Background: Since the introduction of endovascular repair (EVR) for infrarenal abdominal aortic aneurysm (AAA), clinical evaluation has been under way in many countries throughout the world. The main purpose of this retrospective study was to determine outcome of EVR with aortic endovascular prostheses (AEPs) and to evaluate the extent to which French practitioners have complied with regulatory and clinical guidelines for the use of these trial devices.
Methods: This retrospective study was conducted by the French National Health Insurance Fund for Salaried Workers. Data were compiled on EVR procedures performed at health care institutions all over mainland France between June 1999 and May 2001.
Results: A total of 1012 AEPs were deployed for AAA repair in France during the study period. Only 151 (14.9%) of these EVR procedures were carried out within an approved investigational setting with informed patient consent. Only 149 of the 861 patients (17.3%, 95% confidence interval [CI], 14.9 to 19.9%) who underwent endovascular repair in noninvestigational settings signed informed consent forms. In 452 cases (46.5%), the diameter of the AAA was 50 mm or less. Complete outcome data for the first year were available for 891 patients (88%). Complications occurred in 177 of these patients (19.9%, 95% CI, 17.3 to 22.6%). There were a total of 47 deaths (5.3%, 95% CI, 3.9 to 6.9%), including 27 during the first 30 postoperative days. Other major events during the first year after AEP implantation were ruptured AAA in 5 patients, conversion to open operation in 15, and additional endovascular treatment in 52. Data on clinical surveillance were available for 987 patients (97.5%) with a mean follow-up of 345 days. Only 294 patients (29.8%, 95% CI, 27.0 to 32.7%) underwent complete imaging within the first month after AEP implantation. A total of 184 patients (18.6%, 95% CI, 16.3 to 21.2%) received no surveillance at all.
Conclusion: This study shows the need for improvement in the clinical evaluation of new devices and medical technologies in France. Study findings also confirm the significant incidence of adverse outcomes and necessity for routine surveillance after EVR of AAA with AEP. However, risk/benefit analysis is difficult because most procedures were not carried out within a proper investigational context.