Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

Determination of Treatment Efficacy after Revascularization of Intermittent Claudication Patients by Physical Function Assessment.

PURPOSE: There have been few reports examining changes in physical activity (PA) after revascularization of lower extremities from the perspective of physical function at discharge. The purpose of this study was to clarify the effects of physical function before discharge on the amount of PA after discharge in patients who underwent revascularization. METHODS: The subjects were 34 Fontaine class II patients admitted for elective surgical revascularization or endovascular treatment at two hospitals from September 2017 to October 2019. Triaxial accelerometers were used to measure changes in sedentary behavior (SB) before admission and 1 month after discharge. Multiple regression analysis was performed on the 6-min walking distance (6MWD) at the time of discharge and the change in SB 1 month after discharge; the cutoff value was calculated from the receiver operating characteristic (ROC) curve. RESULTS: SB 1 month after discharge significantly decreased in the decreased SB group compared to the increased SB group (575.5 [400-745.2] vs. 649.5 [453.8-809.2], p <0.01). ROC curve was plotted with SB increase/decrease as the dependent variable and 6MWD at discharge as the independent variable; the cutoff value was 357.5 m. CONCLUSION: 6MWD measurement at discharge may help predict changes in SB after discharge.

Socioeconomic factors predict successful supervised exercise therapy completion.

OBJECTIVE: Supervised exercise therapy (SET) for patients with intermittent claudication (IC) can lower the risk of progression to chronic limb-threatening ischemia and amputation, while preserving and restoring functional status. Despite supporting evidence, it remains underutilized, and among those who initiate programs, attrition rates are extremely high. We hypothesize that socioeconomic factors may represent significant barriers to SET completion. METHODS: Patients with IC referred to SET at a multi-hospital, single-institution health care system (2018-2022) from a prospectively maintained database were retrospectively analyzed. Our primary endpoint was SET program completion and graduation, defined as completion of 36 sessions. Our secondary endpoints were vascular intervention within 1 year of referral and change in ankle-brachial index (ABI). Baseline demographics were assessed using standard statistical methods. Predictors of SET graduation were analyzed using multivariable logistic regression generating adjusted odds ratios (aORs) with 95% confidence intervals (CIs). Change in ABI was analyzed using t-test between subgroups. Reasons for attrition were tabulated. Patient Health Questionnaire-9 (PHQ-9), metabolic equivalent level, Vascular QOL, Duke Activity Status, and ABI were analyzed using paired t-tests across the entire cohort. RESULTS: Fifty-two patients met inclusion criteria: mean age 67.85 ± 10.69 years, 19 females (36.54%), mean baseline ABI of 0.77 ± 0.16. The co-pays for 100% of patients were fully covered by primary and secondary insurance plans. Twenty-one patients (40.38%) completed SET. On multivariable analysis, residence in a ZIP code with median household income <$47,000 (aOR, 0.10; 95% CI, 0.01-0.76; P = .03) and higher body mass index (aOR, 0.81; 95% CI, 0.67-0.99; P = .04) were significant barriers to SET graduation. There were no differences in ABI change or vascular intervention within 1 year between graduates and non-graduates. Non-graduates reported transportation challenges (25.00%), lack of motivation (20.83%), and illness/functional limitation (20.83%) as primary reasons for SET attrition. Metabolic Equivalent Level (P ≤ .01) and Duke Activity Status scores (P = .04) were significantly greater after participating in a SET program. CONCLUSIONS: Although SET participation improves lower extremity and functionality outcomes, only 40% of referred patients completed therapy in our cohort. Our findings suggest that both socioeconomic and functional factors influence the odds of completing SET programs, indicating a need for holistic pre-referral assessment to facilitate enhanced program accessibility for these populations.

Objective assessment of functional capacity in patients with peripheral artery disease: a narrative review.

INTRODUCTION: Peripheral artery disease (PAD) patients with claudication symptoms exhibit impaired functional capacity, which has been associated with disease severity, worse quality of life and higher risk of cardiovascular events. Different tests have been used to assess functional capacity in PAD patients. Therefore, understanding the characteristics, strengths and limitations of these tests are important to support the choice of tests to be used in clinical practice. AREAS COVERED: This review summarizes the main methods to assess functional capacity in PAD patients, discussing their psychometric properties, applications, and limitations. EXPERT OPINION: Robust evidence supports the use of treadmill and six-minute walk tests in PAD patients, as their results are associated with clinically meaningful outcomes, adequate psychometric properties and are sensitive to effects of interventions. On the other hand, other functional tests (Shuttle-walk test, outdoor walking capacity test, timed-up and go, four-meter walk test, heel-rise test, short physical performance battery and modified physical performance battery) are related to activities of daily living and do not require sophisticated equipment and can be easily used in clinical practice. However, these other tests still need evidence regarding their clinical relevance, reliability, and ability to detect long-term intervention changes, providing further investigation directions.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Practice patterns surrounding the use of tibial interventions for claudication in the Medicare population.

OBJECTIVE: At present, no data are available to support the use of tibial interventions in the treatment of claudication. We characterized the practice patterns surrounding tibial peripheral vascular interventions (PVIs) for patients with claudication in the United States. METHODS: Using 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients who underwent an index PVI for claudication. Patients with any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during an index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and multivariable hierarchical logistic regression were used to assess the patient and physician characteristics associated with the use of tibial PVI for claudication. RESULTS: Of 59,930 Medicare patients who underwent an index PVI for claudication between 2017 and 2019, 16,594 (27.7%) underwent a tibial PVI (isolated tibial PVI, 38.5%; tibial PVI with concomitant femoropopliteal PVI, 61.5%). Of the 1542 physicians included in our analysis, the median physician-level tibial PVI rate was 20.0% (interquartile range, 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR], 1.23), increasing age (aOR, 1.30-1.96), Black race (aOR, 1.47), Hispanic ethnicity (aOR, 1.86), diabetes (aOR, 1.36), no history of hypertension (aOR, 1.12), and never-smoking status (aOR, 1.64; P < .05 for all). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR, 2.97), practice location in the West (aOR, 1.75), high-volume PVI practice (aOR, 1.87), majority of practice in an ambulatory surgery center or office-based laboratory setting (aOR, 2.37), and physician specialty. The odds of vascular surgeons performing tibial PVI were significantly lower compared with radiologists (aOR, 2.98) and cardiologists (aOR, 1.67; P < .05 for all). The average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs quartile 1-3, $12,023.96 vs $692.31 per patient; P < .001). CONCLUSIONS: Tibial PVI for claudication was performed more often by nonvascular surgeons in high-volume practices and high-reimbursement settings. Thus, a critical need exists to reevaluate the indications, education, and reimbursement policies surrounding these procedures.

Barriers to participation in supervised exercise therapy reported by people with peripheral artery disease.

OBJECTIVE: This study identified barriers to participation in supervised exercise therapy covered by the Centers for Medicare and Medicaid Services (CMS), reported by people with lower extremity peripheral artery disease (PAD). METHODS: People with PAD participating in research studies of walking impairment due to PAD in the Chicagoland area were asked to complete a questionnaire between March 15, 2019, and July 12, 2022, assessing their experience and attitudes about supervised exercise therapy. Participants were identified using mailed postcards to people aged 50 and older in Chicagoland, from medical centers in Chicago, and using bus and train advertisements. The questionnaire was developed based on focus group feedback from people with PAD. RESULTS: Of 516 participants with PAD approached, 489 (94.8%) completed the questionnaire (mean age: 71.0 years [standard deviation: 8.7], mean ankle-brachial index: 0.71 [standard deviation: 0.25]; 204 [41.7%] women and 261 [53.4%] Black). Of the 489 participants, 416 (85.1%) reported that their physician had never prescribed or recommended supervised exercise therapy. Overall, 357 (73.2%) reported willingness to travel three times weekly to the medical center for supervised exercise participation. However, of these, 214 (59.9%) reported that they were unwilling or unable to pay the $11 per exercise session copay required for supervised exercise covered by CMS. Of 51 people with PAD who reported prior participation in supervised exercise, only 5 (9.8%) completed the 12 weeks of supervised exercise therapy covered by CMS and 29 (56.9%) completed 6 or fewer weeks. Of 131 (26.8%) unwilling to travel three times weekly to a center for supervised exercise, the most common reasons for unwillingness to participate were "too time-consuming" (55.0%), "too inconvenient" (45.8%), and "lack of interest in treadmill exercise" (28.2%). CONCLUSIONS: Approximately 2 to 4 years after CMS began covering supervised exercise for PAD, most people with PAD in this study from a large urban area had not participated in supervised exercise therapy. Of those who participated, most completed fewer than half of the sessions covered by CMS. The required CMS copayment was a common barrier to supervised exercise participation by people with PAD.

The assessment of lower extremity peripheral artery disease impact on body mass center disorders.

BACKGROUND: Lower extremity peripheral artery disease is a problem of contemporary medicine and along with the ischemic heart disease it is considered to be a civilization disease. The risk of the disease increases significantly within a group of people reaching the age of 55 years and is closely related to co-occurring hazardous factors, such as diabetes, hyperlipidemia, hypertension or tobacco smoking. The first symptom reported by patients is intermittent claudication. Such symptoms may indicate that lower extremity peripheral artery disease does have an impact on posture disorders and motor skills. METHODS: The study covered four stages. The first stage involved medical interviews to obtain information regarding anthropometry, age, motor organ surgery, concomitant diseases and the lifestyle. In the following stage the value of the ankle brachial index for both lower limbs were calculated. In case of symptomatic patients, additionally, the location of artery stenosis/aortoiliac section, was verified. The third stage involved using a dynamometric platform for determination of the body mass center position for both studied groups. In the fourth stage a treadmill walk test was used to assess the participants for intermittent claudication. FINDINGS: Based on the obtained results, an attempt was taken to observe the relationship between the clinical characteristics of the disease and the body mass center position deviations. INTERPRETATION: The attempt was undertaken to assess whether the measurement of body mass center position might be a diagnostic parameter to evaluate the patient's condition and thus an indication for taking a decision for surgical treatment or rehabilitation.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

A Description of Outcomes Experienced by Patients Whose Orders for Peripheral Artery Revascularization Were Reviewed by a Nondenial Prior Authorization Program.

OBJECTIVE: After a nondenial prior authorization program evaluates orders for peripheral artery revascularization (PAR), ordering physicians sometimes withdraw their orders based upon program recommendations. Some patients with withdrawn orders receive PAR if claudication does not resolve. To characterize patient outcomes under this program, we evaluated whether associations existed between the withdrawal of patients' initial PAR orders and the presence of claims for PAR and claims mentioning intermittent claudication (IC) in the following 16 weeks. METHODS: Orders for PAR placed from 1/1/19 to 9/30/19 for patients with Medicare Advantage health plans were extracted from a national healthcare organization's database. Claims data from 0 to 16 weeks following the order were reviewed to determine if patients had downstream PAR claims, or if they had emergency department or hospital claims mentioning IC. Chi-square tests were used to assess the association between order withdrawal and downstream PAR, as well as claims mentioning IC. Multivariate logistic regressions were run to assess the same, controlling for patient age, sex, urbanicity, local median income, state obesity rate, type of PAR, ordering physician specialty, and whether PAR was ordered in a hospital setting. RESULTS: Of 1588 orders meeting inclusion criteria, 71.9% (1038/1444) of authorized orders and 61.1% (88/144) of withdrawn orders were followed by PAR within 16 weeks, a significant difference (P < .01). Relatedly, 69.8% (1008/1444) of authorized orders and 70.8% (102/144) of withdrawn orders were followed by IC claims, an insignificant difference. Multivariate logistic regressions showed patients with withdrawn PAR orders had significantly lower adjusted odds of PAR (OR: 0.63; 95% CI: 0.44-0.91), but an insignificant difference in their adjusted odds of IC (OR: 1.10; CI: 0.76-1.64). CONCLUSIONS: Although patients with withdrawn PAR orders were significantly less likely to receive PAR in the subsequent 16 weeks, no association was found between withdrawn PAR orders and subsequent claims mentioning IC.

Connecting the past to the present: A historical review of exercise training for peripheral artery disease.

Peripheral artery disease (PAD), a prevalent manifestation of atherosclerosis, is associated with increased cardiovascular morbidity and mortality as well as decreased functional ability. Exercise training for PAD is acknowledged to be a highly effective treatment, which improves walking ability and cardiovascular risk. The historical development of this treatment has not been the focus of a report. Therefore, we present a historical review of research on exercise training for PAD. Overall, this body of knowledge has provided strong evidence of the efficacy of supervised exercise training (SET) to improve walking ability for patients with claudication due to PAD. SET, using intermittent bouts of walking exercise to moderate claudication pain on a treadmill, is considered the most efficacious mode of exercise to improve walking ability in patients with claudication. This compelling evidence published over the past 60 years was evaluated by the Centers for Medicare & Medicaid Services in 2017, which culminated in a national coverage determination for SET to improve symptomatic PAD. Future directions include determining optimal delivery strategies for SET and further elucidation of the mechanisms of improvement in walking ability resulting from SET. In addition, alternative forms of exercise should be evaluated and effective home- and community-based exercise interventions should be assessed. There is an enormous need to increase the inclusion of women and racial and ethnic minority groups in studies. It is to be hoped that researchers will continue with new innovative research and persistence in the treatment of claudication due to PAD.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis.

[Figure: see text].

Trends and causes of readmission following peripheral vascular intervention in patients with peripheral vascular disease.

OBJECTIVES: To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD). BACKGROUND: There has been a paucity of data regarding the trend and predictors of PVI readmission. METHODS: We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. PVI was defined as angioplasty, atherectomy, and/or stenting of lower limb vessels. RESULTS: A total of 453,278 patients (30-day readmission n = 97,235). The mean age of study population was 68.6 ± 12.2 years and included 43.8% women. The 30-day readmission post-PVI was 21.5% (p = .034). Cardiovascular causes constitute 44% of readmission. Chronic limb ischemia and intermittent claudication were two most common cardiovascular causes constituting 11.7 and 4.9% cases of readmissions. Other cardiac causes of readmissions included heart failure (4.64%), dysrhythmias (1.4%), and acute myocardial infarction (1.7%). The high-risk factors for of all-cause 30-day readmission were hypertension, CLI, diabetes, renal failure, dyslipidemia, smoking, chronic pulmonary disease, and atrial fibrillation (p < .005). Length-of-stay was greater than 5 days for 56.2 and 75.4% paid by Medicare. CONCLUSIONS: Our study shows an average yearly readmission rate of 21.5% post-PVI. Chronic comorbidities and prolonged hospitalization were associated with higher risk of readmission.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Intermittent claudication treatment patterns in the commercially insured non-Medicare population.

OBJECTIVE: Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the degree to which treatment patterns have changed over time with the expansion of endovascular interventions and outpatient centers is unclear. Our goal was to characterize IC treatment patterns in the commercially insured non-Medicare population. METHODS: The IBM MarketScan Commercial Database, which includes more than 8 billion US commercial insurance claims, was queried for patients newly diagnosed with IC from 2007 to 2016. Patient demographics, medication profiles, and open/endovascular interventions were evaluated. Time trends were modeled using simple linear regression and goodness-of-fit was assessed with coefficients of determination (R2). A patient-centered cohort sample and a procedure-focused dataset were analyzed. RESULTS: Among 152,935,013 unique patients in the database, there were 300,590 patients newly diagnosed with IC. The mean insurance coverage was 4.4 years. The median patients age was 58 years and 56% of patients were male. The prevalence of statin use was 48% among patients at the time of IC diagnosis and increased to 52% among patients after one year from diagnosis. Interventions were performed in 14.3%, of whom 20% and 6% underwent two or more and three or more interventions, respectively. The median time from diagnosis to intervention decreased from 230 days in 2008 days to 49 days in 2016 (R2 = 0.98). There were 16,406 inpatient and 102,925 ambulatory interventions for IC over the study period. Among ambulatory interventions, 7.9% were performed in office-based/surgical centers. The proportion of atherectomies performed in the ambulatory setting increased from 9.7% in 2007 to 29% in 2016 (R2 = 0.94). In office-based/surgical centers, 57.6% of interventions for IC used atherectomy in 2016. Atherectomy was used in ambulatory interventions by cardiologists in 22.6%, surgeons in 15.2%, and radiologists in 13.6% of interventions. Inpatient atherectomy rates remained stable over the study period. Open and endovascular tibial interventions were performed in 7.9% and 7.8% of ambulatory and inpatient IC interventions, respectively. Tibial bypasses were performed in 8.2% of all open IC interventions. CONCLUSIONS: There has been shorter time to intervention in the treatment of younger, commercially insured patients with IC, with many receiving multiple interventions. Statin use was low. Ambulatory procedures, especially in office-based/surgical centers, increasingly used atherectomy, which was not observed in inpatient settings.

A systematic review of the role of heat therapy for patients with intermittent claudication due to peripheral artery disease.

Intermittent claudication (IC) is associated with impairments in quality of life and walking ability. Heat therapy is an emerging cardiovascular therapy, which may improve walking in patients with IC. We undertook a systematic review to establish current evidence for heat therapy for patients with IC. We searched five databases (Ovid Medline / PubMed, Embase, Scopus / Web of Science, Cochrane Library and Health Technology Assessment Databases). A total of 6751 records were screened with 76 full-text articles assessed for eligibility. We included three randomised control trials and three acute interventions. For chronic interventions, three different heat therapy interventions were used. The 6-minute walk distance significantly improved following whole-body immersion (p = 0.03; ES 0.94, 95% CI: 0.06-1.82), but not after Waon therapy or a water-perfused garment. Ankle-brachial pressure indices were significantly improved following whole-body immersion (p = 0.01; ES 1.10, 95% CI: 0.20-1.99) but not after other therapies. No form of heat therapy demonstrated statistical improvements in quality of life or brachial blood pressure. Acute interventions were characterised by large increases in limb blood flow and core temperature, and transient reductions in blood pressure post-heating. At present there are only three randomised controlled trials assessing heat therapy for patients with IC. Moreover, each of those randomised controlled trials utilised different heat therapies. There is also very limited study of the acute physiological responses to different heat therapy interventions in these populations. Future research should establish appropriate heat therapy protocols and implement more randomised trials to understand its effectiveness. PROSPERO: CRD42020187941.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.