disease to the regional vascular service at The Royal Infirmary, Edinburgh, were calculated for the years 1986-1992. The overall rate of PTA for peripheral arterial disease increased ninefold over this period; that for critical ischaemia increased fivefold. Rates of aortic and femoral reconstruction for all peripheral arterial disease increased by 40 and 100 per cent respectively, but rates for critical ischaemia remained static. The major amputation rate rose by 47 per cent between 1986 and 1990, and thereafter reached a plateau. Increased use of PTA was not associated with a reduction in the number of vascular operations.
Pomposelli FB, Jepsen SJ, Gibbons GW, et al: Efficacy of the dorsal pedis bypass for limb salvage in diabetic patients: short term observations. J Vasc Surg 11:745-752, 1990. Diabetics with distal tibial disease may by shown to have a patent dorsalis pedis with intraarterial digital substraction angiography (91/92 bypassed). A continuous wave Doppler signal may also signify patency (6 of 12 successfully bypassed). At 18 months, actuarial graft patency 82%, limb salvage 87% and patient survival 80%.
Pomposelli FB, Marcaccio EJ, Gibbons GW, Campbell DR, Freeman DV, Burgess AM, Miller A and LoGerfo FW: Dorsalis pedis arterial bypass: durable limb salvage for foot ischemia in patients with diabetes mellitus. J Vasc Surg 21: 375-384, 1995. An effective limb salvage procedure with long-term durability comparable to distal vein grafts placed into more proximal arteries.Comments: This group makes it to the podium at many meetings on foot care. At one such meeting held last year in Philadelphia, they showed something similar to the slide below. The idea was that the presence of neuropathy decreases the tissue perfusion at any given level of blood pressure. Hence, they argued, it made sense to raise the perfusion pressure by bypass surgery when possible. In my adaptation of their slide, I have added (a) "low % bypass" in the left of the slide indicating that the success rates of bypass decrease as the severity of the distal arteriosclerosis increases, (b) "high % bypass" on the right of the slide indicating that bypasses are more successful the more normal the vasculature, and (c) "healing common" on the top right of the slide, indicating that with bedrest healing is common and expected in well vascularized neuropathic feet without bypass surgery. One wonders about the desirability of increasing pressure where it is not needed. The bypassed segment lacks the normal vasomotor regulation of the normal vessel and especially in the erect position delivers high flow under high pressure. Both are risk factors for occlusive arteriosclerotic disease.

