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Introduction: Peripheral artery disease (PAD) is a well-described risk factor for mortality, but few studies have examined secular trends in mortality over time for patients with PAD. We characterized trends in mortality in patients with PAD in recent years among Medicare patients., Methods: We used Medicare claims to identify patients with a new diagnosis code for PAD between January 1, 2006 and December 31, 2018 using International Classification of Diseases (ICD) diagnosis codes. The primary outcome of interest was the 1-year all-cause age-adjusted mortality rate. Our secondary outcome was the 5-year all-cause mortality rate. Multivariable regression was used to identify factors which predict mortality at 1 year., Results: We identified 4,373,644 patients with a new diagnosis code for PAD during the study period. Between 2006 and 2018, 1-year all-cause age-adjusted mortality declined from 12.6% to 9.9% ( p < 0.001). One-year crude all-cause mortality also declined from 14.6% to 9.5% ( p < 0.001). Similar results were observed for 5-year age-adjusted mortality rates (40.9% to 35.2%, p < 0.001). Factors associated with increased risk of death at 1 year included age ⩾ 85 years (hazard ratio [HR] 3.030; 95% CI 3.008-3.053) and congestive heart failure (HR 1.86; 95% CI 1.85-1.88). Patients who were regularly dispensed statins, ace-inhibitors, beta-blockers, antithrombotic agents, and anticoagulants all had lower mortality (range OR 0.36; CI 0.35-0.37 for statins to OR 0.60; CI 0.59-0.61 for anticoagulants; all p < 0.001)., Conclusion: Among US Medicare patients diagnosed with PAD between 2006 and 2019, 1-year age-adjusted mortality declined by 2.7%. This decline in mortality among patients with PAD occurred in the context of a younger mean age of diagnosis of PAD and improved cardiovascular prevention therapy., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Marc P Bonaca reports grant support to Brigham and Women’s Hospital (BWH) from AstraZeneca, Amgen, Daiichi Sankyo, and Merck and grant support to Colorado Prevention Center Clinical Research from AstraZeneca, Amgen, and Sanofi. Mary M McDermott has received grant funding from Helixmith and research support from Helixmith, ChromaDex, Mars, Inc., ArtAssist, and Reserveage. The remaining authors have no conflicts of interest.

Objective: Prior studies have described risk factors associated with amputation in patients with concomitant diabetes and peripheral arterial disease (DM/PAD). However, the association between the severity and extent of tissue loss type and amputation risk remains less well-described. We aimed to quantify the role of different tissue loss types in amputation risk among patients with DM/PAD, in the context of demographic, preventive, and socioeconomic factors., Methods: Applying International Classification of Diseases (ICD)-9 and ICD-10 codes to Medicare claims data (2007-2019), we identified all patients with continuous fee-for-service Medicare coverage diagnosed with DM/PAD. Eight tissue loss categories were established using ICD-9 and ICD-10 diagnosis codes, ranging from lymphadenitis (least severe) to gangrene (most severe). We created a Cox proportional hazards model to quantify associations between tissue loss type and 1- and 5-year amputation risk, adjusting for age, race/ethnicity, sex, rurality, income, comorbidities, and preventive factors. Regional variation in DM/PAD rates and risk-adjusted amputation rates was examined at the hospital referral region level., Results: We identified 12,257,174 patients with DM/PAD (48% male, 76% White, 10% prior myocardial infarction, 30% chronic kidney disease). Although 2.2 million patients (18%) had some form of tissue loss, 10.0 million patients (82%) did not. The 1-year crude amputation rate (major and minor) was 6.4% in patients with tissue loss, and 0.4% in patients without tissue loss. Among patients with tissue loss, the 1-year any amputation rate varied from 0.89% for patients with lymphadenitis to 26% for patients with gangrene. The 1-year amputation risk varied from two-fold for patients with lymphadenitis (adjusted hazard ratio, 1.96; 95% confidence interval, 1.43-2.69) to 29-fold for patients with gangrene (adjusted hazard ratio, 28.7; 95% confidence interval, 28.1-29.3), compared with patients without tissue loss. No other demographic variable including age, sex, race, or region incurred a hazard ratio for 1- or 5-year amputation risk higher than the least severe tissue loss category. Results were similar across minor and major amputation, and 1- and 5-year amputation outcomes. At a regional level, higher DM/PAD rates were inversely correlated with risk-adjusted 5-year amputation rates (R 2  = 0.43)., Conclusions: Among 12 million patients with DM/PAD, the most significant predictor of amputation was the presence and extent of tissue loss, with an association greater in effect size than any other factor studied. Tissue loss could be used in awareness campaigns as a simple marker of high-risk patients. Patients with any type of tissue loss require expedited wound care, revascularization as appropriate, and infection management to avoid amputation. Establishing systems of care to provide these interventions in regions with high amputation rates may prove beneficial for these populations., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques., Methods: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant., Results: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year)., Conclusions: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique., Competing Interests: Disclosures H.A. is a 2022-2024 trainee in the Society for Vascular Surgery Patient Safety Organization Quality Fellowship in Training (FIT) program. J.M. effort is supported by NHLBI career development award K01HL159315., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME ( n = 25) versus those who were in states that did not ( n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality ( p = 0.15) or amputation ( p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Aim: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia)., Methods: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate., Structure: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed., (Copyright © 2024 American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Funding Support and Author Disclosures The VISION registry was supported by a Food and Drug Administration grant (U01FD006936 [to Dr Goodney]). Drs Smolderen and Mena are supported by National Institutes of Health grants 1R21AT012430-01 and 1R01HL163640-01A1. Dr Goodney is supported by a research grant from the American Heart Association (SRFN #18SFRN33900147). Dr Smolderen has received unrestricted research grants from Philips, Abbott, Merck, and Johnson & Johnson; and has served as a consultant for Optum Labs and Abbott, Happify, and Haemonetics. Dr Mena-Hurtado has served as a consultant for Abbott Vascular, Cook, Medtronic, Cardinal Health, and Optum Labs. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI)., Methods and Results: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively., Conclusions: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

