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Effects of handrail support on claudication and hemodynamic responses to single-stage and progressive treadmill protocols in peripheral vascular occlusive disease.

Because handrail support reduces the energy cost of treadmill walking, claudication and hemodynamic responses of patients with peripheral vascular occlusive disease should also be affected. Furthermore, the reliability of the test results may be reduced unless the same pressure is applied to the handrails over repeated tests. The effect of handrail support on claudication and hemodynamic responses, and on their reliability, were examined during single-stage (2 mph, 12% grade) and progressive (2 mph, 0% grade with 2% increase every 2 minutes) treadmill protocols. Ten patients with stable disease performed both protocols 3 times, separated by 1 week, with and without handrail support. Claudication pain distance and maximal walking distance were greater (p less than 0.05) when handrail support was permitted, and they increased (p less than 0.05) over repeated tests of each protocol. No increase was noted over the tests without support. The responses and reliability of foot transcutaneous oxygen tension, ankle systolic pressure and ankle/brachial systolic pressure index after exercise to maximal tolerable pain were not affected by handrail support. Because claudication distances were altered, it is concluded that handrail support should not be allowed when assessing claudicants, unless balance cannot otherwise be maintained.

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Platelet survival, atherosclerotic intermittent claudication and ticlopidine.

Platelet survival times were measured twice within 6 months using autologous 111-Indium-labelled platelets in 13 male patients diagnosed as stable intermittent claudicants. Linear, exponential, weighted mean and gamma function (multiple-hit) analyses were carried out on the data. Of these methods, exact mathematical models such as linear and exponential are unsuitable for the comparison of curves which may alter with treatment or disease progression. Weighted mean platelet survival correlated (r = 0.96) with platelet survival calculated by the precision reference method of analysis, gamma function. Statistics were expressed from gamma function analyses unless otherwise stated. Severity of claudication was measured by doppler; the ratio of brachial to mean ankle pressures was directly related to platelet survival (r = 0.84). In 7 patients, where duration of claudication was greater than 5 years, platelet survival was significantly reduced (P less than 0.02) compared with 6 newly diagnosed claudicants of less than 18 months duration. Six randomly selected patients were treated with 250 mg b.d. ticlopidine during one of the study periods. Ticlopidine significantly increased platelet survival (P less than 0.02) in all patients irrespective of disease duration or severity. The involvement of platelets in atherosclerosis observed in these claudicants, can be reduced by therapy with ticlopidine, however, the lack of clinical improvement following long-term drug treatment only confirms the platelet's secondary role in this disabling disease.

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Reduction of remnant lipoprotein cholesterol concentrations by cilostazol in patients with intermittent claudication.

BACKGROUND: Elevated triglyceride-rich lipoproteins and reduced high-density lipoproteins (HDL) are associated with the development of intermittent claudication (IC), a life-limiting symptom of peripheral arterial disease. Cilostazol, a potent platelet inhibitor and vasodilator, lowers triglycerides and increases HDL concentrations in addition to increasing walking distance in patients with intermittent claudication. However, the association of remnant lipoproteins (a more atherogenic subset of triglyceride-rich lipoproteins) and peripheral arterial disease and the effects of cilostazol on remnant lipoproteins have not been studied. METHODS AND RESULTS: We quantified plasma remnant lipoprotein concentrations using the remnant lipoprotein-cholesterol assay (RLP-C). Patients with intermittent claudication (n = 415) had significantly higher remnant lipoprotein concentrations compared to reference subjects (n = 874; 0.31 +/- 0.32 versus 0.24 +/- 0.17 mmol/l, P < 0.001) in addition to elevated total triglyceride (2.67 +/- 1.92 versus 1.92 +/- 1.24 mmol/l, P < 0.001) and reduced high-density lipoprotein (HDL) cholesterol concentrations (1.06 +/- 0.31 versus 1.22 +/- 0.36 mmol/l, P < 0.001). Cilostazol treatment (100 mg, b.i.d.) in patients with intermittent claudication (n = 56) for 6 months resulted in 20% reduction of remnant lipoprotein-cholesterol (from 0.27 +/- 0.21 to 0.22 +/- 0.09 mmol/l, P < 0.05) versus no significant change (from 0.26 +/- 0.17 to 0.27 +/- 0.12 mmol/l) in the placebo group (n = 67). Cilostazol also reduced triglyceride concentrations significantly (from 2.32+/-1.46 to 1.79+/-0.72 mmol/l, P < 0.01, in the cilostazol group versus 2.38 +/- 1.39 to 2.25 +/- 1.19 mmol/l in the placebo group) and increased HDL cholesterol concentrations (from 1.06 +/- 0.23 to 1.24 +/- 0.34 mmol/l, P < 0.001) in the cilostazol group versus no significant change (1.06 +/- 0.34 to 1.09 +/- 0.36 mmol/l) in the placebo group. Pentoxifylline (400 mg, t.i.d.) did not have any significant effects on lipid variables (n = 66). CONCLUSIONS: Remnant lipoprotein concentrations are significantly elevated in patients with intermittent claudication and can be reduced by cilostazol. Reduction of remnant lipoproteins may provide a long-term benefit to the patients with symptomatic peripheral arterial disease.

