Publications by authors named "Mark Nehler"

63 Publications

Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.

J Am Coll Cardiol 2021 Nov;78(18):1768-1778

Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA.

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 (P = 0.88) and safety of rivaroxaban with respect to bleeding (P = 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).
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http://dx.doi.org/10.1016/j.jacc.2021.08.052DOI Listing
November 2021

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD.

Circulation 2021 Oct 12. Epub 2021 Oct 12.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO.

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior 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. VOYAGER PAD (NCT02504216) 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 confidence intervals. Analyses were performed as intention-to-treat. Among 6,564 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, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, 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 ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). 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.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055146DOI Listing
October 2021

Etiology and Outcomes of Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

J Vasc Surg 2021 Sep 28. Epub 2021 Sep 28.

CPC Clinical Research, Aurora, Colo; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.

Objective: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). Although typically characterized as major or minor on the extent of tissue loss, the etiologies and outcomes after amputation by extent are not well-understood. In addition, emerging data suggest that the drivers and outcomes of amputation in patients with PAD may differ in those with and without diabetes mellitus (DM).

Methods: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5345 with concomitant diabetes, to ticagrelor or clopidogrel and followed them for long-term outcomes. Amputations were prospectively reported by trial investigators. Their primary and contributing drivers were adjudicated using safety data, including infection, ischemia, or multifactorial etiologies. Outcomes following major and minor amputations were analyzed, including recurrent amputation, major adverse limb events, adverse cardiovascular events, and mortality. Multivariable logistic regression models were used to identify independent predictors of minor amputations. Analyses were performed overall and stratified by the presence or absence of DM at baseline.

Results: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity nontraumatic amputation, for a total of 511 amputations (255 major and 256 minor) over a median of 30 months. A history of minor amputation was the strongest independent predictor for a subsequent minor amputation (odds ratio, 7.29; 95% confidence interval, 5.17-10.30; P < .001) followed by comorbid DM (odds ratio, 4.60; 95% confidence interval, 3.16-6.69; P < .001). Compared with patients who had a major amputation, those with a minor amputation had similar rates of subsequent major amputation (12.2% vs 13.6%), major adverse limb events (15.1% vs 14.9%), and major adverse cardiovascular events (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%), followed by infection alone (27%), and multifactorial etiologies (22%); however, infection was the most frequent driver in those with DM (58%) but not in those without DM (15%).

Conclusions: Outcomes after amputation remain poor regardless of whether they are categorized as major or minor. The pattern of amputation drivers in PAD differs by history of DM, with infection being the dominant etiology in those with DM and ischemia in those without DM. Greater focus is needed on the prognostic importance of minor amputation and of the multifactorial etiologies of amputation in PAD. Nomenclature with anatomical description of amputations and eliminating terms "major" or "minor" would seem appropriate.
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http://dx.doi.org/10.1016/j.jvs.2021.08.096DOI Listing
September 2021

Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials.

Eur J Prev Cardiol 2021 Aug 31. Epub 2021 Aug 31.

Department of Cardiology, University of Colorado School of Medicine, 13001 E 17th Pl, Boulder, Colorado 80045, USA.

Aims: Peripheral artery disease (PAD) patients suffer a high risk of major cardiovascular (CV) events, with athero-thrombo-embolism as the underlying pathophysiologic mechanism. Recently, two large randomized clinical trials evaluated the efficacy and safety of low-dose rivaroxaban twice daily plus aspirin in stable PAD outpatients and those immediately after peripheral revascularization. We sought to determine if the effects of low-dose rivaroxaban and aspirin compared to aspirin alone are consistent across this broad spectrum of PAD patients.

Methods And Results: We conducted a random-effects meta-analysis of the COMPASS and VOYAGER randomized trials among 11 560 PAD patients (4996 from COMPASS and 6564 from VOYAGER) in the primary analysis and 9332 (2768 from COMPASS and 6564 from VOYAGER) with lower extremity (LE)-PAD in the secondary analysis. The hazard ratio (HR) for the composite of CV death, myocardial infarction, ischaemic stroke, acute limb ischaemia, or major vascular amputation was 0.79 (95% confidence interval, CI: 0.65-0.95) comparing low-dose rivaroxaban plus aspirin to aspirin alone. While the risk of major bleeding was increased with low-dose rivaroxaban plus aspirin compared to aspirin alone [HR: 1.51 (95% CI: 1.22-1.87)], there was no significant increase in severe bleeding [HR: 1.18 (95% CI: 0.79-1.76)]. Similar effects were observed in the subset with symptomatic LE-PAD.

Conclusions: Among PAD patients, low-dose rivaroxaban plus aspirin is superior to aspirin alone in reducing CV and limb outcomes including acute limb ischaemia and major vascular amputation. This reduction is offset by a relative increase in major bleeding, but not by an excess of fatal or critical organ bleeding. The consistency of findings of these trials supports the use of combination low-dose rivaroxaban plus aspirin in PAD patients across a broad spectrum of disease.
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http://dx.doi.org/10.1093/eurjpc/zwab128DOI Listing
August 2021

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

Eur Heart J 2021 10;42(39):4040-4048

CPC Clinical Research, 2115 N Scranton Street, Suite 2040, Aurora, CO, USA.

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.
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http://dx.doi.org/10.1093/eurheartj/ehab408DOI Listing
October 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 Oct 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

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 (-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]; =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 (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-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]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=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.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

Contemporary outcomes of traumatic popliteal artery injury repair from the popliteal scoring assessment for vascular extremity injury in trauma study.

J Vasc Surg 2021 Nov 21;74(5):1573-1580.e2. Epub 2021 May 21.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of Southern California, Los Angeles, Calif.

Objective: Traumatic 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.

Methods: A 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.

Results: A total of 302 patients from 11 institutions were included in the present analysis. The median age was 32 years (interquartile range, 21-40 years), and 79% were men. The median follow-up was 72 days (interquartile range, 20-366 days). 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 30 days 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.

Conclusions: Traumatic 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.
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http://dx.doi.org/10.1016/j.jvs.2021.04.064DOI Listing
November 2021

Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

J Am Coll Cardiol 2021 Jul 16;78(4):317-326. Epub 2021 May 16.

CPC Clinical Research, Aurora, Colorado, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA. Electronic address:

Background: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. 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 demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.

Objectives: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.

Methods: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.

Results: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years.

Conclusions: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (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 [VOYAGER PAD]; NCT02504216).
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http://dx.doi.org/10.1016/j.jacc.2021.05.003DOI Listing
July 2021

A systematic review and meta-analysis of outcomes after acute limb ischemia in patients with cancer.

J Vasc Surg 2021 09 24;74(3):1033-1040.e1. Epub 2021 Apr 24.

Department of Surgery, University of Colorado, Anschutz Medical Center, Aurora, Colo; CPC Clinical Research, University of Colorado, Anschutz Medical Center, Aurora, Colo; Division of Vascular Surgery and Endovascular Surgery, University of Colorado, Anschutz Medical Center, Aurora, Colo.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: The 1-year mortality after the development of ALI in patients with cancer was >50%. For patients presenting with ALI of unclear etiology, the presence of an underlying cancer should be considered.
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http://dx.doi.org/10.1016/j.jvs.2021.03.058DOI Listing
September 2021

Self-Perceived Comfort Performing Vascular Surgery Procedures among Senior Vascular Surgery Trainees and Recent Graduates.

Ann Vasc Surg 2021 Aug 5;75:1-11. Epub 2021 Apr 5.

Division of Vascular and Endovascular Surgery, Saint Louis University, St. Louis, Missouri.

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.
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http://dx.doi.org/10.1016/j.avsg.2021.03.019DOI Listing
August 2021

Reply to "The VOYAGER PAD Trial in Surgical Perspective: A Debate".

Eur J Vasc Endovasc Surg 2021 05 1;61(5):723-724. Epub 2021 Apr 1.

Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

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http://dx.doi.org/10.1016/j.ejvs.2021.02.051DOI Listing
May 2021

Popliteal scoring assessment for vascular extremity injuries in trauma study.

J Vasc Surg 2021 09 24;74(3):804-813.e3. Epub 2021 Feb 24.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of Southern California, Los Angeles, Calif.

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 < .1) on univariate analysis were included in a multivariable analysis. Those with P < .05 on multivariable analysis were assigned points according to the relative value of their odds ratios (ORs). Receiver operating characteristic curves were generated to determine low- vs high-risk scores. An area under the curve of >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 <90 mm Hg (OR, 3.2; P = .027; 1 point), associated orthopedic injury (OR, 4.9; P = .014; 2 points), and a lack of preoperative pedal Doppler signals (OR, 5.5; P = .002; 2 points [or 1 point for a lack of palpable pedal pulses if Doppler signal data were unavailable]). A score of ≥3 was found to maximize the sensitivity (85%) and specificity (49%) for a high risk of amputation. The receiver operating characteristic curve for the validation group had an area under the curve of 0.750, meeting the threshold for score validation.

Conclusions: The POPSAVEIT score provides a simple and practical method to effectively stratify patients preoperatively into low- and high-risk major amputation categories.
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http://dx.doi.org/10.1016/j.jvs.2021.02.015DOI Listing
September 2021

Resident Opioid Prescribing Habits Do Not Reflect Best Practices in Post-Operative Pain Management: An Assessment of the Knowledge and Education Gap.

J Surg Educ 2021 Jul-Aug;78(4):1286-1294. Epub 2020 Dec 30.

Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, Colorado.

Objective: To evaluate deficiencies in knowledge and education in opioid prescribing and to compare surgical resident opioid-prescribing practices to Opioid Prescribing Engagement Network (OPEN) procedure-specific guidelines.

Design: Anonymous web-based survey distributed to all general surgery residents to evaluate prior education received and confidence in knowledge in opioid prescribing. The number of 5 milligram oxycodone tablets prescribed for common procedures was assessed and compared with OPEN for significance using Wilcoxon signed rank tests.

Setting: General surgery residency program within large university-based tertiary medical center.

Participants: Categorical general surgery residents of all postgraduate years.

Results: Fifty-six of 72 (78%) categorical residents completed the survey. Few reported receiving formal education in opioid prescribing in medical school (32%) or residency (16%). While 82% of residents felt confident in opioid side effects, fewer felt the same with regards to opioid pharmacokinetics (36%) or proper opioid disposal (29%). Opioids prescribed varied widely with residents prescribing significantly more than recommended by OPEN in 9 of 14 procedures.

Conclusions: Tackling the evolving opioid epidemic requires a multidisciplinary approach that addresses prescribing at all steps of the process, starting with trainee education.
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http://dx.doi.org/10.1016/j.jsurg.2020.12.014DOI Listing
June 2021

Polyvascular disease: A narrative review of current evidence and a consideration of the role of antithrombotic therapy.

Atherosclerosis 2020 12 6;315:10-17. Epub 2020 Nov 6.

Division of Cardiology, Department of Medicine Duke University Health System, USA; Duke Clinical Research Institute, Durham, NC, USA.

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.
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http://dx.doi.org/10.1016/j.atherosclerosis.2020.11.001DOI Listing
December 2020

Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.

Circulation 2020 12 3;142(23):2219-2230. Epub 2020 Nov 3.

Department of Vascular Medicine, Klinikum Darmstadt GmbH, Germany (R.B.).

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 ( 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; for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( 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 ( 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.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050465DOI Listing
December 2020

Over Worked and Under Paid: How Resident Finances Impact Perceived Stress, Career Choices, and Family Life.

J Surg Res 2021 02 28;258:82-87. Epub 2020 Sep 28.

Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado. Electronic address:

Background: 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.

Methods: 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.

Results: 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.

Discussion: 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.
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http://dx.doi.org/10.1016/j.jss.2020.07.084DOI Listing
February 2021

Surgeons Underestimate the Importance of Surgical Topics for Non-Surgeons: Results of a National Survey.

J Surg Educ 2021 Mar-Apr;78(2):533-547. Epub 2020 Aug 1.

Department of Surgery, Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Department of Surgery, GI, Trauma, and Endocrine Surgery Division, University of Colorado School of Medicine, Aurora, Colorado.

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 < 0.05).

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.
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http://dx.doi.org/10.1016/j.jsurg.2020.07.026DOI Listing
June 2021

Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

Circ Cardiovasc Qual Outcomes 2020 07 3;13(7):e006399. Epub 2020 Jul 3.

Department of Medicine, Division of Cardiology (M.R.P., W.S.J.), Duke University Health System, Durham, NC.

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 <0.8. Factors associated with a lower risk for major amputation included prior statin use. The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group. The annual mortality rate following major amputation was 22.8% in the CLI at baseline group and 16.0% in the no CLI at baseline group.

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.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006399DOI Listing
July 2020

A systematic review of diagnosis and treatment of acute limb ischemia during pregnancy and postpartum period.

J Vasc Surg 2020 11 20;72(5):1793-1801.e1. Epub 2020 May 20.

CPC Research, Aurora, Colo; Division of Vascular Surgery, University of Colorado, Anschutz Medical Center, Aurora, Colo.

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.
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http://dx.doi.org/10.1016/j.jvs.2020.04.516DOI Listing
November 2020

The Voyager PAD Trial - New Path for Post-revascularisation PAD Patients.

Eur J Vasc Endovasc Surg 2020 May 16;59(5):699-700. Epub 2020 Apr 16.

University Heart Centre at University Medical Centre, Hamburg-Eppendorf, Hamburg, Germany.

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http://dx.doi.org/10.1016/j.ejvs.2020.03.041DOI Listing
May 2020

Rivaroxaban in Peripheral Artery Disease after Revascularization.

N Engl J Med 2020 05 28;382(21):1994-2004. Epub 2020 Mar 28.

From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.

Background: Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.

Methods: In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.

Results: A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).

Conclusions: In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).
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http://dx.doi.org/10.1056/NEJMoa2000052DOI Listing
May 2020

This Surgical Life - An Exploration of Surgical Department Podcasting.

J Surg Educ 2020 Sep - Oct;77(5):1257-1265. Epub 2020 Mar 23.

Department of Surgery, University of Colorado Anschutz, Aurora, Colorado. Electronic address:

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.
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http://dx.doi.org/10.1016/j.jsurg.2020.02.024DOI Listing
June 2021

Tackling Elevated Risk in PAD: Focus on Antithrombotic and Lipid Therapy for PAD.

Curr Cardiol Rep 2020 Jan 29;22(3):13. Epub 2020 Jan 29.

CPC Clinical Research, Aurora, CO, USA.

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.
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http://dx.doi.org/10.1007/s11886-020-1264-zDOI Listing
January 2020

A Targeted Literature Review of the Disease Burden in Patients With Symptomatic Peripheral Artery Disease.

Angiology 2020 Apr 30;71(4):303-314. Epub 2019 Dec 30.

Bayer AG, Berlin, Germany.

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.
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http://dx.doi.org/10.1177/0003319719896477DOI Listing
April 2020

Anti-coagulation management in pediatric traumatic vascular injuries.

J Pediatr Surg 2020 Feb 31;55(2):324-330. Epub 2019 Oct 31.

Division of Pediatric Surgery, Children's Hospital Colorado, Aurora, CO, USA; Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

Background: 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.

Method: 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.

Results: 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.

Conclusion: 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.

Study Type: Treatment Study LEVEL OF EVIDENCE: IV.
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http://dx.doi.org/10.1016/j.jpedsurg.2019.10.009DOI Listing
February 2020

Effects of canagliflozin on amputation risk in type 2 diabetes: the CANVAS Program.

Diabetologia 2019 06 12;62(6):926-938. Epub 2019 Mar 12.

The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.

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 100 mg and 300 mg 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.
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http://dx.doi.org/10.1007/s00125-019-4839-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6509073PMC
June 2019

Management of Patients with Asymptomatic and Symptomatic Carotid Artery Disease: Update on Anti-Thrombotic Therapy.

Thromb Haemost 2019 Apr 31;119(4):576-585. Epub 2019 Jan 31.

I Clinica Medica, Atherothrombosis Centre, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.

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.
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http://dx.doi.org/10.1055/s-0039-1678527DOI Listing
April 2019

Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).

Am Heart J 2018 05 3;199:83-91. Epub 2018 Feb 3.

CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, University of Colorado Denver, Aurora, CO. Electronic address:

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 P2Y 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.
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http://dx.doi.org/10.1016/j.ahj.2018.01.011DOI Listing
May 2018

Examination of Nondesignated Preliminary Surgery Residents Recruited Since the Inception of Supplementary Offer and Acceptance Program: Lessons Learned From a Large Academic Program.

J Surg Educ 2018 Mar - Apr;75(2):294-298. Epub 2017 Sep 5.

Department of Surgery, University of Colorado Denver, Denver, Colorado. Electronic address:

Purpose: The majority of surgery programs roster non-designated preliminary (NDP) residents. We and others have reported on the success of NDP resident mentoring with regard to categorical position placement. Lacking is a focus on the candidates themselves and differences based on initial career of choice.

Methods: NDP residents' files since the institution of SOAP were reviewed for demographics, initial career choice, financial burden, region of medical school of origin, application and interview history, and pre-screen interview candidate score (high score of 22 - data includes USMLE scores, major clerkship grades, and AOA) used for categorical recruitment.

Results: From 2012-16 79 NDP residents have been recruited at UCDenver (82% via SOAP). Median age was 28 years, majority were single (73%), and male (82%). Thirty percent belonged to an under-represented minority group. Mean debt was $156,000 but 20% owe over $250,000. 90% attended US medical schools with 65% from the NRMP "South" region. 86% were recruited as fourth year students. NDPs were categorized as failing to match in general surgery (38%), surgical subspecialties (47%), or other (15%). NDPs applied to median of 68 programs (range 7-200) and granted a median of 8 interviews (range 0-24). NDPs had a mean pre-screening interview score of 13 out of 22 and only 9% would have met the standard threshold to obtain a categorical surgery interview. There were no differences in pre-screening scores in the three groups. 95% NDPs (excluding present year) successfully completed their R1 year (three resigned - one obtained a general surgery spot mid-year and two after matching in non-general surgery fields). 68% NDPs placed in categorical positions after the R1 year. The placement was better for the surgical subspecialty group compared to the other two.

Conclusions: The bias is that due to a more competitive applicant pool recruiting NDPs from surgical subspecialties would be optimal. However, those unmatched surgical subspecialty candidates are no better academically than the unmatched general surgery group, often have career interests that do not always align with scheduled rotations, and may not feel compelled to complete the year if they match. They place minimally better when accounting for those unmatched general surgery NDP R1s continuing as NDP R2s. Ultimately the success in a non-designated preliminary R1 surgery program is alignment of clinical educational opportunities with the needs of the trainee.
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http://dx.doi.org/10.1016/j.jsurg.2017.08.008DOI Listing
December 2018
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