Disparities by sex, race, socioeconomic status, and geography exist in diagnosis, treatment, and outcomes for people with lower extremity peripheral artery disease (PAD). PAD prevalence is similar in men and women, but women have more atypical symptoms and undergo lower extremity revascularization at older ages compared to men. People who are Black have an approximately 2-fold higher prevalence of PAD, compared to people who are White and have more atypical symptoms, greater mobility loss, less optimal medical care, and higher amputation rates. Although fewer data are available for other races, people with PAD who are Hispanic have higher amputation rates than White people. Rates of amputation also vary by geography in the United States, with the highest rates of amputation in the southeastern United States. To improve PAD outcomes, intentional actions to eliminate disparities are necessary, including clinician education, patient education with culturally appropriate messaging, improved access to high-quality health care, science focused on disparity elimination, and health policy changes., Competing Interests: Funding Support and Author Disclosures Dr McDermott has received grant funding from Helixmith; and has received other research support from ArtAssist, Chromadex, ReserveAge, Mars, and Helixmith. Dr Hamburg has received honoraria from Novo Nordisk and Boston Scientific. Dr Pollak is a member of the Janssen Health Equity advisory group (unpaid). Dr Bonaca is the executive director of CPC, a nonprofit academic research organization affiliated with the University of Colorado, that receives or has received research grant and consulting funding between February 2021 and the present from Abbott Laboratories, Adamis Pharmaceuticals, Agios Pharmaceuticals, Alexion Pharma, Alnylam Pharmaceuticals, Amgen, Angionetics, ARCA Biopharma, Array BioPharma, AstraZeneca and Affiliates, Atentiv, Audentes Therapeutics, Bayer and Affiliates, Beth Israel Deaconess Medical Center, Better Therapeutics, Boston Clinical Research Institute, Bristol Myers Squibb, Cambrian Biopharma, Cardiol Therapeutics, CellResearch, Cook Medical, Covance, CSL Behring, Eidos Therapeutics, EP Trading, EPG Communication Holdings, Epizon Pharma, Esperion Therapeutics, Everly Well, Exicon Consulting, Faraday Pharmaceuticals, Foresee Pharmaceuticals, Fortress Biotech, HDL Therapeutics, HeartFlow, Hummingbird Bioscience, Insmed, Ionis Pharmaceuticals, IQVIA, JanOne Biotech Holdings, Janssen and Affiliates, Kaneka, Kowa Research Institute, Kyushu University, Lexicon Pharmaceuticals, LSG Kyushu University, Medimmune, Medpace, Merck & Affiliates, Novartis Pharmaceuticals, Novate Medical, Novo Nordisk, Pan Industry Group, Pfizer, PhaseBio Pharmaceuticals, PPD Development, Prairie Education and Research Cooperative, Prothena Biosciences, Regeneron Pharmaceuticals, Regio Biosciences, Rexgenero, Sanifit Therapeutics, Sanofi, Silence Therapeutics, Smith & Nephew, Stealth BioTherapeutics, the State of Colorado CCPD Grant, Brigham & Women’s Hospital, the Feinstein Institutes for Medical Research, the Thrombosis Research Institute, the University of Colorado, the University of Pittsburgh, VarmX, Virta Health, WCT Atlas, Worldwide Clinical Trials, WraSer, and Yale Cardiovascular Research Group; has received support from the American Heart Association Strategically Focused Research Network under awards 18SFRN3390085 (BWH-DH SFRN Center) and 18SFRN33960262 (BWH-DH Clinical Project); has modest stock holdings in Medtronic and Pfizer; and has received consulting fees from Audentes. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated., Aims: The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stenting, atherectomy, and the combination of stent and atherectomy., Methods: A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) data set. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model., Results: Among the 46,108 included patients, 6896 (14.95%) underwent atherectomy alone, 35,774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stenting and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR = 1.35; 95% confidence interval [CI]:1.16-1.57), and not significantly different odds (OR = 0.93; 95% CI:0.77-1.13) in the combination stent and atherectomy group when compared to stenting alone. With regard to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR = 0.90; 95% CI:0.82-0.98) in the atherectomy group, and not significantly different (HR = 0.92; 95% CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group., Conclusions: Patients in the VQI data set who received combination stenting and atherectomy did not experience significantly different rates of MALE when compared with stenting alone. It is crucial to consider and further evaluate the influence of anatomical characteristics on treatment strategies and potential differential effects of comorbidities and other demographic factors on the short and long-term MALE risks., (© 2023 Wiley Periodicals LLC.)

Objective: To justify the up front risks of offering elective interventions for intermittent claudication (IC), patients should have reasonable life expectancy to derive durable clinical benefits. Open surgery for chronic limb threatening ischaemia (CLTI) is maximally beneficial in patients surviving ≥ 2 years. The aim was to assess long term survival after IC and CLTI interventions., Methods: In a retrospective cohort analysis, the Vascular Quality Initiative (VQI) registry from 1 January 2010 to 31 May 2021 was queried for peripheral vascular intervention (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for IC and CLTI across 286 US centres. VQI linkage to Medicare insurance claims provided five year survival data. Multivariable analysis identified factors associated with five year mortality., Results: There were 31 457 PVIs (44.7% IC, 55.3% CLTI), 7 978 IIBs (26.9% IC, 73.1% CLTI), and 2 149 SIBs (50.1% IC, 49.9% CLTI) recorded in the VQI. Among the PVI, IIB, and SIB cohorts, average ages were 75, 73, and 72 years, respectively. Respective five year mortality after PVI for IC and CLTI was 37.2% and 71.1%; after IIB for IC and CLTI it was 37.8% and 60%; and after SIB for IC and CLTI it was 33.8% and 53.8%. On multivariable analysis, across all procedures, end stage renal disease, CLTI, congestive heart failure, anaemia, chronic obstructive pulmonary disease, and prior amputation were independently associated with increased mortality. Pre-admission home living and pre-operative aspirin use were independently associated with decreased mortality., Conclusion: Long term survival in Medicare patients undergoing interventions in VQI centres for peripheral arterial disease is poor. Two thirds of CLTI patients and over one third of IC patients were not alive at five years. Intervening for IC in patients with high mortality risk should be avoided. For CLTI patients identified with decreased survival likelihood, intervention durability may be less important than invasiveness. Pre-operative medical optimisation should always be undertaken., (Copyright © 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Peripheral artery disease (PAD) affects 200 million individuals worldwide. In the United States, certain demographic groups experience a disproportionately higher prevalence and clinical effect of PAD. The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society. Herein, we present an overview statement of the myriad variables that contribute to PAD disparities and conclude with a summary of potential novel solutions.

Background: Previous studies demonstrate geographic and racial/ethnic variation in diagnosis and complications of diabetes and peripheral artery disease (PAD). However, recent trends for patients diagnosed with both PAD and diabetes are lacking. We assessed the period prevalence of concurrent diabetes and PAD across the United States from 2007 to 2019 and regional and racial/ethnic variation in amputations among Medicare patients., Methods: Using Medicare claims from 2007 to 2019, we identified patients with both diabetes and PAD. We calculated period prevalence of concomitant diabetes and PAD and incident cases of diabetes and PAD for every year. Patients were followed to identify amputations, and results were stratified by race/ethnicity and hospital referral region., Results: 9 410 785 patients with diabetes and PAD were identified (mean age, 72.8 [SD, 10.94] years; 58.6% women, 74.7% White, 13.2% Black, 7.3% Hispanic, 2.8% Asian/API, and 0.6% Native American). Period prevalence of diabetes and PAD was 23 per 1000 beneficiaries. We observed a 33% relative decrease in annual new diagnoses throughout the study. All racial/ethnic groups experienced a similar decline in new diagnoses. Black and Hispanic patients had on average a 50% greater rate of disease compared with White patients. One- and 5-year amputation rates remained stable at ≈1.5% and 3%, respectively. Native American, Black, and Hispanic patients were at greater risk of amputation compared with White patients at 1- and 5-year time points (5-year rate ratio range, 1.22-3.17). Across US regions, we observed differential amputation rates, with an inverse relationship between the prevalence of concomitant diabetes and PAD and overall amputation rates., Conclusions: Significant regional and racial/ethnic variation exists in the incidence of concomitant diabetes and PAD among Medicare patients. Black patients in areas with the lowest rates of PAD and diabetes are at disproportionally higher risk for amputation. Furthermore, areas with higher prevalence of PAD and diabetes have the lowest rates of amputation., Competing Interests: Disclosures None.

Patients with peripheral artery disease (PAD) and diabetes have the highest risk of critical limb ischemia (CLI) and amputation, yet the underlying mechanisms remain incompletely understood. MicroRNA (miRNA) sequencing of plasma from diabetic patients with or without CLI was compared to diabetic mice with acute or subacute limb ischemia to identify conserved miRNAs. miRNA-KO mice on high-fat diet were generated to explore the impact on CLI. Comparison of dysregulated miRNAs from diabetic individuals with PAD and diabetic mice with limb ischemia revealed conserved miR-181 family members. High-fat-fed, diabetic Mir181a2b2-KO mice had impaired revascularization in limbs due to abrogation of circulating Ly6Chi monocytes, with reduced accumulation in ischemic skeletal muscles. M2-like KO macrophages under diabetic conditions failed to produce proangiogenic cytokines. Single-cell transcriptomics of the bone marrow niche revealed that the reduced monocytosis in diabetic KO mice was a result of impaired hematopoiesis, with increased CXCR4 signaling in bone marrow Lineage-Sca1+Kit+ (LSK) cells. Exogenous Ly6Chi monocytes from nondiabetic KO mice rescued the impaired revascularization in ischemic limbs of diabetic KO mice. Increased Cxcr4 expression was mediated by the miR-181 target, Plac8. Taken together, our results show that MiR-181a/b is a putative mediator of diabetic CLI and contributes to changes in hematopoiesis, monocytosis, and macrophage polarization.

