Australia & New Zealand Society of Vascular Surgeons

The Pivotal Trial leading to FDA approval of the Excluder in the United States was undertaken in 19 clinical centers. Study design was a multi center prospective concurrent control design similar to other endograft trials performed in the US. The enrollment dates were from late 1998 until early 2000. Two hundred thirty-five patients were treated with high rate of technical success and few major operative events. Follow-up is complete in more than 90% of available patients at three years. Cumulative major adverse events were significantly lower in the Excluder cohort of patients (p < .0001). Similarly, freedom from first major adverse event significantly favored the Excluder patients. There was no demonstrable survival benefit over conventional repair. At three years, 87% of patients are free of any endoleak, 9% have Type II leaks, and 4% have indeterminant type leaks. Twenty-two percent of patients have decreased aneurysm size, 54% have no change in aneurysm size, and 24% have increase (> 5 mm) in aneurysm size. Late conversions have occurred in a total of five patients for an overall rate of less than 2% with no reports of aneurysm rupture. Compared to conventional open repair, the Excluder at three years follow-up continues to have lower rates of major adverse events, a high rate of aneurysm exclusion, absence of aneurysm rupture, and low late conversion rate. The etiology of aneurysm enlargement in the absence of endoleak and its clinical significance has not yet been defined.