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PubMed1995

Reduction of requirement for leg vascular surgery during long-term treatment of claudicant patients with ticlopidine: results from the Swedish Ticlopidine Multicentre Study (STIMS).

OBJECTIVE: To study the effect of long-term treatment of the platelet inhibitor ticlopidine as secondary prevention against the need of vascular surgery in patients with intermittent claudication. DESIGN: The Swedish Ticlopidine Multicentre Study (STIMS), was conducted in six medical and surgical clinics of university hospitals in Sweden. METHODS: 687 claudicants were randomised to ticlopidine 250 mg bd or placebo and vascular surgery events were recorded prospectively over a 7-year period. Cox proportional hazards models of risk for leg vascular surgery were constructed using drug treatment and 11 putative risk factors for vascular disease as covariates. Surgical event-free survivals were compared by Kaplan-Meier analysis. RESULTS: The overall rate of first operations was 2.4% per annum. More than half of these operations were in the aortoiliac region. One-quarter of patients operated during the period required further operations but amputation was rare. Ticlopidine treatment reduced the need for vascular reconstructive surgery by about half, both in intention-to-treat and on-treatment analyses (unadjusted relative risks 0.486, 95% CI 0.317-0.745; p < 0.001; 0.493, 95% CI 0.290-0.841: p < 0.01, respectively). In Cox model analysis only male sex was confirmed as a risk factor for surgery. Previous peripheral arterial surgery was the strongest predictor of the need for surgery. None of the risk factors examined interacted statistically with the effect of treatment with ticlopidine. CONCLUSION: In patients with intermittent claudication it seems possible to prevent the need for future vascular surgery by the use of platelet inhibition with ticlopidine.

Female↗
PubMed1996

Femorofemoral crossover grafts for claudication: a safe and reliable procedure.

OBJECTIVE: To evaluate the role of femorofemoral crossover grafts in patients with disabling claudication. DESIGN: Retrospective study. SETTING: University hospital. MATERIALS: Two hundred and eleven patients with iliac artery disease undergoing femorofemoral crossover grafts for disabling claudication. CHIEF OUTCOME MEASURES: Perioperative mortality, follow-up cumulative graft patency, limb loss, survival, graft infection and false aneurysm formation were evaluated to determine the immediate and long-term outcome of the procedure. MAIN RESULTS: Primary and secondary graft patency at 5 years was 72% and 89% respectively. There were no perioperative deaths (zero 30 day mortality). Dacron was used in 66 patients (31%) and PTFE in 145 (69%). There were no differences in patency between the two graft materials but eight Dacron grafts (12.1%) were removed because of complications (false aneurysm or infection) compared to four PTFE grafts (2.7%) (p < 0.001 Chi-square). Five patients (2%) have undergone a major lower limb amputation. Forty-one patients (19%) have required subsequent inflow procedures which represents a cumulative need for inflow of 5% per year. CONCLUSIONS: Femorofemoral crossover grafts are a safe and reliable procedure in patients with disabling claudication caused by unilateral iliac artery disease.

Adult↗
PubMed1997

Effect of walking distance on the change in ankle-brachial pressure index in patients with intermittent claudication.

OBJECTIVES: The ankle-brachial pressure index (ABPI) responses to different exercise intensities on a treadmill were evaluated to clarify the relationship between intermittent claudication and the haemodynamics in the leg. PATIENTS AND METHODS: Thirty patients with intermittent claudication (32 symptomatic legs) due to peripheral arterial occlusive disease were exercised on a treadmill to determine their pain-free walking distance, maximum walking distance (MWD) and recovery time. Each subject was exercised at 25% and 50% of the MWD to determine the effect of work intensity on the drop in ABPI, and the recovery time. RESULTS: In the claudicating legs, 25% of the MWD resulted in almost the same reduction in ABPI as 50% of the MWD, and the MWD. In contrast, the ABPI in the asymptomatic legs (13) was significantly decreased in proportion to the walking distance. The recovery time increased linearly in both the groups, as the walking distance increased. CONCLUSION: The recovery time of the ABPI correlated well with the intensity of workload, while the drop in ABPI did not.

