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

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% conf

ObjectiveCarotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with increased risk of stroke and death compared to CEA.Summary background dataTranscarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and one-year outcomes compared to CEA. We aimed to compare the one-year and three-year outcomes of TCAR vs. CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked (Vascular Implant Surveillance & Interventional Outcomes Network [VISION]) database.MethodsThe VISION Database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was one-year and three-years survival. One-to-one propensity-score matching (PSM) without replacement was used to produce two well-matched cohorts. Kaplan-Meier estimates, and Cox regression were used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison.ResultsA total of 43,714 patients underwent CEA and 8,089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7,351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in one-year death (HR=1.13, 95% CI: 0.99-1.30; P=0.065). At three-years, TCAR was associated with slight increased risk of death (HR=1.16, 95% CI: 1.04-1.30; P=0.008). When stratifying by initial symptomatic presentation, the increased three-year death associated with TCAR persisted only in symptomatic patients (HR=1.33, 95% CI: 1.08-1.63; P=0.008). Exploratory analyses of post-operative stroke rates using administrative sources suggested that validated measures of claims-based stro

Clifford A Reilly,1 Makenna L Rice,2 Dylan J Parker,2 Philip P Goodney,3– 6 Jon D Lurie,3,4 Said A Ibrahim,7,8 Eric R Henderson2,4,6 1Larner College of Medicine, University of Vermont, Burlington, VT, USA; 2Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA; 3The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Hanover, NH, USA; 4Geisel School of Medicine, Dartmouth College, Hanover, NH, USA; 5Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA; 6White River Junction VA Medical Center, US Department of Veterans Affairs, White River Junction, VT, USA; 7Zucker School of Medicine, Hofstra University/Northwell Health, Hempstead, NY, USA; 8Department of Medicine, Long Island Jewish Medical Center, New Hyde Park, NY, USACorrespondence: Makenna L Rice, Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, 1 Medical Center Dr, Rubin 592, Lebanon, NH, 03756, USA, Tel +1 831 247-1106, Fax +1 603 653-3581, Email Makenna.L.Rice@hitchcock.orgIntroduction: Decision aids are effective tools in facilitating patient-centered care and patient involvement in the decision-making process. Given unique barriers to providing patient-centered care for Veterans, implementation of decision aids may improve overall quality of care. We aimed to assess the acceptability and feasibility of video-based and pamphlet-based decision aid use in Veterans with knee osteoarthritis.Materials and Methods: Veterans considering treatment for knee osteoarthritis received either an online video-based aid, pamphlet-based aid, or both before their surgical consult. At their visit, patients completed written pre-visit and post-visit questionnaires. The pre-visit questionnaire included questions about the patient’s demographics, decision-making preferences, experiences using the assigned decision aids, and the Hip-Knee Decision Quality Instrument. The post-visit questionnaire assessed the patientâ€

ObjectivesGenerating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.Design setting and participantsWe invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.Main outcome measuresConsensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.ResultsOf 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.ConclusionsWe have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The d

Objective: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). Although typically characterized as major or minor on the extent of tissue loss, the etiologies and outcomes after amputation by extent are not well-understood. In addition, emerging data suggest that the drivers and outcomes of amputation in patients with PAD may differ in those with and without diabetes mellitus (DM). Methods: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5345 with concomitant diabetes, to ticagrelor or clopidogrel and followed them for long-term outcomes. Amputations were prospectively reported by trial investigators. Their primary and contributing drivers were adjudicated using safety data, including infection, ischemia, or multifactorial etiologies. Outcomes following major and minor amputations were analyzed, including recurrent amputation, major adverse limb events, adverse cardiovascular events, and mortality. Multivariable logistic regression models were used to identify independent predictors of minor amputations. Analyses were performed overall and stratified by the presence or absence of DM at baseline. Results: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity nontraumatic amputation, for a total of 511 amputations (255 major and 256 minor) over a median of 30 months. A history of minor amputation was the strongest independent predictor for a subsequent minor amputation (odds ratio, 7.29; 95% confidence interval, 5.17-10.30; P <.001) followed by comorbid DM (odds ratio, 4.60; 95% confidence interval, 3.16-6.69; P <.001). Compared with patients who had a major amputation, those with a minor amputation had similar rates of subsequent major amputation (12.2% vs 13.6%), major adverse limb events (15.1% vs 14.9%), and major adverse cardiovascular events (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%), followed by infection alone (27%), and mul, Funding agencies:National Institutes of Health/National Center for Advancing Translational Sciences Colorado CTSI UL1 TR002535American Heart Association Strategically Focused Research Network in Vascular Disease 18SFRN3390085 18SFRN33960262

