iCVCT 2. Mitral and Tricuspid Valve Devices Trials
Sunday, December 6th: 1:30 – 3:00 pm
Valvular heart disease (VHD) is one the most frequent pathologies treated with cardiac surgery in western countries. However, although treatment with medical therapy is unsatisfactory, high perioperative risks result in low referral rates and high denial rates for surgical treatments. In addition, the benefits of surgical treatments remain controversial; therefore, there is increasing interest in the development of novel minimally invasive transcatheter techniques.
This session will be chaired by Dr. Mayra Guerrero, an interventional cardiologist, and the principal investigator of the MITRAL Trial (Mitral Implantation of Transcatheter Valves) from the Mayo Clinic in Rochester, MN, USA, and Dr. Changfu Wu, a mechanical engineer with the centre for devices and radiological health at the US FDA. Dr. Guerrero will present the state-of-the-art of transcatheter FMR device trials including COAPT and MITRA-FR. Dr. Rebecca Hahn (New York, USA) will bring us up-to-date on transcatheter tricuspid valve repair and replacement trials.
This session will provide an update on the landscape of devices for VHD treatment. Repair devices such as the Cardioband™ or the MitraClip™ are leading the field with promising completed and ongoing trials. Evidence is less convincing for primary mitral regurgitation, but the therapy is more firmly established for secondary mitral regurgitation, and new devices are also under investigation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for both secondary and primary mitral regurgitation. Development of transcatheter tricuspid interventions currently lags behind those for mitral valves. Edge-to-edge repair and tricuspid annuloplasty and replacement such as the Gate bioprosthesis are under investigation.
We will also hear about regulatory considerations from Mauro Moscucci, and Changfu Wu, of the US FDA and reimbursement considerations. Industry viewpoints will be provided by Kartik Sundareswaran, of Abbott, USA, the maker of MitraClip™, and Eric Vang, of Medtronic,USA, the maker of the CoreValve™ Evolut R™ system.
If you are an interventional cardiologist, regulator, payer, patient, or manufacturer of mitral or tricuspid valve devices do not miss the moderated multi-stake holders debate titled, “Evolving Regulatory Considerations for Mitral and Tricuspid Valve Devices.”