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.

Daly/Cost comparison in the management of peripheral arterial disease at 17 Belgian hospitals.

OBJECTIVE: Peripheral arterial disease (PAD) is a manifestation of atherosclerosis that affects the lower extremities and afflicts more than 200 million people worldwide. Because of limited resources, the need to provide quality care associated with cost control is essential for health policies. Our study concerns an interhospital comparison among seventeen Belgian hospitals that integrates the weighting of quality indicators and the costs of care, from the hospital perspective, for a patient with this pathology in 2018. METHODS: The disability-adjusted life years (DALYs) were calculated by adding the number of years of life lost due to premature death and the number of years of life lost due to disability for each in-hospital stay. The DALY impact was interpreted according to patient safety indicators. We compared the hospitals using the adjusted values ​​of costs and DALYs for their case mix index, obtained by relating the observed value to the predicted value obtained by linear regression. RESULTS: We studied 2,437 patients and recorded a total of 560.1 DALYs in hospitals. The in-hospital cost average [standard deviation (SD)] was €8,673 (€10,893). Our model identified the hospitals whose observed values were higher than predicted; six needed to reduce the costs and impacts of DALYs, six needed to improve one of the two factors, and four seemed to have good results. The average cost (SD) for the worst performing hospitals amounted to €27,803 (€28,358). CONCLUSIONS: Studying the costs of treatment according to patient safety indicators permits us to evaluate the entire chain of care using a comparable unit of measurement.

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.

Correlation between physiological assessment and imaging findings during drug-coated balloon treatment for femoropopliteal diseases.

BACKGROUND: This prospective cross-sectional study evaluated the correlation between physiological assessment (PA) and minimum lumen area (MLA) by intravascular ultrasound (IVUS) during drug-coated balloon (DCB) treatment for femoropopliteal (FP) diseases. METHODS: A total of 51 limbs of 44 patients undergoing endovascular treatment with DCB for de novo FP disease were examined from April 2022 to February 2023. PA was conducted at baseline, after balloon dilatation, and after DCB treatment. PA was measured before (pressure ratio; PR) and after vasodilation (peripheral flow fractional flow reserve; pFFR) with the administration of 30 mg papaverine through a guiding catheter. The correlation of PA with percent diameter stenosis (%DS) and MLA was examined, and factors correlated with higher pFFR after balloon dilatation were evaluated in a multivariate analysis. RESULTS: At baseline, there were correlations between pressure ratio (PR) and %DS (coefficients: 0.641 [p < 0.001]) and between pFFR and %DS (0.666 [p < 0.001]). After balloon dilatation, there was no correlation between PR and %DS (coefficients: 0.33 [p = 0.27]) or between pFFR and %DS (0.41 [p = 0.71]). At baseline, PR and MLA were correlated (coefficients: 0.757 [p < 0.001]) as were pFFR and MLA (0.762 [p < 0.001]). After balloon dilatation, PR and MLA were correlated (coefficients: 0.524 [p < 0.001]) as were pFFR and MLA (0.601 [p < 0.001]). Balloon/EEM ratio, calcification >270°, and chronic total occlusion were associated with pFFR after balloon dilatation. CONCLUSION: After balloon dilatation, PA was correlated with MLA by IVUS but not with %DS based on angiography.

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease.

Background: Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. Methods: A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon. Clinical events included target lesion revascularization (TLR), amputation, and death. Transition probabilities and utility values were derived from published literature. Healthcare costs were based on German Diagnosis Related Groups (DRG) codes. Costs and outcomes were discounted at a rate of 3% per year. The incremental cost-effectiveness ratio (ICER) was calculated, and sensitivity analyses were performed to assess the robustness of the results. Results: In the one-year horizon, IVUS-guided PTA resulted in incremental quality-adjusted life-years (QALY) and costs of 0.02 and €919 per patient respectively, with a corresponding ICER of €45,195/QALY gained versus angiography-guided PTA. In the lifetime horizon, IVUS-guided PTA outperforms angiography-guided PTA; it was associated with a cost saving of €46 per patient and incremental QALY of 0.22. Utility value for post-TLR, as well as probabilities of death and TLR had the greatest impact on the one-year ICER, while cost of TLR and probabilities of TLR and amputation influenced the lifetime ICER most. The probability of IVUS-guided PTA being cost-effective at a willingness-to-pay (WTP) threshold of €50,000/QALY was 50.4% in the one-year horizon and increased to 85.9% in the lifetime horizon. Conclusions: In this analysis IVUS-guided PTA among patients with symptomatic FP atherosclerosis was cost-saving in a lifetime horizon from the German healthcare payer perspective.

