Low absolute risk of thrombotic and cardiovascular events in outpatient pregnant women with COVID-19.

INTRODUCTION: Pregnancy may contribute to an excess risk of thrombotic or cardiovascular events. COVID-19 increases the risk of these events, although the risk is relatively limited among outpatients. We sought to determine whether outpatient pregnant women with COVID-19 are at a high risk for cardiovascular or thrombotic events. MATERIALS & METHODS: We analyzed pregnant outpatients with COVID-19 from the multicenter CORONA-VTE-Network registry. The main study outcomes were a composite of adjudicated venous or arterial thrombotic events, and a composite of adjudicated cardiovascular events. Events were assessed 90 days after the COVID-19 diagnosis and reported for non-pregnant women ≤45 years, and for men ≤45 years, as points of reference. RESULTS: Among 6585 outpatients, 169 were pregnant at diagnosis. By 90-day follow-up, two pregnant women during the third trimester had lower extremity venous thrombosis, one deep and one superficial vein thrombosis. The cumulative incidence of thrombotic events was 1.20 % (95 % confidence interval [CI]: 0.0 to 2.84 %). Respective rates were 0.47 % (95 % CI: 0.14 % to 0.79 %) among non-pregnant women, and 0.49 % (95 % CI: 0.06 % to 0.91 %) among men ≤45 years. No non-thrombotic cardiovascular events occurred in pregnant women. The rates of cardiovascular events were 0.53 % (95 % CI: 0.18 to 0.87) among non-pregnant women, and 0.68 % (95 % CI: 0.18 to 1.18) in men aged ≤45 years. CONCLUSIONS: Thrombotic and cardiovascular events are rare among outpatients with COVID-19. Although a higher event rate among outpatient pregnant women cannot be excluded, the absolute event rates are low and do not warrant population-wide cardiovascular interventions to optimize outcomes.

Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD.

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216).

Preliminary Development of a Program ABSITE Dashboard (PAD) to Guide Curriculum Innovation.

PURPOSE: Medical Knowledge for general surgery residents' is assessed by the American Board of Surgery In- Training Examination (ABSITE). ASBITE score reports contain many metrics residency directors can utilize to assess resident progress and perform program evaluation. The purpose of this study was to develop a framework to evaluate program effectiveness in teaching specific subtest and subtopic areas of the ABSITE, using ABSITE score reports as an indicator. The aim is to demonstrate the identification of topic areas of weakness in program-wide performance on the ABSITE to guide proposed modification of the general surgery residency program curriculum, and to initiate development of a data visualizing dashboard to communicate these metrics. METHODS: A single institution retrospective study was performed utilizing ABSITE score reports from general surgery residents at a large academic training program from 2017 to 2020. ABSITE performance metrics from 320 unique records were entered into a database; statistical analysis for linear trends and variance were conducted for standard scores, subtest standard scores, and incorrect subtest topics. Deviation from national average scores were calculated by subtracting the national average score from each subtest score for each trainee. Data were displayed as medians or proportions and are displayed to optimize visualization as a proof-of-concept for the development of a program dashboard. RESULTS: Trends and variance in general surgery program and cohort performance on various elements of the ABSITE were visualized using figures and tables that represent a prototype for a program dashboard. Figure A1 demonstrates one example, in which a heatmap displays the median deviation from national average scores for each subtest by program year. Boxplots show the distribution of the deviation from national average, range for national average scores, and the recorded scores for each subtest by program year. Trends in median deviation from the national average scores are displayed for each program year paneled by subtest or for each exam year paneled by cohort. Median change in overall test scores from one program year to another in a cohort is visualized as a table. Bar graphs show the most often missed topics across all program years and heatmaps were generated showing the proportion of times each topic was missed for each subtest and exam year. CONCLUSIONS: We demonstrate use of ABSITE reports to identify specific thematic areas of opportunities for curriculum modification and innovation as an element of program evaluation. In this study we demonstrate, through data analysis and visualization, feasibility for the creation of a Program ABSITE Dashboard (PAD) that enhances the use of ABSITE reports for formative program evaluation and can guide modifications to surgery program curriculum and educational practices.

