Body mass-normalized moderate dose of dietary nitrate intake improves endothelial function and walking capacity in patients with peripheral artery disease.

Peripheral artery disease (PAD) is characterized by the accumulation of atherosclerotic plaques in the lower extremity conduit arteries, which impairs blood flow and walking capacity. Dietary nitrate has been used to reduce blood pressure (BP) and improve walking capacity in PAD. However, a standardized dose for PAD has not been determined. Therefore, we sought to determine the effects of a body mass-normalized moderate dose of nitrate (0.11 mmol nitrate/kg) as beetroot juice on serum nitrate/nitrite, vascular function, walking capacity, and tissue oxygen utilization capacity in patients with PAD. A total of 11 patients with PAD received either nitrate supplement or placebo in a randomized crossover design. Total serum nitrate/nitrite, resting BP, brachial and popliteal artery endothelial function (flow-mediated dilation, FMD), arterial stiffness (pulse-wave velocity, PWV), augmentation index (AIx), maximal walking distance and time, claudication onset time, and skeletal muscle oxygen utilization were measured pre- and postnitrate and placebo intake. There were significant group × time interactions (P < 0.05) for serum nitrate/nitrite, FMD, BP, walking distance and time, and skeletal muscle oxygen utilization. The nitrate group showed significantly increased serum nitrate/nitrite (Δ1.32 µM), increased brachial and popliteal FMD (Δ1.3% and Δ1.7%, respectively), reduced peripheral and central systolic BP (Δ-4.7 mmHg and Δ-8.2 mmHg, respectively), increased maximal walking distance (Δ92.7 m) and time (Δ56.3 s), and reduced deoxygenated hemoglobin during walking. There were no changes in PWV, AIx, or claudication (P > 0.05). These results indicate that a body-mass normalized moderate dose of nitrate may be effective and safe for reducing BP, improving endothelial function, and improving walking capacity in patients with PAD.

Exercise therapy in routine management of peripheral arterial disease and intermittent claudication: a scoping review.

BACKGROUND: Little is known about the extent to which routine care management of peripheral arterial disease (PAD) and intermittent claudication (IC) align with best practice recommendations on exercise therapy. We conducted a scoping review to examine the published literature on the availability and workings of exercise therapy in the routine management of patients with PAD and IC, and the attitude and practice of health professionals and patients. METHODS: A systematic search was conducted in February 2018. The Cumulative Index of Nursing and Allied Health Literature, Ovid MEDLINE, Allied and Complementary Medicine Database, ScienceDirect, Web of Science and the Directory of Open Access Repositories were searched. Hand searching of reference lists of identified studies was also performed. Inclusion criteria were based on study aim, and included studies that reported on the perceptions, practices, and workings of routine exercise programs for patients with IC, their availability, access, and perceived barriers. RESULTS: Eight studies met the eligibility criteria and were included in the review. Studies conducted within Europe were included. Findings indicated that vascular surgeons in parts of Europe generally recognize supervised exercise therapy as a best practice treatment for IC, but do not often refer their patients for supervised exercise therapy due to the unavailability of, or lack of access to supervised exercise therapy programs. Available supervised exercise therapy programs do not implement best practice recommendations, and in the majority, patients only undergo one session per week. Some challenges were cited as the cause of the suboptimal program implementation. These included issues related to patients' engagement and adherence as well as resource constraints. CONCLUSION: There is a dearth of published research on exercise therapy in the routine management of PAD and IC. Available data from a few countries within Europe indicated that supervised exercise is underutilized despite health professionals recognizing the benefits. Research is needed to understand how to improve the availability, access, uptake, and adherence to the best exercise recommendations in the routine management of people with PAD and IC.

A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease.

Lower extremity peripheral artery disease (PAD) induces an ischemic pain in the lower limbs and leads to walking impairment. Electrical stimulation has been used in patients with PAD, but no systematic review has been proposed to address the efficacy of the technique as a treatment for walking impairment in PAD. A systematic search was performed to identify trials focused on electrical stimulation for the treatment of walking impairment in patients with PAD in the Cochrane Central Register, PubMed, Embase, and the Web of Science. Studies were included where the primary outcomes were pain-free walking distance and/or maximal walking distance. When appropriate, eligible studies were independently assessed for quality using the Cochrane Collaboration's tool for assessing risk of bias. Five studies eligible for inclusion were identified, of which only two were randomized controlled studies. Trial heterogeneity prevented the use of the GRADE system and the implementation of a meta-analysis. Three types of electrical stimulation have been used: neuromuscular electrical stimulation (NMES, n = 3), transcutaneous electrical stimulation (n = 1), and functional electrical stimulation (n = 1). The two available randomized controlled studies reported a significant improvement in maximal walking distance (+40 m/+34% and +39 m/+35%, respectively) following a program of NMES. Owing to the low number of eligible studies, small sample size, and the risk of bias, no clear clinical indication can be drawn regarding the efficacy of electrical stimulation for the management of impaired walking function in patients with PAD. Future high-quality studies are required to define objectively the effect of electrical stimulation on walking capacity.

Effects of Intermittent Calf Muscle Electrical Stimulation on Walking Capacity in Claudicants Living with Type 2 Diabetes.

BACKGROUND: First-line therapy for diabetic patients presenting with intermittent claudication includes supervised exercise programs to improve walking distance. However, exercise comes with a variety of barriers and may be contraindicated in certain conditions. The aim of this study was to evaluate whether calf muscle electrostimulation improves claudication distance. METHODS: A prospective, one-group, pretest-posttest study design was used on 40 participants living with type 2 diabetes mellitus, peripheral artery disease (ankle brachial pressure index, <0.90), and calf muscle claudication. Calf muscle electrostimulation of varying frequencies (1-250 Hz) was prescribed on both limbs for 1-hour daily sessions for 12 consecutive weeks. The absolute claudication distance (ACD) was measured at baseline and after the intervention. RESULTS: The recruited cohort (30 men and ten women; mean age, 71 years; mean ankle brachial pressure index, 0.70) registered a mean ± SD baseline ACD of 333.71 ± 208 m. After a mean ± SD of 91.68 ± 6.23 days of electrical stimulation, a significant mean ± SD increase of 137 ± 136 m in the ACD (P = .001, Wilcoxon signed rank test) was registered. Improvement was found to be sex independent, but age was negatively correlated with proportion of improvement (r = -0.361; P = .011, Pearson correlation test). CONCLUSIONS: Electrical stimulation of varying frequencies on ischemic calf muscles significantly increased the maximal walking capacity in claudicants with type 2 diabetes. This therapeutic approach should be considered in patients with impaired exercise tolerance or as an adjunct treatment modality.

Effectiveness of the Combined Treatment of Functional Electrical Stimulation and Deambulation in Diabetic Arteriopathy.

OBJECTIVE: To determine whether functional electrical stimulation (FES) is able to improve ischemic pain and quality of life of patients with diabetic arteriopathy (DA) in grade-IIa Leriche-Le Fontaine. MATERIAL AND METHODS: This is a single-blinded, randomized, prospective cohort study. We included patients diagnosed with grade-IIa Leriche-Le Fontaine peripheral arterial disease in both lower extremities with and without diabetes mellitus (DM). The ankle-brachial index was 0.4-0.9. Patients were randomized into two experimental groups: nondiabetic (non-DM) (n = 71) and diabetic (DM) (n = 71). The patients received FES while walking for 1 hr on a supervised treadmill. Three months of follow-up were conducted after treatment. RESULTS: A total of 168 patients were randomized; 142 completed the study, with 71 in each group. Both groups reported an improvement after the treatment, but the improvement was statistically significant in the DM group, in which all the parameters studied improved. Greater benefits were observed in all the parameters in the DM group after the follow-up, except for the test of the meters walked in 6 min. CONCLUSIONS: The use of FES during daily walking is effective in patients with DA, reducing intermittent claudication and improving the quality of life of these patients.

