A little device is about to make a big difference in millions of lives.
What is Mitral Regurgitation?
Mitral regurgitation occurs when the valve that separates the main pumping chamber of the heart from the lungs is unable to close properly, allowing blood to go backwards instead of forward. Patients with failing hearts often develop mitral valve insufficiency that can cause shortness of breath, fatigue, and swelling. Whether or not fixing the leaking mitral valve influences patient survival and overall condition has long been controversial.
What is a MitraClip device?
New research shows that the MitraClip device can be used to treat patients with significant mitral regurgitation and severe heart failure, improving their quality of life and reducing their rate of mortality. "The magnitude of the patient response in this trial was pretty impressive," said Frederick Welt, MD, Associate Chief of Cardiovascular Medicine for University of Utah Health. "The likelihood of death after two years was 29% in the patients who got the clip compared to 46% in patients who were treated with medication alone."
Heart failure occurs when the heart becomes dilated, or enlarged. This can occur due to a previous heart attack, or diseases of the heart. When the heart is dilated it does not pump efficiently and may become misshapen as it tries to compensate. That change in shape can affect the mitral valve, causing it not to close fully and leak. "Previously it was not known that fixing the mitral valve in these patients would have a big impact on the overall heart failure," said Welt. "This new research is a surprising finding in that it disproves that assumption."
The MitraClip is not a new device. "We have been using the MitraClip device to treat patients thought to be inoperable who are suffering from severe mitral regurgitation related to a bad valve, not necessarily from a bad heart," said Craig Selzman, MD, Chief of the Division of Cardiothoracic Surgery and the Surgical Director of the Heart Transplant and Mechanical Circulatory Device Program at the University of Utah. "Results from this study suggests that a large group of patients with advanced heart failure will potentially have an additional treatment option. The FDA now needs to take this information and decide if they are going to label this device for this use. We are hoping they will do it quickly."
The MitraClip Procedure
The placement of the MitraClip is an intracardiac device that tethers the two swinging components of the mitral valve together. The clip is inserted in the heart through a vein in the leg and guided into place using an echocardiogram and x-ray. The patient is then observed for 24 to 48 hours and then released. "The fact this is a minimally invasive procedure is important for heart failure patients who may be too sick for open heart surgery," said Welt.
Currently it is estimated that between 1.6 and 2.5 million people could benefit from this new treatment for heart failure. "This could be a life changing for these patients," said Welt. "Not only could it extend their life span but it could improve their quality of life as well. The future could be a lot brighter."