Background: Mitral valve regurgitation (MR) or mitral insufficiency is a common disease, especially among the elderly. MR may be acute or chronic, depending on the underlying pathology: accordingly, it must be distinguished between primary (degenerative) MR (DMR) and secondary (functional) MR (FMR). In recent years new minimally invasive procedures have become available for inoperable or high-risk patients. This assessment seeks to answer questions on the efficacy and safety of mitral valve repair using minimally invasive procedures such as MitraClip® for inoperable patients with DMR or FMR; Carillon® for inoperable patients with FMR; NeoChord DS 1000 for operable patients with DMR.

Methods: The submission documents supplied by the manufacturers were complemented with a systematic search in five literature databases and five databases on ongoing clinical trials.

Results: No comparative studies to assess the effectiveness were identified. To assess safety, one systematic review (SR) and 20 primary studies were included (for MitraClip®, one SR and 16 primary studies; for CARILLON® 2 primary studies; for NeoChordDS1000 3 primary studies). In observational studies all 3 medical devices reduce the MR grades and the NYHA class. The rate of serious adverse events is 20%, the 12-month mortality around 23%. Patients' selection and experience with the intervention are key factors of the reduction of frequency and severity of complications. Currently, several clinical trials are ongoing. 4 studies comparing MitraClip® with guideline-based drug therapy as a comparator are of particular interest. The first results are expected in 2017.

Conclusion: Two of the evaluated medical devices, NeoChord DS1000 and CARILLON® are still at an early stage of development. The MitraClip® however, was already implanted worldwide in around 23,000 patients before results of comparative studies had been published.