"We also need to have an eye on what constitutes success, because a technically successful procedure leading to a reduction in mitral valve regurgitation in these patients is coincidental, if they do not also have some symptomatic and functional benefit," he added.
Finally, Dr. Ray called for a pragmatic randomized trial, driven by a heart team, comparing optimized medical therapy with the addition of cardiac resynchronization therapy, where indicated, against that treatment plus the MitraClip device.
The phase III COAPT (Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients) trial in moderate to severe or severe functional MR patients is not yet recruiting, but will compare the MitraClip device with patients managed nonsurgically based on standard hospital practice. REALISM (Real World Expanded Multicenter Study of the MitraClip System), the phase III follow-up to EVEREST II, continues to enroll patients in the United States and Canada, with a final completion date of December 2016.
Dr. Schillinger reported receiving consulting fees/honoraria from study sponsor Abbott Vascular, as well as Abiomed, AstraZeneca, Edwards Lifesciences, Servier, and St. Jude Medical. Dr. Ray reported no relevant conflicts of interest.