June 12, 2026JACC: Cardiovascular Interventions
30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement
Key result
Transfemoral transseptal TMVR with Intrepid demonstrates 0% mortality, stroke, or reintervention at 30 days.
- n=15
Why the study?
Prohibitive surgical risk can preclude surgical mitral valve replacement, prompting evaluation of transfemoral transcatheter mitral valve replacement.
Does transfemoral transseptal transcatheter mitral valve replacement using the Intrepid valve provide safe and effective outcomes at 30 days in patients with severe symptomatic MR at high surgical risk?
Key Points
- To evaluate the safety and effectiveness of transfemoral transseptal mitral valve replacement in patients at high surgical risk.
- Prospective, multi-center framework for early feasibility study.
- Patients with moderate-severe to severe symptomatic mitral regurgitation were assessed for eligibility.
- Clinical events and echocardiographic outcomes were monitored and evaluated independently.
- 14 out of 15 implants were successful in patients aged around 80 years.
- No deaths, strokes, or reinterventions at 30 days; mean gradient post-procedure was 4.7±1.8 mmHg.
- Patient stay averaged 5 days, with 40% experiencing access site bleeds.
Structured PICO
Does transfemoral transseptal transcatheter mitral valve replacement using the Intrepid valve provide safe and effective outcomes at 30 days in patients with severe symptomatic MR at high surgical risk?
P
Population
15 high-risk patients (median age 80 years, 13% female) with moderate-severe/severe symptomatic mitral regurgitation, followed for 30 days.
I
Intervention
Transcatheter mitral valve replacement (TMVR) using the Intrepid valve via transfemoral/transseptal access
O
Outcome
Safety and performance (mortality, stroke, reintervention, valve function) at 30 dayssafety
Transfemoral transseptal TMVR using the Intrepid system demonstrated excellent early safety and valve function at 30 days in high-risk patients with severe MR.
Limitations
- Additional patients and longer follow-up are needed to confirm these findings.
- Small sample size
- Short follow-up
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
MCMedscape Cardiology
““We've all learned that transapical is just not a viable procedure for a lot of these patients. We've got to get to transfemoral.””
“We've all learned that transapical is just not a viable procedure for a lot of these patients. We've got to get to transfemoral. There are two components: There's the Intrepid valve and how that functions, and the focus of this study is really on how to deliver the valve. Thirty-five French is going to be too big, but it is the first step to iterate to a smaller device.”
“Thirty-day results from the Intrepid TMVR transfemoral early feasibility study demonstrate no mortality, stroke, reinvention or pacemaker implantation at 30 days. Almost half of the patients had major bleeding events primarily related to vascular complications. There was very favorable hemodynamics and almost complete elimination of mitral regurgitation at 30 days with significant improvement in New York Heart Association class.”
Implication
Feasibility shown in small cohort should not change practice; leaves open need for larger trials on durability and outcomes.
Abstract
OBJECTIVES To evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk. BACKGROUND Prohibitive surgical risk may preclude MVR surgery in some patients. The investigational Intrepid TMVR system (Medtronic, Minneapolis, MN) has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve. METHODS This prospective, multi-center, non-randomized early feasibility study (EFS) evaluated safety and performance of the Intrepid valve using transfemoral/transseptal access in patients with moderate-severe/severe, symptomatic mitral regurgitation (MR) at high surgical risk. Candidacy was determined by heart teams with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee. RESULTS Fifteen patients were enrolled at 6 sites from Feb 2020-May 2021. Median age was 80 years and STS-PROM was 4.7%; 87% were male and 53% had prior sternotomy. Fourteen implants were successful. One patient converted to surgery during the index procedure. Patients stayed a median 5 days post-procedure. There were 6 (40%) access site bleeds and 11 (73%) iatrogenic ASD closures. At 30 days, there were no deaths, strokes, or reinterventions. All implanted patients had trace/no valvar or paravalvar MR and mean gradient was 4.7±1.8 mmHg. CONCLUSIONS Thirty-day results from the Intrepid transfemoral TMVR EFS demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings.
Discussion
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Cite This Study
Zahr et al. (2021) studied moderate-severe/severe, symptomatic mitral regurgitation (MR) at high surgical risk (n=15). Transcatheter mitral valve replacement (TMVR) using the Intrepid system via transfemoral/transseptal access was evaluated on Safety and performance (mortality, stroke, and reinterventions at 30 days). Transfemoral transseptal transcatheter mitral valve replacement using the Intrepid system demonstrated excellent valve function with 0% mortality, stroke, or reinterventions at 30 days.