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© 2014 Chatterjee et al.Objective: Inflammation and its resolution are central to vascular injury and repair. Maresins comprise a new family of bioactive lipid mediators synthesized from docosahexaenoic acid, an ω-3 polyunsaturated fatty acid. They have be

Mechanical forces including gravity affect endothelial cell (ECs) function, and have been implicated in vascular disease as well as physiologic changes associated with low gravity environments. The goal of this study was to investigate the impact of gravit

The purpose of this study is to primarily evaluate the lumen area and secondarily evaluate wall area measurements of in vivo lower extremity peripheral vein bypass grafts patients using high spatial resolution, limited field of view, cardiac gated, black blood inner volume three-dimensional fast spin echo MRI. Fifteen LE-PVBG patients prospectively underwent ultrasound followed by T1-weighted and T2-weighted magnetic resonance (MR) imaging. Lumen and vessel wall areas were measured by direct planimetry. For graft lumen areas, T1- and T2-weighted measurements were compared with ultrasound. For vessel wall areas, differences between T1- and T2-weighted measurements were evaluated. There was no significant difference between ultrasound and MR lumen measurements, reflecting minimal MR blood suppression artifact. Graft wall area measured from T1-weighted images was significantly larger than that measured from T2-weighted images (P < 0.001). The mean of the ratio of T1- versus T2-weighted vessel wall areas was 1.59 (95% CI: 1.48-1.69). The larger wall area measured on T1-weighted images was due to a significantly larger outer vessel wall boundary. Very high spatial resolution LE-PVBG vessel wall MR imaging can be performed in vivo, enabling accurate measurements of lumen and vessel wall areas and discerning differences in those measures between different tissue contrast weightings. Vessel wall area differences suggest that LE-PVBG vessel wall tissues produce distinct signal characteristics under T1 and T2 MR contrast weightings. [ABSTRACT FROM AUTHOR]

Objective: To demonstrate lower extremity peripheral vein bypass graft wall thickness changes over time in a patient using very high spatial resolution cardiac gated, black blood inner volume three-dimensional (3D) fast spin echo (FSE) magnetic resonance imaging (MRI).Case Report: A 52-year-old diabetic man with a history of hyperlipidemia underwent uncomplicated bypass grafting for an asymptomatic 5.2 cm popliteal artery aneurysm using reversed great saphenous vein. A segment of the bypass graft was studied at 1 and 6 months after surgery with cardiac gated inner volume 3D-FSE imaging with non-interpolated 0.195 mm(3) voxel volumes (0.3125 x 0.3125 x 2 mm). T1- and T2-weighted images were acquired in 10 min per contrast weighting. Graft imaging at one month after implantation illustrates expansion of the outer wall of the graft that partially resolves 5 months later.Conclusion: In this patient, expansion of the lower extremity peripheral bypass graft wall can be characterized in clinical scan times with a 3D-FSE MRI protocol using highly selective inner volume excitation followed by non-selective refocusing pulses. The resulting 3D images can potentially be used to study the biology of the vessel wall. [ABSTRACT FROM AUTHOR]

Objective: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2., Methods: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models., Results: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12)., Conclusions: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosures None.

The clinical judgment of a physician is one of the most important aspects of medical quality, yet it is rarely captured with quality measures in use today. We propose a novel approach using individualized physician benchmarking that measures the appropriateness of care that a physician delivers by looking at their practice pattern in a specific clinical situation. A prime application of our novel approach to appropriateness measures is the surgical management of peripheral artery disease and claudication. We discuss 4 potential consensus metrics for the treatment of claudication that explore appropriateness of care of claudication management and are meaningful, actionable, and quantifiable. Given the multitude of medical specialties involved in the care of patients with peripheral artery disease and the consequences of both preemptive and delayed care, it is in all of our interests to promote data transparency with confidential communications to outlier physicians while advocating for evidence-based management., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) deemed suitable for either approach who had an available single-segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative-Medicare-linked database., Methods: We queried the Vascular Quality Initiative-Medicare-linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS)., Results: Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 pairs of ET vs BWPG. In the matched cohorts of ET vs BWGSV, ET was associated with greater hazards of death (hazard ratio [HR] = 1.34, 95% confidence interval [CI], 1.25-1.43; P < .001), amputation (HR = 1.30, 95% CI, 1.17-1.44; P < .001), and amputation/death (HR = 1.32, 95% CI, 1.24-1.40; P < .001) up to 4 years. In the matched cohorts of ET vs BWPG, ET was associated with greater hazards of death up to 2 years (HR = 1.11, 95% CI, 1.00-1.22; P = .042) but not amputation or amputation/death., Conclusions: In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation, and amputation-free survival up to 4 years. Moreover, BWPG was superior to ET in terms of OS up to 2 years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial., Competing Interests: Disclosures A.F. is a consultant for Sanifit, LeMaitre, BiogenCell, and DilaysisX. M.T.M. is a member of the advisory board for Janssen, Inc. M.S.C. is a member of the Data and Safety Monitoring Board for Abbott Vascular and is a consultant for Medistim and BioGenCell. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Nonhome discharge (NHD) to a rehabilitation or skilled nursing facility after vascular surgery is poorly described despite its impact on patients. For home-dwelling patients undergoing elective surgery, the need for postoperative NHD can have meaningful implications on quality of life, long-term outcomes, and health-care spending. Understanding postsurgical NHD risk is essential to preoperative counseling and shared decision making. This is particularly true for the treatment of abdominal aortic aneurysms (AAAs) as the postoperative course can vary between open and endovascular surgery. We aimed to identify independent predictors of NHD following elective open abdominal aortic aneurysm repair (OAR), and to create a clinically useful preoperative risk score., Methods: Elective OAR cases were queried from the Society for Vascular Surgery Vascular Quality Initiative from years 2013-2022. A risk score was created by splitting the data set into two-thirds for development and one-third for validation. A parsimonious stepwise hierarchical multivariable logistic regression controlling for hospital level variation was performed in the development dataset, and the beta-coefficients were used to assign points for a risk score. The score was then validated, and model performance assessed., Results: Overall, 8,274 patients were included and 1,502 (18.2%) required NHD. At baseline, patients who required NHD were more likely to be ≥ 80 years old (23.6% vs. 6.5%), female (35.9% vs. 23.1%), not independently ambulatory (14.6% vs. 4.3%), anemic (24.4% vs. 13.9%), have chronic obstructive pulmonary disease (COPD, 41.6% vs. 30.7%), American Society of Anesthesiologists (ASA) class ≥4 (41.0% vs. 32.5%), and a supraceliac proximal clamp (9.8% vs. 5.7%; all P < 0.05). Multivariable analysis in the development group identified the following independent predictors of NHD: age ≥80 years, not independently ambulatory, proximal clamp location, hypogastric artery occlusion, anemia (Hb < 12 g/dL), COPD, female sex, hypertension, and ASA class ≥4. These were then used to create a 14-point risk score. Patients were stratified into three groups based upon their risk score: low risk (0-4 points; n = 4,966) with an NHD rate of 9.9%, moderate risk (5-6 points; n = 2,442) with an NHD rate of 25.5%, and high risk (≥7 points; n = 886) with an NHD rate of 44.6%. The risk score had good predictive ability with c-statistic = 0.73 for model development and c-statistic = 0.72 in the validation dataset., Conclusions: This novel risk score can predict NHD following elective OAR using characteristics that can be identified preoperatively. Utilization of this score may allow for improved risk assessment, preoperative counseling, and shared decision making., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial., Methods: Baseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above-ankle amputation, and all-cause death., Results: Among 1777 patients who underwent LER, 69.2% had DM. Compared with patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins), whereas patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%; P < .001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared with patients with DM (60% vs 52.5%; P = .016). At 3 years, patients with DM exhibited higher rates of above-ankle amputation and all-cause death compared with patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared with patients without DM (3-year estimate: 53.5% vs 46.4%; P < .001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above-ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47])., Conclusions: Patients with DM undergoing LER for chronic limb-threatening ischemia experienced a greater incidence of MALE or all-cause death compared with patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease., Competing Interests: Disclosures J.S. reports education grants provided by Becton, Dickinson and Company and W. L. Gore & Associates; funds were paid to Boston University. A.F. reports consultant to LeMaitre, Sanifit, and BiogenCell, and is on the advisory board of iThera and DilaysisX. C.I.O.C. reports consultant for Envveno. Patent: U.S.S.N. 10,524,891 B1 “Inferior vena cava filter retrieval device and method of retrieving same.”, (Copyright © 2024. Published by Elsevier Inc.)

Objective: Single segment great saphenous vein (SSGSV) traditionally has been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some investigators have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable. We sought to evaluate long-term outcomes of infrainguinal bypass based on conduit type for treating chronic limb-threatening ischemia (CLTI)., Methods: Data from the Best Endovascular vs Best Surgical Therapy of Patients with CLTI multicenter, prospective, randomized controlled trial, comparing infrainguinal bypass with endovascular therapy in patients with CLTI, were evaluated. In this as-treated analysis, we compared outcomes of infrainguinal bypass using prosthetic, alternative autogenous vein (AAV), and cryopreserved vein (Cryo) with SSGSV bypass. Kaplan-Meier and multivariable analyses were performed to examine the associations of conduit type with major adverse limb events (MALE), reinterventions, above-ankle amputations, and all-cause death rates., Results: In total, 784 bypasses were analyzed (120 prosthetic, 33 AAV, 21 Cryo, AND 610 SSGSV). For prosthetic and SSGSV, the distribution was 357 femoropopliteal (93 prosthetic and 264 GSV) and 373 infrapopliteal (27 prosthetic and 346 GSV). The mean age for the overall cohort was 67.1 years; 27.4% were female, 29.9% were non-White, and 11.5% were of Hispanic ethnicity. Patients undergoing prosthetic bypass were older (69.2 years vs 66.7 years); more likely to have chronic obstructive pulmonary disease (22.5% vs 14.0%), prior coronary artery bypass grafting (88.9% vs 66.5%), and prior stroke (23.3% vs 14%); but less often were of Hispanic ethnicity (5.8% vs 12.6%) and had diabetes (59.2% vs 71.3%) (P < .05 for all). For femoropopliteal bypass, use of prosthetic conduit was associated with increased major reinterventions at 3 years overall (19.0% vs 11.5%; P = .06) and on risk-adjusted analysis (hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.09-4.2; P = .028). No significant differences in MALE or death, above-ankle amputation, or death were observed. Outcomes were similar for bypasses to above-knee popliteal targets and below-knee popliteal targets. For infrapopliteal bypass, the use of a prosthetic conduit was associated with increased major reintervention (25.3% vs 10.3%; P = .005), death (68.6% vs 34.8%; P < .001), and MALE or death (90.0% vs 48.1%; P < .001) at 3 years. After risk adjustment, infrapopliteal bypass with prosthetic conduit was associated with higher major reintervention (HR, 4.14; 95% CI, 1.36-12.6; P = .012), above-ankle amputation (HR, 4.64; 95% CI, 1.59-13.5; P = .005), death (HR, 2.96; 95% CI, 1.4-6.2; P = .004), and MALE or death (HR, 3.59; 95% CI, 1.64-7.86; P = .001) compared with bypass with SSGSV. Overall, AAV had similar outcomes at 3 years as SSGSV; however, Cryo had significantly higher above-ankle amputation (50.0% vs 12.8%) (HR, 4.2; 95% CI, 1.68-10.5; P = .002), major reintervention (41.9% vs 10.7%) (HR, 3.12; 95% CI, 1.18-8.22; P = .02), and MALE/death (88.8% vs 37.8%) (HR, 2.96; 95% CI, 1.43-6.14; P = .004)., Conclusions: The use of a prosthetic conduit in infrainguinal bypass is associated with inferior outcomes compared with bypass using SSGSV, particularly for bypass to infrapopliteal targets. Cryo grafts were infrequent and also demonstrated inferior outcomes. SSGSV remains the preferred conduit of choice for infrainguinal bypass., Competing Interests: Disclosures J.S. reports educational grants from W. L. Gore & Associates and BD. M.M. is a member of the scientific advisory board for Janssen. M.C. is on the Abbott Vascular DSMB. K.R. is a member of the Scientific Advisory Board or Consultant for Abbott Vascular, Access Vascular, Boston Scientific-BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and University of Maryland; an unpaid member of the Scientific Advisory Board of Thrombolex, Inc; received grants from NIH and Boston Scientific; has equity from Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture, Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501c3, and National PERT ConsortiumTM, a not for profit 501c3. A.F. is a grant recipient of the Novo Nordisk Foundation; a consultant for Sanifit, LeMaitre, and BioGenCell; and on the advisory board for Dialysis-X and iThera Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Patients with peripheral artery disease (PAD) experience major cardiovascular and limb events. Antithrombotic strategies including antiplatelets and anticoagulants remain a cornerstone of treatment and prevention. Recent trials have shown heterogeneity in the response to antithrombotic therapies in patients presenting primarily with PAD when compared to those presenting primarily with coronary artery disease. In addition, there is observed heterogeneity with regards to the effects of antiplatelets and anticoagulants with respect to different outcomes including cardiovascular and major adverse limb events. This, coupled with risks of bleeding, requires a patient-centered and holistic assessment of benefit-risk when selecting antithrombotic strategies for patients with PAD. A global multidisciplinary work group was convened to evaluate antithrombotic strategies in PAD and to summarize the current state of the art. Common clinical scenarios around antithrombotic decision making were provided. Finally, insights with regard to implementation future investigation were described., Competing Interests: Funding Support and Author Disclosures Drs Bonaca and Hess work with CPC, a nonprofit academic research organization affiliated with the University of Colorado that has received research grant/consulting funding from Abbott Laboratories, Agios Pharmaceuticals Inc, Alexion Pharma, Alnylam Pharmaceuticals Inc, Amgen Inc, Angionetics Inc, Anthos Therapeutics, ARCA Biopharma Inc, Array BioPharma Inc, AstraZeneca and Affiliates, Atentiv LLC, Audentes Therapeutics Inc, Bayer and Affiliates, Beth Israel Deaconess Medical Center, Better Therapeutics Inc, Boston Clinical Research Institute, Bristol Myers Squibb Company, Cambrian Biopharma Inc, Cardiol Therapeutics Inc, CellResearch Corp, Cleerly Inc, Cook Regentec LLC, CSL Behring LLC, Eidos Therapeutics, Inc, EP Trading Co Ltd, EPG Communication Holdings Ltd, Epizon Pharma Inc, Esperion Therapeutics Inc, Everly Well Inc, Exicon Consulting Pvt Ltd, Faraday Pharmaceuticals Inc, Foresee Pharmaceuticals Co Ltd, Fortress Biotech Inc, HDL Therapeutics Inc, HeartFlow Inc, Hummingbird Bioscience, Insmed Inc, Ionis Pharmaceuticals, IQVIA Inc, Janssen and Affiliates, Kowa Research Institute Inc, Kyushu University, Lexicon Pharmaceuticals Inc, Medimmune Ltd, Medpace, Merck & Affiliates, Nectero Medical Inc, Novartis Pharmaceuticals Corp, Novo Nordisk Inc, Osiris Therapeutics Inc, Pfizer Inc, PhaseBio Pharmaceuticals Inc, PPD Development, LP, Prairie Education and Research Cooperative, Prothena Biosciences Limited, Regeneron Pharmaceuticals Inc, Regio Biosciences Inc, Saint Luke’s Hospital of Kansas City, Sanifit Therapeutics SA, Sanofi Groupe, Silence Therapeutics PLC, Smith & Nephew plc, Stanford Center for Clinical Research, Stealth BioTherapeutics Inc, State of Colorado CCPD Grant, The Brigham & Women's Hospital Inc, The Feinstein Institutes for Medical Research, Thrombosis Research Institute, University of Colorado, University of Pittsburgh, VarmX, Virta Health Corporation, Worldwide Clinical Trials Inc, WraSer LLC, and Yale Cardiovascular Research Group. Dr Bonaca has received support from the AHA SFRN under award numbers 18SFRN3390085 (BWH-DH SFRN Center) and 18SFRN33960262 (BWH-DH Clinical Project). Dr Barnes has received grants from Boston Scientific; has received consulting fees from Pfizer, and Bristol Myers Squibb, Janssen, Bayer, AstraZeneca, Sanofi, Anthos, Abbott Vascular, Boston Scientific; has been part of the Data and Safety Monitoring Board (DSMB) for Translational Sciences (Clinical Events Adjudication Committee); and has been a member of the Board of Directors - Anticoagulation Forum. Dr Bauersachs has received personal fees from Bayer, Bristol Myers Squibb, LEO-Pharma, Pfizer, VIATRIS; and has received research support from the Bavarian State Ministry of Health and FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti). Dr Conte has received grants from BioGenCell and Profusa; and has been a member of the DSMB for Abbott Vascular. Dr Mena-Hurtado has received consulting fees from Abbott, Cook, and Penumbra; and has received grants from the National Institutes of Health, Philip, Shockwave, and Abbott. Dr Weitz has received consulting fees from Alnylam, Anthos, Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Ionis, JnJ, Merck, and Regeneron. Dr Beckman has received grants from Bristol Myers Squibb; and has received consulting fees from JanOne, Janssen, Novartis, MingSight, and Merck. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Objective: Cardiovascular complications after revascularization to treat chronic limb-threatening ischemia (CLTI) are a major concern that guides treatment. Our goal was to assess periprocedural cardiac and vascular serious adverse events (SAEs) in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial., Methods: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion., Results: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P = .35). Overall, there were 53 cardiac SAEs (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm, they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P = .2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P = .19). In total, there were 59 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm, they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively., Conclusions: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe., Competing Interests: Disclosures J.J.S. reports education grants from WL Gore and BD paid to Boston University. A.F. is a consultant for Sanifit. M.T.M. has served on the scientific advisory board for Janssen. M.S.C. is on the Data Safety Monitoring Board for Abbott Vascular. K.R. is a member of the scientific advisory board or a consultant for Abbott Vascular, Access Vascular, Boston Scientific-BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and University of Maryland; is an unpaid member of the scientific advisory board of Thrombolex, Inc; received grants from the National Institutes of Health and Boston Scientific; has equity from Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501c3, and National PERT Consortium, a not-for-profit 501c3. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: The prevalence of peripheral artery disease is growing, with millions of people globally suffering its end-stage manifestation, chronic limb-threatening ischemia (CLTI). Revascularization procedures like lower extremity bypass play a vital role in limb salvage but optimal medical therapy is essential for maximizing the benefit of these procedures and reducing long-term risks of cardiovascular and limb-related events., Recent Findings: Patients with PAD who undergo lower extremity bypass warrant a comprehensive approach to risk factor modification for both primary and secondary prevention of cardiovascular and limb-related complications. This includes appropriate use of high-intensity statins, smoking cessation, and management of hypertension and diabetes. Additionally, antiplatelet therapy is indicated for all patients with CLTI and additional treatment with low-dose anticoagulation may also be beneficial., Summary: Optimal medical therapy is essential for optimizing outcomes in patients with PAD undergoing lower extremity bypass., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Postoperative delirium is a common complication following open abdominal aortic aneurysm repair (OAR). Opioids have been found to contribute to delirium, especially at higher doses. This study assessed the impact of early postoperative opioid analgesia on postoperative delirium incidence and time to onset. We hypothesized that higher early postoperative opioid utilization would be associated with increased postoperative delirium incidence., Methods: This was a retrospective analysis of OAR cases at a single quaternary care center from years 2012-2020. The primary exposure was oral morphine equivalents use (OME), calculated for postoperative days 1-7. A cut point analysis using a receiver operator curve for postoperative delirium determined the threshold for high OME (OME>37 mg). The primary outcome was postoperative delirium incidence identified via chart review. Multivariable logistic regression was performed for postoperative delirium and adjusted for covariates meeting P < 0.1 on bivariate analysis., Results: Among 194 OAR cases, 67 (35%) developed postoperative delirium with median time to onset of 3 days (IQR = 2-6). Patients with postoperative delirium were older (74 years vs. 69 years), more frequently presented with symptomatic AAA (47% vs. 27%) and had a higher proportion of comorbidities (all P < 0.05). Cases with high OME utilization on postoperative day 1 (55%) were younger (69 vs. 73 years), less frequently had an epidural (46% vs. 77%), and more frequently developed delirium (42% vs. 25%, all P < 0.05). Epidural use was associated with a significant decrease in OME utilization on postoperative day 1 (33 vs. 83, P < 0.01). Postoperative delirium onset was later in those with high OME use (4 vs. 2 days, P = 0.04). On multivariable analysis, high OME remained associated with postoperative delirium (Table II)., Conclusions: High opioid utilization on postoperative day 1 is associated with increased postoperative delirium and epidural along with acetaminophen use reduced opioid utilization. Future study should examine the impact of opioid reduction strategies on outcomes after major vascular surgery., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Acute vascular injury provokes an inflammatory response, resulting in neointimal hyperplasia (NIH) and downstream pathologies. The resolution of inflammation is an active process in which specialized proresolving lipid mediators (SPM) and their receptors play a central role. We sought to examine the acute phase response of SPM and their receptors in both circulating blood and the arterial wall in a rat angioplasty model. We found that the ratio of proresolving to pro-inflammatory lipid mediators (LM) in plasma decreased sharply 1 day after vascular injury, then increased slightly by day 7, while that in arteries remained depressed. Granulocyte expression of SPM receptors ALX/FPR2 and DRV2/GPR18, and a leukotriene B4 receptor BLT1 increased postinjury, while ERV1/ChemR23 expression was reduced early and then recovered by day 7. Importantly, we show unique arterial expression patterns of SPM receptors in the acute setting, with generally low levels through day 7 that contrasted sharply with that of the pro-inflammatory CCR2 receptor. Overall, these data document acute, time-dependent changes of LM biosynthesis and SPM receptor expression in plasma, leukocytes, and artery walls following acute vascular injury. A biochemical imbalance between inflammation and resolution LM pathways appears persistent 7 days after angioplasty in this model. These findings may help guide therapeutic approaches to accelerate vascular healing and improve the outcomes of vascular interventions for patients with advanced atherosclerosis., (© 2024 The Author(s). Physiological Reports published by Wiley Periodicals LLC on behalf of The Physiological Society and the American Physiological Society.)

Objective: Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial., Methods: As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); (3) time to resolution of presenting CLTI symptoms; and (4) incidence of recurrent CLTI. Time-to-event analyses were performed by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N = 1434; cohort 2: lacking suitable SSGSV, N = 396), and multivariate stratified Cox regression models were created., Results: In cohort 1, there was a significant difference in time to clinical failure (log-rank P < .001), hemodynamic failure (log-rank P < .001), and resolution of presenting symptoms (log-rank P = .009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank P = .006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with a significantly lower risk of clinical and hemodynamic failure in both cohorts and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates (end-stage renal disease [ESRD], prior revascularization, smoking, diabetes, age >80 years, WIfI stage, tissue loss, and infrapopliteal disease). Factors independently associated with clinical failure included age >80 years in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2., Conclusions: Durable clinical and hemodynamic benefit after revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions, and limb loss. When compared with ENDO, initial treatment with OPEN surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms., Competing Interests: Disclosures M.T.M. is the advisor for Janssen. A.F. grants from Novo Nordisk Foundation; is a consultant for Sanifit, LeMaitre, and BioGenCell; and is on the advisor board of Dialysis-X and iThera Medical. L.C.C. is a consulting speaker for Cook Medical. P.A.S. is a consultant for Medtronic, Boston Scientific, Philips, Silk Road, Surmodics, Cagent, and Limflow. B.M.H. reports research grants (site PI for clinical trials, no compensation) from Boston Scientific and NIH/NHLBI. M.D.D. is a consultant for Cook Medical, W.L. Gore, and Boston Scientific. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; and owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi. K.R. or his institution (on his behalf) receives research grants from the following entities: NIH, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. He serves as a member of the Board of Directors of the following organization: The National PERT Consortium. M.S.C. has a relationship with Abbott Vascular DSMB. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Infrapopliteal peripheral vascular interventions (PVIs) for claudication are still performed in the USA. This study aimed to evaluate whether infrapopliteal PVI is associated with worse long term outcomes than isolated femoropopliteal PVI for treatment of claudication., Methods: A retrospective analysis of fee for service claims in a national administrative database was conducted using 100% of the Medicare fee for service claims between 2017 and 2019 to capture all Medicare beneficiaries who underwent an index infra-inguinal PVI for claudication. Hierarchical Cox proportional hazards models were performed to assess the association of infrapopliteal PVI with conversion to chronic limb threatening ischaemia (CLTI), repeat PVI, and major amputation., Results: In total, 36 147 patients (41.1% female; 89.7% age ≥ 65 years; 79.0% non-Hispanic White ethnicity) underwent an index PVI for claudication, of whom 32.6% (n = 11 790) received an infrapopliteal PVI. Of these, 61.4% (n = 7 245) received a concomitant femoropopliteal PVI and 38.6% (n = 4 545) received an isolated infrapopliteal PVI. The median follow up time was 3.5 years (interquartile range 2.7, 4.3). Patients receiving infrapopliteal PVI had a higher three year cumulative incidence of conversion to CLTI (26.0%; 95% confidence interval [CI] 24.9 - 27.2% vs. 19.9%; 95% CI 19.1 - 20.7%), repeat PVI (56.0%; 95% CI 54.8 - 57.3% vs. 45.7%; 95% CI 44.9 - 46.6%), and major amputation (2.2%; 95% CI 1.8 - 2.6% vs. 1.3%; 95% CI 1.1 - 1.5%) compared with patients receiving isolated femoropopliteal PVI. After adjusting for patient and physician level characteristics, the risk of conversion to CLTI (adjusted hazard ratio [aHR] 1.31, 95% CI 1.23 - 1.39), repeat PVI (aHR 1.12, 95% CI 1.05 - 1.20), and major amputation (aHR 1.72, 95% CI 1.42 - 2.07) remained significantly higher for patients receiving infrapopliteal PVI. An increasing number of infrapopliteal vessels treated during the index intervention was associated with increasingly poor outcomes (p < .001 for trend)., Conclusion: Infrapopliteal PVI for claudication is associated with worse long term outcomes relative to isolated femoropopliteal PVI., (Copyright © 2024 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication., Objectives: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication., Methods: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models., Results: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease., Conclusions: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting., Methods: This is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis)., Results: Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot., Conclusions: In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass., Competing Interests: Disclosures M.S.C. reports co-chair, BEST-CLI Executive Committee. J.S.H., W.G.J., P.A.S., and S.M.V. report BEST-CLI investigators., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints., Methods: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models., Results: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial., Conclusions: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions., Competing Interests: Disclosures M.C. is on the DSMB for Abbott Vascular. M.M. is an advisor for Janssen. K.R. receives income as a consultant or member of a scientific advisory board for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, BectonDickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi; serves as a member of the board of directors of the following organization: The National PERT ConsortiumTMA; and K.R. or his institution (on his behalf) receive research grants from the following entities: NIH, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. A.F. received a grant from Novo Nordisk Foundation; is a consultant with Sanifit, LeMaitre, and BioGenCell; and is on the advisory board for Dialysis-X and iThera Medical. E.A. is a consultant with Philips and is participating in clinical trials with Inari Medical. C.M. is a consultant with Cook, Abbott, Penumra, and Optum Labs; and received a research grant from Shockwave and Philips., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits., Methods: A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS., Results: Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12)., Conclusions: In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS., Competing Interests: Disclosures M.C. is an advisory board member for Abbott Vascular., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL)., Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression., Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P =0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P =0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P =0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P =0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P =0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P =0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P =0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P =0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure., Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference., Competing Interests: Disclosures M.T.M. is an advisor to Janssen. A.F. is an advisor to Sanifit. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, InspireMD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi. K.R. owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi. K.R. or his institution (on his behalf) receives research grants from the following entities: National Institutes of Health, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. K.R. serves as a member of the board of directors of the National Pulmonary Embolism Response Team Consortium. M.S.C. is a Data Safety Monitoring Board member for an Abbott Vascular Clinical Trial. J.J.S. received an education grant from WL Gore paid to Boston University and an education grant from Becton Dickinson paid to Boston University. M.D.D. is a consultant for Cook Medical, WL Gore, and Boston Scientific. M.R.J. is a part-time employee for Boston Scientific. B.G. is a consultant to Surmodics and Hart Clinical Consultants. J.A.K. was a consultant and speaker for Cook Medical during the time of the study. The other authors report no conflicts.

Objective: Open abdominal aortic aneurysm repair (OAR) is a major vascular procedure that incurs a large physiologic demand, increasing the risk for complications such as postoperative delirium (POD). We sought to characterize POD incidence, identify delirium risk factors, and evaluate the effect of delirium on postoperative outcomes. We hypothesized that POD following OAR would be associated with increased postoperative complications and resource utilization., Methods: This was a retrospective study of all OAR cases from 2012 to 2020 at a single tertiary care center. POD was identified via a validated chart review method based on key words and Confusion Assessment Method assessments. The primary outcome was POD, and secondary outcomes included length of stay, non-home discharge, 90-day mortality, and 1-year survival. Bivariate analysis as appropriate to the data was used to assess the association of delirium with postoperative outcomes. Multivariable binary logistic regression was used to identify risk factors for POD and Cox regression for variables associated with worse 1-year survival., Results: Overall, 198 OAR cases were included, and POD developed in 34% (n = 67). Factors associated with POD included older age (74 vs 69 years; P < .01), frailty (50% vs 28%; P < .01), preoperative dementia (100% vs 32%; P < .01), symptomatic presentation (47% vs 27%; P < .01), preoperative coronary artery disease (44% vs 28%; P = .02), end-stage renal disease (89% vs 32%; P < .01) and Charlson Comorbidity Index score >4 (42% vs 26%; P = .01). POD was associated with 90-day mortality (19% vs 5%; P < .01), non-home discharge (61% vs 30%; P < .01), longer median hospital length of stay (14 vs 8 days; P < .01), longer median intensive care unit length of stay (6 vs 3 days; P < .01), postoperative myocardial infarction (7% vs 2%; P = .045), and postoperative pneumonia (19% vs 8%; P = .01). On multivariable analysis, risk factors for POD included older age, history of end-stage renal disease, lack of epidural, frailty, and symptomatic presentation. A Cox proportional hazards model revealed that POD was associated with worse survival at 1 year (hazard ratio, 3.8; 95% confidence interval, 1.6-9.0; P = .003)., Conclusions: POD is associated with worse postoperative outcomes and increased resource utilization. Future studies should examine the role of improved screening, implementation of delirium prevention bundles, and multidisciplinary care for the most vulnerable patients undergoing OAR., Competing Interests: Disclosures None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications., (© The Author(s). Published by Elsevier Inc. on behalf of The Society for Vascular Surgery, Elsevier B.V on behalf of European Society for Vascular Surgery and John Wiley & Sons Ltd.)

