Clinical research

DOI: 10.4244/EIJ-D-23-00344

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

Juan Pablo Sanchez-Luna1, MD; Pedro Martín2, MD; Antonio E. Dager3, MD; Pablo D. Charry4, MD; Javier R. Beltrán5, MD; Ángel Sánchez-Recalde6, MD; Francesco Giannini7, MD; Antonio Gómez-Menchero8, MD; Manuel Pan9, MD; Alfonso Ielasi10, MD; Andrea Monastyrski11, MD; Marco Barbanti12, MD; Francisco Fernandez-Avilés13, MD, PhD; Marco Bruno Ancona7, MD; Abdurashid Mussayev14, MD; Juan Pablo De Brahi15, MD; Pablo Lamelas16, MD; Andrés Sánchez-Pérez2, MD; Melissa García Puerta3, MD; Miguel Ortiz3, MD; Jose Carlos Gonzalez-Gutiérrez1, MD; Giorgio Marengo1, MD; Javier Gómez1, MD; Esther Gonzalez-Bartol1, MD; Alexander Stepanenko1, MD; Itziar Gomez-Salvador17, MSc; J. Alberto San Román1,17, MD, PhD; Ignacio J. Amat-Santos1,17, MD, PhD

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: 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...

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Volume 19 Number 7
Sep 18, 2023
Volume 19 Number 7
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