The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial Disease.

BACKGROUND: Treatment for symptomatic peripheral artery disease includes lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs); however, limited comparative effectiveness data exist between the 2 therapies. We assessed the safety and effectiveness of LEB and PVI in patients with symptomatic claudication and critical limb ischemia. METHODS AND RESULTS: In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P<0.001) and critical limb ischemia (19.1±4.8% and 31.6±6.3% at 1 and 3 years versus 10.8±2.5% and 16.0±3.2%, log-rank P<0.001). However, in comparison with PVI, LEB was associated with increased rates of complications up to 30 days following the procedure (37.1% versus 11.9%, P<0.001). There were no differences in amputation rates between the 2 groups. Findings remained consistent in sensitivity analyses by using propensity methods to account for treatment selection. CONCLUSIONS: In patients with symptomatic peripheral artery disease, in comparison with LEB, PVI was associated with fewer 30-day procedural complications, higher revascularization rates at 1 and 3 years, and no difference in subsequent amputations.

[Cost and cost-effectiveness in the treatment of peripheral arterial occlusion disease - what is proven?]. / Kosten und Kosteneffizienz bei der Behandlung der peripheren arteriellen Verschlusskrankheit - was ist gesichert?

BACKGROUND: This overview comments on the health-care relevance of peripheral arterial occlusive disease (PAOD) in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). We evaluated different treatment modalities in terms of cost-effectiveness. METHOD: For the literature review, the Medline database (PubMed) was searched under the key words "critical limb ischemia AND cost", "critical limb ischemia AND economy", "peripheral arterial disease AND cost", "peripheral arterial disease AND economy". RESULTS: In the years 2005 to 2009, the hospitalisations of patients with PAOD rose disproportionately in Germany by 20 %, to 483,961 hospital admissions. By comparison, hospital admissions altogether increased by only 8 %. The average in-patient costs were estimated to be approximately € 5000 per PAOD-patient - a rather conservative estimate. For the patient with IC the economic data position is clear, supervised exercise training is by far the most cost-effective treatment option, followed by percutaneous transluminal angioplasty (PTA) and finally the peripheral bypass. In accordance with the guidelines of the UK, the latter is therefore indicated only if PTA fails or is technically not possible. In patients with CLI, the situation is not obvious. Indeed, a short-term economic advantage can be calculated for the PTA, the long-term comparison of both methods, however, is impossible due to insufficient data. In addition, the risk factors for the patient have to be included in the calculation. This was indeed demonstrated in the short-term, but could not be analysed in the long-term follow-up. CONCLUSION: The issue of greater cost-effectiveness of open or endovascular treatment in patients with CLI is uncertain, the studies and patient populations are too heterogeneous. Further studies are urgently needed to structure the sequence of the various treatment options in guidelines and clinical pathways.

Living a demanding life--spouses' experiences of living with a person suffering from intermittent claudication.

AIM: To report a study of family members' experiences of living with a person suffering from intermittent claudication caused by peripheral arterial disease. BACKGROUND: Intermittent claudication is a symptom caused by peripheral arterial disease. Walking ability is reduced due to pain and this also affects the family members and leads to consequences such as isolation and a restricted life. DESIGN: This study has a qualitative descriptive design. METHODS: Ten spouses living with a person suffering from intermittent claudication were interviewed between December 2009-June 2010. The interviews were then analysed using qualitative thematic analysis. FINDINGS: Four themes were identified: 'Frustrating to not meet intentions', 'Undergoing changes in social life', 'Being a person on the side of things' and 'Intertwining of circumstances'. The overall theme 'Living a demanding life' illustrates that intermittent claudication has great impact on daily life among spouses. CONCLUSION: This study gives an insight into the complexities and the difficulties of living together with someone suffering from intermittent claudication, a symptom that has great impact on both the spouses' and the ill persons' lives. According to the findings in this study, it is important to gain knowledge about the spouses' experiences because an holistic perspective is essential to treat and support the ill persons and their spouses.

The epidemiology of foot wounds in patients with diabetes: a description of 600 consecutive patients in Turkey.

Epidemiological studies describing demographic, clinical, and surgical characteristics of diabetic foot wounds are lacking in Turkey. To further describe the epidemiology of diabetic foot wounds in Turkey, we developed an evaluation form and performed a retrospective cohort study that entailed 600 diabetic patients who were admitted to the hospital for treatment of their foot wound(s). The mean age of the cohort was 62.3 ± 10.3 (range 23-92) years, and their mean duration of diabetes was 17.4 ± 7.4 years. Males accounted for 68.17% of the cohort, and 96.83% of the cohort had type 2 diabetes. Prevalences for lower extremity arterial pulses and peripheral neuropathy, as well as the location, depth, microbiology, and surgical treatment of the pedal wounds are also presented. In conclusion, diabetic foot wounds are common in Turkey, and the morbidity associated with these lesions is generally substantial. Although our investigation aimed primarily at describing risk factors associated with diabetic foot wounds, we believe that the findings of this investigation can be used in the development of prospective cohort studies and randomized controlled trials that focus on foot wounds in diabetic patients in Turkey, and may be useful to investigators in other parts of the world.

Assessment and management of neurogenic claudication associated with lumbar spinal stenosis in a UK primary care musculoskeletal service: a survey of current practice among physiotherapists.

BACKGROUND: Neurogenic claudication (NC) is the clinical syndrome commonly associated with lumbar spinal stenosis (LSS). Non-surgical management is recommended as initial treatment, but little is known about current practice in relation to the assessment and management of these patients in the non-surgical setting. METHODS: We conducted a questionnaire survey of physiotherapists in a large UK primary care musculoskeletal service which provides a city-wide multidisciplinary assessment and treatment facility for patients with spinal and other musculoskeletal problems. Data on therapists' recognition and management of patients with NC and LSS were collected. RESULTS: Fifty out of 54 therapists completed questionnaires, and all but one of these identified a clearly recognised posture-related clinical syndrome of NC. Almost all respondents (48: 96%) reported the routine use of physiotherapy treatments. In particular, advice and education (49: 98%) along with an exercise programme (47: 94%) incorporating flexion-based exercises (41: 82%) and trunk muscle stabilising exercises (35: 70%) were favoured. CONCLUSION: Musculoskeletal physiotherapy clinicians in this survey recognised a clear clinical syndrome of NC, based on the findings of posture-dependent symptoms. Most therapists reported the routine use of flexion-based exercise, reflecting recommendations in the literature which are based on theoretical benefits, but for which trial evidence is lacking. There is a need for research evidence to guide the choice of physiotherapy treatments.

L-arginine supplementation in peripheral arterial disease: no benefit and possible harm.

BACKGROUND: L-arginine is the precursor of endothelium-derived nitric oxide, an endogenous vasodilator. L-arginine supplementation improves vascular reactivity and functional capacity in peripheral arterial disease (PAD) in small, short-term studies. We aimed to determine the effects of long-term administration of L-arginine on vascular reactivity and functional capacity in patients with PAD. METHODS AND RESULTS: The Nitric Oxide in Peripheral Arterial Insufficiency (NO-PAIN) study was a randomized clinical trial of oral L-arginine (3 g/d) versus placebo for 6 months in 133 subjects with intermittent claudication due to PAD in a single-center setting. The primary end point was the change at 6 months in the absolute claudication distance as assessed by the Skinner-Gardner treadmill protocol. L-arginine supplementation significantly increased plasma L-arginine levels. However, measures of nitric oxide availability (including flow-mediated vasodilation, vascular compliance, plasma and urinary nitrogen oxides, and plasma citrulline formation) were reduced or not improved compared with placebo. Although absolute claudication distance improved in both L-arginine- and placebo-treated patients, the improvement in the L-arginine-treated group was significantly less than that in the placebo group (28.3% versus 11.5%; P=0.024). CONCLUSIONS: In patients with PAD, long-term administration of L-arginine does not increase nitric oxide synthesis or improve vascular reactivity. Furthermore, the expected placebo effect observed in studies of functional capacity was attenuated in the L-arginine-treated group. As opposed to its short-term administration, long-term administration of L-arginine is not useful in patients with intermittent claudication and PAD.

Estudio de las repercusiones clínicas y analíticas de una intervención nutricional en pacientes no hospitalizados con claudicación intermitente. Estudio aleatorio controlado / A study of the clinical and analytical repercussions of a nutritional intervention in non-hospitalised patients with intermittent claudication. A controlled randomised study

Introducción. La dieta es un pilar fundamental, a veces olvidado, en el control y tratamiento de la enfermedad vascular periférica (EVP). Objetivo. Estudiar los efectos de la ingesta de ciertos nutrientes con probado efecto beneficioso en la prevención de la enfermedad coronaria en la clínica y el perfil bioquímico de enfermos claudicantes. Pacientes y métodos. Estudio longitudinal, descriptivo, aleatorio y doble ciego, con 60 varones claudicantes (grado IIB de Fontaine), distribuidos en dos grupos. Grupo I (n = 30): además de su dieta habitual consumieron 500 mL/día de leche semidesnatada adicionada de ácidos eicosapentanoico, docoxahexanoico, oleico y fólico y vitaminas A, D, E y B6. Grupo C (n = 26): además de su dieta habitual consumieron 500 mL/día de leche semidesnatada. Ambos grupos obtuvieron los mismos consejos higienicodietéticos, un antiagregante plaquetario (triflusal) y un hemorreológico (pentoxifilina). Con control trimestral, la intervención duró 12 meses. En cada control se realizó una exploración clínica vascular, claudicometría, índice de Yao, placetismografía y analítica. Resultados. La concentración plasmática de los nutrientes suministrados aumentó en el grupo I (p < 0,05), seguido de un descenso en colesterol total y la concentración de apolipoproteína B. La homocisteína total disminuyó en aquellos pacientes con hiperhomocisteinemia (p < 0,01). Paralelamente, la distancia de claudicación triplicó su valor (p < 0,001) y el índice de Yao aumentó de manera gradual (p < 0,05). Conclusiones. La inclusión diaria en la dieta de ciertos nutrientes cardiosaludables produjo, junto con otras recomendaciones dietéticas y hábitos de vida, una mejora significativa en los parámetros clínicos y analíticos de este grupo de claudicantes. La nutrición puede desempeñar un papel importante en el tratamiento y control de la EVP

INTRODUCTION. Diet is a sometimes neglected cornerstone in the control and treatment of peripheral vascular disease (PVD). AIMS. To study how the intake of certain nutrients with a proven beneficial effect in the prevention of heart disease affects the clinical symptoms and biochemical profile of patients with claudication. PATIENTS AND METHODS. A longitudinal, descriptive, randomised, double-blind study was conducted with 60 males with claudication (Fontaine grade IIB), distributed in two groups. Group I (n = 30): in addition to their usual diet, subjects consumed 500 ml/day of semi-skimmed milk with added eicosapentaenoic, docosahexaenoic, oleic and folic acids, as well as vitamins A, D, E and B6. Group C (n = 26): in addition to their usual diet, subjects consumed 500 mL/day of semi-skimmed milk. Both groups received the same hygienic-dietary guidelines, an antiplatelet drug (triflusal) and a haemorrheologic agent (pentoxifylline). Including a three-monthly control, the intervention lasted 12 months. At each control the following tests were carried out: vascular clinical examination, treadmill exercise testing, Yao index, plethysmography and analyses. RESULTS. The plasma concentration of the nutrients given to patients increased in group I (p < 0.05), followed by a decrease in total cholesterol and apolipoprotein B concentration. The total homocysteine level dropped in patients with hyperhomocysteinemia (p < 0.01). In a parallel fashion, the claudication distance become three times longer (p < 0.001) and the Yao index gradually increased (p < 0.05). CONCLUSIONS. Including certain nutrients that are good for the heart in the daily diet, along with other guidelines concerning nutrition and lifestyle, led to a significant improvement in the clinical and analytical parameters of this group of patients with claudication. Nutrition can play an important role in the treatment and control of PVD

Endovascular intervention of aortoiliac occlusive disease in high-risk patients using the kissing stents technique: long-term results.

Endovascular intervention deploying a kissing stents (KS) technique has been used as an alternative to surgical intervention in treating symptomatic aortoiliac occlusive disease. However, the long-term results on high-risk patients are unknown. We retrospectively analyzed data on high-risk patients who underwent endovascular intervention using the KS technique at our institution. Fifty high-risk patients aged 62 +/- 6.4 years with severe aortoiliac stenosis underwent stent-supported angioplasty using the KS technique. Thirty percent of the patients had total occlusion of the distal aorta and/or the iliac arteries. Twelve patients received thrombolytics prior to stenting. The procedure was successful in all 50 patients. There was a 4% acute complication rate (distal embolization). However, there were no vascular complications, myocardial infarction, or perioperative death. Primary patency during follow-up of 20 +/- 12.3 months was 92%, while secondary patency rate was 100%. Amputation-free survival was 100%. Ninety-two percent remained free of lifestyle-limiting claudication.

Diagnosis and medical management of patients with intermittent claudication.

Intermittent claudication is a symptom complex associated with atherosclerosis of the aorta and lower extremities. It is a clinical marker of systemic atherosclerosis, and therefore, management cannot be considered isolated from treatment of underlying risk factors of atherosclerosis. The focus of the management is twofold. The first is to reduce morbidity and mortality from cardiovascular events, including myocardial infarction and stroke. The second focus is to improve the functional status of patients who have impairment of daily activities secondary to symptoms of claudication through pharmacologic and rehabilitative means, that is, exercise. Exercise is the cornerstone of therapy. A conservative approach is favored in patients who have mild and moderate symptoms of claudication. Intervention with percutaneous techniques or surgery is generally reserved for patients who have severe impairment of lifestyle or threatened tissue.

Prospective study of diet, lifestyle, and intermittent claudication in male smokers.

The association between dietary and lifestyle factors and intermittent claudication was investigated in the Finnish Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. The cohort comprised 26,872 male smokers aged 50-69 years who were free of claudication at study entry. At baseline (1985-1988), subjects completed a diet history questionnaire. During a median follow-up period of 4 years (ending in spring 1993), 2,578 men reported symptoms of claudication on the Rose questionnaire, which was administered annually. Smoking status was assessed every 4 months. Smoking, systolic blood pressure, serum total cholesterol, and diabetes mellitus were positively associated with risk for claudication, whereas serum high density lipoprotein cholesterol, education, and leisure time exercise were inversely associated with risk. Dietary carbohydrates, fiber, and n-6 polyunsaturated fatty acids were inversely associated with risk for claudication, as were some dietary and serum antioxidants: dietary vitamin C (highest quartile vs. lowest: relative risk (RR) = 0.86; 95% confidence interval (CI): 0.77, 0.97), dietary gamma-tocopherol (RR = 0.89; 95% CI: 0.79, 1.00), dietary carotenoids (RR = 0.82; 95% CI: 0.73, 0.92), serum alpha-tocopherol (RR = 0.88; 95% CI: 0.77, 1.00), and serum beta-carotene (RR = 0.77; 95% CI: 0.68, 0.86). Smoking cessation reduced subsequent risk for claudication (RR = 0.86; 95% CI: 0.75, 0.99). The authors conclude that classical risk factors for atherosclerosis are associated with claudication. High intakes of antioxidant vitamins may be protective. Further research is needed before antioxidants can be recommended for the prevention of intermittent claudication.

Prevalence and correlates of lower extremity arterial disease in elderly women.

Although lower extremity arterial disease occurs in 15-20% of the population over the age of 75 years, little is known about the etiology of the disease in women. In this cross-sectional study involving 1,601 healthy elderly women (mean age, 71 years; range, 65-93 years), the occurrence of lower extremity arterial disease was assessed noninvasively by measuring brachial and ankle pressures bilaterally. Disease prevalence ranged from 2.9% in those aged 65-69 years to 15.5% in those aged 80 years or older. Approximately 20% of those with disease had symptoms of claudication. Age, systolic blood pressure, and current smoking status were strong independent risk factors for arterial disease; a history of arthritis, use of nonthiazide diuretics, current coffee drinking, and upper body obesity were also independent correlates. The number of pack-years in current and former smokers and the number of cigarettes per day used by current smokers showed a dose-response relation with disease. The population attributable risk for current smoking was 26%. The major correlates for symptomatic arterial disease were current smoking and systolic blood pressure. It is concluded that the major risk factors for lower extremity arterial disease in elderly women are similar to those in men. Preventive efforts should focus on smoking cessation and management of hypertension.