Stenting Complex Aorta Aneurysms with the Cardiatis Multilayer Flow Modulator: First Impressions

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.