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Evaluation of walking capacity over time in 500 patients with intermittent claudication who underwent clinical treatment.

BACKGROUND: The use of physical training in the treatment of intermittent claudication is well established. However, current data do not provide enough information about the prognosis for each case, and there are no data on how walking distances evolve over time with conservative treatment. The goal of this study was to evaluate improvement in walking capacity among patients with intermittent claudication who underwent unsupervised clinical treatment, observing whether sustained treatment would increase or decrease maximum walking distance, whether after 6 months there was a change in the maximum distance, and whether abstinence from smoking and well-conducted walking exercise had independent effects on the outcome. METHODS: Five hundred patients with intermittent claudication were surveyed in a prospective, nonrandomized, and uncontrolled study. Maximum walking distance and treatment compliance over time were analyzed. RESULTS: Nonsmoking patients who walked achieved a mean increase during the first 6 months of 33.70 m/mo and a mean increase thereafter of 4.24 m/mo. Smokers who walked achieved an increase during the first 6 months only (mean, 42.92 m/mo). Patients who did not practice physical training exhibited no effect (smokers) or negligible effect (nonsmokers) from the treatment (mean, 7.58 m/mo). CONCLUSIONS: Patients who adhered to physical training exhibited a significant increase in maximum walking distance during the first 6 months of treatment only. Patients who did not practice physical training exhibited no effect (smokers) or negligible effect (ex-smokers) from the treatment.

Comorbidity↗

Intermittent claudication in a professional rugby player.

Intermittent claudication in a professional rugby player is described. The typical features of a delayed and difficult diagnosis of an external iliac artery stenosis were found. The noninvasive diagnostic protocol used to investigate this young patient with a minimal arterial lesion enabled accurate localization and angioplasty to be performed at the same time as diagnostic angiography. The patient was symptom free with normal arterial pressures on follow-up. It is suggested that appropriate noninvasive investigations should be performed before angiography in young people with minimal lesions.

Adult↗

Repeated exercise induces release of soluble P-selectin in patients with intermittent claudication.

Controversy exists as to whether exercise in patients with intermittent claudication causes a harmful biochemical effect associated with an ischaemia-reperfusion injury of skeletal muscle. We report on exercise-induced changes in neutrophil activation, soluble P-selectin and von Willebrand factor in 34 patients with intermittent claudication and 12 matched controls. Von Willebrand factor (vWF) showed a cyclical pattern of response to exercise in control subjects (rising from 103 +/- 8 to 119 +/- 7 U/dl); claudicants did not show this pattern but had higher levels of vWF throughout (p <0.03). There was no consistent pattern of response in neutrophil hydrogen peroxide production to exercise in either claudicants or control subjects. Soluble P-selectin levels increased after exercise, but this only reached statistical significance after repeated exercise in claudicants (rising from 320 +/- 28 to 357 +/- 28 ng/ml). This rise in soluble P-selectin after exercise may indicate progressive platelet activation which may contribute to the excess cardiovascular mortality that claudicants are prone to.

Adult↗

Effect of clofibrate on blood viscosity in intermittent claudication.

Sixty-two patients with intermittent claudication associated with peripheral arterial diseases were treated with clofibrate, 2 g daily, for a minimum of six months. Progress was compared with that in a similar pretreatment period and also with that of a matched untreated control group of 27 patients. The most striking effect of clofibrate was a steep and sustained fall in whole-blood viscosity measured over a wide range of shear rates. This was associated with a significant fall in abnormally raised initial plasma-fibrinogen levels. An increased proportion of patients on treatment showed evidence of clinical improvement. Clofibrate had no effect on the susceptibility of red blood cells to autoxidation but it led to a significant shift in the red cell fatty acid pattern.

Blood Viscosity↗

Evidence-based symptom relief of intermittent claudication: efficacy and safety of cilostazol.