Efficacy and Feasibility of Pain management and Patient Education for Physical Activity in Intermittent claudication (PrEPAID): protocol for a randomised controlled trial.

BACKGROUND: Physical activity (PA) improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). However, pain and patient lack of knowledge are key barriers to the uptake of, and adherence to, PA recommendations. This trial will test the efficacy and feasibility of a non-invasive pain management intervention with and without patient education to improve PA in individuals with PAD and IC. METHODS: This is a randomised, controlled assessor-blinded feasibility trial with four parallel groups. Eighty adults with PAD and IC will be randomly assigned 1:1:1:1 to Active TENS (transcutaneous electrical nerve stimulation), Placebo TENS, Active TENS + Patient education or Placebo TENS + Patient education groups. All groups will continue to receive usual care over the intervention period. Participants randomised to Active TENS will receive a TENS device (preset at 120 Hz, 200 µs) and will be instructed to use the device daily at home or elsewhere for 6 weeks with a patient-determined intensity of "strong but comfortable". Placebo TENS group participants will receive the same model of TENS device and instructions for use as those in the active group, except that the stimulation dose will be safely altered to produce non-therapeutic, ineffective stimulation. Participants randomised to patient education will receive a one-off 3-h workshop of structured group education (four to five persons in each group) and three sets of twice-weekly phone calls. Efficacy outcomes will be assessed at baseline, after 6 weeks of intervention and at 3 months follow-up. Absolute claudication distance using the Gardner treadmill protocol will be assessed as the primary outcome. Secondary outcomes will assess initial claudication distance, daily PA and patient-reported outcomes including quality of life, pain self-efficacy, depression, disease perception and walking impairment pain intensity and quality. Feasibility outcomes will assess rates of recruitment, retention and adherence. Focus groups with participants at the end of the trial will explore the acceptability of the interventions. DISCUSSION: This trial will determine the efficacy and feasibility of using a low-cost, CE-marked non-invasive pain management modality delivered with or without a patient-centred education intervention to improve PA in individuals with PAD and IC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03204825 . Registered on 2 July 2017.

A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment.

OBJECTIVE: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone. METHODS: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.

Effect of Annurca Apple Polyphenols on Intermittent Claudication in Patients With Peripheral Artery Disease.

Peripheral arterial disease (PAD) is an atherosclerotic process involving both modifiable and nonmodifiable risk factors. Prospective cohort studies show that patients with PAD have a 6-fold greater risk of death from cardiovascular disease than those without PAD. Currently, there is no effective treatment for PAD. The study was a randomized, placebo-controlled trial, involving 180 patients, aged 35 to 75. The subjects were divided into 2 groups. One group underwent 24 weeks of nutraceutical treatment consisting in the administration of 4 capsules of Annurca apple polyphenolic extract (AMS)/day. The placebo group was administered with identically appearing capsules containing only maltodextrin. Primary outcome measures were: walking autonomy, ankle-brachial index, acceleration time. In the AMS group, at the end of the treatment period, walking autonomy was increased on average by 69% (p <0.05), while slighter effects were registered as regards ankle-brachial index (+25%; p <0.05) and acceleration time (-3.6%; p <0.05), when compared with baseline. Placebo group revealed no significant differences as regards variations of all outcomes measures (p >0.05). Our preliminary results may indicate AMS product as a promising natural and safe tool for treatment of symptoms related to PAD.

Beet the Best?

