Early complications and endoleaks after endovascular abdominal aortic aneurysm repair: report of a multicenter study.

OBJECTIVE: The aim of this study was the identification of risk factors for adverse events and the assessment of the early success rate in 1554 patients with abdominal aortic aneurysms (AAAs) who underwent treatment with endovascular technique between January 1994 and March 1999. For this purpose, the clinical and procedural data were correlated with observed complications and endoleaks.

METHODS: The data were collected from 56 European centers and submitted to a central registry. Patient characteristics, aortoiliac anatomic features, operative technical details, types of devices used, and experience of the teams of physicians were correlated with the occurrence of complications and endoleaks. The technical success rate was assessed according to the Society for Vascular Surgery/International Society for Cardiovascular Surgery, North American Chapter, guidelines. For the assessment of correlations between risk factors and adverse events, a multivariate logistic regression analysis was used.

RESULTS: The operative complications were grouped into three categories: failure to complete the procedure (39 patients, of which 27 underwent a conversion to an open AAA repair; 2.5%); device-related or procedure-related complications (149 patients; 10%); and arterial complications (51 patients; 3%). The most important risk factors for failure to complete the procedure included an aneurysm diameter of 60 mm or more and the need for adjuvant procedures. The factors that predicted device-related and arterial complications were the experience of the team with endovascular AAA treatment and the need for adjuvant procedures. Forty patients (2.6%) died within 30 days after operation. American Society of Anesthesiologists III and IV operative risk classification results predicted higher mortality rates than did American Society of Anesthesiologists operative risk classification I and II results. The patients who underwent operation in 1994, the first year documented in this registry, and those who required adjuvant procedures also had an increased risk of perioperative death. The incidence rate of systemic complications within the first 30 days (279 patients; 18%) was higher in patients aged 75 years or more, in patients with an impaired cardiac status, and in patients considered unfit for an open procedure. An endoleak was detected at the completion of the procedure in 16% of the cases and was still present after 1 month in 9%. The risk factors for primary endoleaks were female gender and age of 75 years and older. The observed technical success rate in this patient series was 72%.

CONCLUSION: The learning curve of the doctors and the need for adjuvant procedures were independent risk factors of operative device-related and arterial complications. The importance of proper instruction during an institution's initial phase with this treatment is emphasized by these observations. Although the endovascular management of AAAs is less stressful than open surgery, systemic complications were still the most common adverse events during the first postoperative month. These complications were associated with several patient-related factors, including advanced age, impaired cardiac status, and poor general medical condition. These observations may be a guide for improved patient selection for endovascular AAA repair.