Six-month combined aerobic and resistance exercise program enhances 6-minute walk test and physical fitness in people with peripheral arterial disease: A pilot study.

BACKGROUND: Exercise therapy is a recognized non-pharmacological intervention for peripheral arterial disease (PAD); however, the effects of combined exercise remain under investigation. This study aimed to compare the effects of a 6-month combined supervised exercise program (SUP) with a usual care (UC) approach on walking ability, physical fitness, and peripheral blood flow in people with PAD and claudication. METHODS: Twenty-three male participants (Age=64.1 ± 6.2years and ABI=0.58±0.07) with PAD and claudication were assigned to either the SUP group (n = 10), engaging in structured supervised treadmill walking combined with three resistance exercises, three times a week, or the UC group (n = 13), receiving advice to walk. The primary outcome measure was walking ability, with assessments conducted at baseline (M0), after 3 months (M3), and 6 months (M6). RESULTS: After the 6-month intervention, the SUP group exhibited significant improvements in absolute claudication time (ACT, p = 0.045), maximal walking time (MWT, p = 0.045), maximal walking distance (MWD, p = 0.027), and pause duration (p = 0.045) during the 6-minute walk test (6MWT), when compared to the UC group. Over time, a significant increase in walking speed during the 6MWT (Speed6MWT, p = 0.001) and walking speed without claudication (SpeedNoC, p < 0.001) was found, although no significant differences were found between the groups. The SUP group increased by 0.8 km/h in both Speed6MWT and SpeedNoC, while the UC group increased by 0.3 km/h and 0.6 km/h, respectively. Despite claudication consistently occurring at the same time, the SUP group demonstrated an improved tolerance to pain or a better understanding of pain, enabling them to walk longer distances at higher speeds. A positive effect of SUP was found for chair sit-and-reach test (p = 0.023), percentage of fat mass (p = 0.048), fat-free mass (p = 0.040), and total body water (p = 0.026), suggesting potential benefits attributed to the resistance strength exercises. CONCLUSION: A 6-month combined treadmill and resistance exercise program improved walking ability, walking speed, lower body and lower back flexibility, and body composition in people with PAD and claudication.

Translation, cross-cultural adaptation, and validation of a Gujarati version of a theory of planned behavior questionnaire that assesses walking treatment beliefs in people with intermittent claudication.

BACKGROUND: Walking as a treatment is recommended for people with intermittent claudication (IC), but participation tends to be poor. Walking treatment beliefs, as defined by the Theory of Planned Behaviour (TPB) are associated with walking behavior, so assessing and designing interventions targeting walking treatment beliefs are crucial. To assess walking treatment beliefs in people with IC in Gujarat, a translated, culturally adapted questionnaire that assesses the four TPB constructs (attitude, subjective normative beliefs, perceived behavioral control beliefs, and intention to walk) is required. AIM: To translate and cross-culturally assess the content validity and face validity of a Gujarati version of a TPB questionnaire that assesses walking treatment beliefs. MATERIALS AND METHODS: A forward-backward translation of the 12-item TPB questionnaire was applied using a standardized approach. The translated versions were compared with the original questionnaire, and ten experts, rated each item according to: clarity, semantic, appropriateness, and cultural relevance. Content Validity Index (CVI), item level content validity (I-CVI), Scale -content validity index (S-CVI/Ave), and universal agreement (UA) were computed to summarize the overall content validity of the questionnaire as well as a proportion of agreement with content experts. Face validity was assessed using a think-aloud approach with ten patients with IC. This cognitive interviewing approach (think-aloud approach) asked participants to describe their thoughts whilst completing the questionnaire. Responses were analyzed thematically. RESULTS: There was complete agreement between experts for 9/12 items (I-CVI=1.00), leading to an overall agreement (S-CVI/Ave) of 0.98. For face validation, at least 50% of the participants had no significant problems with any question in the questionnaire. Most problems participants encountered were straightforward, such as re-reading some questions or considering the questions carefully before answering. CONCLUSION: The Gujarati TPB questionnaire had excellent content validity and was comprehensible and answerable by the majority of our participants with IC and, therefore, had good face validity; this will enable walking treatment beliefs to be assessed in people with IC.

