, Critère de jugement principal, p.7

, Les valves aortiques sans sutures constituent une innovation majeure dans le domaine de la chirurgie valvulaire aortique qui n'avait pas connu de nouveauté en termes de prothèses depuis les années, 1960.

. Seulement, comme la plupart des dispositifs médicaux innovants, leur financement est insuffisant et entrave donc leur diffusion. Des études médico-économiques sont donc essentielles pour situer ces nouvelles valves dans la stratégie thérapeutique du remplacement valvulaire aortique

, C'est à ce titre qu'ont été évaluées les bio-prothèses sans sutures, sous l'impulsion de la COMEDIMS et de la Commission innovation de notre CHU

. Ainsi, seule une des deux valves sans sutures commercialisées, la valve Perceval®, semble apporter un intérêt médico-économique dans la chirurgie mini-invasive. La Commission innovation du CHU d'Amiens a alors décidé de ne plus implanter de valves Intuity® au vue de l'absence de preuves médico-économiques, et de soumettre une lettre d'intention pour un PRME pour poursuivre l'étude avec la valve

, L'utilisation des valves aortiques sans sutures, notamment Perceval®, en hémi-sternotomie permettrait de simplifier l'approche mini-invasive et de l'étendre dans l'objectif d'améliorer la prise en charge des patients opérés pour un RVA isolé

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, Instruction n° DGOS/PF4/2016/382 du 9 décembre 2016 relative aux programmes de recherche sur les soins et l'offre de soins pour l'année

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