Comparison of Mortality and Amputation after Lower Extremity Bypass vs. Peripheral Vascular Intervention in Patients with Chronic Limb-Threatening Ischemia and Comorbid Chronic Kidney Disease.

OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data is limited for lower extremity bypass (LEB) vs. peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate 1) 30-day all-cause mortality and amputation and 2) 5-year all-cause mortality and amputation for LEB vs. PVI in patients with comorbid CKD. METHODS: Individuals undergoing LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs. PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, 69.0% were male. Irrespective of CKD status, 30-day mortality (HR 0.94, 95% CI 0.63-1.42, p=0.78) was similar for LEB vs. PVI, but LEB was associated with a lower risk of 30-day amputation (sHR 0.66, CI 0.44-0.97, p=0.04). CKD status, however, did not modify these results. Similarly, LEB vs. PVI was associated with a lower risk of 5-year mortality (HR 0.79, 95% CI 0.71-0.88, p<0.001), but no difference in 5-year amputation (sHR 1.03, 95% CI 0.89-1.20, p=0.67). CKD status did not modify these results. CONCLUSION: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs. PVI. Results may help inform preference-sensitive treatment decisions on LEB vs. PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative.

BACKGROUND: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries. OBJECTIVES: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review. METHODS: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability. RESULTS: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74). CONCLUSIONS: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed.

Evaluation of short-term mortality in patients with Medicare undergoing endovascular interventions for chronic limb-threatening ischemia.

INTRODUCTION: Patients with chronic limb-threatening ischemia (CLTI) have high mortality rates after revascularization. Risk stratification for short-term outcomes is challenging. We aimed to develop machine-learning models to rank predictive variables for 30-day and 90-day all-cause mortality after peripheral vascular intervention (PVI). METHODS: Patients undergoing PVI for CLTI in the Medicare-linked Vascular Quality Initiative were included. Sixty-six preprocedural variables were included. Random survival forest (RSF) models were constructed for 30-day and 90-day all-cause mortality in the training sample and evaluated in the testing sample. Predictive variables were ranked based on the frequency that they caused branch splitting nearest the root node by importance-weighted relative importance plots. Model performance was assessed by the Brier score, continuous ranked probability score, out-of-bag error rate, and Harrell's C-index. RESULTS: A total of 10,114 patients were included. The crude mortality rate was 4.4% at 30 days and 10.6% at 90 days. RSF models commonly identified stage 5 chronic kidney disease (CKD), dementia, congestive heart failure (CHF), age, urgent procedures, and need for assisted care as the most predictive variables. For both models, eight of the top 10 variables were either medical comorbidities or functional status variables. Models showed good discrimination (C-statistic 0.72 and 0.73) and calibration (Brier score 0.03 and 0.10). CONCLUSION: RSF models for 30-day and 90-day all-cause mortality commonly identified CKD, dementia, CHF, need for assisted care at home, urgent procedures, and age as the most predictive variables as critical factors in CLTI. Results may help guide individualized risk-benefit treatment conversations regarding PVI.

Variability in guideline-directed medical therapy across sites and operators and long-term mortality and amputation outcomes risk in patients undergoing peripheral vascular interventions.

BACKGROUND: The use of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) decreases the risk of death and amputation and may decrease hospital readmissions. The variability of GDMT prescription across sites and operators and the proportionality of risk is not well understood. We aimed to study the association between variability of GDMT prescription at the site and operator level and outcomes (including 90-day readmissions and 24-month all-cause mortality and major amputation). METHODS: We examined GDMT discharge rates in PVIs performed between 2017 and 2018 using Medicare-linked Vascular Quality Initiative registry. GDMT included a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACE-i/ARB) if hypertensive. Quartiles (Q1-4) of GDMT rates were documented by operators and sites and variability was quantified using median odds ratios (MOR) and intraclass correlation (ICC). The association between lower GDMT rates (per 10%) by sites and operators with 90-day readmission were calculated using logistic regression, and with 24-month mortality and major amputation using parametric survival model. Models were adjusted for patient-level factors and included sites and operators nested within sites as 2 random effects. RESULTS: GDMT rates for 17,147 patients across 223 sites and 1,263 operators ranged from 0% to 38% (Q1, MOR 1.43, 95%CI 1.39-1.47, P ≤ .001) to 57%-100% (Q4, MOR 1.48, 95%CI 1.44-1.51, P ≤ .001). Four percent of variance in GDMT use was explained by sites (ICC 3.9, 95%CI 2.9-5.3) and operators (ICC 4.1, 95%CI 3.1-5.4). A dose-response relationship was noted between lower GDMT rates and increased risk of 90-day readmission risk by sites (P = .021) and operators (P < .001). Lower GDMT prescription by site was associated with higher risk of 24-month mortality (HR = 1.07, 95%CI 1.02-1.13) and major amputation (HR = 1.08, 95%CI 1.01-1.15). Similar associations were found for GDMT use by provider (mortality HR = 1.05, 95%CI 1.02-1.08 and amputation HR = 1.04, 95%CI 1.00-1.08). CONCLUSION: Both at the operator and health system level, there was significant variability in GDMT prescription following PVI, proportionally translating into risk for readmission, mortality, and major amputation. Targeted quality efforts should prioritize both operator and site levels to improve GDMT use and outcomes for patients undergoing PVI.

