Endovascular Repair of Abdominal Aortic Aneurysm: One-year Results of the French AneuRx Trial

Université de Poitiers, Poitiers, Poitou-Charentes, France
Annals of Vascular Surgery (Impact Factor: 1.17). 12/2002; 16(6):685-92. DOI: 10.1007/s10016-001-0311-5
Source: PubMed


The purpose of this prospective study was to evaluate the results of abdominal aortic aneurysm (AAA) repair using the Medtronic AneuRx endovascular stent graft. Forty-seven patients presenting with asymptomatic AAA were recruited in 17 French vascular centers. The mean age of these patients was 72.2 +/- 7.8 years (range, 54 to 85.2 years). Indications were validated by an independent committee and all procedures were supervised by a trained medicotechnical assistant. Clinical data and follow-up imaging were also reviewed by an independent committee. The primary end point was successful implantation, defined as exclusion of the aneurysm without mortality, morbidity, or reintervention. The secondary end point was durable exclusion at 1 year, assessed by serial computed tomography (CT scan). Implantation of the AneuRx endovascular stent graft in this series of highly selected patients was associated with no mortality and low morbidity. One-year follow-up findings showed reduction in aneurysm diameter in 45% of patients. This finding indicates that endovascular treatment is effective. However, observation of stable aneurysm diameter in 50% and increased aneurysm diameter in 5% suggests that careful, indefinite follow-up surveillance is necessary.

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    • "Several authors reported shrinkage of the aneurysm (45–70% of patients) during follow-up [6] [28] [29]. These observations are consistent with ours. "
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    ABSTRACT: Evaluation of 6-year results of abdominal aortic aneurysm (AAA) treatment by Ella stent-grafts with regard to safety and effectivity in relation to morphology of the aneurysm. From a group of 172 patients with AAA, in whom elective endovascular treatment was considered, 120 of them (69.8%) were found to be suitable for this type of therapy. The bifurcated type of stent-graft was implanted in 97 patients, uniiliacal type in 19 patients and only four patients were found to be suitable for tubular type of stent-graft. Additional necessary procedures (internal iliac artery occlusion or contralateral common iliac artery occlusion in a group of patients with uniiliacal type of stent-graft) were performed surgically during the stent-graft implantation. CT and US controls were performed at 3, 6 and 12 months after implantation, later every 12 months. Primary technical success was achieved in 109 of the 120 patients (91%). Primary endoleak was recorded in 11 patients (primary endoleak type Ia in seven patients, type Ib in three patients and type IIIa in one patient). Assisted technical success after reintervention or spontaneous seal was 98.3%. Surgical conversion was indicated in two patients (1.7%). Perioperative mortality rate was 3.3%. Total average follow-up period was 20.7 months (range from 2 to 60 months). In nine patients (7.5%) secondary endoleak type II was found at control CT or US, in three patients partial thrombosis of the stent-graft was found. There was no aneurysm rupture during follow-up. Treatment of AAA with Ella stent-graft system is effective and safe. Bifurcated stent-graft is the most frequently used type. Uniiliacal type of stent-graft is used by us only in cases of complicated morphology.
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    ABSTRACT: 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. 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. 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. 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.
    Journal of Vascular Surgery 01/2004; 38(6):1273-81; discussion 1282. DOI:10.1016/S0741-5214(03)01042-5 · 3.02 Impact Factor
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