RATIONALE: A primary goal of therapy for patients with peripheral artery disease (PAD) and intermittent claudication is increased ambulatory function. Supervised exercise rehabilitation was recently shown to confer superior walking benefits to pharmacological or surgical interventions. Increases in plasma inorganic nitrite, via oral nitrate, have been shown to increase exercise performance in both human and animal models, especially in hypoxic conditions. OBJECTIVE: To determine whether a 36-session exercise rehabilitation program while consuming oral inorganic nitrate (4.2 mmol concentrated beetroot juice) would produce superior benefits over exercise plus placebo in pain-free walking and markers of increased skeletal muscle perfusion in patients with PAD and intermittent claudication. METHODS AND RESULTS: This was a randomized, double-blind, per-protocol study design. After the 12-week protocol, claudication onset time on a maximal treadmill test increased by 59.2±57.3 s for the exercise plus placebo group (n=13) and by 180.3±46.6 s for the exercise plus beetroot juice group (n=11; P≤0.05). This produced a between treatment medium to large standardized effect size (Cohen d) of 0.62 (95% CI, -0.23 to +1.44). The data for 6-minute walk distance showed a similar pattern with increases of 24.6±12.1 and 53.3±19.6 m ( P≤0.05) in the exercise plus placebo and exercise plus beetroot juice groups, respectively. Measures of gastrocnemius perfusion, including ankle-brachial index, peak reactive hyperemic blood flow, and tissue deoxygenation characteristics, during exercise (assessed my near-infrared spectroscopy) all changed significantly for the exercise plus beetroot juice group with moderate-to-large effect sizes over exercise plus placebo changes. CONCLUSIONS: Although it is premature to speculate on overall clinical utility of a nitrate-based therapy for PAD, this early pilot study evidence is encouraging. Specifically, our data suggests that increasing plasma nitrite before exercise may allow PAD subjects to train with less pain, at higher workloads for longer durations at each training session, thereby maximizing the beneficial peripheral vascular and skeletal muscle adaptations. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01684930 and NCT01785524.

Rhythmic Auditory Music Stimulation Enhances Walking Distance in Patients With Claudication: A FEASIBILITY STUDY.

PURPOSE: Patients with claudication have altered gait, characterized by slower pace and shorter stride length, compared with matched controls. Rhythmic auditory music stimulation has been used successfully to reduce symptoms of pain and improve walking ability in patients with neurological gait alterations. The purpose of this study was to test the hypothesis that rhythmic auditory music stimulation via increased tempo and bass would immediately increase total walking distance in patients with claudication compared with music-without rhythm-enhancement condition or a no-music condition (standard). METHODS: Fourteen patients with claudication (mean age = 66.1 ± 7.7 y; ankle-brachial index = 0.63 ± 17) underwent three 6-min walk tests on the same day in random order. One with music-without rhythm enhancement with the tempo set at the usual walking cadence of the patient, one without music, and one with rhythmically enhanced music with the tempo increased 10 to 15 beats/min above the usual walking cadence of the patient. This increase in tempo is considered imperceptible to the untrained ear. RESULTS: The paired t test indicated an increase in total walking distance by 22.1 ± 25.4 m (P = .006) during the rhythmic auditory stimulation condition compared with the no-music condition and by 20.7 ± 24.4 m compared with the music-without enhancement condition (P = .007). Functional claudication distance increased by 40.0 ± 49.0 m during the rhythmically enhanced music condition (P = .009) compared with the no-music condition. CONCLUSIONS: These results suggest that rhythmic auditory stimulation immediately increases total walking distance in patients with claudication due to peripheral artery disease. This technology may provide a tool for clinicians to use when prescribing exercise, improve motivation, and increase adherence to exercise rehabilitation programs.

Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP): A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of using wearable activity monitors (WAMs) in patients with intermittent claudication (IC) within a single-center randomized controlled trial. BACKGROUND: WAMs allow users to set daily activity targets and monitor their progress. They may offer an alternative treatment to supervised exercise programs (SEPs) for patients with IC. METHODS: Thirty-seven patients with IC were recruited and randomized into intervention or control group. The intervention consisted of a feedback-enabled, wrist-worn activity monitor (WAM) in addition to access to SEP. The control group was given access to SEP only. The outcome measures were maximum walking distance (MWD), claudication distance (CD), and quality of life as measured by the VascuQol questionnaire. Participants were assessed upon recruitment, and at 3, 6, and 12 months. RESULTS: Patients in the WAM group showed significant improvement in MWD at 3 and 6 months (80-112 m, to 178 m; P < 0.001), which was sustained at 12 months. The WAM group also increased CD (40 vs 110 m; P < 0.001) and VascuQol score (4.7 vs 5.8; P = 0.004). The control group saw a temporary increase in VascuQol score at 6 months (4.5 vs 4.7; P = 0.028), but no other improvements in MWD or CD were observed. Significantly higher improvements in MWD were seen in the WAM group compared with that in the control group at 6 months (82 vs -5 m; P = 0.009, r = 0.47) and 12 months (69 vs 7.5 m; P = 0.011, r = 0.52). CONCLUSIONS: The study demonstrates the significant, sustained benefit of WAM-led technologies for patients with IC. This potentially resource-sparing intervention is likely to provide a valuable adjunct or alternative to SEP.

