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Transcatheter Mitral Valve Repair: STS/ACC TVT Registry Report
Study Questions:
What are the in-hospital, 30-day, and 1-year real-world outcomes of transcatheter mitral valve repair in the United States?
Methods:
Data from the Society of Thoracic Surgery (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) 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 (CMS) administrative claims for analyses. Both adjusted and unadjusted hazard ratios were estimated with 95% confidence intervals, and Wald-type p values are reported.
Results:
The median age was 82 years (55.8% men), with a median STS predicted risk of mortality of 6.1% (interquartile range [IQR], 3.7-9.9%) and 9.2% (IQR, 6.0-14.1%) for mitral repair and replacement, respectively. Overall in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with CMS 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 re-hospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation (MR), moderate or severe lung disease, dialysis, and severe tricuspid regurgitation.
Conclusions:
The authors concluded that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety.
Perspective:
This study reports that in the United States, transcatheter mitral valve repair is being performed predominantly for patients with severely symptomatic, degenerative MR, and prohibitive surgical risk in accordance with the labeled indications and with overall good outcomes. The adverse events are related to age, and associated with decreased left ventricular function, functional MR, severe tricuspid regurgitation, moderate or severe lung disease, and post-procedural residual MR. Additional studies are needed to elucidate a causative or associative relation between residual MR and survival in these patients, and potential ways to mitigate risk.
Keywords: Cardiac Surgical Procedures, Dialysis, Geriatrics, Heart Failure, Heart Valve Diseases, Hospital Mortality, Lung Diseases, Mitral Valve Insufficiency, Outcome Assessment, Health Care, Risk, Stroke Volume, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency, Ventricular Function, Left
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