Background: The Australian Safety and Efficacy Register for New Interventional Procedures - Surgical (ASERNIP-S) was contracted by the Commonwealth Department of Health and Aged Care to audit the procedure of endoluminal repair of abdominal aortic aneurysm. The purpose of the audit was to examine the safety and efficacy of the endoluminal graft (ELG) and, where possible, compare it to the open procedure. The first 12 months of data collection has now been completed. An overview of these results and some of the problems associated with the establishment of this audit are given.
Methods: The administrative infrastructure to support the audit is based at the ASERNIP-S office in Adelaide. To achieve high compliance rates, regular contact was maintained with surgeons. A reference group of senior vascular surgeons was established to provide expert support to the audit.
Results: By December 2000, ASERNIP-S had collected data on approximately 85% of privately performed ELG procedures during the first year of the audit. The early mortality rate was 1.3% in the endoluminal group compared to 2.6% in the open group. The rate of procedural complications was 15% in both groups, but the percentage of systemic complications was higher following the open repair. Aneurysm size and the number of pre-existing conditions had a statistically significant relationship to the variation in the number of complications for ELG patients.
Conclusions: Good compliance has been obtained from vascular surgeons for submission of the operative data sets. ASERNIP-S aims to follow this group of patients closely to assess the medium to long-term durability of this procedure.