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Jemi Galani,1 Hillary Mulder,2 Frank W Rockhold,2 E Hope Weissler,2,3 Iris Baumgartner,4 Jeffrey S Berger,5 Juuso I Blomster,6 F Gerry R Fowkes,7 William R Hiatt,8,9 Brian G Katona,10 Lars Norgren,11 Kenneth W Mahaffey,12 Jennifer K Quint,13 Manesh R Patel,1,2 W Schuyler Jones1,2 1Department of Medicine, Duke University Medical Center, Durham, NC, USA; 2Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; 3Department of Surgery, Division of Vascular Surgery, Duke University Health System, Durham, NC, USA; 4Department of Medicine, Swiss Cardiovascular Center, University of Bern, Bern, Switzerland; 5Departments of Medicine and Surgery, New York University School of Medicine, New York, NY, USA; 6University of Turku, Turku, Finland; 7Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK; 8Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA; 9CPC Clinical Research, Aurora, CO, USA; 10AstraZeneca, Gaithersburg, MD, USA; 11Faculty of Medicine and Health, Örebro University, Örebro, Sweden; 12Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA, USA; 13Respiratory Epidemiology, Occupational Medicine and Public Health, National Heart and Lung Institute, Imperial College London, London, UKCorrespondence: W Schuyler JonesDuke University Medical Center, Box 3330, Durham, NC, 27710, USATel +1 919-668-8917Fax +1 919-668-7026Email schuyler.jones@duke.eduBackground: Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of developing lower extremity peripheral artery disease (PAD) and suffering PAD-related morbidity and mortality. However, the effect and burden of COPD on patients with PAD is less well defined. This post hoc analysis from EUCLID aimed to analyze the risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with PAD and concomitant COPD compared with those without COPD, and to describe the adverse events specific to patients with COPD.Methods: EUCLID randomized 13,885 patients with symptomatic PAD to monotherapy with either ticagrelor or clopidogrel for the prevention of MACE. In this analysis, MACE, MALE, mortality, and adverse events were compared between groups with and without COPD using unadjusted and adjusted Cox proportional hazards model.Results: Of the 13,883 patients with COPD status available at baseline, 11% (n=1538) had COPD. Patients with COPD had a higher risk of MACE (6.02 vs 4.29 events/100 patient-years; p< 0.001) due to a significantly higher risk of myocardial infarction (MI) (3.55 vs 1.85 events/100 patient-years; p< 0.001) when compared with patients without COPD. These risks persisted after adjustment (MACE: adjusted hazard ratio (aHR) 1.30, 95% confidence interval [CI] 1.11– 1.52; p< 0.001; MI: aHR 1.45, 95% CI 1.18– 1.77; p< 0.001). However, patients with COPD did not have an increased risk of MALE or major bleeding. Patients with COPD were more frequently hospitalized for dyspnea and pneumonia (2.66 vs 0.9 events/100 patient-years; aHR 2.77, 95% CI 2.12– 3.63; p< 0.001) and more frequently discontinued study drug prematurely (19.36 vs 12.54 events/100 patient-years; p< 0.001; aHR 1.34, 95% CI 1.22– 1.47; p< 0.001).Conclusion: In patients with comorbid PAD and COPD, the risks of MACE, respiratory-related adverse events, and premature study drug discontinuation were higher when compared with patients without COPD.Registration: ClinicalTrials.gov: NCT01732822.Keywords: peripheral artery disease, chronic obstructive pulmonary disease, major adverse cardiovascular events

Objective: The restructuring of non-elective general surgery and nationwide implementation of the acute care surgery paradigm has improved patient outcomes and healthcare resource utilization. Although vascular surgery maintains one of the highest acuity rates among surgical specialties, the acute care vascular surgery (ACVS) practice model has not been widely accepted. In the present study, we investigate the scope and burden of ACVS at a tertiary academic medical system., Methods: All vascular surgical procedures performed at three hospitals comprising a large tertiary academic medical system were retrospectively queried through electronic medical records. Data were collected on procedure, acuity, timing of intervention, primary service, admission type, and total costs and charges. Patients were stratified by acuity of surgical intervention, with ACVS being defined as urgent or emergent operation., Results: A total of 12,689 vascular surgeries were performed from 2018 to 2022. ACVS procedures comprised 22.1% this total (n=2,803; 12.5% urgent, 9.6% emergent), with an annual burden ranging from 19.1% to 28.3%. Vascular surgeons served as primary surgeon in 91.3% of ACVS and co-surgeon in 8.7%. Fourteen separate surgical specialties requested acute vascular assistance, with the most frequently consulting specialties including trauma/acute care surgery (n=109, 3.9%) and cardiac surgery (n=74, 2.6%). ACVS cases were more frequently performed after-hours (30.7% vs 11.6%) and on weekends (27.1% vs 2.0%) compared with elective vascular procedures (p<0.0001 each). The majority of ACVS cases originated from inpatient (n=2,353, 85.0%) and emergency department (n=379, 13.5%) consultations. Overall, ACVS generated $37.5 million in charges, accounting for 14% of total procedure-related charges over the study period., Conclusions: ACVS comprises a substantial portion of modern vascular practice, and is associated with significant human and healthcare resource expenditure. These data support the development of practice models dedicated to acute vascular surgical care., (Copyright © 2024. Published by Elsevier Inc.)

Background: Surgical site infections (SSIs) are among the most common complications after lower extremity bypass (LEB). Both patient and hospital-related factors have been associated with SSI after LEB; however, the impact of surgical closure technique on SSI incidence remains unclear., Methods: Institutional electronic medical records (EMRs) were retrospectively queried for all LEB procedures performed from 2018 to 2022. Data were collected on patient demographics, medical comorbidities, operative details, wound closure techniques, and postoperative outcomes. Closure techniques included skin staples, absorbable monofilament (Monocryl), nonabsorbable monofilament (Nylon), or left open to heal by secondary intention. Logistic regression analysis was utilized to identify risk factors and calculate adjusted odds ratios (ORs) for postoperative SSI., Results: A total of 517 patients underwent LEB surgery over the study period. SSI was diagnosed in 120 (23.2%) patients over a median follow-up period of 1.5 years. The most common SSI locations were groin incision (40.0%), saphenectomy (31.7%), and leg incision (19.2%). The median onset of SSI was 18.5 d (interquartile range [IQR] 11-28 d) post-LEB surgery. Patients with SSI had higher body mass index (BMI) (28.2 [IQR 24.2-33.5] vs. 26.6 [23.1-31.5] kg/m 2 , P = 0.03) compared with non-SSI patients. Patient age, sex, and medical comorbidities were otherwise similar between groups. There were no differences in closure technique (79.2% vs. 78.1% staples, 18.3% vs. 19.7% Monocryl, 0.8% vs. 1.8% Nylon, 1.7% vs. 0.5% open; P = 0.53) in SSI versus non-SSI groups. On multivariate analysis, patient BMI (OR 1.04 per unit, 95% confidence interval [CI] 1.01-1.08, P = 0.02), reoperative field (OR 1.81, 95% CI 1.00-3.25, P = 0.03), and active smoking (OR 2.72, 95% CI 1.12-6.59, P = 0.048) were independently associated with increased SSI incidence. Postoperative SSI resulted in prolonged hospital length of stay (LOS) (7 vs. 6 days, P = 0.04), unplanned hospital readmission (49.2% vs. 12.3%, P < 0.001), and reoperation rates (64.7% vs. 8.1%, P < 0.001). Bypass graft infection rates were also higher among patients suffering postoperative SSI (9.2% vs. 0.0%, P < 0.001). On subset analysis of patients at increased risk of postoperative SSI, as found on multivariate modeling, there were no differences in closure technique between SSI and no SSI groups., Conclusions: This study provides insights on wound closure techniques and postoperative SSI made available through granular, operative data that are not found in large database analyses. Surgical wound closure technique was not associated with postoperative SSI after LEB surgery, even among patients at increased risk of infection. These data support individualization of wound closure techniques among patients undergoing LEB surgery., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Despite decades of research on risk-communication approaches, questions remain about the optimal methods for conveying risks for different outcomes across multiple time points, which can be necessary in applications such as discrete choice experiments (DCEs). We sought to compare the effects of 3 design factors: 1) separated versus integrated presentations of the risks for different outcomes, 2) use or omission of icon arrays, and 3) vertical versus horizontal orientation of the time dimension., Methods: We conducted a randomized study among a demographically diverse sample of 2,242 US adults recruited from an online panel (mean age 59.8 y, s  = 10.4 y; 21.9% African American) that compared risk-communication approaches that varied in the 3 factors noted above. The primary outcome was the number of correct responses to 12 multiple-choice questions asking survey respondents to identify specific numbers, contrast options to recognize dominance (larger v. smaller risks), and compute differences. We used linear regression to test the effects of the 3 design factors, controlling for health literacy, graph literacy, and numeracy. We also measured choice consistency in a subsequent DCE choice module., Results: Mean comprehension varied significantly across versions ( P  < 0.001), with higher comprehension in the 3 versions that provided separated risk information for each risk. In the multivariable regression, separated risk presentation was associated with 0.58 more correct responses ( P  < 0.001; 95% confidence interval: 0.39, 0.77) compared with integrated risk information. Neither providing icon arrays nor using vertical versus horizontal time formats affected comprehension rates, although participant understanding did correlate with DCE choice consistency., Conclusions: In presentations of multiple risks over multiple time points, presenting risk information separately for each health outcome appears to increase understanding., Highlights: When conveying information about risks of different outcomes at multiple time points, separate presentations of single-outcome risks resulted in higher comprehension than presentations that combined risk information for different outcomes.We also observed benefits of presenting single-outcome risks separately among respondents with lower numeracy and graph literacy.Study participants who scored higher on risk understanding were more internally consistent in their responses to a discrete choice experiment., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Study Objective: This study aimed to (1) develop and validate a natural language processing model to identify the presence of pulmonary embolism (PE) based on real-time radiology reports and (2) identify low-risk PE patients based on previously validated risk stratification scores using variables extracted from the electronic health record at the time of diagnosis. The combination of these approaches yielded an natural language processing-based clinical decision support tool that can identify patients presenting to the emergency department (ED) with low-risk PE as candidates for outpatient management., Methods: Data were curated from all patients who received a PE-protocol computed tomography pulmonary angiogram (PE-CTPA) imaging study in the ED of a 3-hospital academic health system between June 1, 2018 and December 31, 2020 (n=12,183). The "preliminary" radiology reports from these imaging studies made available to ED clinicians at the time of diagnosis were adjudicated as positive or negative for PE by the clinical team. The reports were then divided into development, internal validation, and temporal validation cohorts in order to train, test, and validate an natural language processing model that could identify the presence of PE based on unstructured text. For risk stratification, patient- and encounter-level data elements were curated from the electronic health record and used to compute a real-time simplified pulmonary embolism severity (sPESI) score at the time of diagnosis. Chart abstraction was performed on all low-risk PE patients admitted for inpatient management., Results: When applied to the internal validation and temporal validation cohorts, the natural language processing model identified the presence of PE from radiology reports with an area under the receiver operating characteristic curve of 0.99, sensitivity of 0.86 to 0.87, and specificity of 0.99. Across cohorts, 10.5% of PE-CTPA studies were positive for PE, of which 22.2% were classified as low-risk by the sPESI score. Of all low-risk PE patients, 74.3% were admitted for inpatient management., Conclusion: This study demonstrates that a natural language processing-based model utilizing real-time radiology reports can accurately identify patients with PE. Further, this model, used in combination with a validated risk stratification score (sPESI), provides a clinical decision support tool that accurately identifies patients in the ED with low-risk PE as candidates for outpatient management., (Copyright © 2024 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Vascular surgeons play a critical role in the functioning of a healthcare system. As a service line, vascular surgery not only performs its own complex operations but also provides support to other surgical specialties by assisting in the management of vascular-related complications. Previous reports have acknowledged the value of consulting vascular surgeons; however, these studies have primarily been limited to single-center series. In this study, we aim to contribute to the existing literature by sharing our experience and highlighting the financial value of consulting vascular surgeons at a large tertiary academic medical center., Methods: Institutional electronic medical records were retrospectively queried for all operations performed by vascular surgeons from 2020 to 2022. Two separate procedural groups were identified. The first group comprised all surgeries where vascular surgery was listed as a co-surgeon for other surgical specialties. The second group comprised all surgeries where vascular surgery was the primary surgeon for service-level cases. Service-level cases were defined as operations resulting directly from (1) iatrogenic complications from other services, (2) consultations for traumatic injury, or (3) primary surgeon for nonvascular cases. The Centers for Medicare and Medicaid Services Physician Fee Schedule was used to calculate work relative value units (wRVUs) per primary procedure code., Results: A total of 7,821 surgeries were performed with vascular involvement more than the study period. Of these, 726 operations (9.3%) were co-surgeon cases requiring intraoperative vascular assistance, from 109 surgeons across all 16 surgical specialties. There were no missing data. The most common specialties requesting vascular assistance included cardiac surgery (n = 247, 34.0%), orthopedic surgery (n = 152, 20.9%), and neurosurgery (n = 131, 18.0%). Total procedural wRVU for co-surgeon cases was 16,220, and total charges exceeded $77.5 million dollars. Vascular surgery served in a primary surgeon role in an additional 154 service-level cases (2.0%) resulting from 10 nonsurgical services. The most common service-level indication was iatrogenic vascular injury (n = 87, 56.4%), and most service-level cases required urgent or emergent surgery (n = 123, 79.9%). These procedures generated an additional 2,150 wRVUs and $1.1 million dollars in charges for the hospital system. Of all co-surgeon or service-level cases, 19.1% (n = 168) occurred after-hours and 10.3% (n = 91) occurred on a holiday or weekend., Conclusions: Vascular surgery is crucial to the operation of all surgical services and many nonsurgical service lines within an academic medical center. Apart from providing essential services for primary vascular diseases, the vascular surgery service line offers substantial financial benefits to the healthcare system through its consulting role. A considerable portion of operative consultations is performed under urgent or emergent circumstances, often necessitating surgical intervention outside regular working hours or on holidays/weekends. These findings have significant implications for assessing the value and compensation of vascular surgeons in today's healthcare landscape., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from novel approach to well-established treatment modality for aortic arch pathology in appropriately selected patients. Despite this nearly 20-year history of use, long-term results of HAR remain to be determined. As such, objectives of this study are to detail the long-term outcomes for HAR within an expanded classification scheme., Methods: From August 2005 to August 2022, 163 consecutive patients underwent HAR at a single referral institution. Operative approach was selected according to an institutional algorithm and included zone 0/1 HAR in 25% (n = 40), type I HAR in 34% (n = 56), and type II/III HAR in 41% (n = 67). Specific zone 0/1 technique was zone 1 HAR in 31 (78%), zone 0 with innominate snorkel (zone 0 S HAR) in 7 (18%), and zone 0 with single side-branch endograft (zone 0 B HAR) in 2 (5%). The 30-day and long-term outcomes, including overall and aortic-specific survival, as well as freedom from reintervention, were assessed., Results: The mean age was 63 ± 13 years and almost one-half of patients (47% [n = 77]) had prior sternotomy. Presenting pathology included degenerative aneurysm in 44% (n = 71), residual dissection after prior type A repair in 38% (n = 62), chronic type B dissection in 12% (n = 20), and other indications in 6% (n = 10). Operative outcomes included 9% mortality (n = 14) at 30 days, 5% mortality (n = 8) in hospital, 4% stroke (n = 7), 2% new dialysis (n = 3), and 2% permanent paraparesis/plegia (n = 3). The median follow-up was 44 month (interquartile range, 12-84 months). Overall survival was 59% and 47% at 5 and 10 years, respectively, whereas aorta-specific survival was 86% and 84% at the same time points. At 5 and 10 years, freedom from major reintervention was 92% and 91%, respectively. Institutional experience had a significant impact on both early and late outcomes: comparing the first (2005-2012) and second (2013-2022) halves of the series, 30-day mortality decreased from 14% to 1% (P = .01) and stroke from 6% to 3% (P = .62). Improved operative outcomes were accompanied by improved late survival, with 78% of patients in the later era vs 45% in the earlier era surviving to 5 years., Conclusions: HAR is associated with excellent operative outcomes, as well as sustained protection from adverse aortic events as evidenced by high long-term aorta-specific survival and freedom from reintervention. However, surgeon and institutional experience appear to play a major role in achieving these superior outcomes, with a five-fold decrease in operative mortality and a two-fold decrease in stroke rate in the latter half of the series. These long-term results expand on prior midterm data and continue to support use of HAR for properly selected patients with arch disease., Competing Interests: Disclosures G.C.H. discloses a relationship with Terumo Aortic (speaker, consultant, clinical trial principal investigator) and W. L. Gore & Associates (speaker, consultant, clinical trial principal investigator). All other authors have no competing interests., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Carotid endarterectomy (CEA) is currently performed by multiple surgical specialties. The impact of surgical specialty and operative volume on post-CEA outcomes has been well described. However, it is unclear whether trainees of different surgical specialties have similar quality of operative training., Methods: Data from Accreditation Council for Graduate Medical Education annual reports were collected and compared between graduating vascular surgery (VS) residents, VS fellows, and neurological surgery (NS) residents. Only cases reported as chief/senior/lead resident, surgeon junior, or surgeon fellow were included in analysis. Linear regression analysis was utilized to evaluate trends in case-mix and volume., Results: From 2013 to 2022, total CEA case volume was higher among VS residents and fellows, compared to NS residents (52.8 ± 0.8 vs. 44.3 ± 1.4 vs. 12.9 ± 0.6, P < 0.0001). Additionally, VS residents and fellows performed other carotid operations including transfemoral or transcarotid artery stenting (11.1 ± 0.9 vs. 11.2 ± 0.8 vs. 0), carotid body tumor resection (0.7 ± 0.1 vs. 0.7 ± 0.0 vs. 0), and extracranial cervical bypass (6.7 ± 0.3 vs. 6.3 ± 0.3 vs. 0) that were not reported by the NS resident cohort (P < 0.0001 each). On linear regression analysis, total CEA procedures did not change for VS residents (R 2  = 0.03, P = 0.62), decreased for VS fellows (-1.29 cases/yr, R 2  = 0.75, P < 0.0001), and decreased among NS residents (-0.41 cases/yr, R 2  = 0.44, P = 0.01) over the study period., Conclusions: Although residents of multiple surgical specialties are trained in CEA, vascular training offers significantly greater numbers and diversity of extracranial carotid cases. It also appears that CEA volume is decreasing among neurosurgical trainees. In light of recent reports on the volume-outcome effect in carotid surgery, these data may have implications for future practice patterns in the domain of extracranial carotid artery disease., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: Bypass graft failure and major amputation are among the worst complications after femoropopliteal bypass surgery. In this large multicenter analysis, we examined our incidence and risk factors for failure-to-salvage (FTS) following either bypass surgery or bypass graft failure., Methods: A regional multicenter database was retrospectively queried for all femoropopliteal bypass procedures performed between 2002 and 2021. Re-do bypasses were excluded. The primary outcome was FTS, defined as major ipsilateral limb amputation within 90 d following index bypass surgery or bypass graft failure. Bypass graft failure was defined as critical stenosis or occlusion of the bypass graft requiring reintervention. Graft rescue was defined as bypass graft failure without subsequent major ipsilateral limb amputation within 90 d. Multivariable logistic regression analysis was utilized to identify factors associated with bypass graft failure and FTS., Results: Over the study period, 1315 femoropopliteal bypass procedures were performed across five hospitals. There were 25 major amputations within 90 d of initial bypass. Bypass graft failure was diagnosed in an additional 503 (38.3%) patients. Mean time to graft failure was 619 d. On multivariable analysis, bypass for tissue loss (adjusted odds ratio [aOR] 1.38 [95% confidence interval (CI) 1.03-1.83], P = 0.03) was associated with graft failure. Of patients with graft failure, 33 had major amputation, leading to an overall FTS incidence of 4.4% (n = 58) over a mean follow-up period of 3.4 y. Patient demographics, medical comorbidities, and bypass conduits were similar between the FTS and graft rescue groups (n = NS each). The FTS group more frequently underwent bypass for tissue loss (51.7% versus 29.8%, P = 0.002), and an infrageniculate bypass target was more frequently utilized in FTS compared to graft rescue patients (81.0% versus 60.4%, P = 0.002). Anticoagulation (34.5% in FTS versus 37.7% in rescue) and dual antiplatelet therapy (15.5% versus 22.1%, respectively) were similar between groups (P = NS each). On multivariable analysis, factors associated with FTS included infrageniculate target (aOR 2.42 [95% CI 1.22-4.08], P = 0.01), black race (aOR 2.47 [95% CI 1.04-5.84], P = 0.04), and bypass for tissue loss (aOR 4.75 [95% CI 1.41-16.0], P = 0.01). Anticoagulation and dual antiplatelet therapy were not associated with loss of graft patency or FTS., Conclusions: Failure-to-salvage after femoropopliteal bypass surgery is associated with nonmodifiable factors, and may represent progression of underlying disease. These data may help inform vascular surgeons in counseling patients with failing bypass grafts. Further investigation of care delivery factors improving likelihood of graft salvage may be warranted., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background and Aims: Lower extremity bypass surgery is an effective treatment option for patients with chronic limb-threatening ischemia (CLTI). Recent studies have suggested that sex-based differences may impact patient outcomes following lower extremity revascularization, however, results have been inconsistent., Methods: In this multicenter analysis, we retrospectively identified all infrainguinal bypass procedures performed for CLTI from 2002 to 2021. Patients were separated into two groups based on sex. Primary outcomes were major limb amputation and reintervention for graft patency., Results: Of 843 bypasses performed over the study period, 347 (41.2%) patients were female. Racial/ethnic distribution and medical comorbidities were similar across sex groups. Surgical indications and operative details were also similar between groups, including conduit type (49.9% autogenous), bypass target (65.4% infrageniculate), and concurrent endarterectomy (38.9%). Female and male patients had similar hospital length of stay (6 days [4-9] vs 6 days [4-9]), hospital readmission (25.6% vs 25.0%), and postoperative complications (p=NS each). Female patients had higher major amputation rates (10.1% vs 6.3%, p=0.04) after one year, whereas reintervention rates were similar between groups (26.2% vs 24.6%, p=NS). After accounting for patient factors, female sex (odds ratio [OR] 1.02 [1.00-1.04]), infrageniculate target (OR 1.02 [1.00-1.04]), and bypass for tissue loss (OR 1.02 [1.00-1.04]) were associated with major amputation after bypass (p<0.05 each)., Conclusions: Female sex is associated with a small but significant increase major amputation after lower extremity bypass surgery for CLTI, despite similar clinical presentation, medical comorbidities, and operative details. These data support the increasingly recognized sex disparities in peripheral arterial disease., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Preoperative anemia is an important, modifiable risk factor among surgical patients. However, data are scarce on the impact of preoperative anemia on postoperative outcomes after infrainguinal bypass., Methods: In this multi-institutional analysis, data were retrospectively collected on all infrainguinal bypass procedures performed between 2010 and 2020. Patients were grouped by preoperative hemoglobin as per the National Cancer Institute anemia scale (mild, 10 g/dL-lower limit of normal; moderate, 8.0-9.9 g/dL; severe, 6.5-7.9 g/dL). Multivariable comparisons were performed using logistic regression analysis., Results: A total of 492 patients underwent bypass for peripheral artery disease over the 10-year study period. Median preoperative hemoglobin was 11.0 g/dL (interquartile range 9.5-12.7) and median follow-up was 1.7 years. Preoperative anemia was prevalent among bypass patients (mild 52.4% [n = 258], moderate 26.4% [n = 130], and severe 5.1% [n = 25]). Women were more likely to have moderate (49.2% [women] vs. 50.8% [men]) or severe anemia (52.0% [women] vs. 48.0% [men]) compared with normal hemoglobin (17.7% [women] vs. 82.3% [men]) (P < 0.001). Patients with preoperative anemia were more likely to present with tissue loss (22.8% [normal] vs. 47.7% [moderate] vs. 52.0% [severe], P = 0.01). Bypass target and conduit types were similar between groups. Anemic patients had longer median hospital length of stay compared with nonanemic patients (4 days [normal] vs. 5 days [mild] vs. 6 days [moderate] vs. 7 days [severe], P < 0.001). Postoperative mortality at 30 days was similar across anemia groups (2.5% [normal] vs. 4.6% [moderate] vs. 8.0% [severe], P = 0.23). On multivariable analysis, however, postoperative mortality was independently associated with severe anemia (odds ratio 7.5 [1.2-48.8], P = 0.04) and male gender (odds ratio 7.5 [1.2-26.4], P = 0.03)., Conclusions: Preoperative anemia is common among patients undergoing infrainguinal bypass surgery and is an independent risk factor for postoperative mortality. Future investigation is needed to determine whether correction of anemia improves postoperative outcomes in these high-risk patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: After limited root/ascending with or without hemiarch repair for acute type A aortic dissection (ATAAD), 20% to 30% of patients require distal reintervention, frequently for arch pathology. In this report, we describe an institutional algorithm for arch management after previous limited ATAAD repair and detail operative and long-term outcomes., Methods: From August 2005 to April 2021, 71 patients status post previous limited ATAAD repair underwent reoperative arch repair involving zones 1 to 3 for aneurysmal degeneration of residual arch dissection including complete cervical debranching with zone 0/1 thoracic endovascular aortic repair in 6 (8%), open total arch in 13 (18%), type I hybrid arch repair in 23 (32%), and type II/III hybrid arch repair in 29 (41%)., Results: Mean age was 59 ± 12 years; time from index ATAAD repair to reoperation was 4 (interquartile range, 2-9) years. There were 2 (2.8%) in-hospital deaths and 2 (2.8%) postdischarge deaths within 30 days of surgery. Three patients suffered stroke (4.2%) and 2 (2.8%) had acute renal failure requiring dialysis. Overall Kaplan-Meier survival was 78%, 70%, and 58% at 1, 3, and 5 years, respectively. Institutional experience appeared to play a significant role in early and late outcomes, because there have been no operative mortalities in the past 9 years and improved survival of 87% versus 66%, 79% versus 58%, and 79% versus 40% at 1, 3, and 5 years in comparisons of the past 9 years with the previous era (P = .01)., Conclusions: Aneurysmal degeneration of residual arch dissection after limited ATAAD repair presents a complex reoperative challenge. An algorithmic operative approach tailored to patient anatomy and comorbidities yields excellent early and late outcomes, which continue to improve with increasing institutional experience., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Machine learning (ML)-driven clinical decision support (CDS) continues to draw wide interest and investment as a means of improving care quality and value, despite mixed real-world implementation outcomes., Objective: This study aimed to explore the factors that influence the integration of a peripheral arterial disease (PAD) identification algorithm to implement timely guideline-based care., Methods: A total of 12 semistructured interviews were conducted with individuals from 3 stakeholder groups during the first 4 weeks of integration of an ML-driven CDS. The stakeholder groups included technical, administrative, and clinical members of the team interacting with the ML-driven CDS. The ML-driven CDS identified patients with a high probability of having PAD, and these patients were then reviewed by an interdisciplinary team that developed a recommended action plan and sent recommendations to the patient's primary care provider. Pseudonymized transcripts were coded, and thematic analysis was conducted by a multidisciplinary research team., Results: Three themes were identified: positive factors translating in silico performance to real-world efficacy, organizational factors and data structure factors affecting clinical impact, and potential challenges to advancing equity. Our study found that the factors that led to successful translation of in silico algorithm performance to real-world impact were largely nontechnical, given adequate efficacy in retrospective validation, including strong clinical leadership, trustworthy workflows, early consideration of end-user needs, and ensuring that the CDS addresses an actionable problem. Negative factors of integration included failure to incorporate the on-the-ground context, the lack of feedback loops, and data silos limiting the ML-driven CDS. The success criteria for each stakeholder group were also characterized to better understand how teams work together to integrate ML-driven CDS and to understand the varying needs across stakeholder groups., Conclusions: Longitudinal and multidisciplinary stakeholder engagement in the development and integration of ML-driven CDS underpins its effective translation into real-world care. Although previous studies have focused on the technical elements of ML-driven CDS, our study demonstrates the importance of including administrative and operational leaders as well as an early consideration of clinicians' needs. Seeing how different stakeholder groups have this more holistic perspective also permits more effective detection of context-driven health care inequities, which are uncovered or exacerbated via ML-driven CDS integration through structural and organizational challenges. Many of the solutions to these inequities lie outside the scope of ML and require coordinated systematic solutions for mitigation to help reduce disparities in the care of patients with PAD., (©Sabrina M Wang, H D Jeffry Hogg, Devdutta Sangvai, Manesh R Patel, E Hope Weissler, Katherine C Kellogg, William Ratliff, Suresh Balu, Mark Sendak. Originally published in JMIR Formative Research (https://formative.jmir.org), 21.09.2023.)

