Perspectives in Circulation Today

Peripheral Vascular Tests and Long Term Prognosis of Claudication and Critical Leg Ischemia
Beauty is in the Eyes of the Beholder

Factors Affecting Results of Peripheral Vascular Studies and Their Long Terms Comparisons
in Patients with Peripheral Vascular Disease


Systemic Cardiovascular Factors
Cardiac output
Blood and plasma volumes
Blood viscosity
Changes in pulse pressure with changes in heart rate
Sepsis
Pain and anxiety
Desired response to cardiovascular medications
Adverse response to medications/antibiotics
Delirium tremens
Extremity Factors
Allowed body position
Length of rest period after exercise
Venous pressure, scarring and thrombi
Lymphatic scarring, lymphedema, edema
Peripheral arteriosclerosis obliterans
Infection (edema & septic arteritis)
Sympathetic & cholinergic neuropathy
Tremor
Benefit of reconstruction vascular procedures
Complications of vascular procedures
Benefits of endothelial fibrinolytic and vasodilating factors and of neovascularization resulting from boot therapy

The ABI has found prominence as a reputable screening test for PAD. Values under 0.9 are said to signify disease and values under 0.4-0.5 are said to signify advanced arteriosclerotic disease and a decrease in the potential to heal. (See our Vascular Test Library for references relevant to test results and healing: http://www.circulatorboot.com/literature/vasctest.html). A rise of 0.1 in the ABI or ten mm Hg in the toe pressure have been taken as evidence of benefit of angioplasty procedures (Silvestro et al). One might ask if the reproducibility of these tests is sufficient to make such assumptions. Besides the factors listed above, the administration of vasodilators may cloud the issue. They are not helpful in improving flow to tissues distal to arteriosclerotic lesions (Coffman 1972); normal vasculature may dilate but arteriosclerotic lesions cannot. The alcoholic, for example, may benefit from the anesthesia produced by his/her drink but his red nose is of little benefit while his toes have an increase in pallor. Many of the above factors are so altered during hospitalizations for vascular procedures that it would be surprising if the toe pressures and ABI of the good leg (the non-operative leg) remained stable during the immediate postoperative period. Papankolaoul et al concluded that there is a lack of consistent correlation between the measured arm-ankle BP difference, or arm-ankle index, and the estimated stenotic graft pressure gradient. This finding illustrates the limitation of the AAI as a monitoring test to predict failure of stenotic infrainguinal vein grafts. Weatherley et al studied 119 participants in both the Atherosclerosis Risk in Communities (ARIC) study and the NHLBI Family Heart Study (FHS) and did repeat ABIs within 1 year, using a common protocol, automated oscillometric blood pressure measurement devices, and technician pool. Their estimated reliability coefficient for the ankle systolic blood pressure (SBP) was 0.68 (95% CI: 0.57, 0.77) and for the brachial SBP was 0.74 (95% CI: 0.62, 0.83). The reliability for the ABI based on single ankle and arm SBPs was 0.61 (95% CI: 0.50, 0.70) and the reliability of the ABI computed as the ratio of the average of two ankle SBPs to two arm SBPs was estimated from simulated data as 0.70. They concluded their results suggested the need for repeated measures of the ABI in clinical practice, preferably within visits and also over time, before diagnosing peripheral artery disease and before making therapeutic decisions. Augustine et al found that 29% of the measurements taken by the untrained doctors were incorrect by an ABI ratio of more than 0.15, as compared to those taken by the vascular technicians. In contrast, the doctors who received one formal training session and feedback from the vascular technician demonstrated that 15% of the measurements of an ABI ratio differed by greater than 0.15. The results of this study suggested that health professionals should undergo formal training before performing ABI measurements to increase their reliability. Blood pressure determinations at the toes may be more helpful than those at the ankle especially in diabetics, but proper cuff size is important: Påhlsson HI et al found that the toe blood pressure values were 18 mmHg higher (p < 0.01) if measured with a 2.0-cm compared to a 2.5-cm wide cuff. There was a relationship (r = 0.63, p < 0.05 for patients) between toe circumference and the toe blood pressure value, where smaller hallluxes gave lower values. de Graaff et all found significant differences in repeatability coefficients between observers for BP (31 mm Hg), ankle pressure (44 mm Hg), ABI (27%), big toe pressure (41 mm Hg), second toe pressure (67 mm Hg) and TCPO2 (30 mm Hg). Arveschoug et al. studied distal blood pressure measurements using the strain gauge technique. They found a mean day-to-day variation of 11 mmHg at ankle level and 10 mmHg at toe level, thereby giving a minimal significant difference between two distal BP determinations of 22 mmHg at ankle and 20 mmHg at toe level. It would appear that small reported differences in vascular tests after any form of treatment may not be significant. The changes reported after invasive procedures and those associated with slow-acting pneumatic boots are to be compared with those obtained by the Circulator Boot (see Dillon 1980 and Gruenes 2005 in our Pneumatic Boot Library).(Since this Newsletter was published both Angiology and Vascular Medicine have had articles examining the ABI. See Holland-Letz et al and Nukimizu et al in our Vascular Test Library.)


Prognosis of Claudication and Critical Leg Ischemia with Conservative CareThe Placebo Arm of Patients in Such Studies

Patients with severe ischemia may have spontaneous improvement with conservative care. In their patients with severe peripheral leg ischemia, Albers et al found the after 12 months of follow-up, the mean quality of life score was significantly higher than baseline in their 19 conservatively treated group (6.43 vs 3.84, p<0.0001), in their 9 patients having reconstruction surgery (5.64 vs 3.57, p<0.01), but not in their 20 patients who had amputations(4.43 vs 3.62). The QL-INDEX mean score was lower in the amputees than in conservative-treated group (4.15 vs 6.58, p<0.01) or the reconstructed group (4.15 vs 7.11, p<0.0001). Schuler et al performed a prospective randomized, double-blind, multicenter clinical trial in healing ischemic ulcers which had not changed after 3 weeks of conservative care; 57 patients received PGE-1 and 63 received a placebo with no significant difference between the groups. Of interest here was the fate of the placebo group: Nineteen ulcers healed (16%); 38 ulcers decreased in size (33%); 45 ulcers remained unchanged or increased in size (39%); three new ulcers developed during the study (3%); and 10 ulcers had inadequate follow-up (9%). Likewise, patients with claudication have long been known to have a variable course with many spontaneously becoming asymptomatic. Dormandy et al note that over a five year period 1-3% of claudicants will require major amputation while 50% may become symptom-free. Only a fourth of patients with claudication will ever significantly deteriorate. Vascular data that includes a placebo arm is not common. Feinglass et al in a prospective claudication study included a placebo group that did not fare as well as the reconstructed group but there were faults to the study: Dr. Porter doubted the accuracy of patient questionnaires, pointed out the treatments were not randomized and that patients agreeing to surgery in some fashions may have differed from those not desiring surgery. Again, Dr. Porter pointed out that the improvement in ABI gained by bypass was small (0.2) and that by angioplasty even smaller (0.09). Silvestro et al reported on the detrimental effect of an elevated ABI in their patients undergoing revascularization. The study did 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. This study is uncommon among revascularization reports: there was 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.

Perspectives in Circulation Today

Volume 2, Number 6

copyright