Impact of comorbid opioid use disorder and major depressive disorder on healthcare utilization outcomes in patients with peripheral artery disease: A National Readmission Database analysis.

BACKGROUND: Prior research has demonstrated that individuals with peripheral artery disease (PAD) often have comorbid opioid use disorder (OUD) and major depressive disorder (MDD), with limited data regarding their impact on readmission outcomes, length of stay, and cost. This study aimed to investigate these healthcare utilization outcomes in patients with PAD who have comorbid OUD and MDD. METHODS: Data were obtained from the National Readmission Database from 2011 through 2018. The study population included all hospitalizations with PAD as the primary or secondary diagnosis, from which hospitalizations with OUD and MDD were extracted using appropriate ICD-9/10 diagnosis codes. Primary outcomes were 30-day and 90-day readmission, total cost, and total length of stay within the calendar year. We created hierarchical multivariable logistic regression models examining OUD with and without MDD, with a random effect for healthcare facility location. RESULTS: From 2011 to 2018, 13,265,817 weighted admissions with PAD were identified. These admissions were segmented into four categories: No OUD/No MDD (12,056,466), OUD/No MDD (323,762), No OUD/MDD (867,641), and OUD/MDD (17,948). The group with No OUD/No MDD was used as the reference group for all subsequent comparisons. Regarding 30-day and 90-day readmissions, patients with OUD/MDD had odds of 1.14 (95% CI 1.10, 1.18) and 1.09 (95% CI 1.06, 1.13), respectively. Patients with OUD/No MDD bore the highest median cost of $64,354 (IQR $30,797-137,074), and patients with OUD/MDD marked the lengthiest median stay of 6.01 days (IQR 2.01-13.30). CONCLUSION: This study found a significant association between these comorbidities and outcomes and therefore calls for targeted interventions and pain management strategies.

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.

Examining Outcomes in Patients Admitted With Comorbid Peripheral Artery Disease and Microvascular Disease.

BACKGROUND: Peripheral artery disease (PAD) and microvascular disease (MVD) are highly prevalent conditions that share common risk factors. This observational study aimed to characterize patients with both conditions and determine the impact of comorbid PAD/MVD on outcomes. METHODS AND RESULTS: Patients admitted across 31 states January 2011 through December 2018 with a primary or secondary diagnosis of PAD or MVD were included from the National Readmissions Database and weighted to approximate a national sample. Those age <18 years or with nonatherosclerotic leg injuries were excluded. Patients were divided into 3 groups: PAD-only, MVD-only, or comorbid PAD/MVD. Multiple logistic regression was used to evaluate associations with major and minor amputations, major adverse cardiac events, and in-hospital mortality. Cox regression was used to evaluate associations with readmission within 1 year. The PAD group was used as reference. The final cohort included 33 972 772 admissions: 9.1 million with PAD, 21.3 million with MVD, and 3.6 million with both. Annual admissions for PAD/MVD increased to >500 000 in 2018. Major and minor amputations increased ≈50% for PAD/MVD between 2011 and 2018. Compared with PAD-only, PAD/MVD was associated with a higher risk for major amputation (odds ratio [OR], 1.30 [95% CI, 1.28-1.32]), minor amputation (OR, 2.15 [95% CI, 2.12-2.18]), major adverse cardiac events (OR, 1.04 [95% CI, 1.03-1.04]), in-hospital mortality (OR, 1.07 [95% CI, 1.05-1.09]), and readmission (hazard ratio, 1.02 [95% CI, 1.02-1.02]) after adjustment for baseline factors. CONCLUSIONS: Comorbid MVD is present in a large and growing number of patients with PAD and is associated with augmented risk for adverse outcomes. Further prospective research is merited to understand this vulnerable population.

A state-of-the-art review of quality-of-life assessment in venous disease.

OBJECTIVE: Chronic venous disease is a common condition and has a significant impact on patients' health status. Validated patient-reported outcome measures (PROMs) used to assess health status are needed to measure health status. This state-of-the-art review summarizes the current validation evidence for disease-specific PROMs for chronic venous disease and provides a framework for their use in the clinical setting. METHODS: A literature search in OVID Embase and Medline was conducted to identify relevant English-language studies of chronic venous disease that used disease-specific PROMs between January 1, 1993, and June 30, 2022. Abstracts and titles from identified studies were screened by four investigators, and full-text articles were subsequently screened for eligibility. Data on validation of disease-specific PROMs was abstracted from each included article. Classical test theory was used as a framework to examine a priori defined validation criteria for content validity, reliability (construct validity, internal reliability, and test-retest reliability), responsiveness, and expansion of the validation evidence base (use in randomized controlled trials and comparative effectiveness research, cultural or linguistic translations, predictive validity, or establishing the minimal clinically important difference threshold, defined as smallest amount an outcome or measure is perceived as a meaningful change to patients). The PROMs were categorized into three groups based on the manifestations of disease of the population for which they were developed. The overall validity of each PROM was assessed across three stages of validation including content validity (phase 1); construct validity, reliability, and responsiveness (phase 2); and expansion of the validation evidence base (phase 3). RESULTS: Of 2338 unique studies screened, 112 studies (4.8%) met inclusion criteria. The eight disease-specific PROMs identified were categorized into three groups: (1) overall chronic venous disease (C1 to C6); (2) C1 to C4 disease; and (3) C5 to C6 disease. Assessed by group, the Chronic Venous Insufficiency Questionnaire met criteria for validation at all three phases for patients with C1 to C4 disease, and the Charing Cross Venous Ulcer Questionnaire met criteria for validation at all three phases for patients with C5 to C6 disease. There were no PROMs that met all criteria for validation for use in overall chronic venous disease (C1 to C6). CONCLUSIONS: Of the eight PROMs assessed in this review, only two met prespecified criteria at each phase for validation. The Chronic Venous Insufficiency Questionnaire and Charing Cross Venous Ulcer Questionnaire should be considered for use in patients with chronic venous disease without venous ulcers and with venous ulcers, respectively.

Patient knowledge and preferences for peripheral artery disease treatment.

BACKGROUND: Shared medical decision making requires patients' understanding of their disease and its treatment options. Peripheral artery disease (PAD) is a condition for which preference-sensitive treatments are available, but for which little is known about patients' knowledge and treatment preferences as it relates to specific treatment goals. METHODS: In a prospective, multicenter registry that involved patients with PAD experiencing claudication, the PORTRAIT Knowledge and Preferences Survey was administered at 1 year. It asks questions about PAD treatment choices, symptom relief options, disease management, and secondary prevention. PAD treatment preferences were also queried, and patients ranked 10 PAD treatment goals (1-10 Likert scale; 10 being most important). RESULTS: Among 281 participants completing the survey (44.8% women, mean age 69.6 ± 9.0 years), 54.1% knew that there was more than one way to treat PAD symptoms and 47.1% were offered more than one treatment option. Most (82.4%) acknowledged that they had to manage their PAD for the rest of their life. 'Avoid loss of toes or legs,' 'decreased risk of heart attack/stroke,' 'long-lasting treatment benefit,' 'living longer,' 'improved quality of life,' and 'doing what the doctor thinks I should do' had mean ratings > 9.0 (SD ranging between 1.21 and 2.00). More variability occurred for 'avoiding surgery.' 'cost of treatment,' 'timeline of pain relief,' and 'return to work' (SD ranging between 2.76 and 3.58). The single most important treatment goal was 'improving quality of life' (31.3%). CONCLUSIONS: Gaps exist in knowledge for patients with PAD who experience claudication, and there is a need for increased efforts to improve support for shared decision-making frameworks for symptomatic PAD.(ClinicalTrials.gov Identifier: NCT01419080).

