Abstract
Introduction: Ventricular dysfunction in the presence of normal mitral leaflets is characteristic of functional mitral regurgitation (MR). Surgical treatment with mitral valve repair or replacement, address mitral valve annulus and leaflets, not the ventricular muscle. We describe early and mid-term clinical experience with extra-cardiac treatment of FMR with a novel device that is implanted on a beating heart. Hypothesis: External and adjustable support of the cardiac base can effectively reduce functional MR & HF. Methods: The BACE (Basal Annuloplasty of the Cardia Externally) device is a broad belt/band of silicone that is implanted at the base of the heart, by means of slim polyester belt loops sutured on atrial and ventricular sides of the Atrio-Ventricular groove. Forty one patients (mean age 60.24 years) with functional and ischemic MR were evaluated at 10 multi-national centers between December, 2008 and June, 2018. All patients had moderately severe or severe MR (Mean MR grade 3.3) on trans-thoracic and/or trans-esophageal echocardiography, and impaired LV function (Mean EF 38.5%). Risk assessment by Logistic Euroscore showed a mean of 16.5%. Implantation of the BACE device, was performed, according to sizing performed along the base of the heart, overlapping atrial and ventricular surfaces of the atrio-ventricular groove circumferentially. Mean number of coronary grafts was 2.5. Five patients had stand-alone procedures without CABG. Procedures were performed on a beating heart with the majority of them performed off-pump. Intra-operative trans-esophageal echocardiography allowed customized inflation of specific chambers to selectively deform the annulus and sub-annular myocardium. Results: Three patients required peri-operative adjustment of the BACE device. There were no deaths related to the BACE device or device failures. The degree of MR improved from a mean of 3.4 to 0.88. This >2 class improvement in MR was sustained over the 12 month follow up period in all patients. LVEDD decreased from 5.9±0.6 to 5.5±0.6 cm. Conclusions: Ischemic and functional mitral valve regurgitation can be treated by epicardial implantation and dynamic adjustment of the BACE device. Ventricular stabilization may impact HF progression.
Published Version
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