Perfusion Pressure, Degree of Neuropathy and ?Bypass Surgery
Porter JM: Thrombolysis for acute arterial occlusions of the legs. Editorial, N Engl J Med 338: 1148-1149, 1998. Commenting on the TOPAS trial (Ouriel et al above), Porter notes the trial included all forms of limb-threatening ischemia .... arterial embolism, native-artery thrombosis, prosthetic-graft thrombosis and vein-graft thrombosis... and questioned if the patients were too heterogeneous to analyze together. Next, Porter questioned the end-point of the TOPAS study: amputation-free survival at six months. He pointed out the report of Blaisdell and associates (Surgery 84:822-34, 1978) who showed that two-thirds of patients with acute critical limb ischemia were spared leg amputation with heparin anticoagulation alone. Again, he referred to the report of Shuler et al (J Vas Surg 1:160-70, 1984) who found that 50 percent of their placebo patients with ischemic limb ulcers healed or improved as did most of their patients with ischemic rest pain. Porter's point here was that possibly well over half of the patients in the TOPAS trial might have been spared amputation without either thrombolysis or surgery. Porter goes on to question whether the centers in the TOPAS trial had some form of selection bias; the 113 centers acquired their patient population very slowly at the rate of 1 patient per center every 3.5 months. Were there many eligible patients not entered into the study? Next, Porter notes that the immediate patency rate achieved by thrombolysis was similar to that in other reports (65-70 percent) but that the published one-year patency rates of 30-40 percent were "dismal results indeed." Porter expressed concern about the bleeding complications associated with thrombolysis: 12.5 percent with major bleeding and one death. In considering the costs of thrombolysis versus surgery, Porter noted an earlier report of Ouriel (J Vasc Surg 19: 1021-30, 1994) showing that the costs of thrombolytic therapy was 25 percent higher than surgery. Porter noted the "only apparent benefit of thrombolysis in the TOPAS trial involved a secondary end point: fewer patients in the thrombolysis group required open surgical procedures." He found this result not surprising as most patients assigned to a surgical approach may be expected to have a surgical approach. After further observations, Porter concluded, " For the time being, I do not regard thrombolytic therapy as first-line treatment for acute arterial thromboembolism of the legs."
Raby KE, Goldman L, Creager MA, Cook EF et al: Correlation between preoperative ischemia and major cardiac events after peripheral vascular surgery. N Engl J Med 321:1296-1300, 1989. Abstract: Patients who undergo peripheral vascular surgery are at increased risk for postoperative cardiac events and are difficult to assess preoperatively because of limitations on their activity. We prospectively studied 176 consecutive eligible patients undergoing elective vascular surgery to determine the value in predicting a postoperative cardiac event of preoperative electrocardiographic monitoring to detect myocardial ischemia. Of the 176 patients, 32 (18 percent) had 75 episodes of monitored ischemic ST-segment depression preoperatively (of which 73 were asymptomatic), and 13 (7 percent) met strict criteria for major postoperative cardiac events, including 1 with a fatal myocardial infarction, 3 with nonfatal infarctions, 4 with unstable angina, and 5 with ischemic pulmonary edema. Of the 32 patients with ischemia before their operations, 12 had postoperative events (univariate relative risk, 54; 95 percent confidence interval, 7.2 to 400). Only 1 postoperative event occurred among 144 patients who did not have preoperative ischemia. The sensitivity of preoperative ischemia was 92 percent, the specificity 88 percent, the predictive value of a positive result 38 percent, and the predictive value of a negative result 99 percent. In multivariate analyses, preoperative ischemia was the most significant correlate of postoperative cardiac events and remained a statistically significant independent correlate even after we had controlled for all other preoperative factors (multivariate relative risk, 24.4; 95 percent confidence interval, 6.8 to 88) . These preliminary data suggest that preoperative electrocardiographic monitoring to detect episodes of myocardial ischemia is a useful method for assessing cardiac risk in patients who undergo elective vascular surgery. In particular, the absence of ischemia during monitoring indicates a very low risk.
Rafferty TD et al: A metropolitan experience with infrainginal revascularization. Operative risks and late results in northeastern Ohio. J Vasc Surg 6:365-471, 1987. For patients with rest pain or gangrene vs disabling claudication operative risk 5% vs 0.6%, early amputation rate 7% vs 0% and 5-year survival 48-55% vs 77%... 3 year patency rate with autogenous vein 43% for tibialperoneal bypass.
Ramani R, Kundaje GN and Nayak MN: Hemorheologic approach in treatment of diabetic foot ulcers. Angiology 44:623-626, 1993. Healing of diabetic foot ulcers after eight weeks improved after pentoxifylline therapy and less mutilating surgery required. (Maniper, India).
Vasa. 2010 Aug;39(3):229-36. Acute and long-term outcome of Silverhawk assisted atherectomy for femoro-popliteal lesions according the TASC II classification: a single-center experience. Sixt S, Rastan A, Beschorner U, Noory E, Schwarzwälder U, Bürgelin K, Schwarz T, Müller C, Hauk M, Brantner R, Möhrle C, Linnemann B, Macharzina R, Neumann FJ, Zeller T. Department of Angiology, Heart Centre Bad Krozingen, Bad Krozingen, Germany. Sebastian.sixt@herzzentrum.de Abstract BACKGROUND: Directional atherectomy (DA) has become popular in some centers to remove atherosclerotic plaques in femoro-popliteal lesions. Although immediate and also short - term outcome data are promising, solid long-term data are warranted to justify the widespread use in daily practice. PATIENTS AND METHODS: In this prospective study de novo and restenotic lesions of the femoro-popliteal segments were treated with the Silverhawk device. 161 consecutive patients (164 lesions) with peripheral artery disease (PAD) Rutherford classes 2 to 5 were included from June 2002 to October 2004 and October 2006 to June 2007 (59 % male, mean age 67 +/- 11 years, range 40 to 88) and the outcome analyzed according to the TASC II classification. RESULTS: DA alone was performed successfully in 28 % (n = 46), adjunctive balloon angioplasty in 65 % (n = 107) and stenting in 7 % (n = 11). The overall technical success rate was 76 % (124 / 164) and the procedural success rate 95 % (154 / 164). At 12 months primary patency rate was 61 % (85 / 140) and the secondary patency rate was 75 % (105 / 140) in the entire cohort, being less favourable in TASC D compared to TASC A to C lesions (p = 0.034 and p < 0.001, respectively). Furthermore the restenosis rate differed trendwise (p = 0.06) between de novo and restenotic lesions. Changes in the ABI and the Rutherford classes were significantly in favour of TASC A to C lesions compared to TASC D after 12 months (p = 0.004). The event free survival (MI, TIA, or restenosis) was 48 % at 12 months and 38.5 % at 24 months. Predictor for restenosis in the multivariable analysis was only male gender (p=0.04). CONCLUSIONS: The results in TASC D lesions are inferior to those in the lesser stages. DA of femoro-popliteal arteries leads shows a trend to better long-term technical and clinical outcome in de novo lesions compared to restenotic lesions.
Reifsnyder T, Grossman JP, Leers SA: : Limb loss after lower extremity bypass. Am J Surg 174:149-151, 1997. Abstract: Methods: A retrospective chart review of all patients undergoing a major amputation lower extremity amputation after attempted bypass. Results: Between July 1987 and January 1997, 67 major amputations (52 below knee, 15 above knee) followed infrainguinal bypass for limb salvage in 64 patients. Of these patients, 53 (83%) were diabetic and 10 (16%) were on dialysis. The etiology of limb loss included thrombosed bypass (n=33, 49%), lack of limb salvage despite patent bypass (n=23, 34%), intraoperative bypass failure (n=6, 9%), and exposed/infected bypass (n=5, 8%). The 23 patients with patent grafts required amputations because of hind foot necrosis (n=6), persistent forefoot necrosis (n=6), and various other reasons (n=5). Using life-table analysis, survival for the whole group was 56% at 12 months and 17% at 48 months. Patients with limb loss despite a patent bypass fared the worst with survival of 21% at 2 years. Conclusions: Bypass thrombosis caused half of the amputations after limb salvage surgery. A patent bypass was functioning at the time of amputation in another third. Survival after failure of limb salvage was abysmal, especially in patients with patent bypasses.
Repelaer-an-Driel OJ et al: Lumbar sympathectomy for severe lower limb ischemia: results and analysis of factors influencing outcome. J Cardiovasc Surg (Torino) 29:310-314, 1988. Among 66 consecutive patients with rest pain or gangrene relief of pain and healing seen in 48% of patients. All had arm/ankle indices >0.3...others had major amputation.
Robinson JG, Cross MA, Brothers TE and Elliott BM: Do results justify an aggressive strategy targeting the pedal arteries for limb salvage? J Surg Research 59:450-454, 1995. The authors began a policy of bypassing all significant popliteal and tibial disease in the setting of limb-threatening ischemia beginning in September, 1986. Of 194 infrapopliteal bypasses performed for limb salvage during the ensuing six years, 111 (57%) autogeneous vein bypasses were performed to the pedal vessels at or distal to the ankle. By life table analysis, primary graft patency at 60 months for pedal bypasses was 57%, with salvage of failed grafts resulting in patency of 61%. Limb salvage was 64% at 60 months. Of 33 graft thromboses, 24 (73%) resulted in eventual limb loss. Five limbs were amputated due to wound complications or progressive forefoot sepsis despite patent pedal grafts. More bypasses were performed to the dorsalis pedis than the posterior tibial at the ankle (78 vs 33), but patency and limb salvage were similar. Bypasses to the pedal arteries resulted in superior limb salvage compared with the peroneal bypass when forefoot tissue necrosis was present (63 vs 33% at 36 months, P=0.048). Pedal grafts had comparable overall patency (57 vs 64%) and limb salvage (64 vs 75%) to more proximal tibial bypasses. Comments: Limb salvage 64% and limb loss 36%?
Rosman HS, Davis TP, Reddy D, Goldstein S: Cholesterol embolization: clinical findings and implications. J Am Coll Cardiol 15:1296-9, 1990. The clinical characteristics of 13 patients with cholesterol embolization are described. Embolization occurred spontaneously in 2 patients and after a vascular procedure in 11. Acute but vague symptoms were reported by 11 of the 13 patients; skin findings of purple toes or livedo reticularis and renal dysfunction were present in 12 patients, 5 of whom required dialysis. Blood pressure elevation occurred in all 13 patients, eosinophilia in 9 of 10 and elevated sediment rate in 5 of 6. Death occurred within 6 months in three patients. Two distinct patterns were observed: mild (five patients) and severe (eight patients). Compared with the severe pattern, patients with mild cholesterol embolization had early symptoms less frequently (two of five versus eight of eight), less severe renal insufficiency (serum creatinine 1.7 versus 7.4 mg/100 ml), less of an increase in blood pressure (22 versus 34 mm Hg) and later development of skin lesions (14 versus 6 weeks). Baseline blood pressure and development of eosinophilia were comparable in both groups. The presentation of cholesterol embolization is often subtle and may go unrecognized, particularly in its mild form. As vascular interventions increase in elderly atherosclerotic and hypertensive patients, so too will the incidence of this disorder.
Rossi E, Citterio F, Castagneto M, Pennestri F and Loperfido F: Safety of endovascular treatment in high-cardiac-risk patients with limb-threatening ischemia. Authors' abstract: Vascular surgery can be safely performed in approximately 60% of patients with advanced peripheral vascular disease, because of the high frequency of concomitant coronary artery disease and consequent increased risk of perioperative cardiac complications. The aim of this study was to validate the hypothesis that endovascularization could be safely applied to high-risk-cardiac patients with a lower incidence of perioperative cardiac complications. One hundred and fourteen patients with peripheral vascular disease referred for revascularization underwent preoperatively a clinical and echocardiographic evaluation, at rest and under dipyridamole stress test, to assess the cardiac risk. Patients with a high clinical score (according to Goldman and Detsky), or low left ventricular ejection fraction at rest, or positive dipyridamole stress test, were considered high cardiac risk. To record adverse cardiac events, all patients were monitored during surgery, postoperatively, and followed up for 18 months after hospital discharge. Forty eight patients (42%) were found to be at high cardiac risk. In this high-cardiac-risk group, endovascular surgery was performed in 37/48 patients (77%)(group A), while the remaining 11/48 (23%) were bypassed with open surgery (group B). Postoperative cardiac complications occurred in 16% of patients in group A and in 45% of patients in group B with two deaths (p<0.05). At follow-up, 51% of patients in group A and 44% of patients in group B has suffered late cardiac events (p=ns). , with ten deaths in group A and three deaths in group B (p=ns). Limb salvage rate was similar in the two groups (95% group A, 100% group B; p=ns). These data show that high-cardiac-risk patients with limb-threatening ischemia have significantly less perioperative cardiac complications when treated by endovascular procedures instead of bypass surgery. Follow-up data on cardiac events confirm the severity of concomitant coronary artery disease in patients with peripheral vascular disease. > Comments: Yes, the postoperative complication rate was lower in the patients treated with endovascular surgery.... but was still 16%. In contrast, therapy with the Circulator Boot has no immediate post-treatment morbidity.
Rua I, Calligaro KD, Dougherty MJ, Raviola CA, Doerr K, McAfee-Bennett S, DeLaurentis DA: Is balloon angioplasty indicated for "short" stenoses of failing vein grafts? Ann Vasc Surg 12(2):134-7, 1998. Previous reports have suggested "short" focal stenoses in peripheral vein grafts (PVGs), namely less than 2 cm long, can be successfully balloon dilated with good long-term patency rates. We questioned if enthusiasm for balloon angioplasty of these lesions in failing PVGs is warranted. Between August 1, 1993 and December 31, 1996, we performed balloon angioplasty of "short" stenoses in 19 PVGs in 16 patients. Bypasses included seven femoropopliteal, six femorotibial, and six popliteal-tibial or -pedal PVGs. All bypasses were originally performed for limb salvage. Single lesions were present in 13 grafts and two lesions in six grafts. Ten lesions were located at an anastomosis, 10 were located in the body of the graft, and five were peri-anastomotic. Fifteen procedures were performed percutaneously. Four angioplasties were performed using an open surgical approach because a percutaneous attempt failed in one case and three grafts were either in situ or tunneled subcutaneously making them easy to expose. Completion arteriogram documented excellent initial results in all 19 grafts. Cumulative one-year primary patency rate was 39%. The assisted primary patency rate at one year was 73%. Only five grafts remained patent 7-20 months (mean, 10 months) during follow-up without requiring further revision. One patient died with a patent graft 23 months post-balloon angioplasty. Complications included two hematomas following a percutaneous approach that required surgical repair. These results when compared to publications detailing patency following surgical revision suggest that balloon angioplasty of "short" stenoses less than 2 cm long in PVGs may be better treated by surgical revision. We reserve balloon angioplasty for "short" lesions when surgical revision is associated with inordinate difficulty such as a scarred groin wound in an obese patient.

Rutherford RB: Standards for evaluating results of interventional therapy for peripheral vascular disease. Circulation 83(2 Suppl):I6-11, 1991. Uniform standards for evaluating and reporting the results of therapeutic interventions for peripheral vascular disease are clearly needed. They are already established for vascular surgery, as represented by several reports by SVS/ISCVS committees, but they are not always followed by vascular surgeons and have been largely ignored by other vascular interventionists. In this article, the major problematic reporting practices are discussed and illustrated, and 14 recommendations are advanced to deal with them. They are intended to provide precise definitions, objective criteria of success or failure, standardized severity gradation schemes for peripheral vascular disease and its risk factors, and proper procedures for reporting the outcome of all forms of therapeutic intervention. Until these or some other agreed upon reporting standards are accepted and followed, the literature on peripheral vascular disease and its management will continue to be a source of confusion rather than enlightenment. Clinical Categories of Acute Limb Ischemia

Category

Description

Capillary return

Muscle weakness

Sensory Loss

Arterial Doppler

Venous Doppler

Viable

Not immediately threatened

Intact

None

Audible, ankle BY>30mmHg

Audible

Threatened

Salvageable if promptly treated

Intact, slow

Mild, partial

Mild, incomplete

Inaudible

Audible

Irreversible

Major tissue loss, amputation regardless of treatment

Absent (marbling)

Profound, paralysis (rigor)

Profound, anesthetic

Inaudible

Rutherford RB: Clinical Categories of Chronic Limb Ischemia

Grade

Category

Clinical Description

Objective criteria

Asymptomatic - No hemodynamically significant occlusive disease

Normal treadmill or stress test

Mild claudication

Completes treadmill exercise*; Postexercise ankle blood pressure >50 mm Hg but >25 mm Hg less than normal

Moderate claudication

Between categories 1 and 3

Severe claudication

Cannot complete treadmill exercise; post exercise ankle blood pressure <50 mm Hg

Ischemic rest pain

Resting ankle pressure =<40 mm HG; Flat or barely pulsatile ankle metatarsal plethysmographic tracing (PVR); toe pressure <30 mm Hg

III

Minor tissue loss - nonhealing ulcer; focal gangrene with diffuse pedal ischemia

Resting ankle pressure =<60 mm Hg; ankle or metatarsal PVR flat or barely pulsatile; toe pressure <40 mm Hg

III

Major tissue loss - extending above TM level; functional foot no longer salvageable

