Abstract
Mitral regurgitation (MR) affects more than 2 million people in the United States annually and is the second leading cause of heart valve disease after aortic stenosis. Surgical intervention is the currently accepted treatment of choice in patients with either symptomatic degenerative MR or asymptomatic MR with pulmonary hypertension, atrial fibrillation, or left ventricular dysfunction. Based on robust evidence from clinical trials, the MitraClip Transcatheter Mitral Valve Repair system (Abbott Vascular) was approved in the United States for commercial use in 2013. To date, more than 4,000 patients have been treated with the MitraClip in the United States and more than 35,000 patients worldwide. The device is approved in the United States for symptomatic degenerative mitral regurgitation in patients who are at high risk for surgery, as registry data has shown the device to be safe and effective in high-risk patients. In fact, when evaluated in the real-world setting in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, the device appears to be more safe and effective than in the original clinical trials. This review summarizes the clinical trials and registry data, reviews ongoing trials evaluating the device's utility in expanding populations, and introduces novel mitral valve repair devices in various stages of development.
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