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Physiological and symptomatic responses to cycling and walking in intermittent claudication.

To shed light on the potential efficacy of cycling as a testing modality in the treatment of intermittent claudication (IC), this study compared physiological and symptomatic responses to graded walking and cycling tests in claudicants. Sixteen subjects with peripheral arterial disease (resting ankle: brachial index (ABI) < 0.9) and IC completed a maximal graded treadmill walking (T) and cycle (C) test after three familiarization tests on each mode. During each test, symptoms, oxygen uptake (VO2), minute ventilation (VE), respiratory exchange ratio (RER) and heart rate (HR) were measured, and for 10 min after each test the brachial and ankle systolic pressures were recorded. All but one subject experienced calf pain as the primary limiting symptom during T; whereas the symptoms were more varied during C and included thigh pain, calf pain and dyspnoea. Although maximal exercise time was significantly longer on C than T (690 +/- 67 vs. 495 +/- 57 s), peak VO2, peak VE and peak heart rate during C and T were not different; whereas peak RER was higher during C. These responses during C and T were also positively correlated (P < 0.05) with each other, with the exception of RER. The postexercise systolic pressures were also not different between C and T. However, the peak decline in ankle pressures from resting values after C and T were not correlated with each other. These data demonstrate that cycling and walking induce a similar level of metabolic and cardiovascular strain, but that the primary limiting symptoms and haemodynamic response in an individual's extremity, measured after exercise, can differ substantially between these two modes.

Aged↗

Endoluminal femoropopliteal bypass for intermittent claudication.

OBJECTIVES: (i) to describe our initial clinical experience with endoluminal femoropopliteal bypass using a technique developed in a cadaveric model; (ii) to identify areas requiring technical modification to improve patency and complication rates. DESIGN: prospective, experimental pilot study. MATERIALS AND METHODS: fourteen consecutive patients with disabling intermittent claudication and superficial femoral artery occlusion underwent endarterectomy through a groin incision and endoluminal placement of a polytetrafluoroethylene graft. Follow-up was by duplex ultrasound and arteriography. RESULTS: two endovascular technical failures required conversion to open surgery. The cumulative primary (1 degrees), 1 degrees-assisted and secondary (2 degrees) patency rates at 1 year were 35.7%, 42.8% and 71.4% respectively; at 2 years the patency rates were 14.3%, 31.2% and 57.1%. Twenty-three endovascular interventions were required to maintain graft patency in 10 patients. Five patients subsequently required conventional bypass, of whom two proceeded to major amputation because of graft infection. Seven endovascular grafts remain patent at a mean follow-up of 50 months. CONCLUSIONS: this minimally invasive surgical technique is feasible, with acceptable patency rates. However, considerable investment of time and resources is required to maintain graft patency. With increasing experience and improved technical design, this procedure may offer a real alternative to conventional surgery in patients disabled by short-distance claudication.

Adult↗

Above-knee prosthetic femoropopliteal bypass for intermittent claudication. Results of the initial and secondary procedures.

OBJECTIVES: [corrected] to report the results of primary and secondary prosthetic above-knee femoropopliteal bypass for intermittent claudication. DESIGN: a retrospective study in a University hospital. PATIENTS: one hundred and twelve operations performed in 103 patients (26 women) between January 1990 and June 1997. METHODS: a comparison of primary assisted patency was made between Dacron and PTFE, between men and women and between operations performed early and late in the study period. Patency of secondary procedures was also studied. RESULTS: there were no operative deaths. The 5-year survival rate was 81% and equal to that of a demographically matched population. The primary assisted graft patency was 58% after two years. Women had a significantly better graft patency than men (79% vs. 49%). The type of graft and the date of the operation did not influence the outcome. Forty of the 55 occluded grafts were subjected to a redo procedure with a 1-year patency of 29%. CONCLUSIONS: the results after prosthetic above-knee femoropopliteal bypass procedures are disappointing, and a controversy persists as to whether this operation should be performed for intermittent claudication. The results of secondary procedures are even worse, and perhaps should only be considered in patients suffering critical ischaemia.

Adult↗

Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements.

OBJECTIVES: to compare the effect of surgery, exercise and simple observation on maximum exercise power in claudicants. DESIGN: prospective, randomised study. METHODS: a total of 264 unselected claudicants were randomised to supervised exercise training, invasive treatment (open surgical or endovascular procedures) or observation. One year treatment outcomes were analysed on an intention to-treat basis. RESULTS: invasively treated patients showed a significant improvement in maximum walking power, stopping distance, post-ischaemic blood flow and big toe pressure at one year. Patients randomised to physical exercise training or to the control group did not improve in any outcome measure. CONCLUSION: invasive treatment increased walking capacity, leg blood pressure and flow. Supervised physical exercise training offered no therapeutic advantage compared to untreated controls.

Adult↗

Oxygen saturation measurement of calf muscle during exercise in intermittent claudication.

OBJECTIVES: to evaluate the oxygen saturation of the calf muscle measured by means of spatially resolved spectroscopy (SRS) in claudicants. METHODS: a total of 150 legs in 84 consecutive patients with calf claudication were studied by SRS. Oxygen saturation (SmO(2)) and the relative changes in oxygenated haemoglobin (HbO(2)) and deoxygenated haemoglobin (Hb) of the gastrocnemius muscle were measured during a treadmill walking test (2.4 km/h, 12%, 5 min). RESULTS: exercise was associated with a decrease in HbO(2) and an increase in Hb. There was no difference in SmO(2) at rest among all groups. The decrease oxygen saturation correlated well with the severity of symptoms of IC. CONCLUSION: muscle oxygen saturation measurement by SRS can be used clinically to provide objective information regarding the severity of IC.

Adult↗

Leg blood flow and long-term cardiovascular prognosis in men with typical and atypical intermittent claudication.

OBJECTIVES: To compare leg blood flow and the long-term cardiovascular prognosis in men with typical and atypical intermittent claudication (IC) according to Rose's questionnaire. METHODS: Leg blood flow during reactive hyperaemia was assessed at 55 years of age by calf plethysmography. Measurement of the systolic ankle-arm pressure index was used to assess the prevalence of peripheral arterial disease (PAD) at 68 years of age. Mortality and incidence of cardiac events is based on record linkage with regional and national registers. RESULTS: Twenty-one (3%) out of 700 men had typical IC at 55 years of age. Sixteen (76%) of these had normal plethysmography, with a mean peak flow (95% CI) of 24.6 (19.3-30.0) ml/min/100 ml. Peak flows were similar and normal in men with atypical IC (mean 22.5; 95% CI 21.3-23.6) and men having no pain (mean 23.8; 95% CI 23.1-24.4). Mortality rates were increased in men with typical IC but who had normal leg blood flow (49.5 deaths/1000 person years; p = 0.008), and men having atypical IC (35.3 deaths/1000 person years; p = 0.007) in comparison with men having no leg pain (27.4 deaths/1000 person years). This could not be accounted for by an increased cardiac event rate. The prevalence of PAD at 68 years of age was not increased in either of these two groups. CONCLUSIONS: Only 12% of subjects with exertional pain fulfilled all criteria for typical IC. Typical and atypical claudication in absence of objective evidence of PAD was associated with a reduced life expectancy, but not with an increased cardiovascular risk. To properly assess the prognosis, non-invasive assessment of PAD should be used in addition to questionnaires.

Aged↗

Evaluation of the patient with intermittent claudication.

The most common cause of intermittent claudication is atherosclerotic occlusive arterial disease. Differentiation of the common musculoskeletal and neurologic conditions that may mimic intermittent claudication is often possible with a careful history, but when insufficient detail is provided or multiple conditions exist, the findings on physical examination and noninvasive studies are useful. While physical examination provides a rough estimate of the degree of ischemia, assessment of functional impairment produced by occlusive arterial disease is best made with noninvasive studies before and after standard exercise. Arteriography is reserved for the patient for whom restoration of pulsatile flow is planned.

Angiography↗

Incidence and management of intermittent claudication in primary care in The Netherlands.

OBJECTIVE: To study the incidence and management of intermittent claudication in primary care. DESIGN: In a longitudinal survey among 161 general practitioners (GPs) all incident diagnoses of intermittent claudication (IC) were selected and available information on GP management was studied. SETTING: Dutch National Survey of Morbidity and Interventions in General Practice. SUBJECTS: 74153 patients aged 55 years and over. MAIN OUTCOME MEASURES: Age- and sex-specific incidence rates. RESULTS: The overall incidence rate of IC was 6.4 per 1000 person years (95% confidence interval (CI) 5.3-7.7). Incidence rate in creased from 4.0 per 1000 person years in men aged 55-59 to 12.9 per 1000 person years in men aged over 85, and for women in the same age categories from 3.3 per 1000 person years to 8.2 per 1000 person years, respectively. Of the 117 incident cases of IC, 43 (37%) were referred to a hospital specialist. In 55 cases (47%), drugs were prescribed by the GP and in 101 cases (86%) the GP gave advice, notably pertaining to exercise and cessation of smoking. CONCLUSION: The incidence rate of IC in primary care is high in both men and women, and clearly increases with age. Only a minority of patients are referred to a hospital specialist, while the vast majority receive lifestyle advice.

Age Distribution↗

Design of the Del-1 for therapeutic angiogenesis trial (DELTA-1), a phase II multicenter, double-blind, placebo-controlled trial of VLTS-589 in subjects with intermittent claudication secondary to peripheral arterial disease.

The objective of this phase II investigation is to assess the safety and efficacy of a plasmid mediated approach to induce angiogenesis/arteriogenesis with the angiomatrix protein Del-1 (developmentally regulated endothelial locus 1), in subjects with intermittent claudication (IC) secondary to peripheral arterial disease (PAD). VLTS-589 is an investigational nonviral therapeutic comprising a plasmid-expressing Del-1 formulated with poloxamer 188 (facilitating agent). One hundred subjects with bilateral PAD and IC will be randomized after careful screening to bilateral intramuscular delivery of VLTS-589 or placebo. A total of 84 mg of plasmid or placebo will be delivered as 42 intramuscular injections (2 ml per injection, 21 injections or 42 ml in each extremity of either plasmid or placebo) in both lower extremities. The subjects in the study will be followed at regular intervals for a year after study drug administration (days 30, 90, 180, and 365) with the primary endpoint being the safety and tolerability of VLTS-589 and change in peak walking time (PWT) at day 90. The secondary endpoints include percent and absolute change in resting ankle brachial Index, claudication onset time, and quality of life measured at various time points. DELTA-1 represents the largest plasmid-based gene transfer trial designed to test the efficacy of a Del-1 as a therapeutic approach in patients with IC caused by PAD. The novel aspects of the protocol include the usage of a Del-1 plasmid-polaxamer formulation to enhance gene transfer at doses that are an order of magnitude different than other comparable trials in a unique bilateral intramuscular dosing pattern to maximize transfection/clinical efficacy and general applicability to patients with PAD.

Adult↗

Local infections after above-knee prosthetic femoropopliteal bypass for intermittent claudication.

BACKGROUND: The use of prosthetic grafts in the treatment of intermittent claudication is still a controversy. Prosthetic bypass for this usually benign condition may in some cases lead to a graft infection. This potentially disastrous complication is difficult to manage. METHODS: One hundred forty-one consecutive operations done on 129 patients between January, 1990 and December, 2001 in a single university vascular unit have been studied. Lymphatic complications and local infections have been related to preoperative risk factors, complications, secondary procedures, and outcome. RESULTS: During a mean follow-up period of 42 months, lymph complications occurred after 18 operations, surgical site infection after 11 procedures, and graft infection after 17 operations. Eleven infected grafts were treated successfully without graft excision. Six of these grafts healed with antibiotics only. The risk of developing a local infection was significantly correlated with postoperative lymph fistula. Reoperative surgery was associated with graft infection. Graft infection caused by Staphylococcus aureus always warranted surgery, either local revision or graft excision. CONCLUSIONS: The present series had a high frequency of graft infections. Our data suggest that a selective approach should be taken towards excision of infected femoropopliteal prostheses. The need for and extent of surgery should be individualized according to the clinical presentation of the graft infection and the type of bacteria involved. We advocate a conservative attitude towards surgical treatment of intermittent claudication.

Aged↗

Intermittent claudication and subsequent cardiovascular disease in the elderly.

BACKGROUND: This study reports the prevalence of intermittent claudication (IC) in ambulatory community-resident adults age 65 years or older, compares cardiovascular risk factors and comorbidity of persons with and without IC, and examines the independent association of IC in predicting all cause and cardiovascular mortality, myocardial infarction, stroke, and disability. METHODS: Data are from a pooled sample of 8996 older adults from the East Boston, New Haven, and Iowa sites of the Established Populations for Epidemiologic Studies of the Elderly, conducted between 1982 and 1988. RESULTS: 2.4% and 1.5% of men and women, respectively, reported IC. Persons with IC had significantly higher rates of diabetes and cardiovascular comorbidity than persons without IC, and they were more likely to smoke. Claudication predicted higher rates of mortality, myocardial infarction, stroke, and disability independent of associated cardiovascular conditions and risk factors. Among persons with a history of angina, myocardial infarction, and/or stroke, those who reported IC had a twofold greater risk of cardiovascular mortality. CONCLUSION: The study demonstrated that IC is an important predictor of mortality and cardiovascular morbidity in ambulatory older adults independent of associated coronary ischemia and cardiovascular disease risk factors. Results suggest that inclusion of a measure of IC improves the prediction of cardiovascular morbidity and mortality in older adults.

Activities of Daily Living↗

The effect of exercises on walking distance of patients with intermittent claudication: a study of randomized clinical trials.

BACKGROUND AND PURPOSE: There is no consensus about the indication for exercises for patients with intermittent claudication of the lower extremity and the characteristics of an exercise program to improve walking distance. The effect of walking is assessed by a systematic review of randomized clinical trials. METHODS: Literature databases were accessed using the relevant key words. The references of identified articles were screened for additional studies. A checklist was developed to screen the studies with respect to the variables of interest. A methodological assessment form was developed to assess the methodological quality of the studies (maximum possible score: 100). RESULTS: Eighty-two articles were identified, of which 21 studies were considered relevant for inclusion in the review. Following the analysis of the articles, 11 studies were for various reasons eliminated, leaving 10 studies for the systematic review. The score for methodological quality of the studies ranged from 47 to 75 (mean = 62.5, SD = 8.5). Percentage of improvement in walking distance or time ranged from 28% to 210% (mean = 105%, SD = 55.8%). CONCLUSION AND DISCUSSION: All studies showed that walking exercises improved walking distance in patients with intermittent claudication. Further research is needed to determine the optimal exercise program, the effect of adherence to the treatment protocol, and the duration of the effects following a formal exercise program.

Exercise Therapy↗

Anti-inflammatory effects of pentoxifylline in claudication.

We measured neutrophil elastase/alpha 1 proteinase inhibitor complex (E/alpha) levels by ELISA in plasma samples drawn from 19 patients with claudication, before and at 1 and 2 months after initiation of pentoxifylline (PTF), 400 mg. p.o. tid. Plasma E/alpha levels declined in all eight patients whose initial values were more than 300 ng elastase per ml. Whole blood viscosity (wbv) was reduced by two months' treatment in 12 of 14 patients tested. The relative change in wbv was significantly related to the relative change in E/alpha (R2 = 0.8), for patients with elevated initial E/alpha levels, suggesting a common or related mechanism for the two effects. Plasma crosslinked fibrin D-dimer fragments (XDP) measured by ELISA as indicators of coagulation activity were lower compared to pretreatment levels in 9 of 10 samples drawn when symptoms were improved on PTF, whereas they were increased in 6 of 9 samples drawn when symptoms were worse or unchanged. Plasma viscosity, C-reactive protein and alpha 1-acid-glycoprotein did not change significantly with PTF treatment. Together these findings are consistent with the possibility that reduced microvascular neutrophil activation and coagulation play a role in the clinical efficacy of PTF in intermittent claudication.

Anti-Inflammatory Agents, Non-Steroidal↗

Results of ankle ststolic pressure measurements in patients with intermittent claudication being treated with clofibrate.

Ankle systolic pressure measurements in 67 patients with intermittent claudication treated with Clofibrate for an average period of 11 months and 32 untreated patients suggest that 1) patients with a raised initial plasma fibrinogen concentration have more severe disease than those with low initial plasma fibrinogen concentration and 2) the response to treatment with Clofibrate is significantly better in those with a raised plasma fibrinogen concentration. On the basis of the patients own estimation of their claudication distance there was marked symptomatic inprovement in the treated patients. There was also a significant decrease in mean plasma fibrinogen levels in the treated patients and it is suggested that the hypofibrinogenemic effect of Clofibrate may be responsible for the benefit of this drug in patients with vascular disease.

Ankle↗

Femoropopliteal vein grafts for claudication. Analysis of 100 consecutive cases.

One hundred consecutive femoropopliteal venous grafts in 85 patients with claudication were followed for five years. At this time, three limbs had been amputated, approximately one quarter of the patients had expired, and 70% of the grafts in surviving patients remained patent. It is concluded that this operation does not appear to increase the risk of amputation and in fact, may lessen it. Moreover, it is associated with minimal risk and generally provides long term relief of claudication, thus enhancing the quality of life in most patients.

Adult↗

Hemiplegia and contralateral upper limb claudication--a case of dual disability from pseudoaneurysm of the brachiocephalic artery: a brief report.

Thromboembolic obstruction of the brachiocephalic artery can have significant functional consequences because it threatens arterial circulation to the right upper limb and right cerebrum. A case is presented of a young man who sustained right basal ganglia infarct 2 mo after suffering multiple gunshot wounds to his chest. The severity of his hemiplegia rendered his left arm nonfunctional. Later, he developed progressive symptoms of right upper limb claudication, making it impossible to perform activities of daily living independently with the hemiplegic technique. Arteriography revealed a pseudoaneurysm near the bifurcation of the brachiocephalic artery; the likely source was thromboembolism to the right common carotid and right subclavian artery. Surgical ligation of the subclavian artery and vascular bypass from the common carotid to the brachial artery restored blood flow to his right upper limb. The arm claudication was relieved, and he was again able to perform activities of daily living independently. This case represents an unusual cause of dual disability with bilateral upper limb dysfunction from a single thromboembolic source. Accurate diagnosis and treatment prevented this patient from developing permanent impairment and restored him to functional independence.

Activities of Daily Living↗

A dose-effect study of beraprost sodium in intermittent claudication.

We compared the efficacy and safety of three doses of beraprost sodium, an epoprostenol analogue, with placebo in the treatment of intermittent claudication (Fontaine's stage II). One hundred sixty-four patients were randomized to receive either placebo, 20 micrograms beraprost sodium (BPS60 group), 40 micrograms beraprost sodium (BPS120 group), or 60 micrograms beraprost sodium (BPS180 group) three times daily administered orally in a double-blind manner for 12 weeks. Treadmill exercise tests were performed twice during an initial selection phase (D-28 and D0) at week 10 (at trough beraprost concentration) and week 12 (at peak beraprost concentration) of the treatment phase. At week 10, all groups showed an increase in pain-free walking distance, and this distance was greatest in the BPS60 and BPS120 groups (p = 0.055). At week 12, a similar pattern was observed, and the difference was significant between the groups (p = 0.023). The most frequent adverse events reported were gastrointestinal disorders, headaches, skin disorders, and flushes. Patients who received either 60 or 120 micrograms of beraprost sodium daily had an increased pain-free walking distance. Further studies are required to investigate why the highest dose used (180 micrograms daily) showed lower efficacy. Having both vasodilating and antiplatelet properties and being able to increase pain-free walking distance in the short term, beraprost sodium is a promising drug for the treatment of intermittent claudication.

Adult↗

Temporal arteritis presenting with jaw claudication and normal erythrocyte sedimentation rate.

We have described a case of sudden blindness of the right eye in an 81-year-old white woman with a one-month history of increasingly severe jaw claudication and a normal Westergren sedimentation rate. Isolated jaw claudication in the elderly is of diagnostic importance, and the need for temporal artery biopsy and rapid institution of high-dose steroid therapy to prevent blindness is emphasized.

Aged↗