Intermittent claudication (IC) is a common, debilitating symptom of atherosclerotic peripheral arterial disease. There are two therapeutic objectives in patients with IC: relief of symptoms and secondary prevention of acute thrombotic complications. Among patients with Fontaine stage II disease, surgical revascularization for symptom relief is reserved for those in whom exercise/lifestyle modification and medical therapy has failed. To improve exercise tolerance in IC requires favourable alteration in the oxygen supply/demand relationship in the lower limb. Following the largest ever clinical trials programme in patients with IC, cilostazol, a phosophodiesterase III inhibitor, has been licensed for symptom relief in the UK. In double-blind, randomized, placebo-controlled trials involving over 2000 patients, cilostazol 100 mg b.d. produced significant and sustained improvements in pain-free and maximal walking distances as well as improved subjective assessments of quality of life. In particular, comparative studies with pentoxifylline (oxpentifylline) showed that cilostazol had significantly greater effects on functional outcome and exhibited good patient tolerance.

Cilostazol↗

PGE1 and other prostaglandins in the treatment of intermittent claudication: a meta-analysis.

In intermittent claudication, pharmacologic drugs and invasive measures are indicated in patients who do not benefit from exercise training. To evaluate the therapeutic role of prostaglandins (PGs), especially of prostaglandin E1 (PGE1), for this indication, the author performed a meta-analysis of all published prospective, randomized, controlled clinical studies in which descriptive sample statistics of the pain-free walking distance (PFWD) and the maximum walking distance (MWD) were available. In total, 9 studies with PGE1 and 4 studies with other PGs (beraprost, iloprost, AS-013) that met these selection criteria could be analyzed. In patients treated with PGE1 (n = 344), PFWD increased significantly (p < 0.001) more (+107%) than in patients treated with other PGs (n = 402; +42%) or placebo (n = 470; +24%). Similar results were also found for the MWD. Side effects were significantly (p < 0.001) fewer with PGE1 therapy than with other PGs (14.0% vs 30.8% of patients). In conclusion, PGE1 proved to be the most effective and best tolerated of the PGs evaluated.

Alprostadil↗

Intermittent claudication: a condition with underrated risks.

Intermittent claudication (IC) is a symptom of peripheral arterial occlusive disease (PAOD); it is subjective and therefore difficult to measure reliably. Both the WHO/Rose Questionnaire and the Edinburgh Questionnaire have been used widely, but they have a low sensitivity and therefore underestimate the true prevalence of IC. The addition of a clinical examination does not necessarily eliminate errors found on questionnaires alone. The single most important part of the physical examination to confirm a diagnosis of IC is the palpation of the patient's peripheral pulses, which alone appears to be more sensitive, but less specific, than the questionnaires. The most useful noninvasive test is the ankle-brachial pressure index (ABPI), and it has been suggested that a resting ABPI of 0.9 is up to 95% sensitive in detecting angiogram-positive disease, and almost 100% specific in identifying apparently healthy individuals. An ABPI of 0.9 or less is believed to be associated with 50% or greater vessel stenosis. The incidence of IC varies depending on the methodology used to define it, but there is a general pattern of a gradual increase in incidence up to the age of at least 70 years. For a chronic disease, the prevalence is a more relevant indicator of how common it is. The prevalence of IC is 3% to 6% in men aged 60 years and increases with age. The prevalence of asymptomatic PAOD may be as high as 20% in the adult population, using noninvasive testing. This is important because, as will be seen in later articles, PAOD, whether symptomatic or asymptomatic, is a serious risk factor for cardiovascular morbidity and mortality.

Adult↗

Blood flow measurement in patients with intermittent claudication.

Modified isotope clearance tests for the objective investigation of intermittent claudication of the lower limb were performed in 14 normal subjects with clinically patent arteries and 9 patients with calf claudication and arteriographically confirmed peripheral vascular occlusion. The tests involved a standard exercise performed in the supine position. During rest periods the limb under test was subjected to simultaneous venous occlusion plethysmography. In the patients with intermittent claudication, results were abnormal when compared with those of the normal group. The modified testing procedure described gave discriminatory results for each group. Their usefulness in monitoring disease progression, treatment benefit, and patient selection for surgery is discussed.

Adult↗

Vascular surgical society of great britain and ireland: prospective randomized double-blind placebo-controlled crossover study to assess the effect of sublingual glyceryl trinitrate in patients with intermittent claudication

BACKGROUND: The effect of sublingual glyceryl trinitrate (GTN) on the claudication distance (CD) and maximum walking distance (MWD) of patients with intermittent claudication was assessed. METHODS: Inclusion criteria were: history of intermittent claudication; resting ankle : brachial pressure index (ABPI) of 1.00 or less; fall in ABPI of more than 0.1 following exercise; and patient not taking nitrates. In the first study 22 patients (median age 69 (range 60-73) years, 16 men, five diabetic, median resting ABPI 0.57 (range 0.1-0.64)) had their CD and MWD measured on a treadmill set at 3.2 km h-1 and 10 per cent gradient. They were then randomized to either GTN or placebo spray, and the distances were remeasured. The crossover portion of the study was then completed. In the second study 28 patients (median age 68 (range 45-84) years, 20 men, six diabetic, median resting ABPI 0.57 (range 0.13-0.98)) were randomized to either GTN or placebo and walked at their own pace along a flat corridor for 15 min. Following a rest of 15 min, the crossover portion of the study was completed. Statistical analysis was by the Wilcoxon matched pairs signed rank test. RESULTS: CONCLUSION: GTN can increase the MWD by 19 per cent when patients with intermittent claudication are walked on a treadmill and by 9 per cent when walking at their own pace on a flat gradient.

Journal Article↗

Endovascular treatment for intermittent claudication in patients who do not improve with clinical treatment.

PURPOSE: To study the results including long-term follow-up obtained with endovascular treatment of patients with intermittent claudication who did not experience clinical improvement with conservative treatment. METHODS: From January 1992 to January 2002, 62 of 1380 patients (4.5%) with intermittent claudication underwent endovascular treatment and were followed up for up to 120 months (mean 76 months). The variables analyzed were the functioning of the arterial segment undergoing the endovascular procedure, the evolution of the maximum walking distance, and incidence of related morbidity and mortality. RESULTS: Fifty-two patients (84%) experienced no walking limitation after the procedure, and 6 patients (10%) improved but still exhibited some degree of limitation, for a total improved outcome of 94%. The patency rate was 82%. There was no intraoperative mortality. One primary failure and one immediate thrombosis occurred, and both were surgically corrected. Thrombosis of the treated artery occurred in 6 patients 12, 16, 25, 29, 62, and 66 months after the procedure. These patients started to experience intermittent claudication with a walking distance to onset that was similar to their presurgical distance to onset. During follow-up, a mortality rate of 12.9% (8 patients) was observed, 6 due to myocardial infarctions and 2 due cerebral infarction. Three patients underwent coronary bypasses 22, 36, and 55 months after the endovascular surgery, and 2 patients underwent coronary angioplasty after 6 and 26 months. The mean follow up period was 76 months (range 0-120 months). CONCLUSION: This study shows that endovascular treatment of intermittent claudication brought about a lasting regression of the ischemic conditions in a significant number of patients, with excellent patency rates. It was concluded that this is a good alternative for selected patients, with low rates of complications and positive long-term results.

Aged↗

Chelation therapy for intermittent claudication. A double-blind, randomized, controlled trial.

BACKGROUND: The use of repeated intravenous infusions of EDTA, which has become known as "chelation therapy," has been promoted for treating intermittent claudication as well as a wide range of other disorders. Multiple reports of excellent results in large numbers of patients have encouraged the use of this regimen. The lack of well-controlled studies substantiating the benefits of this treatment has limited its use mainly to private clinics. The aim of the study was to assess the benefits of chelation therapy in patients with intermittent claudication. METHODS AND RESULTS: A double-blind, randomized, controlled trial included 32 patients with intermittent claudication who were randomized to a treatment group (15) and a control group (17). Main outcome measures were subjective and measured walking distances and ankle/brachial pulse indices. Other outcome measures included lifestyle and subjective parameters of improvement, cardiac function, ECG, renal function, hematology, blood glucose, and lipid biochemistry. No clinically significant differences in main outcome measures between chelation therapy and placebo groups were detected up to 3 months after treatment. Measures of mood state, activities of daily living, and quality of life factors were not consistently affected by chelation therapy. An equal proportion (13%) of each group thought that they had received the active agent. The proportion of patients showing an improvement in walking distance was not significantly different between the chelation group (60%) and the control group (59%). CONCLUSIONS: Chelation therapy has no significant beneficial effects over placebo in patients with intermittent claudication.

Activities of Daily Living↗

Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study.