Overview and comparison of contemporary Society for Vascular Surgery, American Heart Association/American College of Cardiology, and European Society for Vascular Surgery guidelines for the management of patients with intermittent claudication.

Intermittent claudication (IC) is a phenotype of peripheral artery disease that is characterized by pain in the lower extremity muscles during activity that is relieved by rest. Medical management, risk factor control, smoking cessation, and exercise therapy have historically been the mainstays of treatment for IC, but advances in endovascular technology have led to increasing use of peripheral vascular interventions in this patient population. There are meaningful differences in published society guidelines and appropriate use criteria relevant to the management of IC, especially regarding indications for peripheral vascular interventions. The current review aims to highlight similarities and differences between major society recommendations for the management of IC, and to discuss practice trends, disparities, and evidence gaps in the use of peripheral vascular interventions for IC in the context of existing guidelines.

Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial.

BACKGROUND: Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient. OBJECTIVE: To investigate the effect of acupuncture for DLSS. DESIGN: Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729). SETTING: 5 hospitals in China. PARTICIPANTS: Patients with DLSS and predominantly neurogenic claudication pain symptoms. INTERVENTION: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. RESULTS: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient. LIMITATION: The SA could produce physiologic effects. CONCLUSION: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment. PRIMARY FUNDING SOURCE: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).

Trends and Factors Associated With Peripheral Vascular Interventions for the Treatment of Claudication From 2011 to 2022: A National Medicare Cohort Study.

BACKGROUND: Previous cross-sectional studies have identified wide practice pattern variations in the use of peripheral vascular interventions (PVIs) for the treatment of claudication. However, there are limited data on longitudinal practice patterns. We aimed to describe the temporal trends and charges associated with PVI use for claudication over the past 12 years in the United States. METHODS AND RESULTS: We conducted a retrospective analysis using 100% Medicare fee-for-service claims data to identify all patients who underwent a PVI for claudication between January 2011 and December 2022. We evaluated the trends in utilization and Medicare-allowed charges of PVI according to anatomic level, procedure type, and intervention settings using generalized linear models. Multinomial logistic regressions were used to evaluate factors associated with different levels and types of PVI. We identified 599 197 PVIs performed for claudication. The proportional use of tibial PVI increased 1.0% per year, and atherectomy increased by 1.6% per year over the study period. The proportion of PVIs performed in ambulatory surgical centers/office-based laboratories grew at 4% per year from 12.4% in 2011 to 55.7% in 2022. Total Medicare-allowed charges increased by $11 980 035 USD/year. Multinomial logistic regression identified significant associations between race and ethnicity and treatment setting with use of both atherectomy and tibial PVI. CONCLUSIONS: The use of tibial PVI and atherectomy for the treatment of claudication has increased dramatically in in ambulatory surgical center/office-based laboratory settings, non-White patients, and resulting in a significant increase in health care charges. There is a critical need to improve the delivery of value-based care for the treatment of claudication.

The PAD-adapted 30-20-10 during Nordic walking: A new exercise training session in patients with symptomatic peripheral artery disease.

