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EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023

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

Наблюдательное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Sanchez-Luna Juan Pablo, Martín Pedro, Dager Antonio E, Charry Pablo D, Beltrán Javier R, Sánchez-Recalde Ángel, Giannini Francesco, Gómez-Menchero Antonio, Pan Manuel, Ielasi Alfonso, Monastyrski Andrea, Barbanti Marco, Fernandez-Avilés Francisco, Ancona Marco Bruno, Mussayev Abdurashid, De Brahi Juan Pablo, Lamelas Pablo, Sánchez-Pérez Andrés, García Puerta Melissa, Ortiz Miguel, Gonzalez-Gutiérrez Jose Carlos, Marengo Giorgio, Gómez Javier, Gonzalez-Bartol Esther, Stepanenko Alexander, Gomez-Salvador Itziar, San Román J Alberto, Amat-Santos Ignacio J

Аннотация

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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты