Transcatheter Aortic Valve Implantation with J-Valve: 2-Year Outcomes from the Multi-center Study.

Abstract Background We now report the 2-year follow-up outcomes of the J-Valve in the treatment of either Aortic stenosis (AS) or pure aortic insufficience (AI) from the multi-center study. Methods From March 2014 to October 2016, 107 patients with either AS (n=63) or pure AI (n=44), were enrolled in the trial and treated by TAVI with the J-Valve system. All patients except one completed 2-year clinical and echocardiographic follow-up (follow-up rate 99%). The procedural and clinical outcomes were presented according to Valve Academic Research Consortium-2 criteria (VARC-2). Results The device success rate was 91.5%, respectively. All-cause mortalities were 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% patients at 30 days and 2 years, respectively. No patient showed more than mild aortic prosthetic regurgitation. At 2-year follow-up, 97.6% patients had mild or less than mild paravalvular leak, and 99.8% patients experienced significant improvement in heart failure symptoms (at least one NYHA level reduction). No significant differences in echocardiographic and clinical follow up were found between AS and AI, except for a significantly higher trans-valvular gradient in the AS cohort (p=0.01). Conclusions The present study has demonstrated very good mid-term outcomes of TAVI with the J-Valve system in the treatment of patients with either AS or AI, suggesting the J-Valve system is a compromising alternative therapy in high-risk patients.