Late Failures of Devices Used for Endovascular Treatment of Abdominal Aortic Aneurysm: What Have We Learned and What is the Task for the Future?

Abstract

Since their introduction in 1991, endografts for the exclusion of abdominal aortic aneurysms have evolved by "learning from failures." As significant device failure modes are reported, manufacturers modify device design to improve effectiveness and durability based on analysis of clinical results. This article summarizes what has been learned from a variety of device failures with a view toward understanding the implications for future activity in the continuing development of endovascular technology. Secondary interventions have been used to improve late outcomes of many devices. Long-term durability remains an issue because the limited data on follow-up beyond 3 or 4 years show gradually accumulating device failures in ways that were not anticipated. The future of successful endografting requires more and longer-term follow-up data, better understanding of the interaction between aortoiliac morphology and device design, improved imaging techniques, development of physiologic methods for endograft assessment, investigation of adjunctive measures to control the abdominal aortic aneurysm (AAA) sac environment, and expansion of the dialogue between clinicians and industry.

Bell-bottom aortoiliac endografts: An alternative that preserves pelvic blood flow

“…Although no late endoleak or graft disconnect failure occurred at this junction during our short follow-up period, past experience has shown the importance of diligent surveillance in all patients treated with endovascular therapy. 17 One IIA occlusion case in our series had mild buttock claudication with symptoms unchanged at 6 months, and one patient had distal embolism that necessitated limb salvage bypass. No change was found in CIA diameter during the follow-up period (average, 8 months; range, 1 to 12 months).…”

Ergebnisse der Stentprothesenimplantation beim Bauchaortenaneurysma

“…Diese Endoleckagen decken sich mit denen aus der Literatur [5,8] bekannten. Einige Patienten mit einem definitiven Endoleak zeigen trotzdem eine Abnahme des Aneurysmadurchmessers, während andere wiederum mit kompletter Ausschaltung des Aneurysmas im Follow-up eine Zunahme des Aneurysmadurchmessers aufweisen [1,10]. Sicherlich sind die Endoleckageraten abhängig von den Systemen, die implantiert wurden [3,4].…”

Preclinical testing for aortic endovascular grafts: Results of a Food and Drug Administration workshop

“…5,6 Clinicians, government regulators, and the medical device industry recognized that preclinical testing had not been successful at predicting the various failure modes seen in the clinic. 7,8 This widespread recognition prompted a workshop on endovascular graft preclinical testing sponsored by the US Food and Drug Administration on July 31 and August 1, 2001, which had international attendance of more than 120 people, including 34 invited participants.…”