In-Hospital Outcomes and Predictors of Paravalvular Leak and Deep Implantation With the Evolut R 34-mm Device: A Comparison With Smaller Evolut R Sizes

• DOI: 10.1016/j.carrev.2021.03.024
• Publication Date: 2021-04-21T03:38:25Z
• Authors: Riccardo Gorla; Federico De Marco; Andrea Garatti; Giovanni Bianchi; Elena Acerbi; Omar Alessandro O...; Andrea Arneri; Nedy Brambilla; Luca Testa; Mauro Luca Agnifili; Maurizio Tusa; Francesco Bedogni
• Keywords: Male; Aortic Valve Stenosis; Prosthesis Design; Hospitals; 3. Good health; Transcatheter Aortic Valve Replacement; 03 medical and health sciences; Postoperative Complications; Treatment Outcome; 0302 clinical medicine; Risk Factors; Aortic Valve; Heart Valve Prosthesis; Humans; Retrospective Studies

To compare in-hospital outcome of Evolut-R 34 mm vs. smaller Evolut-R devices and to identify predictors of paravalvular leak (PVL) and deep implantation specific for Evolut-R 34 mm.This single-center retrospective study included 359 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with Evolut-R 34 mm (N = 84,23.4%) and Evolut-R 23/26/29 mm (N = 275,76.6%) between 2016 and 2019.Patients in Evolut-R 34 mm group were more frequently males, had lower STS score, ejection fraction, and mean aortic gradient compared to the Evolut-R 23/26/29 mm group. Horizontal aorta and large LVOT were more frequent findings in the Evolut-R 34 mm group, whereas calcium volume was comparable among the groups. During TAVR, mean implantation depth and contrast volume were greater in the Evolut-R 34 mm group, compared to the Evolut 23/26/29 mm group. Post-procedurally, 30-day mortality, ≥moderate PVL, device success and pacemaker implantation (PM) rates were comparable between groups. Among independent predictors of ≥moderate PVL, calcium volume (OR:1.04; p < 0.001) was predictive with different thresholds in both groups, whereas aortic angulation (OR:1.40; p = 0.005) was predictive only in Evolut-R 34 mm group at a cutoff of 60° (AUC:0.73; p = 0.043). Body weight (OR:1.03; p = 0.027), left ventricular outflow tract (LVOT) diameter (OR:1.34; p = 0.001), and mean aortic gradient (OR:0.96; p = 0.006) were independent predictors of deep implantation (mean depth ≥ 6 mm), with LVOT>27 mm being predictive specifically for Evolut-R 34 mm (AUC:0.66; p = 0.024).TAVR with Evolut-R 34 mm and Evolut-R 23/26/29 mm showed comparable in-hospital outcome. Aortic angulation >60° and LVOT >27 mm were predictive respectively of ≥moderate PVL and deep implantation specifically in Evolut-R 34 mm patients.