Variability in short-term mortality following repair of ruptured abdominal aortic aneurysms across centers and physicians.

BACKGROUND: Variation in the care management of repairs for ruptured infrarenal abdominal aortic aneurysms between centers and physicians, such as procedural volumes, may explain differences in mortality outcomes. First, we quantified the center and physician variability associated with 30- and 90-day mortality risk after ruptured open surgical repair (rOSR) and ruptured endovascular aneurysm repair (rEVAR). Second, we explored wheter part of this variability was attributable to procedural volume at the center and physician levels. METHODS: Two cohorts including rOSR and rEVAR procedures between 2013 and 2019 were analyzed from the Vascular Quality Initiative database. Thirty- and 90-day all-cause mortality rates were derived from linked Medicare claims data. The median odds ratio (MOR) (median mortality risk from low- to high-risk cluster) and intraclass correlation coefficient (ICC) (variability attributable to each cluster) for 30- and 90-day mortality risks associated with center and physician variability were derived using patient-level adjusted multilevel logistic regression models. Procedural volume was calculated at the center and physician levels and stratified by quartiles. The models were sequentially adjusted for volumes, and the difference in ICCs (without vs with accounting for volume) was calculated to describe the center and physician variability in mortality risk attributable to volumes. RESULTS: We included 450 rOSRs (mean age, 74.5 ± 7.6 years; 23.5% female) and 752 rEVARs (76.4 ± 8.4 years; 26.1% female). After rOSRs, the 30- and 90-day mortality rates were 32.9% and 38.7%, respectively. No variability across centers and physicians was noted (30- and 90-day MORs ≈1 and ICCs ≈0%). Neither center nor physician volume was associated with 30-day (P = .477 and P = .796) or 90-day mortality (P = .098 and P = .559). After rEVAR, the 30- and 90-day mortality rates were 21.3% and 25.5%, respectively. Significant center variability (30-day MOR, 1.82 [95% confidence interval (CI), 1.33-2.22]; ICC, 11% [95% CI, 2%-36%]; and 90-day MOR, 1.76 [95% CI, 1.37-2.09]; ICC, 10% [95% CI, 3%-30%]), but negligeable variability across physicians (30- and 90-day MORs ≈1 and ICCs ≈0%) were noted. Neither center nor physician volume were associated with 30-day (P = .076 and P = .336) or 90-day mortality risk (P = .066 and P = .584). The center variability attributable to procedural volumes was negligeable (difference in ICCs, 1% for 30-day mortality; 0% for 90-day mortality). CONCLUSIONS: Variability in practice from center to center was associated with short-term mortality outcomes in rEVAR, but not for rOSR. Physician variability was not associated with short-term mortality for rOSR or rEVAR. Annualized center and physician volumes did not significantly explain these associations. Further work is needed to identify center-level factors affecting the quality of care and outcomes for ruptured abdominal aortic aneurysms.

Clinician perspectives regarding CYP2C19 genotype testing in patients with critical limb ischemia: A Delphi approach.