Introduction: The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene., Methods: A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool., Results: From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO 2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO 2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10)., Conclusions: Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO 2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Introduction: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality., Methods: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided., Results: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions., Conclusions: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO 2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO 2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Background: Nonhome discharge (NHD) to a rehabilitation or skilled nursing facility after elective endovascular aortic repair (EVAR) is uncommon. However, NHD after surgery has an important impact on patient quality of life and postdischarge outcomes. Understanding factors that put patients undergoing EVAR at high risk for NHD is essential to providing adequate preoperative counseling and shared decision making. This study aimed to identify independent predictors of NHD following elective EVAR and to create a clinically useful preoperative risk score., Methods: Elective EVAR cases were queried from the Society for Vascular Surgery Vascular Quality Initiative 2014-2018. A risk score was created by splitting the data set into two-thirds for development and one-third for validation. A parsimonious stepwise hierarchical multivariable logistic regression controlling for hospital level variation was performed in the development dataset, and the beta-coefficients were used to assign points for a risk score. The score was then validated, and model performance assessed., Results: Overall, 24,426 patients were included and 932 (3.8%) required NHD. Multivariable analysis in the development group identified independent predictors of NHD, which were used to create a 20-point risk score. Patients were stratified into 3 groups based upon their risk score: low risk (0-7 points; n = 16,699) with an NHD rate of 1.8%, moderate risk (8-13 points; n = 7,315) with an NHD rate of 7.3%, and high risk (≥14 points; n = 412) with an NHD rate of 21.8%. The risk score had good predictive ability with c-statistic = 0.75 for model development and c-statistic = 0.73 in the validation dataset., Conclusions: This novel risk score can predict NHD following EVAR using characteristics that can be identified preoperatively. Utilization of this score may allow for improved risk assessment, preoperative counseling, and shared decision making., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Based on data supporting a volume-outcome relationship in elective aortic aneurysm repair, the Society of Vascular Surgery (SVS) guidelines recommend that endovascular aortic repair (EVAR) be localized to centers that perform ≥10 operations annually and have a perioperative mortality and conversion-to-open rate of ≤2% and that open aortic repair (OAR) be localized to centers that perform ≥10 open aortic operations annually and have a perioperative mortality ≤5%. However, the number and distribution of centers meeting the SVS criteria remains unclear. This study aimed to estimate the temporal trends and geographic distribution of Centers Meeting the SVS Aortic Guidelines (CMAG) in the United States., Methods: The SVS Vascular Quality Initiative was queried for all OAR, aortic bypasses, and EVAR from 2011 to 2019. Annual OAR and EVAR volume, 30-day elective operative mortality for OAR or EVAR, and EVAR conversion-to-open rate for all centers were calculated. The SVS guidelines for OAR and EVAR, individually and combined, were applied to each institution leading to a CMAG designation. The proportion of CMAGs by region (West, Midwest, South, and Northeast) were compared by year using a χ 2 test. Temporal trends were estimated using a multivariable logistic regression for CMAG, adjusting by region., Results: Overall, 67,865 patients (49,264 EVAR; 11,010 OAR; 7591 aortic bypasses) at 336 institutions were examined. The proportion of EVAR CMAGs increased nationally by 1.7% annually from 51.6% (n = 33/64) in 2011 to 67.1% (n = 190/283) in 2019 (β = .05; 95% confidence interval [CI], 0.01-0.09; P = .02). The proportion of EVAR CMAGs across regions ranged from 27.3% to 66.7% in 2011 to 63.9% to 72.9% in 2019. In contrast, the proportion of OAR CMAGs has decreased nationally by 1.8% annually from 32.8% (n = 21/64) in 2011 to 16.3% (n = 46/283) in 2019 (β = -.14; 95% CI, -0.19 to -0.10; P < .01). Combined EVAR and OAR CMAGs were even less frequent and decreased by 1.5% annually from 26.6% (n = 17/64) in 2011 to 13.1% (n = 37/283) in 2019 (β = -.12; 95% CI, -0.17 to -0.07; P < .01). In 2019, there was no significant difference in regional variation of the proportion of combined EVAR and OAR CMAGs (P = .82)., Conclusions: Although an increasing proportion of institutions nationally meet the SVS guidelines for EVAR, a smaller proportion meet them for OAR, with a concerning downward trend. These data question whether we can safely offer OAR at most institutions, have important implications about sufficient OAR exposure for trainees, and support regionalization of OAR., Competing Interests: Disclosures None., (Copyright © 2023. Published by Elsevier Inc.)

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Objective: Anticipated perioperative morbidity is an important factor for choosing a revascularization method for chronic limb-threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications of patients treated with surgical and endovascular revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial., Methods: BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed., Results: There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events., Conclusions: In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Specialized pro-resolving lipid mediators (SPM) such as resolvin D1 (RvD1) attenuate inflammation and exhibit vasculo-protective properties., Methods: We investigated poly-lactic-co-glycolic acid (PLGA)-based nanoparticles (NP), containing a peptide targeted to tissue factor (TF) for delivery of 17R-RvD1 and a synthetic analog 17-R/S-benzo-RvD1 (benzo-RvD1) using in vitro and in vivo models of acute vascular injury. NPs were characterized in vitro by size, drug loading, drug release, TF binding, and vascular smooth muscle cell migration assays. NPs were also characterized in a rat model of carotid angioplasty., Results: PLGA NPs based on a 75/25 lactic to glycolic acid ratio demonstrated optimal loading (507.3 pg 17R-RvD1/mg NP; P  = ns) and release of RvD1 (153.1 pg 17R-RvD1/mg NP; P  < .05). NPs incorporating the targeting peptide adhered to immobilized TF with greater avidity than NPs with scrambled peptide (50 nM: 41.6 ± 0.52 vs 32.66 ± 0.34; 100 nM: 35.67 ± 0.95 vs 23.5 ± 0.39; P  < .05). NPs loaded with 17R-RvD1 resulted in a trend toward blunted vascular smooth muscle cell migration in a scratch assay. In a rat model of carotid angioplasty, 16-fold more NPs were present after treatment with TF-targeted NPs compared with scrambled NPs ( P  < .01), with a corresponding trend toward higher tissue levels of 17R-RvD1 ( P  = .06). Benzo-RvD1 was also detectable in arteries treated with targeted NP delivery and accumulated at 10 times higher levels than NP loaded with 17R-RvD1. There was a trend toward decreased CD45 immunostaining in vessels treated with NP containing benzo-RvD1 (0.76 ± 0.38 cells/mm 2 vs 122.1 ± 22.26 cells/mm 2 ; P  = .06). There were no significant differences in early arterial inflammatory and cytokine gene expression by reverse transcription-polymerase chain reaction., Conclusions: TF-targeting peptides enhanced NP-mediated delivery of SPM to injured artery. TF-targeted delivery of SPMs may be a promising therapeutic approach to attenuate the vascular injury response., Competing Interests: M.S.C. and T.D. are co-inventors on US Patents Nos. 9,463,177 and 10,111,847 assigned to the University of California and Brigham and Womens Hospital. M.S.C. and T.D. are co-founders of VasaRx., (© 2023 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.)

