The patient, the self-described “only Democrat from Crawford, Texas,” was in severe distress and his life was at risk. After undergoing open-heart surgery, he had developed an infection in his sternum, requiring removal of the sternum approximately two years prior to presentation. Subsequently, he was diagnosed with severe mitral valve regurgitation (MVR), which forced his heart to work harder, caused his breathing to become labored, and made walking more than a few yards more like a marathon activity. Additional open-heart surgery was needed to repair his mitral valve, but the man’s frail physical condition and lack of sternum made it way too risky.
The mitral valve is a one-way valve that connects the left atrium to the left ventricle of the heart. MVR occurs when the valve does not seal completely, allowing blood to trickle back into the left atrium, causing the heart and lungs to swell. It’s estimated that four million Americans suffer from MVR, with about 40,000 undergoing highly invasive surgical repair. This entails a heart-lung machine, slicing through the sternum, and finally valve repair or replacement. Hospitalization typically lasts three to five days, followed by a lengthy recovery at home.
The man from Crawford was in luck. “His son-in-law read about the experimental nonsurgical MVR procedure we were doing with a special clip and was eventually able to enroll him in the EVEREST II [Endovascular Valve Edge-to-Edge REpair STudy] clinical study,” says Samir Kapadia, M.D., an interventional cardiologist in the Cleveland Clinic Department of Cardiovascular Medicine who has performed many of the non-invasive procedures. “He left the hospital two days after the three-hour procedure in the cath lab. Three years later, he’s gone from severe limitation to becoming active and doing almost everything he wants.”
With the innovative clip—a tiny barbed, wishbone-shaped device now in the eighth year of human testing—the heart is fixed non-surgically from the inside out. A catheter is carefully guided through the femoral vein in the groin, up to the heart’s mitral valves. The clip on the tip of a catheter is then clamped on the center of the valve leaflets, which holds them together and quickly helps restore normal blood flow out through the leaflets. When the procedure is finished, a sterile bandage is applied over the small cut on the groin.
“The technology is extremely safe. While the procedure works well for most people with moderate to severe MVR, if the clip does not work for some reason, surgical repair or replacement of the valve is still a possible option,” says Dr. Kapadia. “If the EVEREST trial results are positive, and the device is approved by FDA which could be within two years, it can change the way that we approach patients with mitral valve regurgitation.”
Where Are They Now
This innovative procedure has been demonstrated to work well for some people with moderate to severe mitral regurgitation or leakage of the inlet valve for the left ventricle. This backward leakage of blood through the mitral valve can cause congestion in the lungs, increased work for the heart, and heart failure. During the procedure, which is performed in the cardiac catheterization laboratory, a wishbone-shaped clip is threaded through a catheter in blood vessels in the groin to the leaking mitral valve. The clip is then applied to bring the center of the two mitral valve leaflets together, which eliminates the backward leakage of blood through the valve and restores normal blood flow into the left ventricle.
While open heart surgical techniques remain the clinical standard of care, the mitral valve clip has been an important additional treatment for this disease, particularly in patients for whom surgery is too high a risk. This system received FDA approval in October 2013, and has been placed into over 25,000 patients as of current. The valve repair clip has been found to reduce hospital visits by 73% when compared to 1 year prior to treatment and reduces the total hospital stay to an average of 2.9 days, significantly reducing costs for both medical professionals and their patients. More recent developments have led to the novelty of mitral valve replacement for those patients beyond repair. Like mitral repair, mitral replacement is a procedure with a less invasive approach for treatment of severe aortic stenosis. The global heart valve repair and replacement market is expected to reach USD 3,767 million by 2020. Mitral valve technology is quickly leading to advances in other valves of the heart.