Early clinical and haemodynamic matched comparison of balloon-expandable valves. Issue 9 (20th July 2021)

• Record Type: Journal Article
• Authors: Delgado-Arana, Jose R; Gordillo-Monge, María X; Halim, Jonathan; De Marco, Federico; Trani, Carlo; Martin, Pedro; Infusino, Fabio; Ancona, Marco; den Heijer, Peter; Bedogni, Francesco; Nombela Franco, Luis; Moreno, Raul; Sargella, Gennaro; Montorfano, Matteo; Aristizabal-Duque, Cristhian; Romero-Delgado, Teresa; Santos, Sandra; Barrero, Alejandro; Gomez Salvador, Itziar; IJsselmuiden, Sander; Redondo Diéguez, Alfredo; San Román Calvar, José Alberto; Amat-Santos, Ignacio J
• Is Part Of: Heart. Volume 108:Issue 9(2022)
• Page Start: 725
• Page End: 732
• Publication Date: 2021-07-20
• Subjects: transcatheter aortic valve replacement -- aortic valve stenosis; Heart -- Diseases -- Treatment -- Periodicals; Cardiology -- Periodicals; 616.12
• DOI: 10.1136/heartjnl-2021-319349
• Languages: English
• ISSNs: 1355-6037

Abstract

Abstract : Objectives: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device. Methods: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index. Results: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001). Conclusions: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.