New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome

New generation devices for transcatheter aortic valve replacement have been optimized to improve clinical outcome. We compared procedural, in-hospital, 30 days and 12 months outcome of the new generation repositionable Boston Lotus Valve and the balloon-expandable Edwards Sapien 3 valve with the last generation self-expandable Medtronic CoreValve and the balloon-expandable Edwards Sapien XT. Between 2010 and 2015 consecutive patients treated with the Medtronic CoreValve (N = 100), Edwards Sapien XT (N = 100), Edwards Sapien S3 (N = 100) and Boston Lotus device (N = 100) were enrolled. There was no moderate or severe AR with the new generation devices as compared with 11.5% with last generation devices (p < 0.01). None or trace aortic regurgitation was lowest with the Lotus valve. Pacemaker implantation due to II° or III° atrioventricular block was comparable for the self-expandable CoreValve (21%) and the mechanically deployed Lotus Valve (23%) and lower for the Sapien 3 (15%) and XT valve (8%; p < 0.01). Early safety endpoint at 30 days (21 vs. 9%, p < 0.01), major vascular complications (12 vs. 2.5%, p < 0.01), all-cause mortality (9.5 vs. 2%, p < 0.01) and rate of disabling and non-disabling stroke (7.5 vs. 3.5%, p < 0.01) were significantly lower with the new generation devices. In multivariate analyses, valve type was an independent predictor for 30 days early safety endpoint and 12 months all-cause mortality. TAVR with the new generation Edwards Sapien 3 and Boston Lotus valves was associated with no moderate and severe aortic regurgitation, significantly lower major vascular complications and a significant improvement in 30 days and 12 months outcome.

Clinicaltrials.gov NCT02162069.