Transcatheter Mitral Valve Implantation for the Treatment of Mitral Regurgitation - Thirty days Outcomes of First-in-Man Experience with an Apically Tethered Device
Cesare Quarto, Alison Duncan, Alistair Lindsay, Neil Moat.
Royal Brompton Hospital, London, United Kingdom.
OBJECTIVE: A small number of Transcatheter Mitral Valve Implants (TMVI) have been reported using devices designed to treat secondary mitral regurgitation (MR). However, MR has many etiologies and patients have a broad spectrum of annular size, geometry, and lesions. There are an number of technical challenges for TMVI including left ventricular outflow tract obstruction (LVOTO) and paravalvular MR. In-hospital outcomes of first-in-man (FIM) implants with a novel TMVI device are reported.
METHODS: The Tendyne TMVI system consists of a porcine pericardial valve in a tethered nitinol frame. An apical tether fixed to an epicardial pad stabilizes the device. The device is fully repositionable and retrievable even after complete deployment.Pre-operative assessment was performed with 3D transesophageal echocardiogram (TOE) and multi-slice computed tomography to define annular dimensions, geometry and guide surgical access. 3 patients were deemed not to be candidates for conventional surgery or for treatment with any CE marked device by Heart Team Evaluation. They were; a 68-year-old woman with prior coronary artery bypass grafts and severe functional MR, a 75-year-old man with prior coronary bypass grafts, significant renal dysfunction and severe degenerative MR, and a frail 86-year-old man with severe degenerative MR. Each had a TMVI via a transapical approach through a left mini-thoracotomy. Apical tether tension was adjusted to optimize device position.
RESULTS: Implantation was guided by 2D and 3D TOE. The apical pad facilitated LV apical closure. There were no procedural complications. No patient had residual MR or LVOTO, and there was no significant mitral gradient.
All patients were discharged to their own home (2 on the 5th post-operative day), all with significant improvement in their symptoms. All were alive an well 30 days postimplant.
CONCLUSIONS: The FIM experience with the Tendyne TMVI system is promising. Valve stabilization by an apical tether is a novel way to address some of the challenges of TMVI. The unique Tendyne design features may offer potential for its use across a wide range of mitral valve pathologies. Further details will be presented on the mid term outcome of these patients and of any additional implants.
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