Longitudinal Pathways Between Physical Activity, Depression, and Perceived Stress in Peripheral Artery Disease.

BACKGROUND: One-fifth of the patients with peripheral artery disease (PAD) experience depression and stress. Depression and stress may impact patients' abilities to be physically active, a key recommendation for supporting overall PAD management to improve symptoms and reduce the risk of cardiovascular events. We aimed to study interrelationships between 1-year longitudinal trajectories of depression, stress, and physical activity following a PAD diagnosis. METHODS: Patients with new or worsening PAD symptoms enrolled at 10 US PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) vascular specialty clinics (CT, LA, MI, MO, NC, OH, and RI) were assessed at baseline, 3, 6, and 12 months between June 2, 2011 and December 3, 2015. Depressive symptoms were measured with the 8-item Patient Health Questionnaire, perceived stress with the 4-item Perceived Stress Scale and physical activity with items from the INTERHEART study. Path analysis was used to examine the longitudinal relationship between depression and physical activity and perceived stress and physical activity. RESULTS: A total of 766 patients were included (mean age of 68.2 [±9.4] years; 57.7% male). Overall, 17.8% reported significant depressive symptoms, 36.0% experienced increased perceived stress, and 44.1% were sedentary upon PAD diagnosis. A decrease in physical activity preceded a rise in subsequent depressive symptoms (ß ranges -0.45 [95% CI, -0.80 to -0.09]; -0.81 [95% CI, -1.19 to 0.42]) over the course of 1 year. Low physical activity scores at the initial presentation were followed by high perceived stress at 3 months (ß=-0.44 [95% CI, -0.80 to -0.07]). CONCLUSIONS: In symptomatic PAD, a decrease in physical activity was followed by an increased risk of depressive symptoms and perceived stress at subsequent intervals over the course of 1 year following PAD diagnosis and treatment. Integrated behavioral health approaches for PAD, addressing physical activity and managing depression or distress, are indicated as collective PAD treatment goals.

Representativeness of Peripheral Artery Disease Randomized Clinical Trials Supporting Current Guidelines.

Women, older adults, and racial/ethnic minorities are differentially affected by lower extremity peripheral artery disease (PAD), yet their representation in randomized controlled trials (RCTs) on which current PAD guidelines are based is not known. We therefore evaluated whether RCTs supporting most recent American Heart Association/American College of Cardiology lower extremity PAD guidelines proportionately represent the spectrum of demographic groups affected by PAD. All PAD-specific RCTs cited in the guidelines were included. From 409 references, 78 RCTs were included, representing 101,359 patients. Pooled proportion of women enrolled was 33% (95% confidence interval 29% to 37%) versus 57.5% in US PAD epidemiologic studies. Pooled mean age of all trial participants was 67.4 ± 0.8 years, in comparison with global estimates of PAD, in which 29.4% of the global population with PAD is >70 years old. Race/ethnicity distribution was reported in 27% of studies (21 of 78). In conclusion, in trials supporting current PAD guidelines, women and older adults patients are underrepresented, and different race and ethnic groups are underreported across the spectrum of studies. Underrepresentation of these groups differentially affected by PAD may limit the generalizability of the evidence supporting PAD guidelines.

Lower extremity symptoms and ankle-brachial index screening as predictors of cardiovascular outcomes in Black adults.

