Wild, C. (2015): Transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation (MitraClip®, Carillon®, NeoChord DS1000). German short version of the correspondent EUnetHTA assessment. Decision Support Document 93.
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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.
|Item Type:||Decision Support Document|
|Keywords:||Minimal-invasive intervention, medical device, mitral valve, mitral insufficiency|
|Subjects:||WB Practice of medicine > WB 300-962 Therapeutics|
WO Surgery > WO 500-517 Operative surgical procedures. Techniques
WG Cardiovascular system
WO Surgery > WO 505 Minimally invasive surgical procedures
|Series Name:||Decision Support Document 93|
|Deposited on:||09 Nov 2015 17:31|
|Last Modified:||09 Nov 2015 17:34|
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