A multicenter prospective clinical study on transcatheter aortic valve implantation for aortic stenosis or pure aortic regurgitation: 5-year outcomes.

Abstract

Currently, there is limited evidence regarding the long-term durability of available transcatheter heart valves (THVs). The purpose of this analysis is to evaluate the 5-year outcomes of using the J-Valve for transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) and pure aortic regurgitation (AR). From March 2014 to August 2015, all consecutive patients with severe AS and pure AR treated with the J-Valve THV at 3 centers in China were prospectively enrolled in a clinical study. Clinical and echocardiographic follow-up were performed according to study protocol. All results were reported according to the Valve Academic Research Consortium 3 criteria. At 5-year follow-up, the all-cause mortality rate was 15.31% (16/98), with a cardiovascular mortality rate of 7.14% (7/98). The incidence of stroke was 7.14% (7/98), and the permanent pacemaker implantation rate was 8.16% (8/98). Echocardiographic follow-up showed left ventricular ejection fraction significantly improved at 5 years in both patients with AS (58.98 ± 10.45% vs 61.78 ± 9.07%, P for trend <.01) and pure AR (52.86 ± 10.98% vs 61.45 ± 6.90%, P for trend < .01). Structural or hemodynamic valve deterioration occurred in 3 cases (3.06%). In total, 97.59% of patients had significant improvement in New York Heart Association functional class over the 5-year follow-up, which is associated with significant improvement in quality of life. Our study demonstrates that TAVI with the J-Valve THV provides excellent 5-year clinical and echocardiographic outcomes, suggesting TAVI with a dedicated THV is a good alternative treatment for AS and pure AR in selected high-risk patients.