Purpose: The purpose of this study was to determine the outcome of endovascular aneurysm repair in a defined geographic region during the first 2 years after Food and Drug Administration approval of a new endovascular device.
Method: Clinical results of all attempted endovascular aneurysm repairs from 1999 to 2001 with the AneuRx stent graft in the northern California/Nevada region were reviewed. All cases performed in 23 hospitals by 21 endovascular treatment teams were included on an intent-to-treat basis. Community physician training, proctoring, and assistance in case selection was provided by the manufacturer, with outcome monitored by external physician observers and clinical vascular specialists. Results in 22 community hospitals were compared with concurrent results in the regional university hospital training center and with results from the controlled, multicenter AneuRx clinical trial.
Results: Endovascular aneurysm repair was attempted in 257 patients by 20 endovascular teams working in 22 community hospitals. The mean number of cases per team was 13 +/- 2 (range, 1 to 36). Patient age was 74.1 +/- 6.5 years (89% men and 11% women), and 29% of patients were not candidates for open surgical repair because of multiple medical comorbidities. Mean aneurysm diameter was 5.7 +/- 0.8 cm. The endoluminal stent graft was successfully deployed in 254 patients (98.8%). In two patients, iliac access could not be obtained, and in one case, the iliac limb was misdeployed and the patient underwent successful open surgical repair. The surgical conversion rate was two of 257 patients (0.8%). The 30-day mortality rate was 1.2%, with one patient dying of stroke, one of multisystem organ failure, and one of cerebral hemorrhage. No device-related deaths occurred. Secondary procedures were performed in 8% of patients. Primary graft patency rate was 98%, and secondary graft patency rate was 100%. Concurrent university training center experience with 100 patients with similar characteristics and aneurysm size was not statistically different (deployment success rate, 100%; 30-day mortality rate, 0%; surgical conversion rate, 0%; secondary procedure rate, 8%). No aneurysm ruptures and no late surgical conversions have been seen in either the community or university experience, with follow-up periods extending to 2 years.
Conclusion: Early results of endovascular aneurysm repair introduced into community practice are favorable. Initial community experience, with clinical support from the manufacturer, does not appear to differ significantly from concurrent results in the university training center or from results reported from the multicenter controlled clinical trial with the same device.