105 results on '"Osborne NH"'
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2. 122C: VENOUS THROMBOEMBOLISM IN THERMALLY INJURED PATIENTS: AN ANALYSIS OF THE NATIONAL BURN REPOSITORY
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Pannucci, CJ, primary, Osborne, NH, additional, Wahl, WL, additional, and Cederna, PS, additional
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- 2010
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3. Acquired inpatient risk factors for venous thromboembolism after thermal injury.
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Pannucci CJ, Osborne NH, Park HS, Wahl WL, Pannucci, Christopher J, Osborne, Nicholas H, Park, Hyun Soo, and Wahl, Wendy L
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- 2012
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4. Creation and validation of a simple venous thromboembolism risk scoring tool for thermally injured patients: analysis of the National Burn Repository.
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Pannucci CJ, Osborne NH, Wahl WL, Pannucci, Christopher John, Osborne, Nicholas H, and Wahl, Wendy L
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- 2012
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5. Standardization of variable taper files and corresponding gutta-percha cones amongst manufacturers.
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Keith AM, Hinman SE, Dickens NE, Kim JJ, Scott RV, and Osborne NH
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Introduction: Currently there is no standardization of variable taper endodontic files and corresponding gutta-percha (GP) cones. The aim of this study was to evaluate intra- and inter- manufacturer variability of diameter and taper in the apical third of GP master cones and finishing files from three commercially available variable taper endodontic systems., Methods: Diameter measurements were recorded using digital microscopy at 1mm increments (D1-D4) for F2 files and corresponding GP cones (n = 20 per system) from ProTaper Gold® (Dentsply Tulsa Dental Specialties, Johnson City, TN), EdgeTaper Platinum™ (EdgeEndo, Albuquerque, NM), and ExactTaper H™ (SS White, Lakewood, NJ). Taper was defined as the rate of change in diameter per 1mm increment. Mean differences in diameter were assessed using repeated measures of analysis of variance (ANOVA) for D1 to D4 and the Wilks test for differences in taper., Results: In the apical third, ProTaper and EdgeEndo mean file diameters were significantly smaller than corresponding GP cone diameters (p<0.01, p<0.01, respectively). Contrastingly, SS White file diameters were significantly larger than their corresponding GP cones (p=0.02). Files from all manufacturers had significantly smaller diameters than advertised (nominal) values (p<0.01). ProTaper GP cones had similar diameters to nominal values (p=0.30), while EdgeEndo and SS White GP cones were significantly smaller (p<0.01). Amongst files and corresponding GP cones from all systems, taper was non-standardized., Conclusions: Size discrepancies between finishing files and corresponding GP cones can be expected amongst variable taper endodontic systems. Therefore, clinicians should be prepared to make intra-operative adjustments when obturating., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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6. Real-world application of Wound, Ischemia, and foot Infection scores in peripheral arterial disease patients.
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Smith ME, Braet DJ, Albright J, Corriere MA, Osborne NH, and Henke P
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- Humans, Male, Female, Aged, Risk Assessment, Middle Aged, Risk Factors, Retrospective Studies, Time Factors, Treatment Outcome, Decision Support Techniques, Predictive Value of Tests, Aged, 80 and over, Vascular Surgical Procedures adverse effects, Vascular Surgical Procedures mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Ischemia surgery, Ischemia mortality, Ischemia diagnosis, Amputation, Surgical, Peripheral Arterial Disease surgery, Peripheral Arterial Disease mortality, Peripheral Arterial Disease diagnosis, Limb Salvage, Chronic Limb-Threatening Ischemia surgery
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Objective: The Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system aims to risk stratify patients with chronic limb-threatening ischemia (CLTI), predicting both amputation rates and the need for revascularization. However, real-world use of the system and whether it predicts outcomes accurately after open revascularization and peripheral interventions is unclear. Therefore, we sought to determine the adoption of the WIfI classification system within a contemporary statewide collaborative as well as the impact of patient factor, and WIfI risk assessment on short- and long-term outcomes., Methods: Using data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 and 2022. The primary exposure was preoperative clinical WIfI stage. Patients were categorized according to the SVS Lower Extremity Threatened Limb Classification System into clinical WIfI stages 1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality rates. Multivariable logistic regression was performed to estimate the association of WIfI stage on postrevascularization outcomes., Results: In the cohort of 17,417 patients, 83.4% (n = 14,529) had WIfI stage documented. PVIs were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization. Of the patients, 49.5% were classified as stage 1, 19.3% stage 2, 12.8% stage 3, and 18.3% of patients met stage 4 criteria. Stage 3 and 4 patients had higher rates of diabetes, congestive heart failure, and renal failure, and were less likely to be current or former smokers. One-half of stage 3 patients underwent open surgical revascularization, whereas stage 1 patients were most likely to have received a PVI (64%). As WIfI stage increased from 1 to 4, 1-year mortality increased from 12% to 21% (P < .001), 30-day amputation rates increased from 5% to 38% (P < .001), and 1-year amputation rates increased from 15% to 55% (P < .001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality rates, as well as higher 30-day and 1-year amputation rates., Conclusions: The SVS WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI after lower extremity revascularization. Because nearly 55% of stage 4 patients require a major amputation within 1 year of intervention, this finding study supports use of the WIfI classification system in clinical decision-making for patients with CLTI., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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7. Earned outcomes correlate with reliability-adjusted surgical mortality after abdominal aortic aneurysm repair and predict future performance.
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Jones DW, Simons JP, Osborne NH, Schermerhorn M, Dimick JB, and Schanzer A
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- Humans, Risk Assessment, Risk Factors, Aged, Male, Female, Reproducibility of Results, Treatment Outcome, Time Factors, Databases, Factual, Blood Vessel Prosthesis Implantation mortality, Blood Vessel Prosthesis Implantation adverse effects, Hospitals, High-Volume, United States, Retrospective Studies, Aged, 80 and over, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal mortality, Endovascular Procedures mortality, Endovascular Procedures adverse effects, Hospital Mortality, Quality Indicators, Health Care trends, Quality Indicators, Health Care standards
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Objective: Cumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical "noise." The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical "signal" but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure's performance., Methods: Earned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed - predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes., Results: During the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = -.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (-1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001)., Conclusions: Adjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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8. Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative.
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Pinto Rodríguez P, Fassler M, Obi A, Osborne NH, Robinson ST, Jacobs BN, Aziz F, Nguyen KP, Gwozdz AM, Rodriguez LE, Fukaya E, Sachdev U, and Iyad Ochoa Chaar C
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- Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Treatment Outcome, Risk Factors, Varicose Veins surgery, Varicose Veins diagnostic imaging, Varicose Veins physiopathology, Databases, Factual, Severity of Illness Index, Chronic Disease, Adult, Patient Selection, Time Factors, Risk Assessment, Ablation Techniques adverse effects
- Abstract
Background: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment., Methods: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom., Results: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results., Conclusions: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed., Competing Interests: Disclosures None., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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9. The Surgical Mini-Sabbatical: A Path to Elevate Professional Engagement, Expand Patient Care, and Enhance Trainee Skills.
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Braet DJ, Schechtman DW, Beaulieu RJ, Coleman DM, Corriere MA, Osborne NH, and Eliason JL
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Competing Interests: Conflicts of Interest and Source of Funding: The authors declare no conflicts of interest. This study was not supported by any specific funding mechanism.
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- 2024
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10. Non-high-density lipoprotein cholesterol and treatment targets in vascular surgery patients.
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Braet DJ, Pourak K, Mouli V, Palmon I, Dinh D, Osborne NH, Vemuri C, and Brandt EJ
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- Adult, Humans, Middle Aged, Cholesterol therapeutic use, Lipoproteins, Cholesterol, HDL, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Atherosclerosis, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery
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Introduction: Low-density lipoprotein cholesterol (LDL) is a known contributing factor to atherosclerotic cardiovascular disease (ASCVD) and a primary therapeutic target for medical management of ASCVD. Non-high-density lipoprotein cholesterol (non-HDL) has recently been identified as a secondary therapeutic target but is not yet widely used in vascular surgery patients. We sought to assess if vascular surgery patients were undertreated per non-HDL therapeutic guidelines., Methods: This was an observational study that used a single-center database to identify a cohort of adult patients who received care from a vascular surgery provider from 01/2001 to 07/2021. ICD-9/10-CM codes were used to identify patients with a medical history of hyperlipidemia (HLD), coronary artery disease (CAD), cerebrovascular occlusive disease (CVOD), peripheral artery disease (PAD), hypertension (HTN), or diabetes mellitus (DM). Patient smoking status and medications were also identified. Lab values were obtained from the first and last patient encounter within our system. Primary outcomes were serum concentrations of LDL and non-HDL, with therapeutic thresholds defined as 70 mg/dL and 100 mg/dL, respectively., Results: The cohort included 2465 patients. At first encounter, average age was 59.3 years old, 21.4% were on statins, 8.4% were on a high-intensity statin, 25.7% were diagnosed with HLD, 5.2% with CAD, 15.3% with PAD, 26.3% with DM, 18.6% with HTN, and 2.1% with CVOD. At final encounter, mean age was 64.8 years, 23.5% were on statins with 10.1% on high-intensity statin. Diagnoses frequency did not change at final encounter. At first encounter, nearly two-thirds of patients were not at an LDL <70 mg/dL (62.3%) or non-HDL <100 mg/dL (66.0%) with improvement at final encounter to 45.2 and 40.5% of patients not at these LDL or non-HDL treatment thresholds, respectively. Patients on statins exhibited similar trends with 51.1 and 50.1% of patients not at LDL or non-HDL treatment thresholds at first encounter and 39.9 and 35.4% not at LDL or non-HDL treatment thresholds at last encounter. Importantly, 6.9% of patients were at LDL but not non-HDL treatment thresholds., Discussion: Among vascular surgery patients, over half did not meet non-HDL targets. These results suggest that we may be vastly under-performing adequate medical optimization with only about one-fourth of patients on a statin at their final encounter and approximately one-tenth of patients being treated with a high-intensity statin. With recent evidence supporting non-HDL as a valuable measurement for atherosclerotic risk, there is potential to optimize medical management beyond current high-intensity statin therapy. Further investigation is needed regarding the risk of adverse events between patients treated with these varied therapeutic targets., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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11. Submitting a successful National Institutes of Health career development award for the vascular surgeon scientist.
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Minc S, Ruddy JM, Hicks CW, Nguyen TT, Obi AT, Osborne NH, Tan TW, Ucuzian AA, and Shah SK
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Obtaining a career development award from the National Institutes of Health (K award) is often an important step in establishing a career as a vascular surgeon scientist. The application and review process is competitive, involves many steps, and may be confusing to the prospective applicant. Further, there are requirements involving mentors and the applicant's institution. This article, authored completely by vascular surgeons with active K awards, is intended for potential applicants and personnel at their institution and reviews relevant information including strategies for a successful application., Competing Interests: The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
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- 2024
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12. Direct and Indirect Effects of Race and Socioeconomic Deprivation on Outcomes After Lower Extremity Bypass.
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Powell CA, Albright J, Culver J, Osborne NH, Corriere MA, Sukul D, Gurm H, and Henke PK
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- Humans, Risk Factors, Treatment Outcome, Limb Salvage, Ischemia surgery, Lower Extremity surgery, Socioeconomic Factors, Retrospective Studies, Peripheral Arterial Disease surgery
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Objective: To evaluate the potential pathway, through which race and socioeconomic status, as measured by the social deprivation index (SDI), affect outcomes after lower extremity bypass chronic limb-threatening ischemia (CLTI), a marker for delayed presentation., Background: Racial and socioeconomic disparities persist in outcomes after lower extremity bypass; however, limited studies have evaluated the role of disease severity as a mediator to potentially explain these outcomes using clinical registry data., Methods: We captured patients who underwent lower extremity bypass using a statewide quality registry from 2015 to 2021. We used mediation analysis to assess the direct effects of race and high values of SDI (fifth quintile) on our outcome measures: 30-day major adverse cardiac event defined by new myocardial infarction, transient ischemic attack/stroke, or death, and 30-day and 1-year surgical site infection (SSI), amputation and bypass graft occlusion., Results: A total of 7077 patients underwent a lower extremity bypass procedure. Black patients had a higher prevalence of CLTI (80.63% vs 66.37%, P < 0.001). In mediation analysis, there were significant indirect effects where Black patients were more likely to present with CLTI, and thus had increased odds of 30-day amputation [odds ratio (OR): 1.11, 95% CI: 1.068-1.153], 1-year amputation (OR: 1.083, 95% CI: 1.045-1.123) and SSI (OR: 1.052, 95% CI: 1.016-1.089). There were significant indirect effects where patients in the fifth quintile for SDI were more likely to present with CLTI and thus had increased odds of 30-day amputation (OR: 1.065, 95% CI: 1.034-1.098) and SSI (OR: 1.026, 95% CI: 1.006-1.046), and 1-year amputation (OR: 1.068, 95% CI: 1.036-1.101) and SSI (OR: 1.026, 95% CI: 1.006-1.046)., Conclusions: Black patients and socioeconomically disadvantaged patients tended to present with a more advanced disease, CLTI, which in mediation analysis was associated with increased odds of amputation and other complications after lower extremity bypass compared with White patients and those that were not socioeconomically disadvantaged., Competing Interests: C.A.P. is supported by training grant AG062043 from the National Institute on Aging. P.K.H. and D.S. receive salary support from the Blue Cross Blue Shield of Michigan. Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) is a regional quality collaborative supported by Blue Cross and Blue Shield of Michigan. The remaining authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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13. Characterizing geographic variation in postoperative venous thromboembolism.
