Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair

Purpose: The purpose of this study was to evaluate the importance of experience and the learning curve with endovascular abdominal aortic aneurysm (AAA) repair. Methods: A retrospective analysis was performed of all elective endovascular AAA repairs attempted by an individual surgeon and radiologist over a 4-year period. The primary outcome variable was achievement and 30-day maintenance of initial clinical success as defined by the Society for Vascular Surgery/American Association of Vascular Surgery reporting standards. Following standard statistical analysis, the cumulative sum (CUSUM) method was used to analyze the learning curve, with a predetermined acceptable failure rate of 10% and calculated 80% alert and 95% alarm lines. Results: Ninety-six elective endovascular AAA repairs were attempted by this team between 1998 and 2002 (mean age 74 +/- 0.8 years; mean aneurysm diameter 5.98 +/- 0.8 cm). Initial clinical success was achieved and maintained in 85 of 96 patients (88.5%). Although results were acceptable throughout the study period, improved results with respect to the target failure rate (10%) were not achieved until 60 patients were treated. The learning or CUSUM curves did not differ for different device manufacturers, with improved results being achieved following 20 implantations of each device. The results did differ when comparing aortouniiliac grafts (n = 27) and bifurcated grafts (n = 64). Results with bifurcated grafts remained consistent throughout the study period, whereas with aortouniiliac grafts, results improved after only a few procedures in comparison with the target failure rate. Conclusion: Success rates with endovascular aneurysm repair will improve with an individual's experience. The CUSUM method is a valuable tool in the evaluation of this learning curve, which has credentialing and training implications. Although acceptable results were obtained throughout the study period, this analysis indicates that 60 endovascular aneurysm repairs, or 20 with an individual device, are necessary before optimal rates of initial clinical success can be achieved. These results can be achieved more readily with aortouniiliac grafts than with bifurcated grafts.