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Outcome of conservative therapy of patients with severe intermittent claudication.

BACKGROUND: Intermittent claudication due to peripheral artery disease (PAD) can be treated conservatively, or by revascularization. OBJECTIVES: To assess the short-term outcome of conservatively-treated claudicants, and determine predictors for clinical improvement. Design. A retrospective cohort study. METHODS: We evaluated Fontaine stage, walking distance and ankle brachial index (ABI) at baseline and after median 9 months (interquartile range (IQR) 6-24) in 181 patients with severe claudication. RESULTS: We found clinical improvement by at least one Fontaine stage in 38 patients (21%) with an increased walking distance from baseline median 100 m (IQR 50-150) to follow-up median 650 m (IQR 300 to unlimited; p<0.001), but without changes in ABI (median 0.57, IQR 0.48-0.73 vs. median 0.54, IQR 0.45-0.81; p=0.10). One hundred and thirty-eight patients (76%) remained clinically and hemodynamically stable. A worsening of the clinical stage but without amputation was recorded in five patients (3%). Female gender (hazard ratio (HR) 0.51, p=0.052), diabetes (HR 0.35, p=0.020), and baseline ABI below 0.44 (HR 0.31, p=0.019) were associated with a reduced probability of clinical improvement. CONCLUSION: Certain patients with intermittent claudication show substantial clinical improvement with conservative medical therapy, despite any lack of hemodynamic improvement. Given the low number of patients with clinical deterioration in the short term, primarily conservative therapy should be the preferred initial option for most claudicants.

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Natural history of physical function in older men with intermittent claudication.

PURPOSE: This study was undertaken to determine the natural history of physical function in older men limited by intermittent claudication. METHODS: Forty-three men limited by intermittent claudication (mean age, 69 +/- 7 years) were recruited and followed up for 18 months. At baseline the patients reported a history of intermittent claudication for 6.1 +/- 6.1 years, and were able to walk for 1.9 +/- 1.6 blocks before experiencing claudication pain. Measurements during the 18-month study included ankle-brachial index (ABI), calf blood flow, 6-minute walk performance, monitored and self-reported physical activity, self-reported stability while walking, and summary performance score of physical function determined from a 4-m walk test, a chair stand test, and a tandem stand test. RESULTS: Pain-free walking distance during the 6-minute walk test decreased by 22% (P <.05) from baseline (185 +/- 96 m) to follow-up (144 +/- 93 m), and the total 6-minute walk distance decreased by 9% (P <.05), from 368 +/- 106 m to 334 +/- 90 m. Furthermore, monitored physical activity decreased by 31% (P <.05), from 159 +/- 151 kcal/d to 110 +/- 137 kcal/d; self-reported physical activity declined by 27% (P <.05), from 1.5 +/- 1.0 units to 1.1 +/- 0.8 units; tandem stance time declined by 14% (P <.05), from 9.46 +/- 1.83 seconds to 8.12 +/- 2.10 seconds; summary performance score of physical function decreased by 12% (P <.05), from 6.8 +/- 2.4 units to 6.0 +/- 2.4 units; and the percentage of patients reporting ambulatory unsteadiness and stumbling increased from 28% to 43% (P <.05). Calf blood flow measured at rest declined by 18% (P <.05), from 3.72 +/- 1.81 (mL/100 mL(-1)/min(-1)) to 3.04 +/- 1.43 mL/100 mL(-1)/min(-1), whereas ABI did not change (P >.05). CONCLUSION: Older men limited by intermittent claudication experienced decline in ambulatory function, physical activity, physical function, stability, and calf blood flow over 18 months of follow-up, despite no change in ABI.

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The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication.

PURPOSE: The purpose of this randomized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function, peripheral circulation, and health-related quality of life in peripheral arterial disease (PAD) patients limited by intermittent claudication. METHODS: Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain 3 days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs. RESULTS: After the exercise rehabilitation programs, patients in the two groups had similar improvements in these measures. Initial claudication distance increased by 109% in the low-intensity group (P < .01) and by 109% in the high-intensity group (P < .01), and absolute claudication distance increased by 61% (P < 0.01) and 63% (P < .01) in the low-intensity and high-intensity groups, respectively. Furthermore, both exercise programs elicited improvements (P < .05) in peak oxygen uptake, ischemic window, and health-related quality of life. CONCLUSION: The efficacy of low-intensity exercise rehabilitation is similar to high-intensity rehabilitation in improving markers of functional independence in PAD patients limited by intermittent claudication, provided that a few additional minutes of walking is accomplished to elicit a similar volume of exercise.

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Comparative effects of cilostazol and other therapies for intermittent claudication.

Many patients with peripheral arterial disease (PAD) have intermittent claudication or problems with ambulation and mobility. Exercise and smoking cessation are primary therapies for claudication, but drug treatment may provide additional benefit. The data supporting use of pentoxifylline for claudication are weak, and pentoxifylline is not generally accepted as efficacious. Cilostazol is a new drug for the treatment of claudication. It appears to modestly benefit walking ability and it has other potentially useful effects, including inhibition of platelet aggregation and beneficial effects on serum lipids. In a randomized, prospective, double-blind trial examining walking ability in patients with PAD with moderate-to-severe claudication, cilostazol was superior to both placebo and pentoxifylline.

Cilostazol↗

Gait characteristics of patients with claudication.

OBJECTIVE: Intermittent claudication of the lower extremity vessels produces pain during walking. This study differentiates walking patterns of patients with claudication from walking patterns of healthy individuals. DESIGN: Nonrandomized case control study performed in a teaching university hospital outpatient setting. PATIENTS: The sample of convenience involved male patients with lower extremity claudication (n = 19) and 11 healthy men of similar ages. INTERVENTIONS: Subjects were asked to walk at self-selected speed for 20 meters on a level, indoor surface. OUTCOME MEASURES: Walking velocity and number of steps were averaged over each of five trials, and step length was calculated from these measures. RESULTS: Patients with claudication walked slower and had decreased step length and decreased cadence compared with controls (p < .001). No positive relationship was found between disease severity, peak walking time, and step length, cadence, or speed. CONCLUSION: All patients with claudication, regardless of disease severity, demonstrated abnormal gait parameters compared with controls. Further studies should evaluate whether the abnormal gait parameters significantly curtail walking ability.

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European multicenter study on propionyl-L-carnitine in intermittent claudication.

OBJECTIVES: This study was performed to identify a target population of claudicants for propionyl-L-carnitine treatment. BACKGROUND: Previous studies suggest that the efficacy of propionyl-L-carnitine in intermittent claudication is greater in patients with severe functional impairment than in those with mild walking disability. METHODS: After run-in, 485 claudicant patients were randomized to placebo or propionyl-L-carnitine (1 g bid, p.o.) and then stratified on the basis of maximal walking distance (cutoff point 250 m) and maximal walking distance variability (cutoff point 25%). Treatment lasted 12 months. Walking capacity was assessed by treadmill and quality of life by a questionnaire exploring various aspects of daily life. RESULTS: In the target population, that is, patients who at baseline walked < or = 250 m and showed a maximal walking distance variability < or = 25%, per-protocol analysis showed that the effect of propinyl-L-carnitine was significantly greater than that with placebo for both maximal walking distance and initial claudication distance (ICD). In the intention-to-treat population, maximal walking distance increased by 62 +/- 14% on propionyl-L-carnitine and by 46 +/- 9% (p < 0.05) on placebo, while no difference between treatments was observed for ICD. The beneficial effect of propionyl-L-carnitine was confirmed when data of the target population were pooled with those of patients who at baseline walked < or = 250 m and showed a > 25% maximal walking distance < 50% variability. Actually, maximal walking distance increased by 98 +/- 16% in the propionyl-L-carnitine group and by only 54 +/- 10% in the placebo group (p < 0.01). The corresponding values for ICD were 99 +/- 21% and 51 +/- 8% (p < 0.05). For patients with baseline maximal walking distance > 250 m, no difference between treatments was observed. CONCLUSIONS: Claudicants with maximal walking distance < or = 250 m benefited from the use of propionyl-L-carnitine, with improvement in walking distance and quality of life. However, patients with mild functional impairment (i.e., walking distance > 250 m) showed no response to propionyl-L-carnitine.

Cardiotonic Agents↗

Functional outcome after surgical treatment for intermittent claudication.

PURPOSE: Although patency data for lower extremity bypass grafts are readily available, few reports have focused on patients' satisfaction after surgical reconstruction for claudication. We reviewed our experience with surgical treatment for claudication, focusing on late outcome from the patients' perspective to further refine surgical decision making in patients with intermittent claudication. PATIENTS AND METHODS: From February 1987 through April 1994, 114 consecutive patients underwent surgical bypass for intermittent claudication. Nine patients were lost to follow-up, leaving the study cohort composed of 105 patients with a mean age of 63 years (range 42 to 82 years). Sixty-two percent of the procedures were inflow reconstructions, and the remainder were infrainguinal bypasses. Clinical and demographic data were gathered from record review, and late follow-up was obtained by return visit or telephone interview. Patient satisfaction and level of function were assessed by a simple five-point questionnaire administered by a research nurse. Actuarial methods were used to calculate late graft patency and survival. Cox regression analysis was used to identify clinical and anatomic factors predictive of late survival and favorable outcome. RESULTS: Cardiac risk assessment revealed that 75% of patients either had no clinical markers for cardiac disease or had been treated with previous coronary artery bypass grafting or percutaneous transluminal angioplasty; despite this 61% of patients underwent specific preoperative cardiac testing. Most (68%) inflow procedures were aortobifemoral bypass grafts, and 93% of outflow procedures were femoropopliteal bypass grafts. Two thirds of infrainguinal grafts were performed with autogenous conduits, with prosthetic femoropopliteal bypass grafts performed only to the above-knee popliteal artery. Early graft failure with successful immediate revision occurred in 5% of patients. No operative deaths or early or late amputations occurred. At a mean follow-up of 4.5 years 96% of surviving patients had a patent graft. However, primary unassisted patency at 4 years was superior for inflow (92% +/- 4%) versus outflow (81% +/- 6%) procedures (p = 0.009). Late readmission for cardiac-related events occurred in 12%, and late cardiac-related death occurred in 5%. Actuarial survival at 5 years was 80% +/- 5%, with diabetes being the only negative survival predictor (risk ratio 2.6, 95% confidence interval 1 to 7, p = 0.049); 60% of late deaths were cancer-related. Satisfactory late results were reported by 82% of patients, with age < or = 70 years (odds ratio 4.01, 95% confidence interval 1.2 to 13.7, p = 0.026) and normalization ( > or = 0.85) of ankle/brachial index (odds ratio 5.7, 95% confidence interval 1.6 to 20, p = 0.008) being powerful independent predictors of patient satisfaction. CONCLUSIONS: After considering cardiac-related short- and long-term prognosis, we conclude that lower extremity bypass grafting for intermittent claudication will produce optimal results when restricted to younger ( < 70 years) nondiabetic patients in whom near normalization of the postoperative ankle/brachial index can be anticipated.

