MitraClip could be a powerful treatment against heart failure, according to a study

According to a new study, a seemingly simple yet sophisticated clip can pave the way for a "new era" for patients with a serious and difficult complication to treat heart failure.

The device, called MitraClip, has reduced almost half the hospitalizations related to heart failure and nearly 40% deaths in patients with a specific serious complication of heart failure , compared to those who received standard medical treatment. The results were published Sunday in the New England Journal of Medicine.

"This therapy really offers an important new option for very desperate patients who are suffering from heart failure and who have no alternative treatment," says Dr. Gregg Stone, co-principal investigator of the study. and Director of Cardiovascular Research and Education at the Center. for interventional vascular therapy at the Irving Medical Center of New York-Presbyterian / Columbia University. "This is a new era for truly desperate patients with heart failure."

The study involved 614 patients with severe disease called secondary mitral regurgitation (MR). The mitral valves of these patients flee, causing the blood to return to the heart and forcing the organ to work harder to circulate the blood throughout the body.

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In some patients – those with primary MRI – a leak occurs as a result of an injury to the mitral valve itself, which can usually be surgically repaired. But in those with secondary RM, the heart muscle is damaged, often following a serious event such as a heart attack. The heart enlarges as a result of this damage, deforming the mitral valve and causing blood reflux. This leak then causes an aggravation of the heart, perpetuating the cycle.

People with secondary MRI also tend to be sicker than those with primary MRI, given the weakening of their heart. This means that the risks of death or complications are usually too high for one to consider surgical interventions, leaving these patients with few good options for treating symptoms such as fatigue and shortness of breath. Even with rhythm-regulating drugs and pacemakers, the long-term prognosis is generally poor.

About 5.7 million Americans suffer from heart failure, according to the Centers for Disease Control and Prevention, and Stone says that up to 40% of these patients have some degree of MRI secondary. About 10% have severe secondary MRI as assessed in the study, he estimates.

The MitraClip could offer these patients a new option, says Stone. The device, which is inserted through a minimally invasive procedure, connects the flaps of the mitral valve that are leaking, allowing them to close. This prevents blood reflux and reduces stress and extra volume on the heart, explains Stone.

The more than 600 patients in the study, who received care at 78 medical centers in the United States and Canada, were randomized to receive either MitraClip and standard medical treatment, or medical treatment alone. Each person was then followed for two years. The study was funded by Abbott, the pharmaceutical company that makes the MitraClip, but the data was reviewed by external experts.

During the follow-up period, 151 controls were hospitalized and 61 died. In contrast, 92 patients who received MitraClip were hospitalized for heart failure and 28 died. The researchers also found that MitraClip was largely safe for secondary MRI patients. One year after implantation, less than 4% of patients had had device-related complications.

The Food and Drug Administration (FDA) approved in 2013 the MitraClip for use in patients with primary RM who are not fit for surgery, and it has been used in Europe to treat secondary MRI. But the new study provides the first background study demonstrating its efficacy against specific MRIs, and researchers hope the FDA will approve it for this use.

It is unclear when this approval could occur. But Dr. Mathew Williams, one of the study's researchers and director of the Heart Valve Center at NYU Langone Health University, said, "It would be shocking" that the FDA did not approve, because of the strength of results.

In anticipation of this approval, Williams said the results could totally change the way the secondary MRs are managed.

"Overall, no one has treated this population," says Williams. "It's something that will really change the way we do things. I do not think anyone speculated that it was going to be such a big advantage. "