Objective: The purpose of this study is to provide a systematic review of currently available data about the percutaneous trans-coronary-venous mitral annuloplasty with the Carillon Mitral Contour System.
Method: A systematic literature search was conducted using the common medical and scientific databases. The documented parameters included among others grade of mitral regurgitation (MR), vena contracta (VC), effective regurgitant orifice area (EROA), 6 minute-walk-test (6MWT), NYHA-classification, and Quality of Life (QoL) at baseline, 30 days and in the long-term follow-up.
Results: The exact total number of successfully implantations with available data remains unclear because so many publications are either of the same institution or study group, or they present overlapping results. Reduction of functional mitral regurgitation (FMR) was associated with significant inverse left-ventricular (LV)) remodeling, improvement in 6MWT, QoL and NYHA-class during the 12-month follow-up. In almost half of the enrolled patients, the Carillon System could not be implanted or had to be removed due to coronary compromission. Adverse advent rate (AE) ranged between 2.8-39%.
Conclusions: Results with regard to reduction of MR and inverse LV remodeling have been remarkable. Indication and selection criteria for suitable patients, the expected complications, and the long-term results with regard to survival and quality of life still remain unclear. The available results do not establish superiority of the Carillon Mitral Contour System and support the lack of a clear benefit. The approach with the Carillon Mitral Contour System should be limited to participants of prospective and randomized trials.
Keywords: Carillon-Mitral-Contour-System; LV remodeling; percutaneous mitral annuloplasty.
© 2017, Wiley Periodicals, Inc.