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Pre-clinical Study Of Active Mitral Ring For The Percutaneous Treatment Of Residual And Recurrent Mitral Regurgitation
Giuseppe siniscalchi, Didier Locca, Fabrizio Gronchi, Enrico Ferrari, Rene Pretre, Piergiorgio Tozzi.
University Hospital Lausanne, Lausanne, Switzerland.

OBJECTIVE: The EVEREST study recently outlined the incidence of recurrent mitral regurgitation after surgical repair being higher than is traditionally thought thus affects a patient's clinical outcome. There are few alternatives to a second open heart surgery to treat residual and recurrent mitral regurgitation. Post-implant adjustable mitral rings potentially address this issue, allowing the reshaping of the annulus on the beating heart and avoiding a second surgical approach. This manuscript reports the results of the pre-clinical study of new mitral ring allowing valve geometry remodeling after implant.
METHODS: The device consists of two concentric rings: one internal and flexible, sutured to the mitral annulus and a second, external and rigid. A third element is inserted between the two rings modifying the shape of the flexible ring. This third element is remotely activated using a balloon similar to that used for coronary angioplasty. Animal model: in adult pig, under CPB we shortened primary cordae of P2 segment to reproduce type III regurgitation and implanted the active ring. We used intracardiac ultrasound to assess mitral regurgitation and the efficacy of the active ring to correct it.
RESULTS: Severe mitral regurgitation (3+ and 4+) was induced in 12 animals, 54±6 kg. The activation of the device allowed the reduction of mitral regurgitation in all cases; in nine animals the regurgitation disappeared, in tree animals, it was trivial.
CONCLUSIONS: A post-implant adjustable mitral ring corrects severe mitral regurgitation through reversible modification of the annulus geometry on the beating heart. It will address the frequent and morbid issue of recurrent mitral valve regurgitation. The future looks towards, one unique surgical procedure laying the foundations for future percutaneous corrections.

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