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Assessment of an Edge-to-Edge Mitral Valve Repair Clip and its Implantation

HAS opinion for the reimbursement by the National Health Insurance
Health technology assessment - Posted on Apr 29 2015

HAS emphasises the validation of criteria and surgical contraindication by an ad hoc multidisciplinary team including at minimum an interventional cardiologist, a clinical cardiologist, an echocardiographer, a cardiovascular and thoracic surgeon, and an anaesthesiologist. Obtaining the opinion of geriatrician is highly recommended. Only patients with a life expectancy greater than 1 year should undergo the procedure.

 

In this indication, HAS believes that there is no alternative and that the need is not covered. In this indication, the improvement in treatment is substantial in relation to the lack of alternatives. The population reached in this clinical situation is estimated at 1,350 patients per year in France. In the other indications (functional or mixed mitral insufficiency) and/or for lower surgical risks, the role of the MITRACLIP edge-to-edge mitral valve repair clip in the therapeutic strategy remains undetermined. This role needs to be assessed with trials comparing it to standard treatments. The treatment of functional mitral insufficiency is under clinical research in several national and international trials, and HAS encourages the inclusion of patients in these studies.

 

Considering the difficulty of the technique for implanting an edge-to-edge mitral valve repair clip, the resulting learning curve, and the strict patient selection, HAS recommends that MITRACLIP implantation be supervised, pursuant to Article L. 1151-1 of the French Public Health Code.

 

Finally, HAS recommends the establishment of a registry, carried out with the participation of the involved healthcare professionals, to document, at minimum, in all patients who undergo implantation in France: death, repeat procedures due to mitral valve dysfunction, stage 3+/4+ mitral leak, and the evolution of heart failure. Follow-up should be carried out at 1 month, 1 year, then once per year for 3 years. Patient characteristics at inclusion should be recorded (type and severity of mitral insufficiency, NYHA classification, comorbidities, etc.).

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