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Brown CS, Osborne NH, Nuliyalu U, Obi A, and Henke PK
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- Humans, Aged, United States epidemiology, Retrospective Studies, Aftercare, Patient Discharge, Medicare, Risk Factors, Venous Thromboembolism diagnosis, Venous Thromboembolism epidemiology, Venous Thromboembolism etiology, Pulmonary Embolism
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Objective: Venous thromboembolism (VTE) after major surgery remains an important contributor to morbidity and mortality. Despite significant quality improvement efforts in prevention and prophylaxis strategies, the degree of hospital and regional variation in the United States remains unknown., Methods: Medicare beneficiaries undergoing 13 different major surgeries at U.S. hospitals between 2016 and 2018 were included in this retrospective cohort study. We calculated the rates of 90-day VTE. We adjusted for a variety of patient and hospital covariates and used a multilevel logistic regression model to calculate the rates of VTE and coefficients of variation across hospitals and hospital referral regions (HRRs)., Results: A total of 4,115,837 patients from 4116 hospitals were included, of whom 116,450 (2.8%) experienced VTE within 90 days. The 90-day VTE rates varied substantially by procedure, from 2.5% for abdominal aortic aneurysm repair to 8.4% for pancreatectomy. Across the hospitals, there was a 6.6-fold variation in index hospitalization VTE and a 5.3-fold variation in the rate of postdischarge VTE. Across the HRRs, there was a 2.6-fold variation in 90-day VTE, with a 12.1-fold variation in the coefficient of variation. A subset of HRRs was identified with both higher VTE rates and higher variance across hospitals., Conclusions: Substantial variation exists in the rate of postoperative VTE across U.S. hospitals. Characterizing HRRs with high overall rates of VTE and those with significant variation across the hospitals will allow for targeted quality improvement efforts., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2023
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14. A Novel Preoperative Risk Assessment Tool to Identify Patients at Risk of Contrast-Associated Acute Kidney Injury After Endovascular Abdominal Aortic Aneurysm Repair.
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Braet DJ, Graham NJ, Albright J, Osborne NH, and Henke PK
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- Female, Humans, Creatinine, Risk Factors, Treatment Outcome, Risk Assessment, Retrospective Studies, Endovascular Procedures adverse effects, Acute Kidney Injury chemically induced, Acute Kidney Injury diagnosis, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal complications, Blood Vessel Prosthesis Implantation adverse effects
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Background: Contrast-associated acute kidney injury (CA-AKI) after endovascular abdominal aortic aneurysm repair (EVAR) is associated with mortality and morbidity. Risk stratification remains a vital component of preoperative evaluation. We sought to generate and validate a preprocedure CA-AKI risk stratification tool for elective EVAR patients., Methods: We queried the Blue Cross Blue Shield of Michigan Cardiovascular Consortium database for elective EVAR patients and excluded those on dialysis, with a history of renal transplant, death during procedure, and without creatinine measures. Association with CA-AKI (rise in creatinine > 0.5 mg/dL) was tested using mixed-effects logistic regression. Variables associated with CA-AKI were used to generate a predictive model via a single classification tree. The variables selected by the classification tree were then validated by fitting a mixed-effects logistic regression model into the Vascular Quality Initiative dataset., Results: Our derivation cohort included 7,043 patients, 3.5% of whom developed CA-AKI. After multivariate analysis, age (odds ratio [OR] 1.021, 95% confidence interval [CI] 1.004-1.040), female sex (OR 1.393, CI 1.012-1.916), glomerular filtration rate (GFR) < 30 mL/min (OR 5.068, CI 3.255-7.891), current smoking (OR 1.942, CI 1.067-3.535), chronic obstructive pulmonary disease (OR 1.402, CI 1.066-1.843), maximum abdominal aortic aneurysm (AAA) diameter (OR 1.018, CI 1.006-1.029), and presence of iliac artery aneurysm (OR 1.352, CI 1.007-1.816) were associated with increased odds of CA-AKI. Our risk prediction calculator demonstrated that patients with a GFR < 30 mL/min, females, and patients with a maximum AAA diameter of > 6.9 cm are at a higher risk of CA-AKI after EVAR. Using the Vascular Quality Initiative dataset (N = 62,986), we found that GFR < 30 mL/min (OR 4.668, CI 4.007-5.85), female sex (OR 1.352, CI 1.213-1.507), and maximum AAA diameter > 6.9 cm (OR 1.824, CI 1.212-1.506) were associated with an increased risk of CA-AKI after EVAR., Conclusions: Herein, we present a simple and novel risk assessment tool that can be used preoperatively to identify patients at risk of CA-AKI after EVAR. Patients with a GFR < 30 mL/min, maximum AAA diameter > 6.9 cm, and females who are undergoing EVAR may be at risk for CA-AKI after EVAR. Prospective studies are needed to determine the efficacy of our model., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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15. Characterizing patient-reported claudication treatment goals to support patient-centered treatment selection and measurement strategies.
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Powell CA, Kim GY, Edwards SN, Aalami O, Treat-Jacobson D, Byrnes ME, Osborne NH, and Corriere MA
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- Humans, Female, Middle Aged, Aged, Aged, 80 and over, Child, Preschool, Male, Quality of Life, Intermittent Claudication therapy, Intermittent Claudication drug therapy, Walking, Patient-Centered Care, Goals, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease therapy
- Abstract
Objective: Patient-reported outcomes (PRO) have been increasingly emphasized for peripheral artery disease (PAD). Patient-defined treatment goals and expectations, however, are poorly understood and might not be achievable or aligned with guidelines or clinical outcomes. We evaluated the patient-reported treatment goals among patients with claudication and the associations between patient characteristics, goals, and PAD-specific PRO scores., Methods: Patients with a diagnosis of claudication were prospectively recruited. Patient-defined treatment goals and outcomes related to walking distance, duration, and speed were quantified using multiple-choice survey items. Free-text items were used to identify activities other than walking distance, duration, or speed associated with symptoms and treatment goals. The peripheral artery disease quality of life and walking impairment questionnaire instruments were included as PRO. The treatment goal categories were compared with the PRO percentile scores using 95% confidence intervals (CIs), categorical tests, and logistic regression models. Associations between the patient characteristics and PRO were evaluated using linear and ordinal logistic regression models., Results: A total of 150 patients meeting the inclusion criteria were included in the present study. Of these 150 patients, 144 (96%) viewed the entire survey. Their mean age was 70.0 ± 11.3 years, and 32.9% were women. Most of the respondents had self-reported their race as White (n = 135), followed by Black (n = 3), Asian (n = 2), Native American (n = 2), and other/unknown (n = 2). Two participants self-reported Hispanic ethnicity. The primary treatment goals were an increased walking distance or duration without stopping (62.0%), the ability to perform a specific activity or task (23.0%), an increased walking speed (8.0%), or other/none of the above (7.0%). The specific activities associated with symptoms or goals included outdoor recreation (38.5%), labor-related tasks (30.7%), sports (26.9%), climbing stairs (23.1%), uphill walking (19.2%), and shopping (6%). Among the patients choosing an increased walking distance and duration as the primary goals, 64% had indicated that a distance of ≥0.5 mile (2640 ft) and 59% had indicated a duration of ≥30 minutes would be a minimum increase consistent with meaningful improvement. Increasing age was associated with lower odds of a distance improvement goal of ≥0.5 mile (odds ratio [OR], 0.68 per 5 years; 95% CI, 0.51-0.92; P = .012) or duration improvement goal of ≥30 minutes (OR, 0.76 per 5 years; 95% CI, 0.58-0.99; P = .047). Patient characteristics associated with PAD Quality of Life percentile scores included age, ankle brachial index, and gender. Ankle brachial index was the only patient characteristic associated with the walking impairment questionnaire percentile scores., Conclusions: Patients define treatment goals according to their desired activities and expectations, which may influence their goals and perceived outcomes. Patients' expectations of minimum increases in walking distance and duration consistent with meaningful improvement exceeded reported minimum important difference criteria for many patients and would not be captured using common clinic-based walking tests. Patient age was associated with both treatment goals and PRO scores, and the related floor and ceiling effects could influence sensitivity to PRO changes for younger and older patients, respectively. Heterogeneity in treatment goals supports consideration of tailored decision-making and outcomes informed by patient characteristics and perspectives., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2023
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16. Association of Elective Surgical Volume With State Executive Order Curtailing Elective Surgery in Michigan During the COVID-19 Pandemic.
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Eton RE, Yost ML, Thompson MP, Osborne NH, Nathan H, Englesbe MJ, and Brown CS
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- Adult, Humans, Pandemics, Michigan epidemiology, Retrospective Studies, Elective Surgical Procedures, COVID-19 epidemiology
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Objective: Our objective was to evaluate changes in elective surgical volume in Michigan while an executive order (EO) was in place curtailing elective surgery during the COVID-19 pandemic., Summary Background Data: Many state governors enacted EOs curtailing elective surgery to protect scare resources and generate hospital capacity for patients with COVID-19. Little is known of the effectiveness of an EO on achieving a sustained reduction in elective surgery., Methods: This retrospective cohort study of data from a statewide claims-based registry in Michigan includes claims from the largest private payer in the state for a representative set of elective operations on adult patients from February 2 through August 1, 2020. We reported trends in surgical volume over the period the EO was in place. Estimated backlogs in elective surgery were calculated using case counts from the same period in 2019., Results: Hospitals achieved a 91.7% reduction in case volume before the EO was introduced. By the time the order was rescinded, hospitals were already performing elective surgery at 60.1% of pre-pandemic case rates. We estimate that a backlog of 6419 operations was created while the EO was in effect. Had hospitals ceased elective surgery during this period, an additional 18% of patients would have experienced a delay in surgical care., Conclusions: Both the introduction and removal of Michigan's EO lagged behind the observed ramp-down and ramp-up in elective surgical volume. These data suggest that EOs may not effectively modulate surgical care and could also contribute to unnecessary delays in surgical care., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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17. A magnetic resonance imaging-based computational analysis of cerebral hemodynamics in patients with carotid artery stenosis.
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Schollenberger J, Braet DJ, Hernandez-Garcia L, Osborne NH, and Figueroa CA
- Abstract
Management of asymptomatic carotid artery stenosis (CAS) relies on measuring the percentage of stenosis. The aim of this study was to investigate the impact of CAS on cerebral hemodynamics using magnetic resonance imaging (MRI)-informed computational fluid dynamics (CFD) and to provide novel hemodynamic metrics that may improve the understanding of stroke risk. CFD analysis was performed in two patients with similar degrees of asymptomatic high-grade CAS. Three-dimensional anatomical-based computational models of cervical and cerebral blood flow were constructed and calibrated patient-specifically using phase-contrast MRI flow and arterial spin labeling perfusion data. Differences in cerebral hemodynamics were assessed in preoperative and postoperative models. Preoperatively, patient 1 demonstrated large flow and pressure reductions in the stenosed internal carotid artery, while patient 2 demonstrated only minor reductions. Patient 1 exhibited a large amount of flow compensation between hemispheres (80.31%), whereas patient 2 exhibited only a small amount of collateral flow (20.05%). There were significant differences in the mean pressure gradient over the stenosis between patients preoperatively (26.3 vs . 1.8 mmHg). Carotid endarterectomy resulted in only minor hemodynamic changes in patient 2. MRI-informed CFD analysis of two patients with similar clinical classifications of stenosis revealed significant differences in hemodynamics which were not apparent from anatomical assessment alone. Moreover, revascularization of CAS might not always result in hemodynamic improvements. Further studies are needed to investigate the clinical impact of hemodynamic differences and how they pertain to stroke risk and clinical management., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-22-565/coif). The authors have no conflicts of interest to declare., (2023 Quantitative Imaging in Medicine and Surgery. All rights reserved.)
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- 2023
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18. Impact of Cannabis Use on Outcomes after Lower Extremity Bypass.
