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By Michael J. Rinaldi, MD

Traditionally, patients with heart failure and secondary mitral regurgitation (MR) have had limited options if medical therapy fails. They’ve been consigned to lives spent in and out of the hospital, with little hope their quality of life can improve – until now.

The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) trial recently showed that an innovative, transcatheter device called MitraClip can notably reduce heart failure hospitalizations, improve quality of life and significantly boost survival in patients with moderate to severe secondary MR.

Rigorous Selection Sets COAPT Apart

MitraClip clips the mitral valve leaflets together and is already approved for patients with primary MR who are not candidates for surgery. The COAPT trial investigated whether the device could also help patients with mitral valve leakage due to heart failure and left ventricular dysfunction.

To be eligible, patients had to be symptomatic while taking the maximum tolerated guideline-directed medical therapy – ACE inhibitors, beta blockers, aldosterone antagonists and, sometimes, cardiac resynchronization therapy. Screening also included a comprehensive evaluation process that confirmed patients had grade 3+ or 4+ secondary MR.

Reducing Heart Failure Hospitalizations

The trial enrolled 614 patients, who were randomized between guideline-directed medical care (GDMC) only, or GDMC plus MitraClip.

The trial’s results were published in the New England Journal of Medicine and showed that MitraClip reduced heart failure hospitalizations by nearly half. Annualized hospitalizations within 24 months were 35.8 percent in the device group, compared with 67.9 percent in the medical group.

We also saw an unexpected result: MitraClip reduced all-cause mortality by a whopping 38 percent. Over 24 months, 29.1 percent of patients in the MitraClip group passed away, compared to 46.1 percent of patients in the standard medical therapy group.

Improved Quality of Life for Secondary Mitral Regurgitation

MitraClip patients not only lived longer – they lived better. Participants who received MitraClip reported a 12.6-point bump on the quality of life assessment (Kansas City Cardiomyopathy Questionnaire), which is a key quality of life assessor.

Sanger was one of COAPT’s top enrollment sites, and we were pleased to see that MitraClip patients not only had better outcomes, they also tolerated the procedure well. Most patients spent a night or two in the hospital and were back to normal activities within a week.

The COAPT trial is another chapter in Sanger’s long history with MitraClip: Geoffrey Rose, MD, and I were the tenth team to ever implant the device and were closely involved in the EVEREST II trial that led to the device’s initial FDA approval.

MitraClip: Available at Sanger for Secondary MR

MitraClip isn’t yet approved for secondary MR, but we can still offer it to your patients, without randomization, via a continued access registry. And this is just one part of our push to bring the latest treatments and devices to patients with valve defects and disorders.

We’re the region’s highest-volume mitral valve repair center and were among the world’s first to perform transcatheter mitral valve repair. We’re one of five US centers studying the Edwards PASCAL™ Mitral Valve Repair System for degenerative mitral valve regurgitation, and the only center in the Carolinas offering the CEASE MR study of the Tendyne valve for primary MR.

This unparalleled selection of devices and clinical trials – combined with a team approach that brings together top cardiologists, heart failure specialists, surgeons, radiologists and other experts – means we can give your patients the best chance at longer, healthier lives.

Read the paper in the New England Journal of Medicine

For more information, or to make a referral, call 877-999-7484.