Daxin Zhou1, Wenzhi Pan1, Jianan Wang2, Yongjian Wu3, Mao Chen4, Thomas Modine5, Darren Mylotte6, Niccolo Piazza7, Junbo Ge1. 1. Department of Cardiology, Shanghai Institute of Cardiovascular Disease, Zhongshan Hospital, Fudan University, Shanghai, China. 2. Department of Cardiology, The second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. 3. Department of Cardiology, National Centre for Cardiovascular Disease, Fuwai Hospital, Beijing, China. 4. Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China. 5. Pole de Chirurgie CardioVasculaire, Hôpital cardiologique, CHRU de Lille, France. 6. Galway University Hospitals and SAOLTA Health Care Group, National University of Ireland, Galway, Ireland. 7. Department of Interventional Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.
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.
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 stenosispatients (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.
Authors: Tian-Yuan Xiong; Walid Ben Ali; Yuan Feng; Kentaro Hayashida; Hasan Jilaihawi; Azeem Latib; Michael Kang-Yin Lee; Martin B Leon; Raj R Makkar; Thomas Modine; Christoph Naber; Yong Peng; Nicolo Piazza; Michael J Reardon; Simon Redwood; Ashok Seth; Lars Sondergaard; Edgar Tay; Didier Tchetche; Wei-Hsian Yin; Mao Chen; Bernard Prendergast; Darren Mylotte Journal: Nat Rev Cardiol Date: 2022-06-20 Impact factor: 32.419
Authors: Mauro Chiarito; Alessandro Spirito; Johny Nicolas; Alexandra Selberg; Giulio Stefanini; Antonio Colombo; Bernhard Reimers; Annapoorna Kini; Samin K Sharma; George D Dangas; Roxana Mehran Journal: J Clin Med Date: 2022-07-30 Impact factor: 4.964