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Braet DJ, Albright J, Brown C, Osborne NH, and Henke PK
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- Humans, United States epidemiology, Analgesics, Opioid adverse effects, Treatment Outcome, Limb Salvage, Vascular Patency, Risk Factors, Ischemia surgery, Lower Extremity blood supply, Retrospective Studies, Cannabis adverse effects
- Abstract
Background: Cannabis is one of the most commonly used substances in the United States, with national use on the rise. However, there is a paucity of data regarding the effects of cannabis and surgical outcomes. The aim of this study was to assess the association of cannabis use on postoperative outcomes after lower extremity bypass., Methods: We queried a large statewide registry from 2014 to 2021 to assess patients who underwent lower extremity bypass procedures. Data were gathered regarding cannabis use and the association with postoperative outcomes at 30 days and 1 year., Results: A total of 11,013 patients were identified. Ninety-one percent of patients (10,024) reported no cannabis use, whereas 9.0% (989) reported cannabis use in the past month. Compared with noncannabis users, patients using cannabis had higher opioid use at discharge (odds ratio [OR]: 1.56, 95% confidence interval [CI]: 1.28-1.90), decreased bypass patency at 30 days (OR: 0.52, 95% CI: 0.36-0.78) and 1 year (OR: 0.64, 95% CI 0.47-0.86), and an increased amputation rate at 1 year (OR: 1.25, 95% CI: 1.02-1.52) after lower extremity bypass., Conclusions: This study shows that cannabis use in vascular surgical patients was associated with decreased graft patency, increased amputation, and increased opioid use after lower extremity bypass procedures. Although future studies are needed, the present study provides novel data that can be used to counsel patients undergoing vascular surgery., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2023
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19. Assessment of Determinants of Value in Carotid Endarterectomy.
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Brown CS, Osborne NH, Hider A, Kemp MT, Albright J, Scheidel C, and Henke PK
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- United States, Humans, Aged, Medicare, Patient Readmission, Retrospective Studies, Stents, Treatment Outcome, Endarterectomy, Carotid adverse effects, Carotid Stenosis etiology
- Abstract
Background: Over 150,000 carotid endarterectomies (CEA) are performed annually worldwide, accounting for $900 million in the United States alone. How cost/spending and quality are related is not well understood but remain essential components in maximizing value. We sought to identify determinants of variability in hospital 90-day episode value for CEA., Methods: Medicare and private-payer admissions for CEA from January 2, 2014 to August 28, 2020 were linked to retrospective clinical registry data for hospitals in Michigan performing vascular surgery. Hospital-specific, risk-adjusted, 30-day composite complications (defined as reoperation, new neurologic deficit, myocardial infarction, additional procedure including CEA or carotid artery stenting, readmission, or mortality) and 30-day risk-adjusted, price-standardized total episode payments were used to categorize hospitals into low or high value by defining the intersection between complications and spending., Results: A total of 6,595 patients across 39 hospitals were identified across both datasets. Patients at low-value hospitals had a higher rate of 30-day composite complications (17.9% vs. 10.1%, P < 0.001) driven by a significantly higher rate of reoperation (3.0% vs. 1.4%, P = 0.016), readmission (10.7% vs. 6.2%, P = 0.012), new neurologic deficit (4.6% vs. 2.3%, P = 0.017), and mortality (1.6% vs. 0.6%, P < 0.049). Mean total episode payments were $19,635 at low-value hospitals compared to $15,709 at high-value hospitals driven by index hospitalization ($10,800 vs. $9,587, P = 0.002), professional ($3,421 vs. $2,827, P < 0.001), readmission ($3,011 vs. $1,826, P < 0.001), and post-acute care payments ($2,335 vs. $1,486, P < 0.001). Findings were similar when only including patients who did not suffer a complication., Conclusions: There is tremendous variation in both quality and payments across hospitals included for CEA. Importantly, costs were higher at low-value hospitals independent of postoperative complication. There appears to be little to no relationship between total episode spending and surgical quality, suggesting that improvements in value may be possible by decreasing total episode cost without affecting surgical outcomes., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2023
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20. Low to Moderate Risk Non-orthopedic Surgical Patients Do Not Benefit From VTE Chemoprophylaxis.
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Sutzko DC, Obi AT, Kamdar N, Karamkar M, Wakefield TW, Osborne NH, and Henke PK
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- Humans, Heparin therapeutic use, Anticoagulants therapeutic use, Retrospective Studies, Reproducibility of Results, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Postoperative Complications etiology, Chemoprevention, Venous Thromboembolism epidemiology, Venous Thromboembolism etiology, Venous Thromboembolism prevention & control
- Abstract
This retrospective cohort study analyzes venous thromboembolism (VTE) incidence, morbidity, and mortality amongst postsurgical patients with and without VTE chemoprophylaxis within a quality collaborative. Postoperative thromboprophylaxis was broadly applied, yet was associated with no decrease in VTE, without affecting transfusion or mortality. Predictors of breakthrough VTE development despite evidence-based thromboprophylaxis are identified., Objective: We hypothesized that a high rate of prescription of VTE chemoprophylaxis would be associated with decreased VTE incidence and mortality., Summary Background Data: Recommendations for VTE prevention in surgical patients include chemoprophylaxis based upon preoperative risk stratification., Methods: This retrospective cohort study analyzed VTE incidence, morbidity, and mortality amongst postsurgical patients with and without VTE chemoprophylaxis between April 2013 and September 2017 from 63 hospitals within the Michigan Surgical Quality Collaborative. A VTE risk assessment survey was distributed to providers. Bivariate and multivariate comparisons were made, as well as using propensity score matched cohorts to determine if VTE chemoprophylaxis was associated with decreased VTE events. Hospitals were compared using risk-reliability adjusted VTE prophylaxis and postoperative VTE event rates., Results: Within the registry, 80% of practitioners reported performing formal VTE risk assessment. Amongst 32,856 operations, there were 480 (1.46%) postoperative VTE, and an overall mortality of 609 (1.85%) patients. Using a propensity matched cohort, we found that rates of VTE were similar in those receiving unfractionated heparin or low molecular weight heparin compared to those not receiving chemoprophylaxis (1.22 vs 1.13%, P = 0.57). When stratified further by VTE risk scoring, even the highest risk patients did not have an associated lower VTE rate (3.68 vs 4.22% P = 0.092). Postoperative transfusion (8.28 vs 7.50%, P = 0.057) and mortality (2.00% vs 1.62%, P = 0.064) rates were similar amongst those receiving and those not receiving chemoprophylaxis. No correlation was found between postoperative VTE chemoprophylaxis application and hospital specific risk adjusted postoperative VTE rates., Conclusions: In modern day postsurgical care, VTE remains a significant occurrence, despite wide adoption of VTE risk assessment. Although postoperative VTE chemoprophylaxis was broadly applied, after adjusting for confounders, no reduction in VTE was observed in at-risk surgical patients., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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21. Assessment of Patterns of Atherectomy Use.
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Brown CS, Eton RE, Yaser JM, Syrjamaki JD, Corriere MA, Henke PK, Englesbe MJ, and Osborne NH
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- Humans, Aged, United States, Atherectomy, Fee-for-Service Plans, Michigan, Medicare, Endovascular Procedures
- Abstract
Background Atherectomy has become the fastest growing catheter-based peripheral vascular intervention performed in the United States, and overuse has been linked to increased reimbursement, but the patterns of use have not been well characterized. Methods and Results We used Blue Cross Blue Shield of Michigan Preferred Provider Organization and Medicare fee-for-service professional claims data from the Michigan Value Collaborative for patients undergoing office-based laboratory atherectomy in 2019 to calculate provider-specific rates of atherectomy use, reimbursement, number of vessels treated, and number of atherectomies per patient. We also calculated the rate that each provider converted a new patient visit to an endovascular procedure within 90 days. Correlations between parameters were assessed with simple linear regression. Providers completing ≥20 office-based laboratory atherectomies and ≥20 new patient evaluations during the study period were included. A total of 59 providers performing 4060 office-based laboratory atherectomies were included. Median professional reimbursement per procedure was $4671.56 (interquartile range [IQR], $2403.09-$7723.19) from Blue Cross Blue Shield of Michigan and $14 854.49 (IQR, $9414.80-$18 816.33) from Medicare, whereas total professional reimbursement from both payers ranged from $2452 to $6 880 402 per year. Median 90-day conversion rate was 5.0% (IQR, 2.5%-10.0%), whereas the median provider-level average number of vessels treated per patient was 1.20 (IQR, 1.13-1.31) and the median provider-level average number of treatments per patient was 1.38 (IQR, 1.26-1.63). Total annual reimbursement for each provider was directly correlated with new patient-procedure conversion rate ( R
2 =0.47; P <0.001), mean number of vessels treated per patient ( R2 =0.31; P <0.001), and mean number of treatments per patient ( R2 =0.33; P <0.001). Conclusions A minority of providers perform most procedures and are reimbursed substantially more per procedure compared with most providers. Procedural conversion rate, number of vessels, and number of treatments per patient represent potential policy levers to curb overuse.- Published
- 2022
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22. Women benefit from endovenous ablation with fewer complications: Analysis of the Vascular Quality Initiative Varicose Vein Registry.
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Cher BAY, Brown CS, Obi AT, Wakefield TW, Henke PK, and Osborne NH
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- Female, Humans, Male, Registries, Retrospective Studies, Saphenous Vein surgery, Treatment Outcome, Laser Therapy, Thrombosis surgery, Varicose Veins diagnostic imaging, Varicose Veins surgery, Venous Insufficiency diagnostic imaging, Venous Insufficiency surgery
- Abstract
Objective: To evaluate the association between gender and long-term clinician-reported and patient-reported outcomes after endovenous ablation procedures., Methods: This retrospective cohort study of prospectively collected data from the Vascular Quality Initiative's Varicose Vein Registry included patients undergoing endovenous ablation procedures on truncal veins with or without treatment of perforating veins between 2015 and 2019. A univariate analysis included comparisons of preprocedural, postprocedural, and periprocedural change in Venous Clinical Severity Score (VCSS) and total symptom score by gender. Rates of complications including deep vein thrombosis, endovenous heat-induced thrombosis, leg pigmentation, blistering, paresthesia, incisional infection, and any postprocedural complications were reported by gender. Multivariable analysis leveraged linear regression to examine how gender affected the relationships between patient characteristics, complication rates, and periprocedural change in VCSS score and total symptom score., Results: Of 9743 patients who met the inclusion criteria, 3090 (31.7%) were men and 6653 (68.2%) were women. The perioperative change in VCSS score was greater for men than women (average -4.46 for men vs -4.13 for women; P < .0001). Perioperative change in total symptom score was greater for women than for men (average -10.64 for women vs -9.64 for men; P < .0001). Women had lower incidence of any leg complication (6.1% vs 8.6%; P = .001) endovenous heat-induced thrombosis (1.1% vs 2.2%; P = .002), and infection (0.4% vs 0.7%; P = .001). In multivariable analysis, among patients with a body mass index of more than 40, presence of deep reflux, and preoperative Clinical, Etiologic, Anatomic, and Physiologic classification of 2, women had a greater periprocedural change in VCSS score than men., Conclusions: Women benefited from endovenous ablation similarly as men, with a lower incidence of postprocedural complications. Gender may be useful for patient selection and counseling for endovenous ablation, with particular usefulness among patients with a high body mass index, presence of deep reflux, and preoperative Clinical, Etiologic, Anatomic, and Physiologic classification of 2., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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23. Use of Direct Oral Anticoagulant and Associated Bleeding and Thrombotic Complication after Lower Extremity Bypass.
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Sutzko DC, Kim GY, Novak Z, Bamezai S, Beaulieu RJ, Henke PK, Osborne NH, Beck AW, and Obi AT
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- Administration, Oral, Anticoagulants adverse effects, Hemorrhage, Humans, Lower Extremity surgery, Vitamin K therapeutic use, Atrial Fibrillation drug therapy, Thrombosis etiology, Thrombosis prevention & control
- Abstract
Background: Therapeutic anticoagulation with either a vitamin K antagonist (VKA) or direct anticoagulant (DOAC) is often newly prescribed to patients undergoing lower extremity bypass (LEB) to aid in graft patency when risk factors for thrombosis are present or to treat postoperative venous thromboembolism or atrial fibrillation. There is a gap in knowledge as to how DOAC usage impacts postoperative outcomes compared with the standard-of-care VKAs., Study Design: To determine temporal trends in DOAC prescription after infrainguinal LEB, impact on length of stay (LOS), and associated bleeding and thrombotic complications, patients undergoing elective LEB were identified from the Vascular Quality Initiative between January 2013 and May 2019. Postoperative bleeding, LOS, and graft occlusion for patients receiving VKA compared with DOAC were evaluated., Results: A total of 24,459 LEBs were performed during the study period. Among 2,656 patients newly prescribed an anticoagulant, 78.0% (n = 2,072) received VKA and 22.0% (n = 584) received a DOAC, with DOAC use increasing throughout the study period. There was no significant difference in postoperative bleeding (VKA 2.3%, DOAC 1.7%, p = 0.413) or graft occlusion (VKA 1.2%, DOAC 1.4%, p = 0.762) between the anticoagulant classes. LOS was shorter in the DOAC group than in the VKA group (5.7 vs 6.8 days; p < 0.001)., Conclusions: This analysis demonstrates that DOAC use is increasing with time in Vascular Quality Initiative centers. DOACs are a safe and comparable alternative to VKAs in the postoperative setting with similar rates of bleeding complications and early graft patency and are associated with a reduced postoperative LOS., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2022
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24. Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries.
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Suckow BD, Scali ST, Goodney PP, Sedrakyan A, Mao J, Zheng X, Hoel A, Giles-Magnifico K, Cooper MA, Osborne NH, Henke P, Schanzer A, Marinac-Dabic D, and Stone DH
- Subjects
- Aged, Female, Humans, Incidence, Medicare, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications therapy, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, United States epidemiology, Aortic Aneurysm, Abdominal complications, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation, Endovascular Procedures
- Abstract
Objective: The widespread application of endovascular abdominal aortic aneurysm repair (EVAR) has ushered in an era of requisite postoperative surveillance and the potential need for reintervention. The national prevalence and results of EVAR conversion to open repair, however, remain poorly defined. The purpose of this analysis was to define the incidence of open conversion and its associated outcomes., Methods: The SVS Vascular Quality Initiative EVAR registry linked to Medicare claims via Vascular Implants Surveillance and Interventional Outcomes Network was queried for open conversions after initial EVAR procedures from 2003 to 2016. Cumulative conversion incidence within up to 5 years after EVAR and outcomes after open intervention were determined. Multivariable logistic regressions were used to identify independent predictors of conversion and mortality., Results: Among 15,937 EVAR patients, 309 (1.9%) underwent an open conversion: 43% (n = 132) early (<30 days) and 57% (n = 177) late (>30 days). The longitudinally observed rate of conversion was constant over time, as well as by geographic region. Independent predictors of conversion included female sex (hazard ratio [HR], 1.49; P < .001), aneurysm diameter or more than 6.0 cm at the time of index EVAR (HR, 1.74; P < .001), nonelective repair (compared with elective presentation: HR, 1.72; P < .001), and aortouni-iliac repairs (HR, 2.19; P < .001). In contrast, adjunctive operative procedures such as endo-anchors or cuff extensions (HR, 0.62; P = .06) were protective against long-term conversion. Both early (HR, 1.6; P < .001) and late (HR, 1.26; P = .07) open conversions were associated with significant 30-day (total cohort, 15%) and 1-year mortality (total cohort, 25%). Patients undergoing open conversion experienced high rates of 30-day readmission (42%) and cardiac (45%), renal (32%), and pulmonary (30%) complications., Conclusions: This large, registry-based analysis is among the first to document the incidence and outcomes for open conversion after EVAR in a national cohort with long-term follow-up. Importantly, women, patients with large aneurysms, and complex anatomy, as well as urgent or emergent EVARs are at an increased risk for open conversion. It seems that more conversions are performed in the early postoperative period, despite perceptions that conversion is a delayed phenomenon. In all instances, conversion is associated with significant morbidity and mortality and highlights the importance of appropriate patient selection at the time of index EVAR., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2022
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25. Endovascular surgery is not protective against new persistent opioid use development compared to open vascular surgery.
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Brown CS, Osborne NH, Hu HM, Coleman D, Englesbe MJ, Waljee JF, Brummett CM, and Vemuri C
- Subjects
- Aged, Analgesics, Opioid adverse effects, Humans, Medicare, Retrospective Studies, Risk Factors, United States, Vascular Surgical Procedures adverse effects, Endovascular Procedures adverse effects, Vascular Diseases surgery
- Abstract
Objective: Endovascular techniques continue to be increasingly utilized to treat vascular disease, but the effect of these minimally invasive techniques on opioid use following surgery is not known., Methods: Using Medicare data, we identified opioid-naive patients undergoing vascular procedures between 2009 and 2017. We selected patients ≥65 years old with continuous enrollment 12 months before and 6 months after surgery and had no additional operations. We defined new persistent opioid use (NPOU) as one or more opioid prescription fills both between 4-90 and 91-180 days postoperatively. Multivariable regression was performed for risk adjustment, and frequencies of NPOU were estimated between endovascular and open techniques to compare surgical approach., Results: A total of 77,767 patients were identified, with 2.6% of all patients developing new persistent use. In addition to the identification of several risk factors for new persistent use, patients undergoing endovascular carotid or vertebral interventions were found to have higher adjusted frequencies of persistent use compared to those undergoing open interventions (3.0% vs. 1.8%, p < 0.001) as did those undergoing endovenous compared to open vein procedures (2.2%, vs. 1.6%, p = 0.019). We found no difference for peripheral vascular or aortic/iliac procedures., Conclusions: Patients undergoing vascular surgery are at high risk for new persistent use. Undergoing endovascular carotid or venous surgery was associated with an increased risk of NPOU, whereas no differences were found between endovascular and open approaches for peripheral arterial or aortic disease.
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- 2022
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26. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.
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Woo K, Siracuse JJ, Klingbeil K, Kraiss LW, Osborne NH, Singh N, Tan TW, Arya S, Banerjee S, Bonaca MP, Brothers T, Conte MS, Dawson DL, Erben Y, Lerner BM, Lin JC, Mills JL Sr, Mittleider D, Nair DG, O'Banion LA, Patterson RB, Scheidt MJ, and Simons JP
- Subjects
- Exercise Therapy methods, Femoral Artery, Humans, Lower Extremity blood supply, Intermittent Claudication diagnosis, Intermittent Claudication surgery, Vascular Surgical Procedures adverse effects
- Abstract
The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful., (Copyright © 2022 Society for Vascular Surgery. All rights reserved.)
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- 2022
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27. Outcomes of axillofemoral bypass for intermittent claudication.
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Levin SR, Farber A, King EG, Beck AW, Osborne NH, DeMartino RR, Cheng TW, Rybin D, and Siracuse JJ
- Subjects
- Aged, Amputation, Surgical, Aorta, Abdominal surgery, Female, Humans, Limb Salvage, Male, Middle Aged, Retrospective Studies, Risk Assessment, Risk Factors, Treatment Outcome, Intermittent Claudication diagnostic imaging, Intermittent Claudication surgery, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease surgery
- Abstract
Objective: Although endovascular therapy is often the first-line option for medically refractory intermittent claudication (IC) caused by aortofemoral disease, suprainguinal bypass is often performed. Although this will often be aortofemoral bypass (AoFB), axillofemoral bypass (AxFB) is still sometimes performed despite limited data evaluating its utility in the management of IC. Our goal was to assess the safety and durability of AxFB performed for IC., Methods: The Vascular Quality Initiative (2009-2019) was queried for suprainguinal bypass performed for IC. Univariable and multivariable analyses were used to compare the perioperative and 1-year outcomes between AxFB and a comparison cohort of AoFB., Results: We identified 3261 suprainguinal bypasses performed for IC: 436 AxFBs and 2825 AoFBs. The mean age was 61.4 ± 9.1 years, 58.8% of the patients were men, and 59.7% currently smoked. Patients undergoing AxFB, compared with AoFB, were more often older, male, never smokers and ambulated with assistance (P < .001 for all). They had more often had hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and end-stage renal disease and had more often undergone previous outflow peripheral endovascular interventions and previous inflow or outflow bypass. The AxFBs, compared with the AoFBs, were more often unifemoral (P < .05). Patients who had undergone AxFB, compared with AoFB, had had a shorter postoperative length of stay (median, 4 vs 6 days) and fewer perioperative pulmonary (3% vs 7.9%) and renal (5.5% vs 9.9%) complications but had required more perioperative ipsilateral major amputations (0.9% vs 0.04%; P < .05 for all). No significant differences were found in the incidence of perioperative myocardial infarction (2.8% vs 2.7%), stroke (0.7% vs 1.1%), or death (1.8% vs 1.7%). At 1 year, the Kaplan-Meier analysis demonstrated that the AxFB cohort, compared with the AoFB cohort, had had higher rates of death (7.3% vs 3.6%; P = .002), graft occlusion or death (14.3% vs 7.2%; P = .001), ipsilateral major amputation or death (12.5% vs 5.6%; P < .001), and reintervention, amputation, or death (19% vs 8.6%; P < .001). On multivariable analysis, AxFB was independently associated with an increased risk of 1-year reintervention, amputation, or death (hazard ratio, 1.6; 95% confidence interval, 1.03-2.4; P = .04)., Conclusions: The results from the present retrospective analysis suggest that long-term complications were more frequent in patients who had undergone AxFB compared with AoFB, although patients treated with AxFB had had a greater risk with more comorbidities. Because AxFB was associated with significant perioperative morbidity, mortality, and long-term complications, serious consideration should be given before its use to treat IC., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2022
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28. Reliability of hospital-level mortality in abdominal aortic aneurysm repair.
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Brown CS, Montgomery JR, Kim GY, Kemp MT, and Osborne NH
- Subjects
- Aged, Aortic Aneurysm, Abdominal mortality, Female, Hospital Mortality trends, Humans, Incidence, Male, Reproducibility of Results, Risk Factors, Survival Rate trends, Time Factors, United States epidemiology, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation mortality, Elective Surgical Procedures mortality, Postoperative Complications epidemiology, Risk Assessment methods
- Abstract
Objective: The relationship between volume and surgical outcomes has been shown for a variety of surgical procedures. The effects in abdominal aortic aneurysm repair have continued to be debated. Reliability adjustment has been used as a method to remove statistical noise from hospital-level outcomes. However, its impact on aortic aneurysm repair is not well understood., Methods: We used prospectively collected data from the Vascular Quality Initiative to identify all patients who had undergone abdominal aortic aneurysm repair from 2003 to 2019. We first calculated the hospital-level risk-adjusted 30-day mortality rates. We subsequently used hierarchical logistic regression modeling to adjust for measurement reliability using empirical Bayes techniques. The effect of volume on risk- and reliability-adjusted mortality rates was then assessed using linear regression., Results: Between 2003 and 2019, 67,073 abdominal aortic aneurysms were repaired, of which 11,601 (17.3%) were repaired with an open approach. The median annual volume was 7.4 (interquartile range, 3.0-13.3) for open repairs and 35.4 (interquartile range, 18.8-59.8) for endovascular repairs. Of the 223 hospitals that had performed open repairs during the study period, only 11 (4.9%) had performed ≥15 open repairs annually, and the risk-adjusted mortality rates varied from 0% to 75% across all centers. After reliability adjustment, the variability of the risk-adjusted mortality rates had decreased significantly to 1.3% to 8.2%. The endovascular repair risk-adjusted mortality rate variability had decreased from 0% to 14.3% to 0.3% to 2.8% after reliability adjustment. A decreasing trend in mortality was found with increasing an annual case volume for open repair with each additional annual case associated with a 0.012% decrease in mortality (P = .05); however, the relationship was not significant for endovascular repair (P = .793)., Conclusions: We found that most hospitals do not perform a sufficient number of annual cases to generate a reliable center-specific mortality rate for open aneurysm repair. Center-specific mortality rates for low-volume centers should be viewed with caution, because a substantial proportion of the variation for these outcomes will be statistical noise rather than true center-level differences in the quality of care., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2022
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29. A statewide quality improvement collaborative significantly improves quality metric adherence and physician engagement in vascular surgery.
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Beaulieu RJ, Albright J, Jeruzal E, Mansour MA, Aziz A, Mouawad NJ, Osborne NH, and Henke PK
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- Humans, Michigan, Practice Guidelines as Topic, Prospective Studies, Quality Indicators, Health Care standards, Quality Indicators, Health Care statistics & numerical data, Registries, Retrospective Studies, Guideline Adherence organization & administration, Intersectoral Collaboration, Physicians organization & administration, Quality Improvement, Vascular Surgical Procedures organization & administration
- Abstract
Background: Quality improvement national registries provide structured, clinically relevant outcome and process-of-care data to practitioners-with regional meetings to disseminate best practices. However, whether a quality improvement collaborative affects processes of care is less clear. We examined the effects of a statewide hospital collaborative on the adherence rates to best practice guidelines in vascular surgery., Methods: A large statewide retrospective quality improvement database was reviewed for 2013 to 2019. Hospitals participating in the quality improvement collaborative were required to submit adherence and outcomes data and meet semiannually. They received an incentive through a pay for participation model. The aggregate adherence rates among all hospitals were calculated and compared., Results: A total of 39 hospitals participated in the collaborative, with attendance of surgeon champions at face-to-face meetings of >85%. Statewide, the hospital systems improved every year of participation in the collaborative across most "best practice" domains, including adherence to preoperative skin preparation recommendations (odds ratio [OR], 1.83; 95% confidence interval [CI], 1.76-1.79; P < .001), intraoperative antibiotic redosing (OR, 1.09; 95% CI, 1.02-1.17; P = .018), statin use at discharge for appropriate patients (OR, 1.18; 95% CI, 1.16-1.2; P < .001), and reducing transfusions for asymptomatic patients with hemoglobin >8 mg/dL (OR, 0.66; 95% CI, 0.66-0.66; P < .001). The use of antiplatelet therapy at discharge remained high and did not change significantly during the study period. Teaching hospital and urban or rural status did not affect adherence. The adherence rates exceeded the professional society mean rates for guideline adherence., Conclusions: The use of a statewide hospital collaborative with incentivized semiannual meetings resulted in significant improvements in adherence to "best practice" guidelines across a large, heterogeneous group of hospitals., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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30. Combined risk modelling approach to identify the optimal carotid revascularisation approach.
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Burke JF, Morgenstern LB, Osborne NH, and Hayward RA
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- Carotid Arteries, Humans, Risk Factors, Time Factors, Treatment Outcome, Endarterectomy, Carotid adverse effects
- Abstract
Background: Carotid endarterectomy (CEA) results in fewer perioperative strokes, but more myocardial infarctions (MI) than carotid artery stenting (CAS). We explored a combined modelling approach that stratifies patients by baseline stroke and MI., Methods: Baseline registry-based risk models for perioperative stroke and MI were identified via literature search. We then selected treatment risk models in the Carotid Revascularisation Stenting versus Endarterectomy (CREST) trial by serially adding covariates (baseline risk, treatment (CEA vs CAS), treatment-risk interaction and age-treatment interaction terms). Treatment risk models were externally validated using data from the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) CEA and carotid stenting registries and treatment models were recalibrated to the SVS-VQI population. Predicted net benefit was estimated by summing the predicted stroke and MI risk differences with CEA versus CAS., Results: Perioperative treatment models had moderate predictiveness (c-statistic 0.69 for stroke and 0.68 for MI) and reasonable calibration across the risk spectrum for both stroke and MI within CREST. On external validation in SVS-VQI, predictiveness was substantially reduced (c-statistic 0.61 for stroke and 0.54 for MI) and models substantially overpredicted risk.Most patients (86.7%) were predicted to have net benefit from CEA in CREST (97.0% of symptomatic patients vs 75% of asymptomatic patients)., Discussion: A combined modelling approach that separates risk elements has potential to inform optimal treatment. However, our current approach is not ready for clinical application. These data support guidelines that suggest that CEA should be the preferred revascularisation modality in most patients with symptomatic carotid stenosis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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31. Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.
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Brown CS, Smith ME, Kim GY, Sutzko DC, Henke PK, Corriere MA, Siracuse JJ, Goodney PP, and Osborne NH
- Subjects
- Ambulatory Care economics, Ambulatory Surgical Procedures economics, Angioplasty economics, Angioplasty instrumentation, Atherectomy economics, Centers for Medicare and Medicaid Services, U.S. economics, Centers for Medicare and Medicaid Services, U.S. trends, Databases, Factual, Health Care Costs, Healthcare Disparities trends, Humans, Insurance, Health, Reimbursement trends, Medicare economics, Medicare trends, Peripheral Arterial Disease economics, Peripheral Arterial Disease epidemiology, Practice Patterns, Physicians' economics, Retrospective Studies, Stents, Time Factors, United States epidemiology, Ambulatory Care trends, Ambulatory Surgical Procedures trends, Angioplasty trends, Atherectomy trends, Peripheral Arterial Disease therapy, Practice Patterns, Physicians' trends
- Abstract
Objective: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI)., Methods: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level., Results: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R
2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001)., Conclusions: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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32. A Combined Computational Fluid Dynamics and Arterial Spin Labeling MRI Modeling Strategy to Quantify Patient-Specific Cerebral Hemodynamics in Cerebrovascular Occlusive Disease.
- Author
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Schollenberger J, Osborne NH, Hernandez-Garcia L, and Figueroa CA
- Abstract
Cerebral hemodynamics in the presence of cerebrovascular occlusive disease (CVOD) are influenced by the anatomy of the intracranial arteries, the degree of stenosis, the patency of collateral pathways, and the condition of the cerebral microvasculature. Accurate characterization of cerebral hemodynamics is a challenging problem. In this work, we present a strategy to quantify cerebral hemodynamics using computational fluid dynamics (CFD) in combination with arterial spin labeling MRI (ASL). First, we calibrated patient-specific CFD outflow boundary conditions using ASL-derived flow splits in the Circle of Willis. Following, we validated the calibrated CFD model by evaluating the fractional blood supply from the main neck arteries to the vascular territories using Lagrangian particle tracking and comparing the results against vessel-selective ASL (VS-ASL). Finally, the feasibility and capability of our proposed method were demonstrated in two patients with CVOD and a healthy control subject. We showed that the calibrated CFD model accurately reproduced the fractional blood supply to the vascular territories, as obtained from VS-ASL. The two patients revealed significant differences in pressure drop over the stenosis, collateral flow, and resistance of the distal vasculature, despite similar degrees of clinical stenosis severity. Our results demonstrated the advantages of a patient-specific CFD analysis for assessing the hemodynamic impact of stenosis., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Schollenberger, Osborne, Hernandez-Garcia and Figueroa.)
- Published
- 2021
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33. Intermittent claudication treatment patterns in the commercially insured non-Medicare population.
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Siracuse JJ, Woodson J, Ellis RP, Farber A, Roddy SP, Kalesan B, Levin SR, Osborne NH, and Srinivasan J
- Subjects
- Age Factors, Ambulatory Care trends, Cardiologists trends, Databases, Factual, Female, Hospitalization trends, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Intermittent Claudication diagnosis, Male, Middle Aged, Quality Indicators, Health Care trends, Radiologists trends, Retrospective Studies, Surgeons trends, Time Factors, Time-to-Treatment trends, Treatment Outcome, United States, Atherectomy trends, Endovascular Procedures trends, Intermittent Claudication therapy, Medicare trends, Practice Patterns, Physicians' trends, Vascular Surgical Procedures trends
- Abstract
Objective: Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the degree to which treatment patterns have changed over time with the expansion of endovascular interventions and outpatient centers is unclear. Our goal was to characterize IC treatment patterns in the commercially insured non-Medicare population., Methods: The IBM MarketScan Commercial Database, which includes more than 8 billion US commercial insurance claims, was queried for patients newly diagnosed with IC from 2007 to 2016. Patient demographics, medication profiles, and open/endovascular interventions were evaluated. Time trends were modeled using simple linear regression and goodness-of-fit was assessed with coefficients of determination (R
2 ). A patient-centered cohort sample and a procedure-focused dataset were analyzed., Results: Among 152,935,013 unique patients in the database, there were 300,590 patients newly diagnosed with IC. The mean insurance coverage was 4.4 years. The median patients age was 58 years and 56% of patients were male. The prevalence of statin use was 48% among patients at the time of IC diagnosis and increased to 52% among patients after one year from diagnosis. Interventions were performed in 14.3%, of whom 20% and 6% underwent two or more and three or more interventions, respectively. The median time from diagnosis to intervention decreased from 230 days in 2008 days to 49 days in 2016 (R2 = 0.98). There were 16,406 inpatient and 102,925 ambulatory interventions for IC over the study period. Among ambulatory interventions, 7.9% were performed in office-based/surgical centers. The proportion of atherectomies performed in the ambulatory setting increased from 9.7% in 2007 to 29% in 2016 (R2 = 0.94). In office-based/surgical centers, 57.6% of interventions for IC used atherectomy in 2016. Atherectomy was used in ambulatory interventions by cardiologists in 22.6%, surgeons in 15.2%, and radiologists in 13.6% of interventions. Inpatient atherectomy rates remained stable over the study period. Open and endovascular tibial interventions were performed in 7.9% and 7.8% of ambulatory and inpatient IC interventions, respectively. Tibial bypasses were performed in 8.2% of all open IC interventions., Conclusions: There has been shorter time to intervention in the treatment of younger, commercially insured patients with IC, with many receiving multiple interventions. Statin use was low. Ambulatory procedures, especially in office-based/surgical centers, increasingly used atherectomy, which was not observed in inpatient settings., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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34. Industry Compensation to Physician Vascular Specialist Authors of Highly-referenced Aortic Aneurysm Studies.
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Bellomo TR, Hwang C, Kim GY, Osborne NH, Spector-Bagdady K, Stanley JC, and Corriere MA
- Subjects
- Bibliometrics, Humans, Publishing, United States, Aortic Aneurysm surgery, Conflict of Interest economics, Disclosure statistics & numerical data, Gift Giving, Manufacturing Industry economics, Surgeons economics, Vascular Surgical Procedures
- Abstract
Background: Industry payments to physicians may influence their attitudes toward medical devices and products. Disclosure of industry compensation by authors of scientific manuscripts usually occurs at the authors' discretion and is seldom audited as part of the peer review process. The purpose of this analysis was to characterize industry compensation among highly cited research articles related to aortic aneurysm., Methods: A Web of Science search for English language articles published from 2013-2017 using the search term "aortic aneurysm" identified publications for this study. The top 99 most-cited publications were abstracted by author. Physician authors with reported industry compensation from 2013-2016 were identified using the ProPublica Dollars for Docs search tool (linked to Centers for Medicare and Medicaid Services Open Payments data), based on provider name, medical specialty, and geographic location. Statistical analysis included descriptive statistics and categorical tests., Results: The 99 articles had 1,264 unique authors, of whom 105 physicians (8.3%) received industry compensation during the study period. Fourteen of the 105 authors self-reported having received industry compensation. The remaining 91 authors (86.7%) did not disclose their industry-reported compensation. Industry payments during the study period totaled $6,082,574 paid through 13,489 transactions from 169 different manufacturers. In-kind items and services were the most common form of payment (65.3%). The median transaction amount was $58.32. [$138.34]. Food and beverage accounted for the largest number of transactions (N=9653), followed by travel and lodging (N=2365), consulting (N=513), and promotional speaking (N=436). Consulting accounted for the most total dollars over the study period ($1,970,606), followed by travel and lodging ($1,122,276), promotional speaking ($972,894), food and beverage ($568,251), royalty or license ($504,631), honoraria ($452,167), and education ($428,489). Royalty and license payments had the highest median transaction amount ($15,418. [$29,049]), and was the only category with a median transaction amount greater than $5,000. In contrast, several categories had median transaction amounts under $50, including food and beverage ($32. [$77]), gifts ($34. [$86]), and entertainment ($30. [$69]). No significant difference in payment amounts by medical specialty was identified (P=0.071)., Conclusions: Only 8.3% of physician authors of highly cited aortic aneurysm studies received industry compensation, but 86.7% of those physician authors receiving payments did not disclose industry compensation within the manuscripts. Potential bias associated with industry compensation may be underestimated and conservatively biased based on author self-reporting., (Copyright © 2021. Published by Elsevier Inc.)
- Published
- 2021
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35. Association of Medicaid Expansion with Tunneled Dialysis Catheter Use at the Time of First Arteriovenous Access Creation.
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Levin SR, Farber A, Eslami MH, Tan TW, Osborne NH, Francis JM, Ghai S, and Siracuse JJ
- Subjects
- Adult, Arteriovenous Shunt, Surgical, Central Venous Catheters, Databases, Factual, Female, Humans, Kidney Failure, Chronic mortality, Male, Multivariate Analysis, Renal Dialysis instrumentation, State Government, United States epidemiology, Catheterization, Central Venous, Insurance Coverage, Kidney Failure, Chronic therapy, Medicaid, Renal Dialysis methods
- Abstract
Background: In the United States, many low-income patients initiating hemodialysis are uninsured before qualifying for Medicare. Inadequate access to predialysis care may delay their arteriovenous (AV) access creation and increase tunneled dialysis catheter (TDC) use. The 2014 Affordable Care Act expanded eligibility for Medicaid among low-income adults, but not every state adopted this measure. We evaluated whether Medicaid expansion was associated with decreased TDC use for hemodialysis initiation., Methods: We queried the United States Vascular Quality Initiative state-level database for non-Medicare patients undergoing initial AV access creation from 2011 to 2018. We evaluated associations of receiving initial AV access in states that expanded Medicaid with concurrent TDC use, survival, and insurance coverage., Results: Data were available for patients in 31 states: 19 states expanded Medicaid from January 2014 to February 2015. Among 8462 patients in the postexpansion period from March 2015 to December 2018, 58% were in Medicaid expansion states. Patients in Medicaid expansion states less often had concurrent TDCs (40% vs. 48%, P < 0.001). In multivariable analysis, Medicaid expansion was independently associated with fewer TDCs (OR 0.7, 95% CI 0.6-0.8, P < 0.001). Three-year survival was similar between patients in Medicaid expansion and nonexpansion states (84.7% vs. 85.2%, P = 0.053). Multivariable cox-regression confirmed the finding (HR 0.95, 95% CI 0.82-1.1, P = 0.482). In difference-in-differences analysis, Medicaid expansion was associated with a 9.2-percentage point increase in Medicaid coverage (95% CI 2.7-15.8, P = 0.009). Hispanic patients exhibited a 30.1-percentage point increase in any insurance coverage (95% CI 0.3-59.9, P = 0.048)., Conclusions: Patients in Medicaid expansion states were less likely to have TDCs during initial AV access creation, suggesting earlier predialysis care. Hispanic patients benefited from increased insurance coverage. Expanding insurance options for the underserved may improve quality metrics and cost-savings for hemodialysis patients., (Copyright © 2021. Published by Elsevier Inc.)
