November 4, 2013 — New trial data showed clinically meaningful changes to quality of life, a reduction in rehospitalization for heart failure and functional improvements for patients treated with the Abbott's first-in-class, catheter-based MitraClip therapy. The data was from patients with degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery. Findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013) in San Francisco and simultaneously published in the Journal of the American College of Cardiology.
The MitraClip device, which received U.S. Food and Drug Administration (FDA) approval, provides physicians with a breakthrough treatment option for patients suffering from MR. The MitraClip device is available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery.
"The results of this study show that, even for some of the most ill and debilitated patients, the MitraClip system is safe and results in good clinical outcomes," said D. Scott Lim, M.D., associate professor of cardiovascular medicine, University of Virginia Health System, Charlottesville, Va., and lead author of the publication. "These prohibitive-risk patients have had, until now, no approved therapies to improve the quality of their lives."
Data from 127 patients with degenerative MR at prohibitive surgical risk treated with the MitraClip device demonstrate:
- Clinically meaningful changes to quality of life. Following MitraClip treatment, changes in SF-36 summary scales (a quality-of-life survey) were well above established thresholds showing minimum clinically important differences.
- A reduction in rehospitalization for heart failure of 73 percent.
- Functional improvements, with 76 percent of patients with baseline New York Heart Association (NYHA) Functional Class III improving to NYHA Functional Class I or II and 65 percent of patients with baseline NYHA Functional Class IV improving to NYHA Functional Class I or II.
- Favorable ventricular remodeling, with left ventricular end-diastolic and end-systolic volume decreased significantly at one year compared with baseline.
- A majority of patients discharged to home (87 percent) rather than to nursing care.
Ted Feldman, M.D., FSCAI, director, cardiac catheterization laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill., presented the findings.
Multiple trials published reports and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms and reduction in hospitalizations for heart failure even in some of the most ill and debilitated patients.
For more information: www.abbottvascular.com, www.onlinejacc.org