Early clinical and haemodynamic matched comparison of balloon-expandable valves

• Published in: Heart (British Cardiac Society) Vol. 108; no. 9; pp. 725 - 732
• Main 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
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and British Cardiovascular Society 01.05.2022; BMJ Publishing Group LTD
• Subjects: Aortic stenosis; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Insufficiency - diagnostic imaging; Aortic Valve Insufficiency - etiology; aortic valve stenosis; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - surgery; Calcification; Cardiology; Cardiovascular disease; Ejection fraction; Ethics; Heart; Heart Valve Prosthesis; Hemodynamics; Humans; Life sciences; Pacemakers; Patients; Polyethylene terephthalate; Population; Prostheses; Prosthesis Design; Statistical analysis; transcatheter aortic valve replacement; Transcatheter Aortic Valve Replacement - methods; Treatment Outcome; Valvular heart disease; Vein & artery diseases; United States > US; India; aortic valve stenosis; transcatheter aortic valve replacement
• ISSN: 1355-6037; 1468-201X
• DOI: 10.1136/heartjnl-2021-319349

ObjectivesThe 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.MethodsConsecutive 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.ResultsA 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).ConclusionsThe 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.