Patients with mitral valve disease who are too high risk for heart surgery may be candidates for less invasive, catheter-based (percutaneous) options, such as MitraClip, Transcather Mitral Valve Replacement (TMVR) and Balloon Valvuloplasty .
Cleveland Clinic cardiologists and surgeons work together to offer high-risk patients a variety of treatment options for mitral valve repair and replacement.
Mitral regurgitation (MR) is a common heart disorder that causes blood to leak backwards through the heart’s mitral valve.
Types of mitral regurgitation
There are two common types of MR ─ degenerative and functional.
Degenerative MR – Commonly called mitral valve prolapse or myxomatous mitral valve disease. The leaflet(s) (the flaps inside the valve that open and close to let blood flow through) and chordae (tough, fibrous strings attached to the leaflets) become stretchy. The leaflets become floppy and they do not close tightly. When this happens, surgery is the best treatment option. However, surgery is too risky for some patients. A newer treatment option, called the MitraClip, was approved by the FDA to treat patients who are high-risk for surgery.
Functional MR – The mitral valve leaks due a secondary cause such as enlargement or dysfunction of the left ventricle (the heart’s bottom left chamber that does most of the heart’s pumping), dilatation (widening) of the annulus (a ring attached to the leaflets) or damage to the papillary muscles that support the leaflets. This damage can be caused by changes in how well the left ventricle works as a result of a heart attack or cardiomyopathy. The left ventricle is the bottom left chamber of the heart that does the majority of pumping. If you have functional MR, your valve leaflets may be normal. Many patients with functional MR also develop heart failure.
Although it has been shown that surgery is the best treatment for patients with degenerative MR, there isn’t the same type of recommendation for patients with functional MR. The American College of Cardiology (ACC), American Heart Association (AHA), Heart Failure, and Society of Thoracic Surgeons (STS) treatment guidelines consider surgery as a treatment option but do not recommend it for all patients. A recent trial (COAPT) showed that in appropriately selected patients with functional MR, MitraClip treatment was effective in reducing death and recurrent hospitalization for heart failure.
The MitraClip is the first device approved by the FDA to treat high-risk patients with degenerative mitral regurgitation. This procedure is also called edge-to-edge leaflet repair.
MitraClip is a good option for patients who satisfy all of the following criteria::
- Have degenerative mitral valve disease
- Have a high risk of problems with traditional heart surgery
- Have a valve structure that works well with the MitraClip
A randomized study was designed to learn how well the MitraClip works compared with medical therapy to treat patients who have heart failure with functional MR and who are extremely high-risk for surgery. The Cleveland Clinic participated in this trial. The study was called the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) Trial. The trial results were recently published in The New England Journal of Medicine showing tremendous benefit from MitraClip therapy in patients who had already been treated with optimal medical therapy. The study showed that the number needed to treat with the MitraClip to prevent one hospitalization was 3 patients, and to prevent one death was 6.
Cleveland Clinic continues to be involved in trials looking at innovative ways to treat patients with mitral valve disease. Upcoming trials include:
- Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (ACTIVE)
- The CARILLON Trial - Transcatheter Treatment of Functional Mitral Regurgitation
Transcatheter Mitral Valve Replacement (TMVR)
Cleveland Clinic is using several types of Transcatheter Mitral Valve Replacement (TMVR) devices in carefully selected patients as part of clinical studies. TMVR may be an option for patients who cannot have a MitraClip procedure because of their valve anatomy or for those who have functional mitral regurgitation and too high risk for conventional valve surgery.
There are three Percutaneous Valve studies at Cleveland Clinic:
- Expanded Clinical Study of the Tendyne Mitral Valve System
- Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study (PRELUDE)
- CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study (RELIEF)
Mitral stenosis is narrowing of the mitral valve. This limits the forward flow of blood from the left atrium to the left ventricle. This may cause a back-up of blood and fluid in the lungs.
When you have mitral stenosis, the tissues forming the valve leaflets become stiff and do not open fully. The narrow valve opening causes less blood flow through it. If the valve becomes too narrow (stenotic), it affects heart function and the rest of the body may not receive adequate blood flow. In this case, the valve may need to be repaired or replaced.
Balloon Mitral Valvotomy is used to treat patients with mitral valve and pulmonic valve stenosis (narrowing of the valve). The procedure can also be used to treat patients with stenosis of the aortic valve; however, this treatment is not as widely used. All patients must be carefully screened and selected to make sure the procedure will provide satisfactory results.
While not the preferred option for treatment of mitral valve stenosis, Transcatheter Mitral Valve Replacement (TMVR) using the Tendyne or Edwards valve may be performed in select patients after careful evaluation.