Dual-antiplatelet therapy is commonly prescribed after endovascular intervention for peripheral artery disease. However, it is not known whether therapeutic anticoagulation affects outcomes after peripheral endovascular intervention. We sought to investigate whether therapeutic anticoagulation after peripheral endovascular intervention is associated with lower risk of major adverse limb events (MALEs) and all-cause mortality. We studied patients who underwent index endovascular intervention for peripheral artery disease in the Vascular Study Group of New England (2010 to 2018). The main exposure was anticoagulation at the time of discharge. Outcomes included patency loss (occlusion or target lesion reintervention), MALE (any major amputation or reintervention), and all-cause mortality. We compared outcomes between patients who received anticoagulation on discharge versus those who did not receive anticoagulation using Kaplan-Meier survival analysis and Cox regression. In the cohort of 6,809 patients, 15% were discharged on an anticoagulant (mostly warfarin). These patients had a higher prevalence of acute or chronic limb ischemia than those not receiving an anticoagulant (74% vs 47%, p < 0.001) and were less likely to receive any antiplatelet agent after peripheral endovascular intervention (5% vs 14%, p < 0.001). After risk adjustment, compared with patients not on an anticoagulant, patients receiving therapeutic anticoagulation had a higher risk of 2-year patency loss (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.05 to 1.89), MALE (HR 1.39, 95% CI 1.09 to 1.76), and all-cause mortality (HR 1.24, 95% CI 1.05 to 1.47). In conclusion, anticoagulation after peripheral endovascular intervention was associated with higher risk of adverse events, including patency loss, MALE, and all-cause mortality., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Previous efforts to characterize the burden of peripheral artery disease (PAD) have focused on national populations. A need for a more detailed analysis of how PAD impacts the global population has been identified. Our objective was to study in greater detail the global burden of PAD, including its impact on mortality, over the past three decades., Methods: Using data and models from the Global Burden of Diseases, Injuries and Risk Factors Study, we estimated the prevalence, years of life lost, years lived with disability and disability-adjusted life-years (a measure accounting for incurred morbidity and mortality), attributable to PAD. We analyzed results over time and stratified by sex, age, and sociodemographic index (SDI) group. We compared PAD with other atherosclerosis-related conditions and assessed the contribution of risk factors to PAD disability-adjusted life-years., Results: We observed a 72% increase in the global prevalence of PAD from an estimated 65,764,499 persons in 1990 to 113,443,016 in 2019. Prevalence per 100,000 persons increased 13% and the prevalence per 100,000 age-standardized decreased 22%. Similar patterns were seen for years of live lost, mortality, years lived with disability, and disability-adjusted life-years. The prevalence and disability were higher among women, whereas mortality and years of life lost were higher among men. Disease burden increased with increasing SDI. These increases in PAD were in contrast with global trends for the overall burden of ischemic heart disease and ischemic stroke, which had decreasing prevalence and disease-related mortality over the same time frame. Overall, only approximately 55% of PAD disease burden could be attributed to identified risk factors, with tobacco use, diabetes, and hypertension being the three major contributors in all SDI groups., Conclusions: The global prevalence and mortality associated with PAD has increased substantially, in contrast with other forms of ischemic cardiovascular disease. Globally, there is a growing need for vascular surgical resources to manage PAD, as well as public health efforts to address risk factors for this increasing health threat., (Copyright © 2023. Published by Elsevier Inc.)

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., (© 2023 Wiley Periodicals LLC.)

Background: This study illustrates the use of logistic regression and machine learning methods, specifically random forest models, in health services research by analyzing outcomes for a cohort of patients with concomitant peripheral artery disease and diabetes mellitus., Methods: Cohort study using fee-for-service Medicare beneficiaries in 2015 who were newly diagnosed with peripheral artery disease and diabetes mellitus. Exposure variables include whether patients received preventive measures in the 6 months following their index date: HbA1c test, foot exam, or vascular imaging study. Outcomes include any reintervention, lower extremity amputation, and death. We fit both logistic regression models as well as random forest models., Results: There were 88,898 fee-for-service Medicare beneficiaries diagnosed with peripheral artery disease and diabetes mellitus in our cohort. The rate of preventative treatments in the first six months following diagnosis were 52% (n = 45,971) with foot exams, 43% (n = 38,393) had vascular imaging, and 50% (n = 44,181) had an HbA1c test. The directionality of the influence for all covariates considered matched those results found with the random forest and logistic regression models. The most predictive covariate in each approach differs as determined by the t-statistics from logistic regression and variable importance (VI) in the random forest model. For amputation we see age 85 + (t = 53.17) urban-residing (VI = 83.42), and for death (t = 65.84, VI = 88.76) and reintervention (t = 34.40, VI = 81.22) both models indicate age is most predictive., Conclusions: The use of random forest models to analyze data and provide predictions for patients holds great potential in identifying modifiable patient-level and health-system factors and cohorts for increased surveillance and intervention to improve outcomes for patients. Random forests are incredibly high performing models with difficult interpretation most ideally suited for times when accurate prediction is most desirable and can be used in tandem with more common approaches to provide a more thorough analysis of observational data., (© 2022. The Author(s).)

Peripheral artery disease (PAD) is chronic in nature, and individualized chronic disease management is a central focus of care. To accommodate this reality, tools to measure the impact and quality of the PAD care delivered are necessary. Patient-reported outcomes (PROs) and instruments to measure them, that is, PRO measures, have been well studied in the research and clinical trial context, but a shift toward integrating them into clinical practice has yet to take place. A framework to use PRO measures as indicators of the quality of PAD care delivered, that is, PRO performance measures (PRO-PMs), is provided in this scientific statement. Measurement goals to consider by PAD clinical phenotypes are provided, as well as an overview of potential benefits of adopting PRO-PMs in the clinical practice of PAD care, including reducing unwanted variability and promoting health equity. A central discussion with considerations for risk adjustment of PRO-PMs, individualized PAD care, and the need for patient engagement strategies is offered. Furthermore, necessary conditions in terms of required competencies and training to handle PRO-PM data are discussed because the interpretation and handling of these data come with great responsibility and consequences for designing care that adopts a broader framework of risk that goes beyond the inclusion of biomedical variables. To conclude, health system perspectives and an agenda to reach the next steps in the implementation of PRO-PMs in PAD care are offered.

