Safety and Midterm Durability Study of Evalve's MitraClip Published

The study's background is that mitral valve repair for mitral regurgitation (MR) has been performed using a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed with the use of the MitraClip device to secure the mitral leaflets.

In the study, patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. A total of 107 patients were treated. Ten (9%) experienced major adverse events, including one nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of 1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy endpoint). Kaplan-Meier freedom from death was 95.9%, 94%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability, the investigators reported.

From these data, the investigators concluded that percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and, with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion of patients.