Perspectives in Circulation Today

RISKS OF VASCULAR SURGERY:


Mortality Rates after Leg Amputation

Patients having enough arteriosclerotic cardiovascular disease to lose an extremity have enough disease to risk both the other limb and their life. Likewise, those having partial amputations do not fare well. Such patients have been introduced into the medical community where their needs might be expected to be anticipated. Still, their prognosis remains limited in spite of advances in medical technology.

Mortality Associated with Leg Amputations in Diabetics


Authors (Years) Postoperative 2yrs 3yrs 4yrs 5yrs 7yrs
Silbert (1952)
- - 35% - 59% -
Hoar (1962)
7% 30% - - - -
Cameron (1964)
- - - - 65% -
Whitehouse (1966)
- - - - - 80%
Ecker (1970)
23% inpatient - 39% - 58% -
Kahn (1974)
9% - - - - -
Kolino-Sorensen(1974)
25% - - - - -
Roon et al (1970)
3% inpatient - - - 55% -
Ebslov & Joseph (1980)
16.3% at 3mos - - 22.4% - -
Hayes (1981)
16.4% 2wks & 25.5% inpatient - - - - -
Rozin (1987)
23.7% - - - - -
Eneroth & Persson (1992)
38% at 6mos - 72% - - -
Alpelqvist (1993)
20% at 1yr - 43% - 73% -
Pohjolainen & Perrson (1998)
38% at 1yr 53% - - 80% -

Risks of Vascular Procedures

The Intra-aortic Balloon, an Example of a Support Device with Inherent Risks

Physicians have endeavored to avoid major amputations employing new techniques as they become available. The patient population at risk, however, commonly has advanced cardiac disease challenging the physician to provide means to see them through their procedures. The placement of the aortic balloon pump is one common procedure employed.

Complications Associated with Use of Intra-aortic Balloon Pumps


Authors (Years) Complications
Goldman et al (1982)
From abstract: Overall complication rate of 24.4% . Patients with inoperable ASHD or severe left ventricular dysfunction especially at risk (complications in 47.6%). Vascular complications: aortic dissection 1.3%, perforation 0.3%, bleeding at site 2.3%, femoral or iliac occlusion 1%, thromboembolism 4.3% and limb ischemia 5.4%. Infections developed at the femoral site in 5.7% and systemic infection developed in 2.3%.
Miller et al (1992)
From abstract:...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%).
Makhoul et al (1993)
From abstract: Vascular complications occurred in 46 patients (10.6%) with leg ischemia, the problem in 40 of the 46. Only the absence of pedal pulses on admission correlated with an increase in vascular complications.
Arafa et al (1999)
From abstract: 509 Patients. 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.... Late IABP-related sequelae occurred in 10 patients, 9 of whom had had early vascular complications.

What are the risks of surgery and anesthesia in the older diabetic considering vascular reconstruction procedures? Obviously considerable but perhaps not as well recognized as it might be due to the widespread hope and confidence that medical progress will solve all problems. Indeed, such confidence takes the patient with complications not infrequently to their lawyer. Considerable work has been done to anticipate the needs of the patient and determine the best course to see him/her through their surgical experience.