- Published
- 2021
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36. Thoracic endovascular aortic repair for symptomatic penetrating aortic ulcers and intramural hematomas is associated with poor outcomes.
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Rokosh RS, Rockman CB, Patel VI, Milner R, Osborne NH, Cayne NS, Jacobowitz GR, and Garg K
- Subjects
- Aged, Aged, 80 and over, Aorta, Thoracic diagnostic imaging, Aortic Diseases diagnostic imaging, Aortic Diseases mortality, Blood Vessel Prosthesis Implantation mortality, Comorbidity, Databases, Factual, Endovascular Procedures mortality, Female, Hematoma diagnostic imaging, Hematoma mortality, Hospital Mortality, Humans, Male, Middle Aged, Postoperative Complications mortality, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Ulcer diagnostic imaging, Ulcer mortality, United States, Aorta, Thoracic surgery, Aortic Diseases surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Hematoma surgery, Postoperative Complications etiology, Ulcer surgery
- Abstract
Background: The natural history of penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs) of the aorta has not been well described. Although repair is warranted for rupture, unremitting chest pain, or growth, no threshold has been established for treating those found incidentally. Thoracic endovascular aortic repair (TEVAR) offers an attractive approach for treating these pathologic entities. However, the periprocedural and postoperative outcomes have not been well defined., Methods: Patients aged ≥18 years identified in the Vascular Quality Initiative database who had undergone TEVAR for PAUs and/or IMHs from January 2011 to February 2020 were included. We identified 1042 patients, of whom 809 had follow-up data available. The patient demographics and comorbidities were analyzed to identify the risk factors for major adverse events (MAEs) and postoperative and late mortality., Results: The cohort was 54.8% female, and 69.9% were former smokers, with a mean age of 71.1 years. Comorbidities were prevalent, with 57.8% classified as having American Society of Anesthesiologists class 4. Of the 1042 patients, 89.8% had hypertension, 28.3% chronic obstructive pulmonary disease, 17.9% coronary artery disease, and 12.2% congestive heart failure. Patients were predominately symptomatic (74%), and 44.5% had undergone nonelective repair. The MAE incidence was 17%. The independent predictors of MAEs were a history of coronary artery disease, nonwhite race, emergent procedural indication, ruptured presentation, and deployment of two or more endografts. In-hospital mortality was 4.3%. Of the index hospitalization mortalities, 73% were treatment related. For the 809 patients with follow-up (mean, 25.1 ± 19 months), the all-cause mortality was 10.6%. The predictors of late mortality during follow-up included age >70 years, ruptured presentation, and a history of chronic obstructive pulmonary disease and end-stage renal disease. A subset analysis comparing symptomatic (74%) vs asymptomatic (26%) patients demonstrated that the former were frequently women (58.2% vs 45.3%; P < .001), with a greater incidence of MAEs (20.6% vs 6.9%; P < .001), including higher in-hospital reintervention rates (5.9% vs 1.5%; P = .002) and mortality (5.6% vs 0.7%; log-rank P = .015), and a prolonged length of stay (6.9 vs 3.7 days; P < .0001), despite similar procedural risks. During follow-up, late mortality was greater in the symptomatic cohort (12.2% vs 6.5%; log-rank P = .025), with all treatment-related mortalities limited to the symptomatic group., Conclusions: We found significantly greater morbidity and mortality in symptomatic patients undergoing repair compared with asymptomatic patients, despite similar baseline characteristics. Asymptomatic patients treated with TEVAR had no treatment-related mortality during follow-up, with the overall prognosis largely dependent on preexisting comorbidities. These findings, in conjunction with increasing evidence highlighting the risk of disease progression and attendant morbidity associated with these aortic entities, suggest a need for natural history studies and definitive guidelines on the elective repair of IMHs and PAUs., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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37. Modeling the elective vascular surgery recovery after coronavirus disease 2019: Implications for moving forward.
- Author
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Brown CS, Albright J, Henke PK, Mansour MA, Weaver M, and Osborne NH
- Subjects
- Humans, Retrospective Studies, COVID-19, Elective Surgical Procedures statistics & numerical data, Models, Statistical, Time-to-Treatment statistics & numerical data, Vascular Surgical Procedures statistics & numerical data
- Abstract
Objective: The delays in elective surgery caused by the coronavirus disease 2019 (COVID-19) pandemic have resulted in a substantial backlog of cases. In the present study, we sought to determine the estimated time to recovery for vascular surgery procedures delayed by the COVID-19 pandemic in a regional health system., Methods: Using data from a 35-hospital regional vascular surgical collaborative consisting of all hospitals performing vascular surgery in the state of Michigan, we estimated the number of delayed surgical cases for adults undergoing carotid endarterectomy, carotid stenting, endovascular and open abdominal aortic aneurysm repair, and lower extremity bypass. We used seasonal autoregressive integrated moving average models to predict the surgical volume in the absence of the COVID-19 pandemic and historical data to predict the elective surgical recovery time., Results: The median statewide monthly vascular surgical volume for the study period was 439 procedures, with a maximum statewide monthly case volume of 519 procedures. For the month of April 2020, the elective vascular surgery procedural volume decreased by ∼90%. Significant variability was seen in the estimated hospital capacity and estimated number of backlogged cases, with the recovery of elective cases estimated to require ∼8 months. If hospitals across the collaborative were to share the burden of backlogged cases, the recovery could be shortened to ∼3 months., Conclusions: In the present study of vascular surgical volume in a regional health collaborative, elective surgical procedures decreased by 90%, resulting in a backlog of >700 cases. The recovery time if all hospitals in the collaborative were to share the burden of backlogged cases would be reduced from 8 months to 3 months, underscoring the necessity of regional and statewide policies to minimize patient harm by delays in recovery for elective surgery., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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38. Using Payment Incentives to Decrease Atherectomy Overutilization.
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Brown CS, Eton RE, Corriere MA, Henke PK, Englesbe MJ, and Osborne NH
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- Atherectomy economics, Endovascular Procedures economics, Humans, Medical Overuse economics, Medicare, Michigan, United States, Atherectomy statistics & numerical data, Medical Overuse prevention & control, Peripheral Arterial Disease therapy, Reimbursement, Incentive
- Published
- 2021
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39. Association of state tobacco control policies with active smoking at the time of intervention for intermittent claudication.
- Author
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Levin SR, Hawkins SS, Farber A, Goodney PP, Osborne NH, Tan TW, Malas MB, Patel VI, and Siracuse JJ
- Subjects
- Adult, Age Factors, Aged, Aged, 80 and over, Databases, Factual, Female, Government Regulation, Humans, Intermittent Claudication diagnosis, Intermittent Claudication epidemiology, Male, Medicare, Middle Aged, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease epidemiology, Policy Making, Prevalence, Retrospective Studies, Risk Assessment, Risk Factors, Smoke-Free Policy economics, Smoke-Free Policy legislation & jurisprudence, Smoking economics, Smoking epidemiology, Smoking legislation & jurisprudence, Taxes, Tobacco Products economics, Tobacco Products legislation & jurisprudence, United States epidemiology, Intermittent Claudication therapy, Peripheral Arterial Disease therapy, Smoking adverse effects, Smoking Cessation economics, Smoking Cessation legislation & jurisprudence, Smoking Prevention economics, Smoking Prevention legislation & jurisprudence, Tobacco Products adverse effects, Workplace legislation & jurisprudence
- Abstract
Objective: Active smoking among patients undergoing interventions for intermittent claudication (IC) is associated with poor outcomes. Notwithstanding, current levels of active smoking in these patients are high. State-level tobacco control policies have been shown to reduce smoking in the general US population. We evaluated whether state cigarette taxes and 100% smoke-free workplace legislation are associated with active smoking among patients undergoing interventions for IC., Methods: We queried the Vascular Quality Initiative database for peripheral endovascular interventions, infrainguinal bypasses, and suprainguinal bypasses for IC. Active smoking at the time of intervention was defined as smoking within one month of intervention. We implemented difference-in-differences analysis to isolate changes in active smoking owing to cigarette taxes (adjusted for inflation) and implementation of smoke-free workplace legislation. The difference-in-differences models estimated the causal effects of tobacco policies by adjusting for concurrent temporal trends in active smoking unrelated to cigarette taxes or smoke-free workplace legislation. The models controlled for age, sex, race/ethnicity, insurance type, diabetes, chronic obstructive pulmonary disease, state, and year. We tested interactions of taxes with age and insurance., Results: Data were available for 59,847 patients undergoing interventions for IC in 25 states from 2011 to 2019. Across the study period, active smoking at the time of intervention decreased from 48% to 40%. Every $1.00 cigarette tax increase was associated with a 6-percentage point decrease in active smoking (95% confidence interval, -10 to -1 percentage points; P = .02), representing an 11% decrease relative to the baseline proportion of patients actively smoking. The effect of cigarettes taxes was greater in older patients and those on Medicare. Among patients aged 60 to 69 and 70 to 79 years, every $1.00 tax increase resulted in 14% and 21% reductions in active smoking relative to baseline subgroup prevalences of 53% and 29%, respectively (P < .05 for both); however, younger age groups were not affected by tax increases. Among insurance groups, only patients on Medicare exhibited a significant change in active smoking with every $1.00 tax increase (an 18% decrease relative to a 33% baseline prevalence; P = .01). The number of states implementing smoke-free workplace legislation increased from 9 to 14 by 2019; however, this policy was not significantly associated with active smoking prevalence. At follow-up (median, 12.9 months), $1.00 tax increases were still associated with decreased smoking prevalence (a 25% decrease relative to a 33% baseline prevalence; P < .001)., Conclusions: Cigarette tax increases seem to be an effective strategy to decrease active smoking among patients undergoing interventions for IC. Older patients and Medicare recipients are the most responsive to tax increases., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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40. Elective Surgical Delays Due to COVID-19: The Patient Lived Experience.
- Author
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Byrnes ME, Brown CS, De Roo AC, Corriere MA, Romano MA, Fukuhara S, Kim KM, and Osborne NH
- Subjects
- Adult, Aged, COVID-19 epidemiology, COVID-19 psychology, COVID-19 transmission, Cardiovascular Surgical Procedures psychology, Elective Surgical Procedures psychology, Female, Humans, Male, Middle Aged, Pandemics prevention & control, Patient Preference, Qualitative Research, Time Factors, Triage standards, COVID-19 prevention & control, Cardiovascular Surgical Procedures standards, Elective Surgical Procedures standards, Psychological Distress, Time-to-Treatment
- Abstract
Background: This qualitative research explored the lived experiences of patients who experienced postponement of elective cardiac and vascular surgery due to coronavirus disease 2019 (COVID-19). We know very little about patients during the novel coronavirus pandemic. Understanding the patient voice may play an important role in prioritization of postponed cases and triage moving forward., Methods: Utilizing a hermeneutical phenomenological qualitative design, we interviewed 47 individuals who experienced a postponement of cardiac or vascular surgery due to the COVID-19 pandemic. Data were analyzed and informed by phenomenological research methods., Results: Patients in our study described 3 key issues around their postponement of elective surgery. Patients described robust narratives about the meanings of their elective surgeries as the chance to "return to normal" and alleviate symptoms that impacted everyday life. Second, because of the meanings most of our patients ascribed to their surgeries, postponement often took a toll on how patients managed physical health and emotional well-being. Finally, paradoxically, many patients in our study were demonstrative that they would "rather die from a heart attack" than be exposed to the coronavirus., Conclusions: We identified several components of the patient experience, encompassing quality of life and other desired benefits of surgery, the risks of COVID, and difficulty reconciling the 2. Our study provides significant qualitative evidence to inform providers of important considerations when rescheduling the backlog of patients. The emotional and psychological distress that patients experienced due to postponement may also require additional considerations in postoperative recovery., Competing Interests: The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2021
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41. Effect of concomitant deep venous reflux on truncal endovenous ablation outcomes in the Vascular Quality Initiative.