OBJECTIVES: Antiplatelet therapy is an essential element in the management of patients with arterial vascular disease. In peripheral arterial disease (PAD), dual antiplatelet therapy (DAPT), primarily clopidogrel and aspirin, is routinely prescribed following intervention. There is sparse data regarding the need for DAPT, the appropriate duration, or the heterogeneity of treatment effects for antiplatelet regimens across patients, leading to potential uncertainty and heterogeneity around treatment practices. An example of heterogeneity of treatment effects is a patients' metabolizer status for the use of clopidogrel. The aim of the study was to (1) assess clinicians' knowledge of and attitudes toward managing patients with CYP2C19 mutations, (2) identify barriers to implementation of CYP2C19 testing and management policies, and (3) reach consensus for CYP2C19 testing and management strategies for patients with PAD who undergo peripheral vascular interventions (PVI). METHODS: A modified Delphi method was used to establish consensus amongst PAD interventionalists around CYP2C19 testing. All practicing Yale New Haven Hospital PAD interventionalists with backgrounds in interventional cardiology, vascular surgery, or interventional radiology were approached by email for participation. Round 1 included the collection of baseline demographic questions, knowledge questions, and three statements for consensus. Knowledge questions were rated on a 0-10 Likert scale with the following anchors: 0 ("Not at all"), 5 ("Neutral), and 10 ("Very Much"). Participants were asked to rate the importance of the three consensus statements on a 9-point Likert scale from 1 ("Strongly Disagree") to 10 ("Strongly Agree"). In Round 2, participants were shown the same consensus statements, the median response of the group from the previous round, and their previous answers. Participants were instructed to revise their rating using the results from the previous round. This process was repeated for Round 3. RESULTS: Of the 28 experts invited to participate, 13 agreed (46%). Participants were predominantly male (92.3%) and white (61.5%) with representation from interventional cardiology (46.2%) and vascular surgery (53.8%). Most participants reported more than 10+ years in practice (61.5%). PAD interventionalists felt they would benefit from more education regarding CYP2C19 mutations (median score 8.0, interquartile range 5.0-8.5). They indicated some familiarity with CYP2C19 mutations (7.0, 6.0-9.5) but did not feel strongly that CYP2C19 was important to their practice (6.0, 5.5-7.5). In each round, the median responses for the three consensus statements were 5, 6, and 9, respectively. With each successive round the interquartile range narrowed indicative of evolving consensus but did not reach the prespecified interquartile range for consensus of 1 for any of the statements. CONCLUSIONS: PAD interventionalists practicing at an academic health system recognize the heterogenous response of their patients to clopidogrel therapy but are unsure when to leverage genetic testing to improve outcomes for their patients. Our study identified gaps regarding PAD interventionalists' knowledge, perceived barriers, and attitudes toward CYP2C19 testing in PAD. This information highlights the need for randomized data on genetic testing for clopidogrel responsiveness in peripheral vascular disease following intervention to help guide antiplatelet management.

Comparison of mortality and amputation after lower extremity bypass versus 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 are 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 who underwent 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, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .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 < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: 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.

Successful percutaneous management of hypothenar hammer syndrome with thrombosuction and catheter-directed intra-arterial thrombolysis.

Hypothenar hammer syndrome (HHS) is a rare vascular disorder leading to ulnar artery thrombosis or aneurysm and causing acute or chronic limb ischemia. The optimal approaches to managing this condition lack a definitive consensus and are essentially empirical, typically necessitating conservative methods for symptomatic relief, with surgical intervention reserved for cases for which conservative measures prove inadequate or when acute limb ischemia ensues. Limited data are available on percutaneous management for this condition. We present the case of a 36-year-old male powerlifter who developed acute digital ischemia due to HHS in the left hand that was managed successfully through an innovative approach using antegrade left brachial artery access and combining percutaneous thrombosuction and intra-arterial thrombolysis. This comprehensive approach resulted in restoration of blood flow and resolution of acute limb ischemia. The patient was subsequently prescribed short-term anticoagulation therapy and remained symptom free at 3 months of follow-up. This innovative strategy challenges traditional surgical approaches in HHS management, underscoring the importance of using minimally invasive techniques as a promising alternative and highlighting potential avenues for further research.

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.

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.

Association Between Mental Health Burden, Clinical Presentation, and Outcomes in Individuals With Symptomatic Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Along with the rising burden of peripheral artery disease (PAD), mental health concerns are increasingly being recognized as a comorbidity to address in the chronic disease management of symptomatic PAD. Apart from a high prevalence of comorbid mental health conditions, the role of pain and changing health behaviors and the broader impacts of illness and adaptation to living with PAD require specialized behavioral health expertise. This scientific statement builds a case that this expertise should be integrated within the multidisciplinary PAD team. Furthermore, areas such as cognitive dysfunction and palliative care are highlighted as needing psychological interventions. Although much of the evidence of the efficacy of psychological and psychotropic interventions has been extrapolated from other cardiovascular populations, evidence for the role of psychological interventions for behavior change, for example, uptake of exercise regimens, is increasingly being accrued within PAD. Areas for behavioral health needs and interactions with PAD treatment are discussed, including the use of opioids, depression management, anxiety and stress reduction interventions, the use of benzodiazepines and antidepressants, smoking cessation, rehabilitation trajectories after amputation, and the role of cognitive decline for PAD treatment and outcomes. A case summary highlights the stigma around mental health and vascular disease and the fragmentation of care. This scientific statement provides remarks for building a road map for integrated behavioral PAD care and potential solutions to overcome these barriers. Instrumental to reaching these changes are interprofessional advocacy efforts and initiatives that help break down the stigma around mental health and promote evidence-based collaborative, nonhierarchical, and multidisciplinary PAD care.

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).

Predictors of Revascularization in Lower-Extremity Peripheral Artery Disease: Insights From the PORTRAIT Study.

BACKGROUND: Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown. AIM: We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms. METHODS: Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR). RESULTS: Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57. CONCLUSIONS: About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization. CLINICAL IMPACT: Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

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.

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.

Real-world abdominal aorta aneurysm screening patterns among patients with new or worsening of symptomatic peripheral artery disease.

BACKGROUND: Patients with peripheral artery disease (PAD) have an increased risk of abdominal aortic aneurysms (AAA), but it remains unclear whether practitioners are screening patients for AAA as part of routine PAD management. METHODS: The Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease (PORTRAIT) Registry is an international prospective registry of patients with new or worsening PAD symptoms presenting to 16 specialty centers in the United States, Netherlands, and Australia, from June 2011 to December 2015. Patients were stratified by AAA screening or AAA positivity. An adjusted median odds ratio was calculated for AAA screening rates across sites. RESULTS: Of the 1275 patients in the study, 871 (68%) were screened for AAA, with 53 (6.1%) having AAA. AAA screening rates did not differ significantly by country (p = 0.36), but there was a large variation across sites for documentation of AAA screening with an adjusted median odds ratio 12.0 (95% CI 4.7-93.1), with AAA screening rates ranging from 7% to 100% across vascular specialty centers. CONCLUSIONS: Among patients with PAD in a multicenter registry, over two-thirds were screened for AAA, with 6% having documented aneurysms. A large variation was seen across clinical sites, suggesting efforts are needed to increase awareness for guideline implementation and establish new benefit-risk evidence inclusive of high-risk populations such as patients with PAD.

Variability in Antithrombotic Therapy after Infrainguinal Lower Extremity Bypass.

BACKGROUND: Antiplatelet monotherapy is recommended after infrainguinal lower extremity bypass (LEB). However, there is a paucity of high-quality data to guide therapy, and antiplatelet therapy is often prescribed in combination with anticoagulation. We therefore aimed to assess the variability in the use of antithrombotic therapy after infrainguinal LEB. METHODS: The Vascular Quality Initiative dataset (2015-2021) was retrospectively reviewed to determine discharge patterns of antithrombotic therapy for all patients undergoing infrainguinal LEB. Monotherapy on discharge was defined as either single antiplatelet therapy (SAPT) or single anticoagulant (SAC). Combination therapy was dual antiplatelet therapy (DAPT), anticoagulant + antiplatelet (ACAP), or triple therapy. Hierarchical multivariable logistic regression with random effects for physician and center was used to identify predictors of combination therapy. Median odds ratios (MOR) were derived to quantify degree of variability in antithrombotic therapy. RESULTS: There were 29,507 patients undergoing infrainguinal LEB (monotherapy = 10,634 vs. combination therapy = 18,873). SAPT (90.6%) was the most common form of monotherapy, while DAPT (57.7%) and ACAP (34.6%) were the most common combination therapies. Patients undergoing LEB to popliteal targets were more likely to be prescribed monotherapy (SAC or SAPT) than to infra-popliteal targets (60.6% vs. 56.6%, P < 0.001). Combination therapy (DAPT, ACAP, or triple therapy) was more often used in patients with tibial or plantar arteries as the bypass target. Patients undergoing bypass using autogenous vein were more likely to receive monotherapy compared with those receiving other conduits (64.8% vs. 52.9%, P < 0.001), while patients with prosthetic grafts were more likely to receive combination therapy (37.9% vs. 28.2%, P < 0.001). There were no significant differences in postoperative bleeding (P = 0.491) or 30-day mortality (P = 0.302) between the two groups. Prior peripheral vascular interventions (PVI) (odds ratio [OR]: 1.89, 95% confidence interval [CI]: 1.79-1.99), concomitant PVI (OR: 1.83, 95% CI: 1.66-2.02), prosthetic graft use (OR: 1.74, 95% CI: 1.64-1.85), prior percutaneous coronary intervention (OR: 1.53, 95% CI: 1.43-1.65), plantar distal target (OR: 1.46, 95% CI: 1.29-1.65), alternative conduits (OR: 1.39, 95% CI: 1.25-1.53), and tibial distal targets (OR: 1.36, 95% CI: 1.28-1.44) were independent predictors of combination therapy in a multivariable regression model. Upon adjusting for patient-level factors, there was significant physician-level (MOR: 1.65, 95% CI 1.61-1.67) and center-level (MOR: 1.64, 95% CI 1.57-1.69) variability in the selection of antithrombotic therapy. CONCLUSIONS: Significant physician- and center-level variability in the use of antithrombotic regimens after infrainguinal bypass reflects the paucity of available evidence to guide therapy. Pragmatic trials are needed to assess antithrombotic strategies and guide recommendations aimed at optimizing cardiovascular and graft-specific outcomes after LEB.

