Early Experience with Inner Branch Stent–Graft System for Endovascular Repair of Thoraco-Abdominal and Pararenal Abdominal Aortic Aneurysm

Abstract

Objectives: This study aims to evaluate the technical and clinical outcomes of the E-nside stent graft for thoraco-abdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm (PAAA) endovascular treatment at our University Hospital Center. Methods: We conducted a retrospective analysis of patients electively treated by inner branched EVAR (iBEVAR) between 05/2021 and 03/2023. Demographic, procedural, and clinical data were analyzed. The technical success and clinical outcomes, such as access-site-related complications were reported. The perioperative and early mortality rate, freedom from aortic reintervention, target vessels’ (TVs) patency, and the endoleak rate were evaluated during the follow-up. The technical aspects (external iliac artery diameter, iliac tortuosity, extent of aortic coverage) were retrospectively analyzed. Results: Twenty-two patients were included (age 75.9 ± 5.5; 72.7% male). The aneurism extent was Crawford I = 4 (18.2%), III = 8 (36.4%), IV = 5 (22.7%), V = 1 (4.5%), and PAAA = 4 (18.2%). The mean aortic diameter was 63.5 ± 9.9 mm. The technical success was 95.5% (assisted primary success 100%). The clinical success was 86.4%. The perioperative and early freedom from all-cause mortality rates were 90.9% and 90%, respectively. No case of inter-stage aortic-related mortality was reported, and there was no permanent/temporary spinal cord ischemia (SCI). Seventy-eight out of 81 patent TVs were incorporated through a bridging stent (96.3%). The TV success was 95.1%. The mean external iliac artery (EIA) diameter was 7.5 ± 1.1 mm. Twelve patients (54.5%, including all female patients) were considered outside the instructions for use (IFU) due to narrow iliac arteries. One access-site-related complication was reported. Conclusions: Our experience confirms that E-nside has promising technical and clinical success rates, as well as a low reintervention rate, but it requires a significant compromise of the healthy aortic tissue and adequate iliac arteries that still represents a limitation, especially among women. Mid- to long-term studies and prospective registries are mandatory to evaluate the long-term efficacy and safety, as a comparison between E-nside and other alternative off-the-shelf solutions.

Keywords

• thoraco-abdominal aortic aneurysm (TAAA)
• pararenal abdominal aortic aneurysm (PAAA)
• branched stent graft
• E-nside multibranch stent–graft system
• inner branch