Aged↗
PubMed1998

Vascular morbidity and mortality during long-term follow-up in claudicants selected for peripheral bypass surgery.

OBJECTIVES: To identify claudicants at high risk (and low risk) of late vascular morbidity and mortality after peripheral bypass surgery. DESIGN: Prospective cohort study with mean follow-up of 8.6 years. PATIENTS: One-hundred and fifty-five claudicants selected for peripheral bypass surgery. Only three patients were lost to follow-up. End points were major vascular events, additional interventions, all-cause mortality, and functional outcome. RESULTS: Major vascular events occurred in 59 patients. Life-table analysis revealed an annual risk increase of 3.5%. Strong predictors were hypertension (hazard ratio (HR) 2.7; 95% confidence interval (CI) 1.5-4.8), diabetes (HR 2.4; 95% CI 1.0-5.4) and cardiac disease (HR 2.2; 95% CI 1.2-4.0). Sixty patients needed additional interventions with a highest incidence (17%) in the first year, and thereafter 2.8% each year. None of the known risk factors were associated with an altered incidence of interventions. Approximately 3.5% of patients died per year compared with 2% per year in the control group. Prominent high-risk factors for mortality were cardiac disease (HR 3.3; 95% CI 1.8-6.0) and diabetes (HR 3.0; 95% CI 1.5-7.1). CONCLUSION: Major vascular events and additional interventions are common and serious in claudicants. However, it is possible to select low-risk patients in which peripheral bypass surgery is justified.

Arteriovenous Shunt, Surgical↗
PubMed1998

Exercise therapy for intermittent claudication: a review of the quality of randomised clinical trials and evaluation of predictive factors.

OBJECTIVE: To establish the effect of exercise therapy in patients with intermittent claudication and to identify outcome predictors for exercise training. DESIGN: A methodological study of randomised clinical trials. METHODS: A quality assessment of all eligible studies was performed, using a list of methodological criteria. A weighing scale for the criteria was developed, based on four main categories: study population, intervention, outcome variables and data presentation/analysis. RESULTS: Ten studies were included in the analysis. Seven randomised clinical trials had a methodological score of 60 or more points (maximum 100), and were considered to be of good quality. The mean of the methodological score was 62.5 (S.D. 8.5). Improvement in pain-free/maximum walking distance/time ranged from 28-210% (mean 105, S.D. 55.8). Only one study evaluated outcome predictors for exercise therapy. CONCLUSIONS: All studies reported a positive effect of exercise therapy on walking distance in patients with intermittent claudication, but no predictive factors were clearly identified. Future research efforts should focus on improving the quality of clinical research for patients with intermittent claudication and developing optimal rehabilitation programs.

Exercise Therapy↗
PubMed1999

Relevance of claudication pain distance in patients with peripheral arterial occlusive disease.

BACKGROUND: Determination of both the pain-free and the maximum walking distances is part of a routine program in the angiological examination of patients with PAOD. It is however as yet not clear which of these two parameters is more relevant in determining a patient's pathological condition. PATIENTS AND METHODS: In 150 patients with stable intermittent claudication, the claudication pain distance (CPD) and the maximum pain distance (MPD) were determined on a treadmill at 3.0 km/h and 12% inclination. The results were compared with the angiographic findings, the Doppler pressure values and the subjective quality of life (PAVK-86-Questionnaire). RESULTS: The average pain-free walking distance was 89 +/- 71 m, and the maximum walking distance was 198 +/- 141 m. There was no correlation between both walking distances and the angiographic extent of PAOD. Only the MPD correlated with the ankle systolic Doppler pressure and the ankle/brachial pressure index of the claudicating leg (r = 0.16, p < 0.05 and r = 0.20, p < 0.01). Both the CPD and the MDP had a significant influence on the life quality of the patients (CPD: r = -0.41, p < 0.001; MPD: r = -0.47, p < 0.001). In the multiple regression analysis, beside the body mass index, the MPD was found to be the greatest predictor for the pathologically relevant quality of life dimensions pain, complaints and functional status. CONCLUSIONS: The maximum walking distance correlated in a better way than pain-free walking distance with the objective and subjective assessment criteria of PAOD. Therefore, as regards the stage of the disease and the life quality of the patient, this parameter has a greater importance. This fact deserves to receive greater attention in everyday clinical practice and when conducting clinical trials.