Objective: First-line treatment of peripheral artery disease (PAD) involves medical therapy and lifestyle modification. Multiple professional organizations such as the Society for Vascular Surgery and the American Heart Association/American College of Cardiology make Class I recommendations for medical management including antiplatelet, statin, antihypertensive, and cilostazol medications, as well as lifestyle therapy including exercise and smoking cessation. Although evidence supports up-front medical and lifestyle management prior to surgical intervention, it is unclear how well this occurs in contemporary clinical practice. It is also unclear whether variability in first-line treatment prior to revascularization is associated with postoperative outcomes. This study examined the proportion of patients with claudication actively receiving evidence-based therapy prior to surgery in a statewide surgical registry., Methods: We conducted a retrospective cohort study of adult patients undergoing elective open lower extremity bypass for claudication from 2012 to 2021 within a statewide surgical quality registry. The primary exposure was optimal medical therapy, defined as an antiplatelet agent, a statin, and an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (if the patient had hypertension) on the patient's home medication list on admission for surgery, all of which are Class I recommendations. Despite also being Class I recommendations, cilostazol was not included in the primary exposure due to its highly selective use and our inability to capture intolerance and/or contraindications that are common, and lifestyle therapies were not included as they were only recorded at the time of discharge rather than preoperatively. The primary outcomes were mortality, hospital readmission, amputation, wound complication, myocardial infarction (MI), non-patent bypass, and non-independent ambulatory status at 30 days and 1 year after surgery. Multivariable logistic regression was performed to estimate the association of receiving optimal vs non-optimal medical therapy., Results: A total of 3829 patients with claudication underwent bypass surgery during the study period, with a mean age of 64.8 years (standard deviation, 9.8 years); 2690 (70.3%) were males, and 1873 (48.9%) were current smokers. Of the patients, 1822 (47.6%) were on optimal medical therapy prior to surgery. Additionally, at discharge, 66.5% of smokers received referral to smoking cessation therapy, and 54.1% of patients received referral to exercise therapy. In a multivariable logistic regression, compared with patients not on optimal medical therapy, patients on optimal medical therapy prior to surgery had lower 30-day odds of mortality (adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.26-0.78) and MI (aOR, 0.46; 95% CI, 0.28-0.76), lower 1-year odds of mortality (aOR, 0.57; 95% CI, 0.39-0.82), MI (aOR, 0.48; 95% CI, 0.32-0.74), and lower readmission (aOR, 0.79; 95% CI, 0.64-0.96)., Conclusions: Although medical and lifestyle management is recommended as first-line treatment for patients with PAD, only one-half of patients were on optimal medical therapy prior to surgery. Patients receiving optimal therapy had a lower risk of postoperative mortality, MI, and readmission. This suggests that not only are there significant opportunities to improve clinical utilization of evidence-based treatment of PAD, but that doing so can benefit patients postoperatively., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). Although typically characterized as major or minor on the extent of tissue loss, the etiologies and outcomes after amputation by extent are not well-understood. In addition, emerging data suggest that the drivers and outcomes of amputation in patients with PAD may differ in those with and without diabetes mellitus (DM)., Methods: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5345 with concomitant diabetes, to ticagrelor or clopidogrel and followed them for long-term outcomes. Amputations were prospectively reported by trial investigators. Their primary and contributing drivers were adjudicated using safety data, including infection, ischemia, or multifactorial etiologies. Outcomes following major and minor amputations were analyzed, including recurrent amputation, major adverse limb events, adverse cardiovascular events, and mortality. Multivariable logistic regression models were used to identify independent predictors of minor amputations. Analyses were performed overall and stratified by the presence or absence of DM at baseline., Results: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity nontraumatic amputation, for a total of 511 amputations (255 major and 256 minor) over a median of 30 months. A history of minor amputation was the strongest independent predictor for a subsequent minor amputation (odds ratio, 7.29; 95% confidence interval, 5.17-10.30; P < .001) followed by comorbid DM (odds ratio, 4.60; 95% confidence interval, 3.16-6.69; P < .001). Compared with patients who had a major amputation, those with a minor amputation had similar rates of subsequent major amputation (12.2% vs 13.6%), major adverse limb events (15.1% vs 14.9%), and major adverse cardiovascular events (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%), followed by infection alone (27%), and multifactorial etiologies (22%); however, infection was the most frequent driver in those with DM (58%) but not in those without DM (15%)., Conclusions: Outcomes after amputation remain poor regardless of whether they are categorized as major or minor. The pattern of amputation drivers in PAD differs by history of DM, with infection being the dominant etiology in those with DM and ischemia in those without DM. Greater focus is needed on the prognostic importance of minor amputation and of the multifactorial etiologies of amputation in PAD. Nomenclature with anatomical description of amputations and eliminating terms "major" or "minor" would seem appropriate., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Calls for minimum case thresholds to guide surgeon credentialing paradigms are increasing in contemporary practice. To date, the volume-outcome relationship and the role of surgeon experience as a proxy for quality have remained primarily focused on nonvascular extirpative surgery and aneurysm repair. However, it is unclear whether these data can be rightly extrapolated to predict lower extremity bypass (LEB) outcomes. Thus, the purpose of the present study was to examine whether the annualized case volume vs surgeon experience is more consequential in predicting for successful LEB reconstruction., Methods: A total of 25,852 procedures with sufficient 1-year follow-up data from the Society for Vascular Surgery Vascular Quality Initiative infrainguinal bypass registry (2003-2019) were reviewed for chronic limb threatening ischemia among patients undergoing infrageniculate reconstruction. The procedures were categorized according to surgeon years of practice experience at surgery (ie, 0-5, 6-10, 11-15, >15 years) and the number of LEB procedures performed by the surgeon during the year of surgery (volume quartiles: 1-8, 9-14, 15-21, and >21). Mixed effects logistic and Cox regression models were used to assess the effects of experience, volume, and their interaction on outcomes., Results: Increasing practice experience was more significantly associated with a reduction of in-hospital complications (odds ratio, 0.97; 95% confidence interval [CI], 0.96-0.99; P = .002) and the risk of major adverse limb events (odds ratio, 0.94; 95% CI, 0.92-0.97; P < .0001) compared with the volume. Increasing experience and volume were both associated with increased freedom from thrombosis (hazard ratio, 0.95; 95% CI, 0.93-0.98; P = .001). In contrast, neither experience nor volume had any significant association with early mortality. However, a higher volume was associated with diminished long-term survival (hazard ratio, 1.04; 95% CI, 1.0-1.1; P = .01). The most experienced surgeons (>15 years' experience) were significantly more likely to perform LEB for rest pain (P < .0001). No significant differences were found in the bypass rates among patients with tissue loss. The most experienced and highest volume surgeons were more likely to use an autogenous and/or composite conduit, in situ reconstruction, and/or pedal targets (P < .05). Similarly, more experienced and higher volume surgeons had less blood loss and shorter procedure times (P < .0001). Overall, the most experienced surgeons (>15 years' experience) were significantly more likely to have a higher volume with a diminished risk for all LEB outcomes., Conclusions: Surgeon experience appears to have the most important role in predicting for overall LEB performance with improved in-hospital outcomes and major adverse limb events. The more experienced surgeons performed more complex reconstructions with fewer complications. These findings have significant clinical and educational implications as our most experienced surgeons approach retirement. Mentorship strategies to facilitate ongoing technical development among less experienced surgeons are imperative to sustain optimal limb salvage outcomes and have significant ramifications regarding expectations for regulatory and credentialing paradigms., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The coronavirus disease 2019 (COVID-19) pandemic's impact on vascular procedural volumes and outcomes has not been fully characterized., Methods: Volume and outcome data before (1/2019 - 2/2020), during (3/2020 - 4/2020), and following (5/2020 - 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative (VQI). Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression., Results: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods., Conclusion: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.

Objective: The National Health Service demonstrated that regions of the United Kingdom with the highest number of patients enrolled in research studies had the lowest risk-adjusted mortality when patients were admitted to the hospital. Our goal was to investigate if this correlation was evident for patients with chronic limb threatening ischemia (CLI) treated in the United States (US). Accordingly, we examined correlations among sites participating in the Best Endovascular versus best Surgical Therapy in patients with Critical (BEST-CLI) trial, a multicenter, National Institute of Health-sponsored, international randomized controlled trial (RCT) comparing revascularization strategies in patients with CLI, and regional rates of major amputation from CLI., Methods: We measured regional participation in the BEST-CLI trial by evaluating trial participation and enrollment rosters. To determine regional rates of lower limb amputation, we queried the Medicare database (2007-2016) for patients with concurrent peripheral arterial disease (PAD) and diabetes, then assessed how many had lower extremity amputations. Correlation of regional amputation rates with distribution of BEST-CLI sites in four US geographical regions was calculated using Pearson's correlation coefficients. Simple regression equations were used to calculate the significance of these correlation coefficients., Results: Of 9,231,909 CLI patients, 342,406 underwent amputation in the Medicare dataset. Amputation rates per 1000 CLI patients differed by region (South 40.42, Midwest 40.12, West 34.81, Northeast 31.14). There were 116 US vascular centers, selected by volume and expertise that participated in BEST-CLI with the following distribution: South (n = 30, 26%), Midwest (n = 26, 22%), West (n = 29, 25%), and Northeast (n = 31, 27%). There was a negative correlation between the number of amputations per 1000 for Medicare CLI patients with diabetes and PAD and the number of BEST-CLI sites in the region which trended toward significance (Pearson R= -0.61, P = 0.39)., Conclusions: Amputation rate among Medicare CLI patients is inversely correlated with US BEST-CLI site distribution. Higher participation in clinical research, especially within large RCTs, may be a marker of optimal PAD management., Competing Interests: Conflicts of Interest: A.F.: Consultant for Sanifit. Matthew Menard: Scientific Advisory Board for Janssen; K.R.: multiple conflicts to be delivered under separate cover; No conflicts: J.S., M.E., P.G., M.S., M.V., M.V., T.H. report no conflicts., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD., Methods: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis., Results: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication., Conclusions: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI)., Methods: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level., Results: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R 2  = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R 2  = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001)., Conclusions: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in peripheral artery disease (PAD). Lipid-lowering therapies (LLT) that reduce LDL-C decrease this risk., Objectives: The authors examined LLT use and actual achieved LDL-C in PAD., Methods: PAD patients in MarketScan from 2014 to 2018 were identified. Outcomes included LLT use, defined as high-intensity (HI) (high-intensity statin, statin plus ezetimibe, or PCSK9 inhibitor), low-intensity (any other lipid regimen), or no therapy, and follow-up LDL-C. Factors associated with LDL-C <70 mg/dl were identified with multivariable logistic regression., Results: Among 250,103 PAD patients, 20.5% and 39.5% were treated at baseline with HI and low-intensity LLT, respectively; 40.0% were on no LLT. Over a 15-month median follow-up period, HI LLT use increased by 1.5%. Among 18,747 patients with LDL-C data, at baseline, 25.1% were on HI LLT, median LDL-C was 91 mg/dl, and 24.5% had LDL-C <70 mg/dl. Within the HI LLT subgroup, median LDL-C was 81 mg/dl, and 64% had LDL-C ≥70 mg/dl. At follow-up, HI LLT use increased by 3.7%, median LDL-C decreased by 4.0 mg/dl, and an additional 4.1% of patients had LDL-C <70 mg/dl. HI LLT use was greater after follow-up MACE (55.0%) or MALE (41.0%) versus no ischemic event (26.1%). After MACE or MALE, LDL-C was <70 mg/dl in 41.5% and 36.1% of patients, respectively, versus 27.1% in those without an event. Factors associated with follow-up LDL-C <70 mg/dl included smoking, hypertension, diabetes, prior lower extremity revascularization, and prior myocardial infarction but not prior acute or critical limb ischemia., Conclusions: In PAD, LLT use is suboptimal, LDL-C remains elevated, and LLT intensity is a poor surrogate for achieved LDL-C. Less aggressive lipid management was observed in PAD versus cardiovascular disease, highlighting missed opportunities for implementation of proven therapies in PAD., Competing Interests: Funding Support and Author Disclosures This study was funded through a research grant from Amgen to CPC Clinical Research. Dr. Hess has received research funding to CPC Clinical Research from Merck, Bayer, Janssen, and Amgen. Dr. Cannon has received research grants from Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Janssen, Merck, and Pfizer; and has received consulting fees from Aegerion, Alnylam, Amarin, Amgen, Applied Therapeutics, Ascendia, BI, BMS, Corvidia, Eli Lilly, HLS Therapeutics, Innovent, Janssen, Kowa, Merck, Pfizer, Rhoshan, and Sanofi. Dr. Beckman has provided consulting for AstraZeneca, Amgen, Bayer, GlaxoSmithKline, Janssen, and Sanofi; has provided Data Safety and Monitoring Board service for Novartis; and has ownership in EMX and Janacare. Dr. Patel has received research grants from/served on the advisory board for Bayer, Janssen, Amgen, and Heartflow; and has received research grants from Novartis and the National Heart, Lung, and Blood Institute. Dr. Hiatt has received grant support to CPC Clinical Research from the National Institutes of Health, Bayer, Janssen, Amgen, and Pluristem. Drs. Mues and Orroth and Ms. Shannon are employees of Amgen, Inc. Dr. Bonaca has received research grants to CPC Clinical Research from Amgen, AstraZeneca, Bayer, NovoNordisk, Regeneron, and Sanofi. Dr. Goodney has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices., Methods: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses., Results: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality., Conclusions: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)

Objective: Active smoking among patients undergoing interventions for intermittent claudication (IC) is associated with poor outcomes. Notwithstanding, current levels of active smoking in these patients are high. State-level tobacco control policies have been shown to reduce smoking in the general US population. We evaluated whether state cigarette taxes and 100% smoke-free workplace legislation are associated with active smoking among patients undergoing interventions for IC., Methods: We queried the Vascular Quality Initiative database for peripheral endovascular interventions, infrainguinal bypasses, and suprainguinal bypasses for IC. Active smoking at the time of intervention was defined as smoking within one month of intervention. We implemented difference-in-differences analysis to isolate changes in active smoking owing to cigarette taxes (adjusted for inflation) and implementation of smoke-free workplace legislation. The difference-in-differences models estimated the causal effects of tobacco policies by adjusting for concurrent temporal trends in active smoking unrelated to cigarette taxes or smoke-free workplace legislation. The models controlled for age, sex, race/ethnicity, insurance type, diabetes, chronic obstructive pulmonary disease, state, and year. We tested interactions of taxes with age and insurance., Results: Data were available for 59,847 patients undergoing interventions for IC in 25 states from 2011 to 2019. Across the study period, active smoking at the time of intervention decreased from 48% to 40%. Every $1.00 cigarette tax increase was associated with a 6-percentage point decrease in active smoking (95% confidence interval, -10 to -1 percentage points; P = .02), representing an 11% decrease relative to the baseline proportion of patients actively smoking. The effect of cigarettes taxes was greater in older patients and those on Medicare. Among patients aged 60 to 69 and 70 to 79 years, every $1.00 tax increase resulted in 14% and 21% reductions in active smoking relative to baseline subgroup prevalences of 53% and 29%, respectively (P < .05 for both); however, younger age groups were not affected by tax increases. Among insurance groups, only patients on Medicare exhibited a significant change in active smoking with every $1.00 tax increase (an 18% decrease relative to a 33% baseline prevalence; P = .01). The number of states implementing smoke-free workplace legislation increased from 9 to 14 by 2019; however, this policy was not significantly associated with active smoking prevalence. At follow-up (median, 12.9 months), $1.00 tax increases were still associated with decreased smoking prevalence (a 25% decrease relative to a 33% baseline prevalence; P < .001)., Conclusions: Cigarette tax increases seem to be an effective strategy to decrease active smoking among patients undergoing interventions for IC. Older patients and Medicare recipients are the most responsive to tax increases., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Peripheral artery disease (PAD) is the clinical manifestation of atherosclerosis that primarily affects peripheral arteries within the lower extremities. In this brief review, we describe the epidemiology and burden of disease of PAD within the United States, particularly among high-risk populations. Although the prevalence of PAD continues to increase and is typically higher among the elderly as well as men, women in lower socioeconomic strata are affected at rates two times that of men. Among racial/ethnic groups, Black and African-American patients both experience higher rates of disease as well as lower rates of access to preventative care. Moreover, despite an overall decrease in amputation rates among all patients with PAD, high-risk populations remain disproportionally affected. Specifically, patients in rural areas, African-American and Native-American patients, and those of low socioeconomic status carry the highest risk of amputation. Efforts to improve care among PAD patients should target these high-risk populations and offer comprehensive, evidence-based preventative care. Wide adoption and integration of these practices into comprehensive care models may help to mitigate amputation in the highest-risk populations. As our treatment pathways continue to evolve, we must place further emphasis on patient input and quality of life as we work toward continual improvement in the care of patients with PAD., (Copyright © 2021. Published by Elsevier Inc.)

