Stenting complex aorta aneurysms with the Cardiatis multilayer flow modulator: first impressions

Abstract

Objectives: Our aim was to assess the feasibility and efficacy of the Cardiatis multilayer flow modulator in the treatment of complex aorta aneurysms.

Methods: This is a single-center prospective registry. Six patients (4 males and 2 females; mean age 74 years) with complex aorta aneurysms (unsuitable for endovascular repair with standard, fenestrated, or branched stent grafts) were treated with the Cardiatis multilayer flow modulator.

Results: Clinical success was 100%. Median follow-up was 10 months. One patient died the third postoperative day due to aneurysm rupture. Four aneurysms were completely thrombosed between 1 and 6 months after the procedure. The patency of the covered aortic branches was 100%. At 6 months, the sac volume was decreased in two patients, increased in two patients and remains stable in one patient. There were no stent migrations, retractions, thrombosis, fractures, or reinterventions.

Conclusions: The device preserves flow into the covered aortic branches and completed aneurysm thrombosis occurs gradually; however, the stent did not prevent rupture immediately after the implantation. Longer follow-up is mandatory to prove the efficacy of this technology.

Keywords: Cardiatis multilayer flow modulator; Complex aneurysms; Outcome.