Aged↗
PubMed1999

Naftidrofuryl can enhance the quality of life in patients with intermittent claudication.

BACKGROUND: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. PATIENTS AND METHODS: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. RESULTS: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions "daily living", "pain", "disease specific anxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.

Aged↗
PubMed2006

Quality of life improvement after hospital- based rehabilitation or home-based physical training in intermittent claudication.

BACKGROUND: The magnitude of potential changes in Quality-of-Life (QoL) after structured institution-based or home-based peripheral arterial disease (PAD) rehabilitation programs are largely unknown at present. This pilot study provides first QoL data after PAD rehabilitation or a home-based PAD training. PATIENTS AND METHODS: In a non-randomized, open-label pilot study three groups of out-patients were compared: group 1 (n = 18) PAD rehabilitation; group 2 (n = 17) PAD rehabilitation + clopidogrel 75 mg once daily; group 3 (n = 20) home-based training. The training period was 3 months, which was followed by a 3-month observation phase (without prescribed training). The institution-based rehabilitation program consisted of 3 training hours per week whereas patients training at home were instructed to walk for 1 hour per day on an outdoor track. QoL assessment was performed using MOS SF-36, PAVK-86 and PAD-WIQ questionnaires. RESULTS: At baseline background variables, demographics and claudication distances were comparable between groups. After three months of training the percentage changes for the initial and the absolute claudication distance (ICD, ACD) for groups 1, 2, and 3 amounted to 164%, 201%, 44% (ICD) and 83%, 131%, 5% (ACD), respectively. Statistically significant QoL improvements were recorded for physical functions, pain and disease related anxiety in all three study groups; statistically significant inter-group differences were not found. CONCLUSIONS: In sharp contrast to the development of the claudication distances the improvement in QoL, found after 3 months of training, was comparable and not consistently different between the groups.

Aged↗
PubMed1995

Calf muscle mitochondrial and glycogenolytic ATP synthesis in patients with claudication due to peripheral vascular disease analysed using 31P magnetic resonance spectroscopy.

1. We set out to define abnormalities of oxidative ATP synthesis, cellular proton efflux and the efficiency of ATP usage in gastrocnemius muscle of patients with claudication due to peripheral vascular disease, using data obtained by 31P magnetic resonance spectroscopy during aerobic exercise and recovery. 2. Eleven patients with moderate claudication were studied and results were compared with 25 age-matched control subjects. Changes in pH and phosphocreatine concentration during recovery were used to calculate the maximum rate of oxidative ATP synthesis (Qmax.) and the capacity of net proton efflux. Changes in pH and phosphocreatine concentration were used to estimate rates of non-oxidative and (indirectly) oxidative ATP synthesis throughout exercise, taking account of abnormalities in proton efflux during exercise. 3. In patients with claudication, slow post-exercise phosphocreatine recovery showed a 42 +/- 9% decrease in Qmax., and the slow ADP recovery was consistent with this. pH recovery was slow, showing a 77 +/- 9% decrease in the capacity for proton efflux. Both abnormalities are compatible with a substantial reduction in muscle blood flow. 4. During exercise, increased phosphocreatine depletion and intracellular acidification were a consequence of impaired oxidative ATP synthesis and the consequent increase in non-oxidative ATP synthesis, compounded by reduced proton efflux. The acidification prevented an increase in ADP concentration which could otherwise partially compensate for the oxidative defect. All these abnormalities are compatible with a reduced muscle blood flow. 5. In addition, initial-exercise changes in pH and phosphocreatine concentration implied a 44 +/- 5% reduction in 'effective muscle mass', necessitating an ATP turnover (per litre of muscle water) twice as high for given power output as in control muscle. Some of this is probably due to a localized loss of muscle fibres, but the rest appears to reflect reduced metabolic efficiency of the muscle. This is not a direct consequence of reduced blood flow, and may be related to change in muscle fibre type.