Cardiac Morbidity and Mortality Associated with Vascular Surgical Procedures


Authors (Years) Preoperative Screening Methods or Purpose of Study Number of Patients Surgically correctable CAD Clinically suspicious CAD No Symptoms of CAD cardiac procedures, overall mortality & postop. events
Hertzer (1984)
Coronary angiograms Elective PVD: 263 aortic aneurysms, 295 carotids, 381 infrainguinal 31%, 26%, 21% 44%, 33%, 30% 18%, 17%, 8% 30%, 22%, 19%, mortality 5.3%
Boucher et al (1985)
Thallium Dipyridamole scans 50 stable patients with ? CAD and severe PVD 16 had redistribution defects 32 normal or fixed defect - 6 of 16 had coronary angiograms & 4 CABGs; 8 of 16 had cardiovascular events postop.
Raby et al (1989)
EKG Monitoring 176 PVD patients for elective surgery 32 or 18% had 75 ischemic RST depression episodes - 73/75 ischemic episodes asymptomatic 1 fatal MI, 3 nonfatal MI's, 4 unstable angina & 5 ischemic CHF. 1 postop event among the 144 with no preop. ischemia.
Lette et al (1990)
Dipyridamole-thallium imaging and 5 clinical scoring systems 66 patients with limited exercise tolerance 21 pts with reversible defects & 6 more with reversible defects had angiography showing severe CAD or cardiomyopathy - - 30 had normal scans 9 of the 21 had all of the postoperative events. Scans positive in all patients having events. Clinical symptoms no predictive help.
Berlauk et al (1991)
Prospective, randomized clinical trial optimizing preop. cardiovascular hemodynamics 89 patients for limb-salvage surgery - - - Overall mortality 3.4% in Tuneup group and 9.5% in controls
Kirwin et al (1993)
Continuous ambulatory ECG monitoring preop. Serial EKG's and CPK's postop. 24 patients for aorta and 72 for infrainguinal surgery Monitoring showed ischemia in 9 of 96 patients (9.4%) 7.4% had new rhythm abnormalities: 2 ventricular tachycardia and 5 atrial flutter/fibrillation. 87 had normal preop. monitoring. 1 of the 9 had a postop infarction. 14 of the 87 normals had postop infarctions and 6 died.
Bode et al (1996)
Reported by method of anesthesia for femoral to distal bypass surgery 133 pts general anesthesia, 144 epidural and 136 spinal - - - Cardiac events or death: general 16.7%, Epidural 21.3% & spinal 15.4%. Differences insignificant
Mamode et al (1996)
Reporting Perioperative myocardial infarction in peripheral vascular surgery. 191 patients & 204 operations: 100 elective, 70 urgent & 34 emergency 120 pts of 182 with data had preop ischemic events - - Myocardial infarction and death overall 7.3%; 6% for elective and urgent pts and 12% for emergency pts. 30% of infarctions silent and 50% fatal (8 cardiac deaths).
de Virgilio et al. (1996)
Dipyridamole sestamibi scan and Eagle scoring: 1 point each for age >70, diabetes, Q-waves, angina, history of ventricular ectopy. 70 pts with 0.8 Eagle score not scanned; 31 with Eagle 1.1 & 8 with Eagle 1.6 scanned For the 31: 7 reversible defects; the 8 had CABG or angioplasty. Of the 31, 10 fixed defects. Of the 31, 14 normal scans Overall 4 perioperative infarctions (2.8%), 7 cardiac events (4.8%) & 1 cardiac death (0.7%). Of the 8, all had unstable angina and 2 had infarctions. 3 cardiac events in pts with normal scans or fixed defects.
Krupski et al (2000)
Deleterious outcomes of extensive, comprehensive cardiac evaluation and intervention before planned vascular surgery. 161 pts scheduled for major vascular surgery. Eight patients (19%: one with cerebrovascular disease, and seven with aortic aneurysms) eventually refused vascular surgery after extended cardiac workup. 42 get extended cardiac evaluation: 43% ECHO or radionuclide ventriculography, 52% dipyridamole thallium scintigraphy, 64% Coronary cath, 21% PTCA & 17% CABG. Median elapsed time 14 days. Median time from workup to vascular surgery 25 days. - - 16/42 had untoward events associated with their evaluation. Complications attributed to coronary cath, PTCA & CABG included prosthetic graft infection, pseudoaneurysm(2), sternal wound(2), renal failure & brain anoxia. Two leg amputations resulted from delays.
Landesberg et al (2001)
No preop screening. Continuous 12-lead ST-trend monitoring 48 h to 72 h after surgery & cardiac troponin-I measured first three postop days. 185 patients undergoing vascular surgery - - - 36 pts(20.5%) had 66 iscchemic events, 12 had PMI's (1 death) occurring after an average of 226+/-64 minutes of ischemia. Pts with an average of 36+/-26 minutes ischemia had no infarctions.
McFall et al (2004)
Patients randomized to have CABG (41%), angioplasty (59%) or no procedure prior to vascular surgery 510 VA patients, 33% abdominal aneurysms & 67% PAD - - - Postop MI's in 12% of the cardiac surgery gp & 14% of controls. Mortality rates of 22% and 23% respectively at 2.7 years. Cardiac gp delayed 54 days to PVD surgery.
Bursil et al (2005)
Evaluate prognostic role of pre-operative stratification by ACC/AHA guidelines, the timing of adverse outcomes and predictive role of troponin. 391 patients prospectively 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. - - - Compared to gp 3, gp 1 had 5.21 hazard ratio and gp two 2.58 hazard ratio. Overall, by 18 mos, 18.7% had died or had acute MI. Most events occurred by 30 days. Troponin elevations frequent & independently associated with increased risk.
Ward et al (2005)
Retrospective study of benefit of statin and beta-blocker use on postoperative morbidity and mortality. 446 infrainguinal vascular operations - - - 30 day postop:statin Rx associated with an overall decrease in CV complications (6.9 vs 20.1%) and shorter length of stays. 48% overall death rate at 5.5 years with longer survivals in statin gp.

