Transcatheter mitral valve repair system improves mitral regurgitation at 2 years
Key takeaways:
- A transapical transcatheter mitral valve repair system conferred reduction in mitral regurgitation in high-risk patients at 2 years.
- The system has been redesigned for transfemoral delivery.
A transapical transcatheter mitral valve repair system was linked to extensive reduction in mitral regurgitation at 2 years in patients ineligible for surgery, researchers reported at TVT: The Structural Heart Summit.
Martin B. Leon, MD, FACC, professor of medicine at Columbia University Irving Medical Center, director of Columbia Interventional Cardiovascular Care and director of the Cardiac Catheterization Laboratories and founder of the Cardiovascular Research Foundation, presented 2-year outcomes from a pooled analysis of two studies of the transapical transcatheter mitral valve repair system (Intrepid, Medtronic).
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“In the future, emerging transcatheter mitral regurgitation therapies (including edge-to-edge repair and transcatheter mitral valve replacement [TMVR]) may provide worthwhile alternatives to surgery and guideline-directed medical therapy to reduce [mitral regurgitation] and improve clinical outcomes in various patient populations,” Leon said during a presentation. “The purpose of this study was to determine the feasibility of transapical TMVR using the 35F Intrepid system in patients with high-risk moderate-severe or worse symptomatic [mitral regurgitation] not considered candidates for surgical treatment.”
The trials included 95 patients from a pilot study of the device and 157 patients from the APOLLO study (mean age, 74 years; 60% men). There were 144 patients available for the 2-year pooled analysis.
The all-cause mortality rate at 2 years was 36.2% (40.6% in the pilot study, 33.7% in the APOLLO study), Leon said.
The pooled 2-year rate of HF hospitalization was 36.2% (35.1% in the pilot study, 36.8% in the APOLLO study), he said.
The combined endpoint of all-cause mortality or HF hospitalization at 2 years was 52.8% in the pooled cohort (55.6% in the pilot study, 51.1% in APOLLO), according to the researchers.
Event rates were highest in the first month, and “transapical access site issues, especially bleeding, contributed to increased 30-day mortality and rehospitalization events,” Leon said.
In other 2-year outcomes, 29.6% of patients died from a CV cause, 15% required reoperation or reintervention, 9.3% had a stroke and 29.3% had a major bleeding event, he said.
At 2 years, 38.1% of patients had NYHA class I HF compared with none at baseline, he said.
Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scores improved from 53.9 at baseline to 81 at 2 years in the APOLLO cohort, he said.
The percentage of patients alive and well with at least a 10-point improvement in KCCQ score at 2 years was 39.3% in APOLLO he said, noting that in the pilot study, which used the Minnesota Living with Heart Failure Questionnaire and only followed that metric for 1 year, 47.8% of patients were alive and well with at least a 10 point improvement at 1 year.
All patients had mitral regurgitation severity of mild or better at 2 years, compared with almost none at baseline, according to the researchers.
“In appropriately selected symptomatic patients with moderate-severe or worse [mitral regurgitation] who are high-risk surgical candidates, transapical TMVR using the Intrepid system provides meaningful improvement in patient reported outcomes and marked reduction in [mitral regurgitation] through 2 years,” Leon said during the presentation. “Evolution to a transfemoral TMVR system is incorporated in the current APOLLO trial. A lower-profile transfemoral system plus a larger valve size in the future should improve the safety and application of TMVR in expanding patient populations, including a planned randomized trial under development comparing mitral transcatheter edge-to-edge repair vs. transfemoral TMVR.”
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Leon MB, et al. Late-breaking clinical science I: Mitral valve disease. Presented at: TVT: The Structural Heart Summit; June 7-10, 2023; Phoenix.
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