Transcatheter Aortic Valve Implantation With J-Valve: 2-Year Outcomes From a Multicenter Study.

Abstract

We report the 2-year follow-up outcomes of the J-Valve in the treatment of either aortic stenosis (AS) or pure aortic insufficiency (AI) from a multicenter study. From March 2014 to October 2016, 107 patients with either AS (n = 63) or pure AI (n = 44) were enrolled in a trial and were treated by transcatheter aortic valve implantation with the J-Valve system. All patients except 1 completed a 2-year clinical and echocardiographic follow-up (follow-up rate of 99%). The procedural and clinical outcomes were presented according to Valve Academic Research Consortium-2 criteria. The success rate of the device was 91.5%. All-cause mortality was 4.7% and 10.3% at 30 days and 2 years, respectively. Echocardiographic follow-up showed mild prosthetic valve regurgitation in 1.0% and 6.8% of patients at 30 days and 2 years, respectively. No patient showed more than mild aortic prosthetic regurgitation. At the 2-year follow-up, 97.6% of patients had mild or less than mild paravalvular leak and 99.8% of patients experienced notable improvement in heart failure symptoms (at least 1 NYHA level reduction). We found no major differences in echocardiographic and clinical follow-up between AS and AI, except for a significantly higher transvalvular gradient in the AS cohort (P = .01). This study demonstrated good midterm outcomes of transcatheter aortic valve implantation with the J-Valve system in the treatment of patients with either AS or AI. It suggests that the J-Valve system is a promising alternative therapy in high-risk patients.