Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation
Juan Pablo Sánchez-Luna, Pedro Martín, Antonio Dager, Pablo Charry, Javier Beltran, Ángel Sánchez‐Recalde, Francesco Giannini, Antonio Gómez‐Menchero, Manuel Pan, Alfonso Ielasi, Andrea Monastyrski, Marco Barbanti, Francisco Fernández‐Avilés, Marco Bruno Ancona, Abdurashid Mussayev, Juan Pablo De Brahi, Pablo Lamelas, Andrés Sánchez-Pérez, Melissa García Puerta, Miguel A Ortíz, José Carlos González-Gutiérrez, Giorgio Marengo, Javier Herrero, Esther González-Bartol, Alexander Stepanenko, Itzíar Gómez, J. Alberto San Román, Ignacio J. Amat‐Santos
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: . The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.