Blood Vessel Prosthesis↗

Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease.

PURPOSE: This study evaluated the effects of cilostazol on walking distances in patients with intermittent claudication (IC) caused by peripheral arterial occlusive disease. METHODS: The study was a multicenter, randomized, double-blind, placebo-controlled trial. Two hundred thirty-nine patients with IC were randomly assigned to receive cilostazol (100 mg b.i.d.) or a placebo for 16 weeks. All patients underwent serial, variable-grade, constant-speed treadmill testing. Absolute claudication distance (ACD), assessed at the end of the 12-hour dosing interval (trough), was the primary end point. Secondary end points included ACD assessed 3 to 4 hours after dosing (peak) and initial claudication distances (trough and peak). Functional status measures, including the Medical Outcomes Scale (SF-36) and Walking Impairment Questionnaire, were used to assess subjective changes over the 16-week treatment period. Ankle-brachial indexes were calculated from Doppler-measured systolic pressures at every visit with treadmill testing. RESULTS: Patients treated with cilostazol demonstrated significant improvements over the placebo patients in ACD at all three time points tested after baseline (weeks 8, 12, and 16). Peak treadmill testing at weeks 8 and 12 also showed significant improvement in walking distances for cilostazol-treated patients over placebo-treated patients. At week 16, patients in the cilostazol group had a 96.4-meter (47%) increase in ACD compared with 31.4 meters (12.9%) for the placebo group (p < 0.001). In the SF-36, significant improvement was observed in the physical component subscale and the composite physical component score. In the Walking Impairment Questionnaire, improvements were significant in patient reports of walking speed and specific measures of walking difficulty. Ankle-brachial indexes improved in the cilostazol group (0.64 +/- 0.02 to 0.70 +/- 0.02) compared with the placebo group (0.68 +/- 0.02 to 0.69 +/- 0.02) (p < 0.0125). The most frequent adverse events were headache, abnormal stools (e.g. loose stools), diarrhea, and dizziness. CONCLUSIONS: Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication.

Cilostazol↗

Infrainguinal arterial reconstruction for claudication: is it worth the risk? An analysis of 409 procedures.

PURPOSE: Infrainguinal reconstruction traditionally has been reserved for patients with limb-threatening ischemia. Surgery for debilitating claudication, however, has been discouraged as a result of the perceived fear of bypass graft failure, limb loss, and significant perioperative complications that may be worse than the natural history of the disease. In this study, the results of infrainguinal reconstructions for claudication performed during the past 10 years were evaluated for bypass graft patency, limb loss, and long-term survival rates. METHODS: Data were collected and reviewed from the vascular registry, the office charts, and the hospital records for patients who underwent infrainguinal bypass grafting for claudication. RESULTS: From 1987 to 1997, 409 infrainguinal reconstructions were performed for claudication (9% of all infrainguinal reconstructions in our unit). The patient population had the following demographics: 73% men, 28% with diabetes, 54% smokers, and an average age of 64 years (range, 24 to 91 years). Inflow was from the following arteries: iliac artery/graft, 10%; common femoral artery, 52%; superficial femoral artery, 19%; profunda femoris artery, 16%; and popliteal artery, 2%. The outflow vessels were the following arteries: 165 above-knee popliteal arteries (40%), 150 below-knee popliteal arteries (37%), and 94 tibial vessels (23%). The operative mortality rate was 0%, and one limb was lost in the series from distal embolization. The primary patency rates were 62%, 77%, and 86% for above-knee popliteal artery, below-knee popliteal artery, and tibial vessel reconstructions at 4 years, and the secondary patency rates were 64%, 81%, and 90%, respectively. Cumulative patient survival rates were 93% and 80% at 4 and 6 years as compared with 65% and 52%, respectively, for infrainguinal reconstructions performed for limb salvage. CONCLUSION: Infrainguinal arterial reconstruction for disabling claudication is a safe and durable procedure in selected patients. These data indicate that concern for limb loss, death, and limited life span of the patients with this disease may not be warranted.