Background Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial. Methods and Results In a subanalysis of the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) study, we compared internet participants with those who opted for noninternet participation. Study process measures examined included participant characteristics at consent, study medication adherence, and study retention. The clinical outcome examined was a composite of all-cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke. Noninternet participants were older (mean 69.4 versus 67.4 years), more likely to be female (38.9% versus 30.2%), more likely to be Black (27.3% versus 6.0%) or Hispanic (11.1% versus 2.0%), and had a higher number of comorbid conditions. The composite clinical outcome was more than twice as high in noninternet participants. The hazard of nonadherence to the assigned aspirin dosage was 46% higher in noninternet participants than internet participants. Conclusions Noninternet participants differed from internet participants in notable demographic characteristics while having poorer baseline health. Over the course of ADAPTABLE, they also had worse clinical outcomes and greater likelihood of study drug nonadherence. These results suggest that trials focused on internet participation select for younger, healthier participants with a higher proportion of traditionally overrepresented patients. Allowing noninternet participation enhances diversity; however, additional steps may be needed to promote study retention and study medication adherence. Registration Information clinicaltrials.gov. Identifier: NCT02697916.

Background: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial., Methods: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke., Results: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88-1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001)., Conclusions: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916) .

Background: Clopidogrel resistance is a well-described phenomenon that has been linked to adverse cardiovascular events in patients with coronary artery disease. The impact of clopidogrel resistance in patient outcomes after vascular and endovascular surgery is not well-established., Methods: Using preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a literature review with the medical subject headings (MeSH) terms "(clopidogrel resistance) and (vascular)", "(clopidogrel resistance) and (vascular surgery)", "(clopidogrel resistance) and (endovascular)", and "(clopidogrel resistance) and (endovascular surgery)" was performed in PubMed and Cochrane databases, to identify all peer-reviewed studies performed on clopidogrel resistance in vascular and endovascular surgery. Studies written in the English language from inception to 2022 were included. Case reports, studies with limited information, nonhuman studies, and studies not pertaining to vascular or endovascular surgery were excluded from analysis. Each study was independently reviewed by 2 qualified researchers to assess eligibility., Results: Of the 691 studies identified through the MeSH strategy, 16 studies met the inclusion criteria and were reviewed and summarized. These studies focused on extracranial cerebrovascular disease (n = 5) and peripheral arterial disease (PAD, n = 11), encompassing a total of 1,716 patients. The prevalence of clopidogrel resistance ranged from 0% to 83.3%, depending on the diagnostic assay and cutoff values used. In cerebrovascular disease, clopidogrel resistance may be associated with cerebral embolization, ischemic neurologic events, and vascular-related mortality. In PAD, clopidogrel resistance has been linked to recurrent stent thrombosis, target lesion revascularization, amputation-free survival, and all-cause mortality., Conclusions: This systematic review provides an up-to-date summary of clopidogrel resistance in vascular and endovascular surgery. The impact of clopidogrel resistance remains incompletely investigated, and future studies are needed to clarify the role of resistance testing in patients with vascular disease., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Selective sinus replacement (SSR) allows a tailored repair approach in patients with sinus of Valsalva or asymmetric aortic root aneurysm. SSR avoids the need for coronary reimplantation for nondiseased sinuses and shortens operative time, although potential for late growth of retained sinuses exists. This study describes selection of patients and assesses operative outcomes and late root dimensions after SSR., Methods: From 2006 to 2020, 60 patients underwent SSR at a single referral institution. Mixed effect models were used to assess trajectory of postoperative growth of remaining sinuses, adjusting for age of the patient, valve morphology, and baseline root diameter., Results: Median age of the patients was 57 (interquartile range [IQR], 48-65) years. Twenty-four (40%) had a bicuspid aortic valve. Most patients (n = 55 [92%]) underwent single sinus replacement (n = 46 noncoronary, n = 9 right), whereas 5 (8%) underwent repair of both the right and noncoronary sinuses. Concomitant aortic valve replacement was performed in 15 patients (25%); aortic valve repair with internal ring annuloplasty or cusp plication was performed in 37 (62%). There was no operative death, stroke, renal failure, or respiratory failure. Median preoperative root diameter was 53 mm (IQR, 51-56 mm) vs 42 mm (IQR, 39-45 mm) at median imaging follow-up of 34 (IQR, 13-49) months. Rate of midterm root growth was 0.2 mm/y, and there were no late root reinterventions., Conclusions: For patients with sinus of Valsalva or asymmetric root aneurysm, SSR is associated with excellent operative outcomes, and midterm follow-up suggests that the technique is durable. Longer term follow-up is needed to confirm continued stability of the aortic root., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices., Methods: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE., Results: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material., Conclusion: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric., (Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Importance: Thoracic endovascular aortic repair (TEVAR) has increasingly been used for uncomplicated type B aortic dissection (uTBAD) despite limited supporting data., Objective: To assess whether initial TEVAR following uTBAD is associated with reduced mortality or morbidity compared with medical therapy alone., Design, Setting, and Participants: This cohort study included Centers for Medicare & Medicaid Services inpatient claims data for adults aged 65 years or older with index admissions for acute uTBAD from January 1, 2011, to December 31, 2018, with follow-up available through December 31, 2019., Exposures: Initial TEVAR was defined as TEVAR within 30 days of admission for acute uTBAD., Main Outcomes and Measures: Outcomes included all-cause mortality, cardiovascular hospitalizations, aorta-related and repeated aorta-related hospitalizations, and aortic interventions associated with initial TEVAR vs medical therapy. Propensity score inverse probability weighting was used., Results: Of 7105 patients with eligible index admissions for acute uTBAD, 1140 (16.0%) underwent initial TEVAR (623 [54.6%] female; median age, 74 years [IQR, 68-80 years]) and 5965 (84.0%) did not undergo TEVAR (3344 [56.1%] female; median age, 76 years [IQR, 69-83 years]). Receipt of TEVAR was associated with region (vs South; Midwest: adjusted odds ratio [aOR], 0.66 [95% CI, 0.53-0.81]; P < .001; Northeast: aOR, 0.63 [95% CI, 0.50-0.79]; P < .001), Medicaid dual eligibility (aOR, 0.76; 95% CI, 0.63-0.91; P = .003), hypertension (aOR, 1.26; 95% CI, 1.03-1.54; P = .03), peripheral vascular disease (aOR, 1.24; 95% CI, 1.02-1.49; P = .03), and year of admission (2012, 2013, 2014, and 2015 were associated with greater odds of TEVAR compared with 2011). After inverse probability weighting, mortality was similar for the 2 strategies up to 5 years (hazard ratio [HR], 0.95; 95% CI, 0.85-1.06), as were aorta-related hospitalizations (HR, 1.12; 95% CI, 0.99-1.27), aortic interventions (HR, 1.01; 95% CI, 0.84-1.20), and cardiovascular hospitalizations (HR, 1.05; 95% CI, 0.93-1.20). In a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality over a period of 1 year (adjusted HR [aHR], 0.86; 95% CI, 0.75-0.99; P = .03), 2 years (aHR, 0.85; 95% CI, 0.75-0.96; P = .008), and 5 years (aHR, 0.87; 95% CI, 0.80-0.96; P = .004)., Conclusions and Relevance: In this study, 16.0% of patients underwent initial TEVAR within 30 days of uTBAD, and receipt of initial TEVAR was associated with hypertension, peripheral vascular disease, region, Medicaid dual eligibility, and year of admission. Initial TEVAR was not associated with improved mortality or reduced hospitalizations or aortic interventions over a period of 5 years, but in a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality. These findings, along with cost-effectiveness and quality of life, should be assessed in a prospective trial in the US population.

