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Mitralign percutaneous mitral annuloplasty system for mitral regurgitation in congestive heart failure patients: first-in-man experience

BACKGROUND: Untreated mitral regurgitation results in increased mortality in patients with congestive heart failure (CHF). The Mitralign Percutaneous Annuloplasty System provides a treatment option without surgery in selected cases with mitral annulus dilation. METHODS: The procedure is performed through a single 14 F femoral artery puncture; fluoroscopy and transesophageal echocardiography are both used for visualization. The guide catheter is maneuvered into the left ventricle and positioned at the posterior mitral annulus. A catheter system places sutured pledgets into the posterior mitral annulus and these implants are pulled together to remodel the mitral valve annulus. Once the desired effects are achieved, the suture is locked and cut. RESULTS: The procedure was performed in 6 patients and was well tolerated. Procedure times were generally < 2 hours and in most cases (4/6) immediate mitral regurgitation reduction was achieved. All patients were followed up to 12 months. There were no deaths and 4 patients were New York Heart Association class I, one was class II and one class III. There was a significant reduction of the left ventricular diameters, and left atrium size after the first 90 days of follow up. CONCLUSIONS: Direct percutaneous mitral annuloplasty is achievable and reproducible. This is a technique that can be performed safely and shows a considerable benefit for selected patients in whom surgery is not a good option. A higher number of patients treated with this new procedure will provide us with a better understanding of the limitations of percutaneous mitral annuloplasty approach.

Heart failure; Mitral valve insufficiency; Heart catheterization


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