Risk profiles, access to care, and outcomes in Hispanics hospitalized for lower extremity peripheral artery disease.

OBJECTIVE: Previous studies have shown that Hispanics have worse clinical outcomes for lower extremity peripheral artery disease (PAD) than non-Hispanic White (NHWs). Using a national database, this study aimed to document the contemporary burden of PAD in Hispanics by evaluating their risk profiles, access to care, and outcomes compared with NHWs. METHODS: Hospitalizations of Hispanics and NHWs with a primary diagnosis of PAD were identified using 2011-2017 National Inpatient Sample data. Patient sociodemographic characteristics, comorbidities, whether the admission was through the emergency department (ED) or elective, length of stay, and costs accrued were compared by ethnicity. Temporal trends in revascularizations, amputations, and ED admissions by year were evaluated with the Cochran-Mantel-Haenszel test and stratified by ethnicity. Data were combined across years and multivariable logistic regression was used to evaluate the association of ethnicity with inpatient revascularization, amputation, and mortality, adjusting for sociodemographic and cardiovascular risk factors. RESULTS: From 2011 to 2017, there were a total of 1,018,220 PAD hospitalizations among Hispanics (13.9%) and NHWs (86.1%) between 2011 and 2017. Hispanics were more often low income and uninsured and presented with higher burden of comorbidities including diabetes, renal failure, prior amputations, and chronic limb-threatening ischemia compared with NHWs. Most Hispanics were admitted via the ED compared with NHWs (58.0% vs 36.7%; d = 0.48), and median length of stay was almost a day longer (4.5 days vs 3.7 days). Hispanic ethnicity was associated with lower odds of surgical (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.57-0.67) and endovascular revascularization (OR, 0.94; 95% CI, 0.89-0.996) and mortality (OR, 0.83; 95% CI, 0.75-0.93), but higher odds of minor (OR, 1.25; 95% CI, 1.20-1.31) and major (OR, 1.08; 95% CI, 1.03-1.14) amputation. CONCLUSIONS: Two tiers of health care consumption for inpatient PAD care and outcomes manifested among Hispanics and NHWs. First, Hispanics with PAD had a more vulnerable socioeconomic profile and presented with more severe PAD than NHWs. Second, they sought care more disproportionately through the ED and underwent more amputations than NHWs. To eradicate these inequities in PAD care and risk, strategies that improve access to outpatient care and expand health care coverage, as well as targeted management of risk factors in these vulnerable minority groups are needed.

