TY - JOUR
T1 - Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients
AU - García-Gómez, Mario
AU - Delgado-Arana, Jose Raúl
AU - Halim, Jonathan
AU - De Marco, Federico
AU - Trani, Carlo
AU - Martin, Pedro
AU - Won-Keun, Kim
AU - Montorfano, Matteo
AU - Den Heijer, Peter
AU - Bedogni, Francesco
AU - Sardella, Gennaro
AU - Ijsselmuiden, Alexander J. J.
AU - Campante Teles, Rui
AU - Aristizabal-Duque, Christian H.
AU - Gordillo, Ximena
AU - Santos-Martinez, Sandra
AU - Barrero, Alejandro
AU - Gómez-Salvador, Itziar
AU - Ancona, Marco
AU - Redondo, Alfredo
AU - Román, J. Alberto San
AU - Amat-Santos, Ignacio J.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - TAVR
KW - aortic stenosis
KW - balloon-expandable
KW - TAVR
KW - aortic stenosis
KW - balloon-expandable
UR - http://hdl.handle.net/10807/184724
U2 - 10.1002/ccd.29923
DO - 10.1002/ccd.29923
M3 - Article
SN - 1522-1946
SP - N/A-N/A
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
ER -