Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study.

Objective: Transcatheter aortic valve implantation has become a routine procedure to treat screened inoperable or high-risk patients. In this study, we present the first outcome of echocardiographic midterm using a new second-generation transcatheter aortic valve implantation system, the J-Valve system (Jie Cheng Medical Technologies, Suzhou, China), in patients with aortic stenosis or aortic regurgitation. Methods: From July 2014 to June 2015, 21 patients with isolated aortic valve disease at high risk for open surgery received transapical transcatheter aortic valve implantation using the J-Valve system. The primary end point was a combined efficacy end point after 1 year, which included all-cause mortality after more than 30 days and failure of current therapy for aortic stenosis or aortic regurgitation requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Secondary end points 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 European System for Cardiac Operative Risk Evaluation II score was 11.33% +/- 1.28%, and the mean logistic European System for Cardiac Operative Risk Evaluation I score was 31.13% +/- 9.68%. Transcatheter aortic valve implantation with the J-Valve system was successfully performed in 19 of the 21 patients (90.5%). For patients with aortic stenosis, 12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62 +/- 0.17 cm(2) to 1.52 +/- 0.35 cm(2) and a decrease in transvalvular mean gradient from 61 +/- 15 mm Hg to 18 +/- 9 mm Hg. All surviving patients (n = 18) reported improvements in at least 1 of the New York Heart Association classes. The combined ratio of successful implantation and absence of adverse events in our cohort (n = 21) was 76.19%. Conclusions: The J-Valve system exhibits a convincing midterm performance and is a safe and feasible procedure with low perioperative and postoperative complications.