Publications by authors named "Mark R Nehler"

42 Publications

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, CO; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO. Electronic address:

Objective: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). While 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 PAD may differ in those with and without diabetes mellitus (DM).

Methods: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5,345 with concomitant diabetes, to ticagrelor or clopidogrel and followed 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 (MALE), 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 diabetes mellitus (DM) at baseline.

Results: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity non-traumatic 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 (OR 7.29, 95% CI 5.17-10.30; p<0.001) followed by comorbid DM (OR 4.60, 95% CI 3.16-6.69; p<0.001). Compared with patients who had a major amputation, those with a minor had similar rates of subsequent major amputation (12.2% vs 13.6%), MALE (15.1% vs 14.9%), and MACE (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%) followed by infection alone (27%), and multifactorial (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 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 plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

Eur Heart J 2021 Oct;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 May 21. 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
May 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

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

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

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

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

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

Morbidity of endovascular abdominal aortic aneurysm repair is directly related to diameter.

J Vasc Surg 2017 10 19;66(4):1037-1047.e7. Epub 2017 Apr 19.

Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Colorado, Aurora, Colo. Electronic address:

Objective: Previous randomized controlled trials have defined specific size thresholds to guide surgical decision-making in patients presenting with an abdominal aortic aneurysm (AAA). With recent advances in endovascular techniques, the anatomic considerations of AAA repair are rapidly changing. Our specific aims were to evaluate the most recent national population data to compare anatomic differences and perioperative outcomes in patients with AAA.

Methods: The American College of Surgeons National Surgical Quality Improvement Program was queried from 2011 to 2015 using the targeted vascular public use file. Patients with AAA undergoing elective open or endovascular repair were included. Risk factors and outcomes were stratified by size and divided into quartiles for categorical comparison. A logistic regression model was used to compare the impact of size on morbidity and mortality with each technique. A risk adjustment model used all preoperative criteria to generate observed and expected values for open and endovascular repair.

Results: There were 10,026 patients who underwent elective AAA repair, 8182 (81.6%) endovascular and 1844 (18.4%) open. Repairs were divided into density quartiles for a logistic analysis: smallest quartile, 3.5 to 5 cm; second quartile, 5.01 to 5.5 cm; third quartile, 5.51 to 6.2 cm; and largest quartile, >6.2 cm. Patients with larger aneurysms (>6.2 cm) were more likely to be male, to have a dependent functional status, and to have increased blood urea nitrogen concentration and American Society of Anesthesiologists score (P < .05). Larger aneurysms had longer operative time (162 vs 135 minutes) and greater extension toward the renal and iliac vessels (all P < .05). Risk adjustment revealed an observed/expected morbidity plot that favored endovascular repair throughout the size range but confirmed lack of size effect within the open repair category. The adjusted increase in morbidity with endovascular repair is 9.7% per centimeter increase in size of AAA. These trends remained true with an infrarenal subgroup analysis.

Conclusions: Patients with a larger AAA have comorbidities and anatomic factors associated with a more difficult repair. The higher morbidity seen with larger aneurysms represents both anatomic and patient factors but seems to have a greater impact on endovascular repairs. However, endovascular repair still results in fewer near-term complications than open repair across all size strata.
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http://dx.doi.org/10.1016/j.jvs.2017.01.058DOI Listing
October 2017

A Fourteen-Year Experience with Vascular Anomalies Encountered during Transaxillary Rib Resection for Thoracic Outlet Syndrome.

Ann Vasc Surg 2017 Apr 12;40:105-111. Epub 2016 Dec 12.

Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Colorado Denver, Aurora, CO; Department of Radiology, Presbyterian/St. Luke's Medical Center, Denver, CO. Electronic address:

Background: Transaxillary approach to first rib resection and scalenectomy (TAFRRS) is a well-established technique for treatment of thoracic outlet syndrome (TOS). Although anatomic features encountered during TAFRRS are in general constant, vascular anomalies may be encountered but have not been described to date. Herein we describe vascular abnormalities encountered during TAFRRS.

Methods: We performed a retrospective review of a prospective practice database of 224 operations for TOS performed in 172 patients from March 2000 to March 2014. We excluded 10 patients with missing operative reports, 3 reoperations on the same patient, and 8 non-transaxillary resections. We recorded vascular anomalies identified in operative reports and reviewed computed tomography imaging to delineate the nature of these abnormalities.

Results: The overall incidence of vascular anomalies was 11% (22 of 203 TAFRRS). Most patients with anomalies had venous TOS (vTOS) (9 patients, 41%), followed by 7 (32%) with neurogenic TOS (nTOS). The remainder of the patients had arterial TOS (aTOS) (6 patients, 27%). Seven patients (32%) had an abnormal subclavian artery (SCA) with 5 (23%) having an abnormal arterial course in the anterior scalene muscle (ASM); 6 patients (27%) had an abnormal internal mammary artery (IMA) originating from distal SCA; 4 (18%) had abnormalities in the supreme thoracic artery (bifurcation or duplication); 2 (9%) had an abnormal branch from the SCA with anomalous location in the operative field; and 3 (14%) had an abnormal large venous branch penetrating the ASM. In the 19 patients with arterial anomalies, 8 (42%) were recognized as arterial branches penetrating the ASM, and 11 (58%) were noticed as they had anomalous arterial locations within the operative field. Most arterial anomalies were seen in vTOS (9, 45%), followed by nTOS (7, 35%). No intraoperative vascular complications occurred. Perioperative complications included 1 occurrence of postoperative transfusion for bleeding following axillary drain discontinuation and 2 Horner's syndromes. One aberrant IMA was electively ligated to allow complete thoracic outlet decompression.

Conclusions: Arterial anomalies during TAFRRS are encountered in 11% of operations, and may present with vessel locations in unusual areas within the operative field, or as abnormal vessels penetrating the ASM, thus making scalenectomy precarious. Careful attention must be paid to possible abnormal locations of vessels in the thoracic outlet to avoid bleeding complications.
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http://dx.doi.org/10.1016/j.avsg.2016.08.037DOI Listing
April 2017

Drivers of readmissions in vascular surgery patients.

J Vasc Surg 2016 07 30;64(1):185-194.e3. Epub 2016 Mar 30.

Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, Aurora, Colo.

Objective: Postoperative readmissions are frequent in vascular surgery patients, but it is not clear which factors are the main drivers of readmissions. Specifically, the relative contributions of patient comorbidities vs those of operative factors and postoperative complications are unknown. We sought to study the multiple potential drivers of readmission and to create a model for predicting the risk of readmission in vascular patients.

Methods: The 2012-2013 American College of Surgeons National Surgical Quality Improvement Program data set was queried for unplanned readmissions in 86,238 vascular patients. Multivariable forward selection logistic regression analysis was used to model the relative contributions of patient comorbidities, operative factors, and postoperative complications for readmission.

Results: The unplanned readmission rate was 9.3%. The preoperative model based on patient demographics and comorbidities predicted readmission risk with a low C index of .67; the top five predictors of readmission were American Society of Anesthesiologists class, preoperative open wound, inpatient operation, dialysis dependence, and diabetes mellitus. The postoperative model using operative factors and postoperative complications predicted readmission risk better (C index, .78); postoperative complications were the most significant predictor of readmission, overpowering patient comorbidities. Importantly, postoperative complications identified before discharge from the hospital were not a strong predictor of readmission as the model using predischarge postoperative complications had a similar C index to our preoperative model (.68). However, the inclusion of complications identified after discharge from the hospital appreciably improved the predictive power of the model (C index, .78). The top five predictors of readmission in the final model based on patient comorbidities and postoperative complications were postdischarge deep space infection, superficial surgical site infection, pneumonia, myocardial infection, and sepsis.

Conclusions: Readmissions in vascular surgery patients are mainly driven by postoperative complications identified after discharge. Thus, efforts to reduce vascular readmissions focusing on inpatient hospital data may prove ineffective. Our study suggests that interventions to reduce vascular readmissions should focus on prompt identification of modifiable postdischarge complications.
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http://dx.doi.org/10.1016/j.jvs.2016.02.024DOI Listing
July 2016

Contributions of planned readmissions and patient comorbidities to high readmission rates in vascular surgery patients.

J Vasc Surg 2016 Mar;63(3):746-55.e2

Department of Biostatistics and Informatics, School of Public Health, University of Colorado Denver, Aurora, Colo.

Objective: Administrative data show that among surgical patients, readmission rates are highest in vascular surgery. Herein we analyze the contribution of planned readmissions and patient comorbidities to high readmission rates in vascular surgery.

Methods: The 2012 to 2014 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data set was analyzed for overall and unplanned readmissions. Bivariable and multivariable risk adjustment analyses were performed using patient comorbidities to compare risks of overall and unplanned readmissions in vascular surgery compared with other specialties.

Results: Among 1,164,421 surgical patients, 86,403 underwent a vascular operation (other specialties included general surgery, 587,829 [51%]; orthopedic surgery, 211,507 [18%]; gynecology, 82,771 [7%]; urology, 62,153 [5%]; neurosurgery, 55,030 [4.7%]; plastic surgery, 32,318 [3%]; otolaryngology, 31,070 [2.6%]; and thoracic surgery, 15,340 [1%]). Incidence of 30-day readmission was 10.2% for vascular and 5.5% for other specialties (P < .0001). Planned readmissions were more frequent for vascular than for other specialties (8.8% vs 5.4%; P < .0001). In unadjusted analysis, vascular patients had significantly greater risk for overall readmission (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.93-2.02; P < .0001) and unplanned readmission (OR, 1.89; 95% CI, 1.84-1.93; P < .0001) compared with other specialties. In bivariable analysis, vascular patients were older (67 ± 13 vs 56 ± 17 years) and had more comorbidities such as diabetes (31% vs 14%), dialysis dependence (6.3% vs 0.9%), American Society of Anesthesiology class III/IV status (84% vs 41%), and many others (all P < .0001). After risk adjustment for baseline differences between groups, vascular patients had a marginally greater overall risk of readmission compared with other specialties (OR, 1.04; 95% CI, 1.01-1.07; P < .0001), but the risk of unplanned readmission was not significantly different (OR, 0.98; 95% CI, 0.95-1.01; P = .13).

Conclusions: Incidence of 30-day readmission after vascular surgery appears high, but after account for planned readmissions and risk adjustment, the risk of unplanned readmission is similar to that in other surgical patients. Thus, the use of readmission rate as a quality measure must account for more frequent planned vascular readmissions and patient-specific differences between vascular surgery and other specialties.
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http://dx.doi.org/10.1016/j.jvs.2015.09.032DOI Listing
March 2016

Measures to reduce unplanned readmissions after vascular surgery.

Semin Vasc Surg 2015 Jun 8;28(2):103-11. Epub 2015 Sep 8.

Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Colorado Anschutz Medical Campus, 12631 East 17(th) Avenue, Room 5409, Mail Stop C 312, Aurora, CO 80045. Electronic address:

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.
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http://dx.doi.org/10.1053/j.semvascsurg.2015.09.002DOI Listing
June 2015

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.

N Engl J Med 2015 Jul 24;373(2):145-53. Epub 2015 Jun 24.

From Massachusetts General Hospital, Boston (K.R., M.R.J.); Ochsner Medical Center, New Orleans (C.J.W.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.R.-S.); Yale School of Medicine, New Haven, CT (C.M.-H.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); Medical University of Graz, Graz, Austria (M.B., E.P.); University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (T.Z.), Diakonissenanstalt zu Flensburg, Flensburg (S.M.-H.), and Park-Krankenhaus Leipzig and Universitätsklinikum Leipzig, Leipzig (D.S.) - all in Germany; Mount Sinai Medical Center, New York (P.K.); Austin Heart, Austin, TX (R.G.); University of Colorado Medical Center, Denver (M.R.N.); and Baptist Cardiac and Vascular Institute, Miami (J.F.B.).

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.).
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http://dx.doi.org/10.1056/NEJMoa1406235DOI Listing
July 2015

Computed tomography-guided reoperation for neurogenic thoracic outlet syndrome.

J Vasc Surg 2015 Feb 15;61(2):469-74. Epub 2014 Aug 15.

Section of Vascular Surgery and Endovascular Therapy, University of Colorado, Anschutz Medical Campus, Aurora, Colo; Presbyterian/St. Luke's Medical Center, Denver, Colo.

Objective: Persistent or recurrent symptoms after surgical treatment for neurogenic thoracic outlet syndrome (nTOS) is a problem commonly encountered by high-volume referral centers. The mechanical etiology patterns at reoperation include (1) inadequate previous rib resection, (2) rib regrowth, (3) scar tissue formation, or (4) intact scalene muscle. Reoperative TOS surgery has significant potential morbidity, and therefore, careful patient selection and meticulous planning are required. This study evaluated the utility of multidetector computed tomography (CT) in the differential diagnosis of patients with recurrent or persistent nTOS.

Methods: A retrospective record review was performed of a nTOS referral practice of patients treated from 2003 to 2012 to focus on patients reoperated on for recurrent or persistent symptoms. In 2003, a dedicated high-resolution multidetector TOS CT protocol was established to assist in clinical decision making and reoperative planning. A single designated radiologist interpreted all CT images. Imaging, patient clinical characteristics, interventions, and outcomes were reviewed.

Results: The study group included 20 reoperations for recurrent (n = 15) or persistent (n = 5) symptoms. Mean age was 35 years, and 60% of redo cases were in women. Preoperative CT imaging demonstrated the following anatomic patterns: inadequate previous rib resection in 5 (25%), rib regrowth in 5 (25%), scar tissue formation in 10 (50%), and intact scalene muscle in 3 (15%). Operative findings concurred with preoperative imaging in 85% of patients. There were no neurovascular injuries and no major complications. At a mean follow-up of 43 months, improvement or resolution of symptoms was significant in nine patients (45%), moderate in seven (35%), and minimal in four (20%).

Conclusions: Recurrent/persistent nTOS is an often-vexing problem with challenging solutions. These results demonstrate the utility of a TOS protocol CT scan in providing correlative objective findings and in assisting with reoperative planning. Positive radiographic findings that correlate with patient symptoms inform the decision to reoperate.
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http://dx.doi.org/10.1016/j.jvs.2014.07.008DOI Listing
February 2015

Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population.

J Vasc Surg 2014 Sep 10;60(3):686-95.e2. Epub 2014 May 10.

Vascular Medicine Program, Lillehei Heart Institute and Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minn.

Background: Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease (PAD) and is the major cause of ischemic amputation in the United States. Risk factors and the associated incidence and prevalence of CLI have not been well described in the general population. This study describes the risk factors for PAD progression to CLI and estimates the annual incidence and prevalence of CLI in a representative United States patient cohort.

Methods: This was a retrospective cohort analysis of adults with commercial, Medicare supplemental, or Medicaid health insurance who had at least one PAD or CLI health care claim from January 1, 2003, through December 31, 2008, and 12 months of continuous coverage. Two subgroups of CLI presentation were identified: primary CLI (patients without any prior PAD or subsequent PAD diagnostic code >30 days after CLI diagnostic code) and secondary CLI (patients with prior PAD or subsequent PAD diagnostic codes ≤30 days of a CLI diagnostic code). Patterns of presentation, annual incidence, and prevalence of CLI were stratified by health care plan. Risk factors for progression to CLI were compared by presentation type.

Results: From 2003 to 2008, the mean annual incidence of PAD was 2.35% (95% confidence interval [CI], 2.34%-2.36%) and the incidence of CLI was 0.35% (95% CI, 0.34%-0.35%) of the eligible study population, with primary and secondary presentations occurring at similar rates. The mean annualized prevalence of PAD was 10.69% (95% CI, 10.67%10.70%) and the mean annualized prevalence of CLI was 1.33% (95% CI, 1.32%-1.34%) of the eligible study population, and two-thirds of the cases presented as secondary CLI. CLI developed in 11.08% (95% CI, 11.30%-11.13%) of patients with PAD. A multivariable model demonstrated that diabetes, heart failure, stroke, and renal failure were stronger predictors of primary rather than secondary CLI presentation.

Conclusions: These data establish new national estimates of the incidence and prevalence of CLI and define key risk factors that contribute to primary or secondary presentations of CLI within a very large contemporary insured population cohort in the United States.
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http://dx.doi.org/10.1016/j.jvs.2014.03.290DOI Listing
September 2014

Minimal thoracotomy thoracic bifemoral bypass in the endovascular era.

Ann Vasc Surg 2014 Aug 2;28(6):1420-5. Epub 2014 Apr 2.

Division of Cardiothoracic Surgery, Department of Surgery, University of Colorado Denver, Aurora, CO.

Background: Endoluminal revascularization has supplanted open techniques for most aortoiliac occlusive disease with open surgery reserved for endovascular failure or long-segment aortoiliac occlusions. A number of clinical and anatomic issues can preclude the use of the infrarenal aorta for inflow. Our approach in these select patients is minimal thoracotomy thoracic bifemoral (mini-TBF) bypass.

Methods: Mini-TBF bypass used a 2-team approach. The cardiac surgery team focused on arterial inflow from the distal descending aorta via a ≤8-cm thoracotomy at ninth interspace. The vascular surgery team focused on groin reconstruction and graft tunneling. The body of the graft was tunneled through the posterior left hemidiaphragm. The left limb was tunneled retroperitoneal over the psoas and the right limb anterior to the abdominal fascia below the umbilicus to the groin.

Results: Thirteen patients (mean age, 64; 82% male) underwent mini-TBF bypass between 2009 and 2012 for claudication in 9 (69%) and critical limb ischemia in 4 (31%). Five patients had prior failed iliac endovascular revascularizations and 2 patients had failed prior infrarenal aortobifemoral bypass. The indication for use of thoracic aortic inflow was prior abdominal operations in 4 (31%), pelvic anatomy with a critical inferior mesenteric artery (IMA) in 5 (38%), and the condition of the infrarenal/juxtarenal aorta in 4 (31%). Median operative time was 240 min (range 181-513 min). Median length of stay was 8 days. There was no perioperative mortality. Postoperative complications occurred in 5 patients, stroke 1, pulmonary 2 (both contralateral lung issues), and 2 limb occlusion secondary to outflow disease. At median follow-up of 18 months, 2 patients required amputations, both from preexisting tissue loss despite secondary patent grafts.

Conclusions: Mini-TBF bypass provides another alternative to successfully revascularize Trans-Atlantic Inter-Society Consensus II type D lesions in patients with prior abdominal revascularization, pelvic anatomy with a critical IMA, or calcification/thrombus of the infrarenal/juxtarenal aorta precludes control.
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http://dx.doi.org/10.1016/j.avsg.2014.03.023DOI Listing
August 2014

Selection, mentorship, and subsequent placement of preliminary residents without a designated categorical position in an academic general surgery residency program.

J Surg Educ 2012 Nov-Dec;69(6):785-91. Epub 2012 May 30.

Department of Surgery, University of Colorado-Denver, Aurora, CO 80045, USA.

Background: Academic general surgery residency programs face a reduction in clinical hours for residents at a time of expanding educational material/clinical programs. To meet these challenges, clinical staffing includes additional faculty, physician extenders, or additional residents. Categorical resident expansion is difficult but there is an ample pool of preliminary first year resident (R1) candidates every match week, and this pool is projected to increase markedly as all medical schools have increased enrollment without any real change to the demographics of available categorical residency positions. Our experience with preliminary R1s without a designated categorical position over the last 8 academic years forms the basis of this report.

Methods: The University of Colorado-Denver general surgery residency program recruits 8-12 preliminary R1s annually. Most of these are recruited on scramble day, as we found that having individual interview dates for these positions was labor-intensive and did not yield better candidates. Preliminary R1s were mentored in a systematic fashion by the program during the year to focus on career planning. Files for preliminary R1s were reviewed for demographics, medical school of origin, original prematch career goal, successful completion of the intern year, and subsequent categorical residency placement/type.

Results: We recruited 64 preliminary R1s without a designated categorical position over the past 8 years (16 females and 48 males) with an average age of 30 years old (range 25-45 years). These preliminary R1s attended medical schools throughout the United States (West 24, South 18, Central 11, Northeast 4, or International 7). The average United States Medical Licensing Examination (USMLE) Step 1 test score was 213 (range 185-252). The majority (95%) completed their preliminary year of training or left for a categorical position during the year. Most preliminary R1s (79%) were successfully placed into categorical training programs at the end of the year, with 23% ultimately receiving categorical training at our institution. Four did not complete their preliminary training year due to medical leave or unsatisfactory performance. The categorical positions preliminary R1s obtained include general surgery (n = 7, 15%), surgical subspecialties (n = 31, 65%), and nonsurgical subspecialties (n = 10, 20%). Ultimately, 14 (29%) of preliminary R1s who matched after 1 year did so in their fields of original interest.

Conclusions: A symbiotic relationship can exist between a general surgery residency program and preliminary R1s. An approach that focuses on scramble day recruitment, frequent mentorship meetings, and an active role in secondary placement results in successful placement into categorical positions for the vast majority. In that regard, we would argue that we have provided equal career mentorship to these graduated students in comparison with their medical schools of origin.
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http://dx.doi.org/10.1016/j.jsurg.2012.04.009DOI Listing
April 2013

The computerized rounding report: implementation of a model system to support transitions of care.

J Surg Res 2012 Jan 5;172(1):11-7. Epub 2011 May 5.

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

Objectives: In response to ACGME work-hour restrictions, residency programs that require continuous inpatient clinical care for educational objectives will be forced to increase the proportion of junior resident experience involved in shift work. Maintaining the balance of education over service at these levels will be a challenge, where a considerable amount of time must be spent gathering data for morning rounds and signing out patients at shift change. Patient safety is an issue with this new paradigm. We hypothesized that computerized sign-out would improve resident efficiency.

Materials And Methods: A multidisciplinary clinical team collaborated to design a computerized rounding and sign-out (CSO) program to automate collection of clinical information in addition to a brief narrative describing ongoing care issues. Residents returned a self-administered questionnaire before (n = 168) and after implementation (n = 83) examining: pre-rounding time, missed patients, handoff quality, and duty hours.

Results: Residents reported spending 11 fewer min/d pre-rounding (P = 0.006). After implementation, residents missed fewer patients on rounds (P = 0.01). A majority (70%) of responders stated that the new program helped them with duty hours.

Conclusion: The current study demonstrates the reproducibility of the University of Washington model system for rounding and sign-out at an independent site, using basic infrastructure and leadership common to all residency programs. Developing a CSO was associated with a modest reduction in pre-rounding time and fewer patients missed on rounds. Although automating resident tasks may improve workflow in an increasingly complex hospital environment, structured handoff education and other institutional changes are necessary.
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http://dx.doi.org/10.1016/j.jss.2011.04.015DOI Listing
January 2012

Efficiency of the kidney disease outcomes quality initiative guidelines for preemptive vascular access in an academic setting.

J Vasc Surg 2011 Sep 23;54(3):760-5; discussion 765-6. Epub 2011 Jun 23.

Vascular Surgery Section, University of Colorado at Denver, Denver, CO, USA.

Background: The National Kidney Foundation-Kidney Diseases Outcomes Quality Initiative (KDOQI) for vascular access guidelines state that patients with late-stage chronic kidney disease (CKD) should undergo native arteriovenous fistula (AVF) creation at least 6 months before anticipated start of hemodialysis (HD) treatments to obviate the need for other vascular access types, such as grafts or central catheters.

Objective: The objective of this study was to determine the incidence of HD, the functional patency, and associated morbidity of AVFs in patients with late-stage CKD placed according to KDOQI.

Methods: Consecutive patients with late-stage CKD who underwent AVF creation using KDOQI guidelines for anatomy between January 2003 and December 2007 at two tertiary academic centers were retrospectively evaluated. Baseline demographics, AVF type, and clinical comorbidities were recorded. Patients were stratified into one of four groups (groups A-D) over the follow-up course based on two end points: patency of their AVF and whether or not they began HD. The ideal primary outcome was AVF maturation and use for HD (group A; cumulative functional patency). Other outcomes included AVF patency but no HD (group B), HD with AVF failure (group C), or no HD and AVF abandonment (ie, death, refused hemodialysis, kidney transplant, or fistula failure; group D). Secondary outcomes were time to first cannulation, complications, and secondary interventions.

Results: AVFs were created (46% forearm and 54% upper arm) in 150 patients with CKD (85% men, median age 63 years old). At a median follow-up of 10 months, 74 patients (49%) were receiving HD and of these, 48 patients (65%) were using their AVF (group A), whereas 26 patients (35%) were not due to fistula failure (group C). Thirty-four patients (23%) never initiated HD treatments, but had a viable AVF (group B), and 42 patients (28%) never initiated HD and abandoned their AVF (group D). Overall, AVF abandonment was 51%. Mean maturation time of all AVFs successfully cannulated was 285 days (range, 30-1265 days). Complications encountered were maturation failure for cannulation (15%), focal stenosis requiring intervention (13%), inadequate flows on HD (9%), steal syndrome (9%), and thrombosis (8%). Cumulative functional patency for all AVFs was 19% and 27% at 6 and 12 months, respectively, with a mean number of two interventions per AVF (range, 1-10). Mortality during the study was 23%.

Conclusion: Despite successful creation and maturation of a preemptive AVF in nearly two-thirds of patients who started HD during the follow-up and given the following observations: the high overall mortality of the population, the morbidity and costs in secondary procedures of AVF creation, and the high incidence of abandonment, it is unclear if this strategy would demonstrate a benefit in a randomized trial when compared to other access strategies.
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http://dx.doi.org/10.1016/j.jvs.2011.03.006DOI Listing
September 2011

Assessment of functional status and quality of life in claudication.

J Vasc Surg 2011 May 18;53(5):1410-21. Epub 2011 Feb 18.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO 80045, USA.

Background: Treadmill walking is commonly used to evaluate walking impairment and efficacy of treatment for intermittent claudication (IC) in clinical and research settings. Although this is an important measure, it does not provide information about how patients perceive the effects of their treatments on more global measures of health-related quality of life (HRQOL).

Methods: PubMed/Medline was searched to find publications about the most commonly used questionnaires to assess functional status and/or general and disease-specific HRQOL in patients with peripheral artery disease (PAD) who experience IC. Inclusion criteria for questionnaires were based on existence of a body of literature in symptomatic PAD.

Results: Six general questionnaires and seven disease-specific questionnaires are included, with details about the number of domains covered and how each tool is scored. The Medical Outcomes Study Short Form 36-item questionnaire and Walking Impairment Questionnaire are currently the most used general and disease-specific questionnaires at baseline and after treatment for IC, respectively.

Conclusions: The use of tools that assess functional status and HRQOL has importance in both the clinical and research areas to assess treatment efficacy from the patient's perspective. Therefore, assessing HRQOL in addition to treadmill-measured walking ability provides insight as to the effects of treatments on patient outcomes and may help guide therapy.
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http://dx.doi.org/10.1016/j.jvs.2010.11.092DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3541824PMC
May 2011
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