Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation

Sánchez-Luna J.P. Martín P. Dager A.E. Charry P.D. Beltrán J.R. Sánchez-Recalde Á. Giannini F. Gómez-Menchero A. Pan M. Ielasi A. Monastyrski A. Barbanti M. Avilés F.F. Ancona M. Mussayev A. De Brahi J.P. Lamelas P. Sánchez-Pérez A. Puerta M.G. Ortiz M. Gonzalez-Gutiérrez J.C. Marengo G. Gómez J. Gonzalez-Bartol E. Stepanenko A. Gómez-Salvador I. Román J.A.S. Amat-Santos I.J.
2023 Europa Group

EuroIntervention
2023 #19 Issue 7 580 - 585 pp.

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: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm². 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.

aortic regurgitation , balloon-expandable valve , TAVR , transcatheter valve implantation , valve disease

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Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain
Cardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Gran Canaria, Las Palmas, Spain
Cardiology Department, Angiografía de Occidente Hospital, Cali, Colombia
Cardiology Department, Clínica Medilaser, Neiva, Colombia
Cardiology Department, Los Comuneros Hospital Universitario de Bucaramanga, Bucaramanga, Colombia
Cardiology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain
Cardiology Department, San Raffaele Scientific Institute, Milan, Italy
Cardiology Department, Hospital Juan Ramón Jimenez, Huelva, Spain
Cardiology Department, Hospital Reina Sofía, Cordoba, Spain
University of Cordoba (IMIBIC), Cordoba, Spain
Cardiology Department, IRCCS Ospedale Galeazzi Sant’Ambrogio, Milan, Italy
Cardiology Department, Hospital Universitario Val d’Hebron, Barcelona, Spain
Cardiology Department, Policlinico-Vittorio Emanuele Hospital, Catania, Italy
Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Cardiology Department, National Research Cardiac Surgery Center, Astana, Kazakhstan
Cardiology Department, Sanatorio de La Trinidad Mitre, Buenos Aires, Argentina
Cardiology Department, Instituto Cardiovascular, Buenos Aires, Argentina
Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain

Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
University of Cordoba (IMIBIC)
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Cardiology Department
Centro de Investigación Biomédica en Red

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