ObjectivesWe sought to develop a prediction score with data from the Vascular Quality Initiative (VQI) EVAR in efforts to assist endovascular specialists in deciding whether or not a patient is appropriate for short-stay discharge.BackgroundSmall series describe short-stay discharge following elective EVAR. Our study aims to quantify characteristics associated with this decision.MethodsThe VQI EVAR and NSQIP datasets were queried. Patients who underwent elective EVAR recorded in VQI, between 1/2010-5/2017 were split 2:1 into test and analytic cohorts via random number assignment. Cross-reference with the Medicare claims database confirmed all-cause mortality data. Bootstrap sampling was employed in model. Deep learning algorithms independently evaluated each dataset as a sensitivity test.ResultsUnivariate outcomes, including 30-day survival, were statistically worse in the DD group when compared to the SD group (all P < 0.05). A prediction score, SD-EVAR, derived from the VQI EVAR dataset including pre- and intra-op variables that discriminate between SD and DD was externally validated in NSQIP (Pearson correlation coefficient = 0.79, P < 0.001); deep learning analysis concurred. This score suggests 66% of EVAR patients may be appropriate for short-stay discharge. A free smart phone app calculating short-stay discharge potential is available through QxMD Calculate https://qxcalc.app.link/vqidis.ConclusionsSelecting patients for short-stay discharge after EVAR is possible without increasing harm. The majority of infrarenal AAA patients treated with EVAR in the United States fit a risk profile consistent with short-stay discharge, representing a significant cost-savings potential to the healthcare system.

ObjectiveVascular surgeons treating patients with ruptured abdominal aortic aneurysm must make rapid treatment decisions and sometimes lack immediate access to endovascular devices meeting the anatomic specifications of the patient at hand. We hypothesized that endovascular treatment of ruptured abdominal aortic aneurysm (rEVAR) outside manufacturer instructions-for-use (IFU) guidelines would have similar in-hospital mortality compared to patients treated on-IFU or with an infrarenal clamp during open repair (ruptured open aortic aneurysm repair [rOAR]).MethodsVascular Quality Initiative datasets for endovascular and open aortic repair were queried for patients presenting with ruptured infrarenal AAA between 2013-2018. Graft-specific IFU criteria were correlated with case-specific proximal neck dimension data to classify rEVAR cases as on- or off-IFU. Univariate comparisons between the on- and off-IFU groups were performed for demographic, operative and in-hospital outcome variables. To investigate mortality differences between rEVAR and rOAR approaches, coarsened exact matching was used to match patients receiving off-IFU rEVAR with those receiving complex rEVAR (requiring at least one visceral stent or scallop) or rOAR with infrarenal, suprarenal or supraceliac clamps. A multivariable logistic regression was used to identify factors independently associated with in-hospital mortality.Results621 patients were treated with rEVAR, with 65% classified as on-IFU and 35% off-IFU. The off-IFU group was more frequently female (25% vs. 18%, P = 0.05) and had larger aneurysms (76 vs. 72 mm, P= 0.01) but otherwise was not statistically different from the on-IFU cohort. In-hospital mortality was significantly higher in patients treated off-IFU vs. on-IFU (22% vs. 14%, P= 0.02). Off-IFU rEVAR was associated with longer operative times (135 min vs. 120 min, P= 0.004) and increased intraoperative blood product utilization (2 units vs. 1 unit, P= 0.002). When off-IFU patients wer

