A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation.
Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis, according to the study.
The authors concluded that transapical mitral valve replacement with the Tiara valve in high-risk patients with severe mitral regurgitation and aortic valve prostheses is “technically feasible and can be performed safely.”
“The data available on TMVR in patients with prior aortic prosthesis is extremely limited to nonexistent,” added Mayra Guerrero M.D. and Charanjit Rihal, both of the cardiovascular medicine department at Mayo Clinic in Rochester, Minn., in an accompanying editorial. “This knowledge gap is relevant because patients often have multivalvular disease and may require intervention of both aortic and mitral valves.”
Tiara is a self-expanding mitral bioprosthesis for transcatheter implantation in patients with mitral regurgitation. The device is being evaluated in two ongoing investigational clinical trials, an early feasibility trial in the United States, Canada, and Belgium and a CE Mark trial in Germany, Italy, and the United Kingdom. Patients have also been treated under compassionate programs in Canada, Italy, Germany, Israel, and Switzerland. Tiara is not approved for commercial sale in any country, according to Vancouver-based Neovasc.