Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms in the US IDE Experience

Abstract

Introduction - To report the expanded use of preloaded catheters and wires of fenestrations and directional branches to facilitate access to renal and mesenteric target arteries during endovascular repair of complex aortic aneurysms. Methods - Prospectively collected data from six physician-sponsored investigational device exemption (IDE) studies at US centers was analyzed. Patients were treated with fenestrated and branched aortic endografts for suprarenal (SRA) and thoracoabdominal aortic aneurysms (TAAA) between 2012 and 2017. Technical success was defined as successful intraoperative cannulation and stenting of all intended target visceral arteries. Univariate and stratified analyses were performed to identify differences between preloaded and standard devices. Results - There were 564 patients (73% men, mean age 73±8) treated for 168 SRAs (30%), 216 type IV TAAAs (30%) and 180 type I-III TAAAs (32%). Preloaded grafts (PG) were used in 387 (69%) patients and standard grafts (SG) in 177 (31%). PGs were preferentially used for type IV TAAAs (45% vs. 24%, P<.01), whereas standard devices were used more frequently among patients with type I-III TAAAs (24% vs. 49%; P<.01). The majority of custom-made devices were preloaded (65% vs. 25%; P=.01). A total of 2157 target arteries were incorporated (mean 3.9/patient) utilizing 1469 fenestrations (68%), 603 directional branches (28%), and 85 double-wide scallops (4%). Most PGs included fenestrations (80% vs. 43%, P<.01) whereas directional branches were more frequent in standard devices (17% vs. 53%, P<.01). Contrast volume, fluoroscopy time, radiation dose and operative time were not significantly different between preloaded and standard devices (Table). Upper extremity access was more frequent for PGs (87% vs. 72%, P<.01). Overall technical success was 98.8% and 30-day mortality was 1.9%. Technical success was higher for PGs compared with standard grafts (99.5% vs. 97.2%, P=.02). 30-day mortality was lower among patients undergoing procedures with PGs (1% vs. 5%; P<.01). Stroke rate was the same for PGs and SGs (2%).Tabled 1Preloaded n=387Standard n=177P valueTechnical success385/387 (99.5)172/177 (97.2).02Contrast use (cc)115±56119±67.56Fluoroscopy time (min)85±3582±37.47Total radiation dose (mGy)2474±17232672±1903.31 Open table in a new tab Conclusion - Endovascular repair of complex aortic aneurysm is safe and effective. The expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with even higher technical success and lower early mortality.