Same as category 5

* 5 minutes at 2 mph on a 12 degree incline

Sayers RD, Thompson MM, Varty K, Jager C and Bell PRF: Changing trends in the management of lower limb ischaemia: a 17-year review. BR J Surg 80: 1269-1273, 1993. Over the 17 year period, 2930 vascular procedures were performed for chronic lower limb occlusive disease. The major lower limb amputation rate did not change but there was a decrease in the AK to BKA ratio. In addition there was an increase in the percentage of patients over age 75 and in the attempted proportion of attempted bypass procedures before amputation. The mortality rates for amputation, bypass and angioplasty did not change. The duration of hospitalization for amputations increased while that for reconstruction decreased.
Sayers RD, Thompson MM, Hartshorne T, Budd JS and Bell PRF: Treatment and outcome of severe lower-limb ischemia. British J Surg 81:521-523, 1994. 232 severely ischemic legs in 209 patients... rest pain in 47%, tissue necrosis and/or gangrene 53%, median ABI 45 and 68% with an ABI < 50%. Revascularization attempted in 89 % legs, primary amputation rate 8%, 30-day limb salvage rate 79% and patient morality 20%. One and 2-year salvage rates 74% and 71% and survival rates 75 and 73%.
Schneider PA, Caps MT, Ogawa DY, Hayman ES: Intraoperative superficial femoral artery balloon angioplasty and popliteal to distal bypass graft: an option for combined open and endovascular treatment of diabetic gangrene. J Vasc Surg 33(5):955-62, 2001. PURPOSE: The purpose of this study was to evaluate the results of combining intraoperative balloon angioplasty (IBA) of the superficial femoral artery (SFA) with distal bypass graft originating from the popliteal artery as a method of lower extremity revascularization in diabetic patients with gangrene. METHODS: Among 380 infrainguinal bypass grafts performed over a 6-year period, there were 110 reversed saphenous vein bypass grafts to the tibial or pedal arteries to treat diabetic patients with gangrene. Diffuse infrainguinal disease was treated with femoral-distal bypass graft (long; n = 46). Popliteal-distal bypass graft was performed when the inflow femoral artery was not significantly diseased (short; n = 52). Focal SFA stenosis and severe infrageniculate disease were treated with combined IBA of the SFA and distal bypass graft originating from the popliteal artery (combined; n = 12). Follow-up was performed with duplex scan surveillance of both the bypass graft and IBA sites. Treatment groups were compared with life-table analysis. RESULTS: There were no perioperative graft failures or amputations. The perioperative mortality rate was 1% (1 of 110). The 2-year primary patency rates were similar in the three groups: 72% in the long bypass graft group, 82% in the short bypass graft group, and 76% in the combined group (P =.8, log-rank test). SFA IBA sites developed recurrent stenosis in two patients, at 7 and 48 months; both were detected with surveillance and treated with percutaneous transluminal balloon angioplasty. The overall 5-year rate of primary patency was 63%, secondary patency was 78%, limb salvage was 81%, and survival was 35%. There were no significant differences among the three treatment groups with respect to these outcomes. CONCLUSION: Results with the combined procedure were similar to those achieved with either femoral-distal bypass graft or popliteal-distal bypass graft without SFA IBA. These data suggest that IBA of the inflow SFA may be combined with popliteal to distal bypass graft and that this technique is a reasonable alternative to longer, femoral-origin bypass graft in selected diabetic patients with gangrene.
Schwarzwalder U, Zeller T Below-the-knee revascularization. Advanced techniques. J Cardiovasc Surg (Torino) 50:627-34, 2009. This review summarizes new developments in revascularization and advanced techniques to treat lesions below the knee (BTK). The primary goal of endovascular therapy is the re-establishment of pulsatile, straight-line flow to the foot. This treatment results in relieving ischemic pain, healing of (neuro)ischemic ulcers, preventing limb loss, improving quality of life and potentially prolong survival. Balloon angioplasty is the currently established therapy, bare-metal stents are reserved for failed percutaneous transluminal angioplasty (PTA). Novel devices such as laser, excisional and rotational atherectomy systems, drug eluting stents or drug coated balloons still lack data demonstrating improved efficacy compared to conventional balloon angioplasty. The typical patient group of complex below-the-knee lesions represents an increasing population due to the increasing prevalence of diabetes and end-stage renal failure. Excellent acute technical success rates above 90%, a low frequency of complications, and high limb salvage rate of about 95% even in patients with long segment and diffuse disease seem to justify a more widespread use of endovascular therapy in tibial arteries. However, the current results of balloon angioplasty studies show a 1-year restenosis rate between 30% for short stenoses treatment and up to 80% following recanalization of an occlusion. Comments: These relapse rates are to be compared with those reported by Dillon for his 2177 treatment episodes with the Circulator Boot: a initial relapse overall in 21.6%, a second relapse in 7.3% and a third relapse in 3.3% (http://www.circulatorboot.com/literature/angiology1.html).
Shah DM, Chang BB, Fitzgerald KM, Kaufman JL and Leather RP: Durability of the tibial bypass in diabetic patients. AM J Surg 156:133-135, 1988. In situ tibial bypass patent in diabetic 91% (1 year) and 74% (5 years) vs 90 and 76% for nondiabetics. Salvage rates 96% (1 year) and 86% (5 years) for diabetics vs 99 and 94% for non diabetics.
Silvestro A, Diehm N, Savolainen H, Do DD et al: Falsely high ankle-brachial index predicts major amputation in critical limb ischemia. Vasc Med 11: 69-74, 2006. Falsely high ankle-brachial index (ABI) values are associated with an adverse clinical outcome in diabetes mellitus. The aim of the present study was to verify whether such an association also exists in patients with chronic critical limb ischemia (CLI) with and without diabetes. A total of 229 patients (74 +/- 11 years, 136 males, 244 limbs with CLI) were followed for 262 +/- 136 days. Incompressibility of lower limb arteries (ABI > 1.3) was found in 45 patients, and was associated with diabetes mellitus (p = 0.01) and renal insufficiency (p = 0.035). Limbs with incompressible ankle arteries had a higher rate of major amputation (p = 0.002 by log-rank). This association was confirmed by multivariate Cox regression analysis (relative risk [RR] 2.67; 95% CI 1.27-5.64, p = 0.01). The relationship between ABI > 1.3 and amputation rate persisted after subjects with diabetes and renal insufficiency had been removed from the analysis (RR 3.85; 95% CI 1.25-11.79, p = 0.018). Dividing limbs with measurable ankle pressure according to tertiles of ABI, the group in the second tertile (0.323 < or = ABI < or = 0.469) had the lowest amputation rate (4/64, 6.2%), and a U-shaped association between the occurrence of major amputation and ABI was evident. No association was found between ABI and mortality. In conclusion, this study demonstrates that falsely high ABI is an independent predictor of major amputation in patients with CLI. Comments: Obviously, an elevated ABI must be interpreted with care and the possibility of ischemia not dismissed too quickly as might happen, for example, in a patient with a swollen painful red foot attributed to gout. The study does not include all comers: those having a major amputation during their initial hospitalization were excluded (18 of their 299 patients). Treatments offered to the patients included bypass and angioplasty procedures only (no Circulator Boot). Hemodynamic success after these procedures was defined by an increase in the ABI of 0.1 or in the case of the incompressible artery, an increase in toe pressure greater than 10 mmHg, hardly impressive changes. This study may be unique among revascularization reports: there is a potential control group. Forty-five patients (about equal numbers with ABI's above and below 1.3) had no revascularization procedure. Eighty-two % of the revascularization procedures were angioplasties and 27% open-surgical. The procedures produced no hemodynamic improvement in 21%. The authors lump those amputation patients having no revascularization procedure (10) with those who had a failed revascularization procedure (9) and show in their table that these 19 comprise 50% of those having a major amputation. Such a lumping could be justified if the attempted revascularization procedure in no way compromised the legs. If one places the failed procedures in the angioplasty group, 65% of the amputations are then found in the angioplasty group and 26% in the no procedure group. Again, ten of the 45 (22%) "no procedure" group came to amputation . The "no procedure group" may have done best even without a boot. The moral of the article: beauty is in the eyes of the beholder.
Simosa H, Pomposelli F, Dahlberg S et al: Predictors of failure after angioplasty of infrainguinal vein bypass grafts. J Vasc Surgery 49:117-121, 2009. Abstract: Objective: Percutaneous transluminal angioplasty (PTA) has had an expanding role as primary therapy for vein graft stenosis with variable results. The aim of this study is to identify patient and graft characteristics predictive of failure after PTA of infrainguinal vein grafts. Methods: Retrospective review from Jan 2004 to Mar 2007 of patients undergoing angioplasty for failing grafts. Demographics, comorbidities, procedural data, and follow-up information were recorded. PTA failure was defined as first significant event including restenosis by duplex scan (>3.5 × velocity ratio), occlusion, redo-PTA, surgical revision, or amputation. Descriptive, logistic regression and life-table analyses were performed. Results: Eighty-seven grafts in 79 patients underwent PTA. Mean age was 70 years (median 70; range, 39-89 years), 71% were male and 52% were symptomatic (40% with limb-threat). Mean follow-up was 17 months (median 17.4; range, 0.03-39.8 months). Freedom from PTA failure was 58% (standard error [SE] 0.0574) at 12 months. Predictors of PTA failure by multivariate analysis were: time from bypass <3 months (hazard ratio [HR] 5.8; 95% confidence interval [CI] 1.91-18.0; P = .002), stenosis length >2 cm (HR 2.7; 95% CI 1.33-5.83; P = .007) and multiple stenoses (HR 2.5; 95% CI 1.29-5.1; P = .007). PTA patency for grafts with favorable lesions (single, less than 2 cm lesions in grafts older than 3 months) was 71% vs 35% for unfavorable lesions at 12 months. Limb-salvage was 95% and 90% and overall survival was 92% and 81% at 12 and 24 months, respectively. Conclusion: PTA of failing infrainguinal vein grafts is a reasonable primary therapy for favorable lesions. Early graft stenosis, long, and multiple stenoses are markers for procedural failure and are better served with surgical revision. Comments: We likely would have booted many of their successes and failures.
Sixt S, Rastan A et al:Acute and long-term outcome of Silverhawk assisted atherectomy for femoro-popliteal lesions according the TASC II classification: a single-center experience. Vasa 39:229-36, 2010. Abstract: BACKGROUND: Directional atherectomy (DA) has become popular in some centers to remove atherosclerotic plaques in femoro-popliteal lesions. Although immediate and also short - term outcome data are promising, solid long-term data are warranted to justify the widespread use in daily practice. PATIENTS AND METHODS: In this prospective study de novo and restenotic lesions of the femoro-popliteal segments were treated with the Silverhawk device. 161 consecutive patients (164 lesions) with peripheral artery disease (PAD) Rutherford classes 2 to 5 were included from June 2002 to October 2004 and October 2006 to June 2007 (59 % male, mean age 67 +/- 11 years, range 40 to 88) and the outcome analyzed according to the TASC II classification. RESULTS: DA alone was performed successfully in 28 % (n = 46), adjunctive balloon angioplasty in 65 % (n = 107) and stenting in 7 % (n = 11). The overall technical success rate was 76 % (124 / 164) and the procedural success rate 95 % (154 / 164). At 12 months primary patency rate was 61 % (85 / 140) and the secondary patency rate was 75 % (105 / 140) in the entire cohort, being less favourable in TASC D compared to TASC A to C lesions (p = 0.034 and p < 0.001, respectively). Furthermore the restenosis rate differed trendwise (p = 0.06) between de novo and restenotic lesions. Changes in the ABI and the Rutherford classes were significantly in favour of TASC A to C lesions compared to TASC D after 12 months (p = 0.004). The event free survival (MI, TIA, or restenosis) was 48 % at 12 months and 38.5 % at 24 months. Predictor for restenosis in the multivariable analysis was only male gender (p=0.04). CONCLUSIONS: The results in TASC D lesions are inferior to those in the lesser stages. DA of femoro-popliteal arteries leads shows a trend to better long-term technical and clinical outcome in de novo lesions compared to restenotic lesions.
Smith WJ, Jacobs RL and Fuchs MD: Salvage of diabetic foot with exposed os calcis. Clinical Ortho and Res Res Number:296:71-77, 1993. Fifty consecutive heel ulcers managed with debridements, split-thickness skin graft, bypass procedures and orthotics. Healing occurred in 56.3% of 24 diabetics with PVD, 64.3% of 14 with diabetes only, and 83% of 12 with PVD only. 27% of the combined diabetic groups required partial excision of the Os calcis to facilitate closure; 40% of this group healed, 30% remained open and 30% were amputated. An average of 2.2 procedures were performed per patient and follow-up periods were for a minimum of 2 years or until amputation.
Söder HK, Manninen HI et al: Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 11(8):1021-31, 2000. PURPOSE: To evaluate the safety and efficacy of infrapopliteal percutaneous transluminal angioplasty (PTA) as a primary treatment of chronic critical limb ischemia in a prospective trial. MATERIALS AND METHODS: Infrapopliteal PTA was performed on 72 limbs of 60 patients (mean age, 72 y; range, 38-92 y) and patients were followed for 12-24 months. RESULTS: The primary angiographic success rate for the stenoses was 84% (102 of 121) and that for the occlusions was 61% (41 of 67) with corresponding restenosis rates of 32% and 52% at follow-up angiography performed a mean of 10 months after primary PTA. The rate of major complications was 2.8% (access site pseudoaneurysms in two patients). The primary clinical success was 63% (45 of 72). A 48% cumulative primary patency rate, a 56% secondary patency rate, and a 80% cumulative limb salvage rate were registered at 18 months, as determined with use of Kaplan-Meier analysis. Lack of angiographic improvement at the site of the most severe ischemia and renal insufficiency (serum creatinine level > 130 micromol/L) were independent predictors of poorer long-term clinical results, as determined with use of Cox multiple regression analysis. CONCLUSIONS: Infrapopliteal PTA is a feasible primary treatment of chronic critical limb ischemia with moderate primary angiographic and clinical success, a low complication rate, and a cumulative limb salvage rate comparable with surgical techniques.
Söderström M, Arvela E, Aho PS et al: High leg salvage rate after infrainguinal bypass surgery for ischemic tissue loss (Fontaine IV) is compromised by the short life expectancy. Scand J Surg 99:230-4, 2010. Abstract: BACKGROUND AND AIMS: Most studies analysing the prognosis of infrainguinal bypass surgery (IBS) in patients with critical leg ischemia (CLI) have combined the outcome of patients with rest pain and tissue loss. The aim of the present study was to evaluate amputation-free survival (AFS) after IBS in patients with the most advanced form of peripheral arterial disease, CLI with tissue loss (Fontaine IV), and to analyse the risk factors for an adverse outcome. PATIENTS AND METHODS: 636 patients with CLI and tissue loss who underwent unilateral IBS between January 2000 and December 2006 at our institution were included in this retrospective study. RESULTS: At one year, the leg salvage, survival and amputation-free survival rates were 83%, 71% and 55%, respectively, and at five years 76%, 38% and 30%, respectively. In univariate analysis, diabetes was associated with decreased AFS. In multivariate analysis, age, coronary artery disease, chronic pulmonary disease, gangrene and renal insufficiency were independent risk factors for decreased AFS. CONCLUSION: Infrainguinal bypass grafting results in a high rate of leg salvage. Amputation-free survival was low during the follow-up due to the high mortality of patients with CLI and tissue loss. Several co-morbidities of the CLI patients were associated with decreased amputation-free survival.
Soong CV, Young IS, Lightbody JH, Hood JM, Rowlands BJ, Trimble ER and Barros D'Sa AAB: Reduction of free radical generation minimizes lower limb swelling following femoropopliteal bypass surgery. Eur J Vasc Surg 8: 435-440, 1994. Decreased swelling and malondialdehyde (an end product of lipid peroxidation) seen in group treated with allopurinol.
Stamou SC: Editorial. Stroke and Encephalopathy After Cardiac Surgery. The Search for the Holy Grail. Stroke 37: 284, 2006. The incidence of clinically obvious strokes after coronary artery bypass graft operations (CABG) is reported to be between 0.8% and 5.2%. It is estimated that between 5000 and 35 000 new strokes develop as a result of this procedure, which possibly makes coronary artery bypass surgery the single largest cause of iatrogenic stroke in the United States.1 The typically poor postoperative course of patients who develop stroke after cardiac surgery underlines the need for timely recognition, prevention/modification of factors that predispose to stroke. In the present study, McKhann et al2 are touching on the mechanisms, risk factors and outcomes of postoperative stroke after cardiac surgery. They also suggest possible algorithms for management of postoperative stroke and ways to prevent the occurrence of stroke after cardiac surgery. Previous authors have identified several preoperative, intraoperative, and postoperative risk factors of stroke after cardiac surgery, such as episodes of hypotension during or after the operation (requiring inotropic support or placement of intra-aortic balloon pump), atrial fibrillation, carotid artery disease, history of cerebrovascular accident, manipulation of aorta and others. Preventive strategies such as routine screening of patients for carotid artery disease with carotid duplex are useful. The application of diffuse-weighted MRI to diagnose silent brain infarcts will be more cost effective if applied to the patients identified as high-risk for postoperative stroke, such as elderly patients, patients with low ejection fraction, atrial fibrillation, diabetes, hypertension, and carotid artery disease. This subset of patients will benefit the most by intraoperative maneuvers, such as use of epiaortic scanning, the "no touch" technique to avoid manipulation of the aorta, higher perfusion pressures or use of arterial line filters. Previous studies have suggested that coronary bypass surgery without cardiopulmonary bypass is associated with a lower risk of stroke.3,4 To date, there is no randomized trial evidence to suggest a lower incidence of stroke after off-pump surgery. The timing of occurrence of stroke is different between the 2 approaches suggesting different pathophysiologic mechanisms. Embolic phenomena have been previously implicated in the pathophysiology of stroke after On-pump CABG, whereas myocardial stunning and hypoperfusion may be possible mechanisms associated with delayed onset of stroke after Off-pump CABG.4 The timely administration of platelet inhibitors and/or perioperative anticoagulation, as well as prevention of hypotensive episodes may be indicated in Off-pump CABG as preventive measures against delayed onset of stroke. Moreover, the occurrence of clinically obvious stroke, the outcome measure of most studies, likely represents only the tip of the iceberg. Postoperative cognitive impairment that may not necessarily fall under the rubric of "stroke," possibly represent multiple territory cerebral microinfarcts occurring as a result of embolic phenomena. These patients may be classified in other categories, such as delirium, depression, or dementia. Thus, the complication rate of clinically obvious stroke reported in the previous articles most likely represents an underestimate. Unfortunately, diagnosing these patients has traditionally been difficult in the past. Newer modalities such as diffusion-weighted MRI may show promise in that regard. The increasing recognition of the role played by aortic atheroma and the innovative steps taken to minimize this risk, including epiaortic scanning and the potential for intra-aortic filtration, are all currently undergoing large-scale, prospective evaluations. Previous authors have demonstrated that use of epiaortic scanning and of a "Y" graft, which uses the radial artery joined to the pedicled left internal mammary artery in a Y graft fashion was associated with a significantly decreased incidence of cerebral embolization secondary to aortic instrumentation. Aortic manipulation during CABG is a contributing mechanism for postoperative stroke. The incidence of postoperative stroke increases with increased levels of aortic manipulation. We previously demonstrated that patients who had a full and a tangential aortic clamp applied were 1.8 times more likely to have a stroke versus those without any aortic manipulation (P<0.01) and 1.7 times more likely to develop a postoperative stroke than those with only a tangential aortic clamp applied.5 A modification of the surgical strategy, such as the "no-touch technique" described by Mills and Everson, might also be important in these patients. In addition, pharmaceutical agents such as gangliosides, glutamate receptor antagonists, and antioxidants may potentially minimize neuronal damage and decrease the occurrence of stroke. It has also been suggested that prostacyclin infusion during cardiopulmonary bypass may lower the incidence of encephalopathy and stroke during coronary artery bypass by preventing adhesion of platelets to the extracorporeal tubing and subsequent microembolization. Further studies are needed to prospectively investigate the potential benefits of pharmaceutical agents in reducing the incidence of stroke after coronary artery bypass. Coronary artery bypass without cardiopulmonary bypass needs further investigation as an approach for decreasing the incidence of stroke and should potentially be considered in patients with carotid artery disease, or other high-risk characteristics for stroke. However, the benefits of this technique have not been evaluated in a prospective randomized setting. All these interventions may eventually prevent or decrease the effects of these catastrophic complications after cardiac surgery. The elusive "holy grail" may at last be within grasp.
Stephen M et al: Tibial artery bypass. Arch Surg 111:235, 1976. 72% patent an average of 12.2 months.
Stokes KR, Strunk HM, Campbell DR, Gibbons GW, Wheeler HG and Clouse ME: Five-year results of iliac and femoropoliteal angioplasty in diabetic patients. Radiology 174: 977-982, 1990. 97 diabetics with 70 iliac, 41 femoral and 16 popliteal angioplasties. Patients with claudication or adequate runoff had 5 year patency rates of 76% (iliacs) and 60% (popliteal). The patency rates for 3 and 5 years for limb salvage patients were 66% and 29% (iliacs), 37% and 7% (femorals), and 37% and 0% (popliteals). Severe distal ischemia, poor runoff, and diffuse stenoses had negative effects on success.