Objectives: The use of optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, randomized, controlled trial sponsored by the National Institutes of Health comparing revascularization strategies in patients with CLTI. We evaluated the use of guideline-based OMT among patients with CLTI at the time of their enrollment into the trial., Methods: A multidisciplinary committee defined OMT criteria related to blood pressure and diabetic management, lipid-lowering and antiplatelet medication use, and smoking status for patients enrolled in BEST-CLI. Status reports indicating adherence to OMT were provided to participating sites at regular intervals. Baseline demographic characteristics, comorbid medical conditions, and use of OMT at trial entry were evaluated for all randomized patients. A linear regression model was used to identify the relationship of predictors to the use of OMT., Results: At the time of randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently smoking. Adherence to four OMT components (controlled blood pressure, not currently smoking, use of one lipid-lowering medication, and use of an antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 38% met three, 24% met two, 11% met only one, and 2% met none. Age ≥80 years, coronary artery disease, diabetes, and Hispanic ethnicity were positively associated, whereas Black race was negatively associated, with the use of OMT., Conclusions: A significant proportion of patients in BEST-CLI did not meet OMT guideline-based recommendations at time of entry. These data suggest a persistent major gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial and their impact on clinical outcomes and quality of life will be assessed in future analyses., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Patients with chronic limb-threatening ischemia (CLTI) are at high risk for adverse limb outcomes and mortality. Using the Vascular Quality Initiative (VQI) prediction model to estimate mortality after revascularization can assist with clinical decision-making. We aimed to improve the discrimination of the 2-year VQI risk calculator by incorporating a common iliac artery (CIA) calcification score based on computed tomography scans., Methods: This was a retrospective analysis of patients who underwent infrainguinal revascularization for CLTI from January 2011 to June 2020 and had a computed tomography scan of the abdomen/pelvis 2 years before or up to 6 months after revascularization. CIA calcium morphology, circumference, and length were scored. Bilateral scores were summed for the total calcium burden (CB) score, which was trichotomized (mild, 0-15; moderate, 16-19; severe, 20-22). The VQI CLTI model was used to categorize patients as low, medium, or high risk for mortality., Results: A total of 131 patients with a mean age of 69±12 years were included in the study, and 86 (66%) were men. CB scores were mild in 52 (40%), moderate in 26 (20%), and severe in 53 (40%) patients. Older patients (P = .0002) and those with coronary artery disease (P = .06) had higher CB scores. Patients with severe CB scores were more likely to undergo infrainguinal bypass compared with those with mild or moderate CB scores (P = .006). The 2-year VQI mortality risk was calculated to be low in 102 (78%), medium in 23 (18%), and high in 6 (4.6%) patients. In the "low-risk" VQI mortality subgroup, 46 (45%) patients had mild, 18 (18%) had moderate, and 38 (37%) had severe CB scores, and patients with severe CB scores had significantly higher risk of mortality compared with those with mild or moderate scores (hazard ratio, 2.5; 95% confidence interval, 1.2-5.1; P = .01). In this "low-risk" VQI mortality subgroup, CB score further stratified the risk of mortality (P = .04)., Conclusions: Higher total CIA calcification was significantly associated with mortality in patients undergoing infrainguinal revascularization for CLTI, and preoperative assessment of CIA calcification may help with perioperative risk stratification and guide clinical decision making in this population., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Perioperative statin use has been shown to improve survival in vascular surgery patients. In 2018, the Northern California Vascular Study Group implemented a quality initiative focused on the use of a SmartText in the discharge summary. We hypothesized that structured discharge documentation would decrease sex-based disparities in evidence-based medical therapy., Methods: A retrospective analysis was conducted using Vascular Quality Initiative eligible cases at a single institution. Open or endovascular procedures in the abdominal aorta or lower extremity arteries from 2016 to 2021 were included. Bivariate analysis identified factors associated with statin use and sex. Multivariate logistic regression was performed with the end point of statin prescription at discharge and aspirin prescription at discharge. An interaction term assessed the differential impact of the initiative on both sexes. Analysis was then stratified by prior aspirin or statin prescription. An interrupted time series analysis was used to evaluate the trend in statin prescription over time., Results: Overall, 866 patients were included, including 292 (34%) female and 574 (66%) male patients. Before implementation, statins were prescribed in 77% of male and 62% of female patients (P < .01). After implementation, there was no statistically significant difference in statin prescription (91% in male vs 92% in female patients, P = .68). Female patients saw a larger improvement in the adjusted odds of statin prescription compared with male patients (odds ratio: 3.1, 95% confidence interval: 1.1-8.6, P = .04). For patients not prescribed a statin preoperatively, female patients again saw an even larger improvement in the odds of being prescribed a statin at discharge (odds ratio: 6.4, 95% confidence interval: 1.8-22.7, P < .01). Interrupted time series analysis demonstrated a sustained improvement in the frequency of prescription for both sexes over time. The unadjusted frequency of aspirin prescription also improved by 3.5% in male patients vs 5.5% in female patients. For patients not prescribed an aspirin preoperatively, we found that the frequency of aspirin prescription significantly improved for both male (19% increase, P = .006) and female (31% increase, P = .001) patients. There was no significant difference in the perioperative outcomes between male and female patients before and after standardized discharge documentation., Conclusions: A simple, low-cost regional quality improvement initiative eliminated sex-based disparities in statin prescription at a single institution. These findings highlight the meaningful impact of regional quality improvement projects. Future studies should examine the potential for structured discharge documentation to improve patient outcomes and reduce disparities., (Published by Elsevier Inc.)