Long-Term Durability of Transcatheter Aortic Valve Implantation With Self-Expandable Valve System (from a Real-World Registry).

ABSTRACT

As transcatheter aortic valve Implantation (TAVI) moves to younger and lower risk patients with longer life expectancy, the long-term durability of TAVI is becoming an increasingly relevant issue. We sought to evaluate the long-term clinical outcome and prosthesis performance of the CoreValve self-expandable valve. Clinical registry of 182 patients consecutively treated with TAVI in a tertiary center from January 2009 to July 2017. Of these, 111 died during an average follow-up (FU) of 1,026 ± 812 days (median IQR 745, 477 to 1,400 days; longest survival 11 years; 61% mortality at Kaplan-Meier analysis). At 1 month, functional profile improved in all survivors, with 93.9% of them achieving NYHA class I or II. At Cox analysis, the Society of Thoracic Surgeons score (HR 1.55; p = 0.001), left ventricular ejection fraction <40% (HR 1.65; p = 0.017) and incident acute kidney injury (HR 1.96; p = 0.001) were independently associated with all-cause mortality. During FU, echocardiographically assessed mean transprosthetic aortic gradient remained substantially unchanged (from 9.0 ± 2.7 after TAVI to 9.0 ± 5.0 mm Hg at FU; p >0.05). Most patients had none and/or trivial (34%), or mild (58%), fewer had moderate (8%) and none had severe perivalvular leak, without significant change during FU. At 11 years, cumulative incidence of bioprosthetic valve failure and moderate structural valve deterioration (SVD) were 2.9% (95% CI 0.8% to 10%) and 9.3% (95% CI 3.3% to 26.7%), respectively. In conclusion, our registry confirmed that TAVI with the self-expandable CoreValve system was associated with favorable long-term clinical outcomes, with a reassuring low rate of significant bioprosthetic valve failure and moderate SVD.