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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).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.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.In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.

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).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.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).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.

Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type.Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy.VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.5 mg twice-daily or placebo on aspirin background. Marginal proportional-hazards models used to generate treatment hazard ratios and associated 95% CIs for first and total events; non-thrombotic deaths treated as competing terminal events. Incidence rates calculated as number of events per 100 patient-years follow-up.Over 2.5 years (median), first and total thrombotic event rates: 7.1 and 10.3 events/100 patient-years, respectively, in placebo group. Two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events. Nearly one-third of patients with first event had a second arterial or venous thrombotic event. Rivaroxaban plus aspirin reduced first and total arterial and venous thrombotic events to 5.4 and 7.9 events/100 patient-years, respectively, a reduction in total thrombotic events over aspirin of 23% (HR: 0.77, 95%CI: 0.67-0.89, p = .0005), preventing 6.1 total arterial and venous thrombotic events at 3 years.Assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact. Following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.

Background: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Previous lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. Methods: The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD; rNCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan-Meier estimates, and Cox proportional hazards models were used to generate hazard ratios and associated CIs. Analyses were performed as intention-to-treat. Results: Among 6564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, previous LER, baseline ankle-brachial index P =0.0001), with benefit starting early (HR, 0.45 [95% CI, 0.24–0.85]; P =0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and intensive care unit stay, HR, 0.58 [95% CI, 0.40–0.83]; P =0.003) and regardless of LER type (surgical versus endovascular revascularization, P interaction=0.42) or clopidogrel use ( P interaction=0.59). Conclusions: After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.

Background Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality. Objectives This study assessed DCD safety and effectiveness in LER for PAD. Methods VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models. Results Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 0.57) were observed. Conclusions In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216 )

Aims In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk–benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described. Methods and results The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan–Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding). Conclusion Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.

Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71–1.01) with clopidogrel and 0.86 (95% CI, 0.73–1.01) without clopidogrel without statistical heterogeneity ( P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14–1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22–1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44–7.13]) compared with shorter durations of clopidogrel ( P for trend=0.06). Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02504216.

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.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.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.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.

To describe the first year of the Educational Quality Improvement Program (EQIP) DESIGN: The Educational Quality Improvement Program (EQIP) was formed by the Association of Program Directors in Surgery (APDS) in 2018 as a continuous educational quality improvement program. Over 18 months, thirteen discrete goals for the establishment of EQIP were refined and executed through a collaborative effort involving leaders in surgical education. Alpha and beta pilots were conducted to refine the data queries and collection processes. A highly-secure, doubly-deidentified database was created for the ingestion of resident and program data.36 surgical training programs with 1264 trainees and 1500 faculty members were included in the dataset. 51,516 ERAS applications to programs were also included. Uni- and multi-variable analysis was then conducted.EQIP was successfully deployed within the timeline described in 2020. Data from the ACGME, ABS, and ERAS were merged with manually entered data by programs and successfully ingested into the EQIP database. Interactive dashboards have been constructed for use by programs to compare to the national cohort. Risk-adjusted multivariable analysis suggests that increased time in a technical skills lab was associated with increased success on the ABS's Qualifying Examination, alone. Increased time in a technical skills lab and the presence of a formal teaching curriculum were associated with increased success on both the ABS's Qualifying and Certifying Examination. Program type may be of some consequence in predicting success on the Qualifying Examination.The APDS has proved the concept that a highly secure database for the purpose of continuous risk-adjusted quality improvement in surgical education can be successfully deployed. EQIP will continue to improve and hopes to include an increasing number of programs as the barriers to participation are overcome.

OBJECTIVE Surgical departments are increasingly utilizing media to disseminate knowledge, discuss ideas, and mentor future surgeons. Podcasts are a form of media where digitally recorded content can be downloaded or streamed. This study aims (1) to describe the audience reached by a single surgical department podcast and (2) to evaluate what sources of information surgery residency applicants use to formulate a rank list. DESIGN In Fall 2017, the Rocky Mountain Surgery Podcast (RMSP) was created, produced, and edited by 2 general surgery (GS) residents at a large academic training program. Each episode discussed a topic within GS training and/or educational experiences specific to the program. Interviewing GS applicants for the 2019 match were asked to complete an anonymous voluntary survey on their familiarity and opinion of RMSP and the role of podcasts in the application process. RESULTS Twenty-two episodes were completed over a 16-month period (October 4, 2017 - February 11, 2019). A total of 7002 individual listens occurred in 644 cities across 46 states. Ninety-eight interviewing applicants responded to the survey (99% response rate), and one-fourth had previously listened to the RMSP. Only half felt that the traditional interview experience provided enough information about a GS program, and a significant majority (97%) stated they would listen to one or more podcast episodes to gain information regarding a GS residency program. CONCLUSIONS Applicants to GS residency commonly feel inadequate information is gained during the interview process. Podcasts are a tool familiar to applicants that allow for exploration of topics which cannot be adequately addressed in a typical interview day, thus expanding an applicant's knowledge of a GS training program.

Pediatric traumatic vascular injuries are rare. Given the paucity of data to guide anti-coagulation (AC) management of these injuries in children, who have a lower overall risk for thrombosis compared to their adult counterparts, we sought to examine and summarize our recent experience.We conducted a retrospective review of all patients (18 years old) who sustained traumatic vascular injuries between 2010-2018 at a Level 1 and Level 2 Pediatric Trauma Center.Ninety-nine patients had traumatic vascular injuries. Eighty-four patients sustained a major arterial injury, 26 had a major venous injury, and 11 had both arterial and venous injuries. The arterial injury cohort had a median age of 13.3 years. Most of the arterial injury patients (65/84, 77%) required vascular repair. In-hospital AC management for the arterial injury patients consisted of a post-operative heparin drip (18%, 15/84), aspirin (39%, 26/84), enoxaparin (23%, 19/84), or none (42%, 43/84). Approximately one-half of the patients with arterial injuries (54%, 45/84) were discharged home on AC therapy, most commonly aspirin. Fifty-six patients (66%) followed up post-injury, of which 25% (14/56) had experienced complications.Pediatric traumatic arterial injuries that require surgical intervention other than ligation should be considered for discharge AC - most commonly aspirin - in the absence of contraindications. Pediatric patients with vascular injuries to the aorta, carotid artery, inferior vena cava, portal vein, or lower extremities that are managed non-operatively should also be considered for AC. The preferred AC for pediatric venous injuries is enoxaparin, in the absence of contraindications.Treatment Study LEVEL OF EVIDENCE: IV.

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.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.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.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.

Patients with peripheral artery disease (PAD) have an increased risk of cardiovascular (CV) and limb events, but the disease is frequently underdiagnosed and treatment options are limited. This review examines the disease burden of symptomatic PAD as well as key guideline recommendations. Publications were identified using the ProQuest portal to access the Medline, Medline In-Process, and Embase databases. Search terms for symptomatic PAD were combined with terms relevant to epidemiology, burden, treatment practice, and physiopathology. Articles in English published between January 2001 and September 2016 were screened according to the population, interventions, comparator, outcomes, and study design criteria. Relevant publications (n = 200) were identified. The reported incidence and prevalence of PAD varied depending on the definitions used and the study populations. Patients generally had a poor prognosis, with an increased risk of mortality, CV, and limb events and decreased quality of life. Guideline recommendations included ankle–brachial index measurements, exercise testing, and angiography for diagnosis and risk factor modification, antiplatelets, cilostazol, exercise therapy, or surgical interventions for treatment, depending on the patient profile. The clinical, humanistic, and economic burden of disease in patients with symptomatic PAD is substantial and needs to be reduced through improved PAD management.

ObjectiveTraumatic popliteal artery injuries are associated with the greatest risk of limb loss of all peripheral vascular injuries, with amputation rates of 10% to 15%. The purpose of the present study was to examine the outcomes of patients who had undergone operative repair for traumatic popliteal arterial injuries and identify the factors independently associated with limb loss.MethodsA multi-institutional retrospective review of all patients with traumatic popliteal artery injuries from 2007 to 2018 was performed. All the patients who had undergone operative repair of popliteal arterial injuries were included in the present analysis. The patients who had required a major lower extremity amputation (transtibial or transfemoral) were compared with those with successful limb salvage at the last follow-up. The significant predictors (P< .05) for amputation on univariate analysis were included in a multivariable analysis.ResultsA total of 302 patients from 11 institutions were included in the present analysis. The median age was 32years (interquartile range, 21-40years), and 79% were men. The median follow-up was 72days (interquartile range, 20-366days). The overall major amputation rate was 13%. Primary repair had been performed in 17% of patients, patch repair in 2%, and interposition or bypass in 81%. One patient had undergone endovascular repair with stenting. The overall 1-year primary patency was 89%. Of the patients who had lost primary patency, 46% ultimately required major amputation. Early loss (within 30days postoperatively) of primary patency was five times more frequent for the patients who had subsequently required amputation. On multivariate regression, the significant perioperative factors independently associated with major amputation included the initial POPSAVEIT (popliteal scoring assessment for vascular extremity injury in trauma) score, loss of primary patency, absence of detectable immediate postoperative pedal Doppler signals, and lack of postoperative antiplatelet therapy. Concomitant popliteal vein injury, popliteal injury location (P1, P2, P3), injury severity score, and tibial vs popliteal distal bypass target were not independently associated with amputation.ConclusionsTraumatic popliteal artery injuries are associated with a significant rate of major amputation. The preoperative POPSAVEIT score remained independently associated with amputation after including the perioperative factors. The lack of postoperative pedal Doppler signals and loss of primary patency were highly associated with major amputation. The use of postoperative antiplatelet therapy was inversely associated with amputation, perhaps indicating a protective effect.

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method ( P -interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67–0.98]; P =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding ( P -interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding ( P -interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39–1.95]; P =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage ( P =0.95) and postprocedural bleeding requiring intervention ( P =0.93) was not significantly increased. Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov ; Unique Identifier: NCT02504216.

Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality.This study assessed DCD safety and effectiveness in LER for PAD.VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models.Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (PIn4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).

Individuals with diabetes mellitus (DM) have a high risk of peripheral artery disease (PAD), of which critical limb ischemia (CLI) is the most severe manifestation. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban 2.5mg twice daily plus aspirin for reducing risk of major adverse limb and cardiovascular events (acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or cardiovascular death) in 6,564 PAD patients undergoing revascularization; 1,533 presented with CLI. The risk profile of CLI patients with comorbid DM and whether efficacy and safety of rivaroxaban is consistent in this population has not been described. Overall, 47% of CLI patients (n=716) had comorbid DM at baseline. The HR for the primary outcome at 3 years in CLI patients was 0.85 (CI 0.69-1.05); the risk was higher in DM (28.8%) versus those without (20.7%) although all were high risk; more than 1 in 5 had a first event at 3 years (Figure left). The benefit of rivaroxaban was consistent in CLI patients regardless of DM status as was the bleeding risk. However, due to higher baseline risk, the absolute benefit was greater in those with both CLI and DM vs. CLI alone. In conclusion, in patients with CLI, DM is associated with even greater risk of adverse limb and cardiovascular events. Rivaroxaban provides a robust benefit to reduce this risk in CLI patients having comorbid DM. Disclosure C. C. Low wang: None. M. R. Nehler: Other Relationship; Self; CPCResearch. L. Haskell: Employee; Self; Janssen Research & Development, LLC. S. D. Berkowitz: Employee; Self; Bayer U. S . R. M. Bauersachs: Advisory Panel; Self; Bayer AG, LEO Pharma Inc., Speaker’s Bureau; Self; Bristol-Myers Squibb Company, Pfizer Inc. M. P. Bonaca: Research Support; Self; Grant support to CPC from Amgen, Anthos, AstraZeneca, Bayer, Merck, NovoNordisk, Pfizer, Sanofi, Wraser.

The most common causes of ischaemic stroke are represented by carotid artery atherosclerotic disease (CAAD) and atrial fibrillation. While oral anticoagulants substantially reduce the incidence of thromboembolic stroke (< 1%/year), the rate of ischaemic stroke and other cardiovascular disease events in patients with CAAD remains high, ranging from 8.4 to 18.1 events per 100 patient-years. Similar to any other atherosclerotic disease, anti-thrombotic therapies are proposed for CAAD to reduce stroke and other cardiovascular events. The 2017 European Society of Cardiology (ESC)/European Society for Vascular Surgery (ESVS) guidelines recommend for patients with asymptomatic CAAD ≥60% the use of aspirin 75 to 100 mg once daily or clopidogrel 75 mg once daily at the exception of patient at very high bleeding risk. For patients with symptomatic CAAD ≥50%, the use of aspirin 75 to 100 mg once daily or clopidogrel 75 mg once daily is recommended. New perspectives for anti-thrombotic therapy for the treatment of patients with CAAD come from the novel dual pathway strategy combining a low-dose anticoagulant (i.e. rivaroxaban) and aspirin that may help reduce long-term ischaemic complications in patients with CAAD. This review summarizes current evidence and recommendations for the anti-thrombotic management of patients with symptomatic or asymptomatic CAAD or those undergoing carotid revascularization.

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).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.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.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.Symptomatic VTE was a prespecified secondary outcome and prospectively collected.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).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.

Objective In the last two decades, vascular surgery training evolved from exclusively learning open skills to learning endovascular skills in addition to a functional reduction in training duration with 0+5 residency programs. The implications for this on trainee evolution to independence are unknown. We aimed to assess self-perceived comfort performing open and endovascular procedures and to identify predictors of high comfort among senior vascular surgery trainees and recent graduates. Methods Junior and senior 0+5 vascular surgery residents, traditional fellows, and attendings in their first 4 years of practice were asked to complete a survey assessing the number of vascular procedures performed to date, comfort performing these procedures on a Likert scale, and validated scales of self-efficacy and grit. Groups were then matched by training level and age. Logistic regression identified independent predictors of the top quartile of self-perceived comfort performing procedures. Results Surveys were completed by 92 trainees and 71 attending surgeons in their first 4 years of practice. After matching, completing ≥7 open juxtarenal aortic repairs (OR = 4.73, 95% CI = 1.59–14.07) and a higher self-efficacy score (OR = 3.24, 95% CI = 1.20–8.76), were independent predictors of top quartile comfort performing open vascular procedures. 0+5 residency training inversely correlated with top quartile comfort performing open vascular operations (OR = 0.12, 95% CI = 0.03–0.47). Completing ≥7 complex EVARs (OR = 3.94, 95% CI = 1.61–9.59) and a higher self-efficacy personality score (OR = 2.76, 95% CI = 1.09–7.02) were predictors of top quartile comfort performing endovascular procedures. Conclusion In this nationally representative survey, both trainees and junior attendings completed a paucity of complex open vascular cases, which corresponded to reduced comfort performing these procedures. Furthermore, 0+5 residency training was associated with lower self-perceived comfort performing open vascular surgery, a trend that persisted through the first years of practice. Endovascular comfort did not show a similar correlation.

Introduction: Chronic kidney disease (CKD) is common among patients undergoing lower extremity revascularization (LER) for peripheral artery disease (PAD) and identifies a population at high risk for adverse outcomes. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban in PAD patients after LER on a composite of cardiovascular (CV) and limb ischemic events (HR 0.85 vs placebo, 95% CI 0.76-0.96; p=0.009); this analysis examines the prespecified subgroup of patients with CKD. Methods: VOYAGER PAD (NCT02504216) was a double-blind, placebo-controlled trial which randomized PAD patients with recent LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or CV death. The primary safety endpoint was TIMI major bleeding. Analysis of the intention-to-treat population utilized Kaplan Meier estimates and Cox proportional-hazards models. Results: Among 6319 VOYAGER patients with baseline estimated glomerular filtration rate (eGFR), 21% were 2 . During 28-month (median) follow up, patients with CKD had a higher rate of major CV and limb events: placebo group 10.0 events/100 patient-years (95% CI 8.5, 11.8) for eGFR Conclusions: Rivaroxaban reduced major CV and limb events in patients with PAD undergoing LER, including those with CKD, a particularly high-risk population.

Background: Prior studies suggest that atherosclerotic vascular disease may be associated with risk of venous thromboembolism (VTE), though the relationship remains uncertain and has not been well-studied in peripheral artery disease (PAD) after lower extremity revascularization (LER). Hypothesis: We hypothesized that patients with PAD undergoing LER are at risk for VTE and that this risk may be reduced by low-dose rivaroxaban plus aspirin versus aspirin alone. Methods: VOYAGER PAD randomized 6,564 PAD patients undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. Clopidogrel was allowed for up to 6 months. Patients could not be enrolled if they had an indication for therapeutic anticoagulation, including secondary prevention of VTE. Symptomatic VTE was a prespecified secondary endpoint. Results: Over a median of 28 months, there were 66 patients with VTE. In patients randomized to placebo, risk for VTE accrued steadily after randomization at a rate of ~0.5% per year resulting in a 3-year rate of 1.66%. Compared with placebo, rivaroxaban reduced the risk of VTE by 39% (HR 0.61, 95% CI 0.37-1.00, p=0.047), with benefit apparent early and sustained over time (Figure). The efficacy of rivaroxaban 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-interaction = 0.67). Conclusions: PAD is associated with continuous and linearly increasing risk for VTE after LER. A strategy of low-dose rivaroxaban plus aspirin versus aspirin alone reduced this risk by 39% with benefits apparent early and continued over time. The addition of clopidogrel does not modify this benefit. VTE, along with arterial thrombotic events, is part of the adverse thrombotic risk profile in PAD patients, and low-dose rivaroxaban plus aspirin provides protection against venous and arterial thrombosis.

Background/Introduction: Amputation is a major morbidity of peripheral artery disease (PAD). Although traditionally attributed to ischemia, the multifactorial nature is increasingly recognized, particularly in those with concomitant diabetes mellitus (DM). Elucidating the drivers of amputation in PAD with and without DM may be important in developing strategies for prevention. Purpose: To elucidate the primary drivers of amputations in patients with PAD with and without DM. Methods: EUCLID randomized 13,885 patients with PAD. Investigators prospectively reported all amputations. In this post-hoc analysis, amputations (major – ankle and above, minor – distal to ankle) were retrospectively adjudicated using safety data when available to characterize the drivers including infection, ischemia, or multifactorial. Etiologies were evaluated by DM status at baseline. Results: A total of 415 patients (3% of total) underwent 533 (260 major and 263 minor) amputations over a median of 30 months. Of these, 360 (68%) occurred in the 5,345 patients with DM (n/N of 6.7%) and 173 (32%) occurred in the 8,450 patients without DM (n/N of 2.0%). There were 172 non-traumatic amputations with sufficient documentation to determine drivers. Ischemia was the primary driver overall (51%) followed by infection (27%) and multifactorial (22%). The primary driver, however, varied by DM status with the dominant driver in those with DM being infection (59%) and in those without DM, ischemia (82%) ( Fig. 1 ). The etiology varied for major and minor with the former driven by ischemia (65%) and the latter driven by infection (59%). Conclusions: Amputations in PAD appear to have different primary drivers depending on concomitant DM. Infection may have a larger role in those with DM and ischemia in those without DM. Further research to elucidate the pathobiology and predictors of these outcomes may help in the development of strategies for prevention.

Background: Peripheral artery disease (PAD) is associated with increased risk of mortality, cardiovascular morbidity, and major amputation. Data on major amputation from a large randomized trial that included a substantial cohort of patients without critical limb ischemia (CLI) have not been described. The objective was to describe the incidence and types of amputations in the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) population, subcategorize amputations in the CLI versus no CLI cohorts, and describe the events surrounding major amputation. Methods and Results: Postrandomization major amputation was analyzed in the EUCLID trial. Patients were stratified by baseline CLI status. The occurrence of major amputation was ascertained and defined as the highest level. Perioperative events surrounding major amputation were obtained including acute limb ischemia, revascularization, and all-cause mortality. All variables were assessed for significance in univariable and multivariable models. The rate of major amputation during the course of the trial was 1.6% overall, 8.4% in the CLI at baseline group, and 1.2% in the no CLI at baseline group. The annualized rate of major amputation was 0.6% in PAD overall, 3.9% in the CLI at baseline group, and 0.5% in the no CLI at baseline group. Several factors were associated with increased risk of major amputation, including history of amputation, the presence of diabetes mellitus, baseline Rutherford category 4 to 6, and an ankle-brachial index Conclusions: The risk factors for major amputation in EUCLID patients are similar to previous large registries’ reports except for diabetes mellitus in patients with CLI. The mortality following major amputation is lower in the EUCLID trial compared with registry data. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01732822.

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.

Background Acute limb ischemia (ALI) carries significant overall morbidity and mortality. Pregnant and postpartum women are physiologically hypercoagulable, but little is known about the impact of ALI in this cohort of patients. The goal of this systematic review was to gather available data on diagnosis and treatment of ALI during pregnancy and the postpartum period. Methods A systematic review of studies on patients with ALI during pregnancy and the puerperium was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Three databases including PubMed MEDLINE, Embase, and Cochrane Library were queried. Manuscripts that provided data on diagnosis and treatment of ALI in pregnant and postpartum patients were included regardless of language or study design. Outcomes of interest included type of treatment for ALI (open and endovascular), morbidity, and mortality. Results Fourteen manuscripts of 6222 references were included with a total of 14 patients. The median age of patients was 31.5 years. Embolism, present in eight (57%) patients, was slightly more common than thrombosis. All patients had a pregnancy complication or concomitant medical condition that might have predisposed to arterial occlusion either directly or indirectly by leading to iatrogenic arterial injury; peripartum cardiomyopathy, the most common, occurred in six (43%) patients. Open surgery was the preferred treatment option in 11 (79%) patients, followed by anticoagulation alone. No endovascular procedures were described. One patient underwent major amputation on presentation, and an additional patient required major amputation for recurrent ALI. No deaths occurred. Twelve (86%) patients had complete recovery with no other ALI-associated sequelae. Conclusions ALI is rare in pregnant and postpartum women despite their transient physiologic hypercoagulability and is almost uniformly associated with pregnancy complications. Open surgical revascularization or anticoagulation alone appears to have acceptable outcomes as most patients present with embolism or thrombosis without underlying systemic arterial disease.

The PAD population is at increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Risk factor modification, symptom control, antithrombotic, and lipid therapies are the mainstays of PAD medical therapy. Recent data has challenged prior recommendations regarding the optimal secondary prevention strategies in PAD. PURPOSE OF REVIEW: To review clinical evidence from large randomized controlled trials showing the benefit of antithrombotic and lipid therapy in the PAD population. RECENT FINDINGS: The COMPASS trial challenged prior recommendations regarding anticoagulation in PAD. Among the PAD subgroup, rivaroxaban 2.5 mg plus aspirin reduced MACE (HR 0.72, 95% CI 0.57-0.90, p = 0.0047), MALE (HR 0.54, 95% CI 0.35-0.82, p = 0.0037), and major amputation (HR 0.30, 95% CI 0.11-0.80, p = 0.011) compared with aspirin monotherapy. The THEMIS trial showed a 55% risk reduction for MALE with ticagrelor DAPT compared with aspirin monotherapy (HR 0.45, 95% CI 0.23-0.86). The FOURIER trial revealed that lowering LDL cholesterol below current targets with a PCSK9 inhibitor reduced MACE (HR 0.73, 95% CI 0.59-0.91, p = 0.0040) and MALE (HR 0.43, 95% CI 0.19-0.99, p = 0.042) in subjects with symptomatic PAD. Recent high-quality evidence shows the benefit of antiplatelet therapy, anticoagulation therapy, and lipid therapy in reducing MACE and MALE in PAD. Despite these findings, implementation remains a challenge and focus should now shift towards adopting evidence-based recommendations in clinical practice.

Objective To determine if surgeons and non-surgeons agree on the importance of surgical topics covered in the surgical clerkship to the daily practice of non-surgeons. Design An IRB-approved anonymous survey ranking the relative importance of 35 topics drawn from surgical clerkship curricula asking physicians to rank the relative importance of each topic, using a five-point Likert scale, to the daily practice of non-surgeons. Setting Online anonymous survey. Participants Convenience sample of practicing physicians and trainees. The survey was offered to physicians in all specialties via social media and professional connections, responders identified their practice specialty. Results 295 physicians completed the survey. Two hundred thirty-one (85%) were from non-surgical specialties: emergency medicine (EM, n = 100); primary care (PC, n = 71 – included internal medicine, family medicine, and pediatrics); a variety of others (n = 60). Surgeons and non-surgeons agreed on the relative importance of the acute abdomen, breast disease, inguinal hernias, inflammatory bowel disease, morbid obesity, sinusitis, thyroid and parathyroid disease, and wound care; surgeons believed colorectal cancer and diverticulitis to be more important. Surgeons rated all other topics as less important to non-surgeons than non-surgeons. EM rated most acute problems more important that PC; both groups ranked most topics higher importance to the practice of a non-surgeon than surgeons (p Conclusions Surgeons consistently underestimate the importance non-surgeons place on surgical topics in their practice. These results reinforce the perceived importance of a wide exposure to surgery in the surgical clerkship to all medical students – but topics could be focused differently depending on acute or non-acute non-surgical care career plans.

The magnitude of student debt plaguing our nation is a major topic in political and academic spheres with median medical student debt of $200,000. This is compounded by poor financial health during training. This study evaluates how debt and financial wellness influence resident perceived stress, mental health, career plans, and relationships.General surgery trainees at an academic institution were surveyed regarding financial parameters, perceived stress, and the impact of finances on their career and family life. A validated stress assessment instrument, the Perceived Stress Scale, was used to evaluate trainee stress. The median perceived stress score was compared for groups using a Wilcoxon rank-sum test.Fifty-eight (61% response rate) residents responded to the survey. The median (range) student loan debt was $200,000-500,000 ($0-750,000) and savings was $5000-10,000 ($0-20,000+). 18 (31%) trainees had monthly credit card debt. Half of the respondents did not have enough liquid assets for an emergency fund, defined as 3 mo of living expenses. The median perceived stress score was 16 (1-30) or moderate stress. Perceived stress score was significantly associated with the trainee's response to how finances impacted their future career choice, practice style, and relationships (P 0.005 for all). However, the perceived stress score was not associated with objective measures of financial wellness, such as the overall level of medical school debt, savings, or having an emergency fund.The trainee's subjective perception of financial wellness, rather than objective financial parameters was associated with higher levels of perceived stress, the strain on relationships, and a greater impact on future practice styles. The majority of surgery residents did not have enough liquid assets for an emergency fund, independent of the level of debt, which emphasizes how financially leveraged residents are during training. Although burnout during surgical training is multifactorial, formal financial education incorporated into graduate medical education programs could increase financial literacy, help to mitigate financial risk, and ultimately decrease some of the perceived stress residents possess.

Cancer results in a hypercoagulable state that is associated with both venous and arterial thromboses. However, little is known about the effects of acute limb ischemia (ALI) in this cohort of patients. In the present systematic review and meta-analysis, we analyzed the available clinical data on cancer and its association with ALI and evaluated the outcomes in these patients after a diagnosis of ALI.Three databases, including PubMed, EMBASE, and the Cochrane Library, were queried. Studies that met the inclusion criteria were included regardless of the publication year, language, sample size, or follow-up length. All the steps of the meta-analysis were conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) and MOOSE (meta-analysis of observational studies in epidemiology) guidelines.Seven studies from 6222 references with a total of 2899 patients were included. Of the 2899 patients, 1195 (41%) had had a diagnosis of ALI before their cancer diagnosis, and 1704 (59%) had presented with ALI after a cancer diagnosis. Nearly three quarters of ALI events were among patients with cancer of the skin and soft tissue (19%), genitourinary (18%), lung (17%), and gastrointestinal (16%) systems. ALI recurrence was similar between the two groups, and major amputation was more likely in patients with a diagnosis of ALI after a cancer diagnosis (7.4% vs 4.6%; P .01). The incidence of mortality at 1 year was significantly greater for patients with established cancer who had presented with ALI compared with the patients who had presented with ALI before a cancer diagnosis (50.6% vs 29.9%; P .01). After adjusting for study variability using the random effects model, the mortality at 1 year for all patients was 52.3% (95% confidence interval, 37.7%-66.5%). No significant heterogeneity (P = .73) was found between the two groups of patients, which varied by the timing of the ALI diagnosis in relation to the cancer diagnosis.The 1-year mortality after the development of ALI in patients with cancer was50%. For patients presenting with ALI of unclear etiology, the presence of an underlying cancer should be considered.

Objective Traumatic popliteal vascular injuries are associated with the highest risk of limb loss of all peripheral vascular injuries. A method to evaluate the predictors of amputation is needed because previous scores could not be validated. In the present study, we aimed to provide a simplified scoring system (POPSAVEIT [popliteal scoring assessment for vascular extremity injuries in trauma]) that could be used preoperatively to risk stratify patients with traumatic popliteal vascular injuries for amputation. Methods A review of patients sustaining traumatic popliteal artery injuries was performed. Patients requiring amputation were compared with those with limb salvage at the last follow-up. Of these patients, 80% were randomly assigned to a training group for score generation and 20% to a testing group for validation. Significant predictors of amputation (P 0.65 was considered adequate for validation. Results A total of 355 patients were included, with an overall amputation rate of 16%. On multivariate regression analysis, the risk factors independently associated with amputation in the final model were as follows: systolic blood pressure Conclusions The POPSAVEIT score provides a simple and practical method to effectively stratify patients preoperatively into low- and high-risk major amputation categories.

Aims/hypothesis The primary analysis of the Canagliflozin cardioVascular Assessment Study (CANVAS) Program showed canagliflozin to have a beneficial effect on cardiovascular and renal outcomes in people with type 2 diabetes at high cardiovascular risk, but also an unexpected increased risk of major or minor lower extremity amputation. These secondary analyses explore this finding in more detail.Methods The effect of canagliflozin on amputation risk in the CANVAS Program was calculated for amputations of different types and proximate aetiologies and different canagliflozin doses. Univariate and multivariate associations of baseline characteristics with amputation risk were determined and proportional and absolute effects of canagliflozin were compared across subgroups.Results There were 187 (1.8%) participants with atraumatic lower extremity amputations (minor 71%, major 29%); as previously published, rates were 6.30 vs 3.37 per 1000 participant-years with canagliflozin vs placebo (HR 1.97 [95% CI 1.41, 2.75]). Risk was similar for ischaemic and infective aetiologies and for 100mg and 300mg doses. Overall amputation risk was strongly associated with baseline history of prior amputation (major or minor) (HR 21.31 [95% CI 15.40, 29.49]) and other established risk factors. No interactions between randomised treatment and participant characteristics explained the effect of canagliflozin on amputation risk. For every clinical subgroup studied, numbers of amputation events projected were smaller than numbers of major adverse cardiovascular events averted.Conclusions/interpretation The CANVAS Program demonstrated that canagliflozin increased the risk of amputation (mainly minor) in this study population. Anticipated risk factors for amputation were identified, such as prior history of amputation, peripheral vascular disease and neuropathy, but no specific aetiological mechanism or at-risk subgroup for canagliflozin was identified.

The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention.Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Hospital readmissions are increasingly utilized as a measure of health care quality. Unplanned readmissions in surgical patients are viewed as a marker of poor care quality, and are associated with significant expense both to the health care system and to the patient. Interventions aimed at reducing readmissions have been the focus of several prospective randomized trials addressing medical conditions like congestive heart failure, but few data exist on efforts to reduce readmissions in surgical patients. Vascular surgery patients have been found to be at a particularly high risk for readmission, and a number of groups have reported on the risk factors for readmission in these patients. However, measures to reduce unplanned readmissions after vascular surgery have not be thoroughly investigated. Here, we summarize the existing data on risk factors for readmission in vascular surgery patients, review interventional studies in medical patients aimed at reducing readmissions, and suggest interventions that may be helpful in reducing readmissions in vascular patients. Further investigative work is needed to ascertain practical approaches to reducing unplanned readmissions in vascular surgery patients and thus improve the quality of care they receive.

Background Patients with peripheral artery disease (PAD) undergoing a lower-extremity revascularization are at heightened risk for ischemic cardiac and limb events. Although intensification of antithrombotic therapy after revascularization has demonstrated benefit in coronary disease populations, this approach has not been well studied or shown consistent benefit in PAD. Recent trial evidence demonstrated that a treatment strategy of rivaroxaban added to background antiplatelet therapy reduced ischemic risk in patients following recent acute coronary syndromes, as well as in patients with stable atherosclerotic vascular disease. Whether these benefits extend to the population of patients with symptomatic lower-extremity PAD undergoing revascularization is the objective of the VOYAGER PAD trial. Study design VOYAGER PAD is an international randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of rivaroxaban in symptomatic PAD patients undergoing a peripheral surgical and/or endovascular revascularization. Patients are randomized in a 1:1 ratio to either rivaroxaban 2.5 mg twice daily or placebo, on a background of low-dose aspirin (100 mg daily). In addition, the use of a limited course of P2Y12 inhibition is allowed at the discretion of the site investigator. The primary efficacy end point is a novel composite of myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, and major amputation of vascular etiology. The primary safety end point is major bleeding according to the Thrombolysis in Myocardial Infarction definition. Enrolment began in August 2015 and will complete randomization of at least 6,500 patients by January 2018. This event-driven trial is expected to observe outcomes over a mean patient follow-up of 30 months. Conclusions VOYAGER PAD is evaluating the efficacy of rivaroxaban added to background antiplatelet therapy to reduce major cardiovascular and limb ischemic vascular outcomes in the high-risk population of PAD patients undergoing peripheral revascularization.

Importance Previous studies of resident attrition have variably included preliminary residents and likely overestimated categorical resident attrition. Whether program director attitudes affect attrition has been unclear. Objectives To determine whether program director attitudes are associated with resident attrition and to measure the categorical resident attrition rate. Design, Setting, and Participants This multicenter study surveyed 21 US program directors in general surgery about their opinions regarding resident education and attrition. Data on total resident complement, demographic information, and annual attrition were collected from the program directors for the study period of July 1, 2010, to June 30, 2015. The general surgery programs were chosen on the basis of their geographic location, previous collaboration with some coauthors, prior work in surgical education and research, or a program director willing to participate. Only categorical surgical residents were included in the study; thus, program directors were specifically instructed to exclude any preliminary residents in their responses. Main Outcomes and Measures Five-year attrition rates (2010-2011 to 2014-2015 academic years) as well as first-time pass rates on the General Surgery Qualifying Examination and General Surgery Certifying Examination of the American Board of Surgery (ABS) were collected. High- and low-attrition programs were compared. Results The 21 programs represented different geographic locations and 12 university-based, 3 university-affiliated, and 6 independent program types. Programs had a median (interquartile range [IQR]) number of 30 (20-48) categorical residents, and few of those residents were women (median [IQR], 12 [5-17]). Overall, 85 of 966 residents (8.8%) left training during the study period: 15 (17.6%) left after postgraduate year 1, 34 (40.0%) after postgraduate year 2, and 36 (42.4%) after postgraduate year 3 or later. Forty-four residents (51.8%) left general surgery for another surgical discipline, 21 (24.7%) transferred to a different surgery program, and 18 (21.2%) exited graduate medical education altogether. Each program had an annual attrition rate ranging from 0.73% to 6.0% (median [IQR], 2.5% [1.5%-3.4%]). Low-attrition programs were more likely than high-attrition programs to use resident remediation (21.0% vs 6.8%; P P = .92) and Certifying Examination pass rates (83% [68%-84%] vs 81% [71%-86%]; P = .47) were similar. Program directors at high-attrition programs were more likely than their counterparts at low-attrition programs to agree with this statement: “I feel that it is my responsibility as a program director to redirect residents who should not be surgeons.” Conclusions and Relevance The overall 5-year attrition rate of 8.8% was significantly lower than previously reported. Program directors at low-attrition programs were more likely to use resident remediation. Variations in attrition may be explained by program director attitudes, although larger studies are needed to further define program factors affecting attrition.