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

Background: Standard training for ultrasound-guided cyst needle aspiration is currently performed on live patients during residency. This practice presents risk of iatrogenic injury to patients and provides a high-stress learning environment for medical trainees. Simulation training using synthetic cysts in a formalin-embalmed cadaver model may allow for realistic, practical, and effective training free from patient risk., Methods: Thirty first-year medical students viewed an orientation video, then attended a skills workshop to perform cyst needle aspiration in formalin-embalmed cadaver tissue under ultrasound guidance. Participants were randomly assigned to one of three ultrasound-trained instructor-types which included a medical student, clinical anatomist, or an ultrasound fellowship trained emergency medicine physician. After training, participants underwent a 5-min skills test to assess their ability to drain a synthetic cyst independently. Pre- and post-training self-confidence surveys were administered., Results: Ultrasound images of synthetic cysts in formalin-embalmed tissue were clear and realistic in appearance, and sonographic needle visualization was excellent. Participants took an average of 161.5 s and 1.9 attempts to complete the procedure. Two of the 30 participants could not complete the procedure within the time limit. Participants' self-reported confidence with respect to all aspects of the procedure significantly increased post-training. Mean confidence scores rose from 1.2 (95% CI 0.96 to 1.39) to 4.4 (95% CI 4.09 to 4.53) (P < 0.0001) Procedure time, number of attempts, performance scores, and self-confidence outcomes were not significantly affected by instructor type., Conclusions: The use of synthetic cysts in formalin-embalmed cadaveric tissue is feasible, realistic, and efficacious for the teaching of ultrasound-guided needle aspiration to novice medical trainees. This simulation training method can be delivered effectively by multiple instructor types and may allow medical trainees to increase their tactical skill and self-confidence prior to performing ultrasound-guided cyst needle aspiration on live patients., (© 2024. The Author(s).)

Background: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries., Objectives: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review., Methods: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability., Results: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74)., Conclusions: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed., Competing Interests: Funding Support and Author Disclosures The VISION registry was supported by a Food and Drug Administration grant (U01FD006936 [to Dr Goodney]). Drs Smolderen and Mena are supported by National Institutes of Health grants 1R21AT012430-01 and 1R01HL163640-01A1. Dr Goodney is supported by a research grant from the American Heart Association (SRFN #18SFRN33900147). Dr Smolderen has received unrestricted research grants from Philips, Abbott, Merck, and Johnson & Johnson; and has served as a consultant for Optum Labs and Abbott, Happify, and Haemonetics. Dr Mena-Hurtado has served as a consultant for Abbott Vascular, Cook, Medtronic, Cardinal Health, and Optum Labs. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)