Background: Correction of functional mitral regurgitation in ischaemic heart disease, with a better risk:benefit ratio is an unmet need. A new methodology of external approach of correcting the annulus (BACE: basal annuloplasty of the cardia externally) to repair and stabilise the mitral valve without entering the heart was used in this prospective study. This study was conducted to assess the efficacy and safety of the concept BACE device in patients with moderate functional mitral valve regurgitation as a result of symptomatic coronary artery disease and heart failure.
Methods: The study involved a group of patients who had complex cardiac surgery between January 2000 and December 2001 at the University of Melbourne Campus Hospitals, Melbourne, Australia. Twelve patients with ischaemic heart disease, congestive heart failure, and moderate functional mitral regurgitation (MR) (minimum 2+) underwent the BACE procedure along with coronary artery bypass grafting and/or left ventricular reconstruction.
Results: No peri-operative complications or deaths related to surgical procedures occurred in the study group. There were no clinically significant problems related to the BACE implantation procedure. Mean MR grade was significantly improved in BACE Group from baseline to post BACE implant (2.8 pre- and 0.3 post-surgery; P<0.05). Mean left ventricular ejection fraction (LVEF) was significantly improved (P<0.05) and maintained at 6, 12, and 18 months post BACE implant compared to pre-operative baseline, with a mean improvement of 20% (24% at baseline to 44% at 18 months post-operatively) (P<0.05). In addition to that the patients also had a significant improvement (P<0.05) in mean New York Heart Association (NYHA) functional status from pre-operative baseline to 6 and 18 months post procedure with BACE.
Conclusions: External stabilisation of the cardiac base with BACE was associated with significant improvement in mitral valve function with no significant intra-operative or post-operative problems in patients with moderate functional MR. These findings support further study of BACE in functional MR.