High-risk patients with mitral regurgitation reduced their symptoms and reported better quality of life after treatment with Abbott’s (NYSE:ABT) MitraClip implant, according to newly published results from the Everest II High Risk Registry.
Adding to data presented at last year’s conference of the American College of Cardiology, researchers this week published 12-month results showing that MitraClip helped reduce mitral regurgitation for 84% of patients while improving symptoms and boosting patients’ physical and mental quality of life. The study included patients who were at high risk or prohibited from surgery, representing a population that essentially had no alternatives for treating their heart failure.
"The current study results show that patients who are at very high risk and are either ineligible or marginal candidates for surgery can be successfully treated with the MV device, with morbidity and mortality less than that predicted for surgery using a well-validated surgical risk calculator," the authors wrote. "Additionally, patients remained in the hospital for an average of only 3 days post-procedure, and 91% of patients were discharged home."
The MitraClip patients also reported a host of other benefits, included reduced re-hospitalization, improvement in symptoms of heart failure and reduction in left ventricular dimensions, despite significant co-morbidities present in the patient population.
"Concerns have been raised that high-risk patients might not benefit from an intervention such as the MV device either because of excessive periprocedural morbidity and mortality or because of significant residual co-morbidity that might threaten length and quality of life. These data suggest that this population of high-risk patients can achieve significant improvement in quality of life with relatively little morbidity," according to the study. "Continuing advances in patient selection, patient management, and the procedure itself may further reduce this morbidity."
The MitraClip device is implanted in the heart to help repair a damaged mitral valve, preventing blood from leaking backward into the left atrium in patients with heart failure. MitraClip is threaded to the heart via a catheter inserted in the femoral vein, replacing open heart surgery, which is still the standard of care for most mitral regurgitation patients.
The FDA approved MitraClip for the U.S. market less than 10 months ago, but the implant has been used in more than 10,000 patients globally. Everest II was designed to evaluate the device in treating patients with more severe cases of mitral regurgitation who were not good candidates for open surgery.
