Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms

Objective: The aim of this study was 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: This was an observational retrospective cohort multicentre study. Prospectively collected data from six physician sponsored investigational device exemption studies at US centres were analysed. Patients were treated with fenestrated and branched aortic endografts for pararenal and thoraco-abdominal aortic aneurysms (TAAAs) between 2012 and 2017. Technical success was defined as successful intra-operative catheterisation and stenting of all intended target visceral arteries. Univariable and stratified analyses were performed to identify differences in outcomes between repairs using preloaded and standard devices. Results: There were 564 patients (73% men, mean age 73 +/- 8 years) treated for 168 pararenal aortic aneurysms (29.8%), 216 type IV TAAAs (38.3%), and 180 type I - III TAAAs (31.9%). Preloaded grafts (PGs) were used in 387 (68.6%) patients and standard grafts (SGs) in 177 (31.4%). PGs were used preferentially for type IV TAAAs (45% vs. 24%; p < .001), whereas standard devices were used more frequently among patients with type I - III TAAAs (24% vs. 49%; p < .001). The majority of custom made devices were preloaded (95% vs. 21%; p < .001). A total of 2 157 target arteries were incorporated (mean 3.9/patient) utilising 1 469 fenestrations (68.1%), 603 directional branches (27.9%), and 85 double wide scallops (3.9%). Most PGs included fenestrations (80% vs. 43%; p < .001), whereas directional branches were more frequent in standard devices (17% vs. 53%; p < .001). Contrast volume, fluoroscopy time, radiation dose, and operative time were not significantly different between preloaded and standard devices. Upper extremity access was more frequent for PGs (87% vs. 72%; p < .001). Overall technical success was 98.8% and comparable for both preloaded and standard grafts (99.5% vs. 97.2%; p = .022). The 30 day stroke rate was similar for PGs and SGs (2.3% and 1.7%%, respectively). The 30 day mortality rate was 1.9%, and low for both PGs and SGs (0.8% vs. 4.5%; p = .003). Conclusion: Endovascular repair of complex aortic aneurysms is safe and effective. The expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with a high technical success and low early mortality.