Original Title: Réévaluation des bioprothèses valvulaires aortiques implantées par voie artérielle transcutanée ou par voie transapicale

Authors' recommendations: In the current state of the art, HAS recommends to limit TAVI to patients with contraindication of surgical valve replacement following assessment in a multidisciplinary meeting and who meet the eligibility criteria of the authorised centres. HAS also emphasises the need to give patients written information on the uncertainties related to the mid- and long-term efficacy of the technique and its complications. HAS notes that data from the FRANCE 2 registry show that some implantations are performed in situations not covered by the recommended indications. HAS also reminds practitioners of the need to comply with all the contraindications listed in the CE marks of the devices, and that this technique must not be used on compassionate grounds in patients with a life expectancy of less than one year with regard to the associated comorbidities, or in patients who are eligible for surgery but refuse it. HAS also points out that surgical aortic valve replacement remains the standard treatment irrespective of the surgical risk. Authorised centres must respect the following requirements: ► Authorised centres must comply with the indications and the conditions for prescription and use recommended in HAS guidance (in particular, the need for interventional cardiology and cardiac surgery facilities to be located in the same building); ► A centre must perform at least two transarterial or transapical aortic valve bioprosthesis implantations per month; ► Centres must regularly send clinical data to the national FRANCE 2 registry, set up in accordance with a protocol that complies with HAS guidance; ► The overall analysis of data from the registry, and the results of additional clinical studies, must be sent to HAS once the one-year results for all patients on the FRANCE 2 registry are available. HAS will reassess this technology in 2014 and requests that the following information be submitted: ► Efficacy and safety data for the various types of valves and access routes for each centre performing implantations under the FRANCE 2 registry; ► Annual record of each centre's volume of activity; ► Data comparing the efficacy and safety of the various types of valves in the validated indications. Finally, HAS is of the opinion that any extension of indication to patients for whom surgery is not contraindicated must be subject to a demonstration of efficacy, safety and efficiency versus surgical aortic valve replacement.

Project Status: Completed

Year Published: 2011

URL for published report: http://www.has-sante.fr/upload/docs/application/pdf/2011-11/rapport_has_valves_aortiques_transcutanees_2011_h2com.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr