New Self-Expanding Transcatheter Valve for Off-Pump Transatrial Mitral Valve-In-Ring Implantation

Abstract

Objectives: To validate a self-expanding transcatheter valve for off-pump transatrial mitral valve-in-ring (VIR) implantation via a left thoracotomy. Methods: Mitral valve annuloplasty was performed via sternotomy during cardiopulmonary bypass on 9 pigs. After successful weaning from extracorporal circulation, the custom-made, self-expanding transcatheter VIR device was deployed under fluoroscopic guidance within the annuloplasty ring via a left thoracotomy. Hemodynamic data before and after the implantation were recorded. Mitral annulus diameter and valve area were measured by echocardiography. Transvalvular and left-ventricular outflow-tract pressure gradient were measured invasively. Results: Eight successful implantations were performed. Implantation failed in 1 pig because of difficulty with technical delivery of the sheath. Mean transatrial procedure time was 12.6 ± 1.7 min. Hemodynamic status during transatrial implantation was stable, and differences were not statistically significant. Mean mitral annulus diameter and mean mitral orifice area were 2.32 ± 0.2 and 3.84 ± 0.55 cm2, respectively. Mild regurgitation was detected in 7 animals and moderate regurgitation in 1. Mean gradients were 6.1 ± 5.0 mm Hg across the device. Postmortem examination confirmed adequate positioning of devices within the annuloplasty ring. Conclusions: This custom-made transcatheter device allows for safe and reproducible off-pump transatrial mitral VIR implantations. Transatrial access is a promising route to facilitate VIR implantations. Our custom-made stent-valve may be suitable for VIR procedures.