Background: Although randomized data remain inconclusive, invasive endovenous therapy is increasingly favored in patients with extensive iliocaval or iliofemoral deep vein thrombosis (DVT) to reduce the rates of postthrombotic syndrome. Previously, pharmacomechanical thrombectomy was the therapy of choice, but the Inari ClotTriever device is an appealing, purely mechanical, alternative. It may reduce bleeding risk, intensive care unit admission, and the need for multiple procedures when compared with traditional thrombolysis. We present a series of 18 patients treated with the ClotTriever for extensive iliocaval or iliofemoral DVT., Methods: The Inari ClotTriever is a percutaneous mechanical thrombectomy system consisting of an expandable nitinol collection bag that is dragged along the vein wall, separating and capturing thrombus for collection into the retrieval sheath. We retrospectively reviewed all patients undergoing ClotTriever thrombectomy since the device became available at our quaternary referral center in June 2019. The review of these patients' records was determined to be exempt by our institutional review board., Results: Eighteen patients underwent ClotTriever thrombectomy between June 2019 and November 2021. Most patients (N = 16, 89%) presented within 2 weeks of symptom onset, and identifiable provoking factors were present in all patients. The most common provoking factor was anatomy, with May-Thurner syndrome present in 8 patients. All patients had restoration of unimpeded venous flow in the treated segments, although 3 had some residual nonflow limiting thrombus. There were no bleeding events or repeat venous procedures. The median postprocedure length of stay of 2 days. Postoperative venous imaging was performed in 15 patients and showed patency of the treated segment in 14 patients. Revised Clinical Venous Severity Scores were available in 14 patients during the course of follow-up. Of these, 9 patients' highest scores were 0, 2 patients' highest scores were 2, 2 patients' highest scores were 4, and 1 patient had a high score of 8., Conclusions: Venous flow was re-established in all 18 patients treated with the ClotTriever in this series, with no bleeding complications, and median postprocedure length of stay of 2 days. All patients with available follow-up, except 1, retained patency of the treated venous segments, and most had mild postthrombotic syndrome or none at all. These findings suggest that the ClotTriever is a safe and effective way to treat extensive iliocaval/femoral DVT., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Stent graft-induced new entry has been described in thoracic endovascular aortic repair for aortic dissection. The incidence of stent graft-induced aortic wall injury (SAWI) related to iatrogenic injury in nondissections is incompletely described. We describe incidence, risk factors, and outcomes of SAWI., Methods: All post-thoracic endovascular aortic repair computed tomography angiograms (January 2005 to December 2018) were reviewed for radiographic evidence of SAWI. Endograft-induced aortic dissections were likewise considered SAWI. Patient characteristics, time to SAWI, and need for reintervention were noted. Cox proportional hazards modeling was used to identify risk factors for SAWI., Results: Within the study cohort (n = 430), 38 patients (9%) had SAWI during a median follow-up of 2.3 years (interquartile range, 4.8); 42% (n = 16) were proximal, 53% (n = 20) distal, and 5% (n = 2) both proximal and distal. Nine (23%) were distal intimal flap injuries in dissection cases, thus subclassifying them as stent graft-induced new entry. Twenty-nine percent of SAWI (n = 11) required reintervention. Of these, 45% (n = 5) were open, and 55% (n = 6) were endovascular. Thoracic endovascular aortic repair for acute dissection had a higher incidence of SAWI development (hazard ratio 4.6; 95% confidence interval, 2.4 to 9; P < .001) as compared with other indications. Use of devices with proximal bare springs or barbs was also associated with increased SAWI incidence (hazard ratio 5.3; 95% confidence interval, 2.6 to 11.0; P < .001)., Conclusions: The rate of SAWI after thoracic endovascular aortic repair is low (9%), but nearly one third will require reintervention. Thoracic endovascular aortic repair in the setting of acute dissection and use of devices with proximal bare springs or barbs were associated with an increased incidence of SAWI., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Peripheral artery disease (PAD) is associated with modifiable atherosclerotic risk factors like hypertension, diabetes, hyperlipidemia, and smoking. However, the effect of risk factor control on outcomes and disparities in achieving control is less well understood., Methods: All patients in an integrated, regional health system with PAD-related encounters, fee-for-service Medicare, and clinical risk factor control data were identified. Component risk factors were dichotomized into controlled and uncontrolled categories (control defined as low-density lipoprotein < 100 mg/dL, hemoglobin A1c < 7.0%, SBP < 140 mmHg, and current nonsmoker) and composite categories (none, 1, ⩾ 2 uncontrolled RFs) created. The primary outcome was major adverse vascular events (MAVE, a composite of all-cause mortality, myocardial infarction, stroke, and lower-extremity revascularization and amputation)., Results: The cohort included 781 patients with PAD, average age 72.5 ± 9.8 years, of whom 30.1% were Black, and 19.1% were Medicaid dual-enrolled. In this cohort, 260 (33.3%) had no uncontrolled risk factors and 200 (25.6%) had two or more uncontrolled risk factors. Patients with the poorest risk factor control were more likely to be Black ( p < 0.001), Medicaid dual-enrolled ( p < 0.001), and have chronic limb-threatening ischemia ( p = 0.009). Significant differences in MAVE by degree of risk factor control were observed at 30 days (none uncontrolled: 5.8%, 1 uncontrolled: 11.5%, ⩾ 2 uncontrolled: 13.6%; p = 0.01) but not at 1 year ( p = 0.08). risk factor control was not associated with outcomes at 1 year after adjustment for patient and PAD-specific characteristics., Conclusions: risk factor control is poor among patients with PAD. Significant disparities in achieving optimal risk factor control represent a potential target for reducing inequities in outcomes.

Introduction: Disparities in the care and outcomes of peripheral artery disease (PAD) have been well-established. In part this is due to disparities in enrollment of PAD trial cohorts. However, less attention has been paid to non-random protocol non-adherence after enrollment, which may lead to inaccurate estimates of treatment effects and reduce generalizability of study results. We aimed to ascertain characteristics associated with premature study drug discontinuation in a PAD cohort., Methods: Using data from EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease), factors associated with study drug discontinuation were assessed using univariable and multivariable Cox proportional hazards models with time to study drug discontinuation as the outcome of interest. Relationships between study drug discontinuation and major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, ischemic stroke), major adverse limb events (MALE; acute limb ischemia, major amputation, and lower extremity revascularization), and all-cause hospitalization were assessed., Results: Of 13,842 eligible EUCLID participants, 3,886 (28.1%) prematurely and permanently discontinued study drug over a maximum follow-up of 42 months (annualized rate of 13.2 discontinuations per 100 patient-years). In a multivariable model, premature study drug discontinuation was associated with older age (aHR 1.16, 95%CI 1.14-1.19), eligibility based on prior lower extremity revascularization rather than ABI/TBI criteria (aHR 1.14, 95%CI 1.06-1.23), CLI status (aHR 1.23, 95%CI 1.06-1.42), COPD (aHR 1.36, 95%CI 1.24-1.49), and geographic region. In a multivariable analysis, study drug discontinuation was significantly associated with MACE (aHR 3.27, 95%CI 2.90-3.67, p < 0.001), MALE (aHR 1.84, 95%CI 1.63-2.07, p < 0.001), and all-cause hospitalization (aHR 2.37, 95%CI 2.21-2.54) following study drug discontinuation., Conclusions: This analysis of EUCLID demonstrates that premature, permanent discontinuation of study drug is relatively common in more than a quarter of PAD patients, is unevenly distributed based on geography and other baseline characteristics, and is associated with worse outcomes in a clinical trial context. Study teams leading future PAD trials may want to address the possibility of study drug discontinuation prospectively, as a proactive approach may help investigators to maintain study cohort diversity and representativeness without sacrificing power and precision., Competing Interests: EUCLID was funded by AstraZeneca; AstraZeneca did not fund the analysis in this manuscript, design the analysis, or draft the manuscript, but did approve the manuscript. BK was employed by AstraZeneca. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Weissler, Mulder, Rockhold, Baumgartner, Norgren, Blomster, Katona, Fowkes, Mahaffey, Bonaca, Patel and Jones.)

Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology's (ACC) National Cardiovascular Data Registry's PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI-PVI or non-CLTI-PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI-PVI. There were 1758 (49.7%) patients undergoing CLTI-PVI and 1779 (50.3%) undergoing non-CLTI-PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non-CLTI (n=146), and MALE occurred in 26.1% of patients with non-CLTI (n=465). Predictors of MACE at 1 year in CLTI-PVI included end-stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI-PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end-stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non-modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI-PVI.

Background: Understanding the relationship between patterns of peripheral artery disease and outcomes is an essential step toward improving care and outcomes. We hypothesized that clinician specialty would be associated with occurrence of major adverse vascular events (MAVE)., Methods: Patients with at least 1 peripheral artery disease-related encounter in our health system and fee-for-service Medicare were divided into groups based on the specialty of the clinician (ie, cardiologist, surgeon, podiatrist, primary care, or other) providing a plurality of peripheral artery disease-coded care in the year prior to index encounter. The primary outcome was MAVE (a composite of all-cause mortality, myocardial infarction, stroke, lower extremity revascularization, and lower extremity amputation)., Results: The cohort included 1768 patients, of whom 30.0% were Black, 23.9% were Medicaid dual-enrollment eligible, and 31.1% lived in rural areas. Patients receiving a plurality of their care from podiatrists had the highest 1-year rates of MAVE (34.4%, P <.001), hospitalization (65.9%, P <.001), and amputations (22.6%, P <.001). Clinician specialty was not associated with outcomes after adjustment. Patients who were Medicaid dual-eligible had higher adjusted risks of mortality (adjusted hazard ratio [HR adj ] 1.54, 95% confidence interval [CI] 1.11-2.14) and all-cause hospitalization (HR adj 1.20, 95% CI 1.03-1.40) and patients who were Black had a higher adjusted risk of amputation (HR adj 1.49, 95% CI 1.03-2.15)., Conclusions: Clinician specialty was not associated with worse outcomes after adjustment, but certain socioeconomic factors were. The effects of clinician specialty and socioeconomic status were likely attenuated by the fact that all patients in this study had health insurance; these analyses require confirmation in a more representative cohort., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: There are limited contemporary, national data describing diagnostic cardiac catheterization with subsequent percutaneous coronary intervention (ad hoc percutaneous coronary intervention [PCI]) performed by an invasive-diagnostic and interventional (Dx/IC) operator team versus solo interventional operator (solo-IC). Using the CathPCI Registry, this study aimed at analyzing trends and outcomes in ad hoc PCI among Dx/IC versus solo-IC operators., Methods: Quarterly rates (January 2012 to March 2018) of ad hoc PCI cases by Dx/IC and solo-IC operators were obtained. Odds of inhospital major adverse cardiovascular events, net adverse cardiovascular events (ie, composite major adverse cardiovascular event+bleeding), and rarely appropriate PCI were estimated using multivariable regression., Results: From 1077 sites, 1 262 948 patients were included. The number of invasive-diagnostic operators and cases performed by Dx/IC teams decreased from nearly 9% to 5% during the study period. Patients treated by Dx/IC teams were more often White and had fewer comorbidities compared with patients treated by solo-IC operators. Considerable variation existed across sites, and over two-fifths of sites had 0% ad hoc PCI performed by Dx/IC. In adjusted analyses, ad hoc performed by Dx/IC had similar risks of major adverse cardiovascular event (OR, 1.04 [95% CI, 0.97-1.11]) and net adverse cardiovascular events (OR, 0.98 [95% CI, 0.94-1.03]) compared with solo-IC. Rarely appropriate PCI, although low overall (2.1% versus 1.9%) occurred more often by Dx/IC compared with solo-IC (OR, 1.20 [95% CI, 1.13-1.26])., Conclusions: Contemporary, nationwide data from the CathPCI Registry demonstrates the number of Dx/IC operator teams and cases has decreased but that case volume is stable among operators. Outcomes were independent of operator type, which supports current practice patterns. The finding of a higher risk of rarely appropriate PCI in Dx/IC teams should be further studied.

Introduction: Amputations among younger patients with chronic limb threatening ischemia (CLTI) may carry higher personal and societal costs, but younger patients are often not included in CLTI research because of dataset limitations. We aimed to characterize and compare outcomes between younger (<65 years old) and older patients with CLTI., Methods: This retrospective cohort study identified patients with CLTI between July 1, 2014 and December 31, 2017 in the MarketScan commercial claims database, a proprietary set of claims for over 50 million patients with private insurance in the United States. The primary outcome was major adverse limb events (MALE); secondary outcomes included amputations, major adverse cardiovascular events, and statin prescription fills., Results: The study cohort included 64,663 people with CLTI, of whom 25,595 (39.6%) were <65 years old. Younger patients were more likely to have diabetes mellitus (54.1% versus 49.9%, P<.001) but less likely to have other comorbidities. A higher proportion of younger patients suffered MALE (31.7% versus 30.2%, P=.002), specifically amputation (11.5% versus 9.3%, P<.001). After adjustment, age <65 years old was associated with a 24% increased risk of amputation (HR adj 1.24, 95%CI 1.18-1.32, P<.001) and a 10% increased risk of MALE (HR adj 1.10, 95%CI 1.07-1.14, P<.001)., Conclusions: A significant proportion of commercially insured patients with CLTI are under the age of 65, and younger patients have worse limb-related outcomes. These findings highlight the importance of aggressively treating risk factors for atherosclerosis and intentionally including younger patients with CLTI in future analyses to better understand their disease patterns and outcomes., Competing Interests: Conflict of interest EHW, CBF, PG, AC, and CL have no disclosures. MRP reports research support from the Agency for Healthcare Research and Quality, AstraZeneca, Bayer, Jansen, Procyrion, and Heartflow outside of the submitted work; Honoraria/advisory board participation with Bayer, Janssen Pharmaceuticals, and AstraZeneca outside of the submitted work. WSJ reports research support from Boehringer Ingelheim, Doris Duke Charitable Foundation, National Institutes of Health, and Patient-Centered Outcomes Research Institute outside of the submitted work; Advisory board participation with Bayer, Bristol-Myers Squibb, and Janssen Pharmaceuticals outside of the submitted work., (Copyright © 2021. Published by Elsevier Inc.)