Home-Based Walking Exercise and Supervised Treadmill Exercise in Patients With Peripheral Artery Disease: An Individual Participant Data Meta-Analysis.

Importance: Few people with lower extremity peripheral artery disease (PAD) participate in supervised treadmill exercise covered by the Center for Medicare and Medicaid Services. In people with PAD, the benefits of home-based walking exercise, relative to supervised exercise, remain unclear. Objective: To study whether home-based walking exercise improves 6-minute walk (6MW) more than supervised treadmill exercise in people with PAD (defined as Ankle Brachial Index ≤0.90). Data Sources: Data were combined from 5 randomized clinical trials of exercise therapy for PAD using individual participant data meta-analyses, published from 2009 to 2022. Study Selection: Of the 5 clinical trials, 3 clinical trials compared supervised treadmill exercise to nonexercise control (N = 370) and 2 clinical trials compared an effective home-based walking exercise intervention to nonexercise control (N = 349). Data Extraction and Synthesis: Individual participant-level data from 5 randomized clinical trials led by 1 investigative team were combined. The 5 randomized clinical trials included 3 clinical trials of supervised treadmill exercise and 2 effective home-based walking exercise interventions. Main Outcomes and Measures: Change in 6MW distance, maximum treadmill walking distance, and Walking Impairment Questionnaire at 6-month follow-up. The supervised treadmill exercise intervention consisted of treadmill exercise in the presence of an exercise physiologist, conducted 3 days weekly for up to 50 minutes per session. Home-based walking exercise consisted of a behavioral intervention in which a coach helped participants walk for exercise in or around home for up to 5 days per week for 50 minutes per session. Results: A total of 719 participants with PAD (mean [SD] age, 68.8 [9.5] years; 46.5% female) were included (349 in a home-based exercise clinical trial and 370 in a supervised exercise trial). Compared with nonexercise control, supervised treadmill exercise was associated with significantly improved 6MW by 32.9 m (95% CI, 20.6-45.6; P < .001) and home-based walking exercise was associated with significantly improved 6MW by 50.7 m (95% CI, 34.8-66.7; P < .001). Compared with supervised treadmill exercise, home-based walking exercise was associated with significantly greater improvement in 6MW distance (between-group difference: 23.8 m [95% CI, 3.6, 44.0; P = .02]) but significantly less improvement in maximum treadmill walking distance (between-group difference:-132.5 m [95% CI, -192.9 to -72.1; P < .001]). Conclusions and Relevance: In this individual participant data meta-analyses, compared with supervised exercise, home-based walking exercise was associated with greater improvement in 6MW in people with PAD. These findings support home-based walking exercise as a first-line therapy for walking limitations in PAD.

Longitudinal outcomes following peripheral vascular intervention among older persons living with HIV.

BACKGROUND: Persons living with human immunodeficiency virus (HIV, PLWH) have an increased risk of peripheral artery disease (PAD) in comparison to the general population. However, a gap remains in understanding optimal management for this condition. This study assesses longitudinal outcomes associated with peripheral endovascular intervention (PVI) for PAD among PLWH. METHODS: All Medicare fee-for-service patients undergoing femoropopliteal artery PVI between April 1, 2015 and December 31, 2018 were identified and stratified by HIV serostatus. The primary outcome was major adverse limb events (MALE), defined as major amputation or arterial embolism/thrombosis following an index procedure. The subdistribution hazard was used to evaluate the association between HIV serostatus and MALE, accounting for the competing risk of death. Results were adjusted for sociodemographics and major comorbidities. RESULTS: Of 168,553 patients who underwent PVI, 357 (0.21%) were PLWH. The average age was 77.0 ± 7.6 years; 80.3% had hypertension, 70.3% had hyperlipidemia, and 24.6% had tobacco use disorder. Compared to those without HIV, PLWH were younger and had a higher burden of cardiovascular risk factors. MALE were substantially more frequent among PLWH, with a cumulative incidence of 24.6%, compared to 14.5% among those without HIV. The adjusted subdistribution hazard ratio was 1.26 (95% CI 1.00-1.58, p = 0.05). The use of guideline-directed statin therapy was low in both groups in the 90 days following revascularization (57.9% in PLWH vs 58.1% in those without HIV, p = 0.95). CONCLUSION: Among US Medicare beneficiaries, PLWH had poorer long-term outcomes following PVI. Greater attention to the management of symptomatic PAD is warranted for the HIV population, particularly following revascularization.

Disparities in healthcare utilization by insurance status among patients with symptomatic peripheral artery disease.

BACKGROUND: Peripheral artery disease (PAD) is a common circulatory disorder associated with increased hospitalizations and significant health care-related expenditures. Among patients with PAD, insurance status is an important determinant of health care utilization, treatment of disease, and treatment outcomes. However, little is known about PAD-costs differences across different insurance providers. In this study we examined possible disparities in length of stay and total charge of inpatient hospitalizations among patients with PAD by insurance type. METHODS: We conducted a cross-sectional analysis of length of stay and total charge by insurance provider for all hospitalizations for individuals with PAD in South Carolina (2010-2018). Cross-classified multilevel modeling was applied to account for the non-nested hierarchical structure of the data, with county and hospital included as random effects. Analyses were adjusted for patient age, race/ethnicity, county, year of admission, admission type, all-patient refined diagnostic groups, and Charlson comorbidity index. RESULTS: Among 385,018 hospitalizations for individuals with PAD in South Carolina, the median length of stay was 4 days (IQR: 5) and the median total charge of hospitalization was $43,232 (IQR: $52,405). Length of stay and total charge varied significantly by insurance provider. Medicare patients had increased length of stay (IRR = 1.08, 95 CI%: 1.07, 1.09) and higher total charges (ß: 0.012, 95% CI: 0.007, 0.178) than patients with private insurance. Medicaid patients also had increased length of stay (IRR = 1.26, 95% CI: 1.24,1.28) but had lower total charges (ß: -0.022, 95% CI: -0.003. -0.015) than patients with private insurance. CONCLUSIONS: Insurance status was associated with inpatient length of stay and total charges in patients with PAD. It is essential that Medicare and Medicaid individuals with PAD receive proper management and care of their PAD, particularly in the primary care settings, to prevent hospitalizations and reduce the excess burden on these patients.

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.

Racial Differences in Presentation and Outcomes After Peripheral Arterial Interventions: Insights From the NCDR-PVI Registry.

BACKGROUND: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. METHODS: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. RESULTS: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients. CONCLUSIONS: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.

The importance of socio-economic determinants of health in the care of patients with peripheral artery disease: A narrative review from VAS.

Socio-economic determinants of health (SDoH) include various nonmedical factors in the socio-economic sphere with a potentially significant impact on health outcomes. Their effects manifest through several mediators/moderators (behavioral characteristics, physical environment, psychosocial circumstances, access to care, and biological factors). Various critical covariates (age, gender/sex, race/ethnicity, culture/acculturation, and disability status) also interact. Analyzing the effects of these factors is challenging due to their enormous complexity. Although the significance of SDoH for cardiovascular diseases is well documented, research regarding their impact on peripheral artery disease (PAD) occurrence and care is less well documented. This narrative review explores to what extent SDoH are multifaceted in PAD and how they are associated with its occurrence and care. Additionally, methodological issues that may hamper this effort are addressed. Finally, the most important question, whether this association may contribute to reasonable interventions aimed at SDoH, is analyzed. This endeavor requires attention to the social context, a whole systems approach, multilevel-thinking, and a broader alliance that reaches out to more stakeholders outside the medical sphere. More research is needed to justify the power in this concept to improve PAD-related outcomes like lower extremity amputations. At the present time, some evidence, reasonable consideration, and intuitive reasoning support the implementation of various interventions in SDoH in this field.

Obesity prevalence and variability in management practices for patients with symptomatic peripheral artery disease.

Obesity has been associated with poor disease outcomes in patients with lower extremity peripheral arterial disease (PAD). Given evolving treatments for obesity, evaluating its prevalence and treatment practices are key to develop a holistic management of PAD. We aimed to examine prevalence of obesity and variability of management strategies in symptomatic PAD patients enrolled in the international multicenter PORTRAIT registry from 2011 to 2015. Obesity management strategies studied included weight and/or dietary counseling and prescription of weight loss medications (orlistat, lorcaserin, phentermine-topiramate, naltrexone-buproprion, and liraglutide). Use frequency of obesity management strategies were calculated by country and compared across centers using adjusted median odds ratios (MOR). Of 1002 patients included, 36 % had obesity. No patients received weight loss medications. Weight and/or dietary counseling was prescribed in only 20 % of patients with obesity with significant variability in practices between centers (range 0.0-39.7 %; MOR 3.6, 95 % CI 2.04-9.95, p = < 0.001). In conclusion, obesity is a prevalent modifiable comorbidity in PAD that is hardly addressed during PAD management, with significant variability across practices. As obesity prevalence rates are growing, along with treatment modalities to treat it, especially in those with PAD, building systems to integrate systematic evidence-based weight and dietary management strategies in PAD are essential to close this gap in care.

New Biomarkers (Endocan, Interleukin-17, and Thrombospondin-4) for the Diagnosis, Assessment of Severity, and Follow-Up of Peripheral Arterial Disease.

The present study evaluated the use of endocan, interleukin-17 (IL-17), and thrombospondin-4 (TSP-4) blood levels as potential biomarkers for the diagnosis and follow-up of peripheral arterial disease (PAD). Patients with PAD (Rutherford categories I, II, and III) who were admitted between March 2020 and March 2022 for cardiovascular surgery or outpatient clinic follow-up were included. The patients (n = 60) were divided into 2 groups: medical treatment (n = 30) and surgical treatment (n = 30). In addition, a control group (n = 30) was created for comparison. Endocan, IL-17, and TSP-4 blood levels were measured at the time of diagnosis and at the first month after treatment. Endocan and IL-17 values were found to be significantly higher in both groups that underwent medical (259.7 ± 46 pg/mL, 63.7 ± 16.6 pg/mL) and surgical (290.3 ± 84.5 pg/mL, 66.4 ± 19.6 pg/mL) treatment than the control group (187.4 ± 34.5 pg/mL, 56.5 ± 7.2 pg/mL P < .001). Tsp-4 value was found to be significantly higher only in the surgical treatment group (15 ± 4.3 ng/mL) than the control group (12.9 ± 1.4 ng/mL P < .05). The decreases in endocan, IL-17, and TSP-4 levels at the first month of treatment in both groups were also significant (P < .001). A combination of classical and these new biomarkers could be included in PAD screening, early diagnosis, severity determination, and follow-up protocols in order to provide effective assessment in clinical practice.

Clinical Effectiveness of a Supervised Exercise Therapy Program for Treatment of Peripheral Artery Disease: A Translational Study.

PURPOSE: National guidelines for the treatment and management of symptomatic peripheral artery disease (PAD) recommend supervised exercise therapy (SET) as a first line of therapy. However, it is unknown how these expert opinion-based SET guidelines work in clinical practice as SET programs become established following the 2017 Centers for Medicare & Medicaid Services coverage announcement. The purpose of this prospective, nonrandomized translational study was to evaluate the clinical effectiveness of a SET program and specifically walking exercise modalities that did not incorporate a treadmill (TM). METHODS: Participants enrolled in a 12-wk SET program housed in four rural Midwest cardiac rehabilitation settings and were prescribed an exercise program by an exercise physiologist or nurse based on current SET guidelines. Groups included TM walking, total body recumbent stepping (TBRS), TM walking + TBRS, and multimodal. Pre- and post-tests of walking capacity, physical function, and quality of life were administered. RESULTS: The sample (n = 93) was all White, with 55% female representation, age of 73.7 ± 9.0 yr, and mild-moderate PAD (ankle-brachial index = 0.71 ± 0.19). Collectively, SET significantly improved the 6-min walk test (32.1 ± 6.6 m; P < .01). Within-group changes in the 6-min walk test were seen for all groups except the multimodal group; there were no significant between-group differences in change scores ( P = .30). No significant between-group changes were seen for the TM walking, TBRS, and TM walking + TBRS groups for physical function measures. CONCLUSION: This study demonstrates the clinical effectiveness of SET programs following current guidelines and potential utilization of non-TM walking modalities in SET programs.

Drug-Coated Balloon and Drug-Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease.

Background Patients with severe-stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCBs) and drug-eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods and Results We studied patients undergoing femoropopliteal interventions (September 2016-December 2018) from Medicare-linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4 and 5) CKD receiving DCB/DES, and (4) severe-stage CKD receiving POBA/BMS. We studied 8799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% versus 51% in patients with early-stage versus severe-stage CKD. Twenty-four-month mortality risk for patients with early-stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31-1.65]) for those receiving POBA/BMS; patients with severe-stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06-3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91-4.55]) for those receiving POBA/BMS (interaction P<0.001). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P=0.06) but was higher for the POBA/BMS group at 18 months (post hoc P<0.05). Patients with early-stage CKD receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, and 16% for severe-stage CKD-POBA/BMS (interaction P<0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe-stage CKD did not differ (post hoc P=0.820). Conclusions DCB/DES versus POBA/BMS use in patients with severe-stage CKD was associated with lower mortality and no difference in amputation outcomes.

Cost-Effectiveness of Drug-Coated Balloon Angioplasty versus Plain Old Balloon Angioplasty for Arteriovenous Fistula Stenosis.

OBJECTIVE: To compare the cost-effectiveness of drug-coated balloon angioplasty (DCB) versus plain old balloon angioplasty (POBA) for treatment of arteriovenous fistula (AVF) stenosis. METHODS: A Markov model was created to compare DCB versus POBA for AVF stenosis over a 2-year time horizon from a United States payer's perspective. Probabilities related to complications, restenosis, retreatment, and all-cause mortality were obtained from published literature. Costs were calculated using Medicare reimbursement rates and data from published cost analyses, inflation-adjusted to 2021. Health outcomes were measured with quality-adjusted life years (QALY). Probabilistic and deterministic sensitivity analyses were performed with a willingness-to-pay threshold of $100,000/QALY. RESULTS: Base case calculation showed better quality-of-life outcomes but increased cost with POBA compared to DCB, with an incremental cost-effectiveness ratio of $27,413/QALY, making POBA the more cost-effective strategy in the base case model. Sensitivity analyses showed that DCB becomes cost-effective if the 24-month mortality rate after DCB is no more than 3.4% higher than that after POBA. In secondary analyses where mortality rates were equalized, DCB was more cost-effective than POBA until its additional cost reached more than $4213 per intervention. CONCLUSION: When modeled from a payer's perspective over 2 years, the cost utility of DCB versus POBA varies with mortality outcomes. POBA is cost-effective if 2-year all-cause mortality after DCB is greater than 3.4% higher than after POBA. If 2-year mortality after DCB is less than 3.4% higher than after POBA, DCB is cost-effective until its additional cost per procedure exceeds $4213 more than POBA. LEVEL OF EVIDENCE IV: HISTORICALLY CONTROLLED STUDY.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

BACKGROUND: Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. METHODS: We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. RESULTS: In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). CONCLUSION: There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.

Impact of calcification on clinical outcomes after drug-coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system.

PURPOSE: To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. MATERIALS AND METHODS: We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at seven cardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. RESULTS: The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. CONCLUSION: The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.

Dual-eligible, dual-risk? A brief review on the impact of dual-eligible status on health disparities and peripheral artery disease.

Peripheral artery disease (PAD) has been associated with poorer outcomes based on particular social determinants of health, including insurance status. A unique population to study treatment outcomes related to PAD is those with dual-eligible status-those who qualify for both Medicare and Medicaid-comprising more than 12 million people. We performed a systematic review of the literature surrounding dual-eligible patients and impact on PAD, with final inclusion of six articles. Dual eligibility has been associated with higher rates of comorbidities; more severe symptoms at initial presentation for PAD; and poorer treatment outcomes, including mortality. Further studies are needed to specifically look at the association between PAD and dual-eligible status, but what is clear is that patients in this population would benefit from early identification to prevent disease progression and improve equity.