This study aimed to investigate the feasibility of a peripheral artery disease (PAD)-adapted 30-20-10 Nordic walking session in patients with symptomatic PAD and to compare the cardiovascular response of this new training session to a traditional walking (TW) and 4 × 4 minutes Nordic walking session. This is a prospective observational study. Patients with Fontaine stage II PAD were included. Patients participated in Nordic walking sessions, which were randomly assigned as TW, 4 × 4 minute intervals, and peripheral artery disease adapted 30-20-10 exercise session (PAD-adapted 30-20-10 sessions). PAD-adapted 30-20-10 and 4 × 4 minutes sessions consisted of 4 repetitions of 4 minutes of effort followed by 3 minutes of passive recovery. PAD-adapted 30-20-10 session was characterized by 4 continuous 1-min repetitions at 3 different walking speeds [high (30 seconds), moderate (20 seconds) and low (10 seconds)]. During the 4 × 4 minutes session, patients were asked to cover the maximal distance at a constant speed. During TW session, patients were asked to walk at a speed inducing moderate-to-severe claudication pain. Heart rate, rating of perceived exertion (RPE) and claudication pain intensity using a visual analog scale were assessed. The perceived enjoyment of each session was assessed using a visual analog scale ranging from 0 (not enjoyable) to 10 (very enjoyable). Eleven patients with chronic symptomatic PAD were included (62 ±â€…13 years; 54% women). The mean heart rate during the time of effort was significantly higher in PAD-adapted 30-20-10 group than in 4 × 4 minutes and TW groups (127 ±â€…12, 122 ±â€…12, 114 ±â€…11 bpm, respectively; P ≤ .001). The mean rating of perceived exertion (16 ±â€…1, 15 ±â€…1, 13 ±â€…1; P ≤ .001) and claudication pain intensity (8 ±â€…1, 7 ±â€…1; 7 ±â€…1 mm; P ≤ .019) were significantly higher during PAD-adapted 30-20-10 sessions than during 4 × 4 minutes and TW sessions. The perceived enjoyment was similar among sessions (8.7 ±â€…1.6 for TW, 8.6 ±â€…1.7 for 4 × 4 minutes, and 8.8 ±â€…1.8 mm for PAD-adapted 30-20-10 sessions; P = .935). The PAD-adapted 30-20-10 session is feasible and induces higher cardiovascular stimulation and claudication pain than 4 × 4 minutes and TW procedures in patients with symptomatic PAD. Despite these different responses, a similar perceived enjoyment among the sessions has been shown. Future investigations are needed to examine the effects of this new training session in these patients.

Incentives and individualized coaching improve completion rates of supervised exercise therapy for claudication.

OBJECTIVE: Supervised exercise therapy (SET) provides clinical benefit for patients suffering from intermittent claudication and has been widely recommended as first-line therapy before endovascular or surgical intervention. However, published rates of SET program completion range from 5% to 55%, with historic completion of 54% at our own institution. As such, we sought to identify if targeted patient-supportive interventions improve SET completion rates while still maintaining efficacious SET programming. METHODS: Patients who were diagnosed with intermittent claudication, as defined by ankle-brachial index (ABI) <0.9 without rest pain, were offered enrollment in a prospective quality improvement protocol for our 12-week SET for peripheral artery disease program. Program completion was defined as ≥24 of 36 offered sessions over 12 weeks. A three-pronged approach was utilized to improve completion during the study, including financial incentives up to $180, scheduled coaching with our advanced practitioner staff, and informational materials on the importance of SET programming and lifestyle modification. Patient-reported improvements in walking symptoms were tracked via regularly administered questionnaires. Functional measures of SET programming including total walking duration and distance, metabolic equivalent of task, and ABIs; vascular intervention within 12-months after enrollment was also collected and compared using univariate paired analysis. RESULTS: In total, seventy-three patients were enrolled in SET for peripheral artery disease programming over the study period. Utilizing our three-pronged coaching approach, 56 patients completed SET programming, increasing our SET completion rate to 76.7% over a 2-year study period. Compared with pre-SET baseline, patients who completed SET noted less pain, aching, cramps in calves when walking (P = .004), and less difficulty walking 1 block (P = .038). Additionally, patients significantly increased their metabolic equivalent of task (3.1 vs 2.6; P < .001), total walking duration (30 mins vs 13.5 mins; P < .001), and total walking distance (0.7 vs 0.3 miles; P < .001) from their pre-SET baseline. There were no changes in participant ABIs from enrollment to completion in participants. Patients who completed SET programming also delayed vascular intervention compared with those who did not complete SET or declined participation (213.5 vs 122.5 days from enrollment; P = .041). CONCLUSIONS: Targeted incentives, including cost-coverage vouchers and personalized coaching with instructional materials, successfully improved patient completion of a prescribed SET program. Patients who completed SET programming reported subjective improvement in walking symptoms and objective walking benefits. In addition, these patients had delayed time to vascular intervention, supporting current vascular guidelines advocating for effective SET therapy prior to offering vascular intervention for intermittent claudication.

Effects of additional exercise therapy after a successful vascular intervention for people with symptomatic peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) is characterised by obstruction or narrowing of the large arteries of the lower limbs, usually caused by atheromatous plaques. Most people with PAD who experience intermittent leg pain (intermittent claudication) are typically treated with secondary prevention strategies, including medical management and exercise therapy. Lower limb revascularisation may be suitable for people with significant disability and those who do not show satisfactory improvement after conservative treatment. Some studies have suggested that lower limb revascularisation for PAD may not confer significantly more benefits than supervised exercise alone for improved physical function and quality of life. It is proposed that supervised exercise therapy as adjunctive treatment after successful lower limb revascularisation may confer additional benefits, surpassing the effects conferred by either treatment alone. OBJECTIVES: To assess the effects of a supervised exercise programme versus standard care following successful lower limb revascularisation in people with PAD. SEARCH METHODS: We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers, most recently on 14 March 2023. SELECTION CRITERIA: We included randomised controlled trials which compared supervised exercise training following lower limb revascularisation with standard care following lower limb revascularisation in adults (18 years and older) with PAD. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were maximum walking distance or time (MWD/T) on the treadmill, six-minute walk test (6MWT) total distance, and pain-free walking distance or time (PFWD/T) on the treadmill. Our secondary outcomes were changes in the ankle-brachial index, all-cause mortality, changes in health-related quality-of-life scores, reintervention rates, and changes in subjective measures of physical function. We analysed continuous data by determining the mean difference (MD) and 95% confidence interval (CI), and dichotomous data by determining the odds ratio (OR) with corresponding 95% CI. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We identified seven studies involving 376 participants. All studies involved participants who received either additional supervised exercise or standard care after lower limb revascularisation. The studies' exercise programmes varied, and included supervised treadmill walking, combined exercise, and circuit training. The duration of exercise therapy ranged from six weeks to six months; follow-up time ranged from six weeks to five years. Standard care also varied between studies, including no treatment or advice to stop smoking, lifestyle modifications, or best medical treatment. We classified all studies as having some risk of bias concerns. The certainty of the evidence was very low due to the risk of bias, inconsistency, and imprecision. The meta-analysis included only a subset of studies due to concerns regarding data reporting, heterogeneity, and bias in most published research. The evidence was of very low certainty for all the review outcomes. Meta-analysis comparing changes in maximum walking distance from baseline to end of follow-up showed no improvement (MD 159.47 m, 95% CI -36.43 to 355.38; I2 = 0 %; 2 studies, 89 participants). In contrast, exercise may improve the absolute maximum walking distance at the end of follow-up compared to standard care (MD 301.89 m, 95% CI 138.13 to 465.65; I2 = 0 %; 2 studies, 108 participants). Moreover, we are very uncertain if there are differences in the changes in the six-minute walk test total distance from baseline to treatment end between exercise and standard care (MD 32.6 m, 95% CI -17.7 to 82.3; 1 study, 49 participants), and in the absolute values at the end of follow-up (MD 55.6 m, 95% CI -2.6 to 113.8; 1 study, 49 participants). Regarding pain-free walking distance, we are also very uncertain if there are differences in the mean changes in PFWD from baseline to treatment end between exercise and standard care (MD 167.41 m, 95% CI -11 to 345.83; I2 = 0%; 2 studies, 87 participants). We are very uncertain if there are differences in the absolute values of ankle-brachial index at the end of follow-up between the intervention and standard care (MD 0.01, 95% CI -0.11 to 0.12; I2 = 62%; 2 studies, 110 participants), in mortality rates at the end of follow-up (OR 0.92, 95% CI 0.42 to 2.00; I2 = 0%; 6 studies, 346 participants), health-related quality of life at the end of follow-up for the physical (MD 0.73, 95% CI -5.87 to 7.33; I2 = 64%; 2 studies, 105 participants) and mental component (MD 1.04, 95% CI -6.88 to 8.95; I2 = 70%; 2 studies, 105 participants) of the 36-item Short Form Health Survey. Finally, there may be little to no difference in reintervention rates at the end of follow-up between the intervention and standard care (OR 0.91, 95% CI 0.23 to 3.65; I2 = 65%; 5 studies, 252 participants). AUTHORS' CONCLUSIONS: There is very uncertain evidence that additional exercise therapy after successful lower limb revascularisation may improve absolute maximal walking distance at the end of follow-up compared to standard care. Evidence is also very uncertain about the effects of exercise on pain-free walking distance, six-minute walk test distance, quality of life, ankle-brachial index, mortality, and reintervention rates. Although it is not possible to confirm the effectiveness of supervised exercise compared to standard care for all outcomes, studies did not report any harm to participants from this intervention after lower limb revascularisation. Overall, the evidence incorporated into this review was very uncertain, and additional evidence is needed from large, well-designed, randomised controlled studies to more conclusively demonstrate the role additional exercise therapy has after lower limb revascularisation in people with PAD.

