MitraClip: Valve repair device offers new treatment option for some with severe mitral regurgitation

Mitral valve regurgitation (MR), a condition in which the mitral valve does not close properly, allowing blood to leak back into the heart’s upper chamber, is the most common disease of the heart valves. It can cause symptoms such as cough, fatigue, and trouble breathing. The risk of MR increases with age.

Until recently, there were only two methods of treatment for MR: medication and open-heart surgery. During this surgery, the surgeon accesses the heart by opening up the breastbone. He or she either repairs or replaces the mitral valve while a heart-lung machine takes over the job of the heart and lungs while the heart is stopped.

However, we now have a third option, a new device called MitraClip.

What is mitral regurgitation?

The heart receives blood from the lungs into the upper left chamber (the left atrium) and pumps blood to the body through the heart’s lower left chamber (the left ventricle). The mitral valve is located between these two chambers. The valve has two large leaflets — an anterior leaflet and a posterior leaflet — with parachute strings, called chords, that are attached to the heart muscle. When working normally, the leaflets open and close to move blood forward and prevent blood from returning to the left atrium when the heart contracts.

When these parachute chords rupture or stretch, the leaflet prolapses, so that the valve no longer closes completely. This allows blood to leak backwards, into the left atrium, when the heart contracts. This is called primary MR.

There is also a condition called secondary MR. In secondary MR, the mitral valve is pulled further apart when the heart dilates, as may happen in people with heart failure, atrial fibrillation, or other heart conditions. As a result, blood leaks from the center of the valve. This form of MR is much more common.

What is MitraClip?

MitraClip is a large clip that grasps both the anterior and posterior leaflets of the mitral valve. This creates a bridge in the middle of the valve, along with two openings. (Picture two lenses connected by the bridge on a pair of eyeglasses.) Hence, we call the clipped valve a “double orifice valve.” The double orifice valve originated with a surgical technique in which a suture was placed between the two leaflets to repair the valve.

The difference is that the MitraClip does not require having the chest opened. Rather, the small device is inserted into a vein in the groin. From there, it is threaded through the vein and advanced to the right side of the heart, and across the septum (which separates the heart’s upper chambers), from the right side to the left side of the heart. The surgeon then directs the clip to grasp the mitral valve, under ultrasound guidance. The entire procedure can be done with just a small hole in the groin. No incision in the chest is needed, nor is a heart-lung machine.

What’s new?

Until recently, MitraClip was only FDA-approved to treat primary MR in patients who were too high-risk for surgery. In this high-risk population, the risk of death was lower than expected, recovery time and the frequency of rehospitalization were reduced, and the complication rate was very low, compared to open-heart surgery. What’s more, patients only stayed in the hospital for two days after the procedure.

Then, in December 2018, a study published in the New England Journal of Medicine showed improved survival in patients with secondary MR who received MitraClip plus medical therapy, compared to medical treatment alone. This is the first therapy that has been shown to increase survival in patients with secondary MR. In March 2019, the FDA approved MitraClip for secondary MR in patients who are too high-risk for surgery. This will allow MitraClip to be used in a larger population suffering from this type of disease.

Who is a candidate for this procedure?

The Achilles heel of MitraClip is that it cannot completely eliminate the regurgitation. In another words, some leakage is likely to continue even after the clip is placed. For those with severe MR who can withstand surgery, surgical repair or replacement is still the preferred treatment.

However, those who are high-risk for surgery may be candidates for MitraClip. Valve specialists (cardiac surgeons and cardiologists) are best qualified to assess whether someone is a candidate for this procedure.

Related Information: Diseases of the Heart

Comments:

  1. Bill Noon

    I have Mitral Valve Regurgitateion and have. Scheduled clip procedure on June 6th. St Luke’s H.I. Kansas City. My pumping power has decreased over the years and it’s stayed around 35 pumps per minute. I could tolerate that, with some shortness of breath and dry coughing. My pumping power dropped into the lower 20’s 6 weeks ago and my breathing became troublesome and increased coughing, fatigue also. Has the Mitral Valve Clip helped increase
    Pumping power on patients who had similar situations?

    • Tsuyoshi Kaneko

      That’s a really good question. Typically the clip will not improve the pump function. Instead, it will provide more forward flow rather than backward flow, hence increasing the blood flow to the organs. This leads to improved symptoms. There are some cases where we see improved pump function, but it is not what we expect in every case.

  2. Cora Bole

    As someone in need of a mitral valve I have researched the options. You say the risk is that it doesn’t stop MR completely. Valve replacement doesn’t either but it’s accepted as minor. With all the pros you list how can this not be the first line of defense rather that highly invasive open heart surgery?

    • Tsuyoshi Kaneko

      Valve replacement will rarely leave regurgitation postoperatively, and that is one benefit the patient will have undergoing surgery. The residual regurgitation is directly related to long-term survival, so the clip at this point is not for everyone.

  3. Donald White

    Thank you Mr. Tsyoshi for such a great information…

  4. Tsuyoshi Kaneko

    Thank you for the comment. Last year, 5800 Mitraclip cases were performed, and the complication risks were very low (most complications such as stroke, infection and reinterventions were all below 2%). However, about 12% stayed at NYHA class III or higher, meaning that the improvement was not dramatic. This procedure is not for everyone, but certainly will serve high risk population.

  5. azure

    What is the clip made of? The FDA has a record of approving medical appliances that use reveals is made of compounds that leach into the body & damage it.

    Otherwise, sounds like a good idea although no data on how long it’s been available, how many have been inserted/installed successfully, % of complications resulting from installation (infection, etc), and how much it improves heart functioning are provided. Easy to see that a less invasive procedure would be safer, but no data provided about followup after that very short post-surgery hospitalization.

  6. Soltechlife

    Firstly, I would like to thank Mr. Tsyoshi Kaneko for providing such a detailed description of the Mitral valve regurgitation heart problem, its causes, and methods of cure. With the increasing healthcare and modern technologies, these new inventions provide hope.
    I had heard many times, about the open heart surgery but never knew what valve regurgitation was.
    It was great reading about it.
    thanks.

Post a Comment:

This blog aims to provide reliable information as well as healthy dialog about the topics covered. We do not provide responses to personal medical concerns nor do we endorse any recommendations offered in the comments. We reserve the right to delete comments for any reason, particularly those that do not relate directly to the contents of this post, are commercial in nature, contain objectionable or inappropriate material, or otherwise violate our Privacy Policy. Promotional URLs will be removed from comments. Comments on this blog do not represent the views of our editors or Harvard University, and have not been checked for accuracy. All comments submitted to this site become the non-exclusive property of Harvard University.