April 26, 2026Journal of the American College of Cardiology428 citations
View Full PaperOutcomes With Transcatheter Mitral Valve Repair in the United States
Key Result
Transcatheter mitral valve repair in U.S. clinical practice achieved an acute procedure success rate of 91.8% with an overall in-hospital mortality of 2.7%.
Key Points
- This research aims to evaluate the clinical effectiveness and safety of transcatheter mitral valve repair devices in the U.S.
- Analyzed data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry
- Included 2,952 patients treated at 145 hospitals between November 2013 and September 2015
- Linked data to Centers for Medicare and Medicaid Services for analyses in 1,867 patients.
- In-hospital mortality was 2.7%
- Acute procedure success occurred in 91.8%
- At 30 days, mortality was 5.2%, and at 1 year, mortality was 25.8%; 20.2% had repeat hospitalization for heart failure.
Study Design
Type
Observational (n=2,952)
Multicenter
Yes
Structured PICO
What are the real-world clinical effectiveness and safety outcomes of commercial transcatheter mitral valve repair in the US?
P
Population
2,952 patients with mitral regurgitation treated at 145 hospitals in the United States, median age 82 years, 55.8% men.
I
Intervention
Transcatheter mitral valve repair
O
Outcome
In-hospital mortality and acute procedure success; 30-day and 1-year mortality, and 1-year repeat hospitalization for heart failure (in CMS linked cohort)hard clinical
Commercial transcatheter mitral valve repair in the US demonstrates high acute procedural success (91.8%) and low in-hospital mortality (2.7%), though 1-year mortality and heart failure rehospitalization remain substantial in this high-risk population.
Abstract
BACKGROUND: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices. OBJECTIVES: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. METHODS: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses. RESULTS: The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation. CONCLUSIONS: Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.