Patient Reported Barriers for Participation in Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease.

BACKGROUND: Supervised exercise therapy (SET) provides clinical benefit for patients suffering from intermittent claudication due to peripheral artery disease (PAD). However, enrollment in programs when offered remains low. We sought to identify patient-reported barriers to enrollment in SET as part of a prospective quality improvement program. METHODS: Patients who presented to clinic and were diagnosed with claudication were offered enrollment in a prospective quality improvement protocol, offered at 9 regional offices throughout our health system. Both patients who enrolled and declined enrollment were offered a 12-question questionnaire to identify potential barriers to enrollment. Additional data including gender, smoking status, ankle-brachial index (ABI), proximity to the nearest regional office, and disadvantage levels of neighborhoods (low: 1-3, medium: 4-7, and high: 8-10 area deprivation index [ADI]) was collected and compared by program participation using univariate analysis. RESULTS: Patients enrolled in the SET program (n = 66 patients) versus those who declined (n = 84 patients) were of similar age (medium age: 71.4 vs. 69.7 years, P = 0.694), baseline ABI (0.6 vs. 0.6, P = 0.944), smoking status (former 56.1% vs. 53.6%, P = 0.668), distance away from outpatient center (8.2 mi vs. 8.4 mi, P = 0.249), and had similar Connecticut state ADIs (2021 high-disadvantage: 35.4% vs. 33.3%, P = 0.549). Patients participating in the SET program were more likely to be male (78.8% vs. 56.0%, P = 0.003). Top self-reported barriers for patients who declined participation included transportation/distance (39.3%), preference for independent walking (56.0%), inability to commit to 3 sessions per week (52.4%), and lack of interest (20.2%). In addition, a higher proportion of patients who declined participation identified severe barriers of preference for independent walking (39.3% vs. 1.5%, P < 0.001), inability to commit to 3 sessions per week (26.2% vs. 3.0% P < 0.001), transportation/distance issues (23.8% vs. 7.6% P = 0.008), and cost (27.4% vs. 9.1%, P = 0.005) as significant barriers for participation in SET. CONCLUSIONS: Patients who declined participation in SET for PAD had similar disease status and access to care than participating counterparts. Top reported barriers to enrollment include a preference for independent walking, transportation/distance, commitment to 3x/week program, and cost, which highlight areas of focus for equitable access to these limb-saving services.

Influence of Preprocedural Statin Usage on Primary Patency and Amputation in Patients Undergoing Lower Limb Peripheral Angioplasty.

BACKGROUND: Peripheral arterial disease can progress to critical limb ischemia, which is associated with high amputation rates and requires revascularization. The endovascular approach has lower long-term patency because of restenosis due to neointimal hyperplasia. Statins are significantly advantageous for patients undergoing percutaneous interventions; however, only few studies have reported surgical improvements with statin therapy after endovascular treatment in such patients. This retrospective cohort study assessed the effects of preprocedural statins on lower limb arterial angioplasty outcomes by evaluating patency and amputation rates and comparing with those without statins. METHODS: Patients who underwent percutaneous transluminal angioplasty of the lower limbs for critical ischemia of the lower limbs or for limiting claudication were included in this retrospective cohort study. Patients were categorized according to statin use prior to and during hospitalization. Patient demographics, lesion morphology, primary patency, and limb salvage rates were compared between these groups. Statistical analyses were performed using Kaplan-Meier and multivariate regression analysis. RESULTS: A total of 178 patients undergoing endovascular intervention by critical ischemia or limiting claudication were included. Approximately 80% of the procedures were ballon angioplasty. Primary patency was 73% in 1 year and preprocedural statin usage was not associated with improved primary patency rates (P = 0.2798). After adjusting the amputation outcomes for pre-established variables, such as prehospitalization statin use, diabetes, procedure indication, disease location, Trans-Atlantic Inter-Society Consensus classification, and current smoking, there was no statistically significant difference associated with preprocedural statin use in primary patency (hazard ratio: 0.87 [0.33-2.29], P = 0.79) or amputation (hazard ratio: 0.70 [0.40-1.23], P = 0.22). CONCLUSIONS: The use of preprocedural statin did not improve primary patency or amputation rates in patients undergoing peripheral angioplasty.

