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Mechanical and clinical evaluation of home made abdominal aortic endograft

Identifieur interne : 000093 ( Hal/Corpus ); précédent : 000092; suivant : 000094

Mechanical and clinical evaluation of home made abdominal aortic endograft

Auteurs : Jean-Dominique Singland

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RBID : Hal:pastel-00002999

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English descriptors

Abstract

By conception, the home made endograft (HME) designed by the surgeon suits the size of near 80% of abdominal aortic aneurysms (AAA). This percentage is better than the one of commercial endografts with a given size. We present the results of both mechanical and clinical studies of HME designed and made at the Pitié-Salpétrière Hospital (Paris) from Gianturco Z stents and a woven polyester graft (Twillweave, Vascutek). The sizing is made by cutting and suturing the graft. The study was carried out in order to answer to the query requirements of the AFSSAPS. The static tests showed that the stresses imposed on the HME during the implantation were below those that are able to degrade its components. Besides, to know the dynamical stresses applied to HME, we measured in vivo displacements inside its structure by using a dynamic tomodensitometry and a model of the HME. 11 patients were included in the study. Maximal angular and radial displacements were respectively 4.5° and 4.2% at the junction of the neck and the body of the HME. The measured radial displacements were taken as the boundary conditions in the dynamical test we are carrying out. The HME is exposed to physiological variations of the pressure produced by an electrodynamic engine at a frequency of 15 Hz for a test of 400 millions of cycles (equivalent to 10 years of implantation). The animal implantation in the aorta of 6 sheep during 6 months showed the good compatibility and integration of the HME. Finally, a retrospective clinical study over 11 years showed the efficiency of the HME with a decrease of 27% of the diameter of the AAA in a population of near 500 patients without any mechanical failure.

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<abstract xml:lang="en">By conception, the home made endograft (HME) designed by the surgeon suits the size of near 80% of abdominal aortic aneurysms (AAA). This percentage is better than the one of commercial endografts with a given size. We present the results of both mechanical and clinical studies of HME designed and made at the Pitié-Salpétrière Hospital (Paris) from Gianturco Z stents and a woven polyester graft (Twillweave, Vascutek). The sizing is made by cutting and suturing the graft. The study was carried out in order to answer to the query requirements of the AFSSAPS. The static tests showed that the stresses imposed on the HME during the implantation were below those that are able to degrade its components. Besides, to know the dynamical stresses applied to HME, we measured in vivo displacements inside its structure by using a dynamic tomodensitometry and a model of the HME. 11 patients were included in the study. Maximal angular and radial displacements were respectively 4.5° and 4.2% at the junction of the neck and the body of the HME. The measured radial displacements were taken as the boundary conditions in the dynamical test we are carrying out. The HME is exposed to physiological variations of the pressure produced by an electrodynamic engine at a frequency of 15 Hz for a test of 400 millions of cycles (equivalent to 10 years of implantation). The animal implantation in the aorta of 6 sheep during 6 months showed the good compatibility and integration of the HME. Finally, a retrospective clinical study over 11 years showed the efficiency of the HME with a decrease of 27% of the diameter of the AAA in a population of near 500 patients without any mechanical failure.</abstract>
<abstract xml:lang="fr">L'endoprothèse sur mesure (ESM) construite par le chirurgien permet, par sa conception, une adaptation dimensionnelle à près de 80% des anévrysmes de l'aorte abdominale (AAA), supérieure à celle des endoprothèses aortiques commerciales prédimensionnées. Nous présentons les résultats d'une étude mécanique et clinique de ces ESM imaginées et construites à la Pitié-Salpétrière à partir de stents en Z de Gianturco et d'une prothèse de polyester épais tissé (Twillweave, Vascutek) calibrée par découpe et suture. Cette étude répondait au cahier des charges imposé par l'AFSSAPS. Les essais statiques ont montré que les efforts nécessaires à l'implantation de l'ESM étaient inférieurs aux efforts capables d'endommager ses constituants. Puis, pour connaître les sollicitations dynamiques appliquées à l'ESM, nous avons mesuré les déplacements in vivo au sein de sa structure par scanner dynamique et modélisation de l'ESM chez 11 patients. Les déplacements angulaires et radiaux maximaux étaient respectivement de 4,5° et 4,2%, situés le plus souvent à la jonction des collets et du corps de l'ESM. La pulsation que nous avons observée sert de condition limite sur un banc d'essai que nous développons. L'ESM est soumise à des variations de pression physiologiques par un actionneur électrodynamique à une fréquence de 15 Hz pour un essai de 400 millions de cycles équivalent à 10 ans d'implantation. L'implantation chez 6 brebis pendant 6 mois a monté la biocompatibilité et une bonne intégration de l'ESM dans l'aorte. Enfin, l'expérience clinique depuis 11 ans a montré l'efficacité des ESM avec une diminution du diamètre des AAA de 27% chez près de 500 patients et l'absence de rupture en fatigue.</abstract>
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