Aims: Although models exist to predict amputation among people with type 2 diabetes with foot ulceration or infection, we aimed to develop a prediction model for a broader range of major adverse limb events (MALE)-including gangrene, revascularization and amputation-among individuals with type 2 diabetes., Methods: In a post-hoc analysis of data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial, we compared participants who experienced MALE with those who did not. A multivariable model was constructed and translated into a risk score., Results: Among the 14,752 participants with type 2 diabetes in EXSCEL, 3.6% experienced MALE. Characteristics associated with increased risk of MALE were peripheral artery disease (PAD) (HR adj 4.83, 95% CI: 3.94-5.92), prior foot ulcer (HR adj 2.16, 95% CI: 1.63-2.87), prior amputation (HR adj 2.00, 95% CI: 1.53-2.64), current smoking (HR adj 2.00, 95% CI: 1.54-2.61), insulin use (HR adj 1.86, 95% CI: 1.52-2.27), coronary artery disease (HR adj 1.67, 95% CI: 1.38-2.03) and male sex (HR adj 1.64, 95% CI: 1.31-2.06). Cerebrovascular disease, former smoking, age, glycated haemoglobin, race and neuropathy were also associated significantly with MALE after adjustment. A risk score ranging from 6 to 96 points was constructed, with a C-statistic of 0.822 (95% CI: 0.803-0.841)., Conclusions: The majority of MALE occurred among participants with PAD, but participants without a history of PAD also experienced MALE. A risk score with good performance was generated. Although it requires validation in an external dataset, this risk score may be valuable in identifying patients requiring more intensive care and closer follow-up., (© 2021 Diabetes UK.)

Background: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known., Methods: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation., Results: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation., Conclusions: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD., (Copyright © 2021. Published by Elsevier Inc.)

Background: Thoracic endovascular aortic repair (TEVAR) first gained in popularity for repair of type B aortic dissections (TBADs) in the early 2000's. We aimed to describe patients undergoing open repair, TEVAR, and no repair and analyze factors associated with repair within 14 days of presentation in the contemporary era., Methods: We used the MarketScan database to find patients with TBAD between 2014 and 2017. To assess factors associated with early repair, univariable, and multivariable log-binomial regression were used., Results: There were 2613 patients admitted with TBAD between 2014 and 2017 across the United States, of whom 38.4% underwent repair within 14 days of admission (25.3% open repair and 13.1% TEVAR). The incidence of repair within 14 days decreased over the study period (43% of the study cohort in 2014 to 26.4% in 2017) primarily due to a decrease in open repairs from 30.8% of patients in 2014 to 12.5% in 2017. In multivariable analysis, older age, Middle Atlantic location, diabetes mellitus, insulin use, antiplatelet use, and more recent year were associated with lower likelihood of early repair; male sex, peripheral vascular disease, and the presence of extremity ischemia, rupture, shock, and acidosis were associated with higher likelihood of repair., Conclusions: Overall, repair of TBAD within 14 days of presentation declined from 2014 to 2017, with a steady rate of TEVAR but declining rate of open repairs. Further investigation into provider- and hospital-specific factors as they relate to likelihood of repair is needed., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Evidence for antithrombotic treatment following lower extremity revascularization (LER) for peripheral artery disease (PAD) is limited, leading to weak and conflicting guideline recommendations and heterogeneous practice patterns. This variability in post-LER antithrombotic treatment raises quality-of-care issues that have long been under-studied. This Viewpoint reviews the most updated guidelines, currently-available evidence, and contemporary data about practice patterns and practitioner opinions in this area. Particular attention is paid to distinctions between antiplatelet therapy, anticoagulant therapy, and combination therapy in light of the recent VOYAGER-PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) trial. The implications of VOYAGER-PAD pertaining to various subgroups of patients undergoing LER are explored. Overall, this Viewpoint argues for consideration of post-LER therapy targeted at both platelet function and the coagulation cascade, though further LER-specific analyses, including expected VOYAGER-PAD sub-analyses, are needed., Competing Interests: Funding Support and Author Disclosures Dr. Weissler is supported by the National Heart, Lung, and Blood Institute (grant F32HL151181). Dr. Aboyans has received honoraria and is a speaker, an expert, or a member of steering committees from Amgen, Bayer, Novo Nordisk, Novartis, Bristol Myers Squibb/Pfizer, and Sanofi. Dr. Bauersachs has received speaker and consulting fees from Bayer, Bristol Myers Squibb, Daichii-Sankyo, and Pfizer. Dr. Brodmann has received consulting fees from Bayer Healthcare and Daiichi-Sankyo. Dr. Debus has received institutional grants from Bayer, Cook, and Terumo Aortic Advisory Boards. Dr. Patel has received research grants from AstraZeneca, Bayer, Janssen, the National Heart, Lung, and Blood Institute, and Medtronic; and is an advisory board member or a consultant for Bayer, Janssen, and AstraZeneca. Dr. Jones has received research grants from Boehringer Ingelheim and Medtronic; and is an advisory board member or a consultant for Bristol Myers Squibb, Bayer, and Janssen. Dr. Nikol has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Certain comorbidities and lesion characteristics are associated with increased risk for procedural complications, limb events, and cardiovascular events following peripheral vascular intervention (PVI) in patients with peripheral arterial disease (PAD). The purpose of this review is to provide an overview of high-risk modifiable and unmodifiable patient characteristics and its relative impact on clinical outcomes such as amputation risk and mortality. Furthermore, general approaches to potentially mitigating these risks through pre-intervention planning and use of modern devices and techniques are discussed., Recent Findings: Diabetes, tobacco use, and older age remain strong risk factors for the development of peripheral arterial disease. Recent data highlight the significant risk of polyvascular disease on major limb and cardiac events in advanced PAD, and ongoing studies are assessing this risk specifically after PVI. Challenging lesion characteristics such as calcified disease and chronic total occlusions can be successfully treated with PVI by utilizing novel devices (e.g., intravascular lithotripsy, re-entry devices) and techniques (e.g., subintimal arterial "flossing" with antegrade-retrograde intervention). Understanding high-risk patient comorbidities and lesion characteristics will improve our ability to counsel and manage patients with advanced PAD. Continued device innovation and novel techniques will aid in procedural planning for successful interventions to improve clinical outcomes.

Background: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries., Methods: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved., Results: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844)., Conclusion: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: Patients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort., Methods: LIBERTY 360 is a prospective, multi-center, non-randomized, mono-industry funded observational study of patients undergoing endovascular revascularization. Outcomes included 30-day and 1-year all-cause mortality, major amputation, target vessel/lesion revascularization, and a composite of those events. A multivariable regression model including DM was constructed to examine the effect of DM on outcomes. Multivariable survival estimates were made using Cox proportional hazards models., Results: A total of 1,204 patients were enrolled, of whom 727 had DM (60.4%). Patients with DM had significantly more comorbidities and a third required insulin for DM management. Patients with DM had more severe disease based on Rutherford classification at baseline. After adjusting for comorbidities and disease severity, DM patients had more frequent major amputations at 1 year (5.2% versus 1.2%; HR 2.71, 95%CI 1.05-6.98, p = 0.040). The 1-year rates of all-cause mortality and target vessel/lesion revascularization were not significantly higher for patients with DM., Conclusions: Diabetes mellitus was associated with increased major amputations at 1 year following endovascular revascularization after accounting for demographics, comorbidities, and PAD-related characteristics. Further research is needed to determine which aspects of PAD and DM are most strongly associated with poor outcomes following lower extremity revascularization.

Background and Aims: Polyvascular disease (PVD) affects approximately 20% of patients with atherosclerosis and is a strong independent risk factor for ischemic outcomes. However, guidelines do not address screening or treatment for PVD, and there have been no PVD-specific trials. We reviewed subgroup analyses of large randomized controlled trials of more intense antithrombotic therapy to determine whether increased intensity of therapy improved ischemic outcomes in patients with PVD., Methods: MEDLINE, MEDLINE in-Process, EMBASE, and the Cochrane Library were queried for randomized controlled trials larger than 5000 patients evaluating secondary prevention therapies in patients with coronary artery disease or lower extremity peripheral artery disease., Results: Thirteen trials were included ranging in size from 7243 to 27,395 patients. In 9 trials (CHARISMA, TRA 2°P-TIMI 50, PEGASUS-TIMI 54, VOYAGER PAD, TRACER, EUCLID, TRILOGY ACS, PLATO, and COMPASS), patients in the PVD subgroup treated with increased-intensity antithrombotic therapy had similar or greater relative risk reductions for ischemic events in comparison with the general trial cohorts. In four trials (DAPT, THEMIS, APPRAISE-2, and ATLAS ACS 2 TIMI 51), the PVD subgroup had an increased hazard of ischemic events with increased-intensity therapy compared with the general trial cohorts., Conclusions: More intense antithrombotic therapy in patients with PVD was associated with a similar relative risk reduction for ischemic events compared with patients without PVD. Therefore, patients with PVD benefit from a larger absolute risk reduction because of their higher baseline risk. Future trials in patients with atherosclerotic cardiovascular disease should intentionally include PVD patients to adequately assess treatment options for this under-studied, under-treated population., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: The utility of cerebrospinal fluid drainage (CSFD) for prevention of spinal cord ischemia (SCI) after thoracic endovascular aortic repair (TEVAR) remains unclear. We previously published our institutional algorithm restricting preoperative CSFD to patients deemed high risk for SCI. Since that publication, our algorithm has evolved with preoperative CSFD avoided in all patients undergoing isolated descending TEVAR with or without arch involvement (+/- arch TEVAR). This study evaluated the updated algorithm in a contemporary cohort., Methods: Patients who underwent TEVAR for descending aortic +/-arch pathology between February 2012 and September 2018 at a single center were identified from an institutional aortic surgery database. The algorithm includes left subclavian artery (LSA) revascularization in cases of coverage with no preservation of antegrade flow, permissive hypertension, and use of evoked potential monitoring. The primary end points were SCI or postoperative CSFD., Results: During the study interval, 225 patients underwent descending +/- arch TEVAR. CSFD was used before TEVAR in 2 patients (0.9%) in violation of the algorithm, and they were excluded from the study cohort. Endograft coverage below T6 occurred in 81%. The LSA was fully covered in 100 patients (47%), all of whom underwent LSA revascularization. Following the updated algorithm, the incidence of temporary or permanent SCI was 0%. No patient required postoperative CSFD., Conclusions: A restrictive lumbar CSFD algorithm, including permissive hypertension and LSA revascularization in the setting of descending +/- arch TEVAR, appears safe, with a 0% incidence of SCI in 223 consecutive patients treated during a 6.5-year interval. We recommend consideration of further prospective study to evaluate this algorithm., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients with chronic kidney disease (CKD) have worsened clinical outcomes following percutaneous coronary intervention; however, limited evidence exists in patients undergoing peripheral vascular intervention (PVI)., Purpose: We aimed to assess the effect of CKD on outcomes following PVI for symptomatic peripheral artery disease., Methods: Using patients from the LIBERTY 360 study, we compared the rates of 30 day and 1 year major adverse vascular events (MAVE), a composite of all-cause mortality, major amputation, and target vessel/lesion revascularization, between patients with and without CKD (estimated glomular filtration rate less than 60) following PVI. Multivariable adjustment was performed to assess for independent association between CKD and outcomes., Results: Among 1189 patients enrolled, 378 patients (31.8%) had CKD. At 1 year, patients with CKD had higher rates of MAVE (34.6% vs 25.6%), all-cause mortality (11.9% vs 5.5%), and major amputation (5.9% vs 2.6%) when compared with patients without CKD (all P < .05). After adjustment, patients with CKD had higher risks of 1-year MAVE (HR 1.30, 95% CI 1.04-1.64; P = .023) and all-cause mortality (HR 1.88, 95% CI 1.22-2.91; P = .005) when compared with patients without CKD. There was no statistically significant difference in risk of major amputations (HR 1.70, 95% CI 0.91-3.17; P = .094)., Conclusions: Despite high procedural success and low amputation rates, patients with CKD remain at greater risk for MAVE and all-cause mortality after PVI. Further research is needed to determine treatment strategies to mitigate substantial mortality risk in this vulnerable population., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: Peripheral artery disease (PAD) is underrecognized, undertreated, and understudied: each of these endeavors requires efficient and accurate identification of patients with PAD. Currently, PAD patient identification relies on diagnosis/procedure codes or lists of patients diagnosed or treated by specific providers in specific locations and ways. The goal of this research was to leverage natural language processing to more accurately identify patients with PAD in an electronic health record system compared with a structured data-based approach., Methods: The clinical notes from a cohort of 6861 patients in our health system whose PAD status had previously been adjudicated were used to train, test, and validate a natural language processing model using 10-fold cross-validation. The performance of this model was described using the area under the receiver operating characteristic and average precision curves; its performance was quantitatively compared with an administrative data-based least absolute shrinkage and selection operator (LASSO) approach using the DeLong test., Results: The median (SD) of the area under the receiver operating characteristic curve for the natural language processing model was 0.888 (0.009) versus 0.801 (0.017) for the LASSO-based approach alone (DeLong P <0.0001). The median (SD) of the area under the precision curve was 0.909 (0.008) versus 0.816 (0.012) for the structured data-based approach. When sensitivity was set at 90%, the precision for LASSO was 65% and the machine learning approach was 74%, while the specificity for LASSO was 41% and for the machine learning approach was 62%., Conclusions: Using a natural language processing approach in addition to partial cohort preprocessing with a LASSO-based model, we were able to meaningfully improve our ability to identify patients with PAD compared with an approach using structured data alone. This model has potential applications to both interventions targeted at improving patient care as well as efficient, large-scale PAD research. Graphic Abstract: A graphic abstract is available for this article.

Background: Peripheral artery disease (PAD) affects 8 to 10 million Americans, who face significantly elevated risks of both mortality and major limb events such as amputation. Unfortunately, PAD is relatively underdiagnosed, undertreated, and underresearched, leading to wide variations in treatment patterns and outcomes. Efforts to improve PAD care and outcomes have been hampered by persistent difficulties identifying patients with PAD for clinical and investigatory purposes., Objective: The aim of this study is to develop and validate a model-based algorithm to detect patients with peripheral artery disease (PAD) using data from an electronic health record (EHR) system., Methods: An initial query of the EHR in a large health system identified all patients with PAD-related diagnosis codes for any encounter during the study period. Clinical adjudication of PAD diagnosis was performed by chart review on a random subgroup. A binary logistic regression to predict PAD was built and validated using a least absolute shrinkage and selection operator (LASSO) approach in the adjudicated patients. The algorithm was then applied to the nonsampled records to further evaluate its performance., Results: The initial EHR data query using 406 diagnostic codes yielded 15,406 patients. Overall, 2500 patients were randomly selected for ground truth PAD status adjudication. In the end, 108 code flags remained after removing rarely- and never-used codes. We entered these code flags plus administrative encounter, imaging, procedure, and specialist flags into a LASSO model. The area under the curve for this model was 0.862., Conclusions: The algorithm we constructed has two main advantages over other approaches to the identification of patients with PAD. First, it was derived from a broad population of patients with many different PAD manifestations and treatment pathways across a large health system. Second, our model does not rely on clinical notes and can be applied in situations in which only administrative billing data (eg, large administrative data sets) are available. A combination of diagnosis codes and administrative flags can accurately identify patients with PAD in large cohorts., (©Elizabeth Hope Weissler, Steven J Lippmann, Michelle M Smerek, Rachael A Ward, Aman Kansal, Adam Brock, Robert C Sullivan, Chandler Long, Manesh R Patel, Melissa A Greiner, N Chantelle Hardy, Lesley H Curtis, W Schuyler Jones. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 19.08.2020.)

Objectives: Aortic insufficiency (AI) is common in patients with proximal aortic disease, but limited options exist to facilitate aortic valve repair (AVr) in this population. This study reports 'real-world' early results of AVr using newly FDA-approved trileaflet and bicuspid geometric annuloplasty rings for patients with AI undergoing proximal aortic repair (PAR) in a single referral centre., Methods: All patients undergoing AVr with a rigid internal geometric annuloplasty ring (n = 47) in conjunction with PAR (ascending +/- root +/- arch) were included. Thirty-six patients underwent AVr with a trileaflet ring, and 11 patients underwent AVr with a bicuspid ring. The rings were implanted in the subannular position, and concomitant leaflet repair was performed if required for cusp prolapse identified after ring placement., Results: The median age was 58 years [interquartile range (IQR) 46-70]. PAR included supracoronary ascending replacement in 26 (55%) patients and remodelling valve-sparing root replacement with selective sinus replacement in 20 (42%) patients. Arch replacement was performed in 38 (81%) patients, including hemi-arch in 34 patients and total arch in 4 patients. There was no 30-day/in-hospital mortality. Preoperative AI was 3-4+ in 37 (79%) patients. Forty-one (87%) patients had zero-trace AI on post-repair transoesophageal echocardiography, and 6 patients had 1+ AI. The median early post-repair mean gradient was 13 mmHg (IQR 5-20). Follow-up imaging was available in 32 (68%) patients at a median of 11 months (IQR 10-13) postsurgery. AI was ≤1+ in 97% of patients with 2+ AI in 1 patient. All patients were alive and free from aortic valve reintervention at last follow-up., Conclusions: Early results with geometric rigid internal ring annuloplasty for AVr in patients undergoing PAR appear promising and allow a standardized approach to repair with annular diameter reduction and cusp plication when needed. Longer-term follow-up will be required to ensure the durability of the procedure., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)