Key result
FORTIS TMVI demonstrates feasibility in high-risk severe MR with three early survivors.
Case Report (n=5)
Yes
Initial case series describing the early experience and technical details of transcatheter mitral valve implantation using the FORTIS device in 5 compassionate-use patients.
Early feasibility in compassionate-use cases supports device iteration; leaves open safety and efficacy in larger prospective trials.
Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.
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Bapat et al. (2014) conducted a case report in Severe mitral regurgitation (n=5). Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device was evaluated on Feasibility and early clinical outcomes. Transcatheter mitral valve implantation using the Edwards FORTIS device was feasible in five high-risk patients with severe mitral regurgitation, resulting in three patients surviving beyond 30 days.
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