ObjectiveFrailty is increasingly recognized as a key determinant in predicting postoperative outcomes. Centers that see more frail patients may not be captured in risk adjustment, potentially accounting for poorer outcomes in hospital comparisons. We aimed to (1) determine the effect of frailty on long-term mortality in patients undergoing elective abdominal aortic aneurysm (AAA) repair and (2) evaluate the variability in frailty burden among centers in the Vascular Quality Initiative (VQI) database.MethodsPatients undergoing elective open and endovascular AAA repair (2003-2017) were identified, and those with complete data on component variables of the VQI-derived Risk Analysis Index (VQI-RAI) and centers with ≥10 AAA repairs were included. VQI-RAI characteristics are sex, age, body mass index, renal failure, congestive heart failure, dyspnea, preoperative ambulation, and functional status. Frailty was defined as VQI-RAI ≥35 based on prior work in surgical patients using other quality improvement databases. This corresponds to the top 12% of patients at risk in the VQI. Center-level VQI-RAI differences were assessed by analysis of variance test. Relationships between frailty and survival were compared by Kaplan-Meier analysis and the log-rank test for open and endovascular procedures. Multivariable hierarchical Cox proportional hazards regression models were calculated with random intercepts for center, controlling for frailty, race, insurance, AAA diameter, procedure type, AAA case mix, and year.ResultsA total of 15,803 patients from 185 centers were included. Mean VQI-RAI scores were 27.6 (standard deviation, 5.9; range, 4-56) and varied significantly across centers (F = 2.41, P < .001). The percentage of frail patients per center ranged from 0% to 40.0%. In multivariable analysis, frailty was independently associated with long-term mortality (hazard ratio, 2.88; 95% confidence interval, 2.6-3.2) after accounting for covariates and center-level varia

Matthew J Sabatino,1,2 Clifford A Reilly,1 Samuel T Kunkel,1,2 Alexander J Titus,2,3 Dipak B Ramkumar,1,2 Philip P Goodney,2,4 Said A Ibrahim,5,6 Jonathan D Lurie,1,2 Eric R Henderson2,71Department of Orthopaedic Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA; 2The Geisel School of Medicine, Dartmouth College, Hanover, NH 03755, USA; 3Program in Quantitative Biomedical Sciences, Geisel School of Medicine, Hanover, NH 03755, USA; 4Vascular Surgery Section, White River Junction VAMC, White River Junction, VT 05009, USA; 5Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA; 6Center of Innovation for Health Equity Research and Promotion (CHERP), VA Health Services and Research Development, Philadelphia, PA, 19104, USA; 7Orthopaedic Section, White River Junction VAMC, White River Junction, VT 05009, USAPurpose: Due to the nature of military service, the patient–physician relationship in Veterans is unlike that seen in civilian life. The structure of the military is hypothesized to result in barriers to open patient–physician communication and patient participation in elective care decision-making. Decision quality is a measure of concordance between a chosen treatment and the aspects of medical care that matter most to an informed patient; high decision quality is synonymous with patient-centered care. While past research has examined how age and other demographic factors affect decision quality in Veterans, duration of military service, rank at discharge, and years since discharge have not been studied.Patients and methods: We enrolled 25 Veterans with knee osteoarthritis at a VA hospital. Enrollees completed a survey with demographic, military service, and decision-making preference questions and the Hip-Knee Decision Quality Instrument (HK-DQI), which measures patients’ knowledge about their disease process, c

ImportanceLower extremity revascularization often seeks to allow patients with peripheral arterial disease to maintain the ability to walk, a key aspect of functional independence. Surgical outcomes in patients with high levels of functional dependence are poorly understood.ObjectiveTo determine functional status trajectories, changes in ambulatory status, and survival after lower extremity revascularization in nursing home residents.DesignUsing full Medicare claims data for 2005 to 2009, we identified nursing home residents who underwent lower extremity revascularization. With the Minimum Data Set for Nursing Homes activities of daily living summary score, we examined changes in their ambulatory and functional status after surgery. We identified patient and surgery characteristics associated with a composite measure of clinical and functional failure-death or nonambulatory status 1 year after surgery.SettingAll nursing homes in the United States participating in Medicare or Medicaid.ParticipantsNursing home residents who underwent lower extremity revascularization.Main outcomes and measuresFunctional status, ambulatory status, and death.ResultsDuring the study period, 10,784 long-term nursing home residents underwent lower extremity revascularization. Prior to surgery, 75% of the residents were not walking; 40% had experienced functional decline. One year after surgery, 51% of patients had died, 28% were nonambulatory, and 32% had sustained functional decline. Among 1672 residents who were ambulatory before surgery, 63% had died or were nonambulatory at 1 year; among 7188 who were nonambulatory, 89% had died or were nonambulatory. After multivariate adjustment, factors independently associated with death or nonambulatory status were 80 years or older (adjusted hazard ratio [AHR], 1.28; 95% CI, 1.16-1.40), cognitive impairment (AHR, 1.23; 95% CI, 1.18-1.29), congestive heart failure (AHR, 1.16; 95% CI, 1.11-1.22), renal failure (AHR, 1.09; 95% CI, 1.04-1.14), emerge