Transapical Transcatheter Aortic Valve Implantation Using The J-Valve^TMSystem:A One-year Follow-up Study

Objective:Transcatheter aortic valve implantation(TAVI)has become a routine procedure to treat screened inoperable and/or high-risk patients.In this study,we present the first outcome of echocardiographic midterm using a new second-generation TAVI system,the J-ValveTM system,in patients with aortic stenosis(AS)or aortic regurgitation(AR).Methods:From July 2014 to June 2015,21 patients with isolated aortic valve disease at high risk for open-heart surgery received transapical TAVI using the J-ValveTM system.The primary endpoint was a combined efficacy endpoint after 1 year,which included all-cause mortality after more than 30 days and failure of current therapy for AS or AR requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction.Secondary endpoints were cardiovascular mortality,major stroke,and life-threatening,disabling,or major bleeding after 6 and 12 months.Results:The mean age of the study cohort was 75.52±5.22 years,the EuroSCORE Ⅱscore was 11.33±1.28%,and the mean logistic Euro-SCORE I score was 31.13±9.68%.TAVI with the J-ValveTM system was successfully performed on 19 of the 21 patients(90.5%).For patients with AS,12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62±0.17 cm2 to 1.52±0.35 cm2,and a decrease in transvalvular mean gradient from 61±15 mmHg to 18±9 mmHg.All surviving patients(n=18)reported improvements in at least one of the NYHA classes.The combined ratio of successful implantation and absence of adverse events in our cohort(n=21)was 76.19%.Conclusion:The J-ValveTM system exhibits a convincing midterm performance and is a safe and feasible procedure with low peri-and post-operative complications.