One‐year clinical and echocardiographic outcomes of direct implantation of a self‐expanding valve

Abstract

Objective: To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial.Background: Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking.Methods: DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded.Results: At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm 2 vs. 1.85 ± 0.44 cm 2 , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation Georgios Benetos and Maria Karmpalioti contributed equally to this study.

Predictors for the risk of permanent pacemaker implantation after transcatheter aortic valve replacement: A systematic review and meta‐analysis

“…60 The risk of PPMI has decreased with the introduction of new devices like the Evolut PRO system. 100 However, there was considerable heterogeneity between studies in this meta-analysis, which was explored with a subsequent meta-regression analysis. The result indicated that STS-PROM score, priorCABG, and CoreValve use influenced the heterogeneity.…”