Peripheral arterial disease (PAD) represents a spectrum from asymptomatic stenosis to limb-threatening ischemia. The last decade has seen a tremendous increase in the variety of endovascular devices and techniques to treat occlusive disease. Like many evolving technologies, the literature surrounding therapy for endovascular arterial disease consists of mixed-quality manuscripts without clear standardization. Accordingly, critical evaluation of the reported results may be problematic. As such, providers and their patients make treatment decisions without the full benefit of a comparative effectiveness framework. The purpose of this document is to provide a summary for the reporting of endovascular revascularization techniques in the setting of chronic disease. Much of the work in this document is based on prior publications and standards proposed by the Society for Vascular Surgery. We have also made recommendations based on current literature and have attempted to acknowledge shortcomings and areas for future research. The various sections contain summaries of required reporting standards and should serve as a guide for the design of clinical trials and as reference for journal editors and reviewers when considering scientific work pertaining to endovascular therapy for chronic lower extremity arterial disease. An Appendix is provided with commonly used abbreviations in this document.

Understanding critical limb ischemia and its treatment strategies is important for providing the best care for affected patients. Currently, ongoing randomized clinical trials in North America and the United Kingdom aim to provide data to support the best management of these patients.

BackgroundCritical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence.Methods and ResultsThe Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST‐CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single‐segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event–Free Survival. Key secondary end points include Re‐intervention and Amputation‐Free‐Survival and Amputation Free‐Survival.ConclusionsThe BEST‐CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence‐based standard of care for this challenging patient population.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

Although the natural history of isolated abdominal aortic dissection has not been well defined, our experience adds to the understanding of this rare process. Because aneurysmal degeneration can occur, close surveillance is indicated if definitive treatment is not used initially. Patients with ischemic symptoms and those with intractable pain need intervention, the nature of which should be based on risk profile and aortoiliac anatomy.

Cryografts have low primary patency rates that are not affected by anticoagulation with warfarin sodium. Short-term patency of these grafts may be sufficient to heal ischemic wounds and thereby prevent limb loss. However, other less expensive alternatives, eg, prosthetic grafts with vein cuffs, are available and appear to have better patency. Accordingly, use of Cryografts should be limited to revascularization through infected fields in patients without autogenous conduit.

OBJECTIVES Early thrombosis (ET) contributes to autogenous arteriovenous fistula (AVF) failure. We studied patients undergoing AVF placement in the Hemodialysis Fistula Maturation (HFM) Study, a prospective, observational cohort study, using a nested case-control analysis to identify pre-operative and intra-operative predictors of ET. METHODS ET cases were compared to controls who were matched on gender, age, diabetes, dialysis status, and surgeon fistula volume. ET was defined as thrombosis diagnosed by physical exam or ultrasound within 18 days of AVF creation. Conditional logistic regression models were fit to identify risk factors for ET. RESULTS Thirty-two ET cases (5.3%) occurred among 602 study participants; 198 controls were matched. ET was associated with female gender (OR=2.75, CI 1.19–6.38, P=0.018), fistula location (forearm vs. upper arm) (OR=2.76, CI 1.05–7.23, P=0.039), feeding artery (radial vs. brachial) (OR=2.64, CI 1.03–6.77, P=0.043) and arterial diameter (OR=1.52, CI 1.02–2.26, P=0.039, per mm smaller). Draining vein diameter was nonlinearly associated with ET, with highest risk in 2–3 mm veins. Surprisingly, ET risk was lower in diabetics (OR=0.19, CI 0.07–0.47, P=0.0004), lower with less nitroglycerin-mediated brachial artery dilatation (NMD%) (OR=0.42, CI 0.20–1.92, P=0.029 for each 10% lower) and higher with lower carotid-femoral pulse wave velocity (OR=1.49, CI 1.02–2.20, P=0.041, for each m/sec lower). Intraoperative protamine use was associated with a higher ET risk (OR 3.26, CI 1.28-∞, P=0.038). Surgeon’s intraoperative perceptions were associated with ET: surgeons’ greater concern about maturation success (likely, marginal, unlikely) was associated with higher thrombosis risk (OR 8.09, CI 4.03-∞, p<0.0001, per category change), as were absence vs. presence of intraoperative thrill (OR 21.0, CI 5.07-∞, P=0.0002) and surgeons’ reported frustration during surgery (OR 6.85, CI 2.70-∞, P=0.0004). Reduced extent of intraoperative thrill (proximal, mid or distal third of the forearm or upper arm, based on AVF placement) was also associated with ET (OR 2.91, CI 1.31-∞, P=0.014, per diminished level). Oral antithrombotic medication use was not significantly associated with ET. CONCLUSIONS ET was found to be associated with female gender, forearm AVF, smaller arterial size, draining vein diameter of 2–3 mm, and protamine use. Paradoxically, diabetes and stiff, noncompliant feeding arteries were associated with lower frequency of ET. Absent or attenuated intraoperative thrill, and both surgeon frustration and concern about successful maturation during surgery, were strongly correlated with ET.

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In 2010, it was estimated that more than 200 million people worldwide were living with peripheral arterial disease. Chronic limbthreatening ischemia (CLTI) represents the end stage of peripheral arterial disease, which, left untreated, incurs a risk of major amputation, approaching 25% at 1 year. Despite the global scale and severe clinical consequences of CLTI, it has been poorly defined and variably managed. Prior guidelines, such as the Trans-atlantic Intersociety Consensus Document on the Management of Peripheral Arterial Disease (TASC II), have offered treatment recommendations based on disease anatomy alone. 1 A more contemporary, nuanced definition of the problem and thorough understanding of the state of evidence are required to guide medical treatment, revascularization strategies, and future study. 2 Characteristics of the Guideline SourceThree vascular societies formed the global vascular guideline initiative: the European Society for Vascular Surgery, the Society for Vascular Surgery, and the World Federation of Vascular Societies. The writing group was composed of 58 individuals from 24 countries and multiple medical and surgical specialties. Although the 3 sponsoring societies primarily represent vascular surgeons, these guidelines were endorsed by multiple international groups representing medical and interventional specialties. All funding for the guidelines was from the sponsoring societies. Direct industry funding of the guidelines was prohibited, and industry consultants were ex-cluded from both the writing and reviewing groups. Strict limits were set for contributing authors on industry income during work on the guidelines, and conflicts of interest were reported in detail. An open comment period was observed prior to publication. Evidence BaseAuthors used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methods to rate recommendation strength and quality of evidence. Final grading was determined by the guideline developers and a methodologist. Four systematic reviews were commissioned, subjected to peer review, and published in the Journal of Vascular Surgery, focusing on the natural history of CLTI, 3 nonrevascularization-based treatments, 4 and outcomes associated with revascularization. 5,6 The guidelines were published in the June 2019 issue of the