Background: The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed., Methods: This retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality., Results: Fifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days., Conclusions: Rotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Lower extremity bypass surgery remains an important treatment option for patients with critical limb ischemia (CLI), but is resource intensive. We sought to evaluate the cost and Medicare reimbursement for lower extremity bypass surgery in patients with CLI., Methods: Hospital cost accounting systems were queried for total technical and professional costs incurred and reimbursement received for patients with CLI undergoing lower extremity bypass at our center between 2011 and 2017. Patients were identified by assignment to Diagnosis-Related Group (DRG) 252, 253, or 254 (other vascular procedure with major complication/comorbidity, with complication/comorbidity, and without complication/comorbidity, respectively). Additional clinical data were incorporated from the Vascular Quality Initiative clinical registry. For non-Medicare patients, reimbursement was indexed to Medicare rates. Contribution margins (reimbursement minus cost) from technical and professional services were analyzed for each patient and summarized by DRG. We compared technical, professional, and total costs; reimbursement; and contribution margins across DRGs using univariate statistics and evaluated factors associated with total contribution margin using median quantile regression., Results: We analyzed 68 patients with hemodynamically confirmed CLI (46% rest pain, 54% tissue loss), of whom 25% received a prosthetic graft. Mean age was 66.1 ± 11.6 years, 69% were male, 49% diabetic, 44% current smokers, and 4% on dialysis. In general, total infrainguinal bypass cost was adequately compensated for patients assigned only the most complex DRG 252 (median, $2490; interquartile range [IQR], -$1,621 to $10,080). In the majority of patients with less complex DRG 253 (median, -$3,100; IQR, -$8499 to $109) and DRG 254 (median, -$4902; IQR, -$9259 to $1059), reimbursement did not cover the cost of care. Both technical costs and professional costs varied significantly with the complexity of DRG. Although reimbursement from technical services increased alongside increasing complexity of DRG, there was insignificant variation in professional reimbursement as DRG complexity increased. On multivariable modeling, longer length of stay (-$2547 per additional day) and preoperative dialysis (-$5555) were significantly associated with negative margins., Conclusions: For the majority of patients with CLI, current Medicare reimbursement does not adequately cover the cost of providing care after open bypass surgery. As commercial insurers move toward Medicare reimbursement rates, more granular risk stratification profiles are needed to ensure open surgical care for patients with CLI remains financially sustainable., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Primary amputation (ie, without attempted revascularization) is a devastating complication of peripheral artery disease. Racial disparities in primary amputation have been described; however, rural disparities have not been well investigated. The purpose of this study was to examine the impact of rurality on risk of primary amputation and to explore the effect of race on this relationship., Methods: The national Vascular Quality Initiative amputation data set was used for analyses (N = 6795). The outcome of interest was primary amputation. Independent variables were race/ethnicity (non-Latinx whites vs nonwhites) and rural residence. Multivariable logistic regression examined impact of rurality and race/ethnicity on primary amputation after adjustment for relevant covariates and included an interaction for race/ethnicity by rural status., Results: Primary amputation occurred in 49% of patients overall (n = 3332), in 47% of rural vs 49% of urban patients (P = .322), and in 46% of whites vs 53% of nonwhites (P < .001). On multivariable analysis, nonwhites had a 21% higher odds of undergoing primary amputation overall (adjusted odds ratio [AOR], 1.21; 95% confidence interval [CI], 1.05-1.39). On subgroup analysis, rural nonwhites had two times higher odds of undergoing primary amputation than rural whites (AOR, 2.06; 95% CI, 1.53-2.78) and a 52% higher odds of undergoing primary amputation than urban nonwhites (AOR, 1.52; 95% CI, 1.19-1.94). In the urban setting, nonwhites had a 21% higher odds of undergoing primary amputation than urban whites (AOR, 1.21; 95% CI, 1.05-1.39)., Conclusions: In these analyses, rurality was associated with greater odds for primary amputation in nonwhite patients but not in white patients. The effect of race on primary amputation was significant in both urban and rural settings; however, the effect was significantly stronger in rural settings. These findings suggest that race/ethnicity has a compounding effect on rural health disparities and that strategies to improve health of rural communities need to consider the particular needs of nonwhite residents to reduce disparities., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Peripheral artery disease (PAD) stems from atherosclerosis of lower extremity arteries with resultant arterial narrowing or occlusion. The most severe form of PAD is termed chronic limb-threatening ischemia and carries a significant risk of limb loss and cardiovascular mortality. Diabetes mellitus is known to increase the incidence of PAD, accelerate disease progression, and increase disease severity. Patients with concomitant diabetes mellitus and PAD are at high risk for major complications, such as amputation. Despite a decrease in the overall number of amputations performed annually in the United States, amputation rates among those with both diabetes mellitus and PAD have remained stable or even increased in high-risk subgroups. Within this cohort, there is significant regional, racial/ethnic, and socioeconomic variation in amputation risk. Specifically, residents of rural areas, African-American and Native American patients, and those of low socioeconomic status carry the highest risk of amputation. The burden of amputation is severe, with 5-year mortality rates exceeding those of many malignancies. Furthermore, caring for patients with PAD and diabetes mellitus imposes a significant cost to the healthcare system-estimated to range from $84 billion to $380 billion annually. Efforts to improve the quality of care for those with PAD and diabetes mellitus must focus on the subgroups at high risk for amputation and the disparities they face in the receipt of both preventive and interventional cardiovascular care. Better understanding of these social, economic, and structural barriers will prove to be crucial for cardiovascular physicians striving to better care for patients facing this challenging combination of chronic diseases.

Background: The benefit of long-term anticoagulation or dual antiplatelet therapy (DAPT) for patients with extra-anatomic bypasses to the lower extremity remains poorly defined. Our study analyzed the real-world use of antithrombotic therapy in patients with extra-anatomic bypass grafts to the lower extremity and compared graft and patient outcomes by antithrombotic regimen., Methods: We studied patients who underwent axillofemoral or femoral-femoral bypass within the Vascular Quality Initiative with one-year follow-up data. Primary exposures were anticoagulation and DAPT, at the time of index procedure and one-year follow-up. Primary outcomes were major adverse limb events (MALE) defined as reintervention or above-ankle amputation, and primary patency. Secondary outcomes included perioperative blood transfusion requirements and the need for reoperation specifically for bleeding. We analyzed outcomes using the Kaplan-Meier estimation and examined factors associated with choice of antithrombotic therapy via logistic regression., Results: Our cohort included 2,760 patients (axillofemoral bypass, n = 857; femoral-femoral bypass, n = 1,903) across 168 centers from 2009 to 2018. Mean age was 66.5 ± 10.5 years and 59% were male. Patients were infrequently prescribed long-term anticoagulation (19%) or DAPT (22%). One-year primary patency was 86% and was similar by anticoagulation (log-rank P = 0.12) and DAPT status (log-rank P = 0.26). Freedom from MALE was 87% at 1 year and was slightly inferior for patients on anticoagulation (88 vs. 83%, log-rank P = 0.001) but was similar by DAPT (log-rank P = 0.19). Transfusion was more common in patients who were anticoagulated than those who were not (30 vs. 25%, P < 0.01), but there was no increase in reoperation because of bleeding (anticoagulation 0.8 vs. 0.8, P = 0.98). Anticoagulation was more commonly prescribed according to disease severity, such as rest pain (adjusted odds ratio (OR): 1.6 (95% confidence interval (CI): 1.20-2.20), tissue loss (OR: 1.9, CI: 1.28-2.73), or acute limb ischemia (OR: 1.9, CI: 1.35-2.71) or prior bypass graft (OR: 2.6, CI: 2.07-3.35). Patients were more commonly prescribed DAPT according to comorbidities, including hypertension (OR: 1.4, CI: 1.04-1.94) and coronary artery disease (OR: 1.6, CI 1.26-1.95)., Conclusions: Antithrombotics are selectively used in patients with extra-anatomic bypass to the lower extremity, the selection of which appears associated with disease severity for anticoagulants and patient comorbidities for DAPT. Primary patency and MALE rates are similar with focused utilization of anticoagulants or DAPT. Blood transfusions are more common among patients on antithrombotics without a difference in the need for reoperation for bleeding., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives and Background: Complex peripheral arterial disease (PAD) and critical limb ischemia (CLI) are associated with high morbidity and mortality. Endovascular techniques have become prevalent in treatment of advanced PAD and CLI, and use of techniques such as tibiopedal minimally invasive revascularization (TAMI), have been proven safe in small, single-center series. However, its use has not been systematically compared to traditional approaches., Methods and Results: This is a retrospective, multicenter analysis which enrolled 744 patients with advanced PAD and CLI who underwent 1,195 endovascular interventions between January 2013 and April 2018. Data was analyzed based on access used for revascularization: 840 performed via femoral access, 254 via dual access, and 101 via TAMI. The dual access group had the highest median Rutherford Class and lowest number of patent tibial vessels. Median fluoroscopy time, procedure time, hospital stay, and contrast volume were significantly lower in the TAMI access group when compared to both femoral/dual access groups. There was also a significant difference between all groups regarding location of target lesions: Femoropopliteal lesions were most commonly treated via femoral access; infrapopliteal lesions, via TAMI, and multilevel lesions via dual access., Conclusions: Stand-alone TAMI or tibial access as an integral part of a dual access treatment strategy, is safe and efficacious in the treatment of patients with advanced PAD and CLI who have infrapopliteal lesions. Larger prospective and randomized studies may be useful to further validate this approach., (© 2019 Wiley Periodicals, Inc.)