Tannenbaum GA, Pomposselli FB, Marcaccio EJ, Gibbons GW, Campbell DR et al: Safety of vein bypass grafting to the dorsal pedal artery in diabetic patients with foot infections. J Vasc Surg 15:982-990, 1992. 56 bypasses in 53 diabetic patients. First treated an average of 10.7 days with antibiotics, local debridements, wound care and bedrest. 20% had operative debridement or open partial foot amputations to control sepsis. 3.6% of the bypasses failed with 30 days (1.8% died). 12.5% developed wound infections. Average initial hospitalization 29.8 days. 52 patients discharged with salvaged limbs and patent grafts. 35 rehospitalizations and 31 subsequent foot procedures needed to achieve final healing. Acturial graft patency and limb salvage were 92% and 98% respectively at 36 months.
Toursarkissian B, Shireman PK, Schoolfield J, Blumoff RL: Outcomes following distal bypass graft occlusion in diabetics.. Ann Vasc Surg. 17(6):670-5,2003. The objectives of this study were to define clinical outcomes following distal bypass graft occlusion in diabetic patients and identify factors predictive of limb loss. A retrospective review was conducted of all distal graft occlusions over a 5-year period in diabetic patients. Popliteal grafts, perioperative (30 days) failures, and redo distal bypasses were excluded. Eighty grafts were studied (43 cases done for ulcers, 31 for gangrene, and 6 for rest pain). Time to occlusion averaged 13 +/- 17 months post-bypass (median 6 months). Interventions following graft occlusion (lysis, thrombectomy, revision, or new bypass) were carried out in only 26 cases, leading to limb salvage in 11 cases (42%). This compares to a limb salvage rate of 54% in the 54 cases where no intervention was done ( p = NS). The overall amputation rate was 50% (14 AKAs and 26 BKAs). The interval between graft occlusion and amputation averaged 2 +/- 2 months. Limbs saved were followed an average of 14 +/- 11 months after graft occlusion. The presence of a foot wound (new or old) was associated with a higher likelihood of amputation (67% vs. 32% for cases with no foot wounds at the time of bypass failure; p < 0.005). In cases requiring an amputation, the toebrachial index averaged 0 +/- 0 post-bypass failure vs. 0.2 +/- 0.2 in cases where limbs were saved ( p < 0.05). Patients with congestive heart failure or who were nonambulatory at the time of graft occlusion were more likely to end up with an amputation ( p < 0.05). Limb loss was also more likely when gangrene had been the initial operative indication. No other factors were predictive of limb loss, including vein configuration, inflow or outflow level, prior bypass revision, known graft stenosis, time to occlusion, age, gender, other medical conditions, pre- or post-bypass ABI or TBI, graft velocities, or use of anticoagulants. Limb loss following primary distal bypass failure in diabetics is high. Repeat interventions have limited success. The findings justify aggressive programs of graft maintenance, and vigorous attempts at early closure of foot wounds.
Tsai PH, Liu JJ et al: Effect of lower extremity bypass surgery on inflammatory reaction and endothelial dysfunction in type 2 diabetic patients. Mediators Inflamm 2009:417301, Epub2009 April. Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia and dyslipidemia. The abnormalities in nutrient metabolism and elevated inflammatory mediators resulting from DM lead to impairment of wound healing and vulnerability to infection and foot ulcers. Diabetic lower limb ischemia often leads to limb necrosis. Lower extremity bypass surgery (LEBS) is indicated to prevent limb loss in patients with critical leg ischemia. This study investigated the alteration of inflammatory and endothelium dysfunction markers before and after LEBS in DM patients. Twenty one type 2 DM patients with LEBS were included. Blood was drawn before and at 1 day and 7 days after surgery in the patients. Plasma soluble cellular adhesion molecule levels and blood leukocyte integrin expressions were measured. Also, plasma concentrations of endothelin-1 and nitric oxide were analyzed to evaluate the vascular endothelial function. The results showed that there were no significant differences in plasma cellular adhesion molecules, endothelin-1 and nitric oxide levels, nor did any differences in leukocyte integrin expressions before and after the operation. These results suggest that the efficacy of LEBS on alleviating inflammatory reaction and improving endothelial function in DM patients was not obvious.
Twine CP, Coulston J, Shandall A, McLain AD: Angioplasty versus stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006767. Abstract: BACKGROUND: Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenoses or occlusions in the superficial femoral artery may result in intermittent claudication as an early consequence, which may be treated by balloon angioplasty with or without stenting. OBJECTIVES: The objective was to determine the effect of percutaneous transluminal angioplasty (PTA) when compared with PTA with stenting for lesions of the superficial femoral artery, for people with intermittent claudication or critical limb ischaemia. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their trials register (last searched February 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2009, Issue 1) for publications describing randomised controlled trials (RCTs) of percutaneous angioplasty with or without stenting. SELECTION CRITERIA: Randomised trials of angioplasty alone versus angioplasty with stenting for the treatment of superficial femoral artery stenoses. DATA COLLECTION AND ANALYSIS: Two authors (CT, JC) independently selected suitable trials,assessed trial quality and extracted data. A third author (AS) ranked the concealment of allocation and checked the final manuscript. The fourth author (DM) cross checked all stages of the review process. MAIN RESULTS: Eight trials with 968 participants were included. The average age was 67 and all trials included men and women. Participants were followed for up to two years.There was a small but statistically significant improvement in primary angiographic and duplex patency at six months in patients treated with PTA plus stent over lesions treated with PTA alone (three trials and four trials, respectively). However, primary angiographic patency was non-significant 12 months (five trials, P = 0.23) and 24 months (two trials, P = 0.45). A similar but lesser effect was seen for ankle brachial pressure index (ABPI), while a more pronounced improvement in treadmill walking distance in patients with PTA plus stent insertion was observed at six and 12 (P < 0.0001), but not 24 months (P = 0.81). Only one trial reported quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria between trials showed marked heterogenicity. AUTHORS' CONCLUSIONS: There is limited benefit to stenting lesions of the superficial femoral artery in addition to angioplasty, however this cannot be recommended routinely based on the results of this analysis.
van Hattum ES, Tangelder MJ, Lawson JA et al: The quality of life in patients after peripheral bypass surgery deteriorates at long-term follow-up. J Vasc Surg 53:643-50, 2011. Abstract: OBJECTIVE: We aimed to study the long-term development of health-related quality of life (HR-QoL) in patients with peripheral arterial disease after they underwent peripheral bypass surgery and to evaluate the influence of adverse vascular events that occurred during follow-up. METHODS: We compared current HR-QoL scores with previous measurements in patients who participated in the Dutch Bypass and Oral Anticoagulants or Aspirin (BOA) Study between 1995 and 1998 after they underwent infrainguinal bypass surgery. Patients from six centers that contributed most to the Dutch BOA Study (n = 482) were followed up retrospectively from 1995 up to 2009. RESULTS: At a mean follow-up of 11 years since BOA randomization, 165 of the 482 patients were alive of whom 123 (75%) completed the EQ-5D and RAND-36 questionnaires. Fifty-three patients completed the questionnaires three times: at BOA entry, at BOA close-out, and at BOA long-term follow-up. In these patients the HR-QoL scores decreased over time, especially for the physical health dimension. In comparison with the general population, matched for age and gender, the HR-QoL scores at both BOA entry and long-term follow-up were substantially lower, even if the patient's graft was patent and no other vascular events had occurred. The occurrence of an adverse vascular event worsened the physical health state further. CONCLUSIONS: The physical HR-QoL in patients with peripheral arterial disease (PAD) after peripheral bypass surgery was highly impaired, independent of graft patency, and deteriorated further over time. An adverse vascular event worsened the physical health state and underlined the importance of atherosclerotic risk management as well as stimulation of physical activity in patients with peripheral arterial disease to preserve HR-QoL.
Veith FJ, Gupta SK, Samson RH et al: Progress in limb salvage by reconstructive arterial surgery combined with new or adjunctive procedures. Ann Surg 194:386-401, 1981. In the past nine years, 1196 patients whose lower extremity was threatened because of infrainguinal arteriosclerosis have been treated at Montefiore Hospital. In the last six years, limb salvage was attempted in 679 or 90% of 755 patients. Femoropopliteal (318), small vessel (204) and axillopopliteal (29) bypasses were used along with transluminal angioplasty (128) and aggressive local operations to obtain a healed foot. Immediate (one month) limb salvage was achieved in 583 or 86% of the 679 patients in whom revascularization was possible. The 30-day mortality rate was 3%. The cumulative life table (LT) survival rate of all the patients undergoing reconstructive arterial operations was 48% at five years. The cumulative LT limb salvage rate after all reconstructive arterial operations was 66% at five years. The cumulative LT patency rate of femoropopliteal bypasses was not influenced by angiographic outflow characteristics of the popliteal artery but was increased 15% by appropriate reoperations to 67% at five years. Cumulative LT patency and limb salvage rates of small vessel and axillopopliteal bypasses were more than 50% at two years. Of patients undergoing arterial reconstruction, 88% of those who died within five years did so without losing their limbs. Of all the patients in whom limb salvage was attempted, 68% lived more than one year with a viable, useable extremity, and 54% lived over two years with an intact limb. We believe this aggressive approach to limb salvage is justified, and can be undertaken with a low cost in mortality, knee loss and morbidity.
Velinovic MM, Davidovic BL, Lotina IS, Vranes RM, Djukic LP, Arsov JV, Ristic VM, Kocica JM, Petrovic LP: Complications of operative treatment of injuries of peripheral arteries. Cardiovasc Surg 8(4):256-64, 2000. In 1991 and 1992, a total of 97 patients with 106 peripherial arterial injuries underwent surgery at the Institute for Cardiovascular Diseases, Clinical Centre of Serbia. Civilian injuries accounted for 53 (54.6%) patients (94.3% males, age range: 16-63 yr, mean: 35.2), and 44 patients had war injuries (93.2% males, age range: 19-61 yr, mean: 34.8). The injuries affected the superfitial femoral artery in 31 (29.24%); the popliteal artery in 28 (26.41%); the brachial artery in 17 (16.04%); the posterior tibial artery in 6 (5.66%); the axillary artery in 5 (4.72%); the anterior tibial artery in 5 (4.72%); the tibioperoneal trunk in 4 (3. 77%); the common femoral artery in 4 (3.77%); the external iliac artery in 2 (1.89%); the profound femoral artery in 2 (1.89%); the radial artery in 1 (0.94%); and ulnar artery in 1 (0.94%).A total of 98 reconstructive procedures were used to treat these patients. Graft interposition carried out in 50 (51.02%); by pass in 25 (25. 51%); end-to-end anastomosis in 9 (9.18%); suture in 8 (8.16%); ligation in 4 (4.08%); and patch-angioplasty in 2 (2.04%). Primary reconstruction of injured arteries was performed in 72.2% and secondary repair in 27.8% cases.Infection developed in 51 (52.57%) patients, and it was significantly (P<0.05) more common in the war injuries (70.45%) and in secondary repairs (88.89%). The presence of associated lesions (69.56%) was also correlated with a greater rate of infection.Amputation was necessary in 21 (21.65%) of our patients, and was significantly (P<0.05) more often performed after secondary (44.44%) than primary operations (12.86%) and in the presence of associated injuries (32.61%).Comments: This paper differs from most of the above in involving dirty traumatic injuries occurring variable periods of time before presentation to the surgeon. Such wounds may already be complicated by infection and local thrombi that may defeat cleansing irrigations and the best surgical repair. Boot therapy alone or postoperatively may restore flow through recently thrombosed vessels. Commonly after trauma and especially in the postoperative state other forms of thrombolytic therapy are contraindicated. Likewise, the local injection of antibiotics might be helpful in these patients. The reader is invited to examine the success of booting and local antibiotic injections in the treatment of the advanced lesions in our patient history section. Many of these lesions share characteristics with the traumatic war patient: infection, devitalized tissue, co-morbid conditions and delay in treatment.
