Objective: The purpose of this study was to determine the cause and frequency of aneurysm rupture after endovascular aneurysm repair.
Methods: We reviewed each patient who sustained aneurysm rupture among all patients enrolled for endovascular aortic aneurysm repair in phases I, II, and III of the US AneuRx Multicenter Clinical Trial from June 1996 through October 1999.
Results: A total of 1067 patients were enrolled for endovascular aneurysm repair. The AneuRx stent graft was successfully implanted in 1046 patients (98%). Endovascular repair was unsuccessful in 21 patients (2%); 13 patients (1%) were converted to open aneurysm repair. Among these, two patients (0.2%) sustained aneurysm rupture due to procedure-related instrumentation and underwent open surgical conversion. Aneurysm rupture has occurred in seven patients (0.7%) 3 weeks to 24 months (mean, 16 months) after successful endovascular repair. Four patients survived open surgical repair, and three patients died within 30 days. Overall rupture-related mortality was 0.5% and included late deaths after rupture. Before rupture, two patients had endoleak and aneurysm enlargement, and five patients had no endoleak and no aneurysm enlargement. After aneurysm rupture all seven patients had evidence suggesting that there was poor fixation of the stent graft at the proximal distal, or iliac junction fixation sites. The two patients with endoleak declined recommended open surgical or endovascular repair, which could have prevented aneurysm rupture. In retrospect, the five patients without endoleak could potentially have avoided rupture with better patient selection, better stent graft positioning, or reinforcement of fixation points with stent graft extenders. The probability of no aneurysm rupture for all patients undergoing endovascular repair is 0.996 +/- 0.002 at 1 year and 0.974 +/- 0.011 at 2 years by life table analysis with the longest follow-up of 41 months.
Conclusion: The early risk of aneurysm rupture after endovascular aneurysm repair is low. However, the possibility of rupture persists even in patients with no endoleak after the procedure. Therefore, all patients treated with endovascular aneurysm repair should continue to be monitored after the procedure. Patients with evidence suggesting insecure stent graft fixation should undergo further endovascular treatment or open surgical repair.