Abstract 14749: Extra-cardiac Mitral Valve Repair - Experience With the Adjustable BACE Device

Abstract

Introduction: Functional mitral regurgitation (MR) is primarily due to abnormalities of the ventricular muscle in the presence of normal mitral leaflets. Present surgical treatment, repair or replacement, address the mitral valve annulus and leaflets, not the ventricular muscle. We describe our early and mid-term clinical experience with extra-cardiac treatment of MR with a novel, device that is implanted on a beating heart and can be adjusted remotely. Hypothesis: Evaluation of efficacy and outcomes Methods: Between Dec, 2008 and June, 2015, thirty one patients (mean age 59 years) with functional and ischemic MR were evaluated at 9 multi-national centers. All patients had severe MR (Mean MR grade 3.1) on trans-thoracic and/or trans-esophageal echocardiography, and impaired LV function (Mean EF 33.6%). Risk assessment by Logistic Euroscore was16.58%. Patients underwent implantation of a custom made BACE (Basal Annuloplasty of the Cardia Externally) device, along with CABG (mean 2.5 grafts per patient). The device was placed at the base of the heart, overlapping the atrial and ventricular surfaces of the atrio-ventricular groove circumferentially. All 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. Two patients required delayed peri-operative adjustment of the BACE device. Results: The degree of MR improved from a mean of 3.1 to 0.9. This >2 class improvement in MR was sustained over the 12 month follow up period in all patients. Moderately severe TR in 3 patients went down to trivial. There was one peri-operative death associated with balloon related leg ischemia. One device was explanted early at re-exploration for bleeding. There were no device related complications. Conclusions: Ischemic functional mitral valve regurgitation can be treated by epicardial implantation and dynamic adjustment of the BACE device. This technique has significant implications in the treatment of ischemic functional MR without entering the heart, with the added ability to remotely adjust the device.