OBJECTIVE: The aim of our pilot study was to determine the usefulness of rapid, high-pressure, intermittent pneumatic calf and foot compression (IPCFC) in patients with stable intermittent claudication, with reference to the end points of improvement in initial claudication distance (ICD) (distance at which patient feels pain or discomfort in the legs), and improvement in absolute claudication distance (ACD) (distance at which patient stops walking because the pain or discomfort becomes severe). METHODS: Thirty male patients presenting with stable, intermittent claudication (ACD between 50 and 150 meters on treadmill testing at 3.8 km/h, 10 degrees gradient) were recruited into this pilot study from a single center. Fifteen patients were randomized to treatment with IPCFC (applied for 1 hour twice daily in the sitting position) and were also advised to have daily exercise, and 15 patients served as controls, who were advised exercise alone. All patients received aspirin and had resting and postexercise ankle/brachial index (ABI) measured at enrollment along with ICD and ACD on treadmill testing (3.8 km/h, 10 degrees gradient). The mean age, baseline ICD, and ACD of the treatment and control groups were 70.4 +/- 7 years and 70.7 +/- 9 years, 55.8 +/- 15 meters and 68.4 +/- 17 meters, and 86.7 +/- 19 meters and 103.9 +/- 27 meters, respectively. Both groups were equally matched for risk factors, including smoking, type II diabetes mellitus, and hypercholesterolemia. IPCFC was applied. The study protocol included follow-up visits at 1, 2, 3, 4, 6, and 12 months with the ABI, ICD and ACD being measured at every visit. RESULTS: The percent change from baseline for ICD and ACD for each patient visit and the mean +/- standard deviation (SD), standard error (SE), and median were calculated for the control and treatment groups. The percent change from baseline measurements (mean +/- SD) for ICD and ACD in the control group at 4, 6, and 12 months were 2.2 +/- 18 and 2.3 +/- 18, 2.9 +/- 17 and 5.2 +/- 20, and 3.6 +/- 18 and 5.8 +/- 20, respectively. In contrast, the changes in ICD and ACD at 4, 6, and 12 months in the treatment group were 137.1 +/- 128 (P < .01) and 84.3 +/- 82 (P < .01), 140.6 +/- 127 (P < .01) and 96.4 +/- 106 (P = .01), and 150.8 +/- 124 (P <0.01) and 101.2 +/- 104 (P <0.01), respectively. Although the ABI showed a slight increase in the treatment group, these differences were not statistically significant. CONCLUSIONS: The results of this pilot study show that IPCFC improves walking distance in patients with stable intermittent claudication. A significant increase in ICD and ACD was seen at 4 and 6 months of treatment, respectively, and the improvement was sustained at 1 year. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future.

Administration, Oral↗

Functional benefits of peripheral vascular bypass surgery for patients with intermittent claudication.

Many patients with peripheral arterial disease (PAD) undergo peripheral bypass surgery to relieve the symptom of intermittent claudication. However, measurement of graft patency alone, assessed by change in ankle blood pressure, may not adequately reflect the improvement in functional status following the operation. Fourteen patients with moderately severe intermittent claudication were evaluated before and after bypass surgery to asses changes in hemodynamics (by resting ankle-brachial indices-ABIs), exercise performance (by a graded treadmill protocol), and community-based walking ability (by a questionnaire that characterizes self-reported walking speed and distance). Six weeks after surgery, resting ABIs improved in surgical patients (from 0.56 +/- 0.09 to 0.93 +/- 0.16, P < 0.05). Peak treadmill walking time improved from 6.2 +/- 5.9 to 11.8 +/- 7.1 min (90%), peak oxygen consumption from 15.5 +/- 6.5 to 19.1 +/- 8.5 mL/kg/min (23%), and pain-free walking time from 1.5 +/- 0.4 to 6.0 5.5 min (290%). Questionnaire scores for walking distance improved by 203% and for walking speed by 130% (all P < 0.05). After twelve weeks, improvements other than pain-free walking time were maintained. Changes in peak treadmill performance or questionnaire scores were not correlated with the initial ABI, changes in ABI six or twelve weeks after surgery, or the type or extent of bypass surgery. The results demonstrate that surgical treatment of PAD, indicated for the relief of intermittent claudication, improves exercise performance and self-reported community-based walking ability. The change in functional status of the patient is an important outcome of surgery that cannot be predicted from routine noninvasive testing alone and should be measured directly.

Aged↗