Adenosine Triphosphate↗
PubMed1999

Assessment of intermittent claudication: a comparison of questionnaire, visual analogue scale and subjective estimate information with post-exercise ankle-brachial pressure index.

In order to assess two simple methods of evaluation of claudication, a standard questionnaire and visual analogue scale, a comparison was made between them and the post-exercise pressure index used as a gold standard. Fifty-eight consecutive stable claudicants were recruited to the study, 51/58 having arterial insufficiency according to post-exercise pressure measurements. Both methods appeared to correlate rather poorly with post-exercise pressures. Thus visual analogue scale cannot be used alone to assess walking tolerance but as it offers qualitative information it may be used to supplement pressure measurements in the assessment of incapacity caused by intermittent claudication.

Adult↗
PubMed1999

Exercise and nursing therapy for patients with intermittent claudication.

Intermittent claudication is a common manifestation of arterial disease in the second half of life. Invasive treatments may be inappropriate or unsuccessful, leaving patients with a significant handicap. Nursing intervention can improve the functional ability and the general well-being of many patients. This paper provides an account of the development of an out-patient nursing service for patients with intermittent claudication. It focuses on the exercise training and the psychological support given to patients. A review of the first 102 claudicants referred to the programme shows the outcome for the patients in terms of improved walking ability. The details of the nursing intervention reported in the paper should help the growing number of nurses starting similar programmes for vascular patients. They may also be of interest to nurses caring for patients with other chronic health problems.

Adult↗
PubMed2000

Exercise training for claudicants: changes in blood flow, cardiorespiratory status, metabolic functions, blood rheology and lipid profile.

OBJECTIVE: Exercise training improves the walking distance of claudicants. The aim of this study was to investigate factors associated with the improvement in the maximum walking distance (MWD) in respect to cardiovascular, respiratory and metabolic adaptations. METHODS: Forty claudicants were studied. Common femoral artery blood flow (BF), heart rate (HR), oxygen consumption (VO(2)), respiratory exchange ratio (RER), lactate levels, blood rheology and lipid profiles were measured. Tests were repeated after 3 months of exercise training. RESULTS: Fifteen patients did not complete the exercise program. For patients who did complete the program, MWD improved by 82%. A significant reduction in HR and VO(2)during exercise was demonstrated. No significant changes occurred in BF or RER. Although MWD increased significantly, there was no increase in recovery VO(2)(oxygen debt). A significant reduction in post-exercise lactate levels occurred. Blood rheology was unchanged, but an improvement in HDL levels was noted. CONCLUSIONS: Many claudicants could not complete an exercise program, mainly due to osteoarthritis. Exercise training improved exercise tolerance significantly without any increase in BF. The HR and oxygen cost of similar exercise was reduced. An improved MWD did not correlate with a higher oxygen debt or lactate load. Favourable changes in lipid profiles occurred.

Aged↗
PubMed2001

Treatment efficacy of intermittent claudication by invasive therapy, supervised physical exercise training compared to no treatment in unselected randomised patients II: one-year results of health-related quality of life.