The Circulator Boot in Perspective

You did what? Successfully treated a lady with an acute myocardial infarction and cardiogenic shock with the boot. "An acute myocardial infarction and you did what?" exclaimed the cardiologist over the telephone. "She might have died in your office! Who would have stood by you in court? At least, in the Emergency Room, there would have been other people to hold her hand!"(http://www.circulatorboot.com/casehistory/case26.html) To the Emergency Room? To the Procedure Room? To the Operating Room? To the abatoir? To those of us who faint at the sight of blood, at the sight of fatal wounds incurred by trauma, accidents or battle, the modern operating room is a miracle. Here purposeful wounds are afflicted that elsewhere would be fatal. Here anesthesia is administered to produce a state of consciousness that again is fatal when acheived elsewhere by an overdose of alcohol or drugs. Here we asssume that expert medical/surgical care will take people encumbered by life-threatening or limb-threatening illnesses to a safe and improved condition. Are we too trusting?

Stroke volume, cardiac output, ventricular contraction time and pre-ejection time

With the flip of a switch the Circulator Boot increased cardiac output and stroke volume while generally shortening ventricular ejection time and pre-ejection time as might be expected with an effective cardiac-support device(http://www.circulatorboot.com/introduction/CBCvsECP.html). It has done this without any complications. It can be quickly applied and removed. The intra-aortic balloon clearly suffers in comparison. The success of the Circulator Boot in treating patients with peripheral vascular disease safely and economically has been a thesis of the website (www.Circulatorboot.com).

In previous Newsletters, Medicare data was shown documenting a persisting and perhaps increasing problem with leg amputations among diabetics in spite of the talent and efforts of many. The problem may be likened to street crews plowing the main roads during a snow storm that does not cease; people cannot get around if their side road is not cleared also (or worse, if the plow impacts snow at the head of their road or driveway) and continuing snowfall means the road crews work is never done. In contrast to the invasive procedures, Circulator Boot therapy stimulates blood flow and endothelial factors throughout the entire leg while supporting the general circulation. Still, only when the spring comes (when the metabolic abnormalities are controlled) will a lasting cure be possible. The skillful vascular surgeon generally takes his/her patient through complex procedures safely and effectively. But problems with age, debilities and metabolic abnormalities persist. Yes, technical problems may occur also. Rarely, for example, a saphenous vein may be harvested for bypass without ascertaining there are other venous outflow routes in the leg. If the deep vein system has been compromised by thrombophlebitis, removal of the superficial veins can be catastrophic. During the bypass procedure, bleeders and communicating vessels are frequently tied off. Occasionally, lymph channels can also be ligated leading to severe postoperative lymphedema. Especially on lateral views of an arteriogram of the lower leg, the identity of the three tibial arteries can be confused and a bypass inserted into the wrong vessel, e.g. one without any runoff. On rare occasion, our surgeons have not been able to complete a bypass because the target distal vessel was too calcified to allow sewing. Healing of the anastomosis sites may be compromised by infection and especially distally by stasis disease. Infected sutures may fail and life-threatening hemorrhage occur. If runoff is not sufficient, the bypass may thrombose. When the bypass is successful, a non-innervated conduit is commonly provided from the groin to the distal leg with the result that (a) blood flow distal to the proximal anastomosis is diminished occasionally sufficiently to produce ischemic symptoms in the thigh muscles and calf; (b) a male patient loses the capacity to stiffen his legs and diminsh blood flow down the legs worsening his tendency to erectile dysfunction; and (c) blood pressure regulation is lost over the distance of the bypass so that the pressure head at the ankle is increased by the length of the bypass in the erect position; and (d) the arterial pressure gradient down the leg is disturbed: high pressure at the groin may push blood towards the knee while even higher pressure in the erect position at a distal anastomosis may push blood backwards up the leg again toward the knee where the pressures may oppose one another cancelling flow through the larger channels but supplying the small vessels where flow is regulated by tissue needs. Slow flow may promote thrombotic events. The integrity of the distal leg may become dependent on the patency of the bypass which in turn may be affected by the skill of the surgeon in placing the bypass and the habits of the patient in not stopping flow in the bypass by leg-crossing in a chair or while sleeping. We have had patients referred for boot therapy who were noted to have or hypothesized to have all of these problems. Perhaps, related to such factors were the results of Morris et al. In doing repeated arteriograms in patients with with bilateral arteriosclerosis but an unilateral bypass, they have performed perhaps the only controlled study of the bypass procedure. Repeat angiograms were 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.

The incidence of stroke following cardiovascular surgery was not discussed above. Stamou reports a range of 0.8-5.2%. Stroke following peripheral vascular surgery is uncommon (Axelrod et al). In the latter situation it is associated with a history of previous stroke and a greater degree of illness. When it does occur, it greatly increases mortality and hospital length of stay. Peripheral vascular and cardiovascular procedures pose greater risks.

The literature quoted above clearly shows much remains to be done. Good pre-operative care and preparation is helpful, but need not include cardiac revascularization procedures in stable patients. Indeed, long term mortality may not be improved by cardiac revascularization procedures prior to peripheral vascular surgery (McFall et al above) and may entail delays and complications of their own (Krupski et al above). Treatment with statins is worth considering.

Perspectives in Circulation Today

Volume 2, Number 3

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