Anne Lejay1, Benjamin Colvard2, Louis Magnus3, Delphine Dion4, Yannick Georg3, Julie Papillon4, Fabien Thaveau3, Bernard Geny5, Lee Swanström6, Fréderic Heim7, Nabil Chakfé3. 1. Groupe Européen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS), Strasbourg, France; Department of Vascular Surgery and Kidney Transplantation, University of Strasbourg, Strasbourg, France. Electronic address: anne.lejay@chru-strasbourg.fr. 2. Division of Vascular Surgery, Department of Surgery, Stanford University, Stanford, CA, USA. 3. Groupe Européen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS), Strasbourg, France; Department of Vascular Surgery and Kidney Transplantation, University of Strasbourg, Strasbourg, France. 4. Groupe Européen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS), Strasbourg, France. 5. Department of Physiology, University of Strasbourg, Strasbourg, France. 6. Laboratoire de Physique et Mécanique Textile, ENSISA, Mulhouse, France. 7. Groupe Européen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS), Strasbourg, France; Laboratoire de Physique et Mécanique Textile, ENSISA, Mulhouse, France.
Abstract
OBJECTIVE/ BACKGROUND: Since the late 1950s, major advances in vascular surgical practice have been closely associated with the introduction of novel vascular implants. These devices have been constructed from a variety of materials and have been designed to be implanted in several different ways. Despite a rigorous regulatory process, regular failures continue to be observed. A systematic review of the literature and of the Geprovas registry was performed in order to improve understanding of the failures. METHODS: A systematic review was performed via a search of the MEDLINE and Embase databases. Full text, English, German, or French language studies without any chronological limit were included. The reference lists of included studies, as well as the first 20 related items, were scanned for other potentially relevant studies. RESULTS: Data extraction allowed the evaluation of 184 publications; 72 publications met the inclusion criteria. Only 12 publications reported sufficient data for structural, histopathological, and epidemiological analysis. However, explant analysis allowed the understanding of degenerative phenomena: "warp knitted" replaced "weft knitted" polyethylene terephthalate grafts, decreasing the risk of dilatation or rupture; inter-nodal distance was modified in order to improve polytetrafluoroethylene graft incorporation capacities; and index of saturation, endograft fabric/stent interactions, and stent fatigue phenomena have been extensively studied in an attempt to improve endovascular device durability. CONCLUSION: A general lack of depth of reporting of explants remains. Dedicated systematic explant analysis programs are the key to improving the performance of future generations of devices.
OBJECTIVE/ BACKGROUND: Since the late 1950s, major advances in vascular surgical practice have been closely associated with the introduction of novel vascular implants. These devices have been constructed from a variety of materials and have been designed to be implanted in several different ways. Despite a rigorous regulatory process, regular failures continue to be observed. A systematic review of the literature and of the Geprovas registry was performed in order to improve understanding of the failures. METHODS: A systematic review was performed via a search of the MEDLINE and Embase databases. Full text, English, German, or French language studies without any chronological limit were included. The reference lists of included studies, as well as the first 20 related items, were scanned for other potentially relevant studies. RESULTS: Data extraction allowed the evaluation of 184 publications; 72 publications met the inclusion criteria. Only 12 publications reported sufficient data for structural, histopathological, and epidemiological analysis. However, explant analysis allowed the understanding of degenerative phenomena: "warp knitted" replaced "weft knitted" polyethylene terephthalate grafts, decreasing the risk of dilatation or rupture; inter-nodal distance was modified in order to improve polytetrafluoroethylene graft incorporation capacities; and index of saturation, endograft fabric/stent interactions, and stent fatigue phenomena have been extensively studied in an attempt to improve endovascular device durability. CONCLUSION: A general lack of depth of reporting of explants remains. Dedicated systematic explant analysis programs are the key to improving the performance of future generations of devices.