During multiple sessions at TCT 2007, researchers participating in the EVEREST II study presented data from a 107-person, non-randomized patient registry. The presentations evaluated the reduction of mitral regurgitation severity with the MitraClip device and the positive impact of this reduction for patients. The ongoing randomized study arm of EVEREST II is evaluating the safety and efficacy of the MitraClip device compared to surgical mitral valve repair or replacement for the treatment of mitral regurgitation (MR; a condition in which blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body). Highlights of the data presented this week include:
36 Month Follow-up Shows Ongoing Effectiveness and Durability
82 percent of patients who had a successful result with the MitraClip device remain free from surgery 36 months after the procedure.
Reduction in Mitral Regurgitation Severity
74 percent of patients with one or more Clips implanted experienced a reduction to ≤ Grade 2+ MR as assessed by the EVEREST Core Laboratory and graded per the American Society of Echocardiography guidelines.
Significant Reverse Remodeling of the Left Ventricle
12 months after a successful MitraClip procedure, significant reverse remodeling of the left ventricle was demonstrated. Reverse remodeling was assessed based on five echocardiographic measures, including left ventricular end-systolic dimension.
In line with the reverse remodeling, 94 percent of patients who had a successful result with the MitraClip device had improved or stable New York Heart Association (NYHA) Class at 12 months following the procedure.
“Our work to reduce mitral regurgitation with a percutaneous approach continues to produce compelling results,” said Ted Feldman, M.D., who presented the 36 month follow-up data at TCT. Dr. Feldman is the EVEREST II national co-principal investigator and director of the cardiac catheterization lab at Evanston Northwestern Healthcare in Evanston, Illinois. “The reduction in MR severity achieved, along with the stability of the results at 36 months and the preservation of subsequent surgical options, leads us to believe that the MitraClip device is likely to become a viable first-line option for treating MR in many patients.”
Dr. Michael Rinaldi, who presented the reverse remodeling data at TCT, concurred. “The reverse remodeling data is important in that it provides compelling, objective evidence that the MitraClip device is having a positive impact on patients,” said Dr. Rinaldi, director of clinical research at Sanger Clinic/Carolinas Medical Center. “Additionally, patients with the MitraClip report that they feel better and are able to engage more fully in activities they enjoy.”-Edelman Public Relations
