Feasibility of aortic aneurysm sac embolization using a novel shape memory polymer embolic device

Abstract

Background: We investigated the feasibility of aneurysm sac embolization using a novel self-expanding porous shape memory polymer (SMP) device during endovascular aortic abdominal or thoracic aneurysm repair (EVAR). Methods: Retrospective analysis of consecutive patients treated at 2 centers in Germany. Patients were treated from January 2019 to July 2021 with follow-up at 7 days and 3, 6, and 12 months. Aneurysm sacs were implanted with SMP devices immediately following endograft placement during the same procedure. Primary endpoint was technically successful SMP-device deployment into the aneurysm sac outside the endograft. Secondary endpoints were changes in aneurysm volume and associated complications (e.g., endoleaks). Results: We included 18 patients (16 males), aged 72 ± 9 years, achieving 100% technical success. Mean preprocedure aortic aneurysm sac volume was 195 ± 117 mL with a perfused aneurysm volume of 97 ± 60 mL. A mean of 24 ± 12 SMP devices per patient were used (range 5–45, corresponding to 6.25–56.25 mL expanded embolic material volume). All evaluable patients exhibited sac regression except 2 patients yet to reach 3-month follow-up. At mean 11 ± 7 months (range 3–24), change in aneurysm volume from baseline was -30 ± 21 mL (p < 0.001). In 8 patients, aneurysm regression was observed despite type 2 endoleaks in 6 and type 1A endoleaks in 2, none of them requiring further intervention to date. No morbidity or mortality related to this treatment occurred. Conclusions: SMP devices for aortic aneurysm sac embolization during endovascular repair appear feasible and safe in this small case series. Prospective studies are needed. Key points: • Shape memory polymer is a novel, self-expanding, porous, and radiolucent embolic device material. • Aortic aneurysm sacs were treated with polymer devices immediately following endograft placement. • Aortic aneurysm sac regression was observed in all patients with over 3-month follow-up. • Aortic aneurysm sac regression was observed even in the presence of endoleaks.