Researchers say the MitraClip reduces the mortality risk as well as hospitalizations for people with serious heart failure.
For the 5.7 million Americans living with heart failure, everyday life is a challenge.
For patients with severe heart failure who fail to respond to typical treatments and medications, things are even more difficult.
“They’re desperate patients. Their prognosis is as bad as having cancer in terms of their mortality. They’re frequently miserable. They can’t walk very far without getting short of breath or fatigued. They’re frequently admitted to the hospital, and there are few therapeutic options for these patients,” Dr. Gregg Stone, a professor of medicine at the Columbia University Medical Center in New York and one of the lead investigators of the study, told Healthline.
However, research presented at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Diego is offering hope to these patients.
Researchers say they have found that inserting a small clip called a MitraClip into the heart resulted in significantly lower mortality rates and fewer hospitalizations.
Heart failure is the number one cause of morbidity and mortality among patients with heart disease. It’s also the most frequent cause of hospital admissions in the United States as well as the leading driver of healthcare costs.
However, Stone says these statistics may soon be a thing of the past.
“This trial has profound implications for hundreds of thousands of patients with severe heart failure who have no other alternative options that may help them,” he said. “To have a study demonstrating that a relatively safe and painless procedure can lead to profound improvements in quality of life, reduction in hospitalizations, and prolonged survival was quite profound an achievement and can very favorably affect the lives of these desperate patients.”
The heart has two main functions.
One is to accept blood from the lungs or veins. The other is to pump blood to the lungs and circulatory system.
Heart failure occurs when the heart can’t achieve one or both of these functions.
The impact on the patient can be significant.
“Day-to-day life can be impacted in many ways. Mild forms of heart failure lead to mild fatigue, low energy, and some breathlessness with activity. Moderate forms impact a person’s ability to do activities of daily living like taking out the trash or walking a flight or two or stairs. Severe heart failure can be life-threatening, requiring hospitalization, and can lead to shock,” Dr. Mark J. Ricciardi, director of cardiac catheterization and interventional cardiology at Northwestern’s Bluhm Cardiovascular Institute in Chicago who assisted in the trial, told Healthline.
In heart failure, the muscles weaken and dilate.
This stretches the mitral valve, which allows blood to flow from the left ventricle of the heart to the left atrium.
As the mitral valve stretches so do its supporting structures, causing it to leak. This is known as mitral regurgitation.
“The mitral valve commonly has some degree of regurgitation with heart failure. This can frequently respond to medications. There are some patients where despite maximally tolerated medical therapy, the mitral valve continued to regurgitation severely. These patients were known to have worse prognosis,” Dr. Gregg Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center in Los Angeles, told Healthline.
The MitraClip helps to minimize mitral regurgitation.
“The MitraClip is a small, dime sized, V-shaped device designed to grasp the tips of the mitral valve leaflets to allow them to close more fully — thus reducing mitral leak or regurgitation. The clip is delivered through a catheter inserted into the femoral vein in the leg. It requires no incisions. Because delivery and deployment of the device does not require open heart surgery or heart lung machine, it can be done on the beating heart,” Ricciardi said.
Prior to this trial, patients experiencing both heart failure and secondary mitral regurgitation were treated with medications and in some cases specialized pacemakers.
But these treatments weren’t always successful.
The only options remaining for these patients were artificial heart support or a heart transplant.
But open-heart surgery is risky for patients with considerably compromised heart function.
“One of the reasons for this is worsening heart function that can occur with open heart surgery and heart lung bypass. In addition, surgical patients are at risk for irregular heart rhythm, stroke, kidney failure, pneumonia, prolonged time on the respirator, prolonged hospitalization time, and prolonged time for recovery. There is also incisional pain and worsening mental function that can occur,” Ricciardi said.
Previous studies had failed to show that fixing the mitral valve would improve outcomes for patients.
But after studying 614 patients across 78 sites in the United States and Canada, researchers said the results for those who underwent the MitraClip procedure were impressive.
Hospitalizations for heart failure were reduced by nearly half and the risk of all-cause mortality reduced by 37 percent.
Patients who were treated with the MitraClip also had an improved quality of life and less required left ventricular assistance devices or heart transplantation.
“This trial has important clinical implications and would be expected to have a significant impact on clinical practice among patients with heart failure and severe secondary mitral regurgitation,” Fonarow said.
The device is already approved for use in patients whose hearts are otherwise fine except for a faulty mitral valve.
The researchers are hopeful the U.S. Food and Drug Administration (FDA) will also approve the device for use in patients with severe heart failure who remain symptomatic and have failed to respond to other treatment options and medications.
Experts have called it a truly impressive game changer.
“The improvement seen is markedly better than any other device or single medication previously tested to treat patients with heart failure. Having a relatively simple cardiac procedure that offers patients improved hospitalization rates and survival is a game changer for this type of heart failure,” Ricciardi said.