Background: To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry., Methods: Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions., Results: In propensity-matched analyses, mortality was similar after plain balloon angioplasty (12.6%) and paclitaxel-coated balloon angioplasty (9.6%; HR=0.84 [95% CI, 0.66-1.06], P =0.14). In propensity-matched groups, mortality was similar after bare-metal stenting (9.8%) and paclitaxel-eluting stenting (8.8%; HR=0.93 [95% CI, 0.62-1.41], P =0.75). In the combined, matched analysis mortality was significantly lower in the paclitaxel device group (8.5%) compared with the nonpaclitaxel device group (11.5%; HR=0.82 [95% CI, 0.68-0.98], P =0.03). Secondary interventions were similar after nonpaclitaxel (N=1113/4149, 26.8%) and paclitaxel device use (N=1113/4227, 26.3%). For intermittent claudication, mortality was lower after paclitaxel device use (1.6%) compared with nonpaclitaxel devices (4.4%; adjusted HR=0.59 [95% CI, 0.39-0.89], P =0.01). For chronic limb-threatening ischemia, the mortality difference was not significant; paclitaxel (12.8%) versus nonpaclitaxel devices (15.5%; adjusted HR=0.85 [95% CI, 0.72-1.00], P =0.05)., Conclusions: At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.

Background: Single-segment great saphenous vein (GSV) has been the preferred conduit for femoral-popliteal (FP) bypass, particularly for a popliteal artery target below the knee. Yet, controversy persists surrounding whether prosthetic conduit can yield comparable outcomes to GSV for FP bypass to either the above-knee (AK) or below-knee (BK) popliteal artery. We sought to analyze national variation in conduit use and to compare contemporary outcomes in FP bypass., Methods: A retrospective review of elective FP bypass in the Vascular Quality Initiative database using single-segment GSV or polytetrafluoroethylene (PTFE) from 2003 to 2018 was performed. Variation in conduit use was examined on a regional and center level. Characteristics of the patients and operative factors were compared. Effects of conduit on 1-year outcomes were assessed using Kaplan-Meier and multivariable Cox regression analyses., Results: Of 7430 FP bypasses performed in the Vascular Quality Initiative, 3930 (53%) used GSV and 3500 (47%) used PTFE. Conduit use differed for AK-popliteal bypass (38% GSV and 62% PTFE) and BK-popliteal bypass (67% GSV and 33% PTFE). PTFE use was inversely correlated with preoperative vein mapping among centers (ρ = -0.55; P < .001). This inverse correlation was stronger for AK-popliteal bypasses (ρ = -0.61; P < .0001) than for BK-popliteal bypasses (ρ = -0.34; P = .0004). Overall, patients undergoing FP bypass with PTFE were more likely to be older and to have multiple medical comorbidities. Operative outcomes were similar between groups, although FP bypass with GSV incurred higher rates of wound infection (P < .001) and reoperation for bleeding, thrombosis, or revision (P < .01). At 1-year follow-up, GSV patients had higher graft occlusion-free survival (83% vs 78%; P < .001) and amputation-free survival (87% vs 82%; P < .001). These differences were observed for both AK-popliteal and BK-popliteal artery subgroups. On multivariable analyses stratified by bypass target, PTFE use was independently associated with increased risk of graft occlusion (AK-popliteal: hazard ratio [HR], 1.4 [P = .002]; BK-popliteal: HR, 1.3 [P = .02]) and amputation (AK-popliteal: HR, 1.4 [P = .006]; BK-popliteal: HR, 1.6 [P < .001]) at both target levels., Conclusions: PTFE is frequently used in FP bypass, representing two-thirds of AK-popliteal FP bypasses and one-third of BK-popliteal FP bypasses. However, PTFE use varies widely among centers. GSV was associated with higher rates of wound infection and reoperation and PTFE was associated with inferior 1-year outcomes independent of target artery level. GSV should be used for FP bypass whenever it is clinically feasible. Decreasing variation in prosthetic conduit use may be a useful quality improvement metric., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The Vascular Study Group of New England (VSGNE) conducted a pilot study evaluating the feasibility of 30-day data collection in patients undergoing infrainguinal bypass (INFRA) which was subsequently expanded to include a limited number of additional sites within the Vascular Quality Initiative (VQI). The purpose of our study was to use these data to evaluate the incidence of 30-day readmission after infrainguinal bypass. A secondary goal of the study was to perform a critical appraisal of the data elements and definitions in the 30-day dataset., Methods: All infrainguinal bypass procedures performed during the pilot study period (7/2008 and 4/2016) were identified and merged with a dataset containing the 30-day data. Incidence and types of readmission were assessed. The primary endpoint was 30-day readmission, defined as any hospital readmission within 30 days of index operation; unplanned 30-day readmission was the secondary endpoint. Covariates tested for association with the primary and secondary endpoints included patient demographics, comorbidities, procedural, and postoperative characteristics. Variables significant on univariate screen (P < 0.2) were evaluated with logistic regression to identify independent determinants., Results: Of 9,847 infrainguinal bypass patients, 5,842 (59%) patients were identified with 30-day data, and 907 (16%) were readmitted within 30 days. Of readmissions, 675 (85%) were unplanned. Potentially modifiable independent determinants of any 30-day readmission included 30-day surgical site infection (SSI) (odds ratio [OR]: 10, 95% confidence interval [CI]: 8.2-12, P < 0.0001), postoperative acute kidney injury (OR: 1.7, 95% CI: 1.2-2.5, P = 0.002), and discharge anticoagulation (OR: 1.2, 95% CI: 1.04-1.5; P = 0.02). Predictors of unplanned 30-day readmission were very similar but identified in-hospital major amputation as an additional independent predictor (OR: 2.8, 95% CI: 1.6-4.9, P = 0.0002)., Conclusions: This study demonstrates the interest in, and value of, 30-day data collection in VSGNE/VQI and documents the frequency of readmission after infrainguinal bypass. Readmission within 30 days is strongly associated with SSI, stressing the importance of efforts to decrease this complication. Given that many other predictors are unmodifiable, 30-day readmission is only appropriate as a quality metric if it is risk adjusted using large, real-world datasets such as VQI. Lessons learned from this analysis can be used to select optimal 30-day data elements., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Lower extremity revascularization for critical limb ischemia (CLI) remains a subject of clinical equipoise. Readmissions and repeat lower extremity revascularization increase the cost of care and decrease the value of initial treatment. This study examines readmissions and repeat inpatient revascularization and major amputation up to 1 year after initial open and endovascular lower extremity revascularization., Methods: The 2014 Nationwide Readmissions Database (NRD) was reviewed. The NRD provides all subsequent readmissions of any hospitalization for the calendar year. A cohort of patients undergoing lower extremity revascularization in January only was selected based on International Classification of Diseases, Ninth Revision, Clinical Modification codes. Patients were divided into open and endovascular groups. Readmissions for repeat lower extremity revascularization (RFR) were identified based on procedural codes. Open and endovascular lower extremity revascularization were compared in terms of patient characteristics as well as readmissions, RFR, major amputation, and inpatient mortality at 1 year. Risk-adjusted outcomes accounting for differences in age, gender, income, and Charlson Comorbidity Index (CCI) were derived using regression analysis., Results: There were 1,668 open and 1,410 endovascular lower extremity revascularizations. Patients in the endovascular group were significantly older (P < 0.01), more likely to be women (P < 0.01), and had higher CCI (P < 0.01). Patients undergoing endovascular lower extremity revascularization had significantly higher readmission rate (49 vs. 33.7, P < 0.01) and higher mortality (10.4 vs. 5.3, P < 0.01). Readmitted patients after endovascular lower extremity revascularization had significantly higher mean number of repeat readmissions compared to open lower extremity revascularization (2.49 ± 0.12 vs. 2.13 ± 0.08, P = 0.01). There was no difference in RFR (P = 0.82) or major amputation (P = 0.19). Open revascularization was independently associated with decreased readmission (odds ratio = 0.55 [0.43-0.71]) compared to endovascular. However, there was no significant association between the type of lower extremity revascularization and major amputation or RFR., Conclusions: Endovascular lower extremity revascularization for CLI is performed on older and sicker patients and seems to be associated with increased readmission at 1 year compared to open lower extremity revascularization. Regardless of the initial modality of treatment, patients are likely to undergo at least 1 revascularization during readmissions., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan-Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1-3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74-0.82]; atherectomy risk ratio=0.69 [0.58-0.82]) and tibial arteries (stent risk ratio=0.70 [0.55-0.89]; atherectomy risk ratio=0.87 [0.70-1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17-1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12-1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06-1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence-based guidelines are needed to guide optimal use of endovascular treatments for men and women.