A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication.

BACKGROUND: Intermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. METHODS: Patients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. RESULTS: Thirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. CONCLUSIONS: ESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.

The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study.

BACKGROUND: In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking. TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class-II PAD. We now seek to assess the efficacy of a chronic intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in Leriche-Fontaine stage-II PAD patients. METHODS/DESIGN: This is a prospective, double-blind, multicentre, randomised, placebo-controlled trial. One hundred subjects with unilateral PAD (Leriche-Fontaine stage II) will be randomised into two groups (1:1). For the experimental group (TENS group): the treatment will consist of stimulation of the affected leg (at a biphasic frequency of 10 Hz, with a pulse width of 200 µs, maximal intensity below the motor threshold) for 45 min per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. For the control group (SHAM group): the placebo stimulation will be delivered according to the same modalities as for the TENS group but with a voltage level automatically falling to zero after 10 s of stimulation. First outcome: walking distance without pain. SECONDARY OUTCOMES: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak), endothelial function (EndoPAT®), Ankle-brachial Pressure Index, Body Mass Index, lipid profile (LDL-C, HDL-C, triglycerides), fasting glycaemia, HbA1c level, and the WELCH questionnaire. DISCUSSION: TENS-PAD is the first randomised controlled trial that uses transcutaneous electrical therapy as an adjuvant technique to improve vascular function in the treatment of PAD. If the results are confirmed, this technique could be incorporated into the routine care in cardiovascular rehabilitation centers and used in the long term by patients to improve their walking capacity. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02678403 . Registered on 9 February 2016. SPONSOR: Toulouse University Hospital.

The Effectiveness of Calf Muscle Electrostimulation on Vascular Perfusion and Walking Capacity in Patients Living With Type 2 Diabetes Mellitus and Peripheral Artery Disease.

The aim of the study was to explore calf muscle electrostimulation on arterial inflow and walking capacity in claudicants with peripheral artery disease and diabetes mellitus. A prospective, 1-group, pretest-posttest study design was used on 40 high-risk participants (n = 40) who exhibited bilateral limb ischemia (ankle brachial pressure index [ABPI] <0.90), diabetes mellitus, and calf muscle claudication. A program of calf muscle electrical stimulation with varying frequency (1-250 Hz) was prescribed for 1 hour per day for 12 weeks. Spectral waveforms analysis, ABPI, absolute claudication distance (ACD), and thermographic temperature patterns across 4 specified regions of interest (hallux, medial forefoot, lateral forefoot, heel) at rest and after exercise, were recorded at baseline and following intervention to evaluate for therapeutic outcomes. A significant improvement in ACD and ABPI was registered following the intervention ( P = .000 and P = .001, respectively). Resting foot temperatures increased significantly ( P = .000) while the postexercise temperature drops were halved across all regions at follow-up, with hallux ( P = .005) and lateral forefoot ( P = .038) reaching statistical significance. Spectral Doppler waveforms were comparable ( P = .304) between both serial assessments. Electrical stimulation of varying frequency for 1 hour per day for 12 consecutive weeks registered statistically significant improvement in outcome measures that assess arterial inflow and walking capacity in claudicants with diabetes mellitus. These results favor the use of electrostimulation as a therapeutic measure in this high-risk population.

Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions.

OBJECTIVE: The objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery. METHODS: This prospective, multicenter (15 hospitals) study assessed heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease. Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ankle-brachial index ≤0.9, and color flow duplex ultrasound-assessed SFA lesions with cumulative length ≥10 cm and ≥50% stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events, respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio <2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria. RESULTS: Of 103 enrollees (74.2 ± 7.0 years old; 17.5% female; 97.1% claudicants), 100 subjects were evaluated through postoperative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7% were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1% (95% confidence interval [CI], 87.3%-97.3%) at 12 months. The primary patency-surgical rate was 92.1% (95% CI, 84.8%-96.0%), the primary patency-interventional rate was 88.1% (95% CI, 80.0%-93.1%), and freedom from TLR was 93.1% (95% CI, 86.1%-96.7%). Mean ankle-brachial index increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (P < .0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through postoperative 30 days. No life- or limb-threatening intraoperative or perioperative adverse events and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6% ± 15.7% to 72.9% ± 18.6% at 12 months (P < .0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median postoperative hospital stay was 2.0 days (mean, 3.4 ± 2.9 days) in the Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) claudicant subgroup, values that were significantly lower than the 76.5% general anesthesia rate (P < .0001) and 11.0 days median hospitalization stay (mean, 12.7 ± 5.3 days; P < .0001) in the 51 open bypass claudicant subjects. CONCLUSIONS: Stent grafting appears to be a safe and less invasive alternative to above-knee bypass surgery, providing 88% to 92% primary patency at 12 months in long, complex lesions.

Supervised exercise therapy: it does work, but how to set up a program?

Intermittent claudication (IC) is a manifestation of peripheral arterial disease. IC has a high prevalence in the older population, is closely associated with other expressions of atherosclerotic disease and often co-exists in multimorbid patients. Treatment of IC should address reduction of cardiovascular risk and improvement of functional capacity and health-related quality of life (QoL). As recommended by contemporary international guidelines, the first-line treatment includes supervised exercise therapy (SET). In several randomized controlled trials and systematic reviews, SET is compared with usual care, placebo, walking advice and endovascular revascularization. The evidence supporting the efficacy of SET programs to alleviate claudication symptoms is robust. SET improves walking distance and health-related QoL and appears to be the most cost-effective treatment for IC. Nevertheless, only few of all newly diagnosed IC patients worldwide receive this safe, efficient and structured treatment. Worldwide implementation of structured SET programs is seriously impeded by outdated arguments favoring an invasive intervention, absence of a network of specialized physical therapists providing standardized SET and lack of awareness and/or knowledge of the importance of SET by referring physicians. Besides, misguiding financial incentives and lack of reimbursement hamper actual use of SET programs. In the Netherlands, a national integrated care network (ClaudicatioNet) was launched in 2011 to combat treatment shortcomings and stimulate cohesion and collaboration between stakeholders. This care intervention has resulted in optimized quality of care for all patients with IC.

Transcutaneous calf-muscle electro-stimulation: A prospective treatment for diabetic claudicants?

BACKGROUND: First-line therapy for claudicants with diabetes include supervised exercise programmes to improve walking distance. However, exercise comes with a number of barriers and may be contraindicated in certain conditions. The aim of this study was to evaluate whether calf-muscle electro-stimulation improves claudication distance. METHOD: A prospective, one-group, pretest-posttest study design was employed on 40 participants living with type 2 diabetes mellitus, peripheral artery disease (ankle-brachial pressure index < 0.90) and calf-muscle claudication. Calf-muscle electro-stimulation of varying frequencies (1-250 Hz) was applied on both ischaemic limbs (N = 80) for 1 h per day for 12 consecutive weeks. The absolute claudication distance was measured at baseline and following the intervention. RESULTS: The cohort (n = 40; 30 males; mean age = 71 years; mean ankle-brachial pressure index = 0.70) registered a mean baseline absolute claudication distance of 333.71 m (standard deviation = 208). Following 91.68 days (standard deviation = 6.23) of electrical stimulation, a significant mean increase of 137 m (standard deviation = 136) in the absolute claudication distance was registered (p = 0.000, Wilcoxon signed rank test). CONCLUSION: Electrical stimulation of varying low to high frequencies on ischaemic calf muscles significantly increased the maximal walking capacity in claudicants with type 2 diabetes. This therapeutic approach may be considered in patients with impaired exercise tolerance or as an adjunct treatment modality.

The role of kinesitherapy and electrotherapeutic procedures in non-operative management of patients with intermittent claudications.

PURPOSE: To examine the effects of physical therapy (kinesitherapy and electrotherapeutic procedures) on the course of peripheral arterial occlusive disease by monitoring the changes in values of claudication distance and ankle-brachial indexes. METHODS: Prospective randomized study included 47 patients with peripheral arterial occlusive disease manifested by intermittent claudications associated with ankle-brachial indexes values ranging from 0.5 to 0.9. Patients from the first group (25 pts) were treated with medicamentous therapy, walking exercises beyond the pain threshold, dynamic low-burden kinesi exercises and electrotherapeutic ageneses (interference therapy, diadynamic therapy, and electromagnetic field), while the second group of patients (22 pts) was treated with "conventional" non-operative treatment - medicamentous therapy and walking exercises. The values of newly established absolute claudication distance and ankle-brachial indexes were measured. FINDINGS: Significant increase of absolute claudication distance in both groups of patients was registered, independently of therapeutic protocol applied (p < 0.001), as well as the increase in the claudication distance interval in the physical therapy group. There was no significant increase in ankle-brachial indexes values in both groups of patients. CONCLUSION: Methods of physical therapy presented valuable supplement in non-operative treatment of peripheral arterial occlusive disease patients, improving their functional ability and thus postponing surgical treatment. However, further investigations including larger number of patients are needed.

Improved Walking Claudication Distance with Transcutaneous Electrical Nerve Stimulation: An Old Treatment with a New Indication in Patients with Peripheral Artery Disease.

OBJECTIVE: The aim of this study was to determine whether 45 mins of transcutaneous electrical nerve stimulation before exercise could delay pain onset and increase walking distance in peripheral artery disease patients. DESIGN: After a baseline assessment of the walking velocity that led to pain after 300 m, 15 peripheral artery disease patients underwent four exercise sessions in a random order. The patients had a 45-min transcutaneous electrical nerve stimulation session with different experimental conditions: 80 Hz, 10 Hz, sham (presence of electrodes without stimulation), or control with no electrodes, immediately followed by five walking bouts on a treadmill until pain occurred. The patients were allowed to rest for 10 mins between each bout and had no feedback concerning the walking distance achieved. RESULTS: Total walking distance was significantly different between T10, T80, sham, and control (P < 0.0003). No difference was observed between T10 and T80, but T10 was different from sham and control. Sham, T10, and T80 were all different from control (P < 0.001). There was no difference between each condition for heart rate and blood pressure. CONCLUSIONS: Transcutaneous electrical nerve stimulation immediately before walking can delay pain onset and increase walking distance in patients with class II peripheral artery disease, with transcutaneous electrical nerve stimulation of 10 Hz being the most effective.

Upper versus lower limb exercise training in patients with intermittent claudication: a systematic review.

Lower extremity (LE) exercise training has been shown to contribute to improvements in Maximum Walking Distance (MWD), Claudication Distance (CD), peak oxygen uptake (VO2peak) and Quality of Life (QoL) in patients with intermittent claudication (IC). However, little is known regarding the efficacy of upper extremity (UE) exercise training in comparison to the widely used LE training. The objective of this systematic literature review is to identify and synthesize the available literature on the effects of UE versus LE exercises using the International Classification of Functioning (ICF) conceptual framework. A total of 6 randomized controlled trials comparing UE to LE exercises were included in this study. Two of the articles were considered to be of high quality using the PEDro grading list. Both UE and LE training groups demonstrated significant improvements in MWD, CD, VO2peak and QoL in comparison to the control group but LE was not better than UE training. This supports the use of UE training as an alternative to LE, which could provide symptomatic relief to patients with IC without the discomfort caused during the LE training.