VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One‐year results of a multicenter study

Abstract Objective This study reports the 1‐year clinical outcomes of the VitaFlow™ transcatheter aortic valve system in the treatment of severe aortic stenosis. Background The VitaFlow™ system (MicroPort®, Shanghai, China) was developed as a novel transcatheter aortic valve replacement system to mitigate or circumvent some of the challenges associated with heavily calcified valves and bicuspid valves. Methods From September 2014 to November 2017, a prospective, multicenter, single arm study was conducted in 11 centers in China. The primary end point was all cause mortality at 12 months. Results One hundred and ten symptomatic aortic stenosis patients (60 men, 50 women; mean age 77.73 ± 4.78 years) at prohibitive or high risk for surgery were enrolled. Mean society of thoracic surgeons score was 8.84 ± 5.58%. All‐cause mortality was 2.7% at 1‐year. Major stroke, major vascular complication, coronary artery obstruction, new pacemaker implantation occurred in 2.7, 2.7, 1.8, and 19.1% at 1‐year follow‐up, respectively. No patients had moderate or severe paravalvular leak at 1‐year. At 1 year follow‐up, 97% of patients had New York heart association ≤II. Patients with bicuspid valves had similar outcomes as those patients with tricuspid aortic valve stenosis. Conclusions The 12‐month clinical results support the safety and efficacy of VitaFlow™ in the treatment of patients with severe aortic stenosis, including patients with bicuspid aortic valve.