OBJECTIVE: to compare the effectiveness of invasive therapy, supervised physical training and no treatment in terms of health-related quality of life (HRQL) in patients with intermittent claudication (IC). DESIGN: a prospective, randomised, controlled study. MATERIALS: a total of 253 unselected patients with stable IC were sequentially randomised into 3 balanced treatment groups. At 1 year follow-up data from a battery of generic and disease specific HRQL questionnaires, and global indices of quality of life and physical condition were available in 171 patients. RESULTS: compared with a non-diseased reference group, claudicants were substantially limited in daily physical functioning, but little affected regarding emotional, cognitive and social functioning, or well-being. Invasive therapy yielded significantly greater improvements in some aspects of physical functioning and walk-related symptoms than training. Training was not superior to invasive therapy on any HRQL dimension and superior to no treatment on only one dimension. Treatment effects, however, were generally small-to-moderate and levels of physical dysfunction in all groups remained higher than reference values. CONCLUSIONS: invasive therapy is more effective than supervised training in alleviating illness-specific symptoms and improving certain aspects of physical functioning - the primary HRQL domains impacted on by IC and the principal goals of its treatment. However, since treatment effect sizes were at most moderate and given that untreated claudicants reported at most small deterioration in HRQL, the level of evidence supporting invasive therapy is modest.

Activities of Daily Living↗
PubMed2001

The systemic effects of intermittent claudication are reversed by angioplasty.

INTRODUCTION: exercise in patients with intermittent claudication causes systemic effects, the consequences of which are unknown. This study investigates whether successful PTA reverses the systemic effects. PATIENTS AND METHODS: ten patients with IC were recruited prior to PTA. Having emptied their bladders and rested for 1 h, pre-exercise blood and urine samples were collected. Patients underwent treadmill exercise to maximum walking time and blood samples were collected at 10, 20 and 30 min. A second urine sample was collected at 60 min. Total antioxidant capacity (TAC) and von Willebrands Factor (vWF) were measured in blood and albumin/creatinine ratio (ACR) and retinol binding protein/creatinine ratio (RBP/Cr) in urine. Patients were recalled 2 weeks after successful angioplasty and the protocol repeated. Following PTA patients walked for a maximum of 5 min. RESULTS: there was no significant change in vWF. Exercise in claudicants induced a significant increase in median ACR (pre/post exercise=0.85 p =0.03) and in median RBP/Cr (pre/post exercise=1.8 p =0.04). These changes were no longer evident after successful PTA. TAC was significantly different before and after angioplasty at all time intervals. CONCLUSION: successful PTA reverses glomerular effects of exercise in claudicants. Future work should investigate the use of PTA in conjunction with exercise in the treatment of peripheral vascular disease.

Adult↗
PubMed2002

The role of pedometers in the assessment of intermittent claudication.

OBJECTIVES: to evaluate the role of pedometers in the assessment of patients with intermittent claudication by comparing them with treadmill testing, post-exercise ankle brachial pressure index (ABPI) and physical function questionnaires. PATIENTS AND METHODS: fifty patients with intermittent claudication were prospectively assessed by treadmill examination measuring maximum walking distance (MWD) and post-exercise ABPI. Three physical function questionnaires: (1) Medical Outcome Study Short Form-36 (MOS SF-36), Physical Function (PF). (2) MOS SF-36 Role limitation due to Physical Problems (RP). (3) Walking Impairment Questionnaire (WIQ) were completed. Pedometers were used for one week and the daily average number of steps taken by each patient recorded. Pedometers scores were compared with MWD, post-exercise ABPI and physical function questionnaires scores using Spearman correlation test. RESULTS: pedometers estimation of daily physical activity moderately correlated with MWD (Rho=0.35, p=0.01), post-exercise ABPI (Rho=0.35, p=0.01), MOS-SF 36 PF (Rho=0.31, p=0.02), MOS-SF RP (Rho=0.28, p=0.05) and with WIQ (Rho=0.42, p=0.003). CONCLUSIONS: they moderately correlate with treadmill testing, post-exercise ABPI, and with physical function questionnaires. Pedometers may provide a simple and cheap alternative for the assessment of physical and functional disability in intermittent claudication.

