Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Regional variation in racial disparities among patients with peripheral artery disease.

OBJECTIVE: Prior studies identified significant racial disparities as well as regional variation in outcomes of patients with peripheral artery disease (PAD). We aimed to determine whether regional variation contributes to these racial disparities. METHODS: We identified all white or black patients who underwent infrainguinal revascularization or amputation in 15 deidentified regions of the Vascular Quality Initiative between 2003 and 2017. We excluded three regions with <100 procedures. We used multivariable linear regression, allowing clustering at the hospital level to calculate the marginal effects of race and region on adjusted 30-day mortality, major adverse limb events (MALEs), and amputation. We compared long-term outcomes between black and white patients within each region and within patients of each race treated in different regions using multivariable Cox regression. RESULTS: We identified 90,418 patients, 15,527 (17%) of whom were black. Patients underwent 31,263 bypasses, 52,462 endovascular interventions, and 6693 amputations. Black patients were younger and less likely to smoke, to have coronary artery disease, or to have chronic obstructive pulmonary disease, but they were more likely to have diabetes, limb-threatening ischemia, dialysis dependence, and hypertension and to be self-insured or on Medicaid (all P < .05). Adjusted 30-day mortality ranged from 1.2% to 2.1% across regions for white patients and 0% to 3.0% for black patients; adjusted 30-day MALE varied from 4.0% to 8.3% for white patients and 2.4% to 8.1% for black patients; and adjusted 30-day amputation rates varied from 0.3% to 1.2% for white patients and 0% to 2.1% for black patients. Black patients experienced significantly different (both higher and lower) adjusted rates of 30-day mortality and amputation than white patients did in several regions (P < .05) but not MALEs. In addition, within each racial group, we found significant variation in the adjusted rates of all outcomes between regions (all P < .01). In adjusted analyses, compared with white patients, black patients experienced consistently lower long-term mortality (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.73-0.88; P < .001) and higher rates of MALEs (HR, 1.15; 95% CI, 1.06-1.25; P < .001) and amputation (HR, 1.33; 95% CI, 1.18-1.51; P < .001), with no statistically significant variation across the regions. However, rates of all long-term outcomes varied within both racial groups across regions. CONCLUSIONS: Significant racial disparities exist in outcomes after lower extremity procedures in patients with PAD, with regional variation contributing to perioperative but not long-term outcome disparities. Underperforming regions should use these data to generate quality improvement projects, as understanding the etiology of these disparities is critical to improving the care of all patients with PAD.

Racial disparities in outcomes after intact abdominal aortic aneurysm repair.

OBJECTIVE: We aimed to compare perioperative morbidity and mortality and late survival among black, white, and Asian patients undergoing intact abdominal aortic aneurysm (AAA) repair. METHODS: We identified all patients undergoing intact, infrarenal AAA repair in the Vascular Quality Initiative (VQI) from 2003 to 2017. We compared in-hospital outcomes by race using the Fisher exact and Kruskal-Wallis tests. Multivariable logistic and linear regression models of perioperative outcomes adjusted for differences in demographics, comorbidities, hospital volume, and procedure. We used Cox regression to evaluate late survival by race. RESULTS: In the cohort, 21,961 (94%) patients were white, 1215 (5.2%) were black, and 318 (1.4%) were Asian. Black patients were more likely to be symptomatic (black, 16%; white, 9.1%; Asian, 11%; P < .001) and to undergo endovascular aneurysm repair (EVAR; black, 87%; white, 83%; Asian, 84%; P < .001). There were no differences in 30-day mortality after EVAR (black, 1.1%; white, 1.1%; Asian, 0.8%; P = .80) or open repair (black; 4.3%; white, 2.6%; Asian, 1.9%; P = .33). However, black patients were more likely to receive new postoperative dialysis (black, 1.6%; white, 0.8%; Asian; 0.7%; P = .01) and to return to the operating room (black, 4.3%; white, 2.9%; Asian, 0.9%; P < .01). Mean hospital length of stay was longer in black patients after EVAR (black, 3.3 days; white, 2.6 days; Asian, 2.6 days; P < .001) and in Asian and black patients after open repair (black, 10.5 days; white, 8.5 days; Asian, 13.0 days; P < .001). After multivariable adjustment, black patients were more likely than white patients to have postoperative dialysis (odds ratio, 2.2; 95% confidence interval [CI], 1.3-3.6; P < .01) and return to the operating room (odds ratio, 1.6; 95% CI, 1.2-2.2; P < .01). Five-year survival was highest for Asian patients (black, 84%; white, 85%; Asian, 92%), even in the adjusted Cox model (Asian: hazard ratio, 0.6; 95% CI, 0.4-0.97; P = .04). CONCLUSIONS: Although perioperative mortality is comparable across races after AAA repair, black patients are more likely than white or Asian patients to develop new postoperative renal failure and return to the operating room, even after adjusting for differences in comorbidities, operative variables, and hospital volume. In addition, whereas Asian patients have the highest rate of postoperative myocardial infarction, they also have the highest late survival. Further studies are warranted to elucidate the mechanism of these disparities.

Long-Term Outcomes of Abdominal Aortic Aneurysm in the Medicare Population.

BACKGROUND: Randomized trials and observational studies have shown that perioperative morbidity and mortality are lower with endovascular repair of abdominal aortic aneurysm than with open repair, but the survival benefit is not sustained. In addition, concerns have been raised about the long-term risk of aneurysm rupture or the need for reintervention after endovascular repair. METHODS: We assessed perioperative and long-term survival, reinterventions, and complications after endovascular repair as compared with open repair of abdominal aortic aneurysm in propensity-score-matched cohorts of Medicare beneficiaries who underwent repair during the period from 2001 through 2008 and were followed through 2009. RESULTS: We identified 39,966 matched pairs of patients who had undergone either open repair or endovascular repair. The overall perioperative mortality was 1.6% with endovascular repair versus 5.2% with open repair (P<0.001). From 2001 through 2008, perioperative mortality decreased by 0.8 percentage points among patients who underwent endovascular repair (P=0.001) and by 0.6 percentage points among patients who underwent open repair (P=0.01). The rate of conversion from endovascular to open repair decreased from 2.2% in 2001 to 0.3% in 2008 (P<0.001). The rate of survival was significantly higher after endovascular repair than after open repair through the first 3 years of follow-up, after which time the rates of survival were similar. Through 8 years of follow-up, interventions related to the management of the aneurysm or its complications were more common after endovascular repair, whereas interventions for complications related to laparotomy were more common after open repair. Aneurysm rupture occurred in 5.4% of patients after endovascular repair versus 1.4% of patients after open repair through 8 years of follow-up (P<0.001). The rate of total reinterventions at 2 years after endovascular repair decreased over time (from 10.4% among patients who underwent procedures in 2001 to 9.1% among patients who underwent procedures in 2007). CONCLUSIONS: Endovascular repair, as compared with open repair, of abdominal aortic aneurysm was associated with a substantial early survival advantage that gradually decreased over time. The rate of late rupture was significantly higher after endovascular repair than after open repair. The outcomes of endovascular repair have been improving over time. (Funded by the National Institutes of Health.).