Verna E, Ceriani L, Casucci R et al: Myocardial uptake of indium-111 antimyosin after coronary angioplasty. Relationship with the total burden of ischaemia. European Heart J 16: 478-484, 1995. Abstract: Indium-111 antimyosin scintigraphy was performed in 24 consecutive patients after percutaneous transluminal coronary angioplasty to assess whether repeated periods of ischaemia during balloon inflation results in myocardial cell damage even after a successful procedure. Patients with unstable angina, prior myocardial infarction and whose procedure was complicated were excluded. Indium-111 monoclonal antimyosin antibodies (80 MBq) were injected 24 h after coronary angioplasty and planar images were collected 24 h later. The relative antimyosin uptake was assessed subjectively and by a heartllung count density ratio. In addition, the intracardiac gradient of activity was assessed by a count density profile analysis of the cardiac region of interest to distinguish better the focal as opposed to the diffuse antimyosin uptake. The antimyosin uptake index was calculated by multiplying the heartllung ratio to the intracardiac gradient of activity. After coronary angioplasty, nine patients had minor ST-T wave changes on the surface ECG, but no patient demonstrated a new Q wave. Only three patients showed a mild rise in cardiac enzyme (CK-MB) serum levels. Indium-Ill antimyosin uptake (heartllung>1.55) was present in eight patients (33%) and was intense (heartllung>1.9) in five (21%). Antimyosin uptake was always seen in myocardial segments corresponding to the treated coronary artery. Patients with a positive antimyosin scan had a longer duration of balloon-induced ischaemia compared with patients with no evidence of antimyosin uptake (541 ± 211 vs 331 ± 137 s, P<0.007). The antimyosin uptake index ranged from 2.0 to 21 and was significantly greater (10.9 ± 6.9 vs 3.4 ± 1.7, P<0.001) in patients with overall inflation times >500 s. There was a significant correlation between the antimyosin index and the total duration of ischaemia during the procedure (r=0.76, P<0.001). This study indicates that myocardial uptake of antimyosin antibodies may detect myocardial injury in a significant proportion of patients undergoing angiographically successful coronary angioplasty. Myocardial cell damage seems to be related to the overall duration of balloon-induced ischaemia,
Voisine P, Ruel M, Khan TA et al: Differences in gene expression profiles of diabetic and nondiabetic patients undergoing cardiopulmonary bypass and cardioplegic arrest. Circulation 110(11 Suppl 1):11280-6, 2004. BACKGROUND: Diabetes mellitus is an independent risk factor for early postoperative mortality and complications after coronary artery bypass grafting (CABG). We sought to compare the cardiac gene expression responses to cardiopulmonary bypass (CPB) and cardioplegic arrest (C) in patients with and without diabetes. METHODS AND RESULTS: Twenty atrial myocardium samples were harvested from 5 type II insulin-dependent diabetic and 5 matched nondiabetic patients undergoing CABG, before and after CPB/C. Oligonucleotide microarray analyses of 12625 genes were performed on the 10 sample pairs using matched pre-CPB tissues as controls. Array results were validated with Northern blotting and immunoblotting. Compared with pre-CPB/C, post-CPB/C myocardial tissues revealed 851 upregulated and 480 downregulated genes with a threshold P< or =0.025 (signal-to-noise ratio, 4.04) in the diabetic group, compared with 480 upregulated and 626 downregulated genes (signal-to-noise ratio, 3.04) in the nondiabetic group (P<0.001). There were 18 genes that were upregulated >4-fold in diabetic and nondiabetic patients (including inflammatory/transcription activators FOS, CYR 61, and IL-6, apoptotic gene NR4A1, stress gene DUSP1, and glucose-transporter gene SLC2A3). However, 28 genes showed such marked upregulation in the diabetic group exclusively (including inflammatory/transcription activators MYC, IL8, IL-1beta, growth factor vascular endothelial growth factor, amphiregulin, and glucose metabolism-involved gene insulin receptor substrate 1), and 27 genes in the nondiabetic group only, including glycogen-binding subunit PPP1R3C. CONCLUSIONS: Gene expression profile after CPB/C is quantitatively and qualitatively different in patients with diabetes. These results have important implications for the design of tailored myocardial protection and operative strategies for diabetic patients undergoing CPB/C. Comments: Interesting results in that they show diabetics undergoing heart surgery differ from non-diabetics requiring heart surgery. In Boston, some (Akbari et al) have reported that diabetes alone is not a risk factor for surgery unless presumably it is complicated by end-organ damage from the diabetes.
Vogel TR, Su LT, Symons RG, Flum DR: Lower extremity angioplasty for claudication: a population-level analysis of 30-day outcomes. J Vasc Surg 45: 762-7, 2007. OBJECTIVE: With the increased availability of lower extremity percutaneous transluminal angioplasty (PTA), the conventional, non-interventional management of claudication may be evolving. This study evaluated changes in the use and short-term outcomes of PTA among patients with claudication and other manifestations of peripheral arterial disease (PAD). METHODS: A retrospective cohort study was conducted using the linked Washington State hospital discharge database (CHARS). Cases included all patients undergoing inpatient lower extremity PTA from 1997 to 2004. Patients with claudication were compared with those having PTA for other lower extremity diagnoses. The main outcome measures were readmission, reintervention (angiography, angioplasty/stent, surgical revascularization, or amputation), and death (up to 30 days). RESULTS: A total of 1718 patients (mean age 69.7 +/- 11.2, 52.4% male) underwent PTA for claudication (51.9%), rest pain (12.1%), ulceration (23.2%), or not otherwise specified (12.9%). Yearly PTA use nearly doubled between 1997 and 2004, from 182 to 360, with a more dramatic increase in PTA among patients with claudication. Patients undergoing PTA for claudication were younger (67.9 +/- 10.3 vs 71.7 +/- 11.7 years, P < .01), more likely male (58.2% vs 46.2%, P < .01), and had a lower comorbidity index (0.7 vs 1.1, P < .01) compared with all others. A total of 65.3% were Medicare eligible. Among 555 patients aged <65 years, the indication for PTA was claudication more often when they had private insurance compared with uninsured or Medicaid beneficiaries (70.3% vs 49.1%, P < .01). Patients with claudication had shorter hospitalizations (2.4 +/- 2.3 vs 5.2 +/- 5.8 days, P < .01), lower rates of in-hospital death (0.8% vs 3.3%, P < .01), 30-day mortality (1.2% vs 4.7%, P < .01), and 30-day readmission (10% vs 23.1%, P < .05). Reintervention was required in 28.1% of readmitted patients with claudication, but none underwent amputation (up to 30 days). CONCLUSION: The use of PTA for claudication dramatically increased during the 8-year study period. Claudication was more often the diagnosis for PTA in patients who were younger, healthier, and privately insured. PTA for claudication had a higher-than-expected morbidity, 30-day readmission, and rate of reintervention. Future studies should focus on the factors motivating the use of PTA, its associated outcomes, and global impact on patients and the health care system.
Vraux H, Hammer F, Verhelst R, Goffette P, Vandeleene B: Subintimal angioplasty of tibial vessel occlusions in the treatment of critical limb ischaemia: mid-term results. Eur J Vasc Endovasc Surg 20(5):441-6, 2000. OBJECTIVES: to evaluate the feasibility and preliminary results at 1 year of subintimal angioplasty of tibial occlusions in critical limb ischaemia (CLI). MATERIAL: from December 1997 to December 1999, we intended to treat 36 patients and 40 limbs by subintimal angioplasty of occlusions of tibial vessels. Thirty-one had gangrene or ulceration and nine had rest pain. Twenty-seven occlusions were more than 10 cm, 10 were 5 to 10 cm and three were less than 5 cm in length. Three patients had an occluded previous ipsilateral bypass graft. All patients were followed 3 monthly for a median of 10 months by means of clinical and duplex examination. RESULTS: the technical success rate was 78% (31/40). Nine technical failures were treated by conventional surgery or angioplasty of another diseased tibial vessel. The clinical success rate was 68% (27/40). Four below-the-knee amputations were performed despite a patent recanalisation. Primary and secondary patency rates at 12 months were 56% (72% without technical failures). The 12-month limb salvage rate was 81% and survival rate was 78%. Three of five complications were treated by endovascular procedures. The length of occlusion (>10 cm) but not the location of distal re-entry, the type of vessel re-entry and the presence of diabetes are predictors of technical success and patency. CONCLUSIONS: subintimal angioplasty can be used to treat tibial occlusions in patients with CLI. Technical failure does not preclude conventional surgery and complications may often be treated by endovascular procedures. However, the durability of angioplasty is as yet uncertain.
Wagner H-J, Schmitz R et al: Influence of Percutaneous Transluminal Angioplasty on Transcutaneous Oxygen Pressure in Patients with Peripheral Arterial Occlusive Disease. Radiology 226: 791-7, 2003. PURPOSE: To determine in a prospective controlled trial the effect of percutaneous transluminal angioplasty (PTA) on skin oxygen supply and microcirculation as measured by means of transcutaneous oxygen pressure in patients with disabling lower-limb ischemia compared with that in patients who underwent intraarterial angiography for the assessment of disabling lower-limb ischemia. MATERIALS AND METHODS: Thirty-four patients (17 men, 17 women; mean age, 68.6 years ± 9.8 [SD]) with peripheral arterial occlusive disease (PAOD) (claudication, n = 15; critical ischemia, n = 19) underwent transcutaneous oxygen pressure measurement at the dorsum of the foot 1 day before PTA, during PTA, 1 day after PTA, and 6 weeks after PTA. Measurements were obtained with the patient in the supine and erect sitting positions, as well as after exercise. Thirty-one patients (21 men, 10 women; mean age, 68.5 years ± 9.3) with symptomatic PAOD who were undergoing intraarterial angiography served as the control group. RESULTS: Mean pressure before PTA was 31.6 mm Hg ± 24 in the supine position, 50.8 mm Hg ± 22 in the sitting position, and 22.2 mm Hg ± 23 after exercise. Immediately after PTA, a significant increase to 34 mm Hg ± 20 in the supine position was noted (P < .05). One day after PTA, pressure was 37.3 mm Hg ± 20 for the supine position and 52 mm Hg ± 20 for the sitting position. Six weeks after treatment, a further significant increase to 43.9 mm Hg ± 19 in the supine position, 61 mm Hg ± 15 in the sitting position, and 44.7 mm Hg ± 24 after exercise was noted (P < .05). In the control group, a significant pressure decrease immediately after and 1 day after angiography was noted (P < .05). Measurements returned to baseline at 6 weeks follow-up. CONCLUSION: PTA has a positive effect on oxygen supply to the skin in patients with PAOD. Conversely, intraarterial angiography in patients with PAOD deteriorates skin microcirculation temporarily. A control group who underwent arteriography. Baseline values in control group lower by 3-7 mm Hg and walking distance 82+/-93 vs 100 +/-87. Comments: Normal values for TcPO2 approximate 80% of the arterial PO2 and are the same in healthy skin of the foot and chest. Normal supine values are generally over 40mm Hg. Healing becomes less likely as values drop so that values below 20-22 mmHg are commonly reported to signify an inability to heal. Likewise a foot/chest index below the 0.44 to 0.53 range has been associated with nonhealing.
