Comparison of the Hemodynamic Performance of the Balloon-expandable SAPIEN 3 Versus Self-expandable Evolut R Transcatheter Valve: A Case-matched Study

Abstract

Introduction and objectivesThe SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. MethodsOf a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography. All echocardiographic examinations collected at baseline and at 1- and 6-month follow-up were centrally analyzed. ResultsThe 2 groups were well balanced in baseline clinical and echocardiographic characteristics. The EVR valve showed a better hemodynamic profile as assessed by peak aortic gradient (EVR 13 ± 7 vs S3 20 ± 10mmHg; P<.001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6mmHg; P<.001), and Doppler velocity index (EVR 0.65±0.15 vs S3 0.51±0.16; P<.001). The rate of moderate-severe or any paravalvular (≥ mild) AoR was higher in the EVR group (11% and 50%) than in the S3 group (2.5% and 21%; P <.05, respectively), with a larger number of paravalvular jets (P <.001). ConclusionsIn a case-matched cohort of transcatheter aortic valve implantation patients, the S3 valve was associated with a lower rate of paravalvular AoR but also with a higher residual gradient than the EVR system.