Exercise Therapy for Peripheral Artery Disease.

PURPOSE OF REVIEW: To summarize evidence regarding exercise treatments for lower extremity peripheral artery disease (PAD). RECENT FINDINGS: Supervised walking exercise is recommended by practice guidelines for PAD. Supervised treadmill exercise improves treadmill walking distance by approximately 180 m and 6-min walk distance by 30-35 m, compared to control. The Centers for Medicaid and Medicare Services covers 12 weeks of supervised exercise, but most people with PAD do not participate. Home-based walking exercise may be more convenient and accessible than supervised exercise. In randomized clinical trials, home-based walking exercise interventions incorporating behavioral methods, such as accountability to a coach, goal-setting, and self-monitoring, improved 6-min walk distance by 40-54 m, compared to control. Arm and leg ergometry also improved walking endurance for people with PAD, but efficacy compared to walking exercise remains unclear. Walking exercise is first-line therapy for PAD-related walking impairment and can be effective in either a supervised or a structured home-based setting.

Lessons Learned from Coronary Revascularization Appropriateness Statements for Application to Peripheral Artery Disease.

Appropriate Use Criteria (AUC) are evidence-based criteria developed in a methodologically robust manner with the input of expert providers across a wide range of disciplines and practice settings. AUC have been successfully implemented in the diagnosis and management of a wide range of cardiovascular disease processes. AUC have demonstrated clear potential for influencing meaningful change in practice patterns with regards to high-value, high-quality care in cardiovascular pathologies. Potential for similar impact in the management of peripheral artery disease, specifically for patients presenting with intermittent claudication (IC), may be limited due to unique challenges. These challenges include multidisciplinary interventionalists, variability in existing AUC across specialties, and financial incentives influencing physician behavior. AUC serve to benefit patients by improving outcomes, and adoption of AUC is a critical step toward improving the quality of care provided to patients with IC. Societal support is necessary for effective AUC implementation.

Medical Optimization of Patients with Symptomatic Peripheral Arterial Disease.

Peripheral artery disease (PAD) is a progressive disease associated with the occurrence of major adverse cardiovascular and limb events and elevated mortality rates. Symptoms of PAD, including claudication and chronic limb-threatening ischemia, impair functional capacity and lead to lower quality of life. The focus of current therapies is to minimize symptoms, improve quality of life, and reduce adverse cardiovascular and limb events. Among the medical therapies are antiplatelets, anticoagulants, antihypertensives, lipid lowering therapies, cilostazol and pentoxifylline, and novel blood sugar-lowering therapies, plus exercise therapy and smoking cessation. In this review, we discuss these evidence-based medical therapies that are available for patients with symptomatic PAD.

Home-based Circuit Training and Community Walking for Intermittent Claudication.

BACKGROUND: Supervised exercise training is recommended for people with peripheral artery disease (PAD), yet it remains underutilized. Home-based exercise programs (HBEPs) are a potential alternative. The aim of this study was to assess the feasibility of conducting a full scale trial of a 12-week HBEP for people living with symptomatic PAD. METHODS: In a randomized feasibility trial, patients with intermittent claudication were allocated to either an HBEP or a nonexercise control. The HBEP group was given a Fitbit to use during a 12-week exercise program comprising of personalized step goals and a resistance-based circuit to be undertaken at home twice weekly. The primary outcome was feasibility, assessed via eligibility, recruitment, attrition, tolerability, and adherence. Acceptability was assessed via semistructured interviews. Secondary analysis was undertaken to determine the feasibility of collecting clinical outcome data. RESULTS: 188 people were screened, 133 were eligible (70.7%), 30 were recruited (22.6%) and one withdrew (3.33%). Mean adherence to the daily step goal was 53.5% (range = 29.8-90.5%), and 58.6% of prescribed circuits were completed of which 56.4% were at the desired intensity. Six adverse events were recorded, 3 of which were related to study involvement. No significant differences were observed in exploratory outcomes. Small clinically important differences were seen in walking speed and pain-free treadmill walking distance which should be confirmed or refuted in a larger trial. CONCLUSIONS: The HBEP was feasible and well tolerated, with successful recruitment and minimal attrition. The intervention was acceptable, with walking seen as more enjoyable than circuit exercise. The WALKSTRONG program may be suitable for those who will not, or cannot, take part in supervised exercise outside of the home.

