Authors' objectives: Bypass prostheses are used for vascular replacement or vascular reconstruction in a range of diseases. There are a number of diseases concerned, which vary in terms of the location of the lesion, type of lesion (occlusion, stenosis, fistula, dissection, aneurism) and origin of lesion (post-traumatic, post-procedural or de novo). The objectives of this work were to reassess bypass prostheses in order to: - determine the indications for bypass prostheses; - assess their actual benefit in each indication; - define their place in therapeutic strategy; - characterise the technical specifications which determine the actual benefit, so as to avoid classification mistakes and to clarify which devices are covered by the current generic description; - propose an updated nomenclature; - estimate the target population; - define CNEDIMTS' expectations regarding clinical trials needed for inclusion under the brand name on the LPPR; - define the conditions of use and prescription for inclusion of the products on the LPPR. The working method is based on a systematic review of the literature and an analysis of the dossiers submitted by manufacturers, and draws on the expertise of healthcare professionals meeting in the multidisciplinary working group dedicated to the subject.

Authors' recommendations: The CNEDiMTS has accepted the working group's proposals. For prostheses that are included under a generic description, the CNEDiMTS recommends the following indication for all bypass prostheses : "Vascular replacement in arterial or venous occlusive or aneurysmal diseases, and creation of vascular access", considering the multiple clinical situations and anatomical contexts. As regards their place in therapeutic strategy, bypass prostheses have clinical value : - in the replacement of large-diameter vessels, due to a lack of suitable autologous grafts; - in the replacement of small-diameter vessels, such as in the subinguinal region, when an autologous graft is not available or of insufficient quality; - in the creation of vascular access, when the native arteriovenous fistula is not available. Bypass prostheses may be used in combination with endoprostheses. Several bypass prostheses may be used during the same procedure. The CNEDiMTS has also indicated the technical specifications and conditions for use of bypass prostheses.

Project Status: Completed

Year Published: 2013

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2013-04/rapport_ep_implants_de_pontage_vd.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