BACKGROUND: The prevalence of peripheral artery disease (PAD) and leg symptoms are higher in Black than White adults. We studied the effects of self-reported lower extremity symptoms and ankle-brachial indices (ABI) groups on outcomes. METHODS: Black participants in the Jackson Heart Study with baseline ABI and PAD symptom assessments (exertional leg pain by the San Diego Claudication questionnaire) were included. Abnormal ABI was < 0.90 or > 1.40. Participants were divided into (1) normal ABI, asymptomatic, (2) normal ABI, symptomatic, (3) abnormal ABI, asymptomatic, and (4) abnormal ABI, symptomatic to examine their associations with MACE (stroke, myocardial infarction, fatal coronary heart disease) and all-cause mortality, using Kaplan-Meier survival curves and stepwise Cox proportional hazard models adjusting for Framingham risk factors. RESULTS: Of 4586 participants, mean age was 54.6 ± 12.6 years, with 63% women. Compared with participants with normal ABI who were asymptomatic, participants with abnormal ABI and leg symptoms had highest risk of MACE (adjusted HR 2.28; 95% CI 1.62, 3.22) and mortality (aHR 1.82; 95% CI 1.32, 2.56). Participants with abnormal ABI without leg symptoms had higher risk for MACE (aHR 1.49; 95% CI 1.06, 2.11) and mortality (aHR 1.44; 95% CI 1.12, 1.99). Participants with normal ABI and no leg symptoms did not have higher risks. CONCLUSION: Among Black adults, the highest risk for adverse outcomes were in symptomatic participants with abnormal ABIs, followed by asymptomatic participants with abnormal ABIs. These findings underscore the need for further studies to screen for PAD and develop preventative approaches in Black adults with asymptomatic disease.

Comparison of lower extremity bypass and peripheral vascular intervention for chronic limb-threatening ischemia in the Medicare-linked Vascular Quality Initiative.

OBJECTIVE: There is a relative lack of comparative effectiveness research on revascularization for patients with chronic limb-threatening ischemia (CLTI). We examined the association between lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) for CLTI and 30-day and 5-year all-cause mortality and 30-day and 5-year amputation. METHODS: Patients undergoing LEB and PVI of the below-the-knee popliteal and infrapopliteal arteries between 2014 and 2019 were queried from the Vascular Quality Initiative, and outcomes data were obtained from the Medicare claims-linked Vascular Implant Surveillance and Interventional Outcomes Network database. Propensity scores were calculated on 15 variables using a logistic regression model to control for imbalances between treatment groups. A 1:1 matching method was used. Kaplan-Meier survival curves and hierarchical Cox proportional hazards regression with a random intercept for site and operator nested in site to account for clustered data compared 30-day and 5-year all-cause mortality between groups. Thirty-day and 5-year amputation were subsequently compared using competing risk analysis to account for the competing risk of death. RESULTS: There was a total of 2075 patients in each group. The overall mean age was 71 ± 11 years, 69% were male, and 76% were white, 18% were black, and 6% were of Hispanic ethnicity. Baseline clinical and demographic characteristics in the matched cohort were balanced between groups. There was no association between all-cause mortality over 30 days and LEB vs PVI (cumulative incidence, 2.3% vs 2.3% by Kaplan Meier; log-rank P-value = .906; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.62-1.44; P-value = .80). All-cause mortality over 5 years was lower for LEB vs PVI (cumulative incidence, 55.9% vs 60.1% by Kaplan Meier; log-rank P-value < .001; HR, 0.77; 95% CI, 0.70-0.86; P-value < .001). Accounting for competing risk of death, amputation over 30 days was also lower in LEB vs PVI (cumulative incidence function, 1.9% vs 3.0%; Fine and Gray P-value = .025; subHR, 0.63; 95% CI, 0.42-0.95; P-value = .025). There was no association between amputation over 5 years and LEB vs PVI (cumulative incidence function, 22.6% vs 23.4%; Fine and Gray P-value = .184; subHR, 0.91; 95% CI, 0.79-1.05; P-value = .184). CONCLUSIONS: In the Vascular Quality Initiative-linked Medicare registry, LEB vs PVI for CLTI was associated with a lower risk of 30-day amputation and 5-year all-cause mortality. These results will serve as a foundation to validate recently published randomized controlled trial data, and to broaden the comparative effectiveness evidence base for CLTI.

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.

Community distress and risk of adverse outcomes after peripheral vascular intervention.

INTRODUCTION: Community distress is associated with adverse outcomes in patients with cardiovascular disease; however, its impact on clinical outcomes after peripheral vascular intervention (PVI) is uncertain. The Distressed Communities Index (DCI) is a composite measure of community distress measured at the zip code level. We evaluated the association between community distress, as measured by the DCI, and 24-month mortality and major amputation after PVI. METHODS: We used the Vascular Quality Initiative database, linked with Medicare claims data, to identify patients who underwent initial femoropopliteal PVI between 2017 and 2018. DCI scores were assigned using patient-level zip code data. The primary outcomes were 24-month mortality and major amputation. We used time-dependent receiver operating characteristic curve analysis to determine an optimal DCI value to stratify patients into risk categories for 24-month mortality and major amputation. Mixed Cox regression models were constructed to estimate the association of DCI with 24-month mortality and major amputation. RESULTS: The final cohort consisted of 16,864 patients, of whom 4734 (28.1%) were classified as having high community distress (DCI ≥70). At 24 months, mortality was elevated in patients with high community distress (30.7% vs 29.5%, P = .02), as was major amputation (17.2% vs 13.1%, P <.001). After adjusting for demographic and clinical characteristics, a 10-point higher DCI score was associated with increased risk of mortality (hazard ratio: 1.01; 95% confidence interval: 1.00-1.03) and major amputation (hazard ratio: 1.02; 95% confidence interval: 1.00-1.04). CONCLUSIONS: High community distress is associated with increased risk of mortality and major amputation after PVI.

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.

A new cure model that corrects for increased risk of non-cancer death: analysis of reliability and robustness, and application to real-life data.

BACKGROUND: Non-cancer mortality in cancer patients may be higher than overall mortality in the general population due to a combination of factors, such as long-term adverse effects of treatments, and genetic, environmental or lifestyle-related factors. If so, conventional indicators may underestimate net survival and cure fraction. Our aim was to propose and evaluate a mixture cure survival model that takes into account the increased risk of non-cancer death for cancer patients. METHODS: We assessed the performance of a corrected mixture cure survival model derived from a conventional mixture cure model to estimate the cure fraction, the survival of uncured patients, and the increased risk of non-cancer death in two settings of net survival estimation, grouped life-table data and individual patients' data. We measured the model's performance in terms of bias, standard deviation of the estimates and coverage rate, using an extensive simulation study. This study included reliability assessments through violation of some of the model's assumptions. We also applied the models to colon cancer data from the FRANCIM network. RESULTS: When the assumptions were satisfied, the corrected cure model provided unbiased estimates of parameters expressing the increased risk of non-cancer death, the cure fraction, and net survival in uncured patients. No major difference was found when the model was applied to individual or grouped data. The absolute bias was < 1% for all parameters, while coverage ranged from 89 to 97%. When some of the assumptions were violated, parameter estimates appeared more robust when obtained from grouped than from individual data. As expected, the uncorrected cure model performed poorly and underestimated net survival and cure fractions in the simulation study. When applied to colon cancer real-life data, cure fractions estimated using the proposed model were higher than those in the conventional model, e.g. 5% higher in males at age 60 (57% vs. 52%). CONCLUSIONS: The present analysis supports the use of the corrected mixture cure model, with the inclusion of increased risk of non-cancer death for cancer patients to provide better estimates of indicators based on cancer survival. These are important to public health decision-making; they improve patients' awareness and facilitate their return to normal life.

Guideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions.

BACKGROUND: Lack of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) may increase mortality and amputation risk. OBJECTIVES: The authors sought to study the association between GDMT and mortality/amputation and to examine GDMT variability among providers and health systems. METHODS: We performed an observational study using patients in the Vascular Quality Initiative registry undergoing PVI between 2017 and 2018. Two-year all-cause mortality and major amputation data were derived from Medicare claims data. Compliance with GDMT was defined as receiving a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker if hypertensive. Propensity 1:1 matching was applied for GDMT vs no GDMT and survival analyses were performed to compare outcomes between groups. RESULTS: Of 15,891 patients undergoing PVIs, 48.8% received GDMT and 6,120 patients in each group were matched. Median follow-up was 9.6 (IQR: 4.5-16.2) months for mortality and 8.4 (IQR: 3.5-15.4) for amputation. Mean age was 72.0 ± 9.9 years. Mortality risk was higher among patients who did not receive GDMT versus those on GDMT (31.2% vs 24.5%; HR: 1.37, 95% CI: 1.25-1.50; P < 0.001), as well as, risk of amputation (16.0% vs 13.2%; HR: 1.20; 95% CI: 1.08-1.35; P < 0.001). GDMT rates across sites and providers ranging from 0% to 100%, with lower performance translating into higher risk. CONCLUSIONS: Almost one-half of the patients receiving PVI in this national quality registry were not on GDMT, and this was associated with increased risk of mortality and major amputation. Quality improvement efforts in vascular care should focus on GDMT in patients undergoing PVI.