- Author
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Brown CS, Osborne NH, Kim GY, Sutzko DC, Wakefield TW, Obi AT, and Henke PK
- Subjects
- Adult, Aged, Chronic Disease, Databases, Factual, Female, Humans, Male, Middle Aged, Postoperative Complications etiology, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Venous Insufficiency diagnostic imaging, Venous Insufficiency physiopathology, Ablation Techniques adverse effects, Endovascular Procedures adverse effects, Venous Insufficiency surgery
- Abstract
Objective: Few studies have investigated outcomes after truncal endovenous ablation in patients with combined deep and superficial reflux and no studies have evaluated patient-reported outcomes., Methods: We investigated the short- and long-term clinical and patient-reported outcomes among patients with and without deep venous reflux undergoing truncal endovenous ablation from 2015 to 2019 in the Vascular Quality Initiative. Preprocedural and postprocedural comparisons were performed using the t-test, χ
2 , or their nonparametric counterpart when appropriate. Multivariable logistic regression models were used to assess for confounding., Results: A total of 4881 patients were included, of which 2254 (46.2%) had combined deep and superficial reflux. The median follow-up was 336.5 days. Patients with deep reflux were less likely to be female (65.9% vs 69.9%; P = .003), more likely to be Caucasian (90.2% vs 86.5%; P = .003) and had no difference in BMI (30.6 ± 7.5 vs 30.6 ± 7.2; P = .904). Additionally, no difference was seen in rates of prior varicose vein treatments, number of pregnancies, or history of deep venous thrombosis; however, patients without deep reflux were more likely to be on anticoagulation at the time of the procedure (10.9% vs 8.1%; P < .001). Patients without deep reflux had slightly higher median preprocedural Venous Clinical Severity Score (VCSS) scores (8 [interquartile range (IQR), 6-10]) vs 7 [IQR, 6-10]; P = .005) as well as postprocedural VCSS scores (5 [IQR, 3-7] vs 4 [IQR, 2-6]; P < .001). The median change in VCSS from before to after the procedure was lower for patients without deep reflux (3 [IQR, 1.0-5.5] vs 3.5 [IQR, 1-6]; P = .006). Total symptom score was higher for patients without deep reflux both before (median, 14 [IQR, 10-19] vs median, 13.5 [IQR, 9.5-18]; P = .005) and postprocedurally (median, 4 [IQR, 1-9] vs median, 3.25 [IQR, 1-7]; P < .001), but no difference was seen in change in symptom score (median, 8 [IQR, 4-13] vs median, 9 [IQR, 4-13]; P = .172). Patients with deep reflux had substantially higher rates of complications (10.4% vs 3.0%; P < .001), with a particular increase in proximal thrombus extension (3.1% vs 1.1%; P < .001). After controlling for confounding, this estimate of effect size for any complication increased (odds ratio, 5.72; 95% confidence interval, 2.21-14.81; P < .001)., Conclusions: No significant difference is seen in total symptom improvement when patients undergo truncal endovenous ablation with concomitant deep venous reflux, although a greater improvement was seen in VCSS score in these patients. Patients with deep venous reflux had a significantly increased rate of complications, independent of confounding variables, and should be counseled appropriately before the decision for treatment., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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42. Outcomes after truncal ablation with or without concomitant phlebectomy for isolated symptomatic varicose veins (C2 disease).
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Brown CS, Obi AT, Cronenwett JL, Kabnick L, Wakefield TW, and Osborne NH
- Subjects
- Adult, Aged, Chronic Disease, Combined Modality Therapy, Female, Functional Status, Humans, Male, Middle Aged, Postoperative Complications etiology, Recovery of Function, Registries, Retrospective Studies, Severity of Illness Index, Time Factors, Treatment Outcome, Varicose Veins diagnostic imaging, Varicose Veins physiopathology, Venous Insufficiency diagnostic imaging, Venous Insufficiency physiopathology, Ablation Techniques adverse effects, Varicose Veins surgery, Vascular Surgical Procedures adverse effects, Venous Insufficiency surgery
- Abstract
Objective: Many insurance payers are hesitating to cover interventional treatments in patients with isolated symptomatic varicose veins. In this study, we sought to determine the outcomes of patients with varicose veins who were treated with venous ablation alone or ablation plus phlebectomy using the Vascular Quality Initiative Varicose Vein Registry., Methods: Using data from the Varicose Vein Registry between January 2015 and March 2019, we investigated immediate postoperative as well as long-term clinical and patient-reported outcomes among patients with documented symptomatic C2 disease undergoing truncal endovenous ablations alone and combined ablation and phlebectomy. Preprocedural and postprocedural comparisons were performed using t-test, χ
2 test, or nonparametric tests when appropriate. Multivariable ordinal logistic regression was performed on ordinal outcome variables., Results: Among 3375 patients with symptomatic C2 disease, 40.1% of patients (1376) underwent isolated truncal ablation and 59.9% (1999) underwent ablation and phlebectomy. Complications overall were low (8.6%) and varied between 8.4% and 8.7% in patients undergoing ablation alone and ablation plus phlebectomy, respectively (P = .820). The most common complication noted was paresthesia, 3.4% overall, which occurred more commonly after ablation and phlebectomy (4.5%) than after ablation alone (1.3%; P < .001). An improvement in Venous Clinical Severity Score (VCSS) was experienced by 87.4% of patients; median change in VCSS was 4 points (interquartile range [IQR], 2-5 points), with an improvement of 3 points among patients undergoing ablation alone (IQR, 1-5 points) and 5 points among patients undergoing ablation and phlebectomy (IQR, 3-5 points; P < .001). An improvement in overall symptoms was experienced by 94.4% of patients (median improvement, 11 points; (maximum, 30 points), with more significant decreases among patients undergoing ablation and phlebectomy (median, 12 points; IQR, 8-17 points) compared with ablation alone (median, 9 points; IQR, 5-13 points; P < .001)., Conclusions: Among patients with isolated symptomatic varicose veins (C2 disease), ablation and ablation with phlebectomy are safe and effective in improving both patient-reported outcomes and clinical severity (VCSS). Given these data, payers should continue to cover these treatments., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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43. The Impact of Nonpharmacological Interventions on Patient Experience, Opioid Use, and Health Care Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study.
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Brescia AA, Piazza JR, Jenkins JN, Heering LK, Ivacko AJ, Piazza JC, Dwyer-White MC, Peters SL, Cepero J, Brown BH, Longi FN, Monaghan KP, Bauer FW, Kathawate VG, Jafri SM, Webster MC, Kasperek AM, Garvey NL, Schwenzer C, Wu X, Lagisetty KH, Osborne NH, Waljee JF, Riba M, Likosky DS, Byrnes ME, and Deeb GM
- Abstract
Background: Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated comfort coach has not been evaluated in an adult surgical setting., Objective: This trial aims to assess whether nonpharmacological interventions administered by a trained comfort coach affect patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. This study has 3 specific aims: assess the effect of a comfort coach on patient experience, measure differences in inpatient and outpatient opioid use and postoperative health care utilization, and qualitatively evaluate the comfort coach intervention., Methods: To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at 6 points: preoperative outpatient clinic, preoperative care unit on the day of surgery, extubation, chest tube removal, hospital discharge, and 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up. For aim 2, we will record inpatient opioid use and collect postdischarge opioid use and pain-related outcomes through an 11-item questionnaire administered at the 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 days after surgery. For aim 3, we will perform semistructured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis., Results: This trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020., Conclusions: Data generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study's findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery., Trial Registration: ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021., International Registered Report Identifier (irrid): DERR1-10.2196/21350., (©Alexander A Brescia, Julie R Piazza, Jessica N Jenkins, Lindsay K Heering, Alexander J Ivacko, James C Piazza, Molly C Dwyer-White, Stefanie L Peters, Jesus Cepero, Bailey H Brown, Faraz N Longi, Katelyn P Monaghan, Frederick W Bauer, Varun G Kathawate, Sara M Jafri, Melissa C Webster, Amanda M Kasperek, Nickole L Garvey, Claudia Schwenzer, Xiaoting Wu, Kiran H Lagisetty, Nicholas H Osborne, Jennifer F Waljee, Michelle Riba, Donald S Likosky, Mary E Byrnes, G Michael Deeb. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.02.2021.)
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- 2021
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44. Fenestrated repair improves perioperative outcomes but lacks a hospital volume association for complex abdominal aortic aneurysms.
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Davis FM, Albright J, Battaglia M, Eliason J, Coleman D, Mouawad N, Knepper J, Mansour MA, Corriere M, Osborne NH, and Henke PK
- Subjects
- Aged, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis, Female, Humans, Male, Michigan, Middle Aged, Postoperative Complications etiology, Prosthesis Design, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Endovascular Procedures mortality, Hospitals, High-Volume, Hospitals, Low-Volume
- Abstract
Background: Complex abdominal aortic aneurysms (AAAs) have traditionally been treated with an open surgical repair (OSR). During the past decade, fenestrated endovascular aneurysm repair (FEVAR) has emerged as a viable option. Hospital procedural volume to outcome relationship for OSR of complex AAAs has been well established, but the impact of procedural volume on FEVAR outcomes remains undefined. This study investigated the outcomes of OSR and FEVAR for the treatment of complex AAAs and examined the hospital volume-outcome relationship for these procedures., Methods: A retrospective review of a statewide vascular surgery registry was queried for all patients between 2012 and 2018 who underwent elective repair of a juxtarenal/pararenal AAA with FEVAR or OSR. The primary outcomes were 30-day mortality, myocardial infarction, and new dialysis. Secondary end points included postoperative pneumonia, renal dysfunction (creatine concentration increase of >2 mg/dL from preoperative baseline), major bleeding, early procedural complications, length of stay, and need for reintervention. To evaluate procedural volume-outcomes relationship, hospitals were stratified into low- and high-volume aortic centers based on a FEVAR annual procedural volume. To account for baseline differences, we calculated propensity scores and employed inverse probability of treatment weighting in comparing outcomes between treatment groups., Results: A total of 589 patients underwent FEVAR (n = 186) or OSR (n = 403) for a complex AAA. After adjustment, OSR was associated with higher rates of 30-day mortality (10.7% vs 2.9%; P < .001) and need for dialysis (11.3% vs 1.8; P < .001). Postoperative pneumonia (6.8% vs 0.3%; P < .001) and need for transfusion (39.4% vs 10.4%; P < .001) were also significantly higher in the OSR cohort. The median length of stay for OSR and FEVAR was 9 days and 3 days, respectively. For those who underwent FEVAR, endoleaks were present in 12.1% of patients at 30 days and 6.1% of patients at 1 year, with the majority being type II. With a median follow-up period of 331 days (229-378 days), 1% of FEVAR patients required a secondary procedure, and there were no FEVAR conversions to an open aortic repair. Hospitals were divided into low- and high-volume aortic centers based on their annual FEVAR volume of complex AAAs. After adjustment, hospital FEVAR procedural volume was not associated with 30-day mortality or myocardial infarction., Conclusions: FEVAR was associated with lower perioperative morbidity and mortality compared with OSR for the management of complex AAAs. Procedural FEVAR volume outcome analysis suggests limited differences in 30-day morbidity, although long-term durability warrants further research., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)
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- 2021
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45. Tibial bypass in patients with intermittent claudication is associated with poor outcomes.
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Levin SR, Farber A, Osborne NH, Beck AW, McFarland GE, Rybin D, Cheng TW, and Siracuse JJ
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- Aged, Amputation, Surgical, Canada, Female, Humans, Intermittent Claudication diagnostic imaging, Intermittent Claudication mortality, Intermittent Claudication physiopathology, Length of Stay, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease mortality, Peripheral Arterial Disease physiopathology, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology, Postoperative Complications etiology, Postoperative Complications surgery, Registries, Reoperation, Retrospective Studies, Risk Assessment, Risk Factors, Tibial Arteries diagnostic imaging, Tibial Arteries physiopathology, Treatment Outcome, United States, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Intermittent Claudication surgery, Peripheral Arterial Disease surgery, Popliteal Artery surgery, Saphenous Vein transplantation, Tibial Arteries surgery
- Abstract
Objective: Given that intermittent claudication (IC) rarely progresses to chronic limb-threatening ischemia and limb loss, safety and durability of elective interventions for IC are essential. Whether patients with IC benefit from tibial intervention is controversial, and data supporting its utility are limited. Despite endovascular therapy expansion, surgical bypass is still commonly performed. We sought to assess outcomes of bypass to tibial arteries for IC., Methods: The Vascular Quality Initiative (2003-2018) was queried for infrainguinal bypasses performed for IC. Perioperative and 1-year outcomes were compared between bypasses constructed to tibial and popliteal arteries., Results: Of 5347 infrainguinal bypasses, 1173 (22%) and 4184 (78%) were tibial and popliteal bypasses, respectively. Overall, mean age was 65 ± 10 years, and patients were often men (72%) and current smokers (42%). Tibial bypasses commonly targeted posterior tibial (40%), tibioperoneal trunk (23%), and anterior tibial (19%) arteries. Great saphenous vein was more often used for tibial bypass than for popliteal bypass (78% vs 54%; P < .001). Patients undergoing tibial compared with popliteal bypass more often had impaired ambulation and prior ipsilateral bypasses and were less often taking antiplatelets and statins (all P < .05). In the perioperative period, tibial bypass patients had longer postoperative length of stay (4.5 ± 3.5 vs 3.5 ± 2.8 days), more pulmonary complications (1.3% vs 0.6%), and higher return to the operating room (7% vs 4%; all P < .05). Perioperative myocardial infarction (1.2% vs 0.8%; P = .19), stroke (0.4% vs 0.4%; P = .91), and mortality (0.3 vs 0.3%; P = .86) rates were similar between the cohorts. At 1 year, tibial compared with popliteal bypasses exhibited lower freedom from occlusion/death (81% vs 89%; P < .001), ipsilateral major amputation/death (90% vs 94%; P < .001), and reintervention/amputation/death (73% vs 80%; P < .001), but patient survival was similar (96% vs 97%; P = .07). On multivariable analysis, tibial compared with popliteal bypass was independently associated with increased occlusion/death (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.28-2.11; P < .001), major ipsilateral amputation/death (HR, 1.6; 95% CI, 1.12-2.19; P = .003), and ipsilateral reintervention/amputation/death (HR, 1.51; 95% CI, 1.28-1.79; P < .001), with similar patient survival., Conclusions: In patients with IC, tibial bypass was associated with poor outcomes, including major amputation. Surgeons should exhaust nonoperative therapies and present realistic outcome expectations to their patients before offering such intervention., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2021
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46. Comparison of unilateral vs bilateral and staged bilateral vs concurrent bilateral truncal endovenous ablation in the Vascular Quality Initiative.
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Brown CS, Osborne NH, Kim GY, Sutzko DC, Wakefield TW, Obi AT, and Koleilat I
- Subjects
- Adult, Aged, Chronic Disease, Female, Humans, Male, Middle Aged, Postoperative Complications etiology, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Saphenous Vein diagnostic imaging, Saphenous Vein physiopathology, Time Factors, Treatment Outcome, Varicose Veins diagnostic imaging, Varicose Veins physiopathology, Venous Insufficiency diagnostic imaging, Venous Insufficiency physiopathology, Endovascular Procedures adverse effects, Saphenous Vein surgery, Varicose Veins surgery, Venous Insufficiency surgery
- Abstract
Objective: Venous insufficiency is commonly bilateral, and patients often prefer single-episode care compared with staged procedures. Few studies have investigated clinical outcomes after unilateral vs bilateral venous ablation procedures or between staged and concurrent bilateral procedures. Here, we report data from the Vascular Quality Initiative regarding truncal venous ablation for chronic venous insufficiency., Methods: Using data from the Vascular Quality Initiative, we investigated immediate postoperative as well as long-term clinical and patient-reported outcomes of patients undergoing unilateral vs bilateral truncal endovenous ablation from 2015 to 2019. We further investigated outcomes between staged bilateral and concurrent bilateral ablations. Preprocedural and postprocedural comparisons were performed using t-test, χ
2 test, or their nonparametric counterpart when appropriate. Multivariable ordinal logistic regression was performed on ordinal outcome variables., Results: A total of 5029 patients were included, of whom 3782 (75.2%) underwent unilateral procedures. Median follow-up was 227 days (interquartile range [IQR], 55-788 days). Unilateral patients were less likely to be female (67.0% vs 70.3%; P = .031) and white (86.3% vs 91.2%; P < .001) and had lower body mass index (30.3 ± 7.3 kg/m2 vs 31.8 ± 7.6 kg/m2 ; P < .001) compared with patients undergoing bilateral procedures. In addition, unilateral patients had fewer prior varicose vein treatments (23.0% vs 15.7%; P < .001) and had higher median preprocedural Venous Clinical Severity Score (VCSS; 8 [IQR, 6-10] vs 7 [IQR, 5.5-9]; P < .001). No difference was seen in complications (6.9% vs 8.2%; P = .292), and systemic complications were rare in both groups. No difference was seen in VCSS improvement after treatment (median, 3 [IQR, 1-6] for unilateral; median, 3 [IQR 1-5] for bilateral; P = .055). In comparing staged with concurrent bilateral procedures, there was no difference in overall complications (7.5% vs 12.2%; P = .144). Staged bilateral patients were older (56.9 ± 13.3 years vs 54.2 ± 12.9 years; P = .002), less likely to have had prior varicose vein treatment (14.3% vs 19.8%; P = .020), and more likely to be therapeutically anticoagulated (10.8% vs 6.5%; P = .028) compared with concurrent bilateral patients. Staged patients also have higher preprocedural VCSS compared with concurrent patients (median, 8 [IQR, 6-10] vs 7 [IQR, 5.5-9]; P < .001). In multivariable analysis, there was no difference in the likelihood of VCSS improvement for concurrent compared with staged procedures (odds ratio, 0.70; 95% confidence interval, 0.40-1.24; P = .226)., Conclusions: Concurrent bilateral truncal endovenous ablation can be performed safely without increased morbidity compared with staged bilateral or unilateral ablations., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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47. A versatile technique for high-resolution three-dimensional imaging of human arterial segments using microcomputed tomography.
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Robinson ST, Levey RE, Beatty R, Connolly D, Dolan EB, Osborne NH, Dockery P, Henke PK, and Duffy GP
- Abstract
Background: Quantitative methods for evaluating microstructure of arterial specimens typically rely on histologic techniques that involve random sampling, which cannot account for the unique spatial distribution of features in three dimensions., Methods: To overcome this limitation, we demonstrate a nondestructive method for three-dimensional imaging of intact human blood vessels using microcomputed tomography (microCT). Human artery segments were dehydrated and stained in an iodine solution then imaged with a standard laboratory microCT scanner. Image visualization and segmentation was performed using commercially available and open source software., Results: Staining of cadaveric vessels with iodine enabled clear visualization of the arterial wall with microCT, preserved tissue morphology, and generated high-resolution images with a voxel size of 5.4 μm. Various components of the arterial wall were segmented using a combination of manual and automatic thresholding algorithms., Conclusions: Our approach allows for spatial mapping of human artery tissue samples that can guide targeted histologic analysis of smaller tissue segments, provide geometric data to inform finite element models, quantify degree of atherosclerosis, and help to evaluate the foreign body response to intravascular medical implants. (JVS-Vascular Science 2020;2:13-19.)., Clinical Relevance: In this article, we describe a powerful technique for whole artery analysis of pathologic human tissue specimens that provides high-resolution spatial detail regarding composition of the blood vessel wall. The protocol described here is a valuable adjunct that can be used as a research tool to inform finite element modeling of arteries, quantify pathologic response (ie, neointimal hyperplasia and vascular calcification), and evaluate the tissue/device interface of implanted medical devices., (© 2020 by the Society for Vascular Surgery. Published by Elsevier Inc.)
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- 2020
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48. The decline of open abdominal aortic aneurysm surgery among individual training programs and vascular surgery trainees.
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Smith ME, Andraska EA, Sutzko DC, Boniakowski AM, Coleman DM, and Osborne NH
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- Adult, Education, Medical, Graduate, Endovascular Procedures education, Endovascular Procedures methods, Female, Humans, Male, Medicare, United States, Workload, Aortic Aneurysm, Abdominal surgery, Vascular Surgical Procedures education, Vascular Surgical Procedures methods
- Abstract
Objective: In the past decade, treatment of abdominal aortic aneurysm (AAA) has dramatically shifted from open repair to an endovascular approach. The decreasing number of open AAA repairs (OAR) has raised concerns regarding future vascular surgeons' competence to perform this complex and high-risk procedure. Prior work has documented decreasing open aortic volume among surgical residents. However, these studies report average national case volume with a limited understanding of the variation in OAR exposure among training programs and trainees. We sought to evaluate the current open AAA repair trends among individual accredited vascular surgery training programs and vascular surgery residents to better evaluate trainees' exposure to OAR., Methods: We identified elderly Medicare beneficiaries undergoing OAR and endovascular aneurysm repair (EVAR) between 2010 and 2014. Accredited vascular surgery training program hospitals were identified. OAR and EVAR volume was aggregated at the program level and the number of senior vascular surgery trainees per year at each program was captured. The training program all-payer total AAA repair volume was calculated based on the national proportion of patients undergoing AAA covered by Medicare in the Vascular Quality Initiative. Temporal trends in program and vascular surgery trainee OAR and EVAR volume were calculated., Results: A total of 119,408 (77%) EVAR and 35,042 (23%) were identified in the Medicare database between 2010 and 2014. Of these, 21% were performed among the 111 training programs, including 22,227 (73%) EVAR and 8416 (27%) OAR. The total OAR volume among training programs decreased by 38% during the study period, from a median of 29.1 to 18.2 OAR. In 2014, 25% of programs performed fewer than 10 OARs annually. Among senior vascular surgery trainees, the median number of OAR decreased from 10.0 in 2010 to 6.4 in 2014 and approximately one-half of senior trainees had exposure to fewer than five OAR in 2014., Conclusions: Exposure to OAR among vascular surgery training programs has dramatically decreased, with nearly one-half of senior trainees performing fewer than five OAR in 2014. The variable and diminishing OAR exposure among vascular surgery training program highlights growing concerns surrounding competence in complex open repairs and suggest that only a small proportion of current trainees have ample opportunity to develop confidence and proficiency in this high-risk operation., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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49. Effect of Mentoring on Match Rank of Integrated Vascular Surgery Residents.
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Jacobs BN, Boniakowski AE, Osborne NH, and Coleman DM
- Subjects
- Adult, Female, Humans, Male, Surgeons education, Surveys and Questionnaires, Young Adult, Attitude of Health Personnel, Career Choice, Education, Medical, Internship and Residency, Mentors, Students, Medical psychology, Surgeons psychology, Vascular Surgical Procedures
- Abstract
Background: Mentoring relationships have been encouraged for medical students interested in surgical specialties. We investigated the role of mentoring relationships of integrated vascular surgery residents, while in medical school. We hypothesized that mentoring relationships between medical students and vascular surgeons would have a positive effect on match outcome in the integrated vascular surgery residency match., Methods: We used an online survey that respondents completed on a smartphone, tablet, or computer. This was created with Qualtrics Software. The survey was circulated to all North American Integrated Vascular Surgery residents, with the support of the Association of Program Directors in Vascular Surgery Recruitment Committee and the Society for Vascular Surgery Resident/Student Outreach Committee. Questions were posed either as Likert Scale or as multiple choice. Data were analyzed in Stata., Results: Response rate (67 total responses of 241 polled residents) was 28%. Earlier postgraduate year residents were more likely to have had vascular surgeon mentors (P = 0.033). There was no association between having a mentor and match rank; however, those with vascular surgeon mentors matched higher on their rank list (P = 0.022). 50% of respondents indicated that mentoring was influential in the choice of integrated residency. Respondents with nonvascular surgeon mentors were more likely to answer negatively regarding their mentor's knowledge about other integrated (P < 0.0001) and traditional programs (P < 0.0001) while residents with a vascular surgeon mentor were more likely to respond positively to this question (P < 0.0001). Regarding the effectiveness of mentorship, 81% indicated their mentor was accessible, 92% responded that their mentor demonstrated professional integrity, and 76% responded that their mentor prioritized their success., Conclusions: Integrated vascular surgery residents were generally positive about their medical school mentors. Our data indicate that surgical mentorship in medical school is effective, both in influencing medical students to choose the vascular surgery specialty and in improving match rank-vascular surgeons were more knowledgeable and mentees with vascular surgeon mentors tended to be more successful in the match., (Copyright © 2019. Published by Elsevier Inc.)
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- 2020
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50. Reinterventions in the modern era of thoracic endovascular aortic repair.
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Fairman AS, Beck AW, Malas MB, Goodney PP, Osborne NH, Schermerhorn ML, and Wang GJ
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- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic mortality, Female, Humans, Male, Middle Aged, Retreatment, Retrospective Studies, Survival Rate, Aortic Aneurysm, Thoracic surgery, Endovascular Procedures
- Abstract
Objective: Using a national data set, we sought to describe the population of patients and the nature and timing of reinterventions after thoracic endovascular aortic repair (TEVAR) by aortic disease as well as their impact on survival., Methods: We evaluated the national data set for TEVAR in the Vascular Quality Initiative from 2010 to 2017. Student t-test and χ
2 analysis were used to compare continuous and categorical variables in the reintervention and no reintervention groups, respectively. Freedom from reintervention and survival analysis was performed using Kaplan-Meier methods., Results: A total of 7006 patients were evaluated: 51.2% thoracic aortic aneurysm, 33.5% type B dissection (TBD), 7.0% penetrating aortic ulcer, 6.7% trauma, and 1.6% intramural hematoma. Overall, 553 patients (7.9%) underwent at least one reintervention, with an in-hospital reintervention rate of 3.5%. Reinterventions were most commonly performed for TBD (11.5%), with reinterventions for other diseases occurring at lower rates: thoracic aortic aneurysm, 6.7%; intramural hematoma, 5.4%; penetrating aortic ulcer, 4.8%; and trauma, 1.8%. The most common cause of reintervention across all aortic diseases was type I endoleak. The most common long-term reinterventions were placement of endovascular stent graft (65%), other surgical treatments (15.9%), other endovascular treatment (13%), endovascular branch treatment (12.4%), surgical treatment with no device removal (11.0%), and surgical branch treatment (10.4%). Freedom from reintervention was decreased for TBD compared with other diseases (P < .001). There was no difference in survival comparing patients undergoing reinterventions and those without (P = .87). However, patients undergoing in-hospital reintervention trended toward increased mortality (P = .075)., Conclusions: Whereas reinterventions were not rare after TEVAR, there was no difference in mortality between patients undergoing reintervention and those without. Patients undergoing TEVAR for TBD demonstrated the highest reintervention rate. This study highlights the importance of long-term follow-up to address disease-specific patterns of reintervention., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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