Implementation of a Holistic Review Process of US Allopathic Medical Students Eliminates Non-Comparable Metrics and Bias in General Surgery Residency Interview Invitations.

OBJECTIVE: Use of traditional scoring metrics for residency recruitment creates racial and gender bias. In addition, widespread use of pass/fail grading has led to noncomparable data. To adjust to these challenges, we developed a holistic review (HR) rubric for scoring residency applicants for interview selection. DESIGN: Single-center observational study comparing the proportion of underrepresented in medicine (URM) students and their United States Medical Licensing Exam (USMLE) scores who were invited for interview before (2015-2020) and after (2022) implementation of a holistic review process. SETTING: General surgery residency program at a tertiary academic center. PARTICIPANTS: US allopathic medical students applying for general surgery residency. RESULTS: After initial screening, a total of 1514 allopathic applicants were narrowed down to 586 (38.7%) for HR. A total of 52% were female and 17% identified as URM. Based on HR score, 20% (118/586) of applicants were invited for an interview. The median HR score was 11 (range 4-19). There was a fourfold higher coefficient of variation of HR scores (22.3; 95% CI 21.0-23.7) compared to USMLE scores (5.1; 95% Cl 4.8-5.3), resulting in greater spread and distinction among applicants. There were no significant differences in HR scores between genders (p = 0.60) or URM vs non-URM (p = 0.08). There were no significant differences in Step 1 (p = 0.60) and 2CK (p = 0.30) scores between those who were invited to interview or not. On multivariable analysis, USMLE scores (OR 1.01; 95% CI 0.98-1.03), URM status (OR 1.71 95% CI 0.98-2.92), and gender (OR 0.94, 95% CI 0.60-1.45) did not predict interview selection (all p > 0.05). There was a meaningful increase in the percentage of URM interviewed after HR implementation (12.9% vs 23.1%, p = 0.016). CONCLUSION: The holistic review process is feasible and eliminates the use of noncomparable metrics for surgical applicant interview invitations and increases the percentage of URM applicants invited to interview.

Major cardiovascular events after COVID-19, event rates post-vaccination, antiviral or anti-inflammatory therapy, and temporal trends: Rationale and methodology of the CORONA-VTE-Network study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with excess risk of cardiovascular and thrombotic events in the early post-infection period and during convalescence. Despite the progress in our understanding of cardiovascular complications, uncertainty persists with respect to more recent event rates, temporal trends, association between vaccination status and outcomes, and findings within vulnerable subgroups such as older adults (aged 65 years or older), or those undergoing hemodialysis. Sex-informed findings, including results among pregnant and breastfeeding women, as well as adjusted comparisons between male and female adults are similarly understudied. METHODS: Adult patients, aged ≥18 years, with polymerase chain reaction-confirmed COVID-19 who received inpatient or outpatient care at the participating centers of the registry are eligible for inclusion. A total of 10,000 patients have been included in this multicenter study, with Brigham and Women's Hospital (Boston, MA) serving as the coordinating center. Other sites include Beth Israel Deaconess Medical Center, Anne Arundel Medical Center, University of Virginia Medical Center, University of Colorado Health System, and Thomas Jefferson University Health System. Data elements will be ascertained manually for accuracy. The two main outcomes are 1) a composite of venous or arterial thrombotic events, and 2) a composite of major cardiovascular events, defined as venous or arterial thrombosis, myocarditis or heart failure with inpatient treatment, new atrial fibrillation/flutter, or cardiovascular death. Clinical outcomes are adjudicated by independent physicians. Vaccination status and time of inclusion in the study will be ascertained for subgroup-specific analyses. Outcomes are pre-specified to be reported separately for hospitalized patients versus those who were initially receiving outpatient care. Outcomes will be reported at 30-day and 90-day follow-up. Data cleaning at the sites and the data coordinating center and outcomes adjudication process are in-progress. CONCLUSIONS: The CORONA-VTE-Network study will share contemporary information related to rates of cardiovascular and thrombotic events in patients with COVID-19 overall, as well as within key subgroups, including by time of inclusion, vaccination status, patients undergoing hemodialysis, the elderly, and sex-informed analyses such as comparison of women and men, or among pregnant and breastfeeding women.

Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial.

BACKGROUND: Thrombo-inflammation is central to COVID-19-associated coagulopathy. TF (tissue factor), a driver of disordered coagulation and inflammation in viral infections, may be a therapeutic target in COVID-19. The safety and efficacy of the novel TF inhibitor rNAPc2 (recombinant nematode anticoagulation protein c2) in COVID-19 are unknown. METHODS: ASPEN-COVID-19 was an international, randomized, open-label, active comparator clinical trial with blinded end point adjudication. Hospitalized patients with COVID-19 and elevated D-dimer levels were randomized 1:1:2 to lower or higher dose rNAPc2 on days 1, 3, and 5 followed by heparin on day 8 or to heparin per local standard of care. In comparisons of the pooled rNAPc2 versus heparin groups, the primary safety end point was major or nonmajor clinically relevant International Society of Thrombosis and Haemostasis bleeding through day 8. The primary efficacy end point was proportional change in D-dimer concentration from baseline to day 8, or discharge if before day 8. Patients were followed for 30 days. RESULTS: Among 160 randomized patients, median age was 54 years, 43.1% were female, and 38.8% had severe baseline COVID-19. There were no significant differences between rNAPc2 and heparin in bleeding or other safety events. Overall, median change in D-dimer was -16.8% (interquartile range, -45.7 to 36.8; P=0.41) with rNAPc2 treatment and -11.2% (-36.0 to 34.4; P=0.91) with heparin (Pintergroup=0.47). In prespecified analyses, in severely ill patients, D-dimer levels tended to increase more within the heparin (median, 29.0% [-14.9 to 145.2]; P=0.02) than the rNAPc2 group (median, 25.9% [-49.1 to 136.4]; P=0.14; Pintergroup=0.96); in mildly ill patients, D-dimer levels were reduced within each group with a numerically greater reduction with rNAPc2 versus heparin (rNAPc2 median, -32.7% [-44.7 to 4.3]; P=0.007 and heparin median, -16.8% [-36.0 to 0.5]; P=0.008, Pintergroup=0.34). CONCLUSIONS: rNAPc2 treatment in hospitalized patients with COVID-19 was well tolerated without excess bleeding or serious adverse events but did not significantly reduce D-dimer more than heparin at day 8. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04655586.

Retrospective Review of Directional Atherectomy and Drug-Coated Balloon Use in a PAD Safety-Net Population.

BACKGROUND: Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population. OBJECTIVE: To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER. METHODS: In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital. RESULTS: The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years. CONCLUSION: In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.

Morbidity and Long-Term Patient-Reported Outcomes Following Advanced Carotid Body Tumor Resection.

BACKGROUND: The reported risk of a cranial nerve (CN) injury is up to 1 in 4 patients in large registries of carotid body tumor (CBT) resection. Functional outcome for this population is unknown. METHODS: We evaluated consecutive patients who underwent CBT resection from November 2013 through October 2020. Demographics, intraoperative details, complications, and outcomes were recorded from the medical record. Permanent CN nerve injury was defined as deficits lasting >6 months. Frequency statistics, averages, chi-squared test, and multiple logistic regression were completed for primary end points of complications and disease-free survival. Patient-reported outcomes were gathered via telephone survey of patients conducted in September 2021. RESULTS: Fifty-one patients presented with CBTs and the following Shamblin classes: I (n = 7; 14%), II (n = 36; 69%), and III (n = 9; 17%). Head and neck oncology and vascular surgery jointly did 52% of CBT resections, including 6 of 9 Shamblin III cases. Eight patients (15.3%, all Shamblin II or III) suffered a total of 12 CN injuries - 8 CN XII (5 temporary and 3 permanent), 3 CN X (all permanent), and 1 CN XI (permanent). Seven of the CN injury subgroup had preoperative embolization and 5 were joint oncology/vascular cases. In addition, 4 separate carotid injuries required repair. Notably, all patients had disease-free survival postoperatively at a mean follow-up of 6 months. Patient-reported outcomes obtained in 70.6% of patients 1 year or more from index operation demonstrated that two-thirds of patients live without any permanent functional deficits, and the majority of those with continued deficits rate the symptoms as daily but mild in severity. CONCLUSIONS: In a series of complex CBT patients treated with preoperative embolization capabilities and multidisciplinary surgical approach, disease-free survival was achieved in all patients despite a high rate of iatrogenic CN injuries, most commonly CN XII. Patient-reported outcomes survey results indicate that injuries identified on clinical exam underreport patients' true postoperative CN deficits - especially branches of CN X. This data support the practice of aggressive primary resection of CBTs while providing guidance for expected functional outcomes due to CN injury risk.

Readmission after early thoracic endovascular aortic repair versus medical management of acute type B aortic dissection.

BACKGROUND: The use of thoracic endovascular aortic repair (TEVAR) for the management of acute uncomplicated type B aortic dissection (TBAD) has increased. Although the results from early studies were promising, larger randomized trials evaluating TEVAR are lacking. It is also unclear where sufficient equipoise exists for such trials. In the present study, we evaluated the number of readmissions and unplanned operations after TEVAR vs those after medical management as the initial treatment of acute uncomplicated TBAD and the frequency of each treatment in this population. METHODS: We performed a multi-institutional retrospective review of patients with acute TBAD from 2015 to 2020 with the 1-year outcomes available, excluding patients with prior aortic intervention or chronic, iatrogenic or traumatic etiologies. The primary exposure was TEVAR vs medical management at the index admission. The patient demographics, clinical presentation, and imaging findings were analyzed using bivariate and multivariate logistic regression for the primary outcomes of unplanned readmission and/or operation after the initial admission. The secondary outcomes were mortality, myocardial infarction, stroke, renal failure requiring dialysis, retrograde type A dissection, and length of stay. We hypothesized that the readmissions would be higher with medical management. RESULTS: A total of 216 patients with TBAD (47 with complicated and 169 with uncomplicated) from two large academic centers were identified. Of the 169 patients with uncomplicated TBAD, 83 (49%) had been treated medically and 86 (51%) had undergone TEVAR at the initial admission. No differences were found in the demographics or high-risk imaging features at presentation. The medically managed patients had had higher rates of unplanned readmission (34% vs 9%; P = .0001) and operation (28% vs 8%; P = .0007) but shorter lengths of stay (6.3 vs 13.1 days; P < .0001). No differences were found in mortality, although the rate of myocardial infarction was higher in the medically managed group (10.8% vs 2.3%; P = .02). Although 28% of the medically managed patients had later required operation, they had had morbidity and mortality similar to those of patients who had undergone initial TEVAR. Initial medical management was associated with unplanned readmission (odds ratio, 8.3; P = .02) and the need for operation (odds ratio, 4.56; P = .006). No differences were found in the outcomes according to the involved aortic zones. CONCLUSIONS: In the present study, medical management of acute uncomplicated TBAD was associated with higher rates of readmission and the need for unplanned operation compared with TEVAR. However, no differences were found in the 1-year mortality for the patients for whom medical management had failed. Because one half of the patients had undergone medical management and one half had undergone early TEVAR, this finding suggests clinical equipoise for the treatment of acute uncomplicated TBAD. Therefore, a larger randomized trial appears warranted to determine whether a clear benefit exists for early TEVAR.

Proactive Coaching in General Surgery Internship: Incorporating Well-being Practices into Resident Professional Life.

OBJECTIVE: Coaching can provide learners with space to reflect on their performance while ensuring well-being and encouraging professional achievement and personal satisfaction outside of traditional mentorship and teaching models. We hypothesized that a proactive coaching program for general surgery interns coupled with individualized learning plans would help build foundational skills necessary for residency success and facilitate the incorporation of well-being practices into resident professional life. Here, we present the development, implementation, and outcomes of a novel well-being coaching program for surgical interns. DESIGN AND SETTING: A well-being coaching program was developed and implemented from July 2020 through June 2021 at a single university-based surgical residency program. To assess impact of the coaching program, we designed a mixed-methods study incorporating end-of-program survey results as well as participant narratives from commitment-to-act statements for thematic content. PARTICIPANTS: All 32 general surgery interns participated in aspects of the coaching program. RESULTS: The end-of-program survey was completed by 19/32 (59%) interns and commitment-to-act statements were completed by 22/32 (69%). The majority (89%) of survey respondents "agreed" or "strongly agreed" that the longitudinal intern coaching program helped them reach goals they had set for themselves this academic year; 15/19 (79%) noted that the coaching experience was effective in promoting well-being practices in their life. Well-being and professional goals were identified as major themes in the end-of-the-year commitment-to-act statements. Statements specifically mentioned resources highlighted and skills taught in our coaching program such as mindfulness techniques, gratitude journals, and self-compassion strategies. CONCLUSIONS: Our study illustrates the effectiveness of a coaching pilot program on promoting well-being practices in a university-based general surgery internship and can be a roadmap with proven efficacy and measurable outcomes.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Comparison Study of Iliac Branch Endoprosthesis when Used on and off Label.

BACKGROUND: The aim of this study is to compare how instructions for use (IFU) affected perioperative and intermediate term outcomes for common iliac artery aneurysms (CIAA) treated with the Gore Excluder iliac branch endoprosthesis (IBE). METHODS: A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and nonIFU IBE cases. Criteria for nonIFU included: (1) use with a nonGore aortic endoprosthesis (n = 10), (2) isolated IBE (n = 3), and (3) requiring nondedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n = 11). Perioperative and intermediate term data were collected for both groups. The primary end points were free from the major adverse event (MAE) at 30 days and primary effectiveness at 1 year. RESULTS: A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 under nonIFU. The IFU group mean age was older (72 vs. 67 years, P = 0.03), and males (97%) were primarily treated. Comorbidities were similar except nonIFU had more patients with previous endovascular abdominal aortic aneurysm repair on presentation (0 vs. 4 cases, P = 0.04). Procedure (178 vs. 264 min, P = 0.02) and fluoroscopy (52 vs. 74 min, P = 0.04) times were longer in the nonIFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs. 1, P = 0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs. 3, P = 0.94). Percent CIAA sac regression was similar between the groups (19% vs. 18%, P = 0.21). There was no difference for primary effectiveness at 1 year (93% vs. 92%, P = 0.85). There was one death per group at one year not related to an aortic or iliac cause. CONCLUSIONS: In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.

Muffins and Meditation: Combatting Burnout in Surgical Residents.

OBJECTIVE: To quantify the prevalence of burnout in our surgical residency program and to assess the impact of a weekly wellness program for surgical residents through validated tools measuring mindfulness, self-compassion, flourishing, and burnout. Our hypothesis was that participants with more frequent attendance would: (1) be more mindful and self-compassionate and (2) experience less burnout and more flourishing. DESIGN: An optional one-hour weekly breakfast conference was facilitated by a senior surgical faculty member with the time protected from all clinical duties. Following a guided meditation, participants were given time for reflection and dialogue about their training experiences or led in a wellness exercise. TRANCE (tolerance, respect, anonymity, nonretaliation, compassion, egalitarianism) principles were utilized to create a safe and open environment. Residents were surveyed at the end of the study period, which was from March 2017 through June 2018. SETTING: The conference and data analysis was conducted at Denver Health Medical Center, affiliated with the University of Colorado School of Medicine. PARTICIPANTS: This study analyzed survey responses from 85 surgical residents. RESULTS: Following the wellness program, when answering the 2-question Maslach Burnout Inventory, 35.7% of residents reported feeling burned out by their work once a week or more, and 29.7% reported feeling more callous toward people once a week or more. After multivariate analysis, the only independent predictors of increased burnout were "not being married or in a committed relationship," lower positive affect, and higher negative affect. Written feedback was overwhelmingly positive, and residents expressed gratitude for the conference, the opportunity for self-reflection, and open dialogue with attendings and colleagues. CONCLUSIONS: The prevalence of burnout is high among surgical residents. Allowing time to practice a mindfulness meditation while providing space for residents to share their experiences may be protective, and efforts should be made to reduce barriers to participation.

Efficacy and safety of rivaroxaban versus placebo after lower extremity bypass surgery: A post hoc analysis of a "CASPAR like" outcome from VOYAGER PAD.

BACKGROUND: The Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease (CASPAR) trial is the only large, double-blind, placebo-controlled trial of dual antiplatelet therapy (DAPT) versus aspirin in patients with peripheral artery disease (PAD) after lower extremity revascularization (LER). The trial was neutral for index-graft occlusion/revascularization, amputation or death (hazard ratio [HR] 0.98, 95% confidence interval [CI] 0.78-1.23, p = .87) with an excess of global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries moderate or severe bleeding (HR 2.84, 95% CI 1.32-6.08, p = .007). HYPOTHESIS AND METHODS: VOYAGER-PAD demonstrated that rivaroxaban significantly reduces acute limb ischemia (ALI), major amputation, myocardial infarction (MI), stroke and CV death but increased bleeding. The relative efficacy and safety of rivaroxaban in a CASPAR like population and for similar outcomes is unknown. The current analysis is a post-hoc exploratory analysis of a "CASPAR like" composite of ALI, unplanned index limb revascularization (UILR), amputation or CV death in surgical patients. RESULTS: In the 2185 who underwent surgical LER, rivaroxaban reduced the CASPAR endpoint at 1 (HR 0.76, 95% CI 0.62-0.95, p = .0133) and 3 years (HR 0.84, 95% CI 0.71-1.00, p = .0461, Figure). There were similar reductions in composites of ALI, amputation or CV death (HR 0.79, p = .0228) and ALI, UILR, amputation, MI, IS or CV death (HR 0.85, p = .0410). CONCLUSIONS: The combination of rivaroxaban and aspirin significantly reduces ischemic outcomes in patients with PAD after LER. Although no formal head-to-head comparison exists, in a similar population and for similar outcomes, this regimen demonstrated benefit where trials of DAPT were neutral. These data suggest that factor Xa inhibition may provide specific benefits in this population and that DAPT should not be considered a proven substitution.

High Rates of Recurrent Revascularization in Acute Limb Ischemia - A National Surgical Quality Improvement Program Study.

BACKGROUND: We queried the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to review outcomes of acute limb ischemia (ALI) patients following open surgical intervention for ALI. METHODS: A previously validated tool was used to identify ALI patients in NSQIP undergoing open surgical revascularization from 2012 to 2017. Multivariable analysis was performed for the primary outcome of reoperation and secondary outcome of readmission and infection. RESULTS: A total of 2,878 ALI patients underwent open revascularization; 35.7% were transfers from another acute care hospital. A total of 13.8% required reoperation and 7.9% required readmission within 30 days. A total of 32% of reoperations were recurrent revascularization, representing 4.4% of all ALI patients. A total of 58.7% of patients were female and either overweight or obese. Younger age (odds ratio OR 0.991 [0.984-0.999], P = 0.02), underweight patients (OR 1.159 [0.667-2.01], P = 0.05), pre-operative steroid use (OR 1.61 [1.07-2.41], P = 0.02), and perioperative transfusion (OR 2.02 [1.04-3.95], P = 0.04) predicted reoperations. CONCLUSIONS: This registry series demonstrates all-cause ALI patients are a different population than PAD with different risk factors. Despite being a time-critical condition, ALI has higher interhospital transfer rates than ACS or ruptured aneurysm. Following open revascularization, ALI outcomes are worse than ACS but better than ruptured AAA. These outcomes do not appear related to patient factors in contrast to revascularization for chronic PAD.

Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD.

Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28 months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74-1.09]; P=0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00-1.40]; P=0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome (P-interaction=0.22), unplanned index limb revascularization (P-interaction=0.64), and bleeding (P-interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25]; P=0.0099). Conclusions Among >1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex-based outcomes and treatment adherence following LER is needed. Registration URL: http://clinicaltrials.gov; Unique identifier: NCT02504216.

Rivaroxaban and Risk of Venous Thromboembolism in Patients With Symptomatic Peripheral Artery Disease After Lower Extremity Revascularization.

Importance: Prior studies have observed an association between the burden of atherosclerotic vascular disease and the risk of venous thromboembolism (VTE). The association is not well described in peripheral artery disease (PAD) after lower extremity revascularization (LER). Objective: To describe the risk of, factors associated with, and outcomes after VTE, as well as the association of low-dose rivaroxaban plus antiplatelet therapy with VTE after LER. Design, Setting, and Participants: This global, multicenter cohort study used data from the Vascular Outcomes Study of ASA (acetylsalicylic acid) Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD (VOYAGER PAD) randomized clinical trial, which enrolled patients from 2015 to 2018 with median follow-up of 28 months. Participants included patients with PAD undergoing LER. Patients with an indication for therapeutic anticoagulation were excluded. Data were analyzed from September 2020 to September 2021. Exposure: Randomization to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily; short-term clopidogrel was used at the discretion of the treating physician. Main Outcomes and Measures: Symptomatic VTE was a prespecified secondary outcome and prospectively collected. Results: Among 6564 patients (median [IQR] age, 67 [61-73] years; 4860 [74.0%] men), 66 patients had at least 1 VTE. The 3-year rate of VTE in patients receiving placebo was 1.7%, and the pattern of risk was linear (year 1: 0.5%; year 2: 1.1%). After multivariable modeling, weight (hazard ratio [HR], 3.04; 95% CI, 1.09-8.43), hypertension (HR, 2.11; 95% CI, 0.91-4.89), prior amputation (HR, 2.07; 95% CI, 0.95-4.53), and older age (HR, 1.81; 95% CI, 1.06-3.11) were associated with increased risk of VTE. VTE was associated with risk of subsequent mortality (HR, 7.22; 95% CI, 4.66-11.19). Compared with aspirin alone, rivaroxaban plus aspirin was associated with lower VTE risk (HR, 0.61; 95% CI, 0.37-0.998; P = .047), with benefit apparent early and sustained over time. This association was not modified by use of clopidogrel at randomization (without clopidogrel: HR, 0.55; 95% CI, 0.29-1.07; with clopidogrel: HR, 0.69; 95% CI, 0.32-1.48; P for interaction = .67). Conclusions and Relevance: In this cohort study, there was continuous risk for VTE after LER in patients with PAD, with greater risk in patients who were older and had obesity and those with more severe PAD, as reflected by prior amputation. Low-dose rivaroxaban plus aspirin was associated with lower VTE risk compared with aspirin alone, with benefits apparent early and continued over time. The spectrum of venous and arterial thrombotic events and overall benefits of more potent antithrombotic strategies for prevention should be considered after LER for PAD.

Cadaver Simulation is Associated with Increased Comfort in Performing Open Vascular Surgery Among Integrated Vascular Surgery (0+5) Residents and Recent Graduates.

BACKGROUND: With the evolution in vascular surgery toward increased endovascular therapy and decreased open surgical training, comfort with open procedures by current trainees is declining. A proposed method to improve this discomfort is simulator training. We hypothesized that open, cadaver, and endovascular surgery simulation would be associated with increased self-perceived comfort in performing corresponding procedures. METHODS: Integrated (0 + 5) vascular surgery residents and recent graduates in the United States were asked to complete a survey quantifying comfort via a Likert scale with procedures and experience with simulation training. Simulation groups were then matched using coarsened exact matching. Ordinal logistic regression assessed the association between simulation experience and comfort in performing procedures. RESULTS: Surveys were completed by 68 trainees and 20 attending surgeons in their first 5 years of practice. On unmatched analyses, there were no significant differences in comfort in performing any open or endovascular aorto-mesenteric or peripheral vascular procedures between respondents who reported experience with open or endovascular simulation, respectively. However, respondents who reported cadaver simulation experience (58%, 51/88) had a significantly higher reported comfort score performing open juxtarenal aortic repair (2.4 vs. 1.7), superior mesenteric artery thrombectomy or bypass (2.5 vs. 1.9), inferior vena cava or iliac vein repair (2.2 vs. 1.7), axillary-femoral artery bypass (3.4 vs. 2.5), femoral-popliteal artery bypass (3.7 vs. 2.8), and inframalleolar artery bypass (2.8 vs. 2.1; all P < 0.05). After matching on training level, number of abdominal cases completed, and number of open vascular cases completed, ordinal logistic regression demonstrated that previous cadaver simulation was significantly associated with increased comfort in performing open aortic repairs, venous repair, visceral revascularization, and peripheral bypasses. CONCLUSIONS: In this nationally representative sample, cadaver, but not open or endovascular, simulation was associated with increased comfort in performing open vascular surgery. Providing cadaver simulation to trainees may help to improve comfort levels in performing open surgery. Integrated vascular surgery training programs should consider implementing these experiences into their curriculum.