Aged↗
PubMed2003

Disease-specific quality of life assessment in intermittent claudication: review.

OBJECTIVES: intermittent claudication (IC) is a common condition that has a major impact on the patients' quality of life (QoL). Generic QoL instruments often lack sensitivity to detect small but clinically significant variation in QoL. Disease-specific instruments may overcome this problem. This study aims to review various disease-specific QoL instruments available for use in IC and make recommendations for clinical utilization based on validity, reliability and responsiveness. METHODS: a detailed literature search and extensive bibliography review of all papers relating to disease-specific QoL and IC. RESULTS: several disease-specific QoL instruments are available for use in patients with IC. The most notable of these are the Claudication Scale (CLAU-S), Sickness Impact Profile - Intermittent Claudication (SIP(IC)) and the VascuQoL. The Walking Impairment Questionnaire (WIQ) is an objective measure of the patient's walking ability and not a QoL instrument. CONCLUSION: many of the questionnaires are new and have undergone only a limited validation process. More work is required in this field before any one disease-specific QoL instrument can be recommended for use in patients with IC.

Activities of Daily Living↗
PubMed2003

Cost-effectiveness of diagnostic imaging work-up and treatment for patients with intermittent claudication in The Netherlands.

OBJECTIVE: to determine the societal cost-effectiveness of various management strategies, including both the diagnostic imaging work-up and treatment, for patients with intermittent claudication in The Netherlands. METHODS: a decision-analytic model was used and included probability and quality of life data available from the literature. A cost-analysis was performed in a university setting in The Netherlands. Imaging work-up options included magnetic resonance angiography (MRA), color-guided duplex ultrasound, or intraarterial digital subtraction angiography (DSA) and treatment options were percutaneous transluminal angioplasty with selective stent placement if feasible or bypass surgery. Management strategies were defined as combinations of imaging work-up and treatment options. A conservative strategy with no imaging work-up and walking exercises was considered as reference. Main outcome measures were quality-adjusted life years (QALYs), lifetime costs (euro), and incremental cost-effectiveness (CE) ratios. The base-case analysis evaluated 60-year-old men with severe unilateral intermittent claudication of at least one year duration. RESULTS: the range in QALYs and costs across management strategies that considered angioplasty as only treatment option was small (maximum difference: 0.0033 QALYs and 451 euros). Similarly, the range was small across management strategies that considered angioplasty if feasible otherwise bypass surgery (maximum difference: 0.0033 QALYs and 280 euros). MRA in combination with angioplasty (6.1487 QALYs and 8556 euros) had a CE ratio of 20,000 euros/QALY relative to the conservative strategy. The most effective strategy was DSA in combination with angioplasty if feasible otherwise bypass surgery (6.2254 QALYs and 18,583 euros) which had a CE ratio of 131,000 euros/QALY relative to MRA in combination with angioplasty. CONCLUSION: the results suggest that the imaging work-up with non-invasive imaging modalities can replace DSA for the work-up of patients with intermittent claudication without a substantial loss in effectiveness and a minimal cost-reduction. Management strategies including angioplasty are cost-effective in the Netherlands but although strategies including bypass surgery are more effective, their incremental costs are very high.

Adult↗
PubMed2002

Can claudication be improved with medication?

Intermittent claudication is a common disabling condition that affects approximately 5% to 15% of patients with atherosclerotic disease. Recommended treatment involves lifestyle modification and physical conditioning through the adoption of a regular exercise program. These methods of treatment often have been unsuccessful in the past because of noncompliance, in large part related to the relatively minor degree of improvement experienced by the patient. However, some recent trials have resulted in greater relative improvements in both pain-free and maximal walking distances in some patients treated with medication. Surgical and endovascular options offer greater degrees of improvement but also greater morbidity and should be reserved as treatment for severe claudication. The efficacies, as well as common adverse reactions associated with current medications used to treat patients with intermittent claudication are reviewed.

Carnitine↗