Valvular & structural heart disease
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid Transcatheter Mitral Valve Replacement (TMVR) Early Feasibility Study Results
Authors' conclusion
The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.
Study context
- Population
- Patients with ≥moderate-severe mitral regurgitation (MR) at high surgical risk31 (93.9%) successfully implanted
- Participants
- 33 patients
- Outcome
- 1-year outcomes
- Follow-up
- Up to 1 year
Methodological detailsmulticentre, 9 US sites, Enrolled February 2020 to August 2022, Clinical events adjudicated by a clinical events committee; endpoints per Mitral Valve Academic Research Consortium criteria
- Multicentre
- 9 US sites
- Enrolled February 2020 to August 2022
- Clinical events adjudicated by a clinical events committee; endpoints per Mitral Valve Academic Research Consortium criteria
Main finding
As reported in the abstract
Kaplan-Meier all-cause mortality
6.7%
Median mitral valve mean gradient, mm Hg (Q1-Q3: 3.9-5.3)
4.6
Survivors in NYHA class I/II
91.7%
Median improvement in KCCQ overall summary score, points
11.4
Observational data: associations, not effects.
Further findings
Successful implantation
- Patients successfully implanted
- 31 (93.9%)
Postprocedural hospitalisation
- Median length of stay, days
- 5
- Discharged to home
- 87.9%
Safety
30-day safety events
- Deaths
- 0
- Strokes
- 0
- Major vascular complications (none required surgical intervention)
- 8 (24.2%)
- VTE cases, all successfully treated without sequelae
- 4
- Mitral valve reintervention for severe LV outflow tract obstruction
- 1
Original publication
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. Published 23 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →