Objective: The purpose of this study was to present the experience with aneurysm rupture after deployment of Guidant/EVT (Guidant) endografts and review previously reported cases with other devices.
Methods: Records from Guidant/EVT clinical trials and postmarket approval databases from February 1993 to August 2000 were analyzed to identify patients with rupture and to extract pertinent data. Previously reported cases were obtained with a Medline search.
Results: Seven ruptures were found with Guidant/EVT devices. Five of these occurred among the 686 patients in US Food and Drug Administration protocols (group I) who were followed for a mean of 41.8 +/- 21.9 months and limited to the subgroup of 93 first generation tube endografts. Two ruptures occurred in group II (3260 patients after market approval with limited follow-up), specifically in the subgroup of 166 patients who underwent treatment with second generation tube grafts. No ruptures were found in patients with bifurcation or unilateral iliac implants followed for a mean of 37.5 months. All ruptures were caused by distal aortic type I endoleaks on the basis of attachment system fractures (first generation devices only), aortic neck dilatations, persistent primary endoleaks, migration, overlooked imaging abnormalities, refused reintervention, and poor patient selection. The mortality rate was 57% (4/7) overall and was 50% for surgical repair (3/6). A literature search identified 40 additional ruptures related to other devices, for a total of 47. All 44 that were documented with adequate data were caused by endoleaks (26 type I, 2 type II, 11 type III, and 5 source not reported). Other contributing factors were graft module separation and graft wall deterioration. The overall mortality rate for the combined series was 50%, with an operative mortality rate of 41%.
Conclusion: Postendograft AAA rupture is infrequent, although the true incidence rate is unclear because of inadequate follow-up of individual device designs. Tube endografts should be limited to the rare patient with ideal anatomy, no other alternatives, and at high risk for standard open repair. Prevention of aneurysm rupture requires long-term surveillance with attention to subtle imaging abnormalities and the establishment of reliable follow-up protocols for specific devices. The outcome of postendograft aneurysm rupture is similar to that of rupture without prior endograft therapy.