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Paravalvular aortic regurgitation was frequent with first generation TAVR devices (Edwards XT, Medtronic CoreVale) and associated with an increased mortality. New generation devices were developed to reduce the risk of paravalvular aortic regurgitation by adding an outer skirt (Edwards Sapien 3) or an adaptive seal (Boston Scientific Lotus valve).
We compared procedural, in-hospital and 30 days outcome of the new generation mechanically expandable and repositionable Boston Scientific 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. Postprocedural aortic regurgitation, pre- and postdilation, permanent pacemaker implantation, device success and 30 days safety endpoint were studied according to VARC-2 criteria. Multivariable analyses using stepwise forward regression were performed to evaluate independent predictors for mortality in the total study group. The following variables were included for multivariable analysis: age, diabetes, year of implantation, valve type, atrial fibrillation and STS score.
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 Scientific Lotus device (N=100) were enrolled (clinicaltrials.gov NCT02162069). 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. Device success according to Valve Academic Research Consortium-2 criteria was 88% with the CoreValve system, 92% with the Edwards Sapien XT, 95% with the Edwards Sapien 3 and highest for the Boston Scientific Lotus valve (96%, p=0.03). 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 Edwards Sapien 3 (15%) and Edwards XT valve (8%; p<0.01). Early safety endpoint at 30 days was significantly lower with the new generation devices (Edwards Sapien 3 9%, Lotus valve 9%, CoreValve 20%, Edwards XT 22%, p<0.01). In multivariate analyses valve type was an independent predictor of 30 days' mortality.
TAVR with the new generation Edwards Sapien 3 and Boston Scientific Lotus valves was associated with no moderate and severe aortic regurgitation and a significant improvement in 30 days outcome compared to last generation devices (Edwards XT, Medtronic CoreValve).
STRUCTURAL: Valvular Disease: Aortic