Loss to follow-up (LTF) has been associated with worse outcomes after procedures. We sought to identify differences in lower extremity peripheral vascular intervention (PVI) patients with and without LTF, and to determine if LTF impacted survival. Patients in the PVI registry of the Vascular Quality Initiative (VQI) were included ( n = 39,342), where t -test and chi-squared analysis were used to compare those with and without LTF. Multivariable logistic regression was used to identify factors associated with LTF while Cox regression analysis was applied to compare survival among those with and without LTF. The overall 1-year follow-up rate was 91.6%. LTF patients were more often male, Hispanic, of black race, and had a higher rate of diabetes, coronary artery disease, congestive heart failure, and dialysis. LTF patients had a higher prevalence of critical limb ischemia, underwent popliteal or distal intervention, and were intervened upon urgently. There was also a higher rate of postoperative complications, and a lower rate of technical success for LTF patients. After controlling for center effects, the independent variables associated with LTF included male sex, age, diabetes, dialysis dependence, ASA class 3 or greater, as well as complications requiring admission. Preoperative aspirin, preadmission home living status, prior carotid intervention, and discharge aspirin were protective against LTF. Adjusted survival analysis showed decreased survival in LTF, with those returning face-to-face surviving longer than those with phone follow-up. Efforts should be focused on understanding these differences to improve follow-up rates and help improve overall survival.

Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P<0.001) and had worse disease severity (Trans-Atlantic Inter-Society Consensus score [TASC] B and greater; atherectomy: 77%; PTA : 68%; stenting: 67%; P<0.001). The 5-year rate of major adverse limb events was 38% in patients receiving atherectomy versus 33% for PTA and 32% for stenting (log rank P<0.001). Controlling for unmeasured confounding using instrumental-variable analysis, patients treated with atherectomy experienced outcomes similar to those of patients treated with PTA , except for a higher risk of any amputation (hazard ratio: 1.51; 95% CI , 1.08-2.13). However, compared with stenting, atherectomy patients had a higher risk of major amputation (hazard ratio: 3.66; 95% CI , 1.72-7.81), any amputation (hazard ratio: 2.73; 95% CI , 1.60-4.76), and major adverse limb event (hazard ratio: 1.61; 95% CI , 1.10-2.38). Conclusions Atherectomy is used to treat severe femoropopliteal and tibial peripheral arterial disease even though long-term adverse outcomes occur more frequently after this treatment modality.

Purpose: To present the chronic total occlusion (CTO) crossing approach based on plaque cap morphology (CTOP) classification system and assess its ability to predict successful lesion crossing., Methods: A retrospective analysis was conducted of imaging and procedure data from 114 consecutive symptomatic patients (mean age 69±11 years; 84 men) with claudication (Rutherford category 3) or critical limb ischemia (Rutherford category 4-6) who underwent endovascular interventions for 142 CTOs. CTO cap morphology was determined from a review of angiography and duplex ultrasonography and classified into 4 types (I, II, III, or IV) based on the concave or convex shape of the proximal and distal caps., Results: Statistically significant differences among groups were found in patients with rest pain, lesion length, and severe calcification. CTOP type II CTOs were most common and type III lesions the least common. Type I CTOs were most likely to be crossed antegrade and had a lower incidence of severe calcification. Type IV lesions were more likely to be crossed retrograde from a tibiopedal approach. CTOP type IV was least likely to be crossed in an antegrade fashion. Access conversion, or need for an alternate access, was commonly seen in types II, III, and IV lesions. Distinctive predictors of access conversion were CTO types II and III, lesion length, and severe calcification., Conclusion: CTOP type I lesions were easiest to cross in antegrade fashion and type IV the most difficult. Lesion length >10 cm, severe calcification, and CTO types II, III, and IV benefited from the addition of retrograde tibiopedal access.

Objectives: To date, studies of vascular amputees primarily examine quantitative outcomes following limb loss. Less is known about the patient's perspective after major lower limb amputation. Here, we define and describe the postamputation recovery period., Methods: Qualitative study using purposive, maximum variation sampling on the variables of amputation level and times since surgery. We first conducted structured interviews with 20 participants (median age: 65 years, range: 45-88 years; 85% male; below knee amputation n = 14; above knee amputation n = 6; median time from amputation to interview = 16 months, range: 4-51 months). Findings were validated via a focus group with 5 amputees. Data were coded, analyzed, and interpreted by 2 reviewers., Results: All participants expressed the desire to have an active role in the decision to undergo amputation, even while acknowledging that limb salvage options were exhausted. Following amputation, participants described a 6-month recovery period when they learned to modify daily activities to accommodate their new functional and psychological needs. Participants defined recovery as when they had regained functional independence, which was described as a level of mobility that allowed them to perform daily activities with minimal assistance. Concerns that participants felt were poorly addressed included uncontrolled pain, feeling unprepared to live with an amputation, and questions about prosthetics. Two of the 5 focus group participants stated a preference for amputation earlier in the treatment course., Conclusions: Postamputation recovery has an early (up to 6 months) and late phase (after 6 months) and concludes when amputees regain what they perceive as independence. Patients desire to participate in amputation decision-making; in this study, some would have preferred amputation earlier in their clinical course. Attention to the domains that impact quality of life, and fostering a shared decision-making process, are opportunities to enhance postamputation recovery.

Background: Statin dose guidelines for patients with peripheral artery disease (PAD) are largely based on coronary artery disease and stroke data. The aim of this study is to determine the effect of statin intensity on PAD outcomes of amputation and mortality., Methods: Using an observational cohort study design and a validated algorithm, we identified patients with incident PAD (2003-2014) in the national Veterans Affairs data. Highest statin intensity exposure (high-intensity versus low-to-moderate-intensity versus antiplatelet therapy but no statin use) was determined within 1 year of diagnosis of PAD. Outcomes of interest were lower extremity amputations and death. The association of statin intensity with incident amputation and mortality was assessed with Kaplan-Meier plots, Cox proportional hazards modeling, propensity score-matched analysis, and sensitivity and subgroup analyses, as well, to reduce confounding., Results: In 155 647 patients with incident PAD, more than a quarter (28%) were not on statins. Use of high-intensity statins was lowest in patients with PAD only (6.4%) in comparison with comorbid coronary/carotid disease (18.4%). Incident amputation and mortality risk declined significantly with any statin use in comparison with the antiplatelet therapy-only group. In adjusted Cox models, the high-intensity statin users were associated with lower amputation risk and mortality in comparison with antiplatelet therapy-only users (hazard ratio, 0.67; 95% confidence interval, 0.61-0.74 and hazard ratio, 0.74; 95% confidence interval, 0.70-0.77, respectively). Low-to-moderate-intensity statins also had significant reductions in the risk of amputation and mortality (hazard ratio amputation, 0.81; 95% confidence interval, 0.75- 0.86; hazard ratio death, 0.83; 95% confidence interval, 0.81-0.86) in comparison with no statins (antiplatelet therapy only), but effect size was significantly weaker than the high-intensity statins ( P <0.001). The association of high-intensity statins with lower amputation and death risk remained significant and robust in propensity score-matched, sensitivity, and subgroup analyses., Conclusions: Statins, especially high-intensity formulations, are underused in patients with PAD. This is the first population-based study to show that high-intensity statin use at the time of PAD diagnosis is associated with a significant reduction in limb loss and mortality in comparison with low-to-moderate-intensity statin users, and patients treated only with antiplatelet medications but not with statins, as well., (© 2018 American Heart Association, Inc.)