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2-Year Outcomes of Transcatheter MV Replacement for MV Disease
Quick Takes
- Findings from this prospective trial assessing use of a balloon-expandable aortic transcatheter valve to treat mitral valve (MV) disease secondary to severe mitral annular calcification (MAC), failed annuloplasty ring, and bioprosthetic MV dysfunction suggest a durable effect over 2 years among survivors.
- Two-year mortality rates varied among the groups (valve-in-ring > valve-in-MAC > valve-in-valve; 50% > 39% > 6.7%).
- The majority of survivors had improved functional class, quality of life, and stable prosthetic function at 2 years.
Study Questions:
What are the 2-year outcomes of valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and valve-in-valve (MViV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial?
Methods:
This multicenter prospective study enrolled high surgical risk patients with severe mitral annular calcification (MAC), prior failed mitral annuloplasty ring repair, or failed bioprosthetic mitral valve (MV) replacement at 13 US sites. The primary performance endpoint of this analysis was absence of mitral regurgitation (MR) grade 2+ or higher and mean MV gradient ≥10 mm Hg at 2 years. The secondary safety endpoint was all-cause mortality at 2 years. The other study endpoint included New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and 6-minute walk distance at 2 years.
Results:
Between February 2015 and December 2017, 91 patients were enrolled (31 ViMAC, 30 MViR, and 30 MViV). In ViMAC, 2-year all-cause mortality was 39.3%, 66.7% were NYHA class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In MViR, 2-year all-cause mortality was 50%, 65% were NYHA class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In MViV, 2-year all-cause mortality was 6.7%, 85% were NYHA class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had mild MR and survivors in all three arms showed sustained improvement in KCCQ scores compared to baseline.
Conclusions:
Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates compared to MViV and ViMAC groups.
Perspective:
Findings from this small, nonrandomized, prospective trial assessing use of balloon-expandable aortic transcatheter valve to treat MV disease secondary to severe MAC (ViMAC), failed annuloplasty ring (MViR), and bioprosthetic MV dysfunction (MViV), suggest a durable effect over 2 years among survivors. Two-year mortality rates varied among the groups (valve in ring > valve in MAC > valve in valve). The majority of survivors had improved functional class, quality of life, and stable prosthetic function at 2 years. Though transcatheter MV replacement shows promise as a therapeutic option for high surgical risk patients with severe MV disease, there remains uncertainty about low procedural success rates, identifying optimal patient selection, and long-term outcomes.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Bioprosthesis, Cardiac Surgical Procedures, Cardiomyopathies, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Quality of Life, Survivors, Transcatheter Aortic Valve Replacement
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