Association of depression and anxiety disorders with outcomes after revascularization in chronic limb-threatening ischemia hospitalizations nationwide.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI), the end stage of peripheral artery disease, often present with comorbid depression and anxiety disorders. The prevalence of these comorbidities in the inpatient context over time, and their association with outcomes after revascularization and resource usage is unknown. METHODS: Using the 2011 to 2017 National Inpatient Sample, two cohorts were created-CLTI hospitalizations with endovascular revascularization and CLTI hospitalizations with surgical revascularization. Within each cohort, the annual prevalence of depression and anxiety disorder diagnoses was determined, and temporal trends were evaluated using the Cochran-Mantel-Haenszel test. Hierarchical multivariable logistic and linear regression analyses were used to examine the association of depression and anxiety disorder diagnoses with inpatient major amputation, mortality, length of stay (LOS), and cost, adjusting for illness severity, comorbidities, and potential bias in the documentation of depression and anxiety disorder diagnoses stratified by patient sociodemographic data. RESULTS: Across the study period were a total of 245,507 CLTI-related hospitalizations with endovascular revascularization and 138,922 with surgical revascularization. Hospitalizations with a depression or anxiety disorder diagnosis increased from 10.8% in 2011 to 15.3% in 2017 in the endovascular revascularization cohort and from 11.7% in 2011 to 14.4% in 2017 in the surgical revascularization cohort (Ptrend < .001). In the endovascular revascularization cohort, depression was associated with higher odds of major amputation (odds ratio, 1.15; 95% confidence interval, 1.03-1.30). In addition, depression (9 vs 8 days [P < .001]; $105,754 vs $102,481 [P = .018]) and anxiety disorder (9 vs 8 days [P < .001]; $109,496 vs $102,324 [P < .001]) diagnoses were associated with a longer median LOS and higher median costs. In the surgical revascularization cohort, depression was associated with a higher odds of major amputation (odds ratio, 1.33; 95% confidence interval, 1.13-1.58) and a longer LOS (median, 9 vs 9 days; P = .004). CONCLUSIONS: Depression and anxiety disorder diagnoses have become increasingly prevalent among CLTI hospitalizations including revascularizations. When present, these psychiatric comorbidities are associated with an increased risk of amputation and greater resource usage.

Derivation and validation of a predictive model for chronic stress in patients with cardiovascular disease.

BACKGROUND: Chronic stress in patients with cardiovascular disease (CVD), including peripheral artery disease (PAD), is independently associated worse outcomes. A model that can reliably identify factors associated with risk of chronic stress in patients with CVD is needed. METHODS: In a prospective myocardial infarction (MI) registry (TRIUMPH), we constructed a logistic regression model using 27 patient demographic, socioeconomic, and clinical factors, adjusting for site, to identify predictors of chronic stress over 1 year. Stress at baseline and at 1-, 6- and 12-month follow-up was measured using the 4-item Perceived Stress Scale (PSS-4) [range 0-16, scores ≥6 depicting high stress]. Chronic stress was defined as at least 2 follow-up PSS-4 scores ≥6. We identified and validated this final model in another prospective registry of patients with symptomatic PAD, the PORTRAIT study. RESULTS: Our derivation cohort consisted of 4,340 patients with MI (mean age 59.1 ± 12.3 years, 33% females, 30% non-white), of whom 30% had chronic stress at follow-up. Of the 27 factors examined, female sex, current smoking, socioeconomic status, and economic burden due to medical care were positively associated with chronic stress, and ENRICHD Social Support Instrument (ESSI) score and age were inversely related to chronic stress. In the validation cohort of 797 PAD patients (mean age 68.6±9.7 years, 42% females, 28% non-white, 18% chronic stress) the c-statistic for the model was 0.77 and calibration was excellent. CONCLUSIONS: We can reliably identify factors that are independently associated with risk of chronic stress in patients with CVD. As chronic stress is associated with worse outcomes in this population, our work identifies potential targets for interventions to as well as the patients that could benefit from these.

Patient-level and external factors in the use of drug-coated balloons and drug-eluting stents in femoropopliteal endovascular interventions.

OBJECTIVE: Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset. METHODS: All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR). RESULTS: A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27). CONCLUSIONS: DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors.