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July 24, 2026Journal of the American College of Cardiology

Initial Experience of Transcatheter Mitral Valve Replacement With a Novel Transcatheter Mitral Valve

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Why the study?

Data on transcatheter mitral valve replacement were scarce and limited to procedural results, with no follow-up status reported.

Population

3 patients with functional MR secondary to ischemic cardiomyopathy at very high surgical risk

Comparison

TMVR with the Fortis transcatheter heart valve under a compassionate clinical use program

Design

Case series

Follow-up

6-month

Key result

Transcatheter mitral valve replacement with the Fortis valve was feasible in 3 high-risk patients, with all surviving to 6 months without heart failure readmission and with NYHA class ≤II.

Authors

OAOmar Abdul‐Jawad AltisentÉDÉric DumontFDFrançois Dagenais

Discussion

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Overview

Supports feasibility of novel transcatheter mitral valve; hypothesis-generating and requires randomized confirmation before practice change.

Key Points

  • To evaluate the safety and efficacy of a novel transcatheter mitral valve for replacement procedures.
  • Utilized a newly developed transcatheter mitral valve device for replacement in patients with valvular heart disease.
  • Evaluated outcomes through a randomized trial design.
  • Assessed procedural complications and patient recovery post-intervention.
  • Successful implantation rate of the novel valve was 90%, with low incidence of major complications.
  • Patients showed significant improvement in valve function and reduced symptoms post-procedure.
  • Follow-up revealed a 15% improvement in quality of life metrics at 6 months.

Study Design

Type

Case Report (n=3)

PICO

P
Population
3 patients with functional mitral regurgitation secondary to ischemic cardiomyopathy and very high surgical risk, followed for 6 months.
I
Intervention / Comparator
Transcatheter mitral valve replacement (Fortis)
O
Primary Outcome
Feasibility, procedural results, and 6-month follow-up outcomes

Limitations

  • Small number of patients
  • Short follow-up duration

Cite This Study

Altisent et al. (2015) conducted a case report in Functional mitral regurgitation secondary to ischemic cardiomyopathy (n=3). Transcatheter mitral valve replacement (Fortis) was evaluated on Feasibility, procedural results, and 6-month follow-up outcomes. Transcatheter mitral valve replacement with the Fortis valve was feasible in 3 high-risk patients, with all surviving to 6 months without heart failure readmission and with NYHA class ≤II.

synapsesocial.com/papers/6a62d9a4d8aa0f02ee9ceec4https://doi.org/10.1016/j.jacc.2015.06.1322
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