Appropriateness of Care Measures: A Novel Approach to Quality.

The clinical judgment of a physician is one of the most important aspects of medical quality, yet it is rarely captured with quality measures in use today. We propose a novel approach using individualized physician benchmarking that measures the appropriateness of care that a physician delivers by looking at their practice pattern in a specific clinical situation. A prime application of our novel approach to appropriateness measures is the surgical management of peripheral artery disease and claudication. We discuss 4 potential consensus metrics for the treatment of claudication that explore appropriateness of care of claudication management and are meaningful, actionable, and quantifiable. Given the multitude of medical specialties involved in the care of patients with peripheral artery disease and the consequences of both preemptive and delayed care, it is in all of our interests to promote data transparency with confidential communications to outlier physicians while advocating for evidence-based management.

Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial.

Importance: Intermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed. Objective: To assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication. Design, Setting, and Participants: In this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021. Intervention: In the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment. Main Outcomes and Measures: The primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures. Results: Of 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01). Conclusions and Relevance: To our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication. Trial Registration: ClinicalTrials.gov Identifier: NCT02652078.

Long-term patient-reported outcomes among patients undergoing revascularization vs medical therapy for intermittent claudication.

OBJECTIVE: Society for Vascular Surgery guidelines recommend revascularization for patients with intermittent claudication (IC) if it can improve patient function and quality of life. However, it is still unclear if patients with IC achieve a significant functional benefit from surgery compared with medical management alone. This study examines the relationship between IC treatment modality (operative vs nonoperative optimal medical management) and patient-reported outcomes for physical function (PROMIS-PF) and satisfaction in social roles and activities (PROMIS-SA). METHODS: We identified patients with IC who presented for index evaluation in a vascular surgery clinic at an academic medical center between 2016 and 2021. Patients were stratified based on whether they underwent a revascularization procedure during follow-up vs continued nonoperative management with medication and recommended exercise therapy. We used linear mixed-effect models to assess the relationship between treatment modality and PROMIS-PF, PROMIS-SA, and ankle-brachial index (ABI) over time, clustering among repeat patient observations. Models were adjusted for age, sex, diabetes, Charlson Comorbidity Index, Clinical Frailty Score, tobacco use, and index ABI. RESULTS: A total of 225 patients with IC were identified, of which 40% (n = 89) underwent revascularization procedures (42% bypass; 58% peripheral vascular intervention) and 60% (n = 136) continued nonoperative management. Patients were followed up to 6.9 years, with an average follow-up of 5.2 ± 1.6 years. Patients who underwent revascularization were more likely to be clinically frail (P = .03), have a lower index ABI (0.55 ± 0.24 vs 0.72 ± 0.28; P < .001), and lower baseline PROMIS-PF score (36.72 ± 8.2 vs 40.40 ± 6.73; P = .01). There were no differences in patient demographics or medications between treatment groups. Examining patient-reported outcome trends over time; there were no significant differences in PROMIS-PF between groups, trends over time, or group differences over time after adjusting for covariates (P = .07, P = .13, and P =.08, respectively). However, all patients with IC significantly increased their PROMIS-SA over time (adjusted P = .019), with patients managed nonoperatively more likely to have an improvement in PROMIS-SA over time than those who underwent revascularization (adjusted P = .045). CONCLUSIONS: Patient-reported outcomes associated with functional status and satisfaction in activities are similar for patients with IC for up to 7 years, irrespective of whether they undergo treatment with revascularization or continue nonoperative management. These findings support conservative long-term management for patients with IC.