MitraClip Reduces Hospital Stays, Deaths Among Patients With Heart Failure

A tiny clip to repair the mitral valve in patients with heart failure kept more of them alive and out of the hospital, in results that surprised physicians who attended a meeting this weekend.

Results from the COAPT trial, funded by Abbott, showed that transcatheter mitral valve repair dramatically improved survival, quality of life, and the ability of patients with heart failure to function—especially those who received the procedure before they become too frail. However, it’s not clear how many of the estimated 2 million patients with heart failure would gain access to the device if FDA approved expanded use, and Medicare covered it. The device costs $30,000 before any other costs are factored in, including hospital and physician payments.

In heart failure, the organ becomes damaged, possibly after a heart attack, and it no longer efficiently pumps blood throughout the body. Patients become so weak they often cannot walk more than a few steps or find themselves gasping for air. As this occurs, the heart becomes enlarged and the mitral valve that regulates blood flow from the left ventricle stops working properly. Flaps to the valve flip apart. Medical therapy helps, but only to a point. The device in the study, called MitraClip, repairs the valve by clipping the flaps back together. The findings were presented Sunday at the 30th annual meeting of Transcatheter Cardiovascular Therapeutics in San Diego, California.

Hospitalization for heart failure is a major cost driver in healthcare, and reducing it has been a chief target for accountable care organizations seeking to rein in spending. On the American College of Cardiology website, Peter Block, MD, and Deepak Bhatt, MD, MPH, FACC, said that subgroup findings show that it may make sense to perform the procedure before patients become too sick, because comparatively healthy patients seemed to get more benefits. “The endpoint was repeat hospitalization for heart failure,” Block noted, saying it was a unique endpoint, and “there was a significant difference.”

An interview with Dr Eldrin Lewis on the need for heart failure to be an endpoint in drug trials.

Bhatt noted the results were surprising given that an earlier study in Europe did not produce positive results. This new study involved 614 patients; 302 were assigned to receive the device along with guideline-directed medical therapy, while 312 received guideline-directed therapy only. Only specially trained doctors were allowed to implant the device, and Block said the results show that the skill of the doctor matters greatly in attaining good results. The procedure is not as invasive as open heart surgery and calls for the device to be implanted through a blood vessel in the leg and then guided into place by an echocardiogram camera placed in the patients esophagus.

MitraClip was approved in 2013 to treat primary, or degenerative, mitral regurgitation, in patients at risk for surgery-related complications or death. If approved for patients with moderate-to-severe or severe secondary mitral regurgitation that is not responding to therapy, it would be expected to received coverage from Medicare and be used in more patients. Study authors, including co-principal investigator Gregg Stone, MD, FACC, of New York/Presbyterian and Columbia University, said more follow-up is needed but the results are groundbreaking nonetheless.

“These highly anticipated results from the COAPT trial are quite remarkable, and conclusively demonstrate that heart failure patients with clinically significant secondary mitral regurgitation who remain symptomatic despite best medical practices benefit from treatment with MitraClip,” Stone said in a statement. “These results have the potential to transform clinical practice and help patients who otherwise have an extremely poor prognosis - patients who, to date, have had to rely only on medications to manage their symptoms without treating the underlying cause.”

It was not clear heading into this weekend’s meeting that the clips would work; an earlier study in Europe did not produce positive results. But this study ensured that only specially trained doctors were permitted to implant the device, and that patients received top-flight care. The results showed:

• Among the 302 patients scheduled to receive the device (average 71.7 years of age), the annualized rate of hospitalization for heart failure over 24 months was 35.8% per patient-year. The implantation rate was 98%.
• Among the 312 in the control group, the rate was 67.8% per patient-year (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.40 to 0.70; P <.001).
• Death from any cause within 24 months happened in 29.1% of the device group and 46.1% of the control group (HR, 0.62; 95% CI, 0.46 to 0.82; P <.001).
• Among the device group, the rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P <.001 for comparison with performance goal)

Reference

Stone GW, Lindenfeld JA, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure [published online September 23, 2018]. N Engl J Med. doi:10.1056/NEJMoa1806640.