Columbo, Jesse A.

ImportanceFenestrated and branched endovascular aortic repairs (F/BEVAR) have been adopted by many centers. However, national trends of F/BEVAR use remain unclear, particularly at sites who perform them without an US Food and Drug Adminstration (FDA)–approved investigational device exemption (IDE).ObjectiveTo quantify the use of F/BEVAR in the US and to determine if mortality was different at IDE vs non-IDE sites.Design, Setting, and ParticipantsThis retrospective cohort study examined 100% fee-for-service Medicare claims data from 2016 to 2023. Participants were patients who underwent endovascular treatment of the visceral aorta incorporating 2 or more visceral artery endoprostheses. Hospitals with vs without an IDE were identified using hospitals’ Employer Identification Number as a time varying exposure.ExposureF/BEVAR.Main Outcomes and MeasuresTrends in the center-level F/BEVAR case volume stratified by IDE status were assessed using cumulative incidence curves. Mortality outcomes at 30 days and 3 years were compared using Kaplan-Meier methods and Cox proportional hazards models with adjustment for baseline patient characteristics.ResultsFrom 2016 to 2023, 8017 patients were treated with F/BEVAR at 549 hospitals. The median (IQR) age was 75.8 (71.3-80.8) years; 5795 patients (72.3%) were male and 2222 (27.7%) female. A total of 2226 F/BEVAR (27.8%) were performed at 22 hospitals with an IDE. The number of patients treated with F/BEVAR increased from 771 in 2016 to 1251 in 2023. The median (IQR) annual case volume per hospital was significantly higher at IDE sites (22.3 [11.0-30.4] vs 1.2 [1.0-2.0] cases/y; P < .001); 18 IDE sites (90.0%) and 20 non-IDE sites (3.7%) completed 9 or more cases per year. The 30-day mortality (3.0% vs 4.9%) but not 3-year mortality (26.0% vs 27.1%) was lower for patients treated at hospitals with vs without an IDE. After risk adjustment, both 30-day (odds ratio, 0.47; 95% CI, 0.32-0.69) and midterm mortality (hazard ratio, 0.81; 95% CI, 0.69-0.95) were lower for patients treated at IDE sites.Conclusions and RelevanceThe use of F/BEVAR is increasing across the United States, with the majority of cases being performed outside of IDE studies and at low-volume centers. F/BEVAR performed at non-IDE centers are associated with higher adjusted 30-day and midterm mortality. Transparent outcome reporting and identification of process measures from IDE sites may help achieve more equity in patient outcomes.

Background: There is wide variation in stress test utilization before major vascular surgery and adherence to practice guidelines is unclear. We defined rates of stress test compliance at our institution and led a quality improvement initiative to improve compliance with American Heart Association (ACC/AHA) guidelines. Methods: We implemented a stress testing order set in the electronic medical record at one tertiary hospital. We reviewed all patients who underwent elective, major vascular surgery in the 6 months before (Jan 1, 2022 – Jul 1, 2022) and 6 months after (Aug 1, 2022 – Jan 31, 2023) implementation. We studied stress test guideline compliance, changes in medical or surgical management, and major adverse cardiac events (MACE). Results: Before order set implementation, 37/122 patients (30%) underwent stress testing within the past year (29 specifically ordered preoperatively) with 66% (19/29) guideline compliance. After order set implementation, 50/173 patients (29%) underwent stress testing within the past year (41 specifically ordered preoperatively) with 80% (33/41) guideline compliance. In the pre- and postimplementation cohorts, stress testing led to a cardiovascular medication change or preoperative coronary revascularization in 24% (7/29) and 27% (11/41) of patients, and a staged surgery or less invasive anesthetic strategy in 14% (4/29) and 4.9% (2/41) of patients, respectively. All unindicated stress tests were surgeon-ordered and none led to a change in management. There was no change in MACE after order set implementation. Conclusions: Electronic medical record-based guidance of perioperative stress testing led to a slight decrease in overall stress testing and an increase in guideline-compliant testing. Our study highlights a need for improved preoperative cardiovascular risk assessment prior to major vascular surgery, which may eliminate unnecessary testing and more effectively guide perioperative decision-making.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME ( n = 25) versus those who were in states that did not ( n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality ( p = 0.15) or amputation ( p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

Objective: A significant cohort of patients who have undergone carotid artery stenting (CAS) will have in-stent restenosis (ISR). The optimal management of symptomatic or severe ISR remains poorly defined. The purpose of this study was to describe the indications, treatment, and mid- to long-term outcomes of patients undergoing CAS explantation for ISR. Methods: All patients undergoing internal carotid artery stent explantation with carotid artery reconstruction at Mayo Clinic Rochester, Dartmouth-Hitchcock Medical Center, and Beth-Israel Deaconess Medical Center from 2003 to 2013 were retrospectively reviewed. Isolated common carotid artery stents were excluded. Demographics, comorbidities, indications for explantation, operative details, and perioperative and postoperative outcomes were reviewed. Results: Over the study interval, a total of 971 patients underwent carotid stenting across the 3 centers. Of these, 8 patients ultimately underwent CAS explantation with carotid artery reconstruction. Mean age was 69 years and 5 patients were male. Index stent placement was for symptomatic stenosis in 4 patients, asymptomatic restenosis after endarterectomy in 2 patients, asymptomatic high lesion in 1 patient, and asymptomatic critical stenosis in 1 patient. Indications for explantation were symptomatic ISR in 4 patients and asymptomatic severe ISR in 4 patients. Method of repair was stent explantation and patch angioplasty in 5 and en bloc carotid resection with bypass in 3 patients. There were no perioperative neurologic events or cranial nerve injuries. At a mean follow-up of 38.7 months, there were 2 late disabling ipsilateral strokes (14.4 months and 19.1 months). Conclusion: A significant cohort of patients who have undergone CAS will have ISR. Although excellent perioperative results after surgical explantation can be obtained, this patient subgroup remains at risk for late neurologic events. Appropriate patient selection and diligent long-term follow-up are mandated to obtain optimal outcomes.