Black, James H.

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: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. Methods: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. Results: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%–21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality ( P <0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency ( P <0.0001). Conclusions: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers’ experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.