Transcatheter Mitral-Valve Repair in Patients with Heart Failure – COAPT
Stone, G. W., Lindenfeld, J., Abraham, W. T., Kar, S., Lim, D. S., Mishell, J. M., Whisenant, B., Grayburn, P. A., Rinaldi, M., Kapadia, S. R., Rajagopal, V., Sarembock, I. J., Brieke, A., Marx, S. O., Cohen, D. J., Weissman, N. J., Mack, M. J., for the COAPT investigators, including Dr. Andrew Berke (2018).
By Anne Li, Research Assistant
Published in The New England Journal of Medicine (2018), the COAPT study comprises a landmark trial that sought to demonstrate transcatheter mitral-valve repair’s safety and efficacy in patients with heart failure and mitral regurgitation due to left ventricular dysfunction. Mitral regurgitation places strain on the heart’s function by increasing the severity of volume overload, and is strongly correlated with decreased quality of life, increased rate of hospitalization for heart failure, and shortened survival. While medication and cardiac resynchronization therapy can help treat these patients, it is not known whether correction of secondary mitral regurgitation improves their prognoses.
St. Francis Hospital was one of 78 centers in the US and Canada which participated in this trial. Transcatheter mitral-valve repair is performed percutaneously using the MitraClip® device, which was approved by the (FDA) Foodand Drug Administration in 2013 for use in treating primary mitral regurgitation in patients who are at a prohibitive risk for surgery-related complications or death. This trailblazing study, first presented at TCT (Transcather Cardiovascular Therapeutics) Scientific Symposium in 2018, found that for patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation, who presented with symptoms despite using the maximum doses of guideline -based medication, transcatheter mitral-valve repair with the MitraClip® device not only decreased severity of secondary mitral regurgitation, but also led to a significantly lower rate of hospitalization for heart failure, lower all-cause mortality, and improved quality of life and functional abilities within 24 months of follow-up, compared to use of medical therapy alone. The amount of device-related complications from the procedure also exceeded the study’s performance objective. Furthermore, the benefits of transcatheter mitral-valve repair were seen across many subgroups, such as patients with ischemic and non-ischemic cardiomyopathy, and patients who were and were not at high risk for surgery-related complications or death, and the benefits were not dependent on mitral regurgitation grade and left ventricular volume and function at baseline.