VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One‐year results of a multicenter study. Issue 2 (24th April 2019)

• Record Type: Journal Article
• Authors: Zhou, Daxin; Pan, Wenzhi; Wang, Jianan; Wu, Yongjian; Chen, Mao; Modine, Thomas; Mylotte, Darren; Piazza, Niccolo; Ge, Junbo
• Is Part Of: Catheterization and cardiovascular interventions. Volume 95:Issue 2(2020)
• Page Start: 332
• Page End: 338
• Publication Date: 2019-04-24
• Subjects: aortic stenosis -- bicuspid aortic valve -- self‐expanding -- transcatheter aortic valve replacement; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.28226
• Languages: English
• ISSNs: 1522-1946

Abstract

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.