Wahlgren CM, Sten-Linder M, Egberg N et al: The Role of Coagulation and Inflammation After Angioplasty in Patients with Peripheral Arterial Disease. CardioVascular and Interventional Radiology 29: 630-35, 2006. Abstract: Purpose Restenosis remains a frequent complication after angioplasty in peripheral arterial disease. Inflammation plays a critical role in the vascular response to injury. Effective medical treatment to improve patency after angioplasty is still elusive. The aims of this prospective clinical study were to investigate changes in blood coagulation and inflammatory markers after angioplasty and their significance for restenosis. Methods Thirty-four patients with peripheral arterial disease underwent angioplasty of the iliac and superficial femoral arteries. Ten patients undergoing diagnostic angiography were included in the study as controls. Plasma levels of tissue factor, prothrombin fragment 1 + 2, D-dimer, P-selectin, C-reactive protein (CRP), and fibrinogen were analyzed before and after angioplasty. Patients were followed up with angiography after 6 months to assess restenosis. Results CRP was elevated the day after angioplasty (6.6 mg/l, p = 0.0001) and tended to peak after 1 week (11 mg/l, p = 0.09). There was a significant increase of D-dimer and P-selectin 1–4 hr after angioplasty (0.4 mg/l, p = 0.001 and 68 ng/ml, p = 0.05, respectively). None of the biochemical markers was a statistically significant predictor of restenosis. Conclusion We have observed a much more prolonged inflammatory response than previously noted, but only minor changes in coagulation activity after angioplasty. The biochemical markers, before and after angioplasty, were not related to restenosis. Further studies are needed to delineate the molecular mechanisms behind these observations and their involvement in thrombosis and restenosis. If these pathways are further defined, improved treatment strategies, including antithrombotic treatments and statins, could be tailored to modulate postprocedural inflammation. Comments: Considering the damage done to the endothelium, it is no surprise the CRP might go up.
Ward RP, Leeper NJ, Kirkpatrick JN et al: The effect of preoperative statin therapy on cardiovascular outcomes in patients undergoing infrainguinal vascular surgery. Int J Cardiol 104: 264-8, 2005. BACKGROUND: Patients undergoing vascular surgery are at increased risk for perioperative cardiovascular (CV) complications. Our goal was to determine the effect of preoperative statin therapy on perioperative cardiac and vascular outcomes, and long-term survival in patients undergoing infrainguinal vascular bypass surgery. METHODS: We retrospectively reviewed consecutive infrainguinal vascular bypass surgeries on 446 patients performed between 1995-2001 at the University of Chicago Medical Center. Information was collected on preoperative statin and beta-blocker use, baseline characteristics, perioperative cardiac and major vascular complications, and length of stay (LOS). Long-term survival was assessed using the Social Security Death Index (SSDI). RESULTS: Thirty day perioperative complications included all-cause mortality (2.5%), CV mortality (1.8%), myocardial infarction (MI) (4.7%), stroke (1.1%), and major peripheral vascular complications (12.8%), and the composite of cardiac and vascular complications [combined CV complications] (17.9%). Statin therapy was associated with fewer combined CV complications (6.9% vs 20.1%, p=0.008), and a shorter LOS (6.4 vs 9.7 days, p=0.007). On multivariate logistic regression analysis, adjusting for significant baseline characteristics including beta-blocker use, statin therapy was independently associated fewer combined CV complications (odds ratio (OR) 0.36, 95% confidence interval (CI) 0.14-0.93, p=0.035) and a shorter LOS (OR 1.49, 95% CI 1.14-1.95, p=0.003). In a mean follow up period of 5.5 years, 215 deaths (48%) occurred. Statin therapy was independently associated with improved long-term survival (OR 0.52, 95% CI 0.32-0.84, p<0.004), after adjusting for significant baseline characteristics. CONCLUSION: Preoperative statin therapy is associated with fewer combined perioperative cardiac and major vascular complications, a shorter length of stay, and improved long-term survival in patients undergoing infrainguinal vascular bypass surgery.
Wexler L, Ginsburg R, Mitchell RS and Mehigan JT: The vascular War of 1988. JAMA 261:418-419, 1988. "Turf" battle among vascular surgeons, radiologists and cardiologists. We might do well to have the "angiology" specialist found in Europe. Stanford approach: a Center of Interventional Vascular Therapies where all consult and team together in care.
Wolf GL, Wilson SE, Cross AAP et al: Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. J Vasc Interv Radiol 4:639-48, 1993. PURPOSE: Surgical revascularization and angioplasty (PTA) are effective therapies for patients with peripheral arterial disease, but there are no data on long-term survival, limb salvage, and hemodynamic status from a randomized study of such patients. A multicenter, prospective trial compared PTA with bypass surgery (BP) in 263 men who had iliac, femoral, or popliteal artery obstruction. PATIENTS AND METHODS: Lesions in the iliac versus the femoropopliteal artery and rest pain versus claudication were separately randomized to the two treatment interventions. One hundred twenty-six patients underwent BP, 129 patients underwent PTA, and eight patients were not treated for lower extremity ischemia. RESULTS: Three operative deaths occurred in the BP group and none in the PTA group. For the entire study, average annual mortality was higher in the BP group, but survival was not significantly different on life-table analysis (P = .08). Primary success favored BP, while limb salvage favored PTA, but differences were not statistically significant (P = .08 and .35, respectively). Patients with iliac disease or claudication fared better, but there was no statistical difference in response to PTA or BP. CONCLUSION: Patients in both treatment groups had prompt and sustained increases in hemodynamics and quality of life. This study of patients randomly assigned to BP or PTA shows no significant difference in outcomes during a median follow-up of 4 years.Comments: Admission criteria essentially an opportunity for a procedure. A control group? None.
Wolfle KD, Bruijnen H, Reeps C, Reutemann S, Wack C, Campbell P, Loeprecht H, Hauser H, Bohndorf K: Tibioperoneal arterial lesions and critical foot ischaemia: successful management by the use of short vein grafts and percutaneous transluminal angioplasty. Vasa 29(3):207-14, 2000. BACKGROUND: In a substantial number of mainly diabetic patients isolated crural arterial lesions are found to be the underlying cause for severe ischaemic foot lesions. Without revascularisation, patients with this specific occlusion pattern will inevitably face major amputation. To attain limb salvage in this setting, since the early eighties short vein grafts were used to bypass the occluded infrapopliteal arteries. More recently, percutaneous transluminal angioplasty (PTA) was also attempted to avoid limb loss in selected patients. PATIENTS AND METHODS: Since May 1986 in 125 patients 130 autologous bypass grafts from the BK-popliteal artery or the proximal tibioperoneal arteries to malleolar vessels were performed in the presence of extended crural arterial occlusions and critical foot ischaemia (rest pain 3, tissue loss 127). In another series in 89 limbs (rest pain 5, tissue loss 84) of 84 patients PTA was done to treat 168 focal stenoses of > 50% diameter reduction and 11 short occlusions in a total of 135 crural arteries. RESULTS: Using life-table analysis, primary and secondary cumulative patency rates for short vein grafts with distal graft origin were 90% and 98% at 30 days, 76% and 83% at one year and 46% and 49% at seven years, respectively. The corresponding limb salvage rates amounted to 95%, 80% and 63%. Initial complete or partial technical success after PTA of crural arteries could be obtained in 93%: The limb salvage rates achieved were 95% at 30 days, 82% at one year and 63% at six years. CONCLUSION: Our results suggest that--depending on the extent of lesions--both short vein grafts as well as PTA are successful complementary treatment modalities to avoid limb loss in predominantly diabetic patients with infrapopliteal artery disease and critical ischaemia.
Wong T, Detsky AS: Preoperative cardiac risk assessment for patients having peripheral vascular surgery. Ann Intern Med: 116: 743-63, 1992. PURPOSE: To review the methods used for preoperative cardiac risk stratification of patients having peripheral vascular surgery. DATA SOURCES: Relevant studies published before August 1991 were identified using a MEDLINE search of the English-language literature, followed by a manual search of the references of all identified articles. STUDY SELECTION: All clinical studies evaluating methods used for preoperative cardiac risk stratification of patients having peripheral vascular surgery. DATA EXTRACTION: The key data extracted from each article included the inclusion and exclusion criteria of the study patients, the techniques used for testing and the corresponding definitions of positive test results, and the clinical outcomes of the tested patients. Data were analyzed using a Bayesian conceptual framework, and pretest probabilities were converted to post-test probabilities using calculation of likelihood ratios. RESULTS: Patients with high scores on clinical cardiac risk indexes (Goldman index greater than 12 or Detsky index greater than 15), or more than three of the criteria identified by Eagle (age greater than 70 years, diabetes, angina, Q waves on electrocardiogram, or ventricular arrhythmias) are likely to be at higher risk for cardiac death and myocardial infarction after vascular surgery . Those with both low scores and none of Eagle's criteria may be at lower risk, but this result has not been reproduced by independent studies. Neither group of patients would benefit from further investigation for cardiac risk stratification. Patients with one or two of these criteria may be at intermediate risk and would benefit most from further testing for the purposes of risk stratification. Most of the published evidence shows that the absence of redistribution on dipyridamole-thallium scanning identifies a low risk for postoperative cardiac complications, whereas the presence of redistribution predicts a high risk. Preliminary reports suggest that preoperative monitoring for silent myocardial ischemia may also be useful in identifying a high-risk subset of patients. CONCLUSIONS: Patients identified clinically to be at either very low or high risk for cardiac complications after peripheral vascular surgery are unlikely to benefit from further risk stratification. Dipyridamole-thallium scanning is the test of choice for further evaluation of patients at intermediate clinical risk because studies have shown that it is sensitive enough to rule out a high-risk status for patients who do not have redistribution.
Zarins CK: The vascular war of 1988: The enemy is met. JAMA 2561:416-417, 1988. Discussion of competition among cardiologists, radiologists and vascular surgeon with patient interest sometimes lost. "We have met the enemy and he is us".

Return to CBC Homepage
Return to Menu of Medical Literature
Pneumatic Boot Therapies