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Myval Octacor expandible por globo frente a Evolut PRO/PRO+ y Acurate Neo2: Resultados a corto plazo del análisis de

Elisabetta Moscarella^1,2, Alfonso Ielasi³, Won-Keun Kim⁴

¹Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

|September 5, 2025

Resumen

La válvula Myval Octacor mostró un mejor éxito del dispositivo en la implantación de válvula aórtica transcatéter (TAVI) en comparación con las válvulas de autoexpansión, con resultados de seguridad similares. Se necesitan más estudios aleatorizados para confirmar estos hallazgos para los procedimientos TAVI.

Área de la Ciencia:

Medicina cardiovascular
Cardiología intervencionista
Ingeniería de Biomateriales

Sus antecedentes:

La implantación de válvula aórtica transcatéter (TAVI) se está expandiendo a pacientes más jóvenes y de menor riesgo, lo que requiere resultados hemodinámicos y de procedimiento optimizados.
La válvula expandible por globo de Myval Octacor (BEV) tiene como objetivo reducir la regurgitación paravalvular (PVL), la implantación del marcapasos (PPI) y mejorar la hemodinámica.
Existen datos comparativos limitados para Myval Octacor con respecto a las válvulas supraanulares de autoexpansión (SEV) contemporáneas como Evolut PRO/ PRO+ y Acurate Neo2.

Objetivo del estudio:

Para comparar la seguridad, la eficacia y los resultados clínicos a corto plazo del Myval Octacor BEV frente a los SEV en el TAVI transfemoral.
Evaluar el éxito del dispositivo, el éxito técnico, el rendimiento de la válvula y los parámetros de seguridad tempranos a los 30 días después de TAVI.

Principales métodos:

Registro prospectivo y multicéntrico de pacientes con Myval Octacor comparado con los receptores de VSE del registro NEOPRO2.
Se utilizó el emparejamiento de la puntuación de propensión para ajustar las diferencias basales entre los grupos.
El objetivo primario: el éxito del dispositivo Valve Academic Research Consortium-3 (VARC-3) durante 30 días. Puntos finales secundarios: éxito técnico, rendimiento de la válvula y seguridad temprana.

Principales resultados:

Myval Octacor demostró un mayor éxito del dispositivo VARC-3 a los 30 días (97% frente a 88%, p=0,024) en comparación con los SEV.
En el grupo de Myval Octacor se observó una tendencia hacia un menor PVL de moderado a severo (1% frente a 7%, p=0,06).
Las áreas de orificios efectivos indexadas fueron más grandes con Myval Octacor; las tasas de mortalidad, accidente cerebrovascular, IPP e IM fueron similares a los 30 días.

Conclusiones:

Myval Octacor muestra una seguridad y eficacia tempranas comparables a las de los SEVs supraanulares en TAVI.
El Myval Octacor ofrece ventajas potenciales en el éxito del dispositivo y el rendimiento hemodinámico.
Se necesitan ensayos aleatorizados más grandes para validar estos hallazgos para los procedimientos TAVI.

Palabras clave:

Estenosis de la aorta Myval expandible con globo Acurate Neo2 autoexpansivo Evolut PRO/PRO+ de expansión automática Sustitución de la válvula aórtica mediante catéter Las válvulas cardíacas transcatéter

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