Original Title: MitraClip® para la reparación del reflujo de la válvula mitral

Authors' objectives: Analyse the effectiveness, safety and efficiency of percutaneous mitral valve repair with the MitraClip® device, in order to determine whether this procedure is of interest as a therapeutic alternative for the treatment of severe MR.

Authors' results and conclusions: Percutaneous mitral valve repair with the MitraClip® system is seen as a safe alternative for the treatment of MR. Regarding its effectiveness for all MR patients, to date this device has not demonstrated superiority over conventional surgical treatments. However, in patients with high surgical risk, more beneficial effects have been observed with this technique than with medical treatment or thoracic surgery, although the level of evidence underpinning these results is low. Conclusions and Recommendations Percutaneous mitral valve repair with the MitraClip® system should be considered as a treatment option in patients who meet ALL of the following criteria: • Severe symptomatic mitral regurgitation (MR) (≥3+). • Unresponsive to optimal medical treatment. • Life expectancy of a year or more. • Fulfils the appropriate anatomical criteria (the primary jet is caused by poor coaptation of the middle scallops – A2 and P2 – of the mitral leaflets). • Excessive risk for open-heart surgery according to the assessment of a surgeon or member of a team experienced in mitral surgery. • Morbidity does not diminish the expected benefit from correction of MR. With regard to authorising health centres, it would be preferable that they meet the following criteria: • Implementation of a written patient selection protocol. • Commitment to provide pre-defined, standard information about the characteristics and outcomes of treated cases.

Authors' methods: Systematic review of scientific evidence up to 1st November 2012.

Project Status: Completed

Year Published: 2014

URL for published report: https://www.euskadi.eus/contenidos/informacion/2014_osteba_publicacion/es_def/adjuntos/MitraClip.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government