Adult↗

Assessment of intermittent claudication by quantitation of exercise-induced microalbuminuria.

Urinary albumin excretion rates, expressed as albumin-creatinine ratios (ACR, mg/mmol) were measured before and after exercise in 23 claudicants and 10 controls. The mean (range) resting ACRs in the claudicants and controls were 4.42 (0.2-34.6) and 0.77 (0.3-2.8) respectively (P less than 0.001). ACR increased after exercise by a mean of 153% in claudicants to 9.7 (0.2-48.1; P less than 0.001) with no change in controls, 0.79 (0.2-2.1). In patients with claudication there was a positive correlation between ankle pressure recovery time and the relative increase in ACR after exercise (r = 0.64, P less than 0.01). The post-exercise increase in ACR was reduced in all nine patients who underwent bypass surgery. Measurement of ACR after exercise appears to be related to severity of muscle ischaemia and may assist in the assessment of patients with intermittent claudication.

Aged↗

Impact of intermittent claudication on quality of life. The Scottish Vascular Audit Group.

OBJECTIVES: Surgical treatment of intermittent claudication is aimed primarily at improving quality of life, rather than survival. The aim of this study was to examine the impact of claudication on quality of life and the ability of surgeons to judge this. DESIGN AND MATERIALS: 201 claudicants rated their quality of life and completed an SF36 health status questionnaire prior to their first consultation. Following the consultation, the surgeons rated their perceptions of the patients' quality of life. CHIEF OUTCOME MEASURES: SF36 scores were compared with population norms. Multiple linear regression analysis determined the factors influencing quality of life. Agreement between surgeon and patient ratings of quality of life was expressed as a kappa coefficient. MAIN RESULTS: Compared to population norms, claudicants had significantly reduced quality of life in all respects. The severity of disease, as measured by stopping distance, was a significant predictor of general health, pain, vitality and physical and social parameters. Mental and emotional wellbeing were also reduced, but were not related to disease severity. The agreement between patient and surgeon assessments of quality of life was not high (k = 0.4). Patients had a higher perception of their quality of life than their surgeons. CONCLUSIONS: Intermittent claudication impairs quality of life in all respects. The type of treatment offered to patients should reflect their quality of life at presentation, but subjective assessments by surgeons may not be sufficiently accurate. Health status questionnaires have been used almost exclusively in research, but they may also be of use in clinical settings as an objective measure of quality of life.

Activities of Daily Living↗

Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication.

OBJECTIVES: To determine differences between PTA and conventional medical treatment in treadmill distance until onset of claudication, treadmill maximum walking distance, patient reported maximum walking distance, ankle brachial pressure index (ABPI), quality of life (Nottingham Health Profile, NHP) and Duplex measured extent of occlusive disease. DESIGN: Randomised controlled clinical trial. METHODS: Six hundred claudicants were screened. Fifty-one men and 11 women with intermittent claudication due to short femoral stenoses or occlusions (n = 47) and iliac stenoses (n = 15) were randomised to either PTA plus medical treatment (PTA group, n = 30) or to medical treatment alone (control group, n = 32). Medical treatment consisted of daily low dose aspirin and advice on smoking and exercise. RESULTS: At 6 month follow up: In the PTA group more patients reported no claudication (p < or = 0.05) and were asymptomatic on the treadmill (p < or = 0.01) compared to the control group. The ABPI was significantly higher in the PTA group. More of the PTA group reported lower NHP pain scores (p < or = 0.05). In the control group there were more occluded arteries (p < or = 0.001), and the stenosis velocity ratio of patient arteries was significantly higher (p < or = 0.001). CONCLUSIONS: Only 10% of claudicants had discrete lesions suitable for PTA. Treatment of these patients with PTA produces a greater short-term improvement in walking and quality of life than medical treatment alone and is associated with less progression of disease.

Angioplasty, Balloon↗

Quality of life in patients with intermittent claudication.

OBJECTIVE: As intermittent claudication (IC) infrequently progresses to limb loss many clinicians adopt a conservative approach to treatment. Recently percutaneous transluminal angioplasty (PTA) has been applied to patients with IC. If this were to become the first line treatment for IC it would have major implications in terms of hospital facilities as well as cost. A measure is required, therefore, to decide on rationing of limited financial resources. "Quality of life" may be more influential in determining demand on services since objective medical criteria cannot give an insight into the patients feelings of well being. DESIGN: We applied the Nottingham Health Profile, by post, to a group of claudicants and age/sex matched controls. 70% responded from both groups. Claudicants who had recently received intervention were excluded, as were controls complaining of any leg pains on walking. RESULTS: The results showed that claudicants have greater perceived problems in the areas of energy, pain, emotional reactions, sleep, and physical mobility compared to controls (p < 0.05; Mann-Whitney Test). This was reflected by a significantly greater positive response rate to problems with activities of daily living (0.05 > p > 0.02; Chi-square Test) in the claudicant group. CONCLUSION: Because of the cost and resource implications of introducing measures such as PTA to the treatment of vast numbers of patients with IC, we suggest that trials are needed to compare various treatments using quality of life measurements in addition to traditional efficacy/safety parameters.

Activities of Daily Living↗

Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomised trial.

OBJECTIVES: To compare percutaneous transluminal angioplasty (PTA) against exercise training in the treatment of stable claudication. DESIGN: Prospective, randomised trial. MATERIALS: Fifty-six patients with unilateral, stable, lower limb claudication assessed prior to randomisation, at 3 monthly intervals for 15 months, and at approximately 6 years follow-up. Thirty-seven patients were available for long term review. OUTCOME MEASURES: Ankle/brachial pressure index (ABPI), treadmill claudication and maximum walking distances, percentage fall in ankle systolic pressure after exercise. RESULTS: Significant increases were seen in ABPI in the patients treated with PTA at all assessment to 15 months. However in terms of improved walking performance, the most significant changes in claudication and maximum walking distance were seen in the exercise training group. At long term follow-up, there was no significant difference between the groups. Subgroup analysis by angiographic site of disease showed greater functional improvement in those patients with disease confined to the superficial femoral artery treated by exercise training. The overall prognosis for the whole group of patients was benign, with only two (4%) undergoing amputation. CONCLUSIONS: Exercise training confers a greater improvement in claudication and maximum walking distance than PTA, especially in patients with disease confined to the superficial femoral artery.

Angioplasty, Balloon↗

Exercise training for intermittent claudication: does it adversely affect biochemical markers of the exercise-induced inflammatory response?

OBJECTIVES: To identify a stable biochemical marker of disease severity in patients with intermittent claudication and to use these findings to assess the effect of therapeutic exercise training. DESIGN: Case-control study: prospective randomised-controlled trial of exercise training. MATERIALS AND METHODS: Plasma fibrinogen, serum amyloid A protein (SAA), C-reactive protein (CRP) and urinary albumin-creatinine ratio (ACR) were measured in 67 claudicants and 15 controls. Twenty-two patients were randomised to supervised exercise training and 17 randomised to observation. Subjects were reviewed at 3, 6 and 12 months. RESULTS: The median (interquartile range) baseline fibrinogen was 3.7 g/l (3.3-4.25) in claudicants and 3.5 g/l (2.9-3.95) in controls (p = 0.045); CRP was 4.7 mg/l (2.2-9.0) and 2.1 mg/l (1.0-2.8), respectively (p < 0.0001); SAA was 72 mg/l (35-132) and 30 mg/l (20-89) (p = 0.0009). Claudicants showed an increased urinary ACR following treadmill exercise (Wilcoxon, p < 0.0001) with no change in controls. Exercise training reduced SAA at 6 months, CRP at 3 months and progressively attenuated the post-exercise increase in ACR. No similar changes were found in controls. CONCLUSIONS: Repetitive low-grade inflammatory events in claudicants lead to elevation of serum acute-phase proteins. Exercise training is associated with symptomatic improvement and reduction inflammatory markers. The concern that exercise has adverse systemic effects therefore seems to be unjustified.

Aged↗