Next‐generation balloon‐expandable Myval transcatheter heart valve in low‐risk aortic stenosis patients

• Published in: Catheterization and cardiovascular interventions 2022-02, Vol.99 (3), p.889-895
• Main Authors: García‐Gómez, Mario, Delgado‐Arana, Jose Raúl, Halim, Jonathan, De Marco, Federico, Trani, Carlo, Martin, Pedro, Won‐Keun, Kim, Montorfano, Matteo, Heijer, Peter, Bedogni, Francesco, Sardella, Gennaro, IJsselmuiden, Alexander J. J., Campante Teles, Rui, Aristizabal‐Duque, Christian H., Gordillo, Ximena, Santos‐Martinez, Sandra, Barrero, Alejandro, Gómez‐Salvador, Itziar, Ancona, Marco, Redondo, Alfredo, Román, J. Alberto San, Amat‐Santos, Ignacio J.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic stenosis; Aortic valve; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - etiology; Aortic Valve Stenosis - surgery; Balloon treatment; balloon‐expandable; Clinical outcomes; Coronary artery; Embolization; Female; Heart Valve Prosthesis; Humans; Male; Occlusion; Pacemakers; Patients; Prosthesis Design; Regurgitation; Retrospective Studies; TAVR; Thorax; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - methods; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.29923

Objectives We aimed to describe hemodynamic performance and clinical outcomes at 30‐day follow‐up of the balloon‐expandable (BE) Myval transcatheter heart valve (THV) in low‐risk patients. Background The results of the next‐generation BE Myval THV in low‐risk aortic stenosis (AS) patients are still unknown. Methods Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE‐II) scores. Results Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE‐II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30‐day follow‐up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p