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 < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. Conclusions: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.
Garcia-Gomez, M., Delgado-Arana, J. R., Halim, J., De Marco, F., Trani, C., Martin, P., Won-Keun, K., Montorfano, M., Den Heijer, P., Bedogni, F., Sardella, G., Ijsselmuiden, A. J. J., Campante Teles, R., Aristizabal-Duque, C. H., Gordillo, X., Santos-Martinez, S., Barrero, A., Gomez-Salvador, I., Ancona, M., Redondo, A., Roman, J. A. S., Amat-Santos, I. J., Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients, <<CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS>>, 2021; (14): N/A-N/A. [doi:10.1002/ccd.29923] [http://hdl.handle.net/10807/184724]
Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients
Trani, C.;Bedogni, F.;
2021
Abstract
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 < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. Conclusions: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.
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