Trends and outcomes over time with fenestrated and branched endovascular aortic repair in the United States Aortic Research Consortium

Abstract

Objective: To characterize trends and outcomes with fenestrated and branched endovascular aortic repair (F/B-EVAR) performed at centers participating in the US Aortic Research Consortium.

Methods: F/B-EVARs performed in 10 prospective, nonrandomized, physician-sponsored investigative device exemption studies from 2015 to 2023 were studied retrospectively. Outcomes included 30-day major adverse event (MAE) and 1-year secondary reintervention. Outcome determinants were modeled with mixed effects multivariable regression. Adjusted observed minus expected cumulative sum analysis was used to evaluate outcomes achieved over time.

Results: In the study period, 2377 patients underwent F/B-EVAR. The median follow-up was 2.3 years (interquartile range [IQR], 0.7-3.5 years). The proportion of thoracoabdominal aneurysms (P = .01) and aortic dissections (P = .001) increased over the study period while technical failure rates (P = .6) and length of hospital stay (P = .1) remained stable. Fusion imaging (P = .0005), low-profile devices (P < .0001), and completely transfemoral repair (P = .0005) were adopted increasingly over time. There were decreases in fluoroscopy time, procedure time, radiation dosage, and blood loss throughout the study (all P < .0001). Adjusted 30-day survival was 99.6% (IQR, 99.3%-99.8%) and MAE occurred in 240 (10%). MAE determinants included age (odds ratio [OR], 1.3 per 10-years; 95% confidence interval [CI], 1.1-1.6; P = .005), estimated glomerular filtration rate (OR, 0.9 per 10-mL/min/1.73 m²; 95% CI, 0.82-0.95; P = .001), thoracoabdominal aneurysm (OR, 1.8; 95% CI, 1.3-2.6; P = .002), operative time (OR, 1.04 per 10 minutes; 95% CI, 1.03-1.06; P < .0001), and technical failure (OR, 3.0; 95% CI, 1.7-5.1; P = .0001). The cumulative rate of 30-day MAE remained stable, reflecting expected outcomes rates. The 1-year reintervention rate was 18% (n = 435). Secondary intervention determinates included patient-specific device use (OR, 0.4; 95% CI, 0.28-0.65; P = .045), technical failure (OR, 3.1; 95% CI, 1.9-5.3; P < .0001), total target vessels (OR, 1.3 per vessel; 95% CI, 1.05-1.6; P = .002), and prior aortic dissection (OR, 1.9; 95% CI, 1.3-2.6; P = .0005). The cumulative rate of 1-year reintervention remained stable during the study period.

Conclusions: Data from multiple US centers demonstrate that F/B-EVAR can be performed safely and with acceptable outcomes. Despite increasing repair extent and complexity, the rates of technical failure, adverse events, and reintervention remained stable, likely driven, in part, by evolutions in minimally invasive techniques.

Keywords: Aortic aneurysm; Endovascular aneurysm repair; Endovascular procedures; Outcomes.