European multicentre experience with modular device (Medtronic AneuRx) forthe endoluminal repair of infrarenal abdominal aortic aneurysms.

Objective. Transfemoral endoluminal repair of AAA, introduced for the first time in the early 90's, has become a very promissing alternative to conven tional open repair and more and more centers are reporting satisfactory pos toperative results in a high percentage of cases. Straight and bifurcated grafts represent the devices available on the marke t at present and aortic, as well as iliac aneurysmal lesions can be safely treated through a transfemoral approach. The possibility to indicate an end ovascular AAA repair is related to the configuration (length and size) of t he proximal and distal necks, tortuosity and calcification of the access ar teries and to vascular and nonvascular comorbidities, which afflict the pat ients. The objective of our study was to evaluate the early and late postop erative results in a series of patients affected by infrarenal AAA, who und erwent endoluminal repair. Materials and Methods. From December 1996 to 31 October 1997 in 5 different European Centers, 100 Medtronic AneuRx bifurcated stent grafts were implan ted for infrarenal abdominal aortic aneurysms. The diameter of the AAA vari ed from 33 to 77 mm (average 64 mm) and the mean age of the patients was 70 .8 years (51-87 years). Ln one patient with a 33 mm diameter of the aneurys m, the surgical procedure was indicated because the size of the aneurysm ha d increased by 5 mm, compared to the previous control made 2 months before. In addition the aneurysms became symptomatic. There were 92 male and 8 fem ale patients. The average time of the surgical procedure was 150 minutes (7 5-480 minutes) with an average blood loss of 570 ml (100-2 600 ml). Exclusion criteria included a proximal neck shorter than 10 mm, excessive t ightness of the aortic bifurcation and tortuosity and calcification or exce ssive stenosis or occlusion of the access arteries. All patients had a CT s can control at 72 hours and 1, 6 and 12 months postoperatively and yearly t hereafter. Intraoperative IVUS for the deployment of the stent was applied in 68 cases (68 %). Results. No early or late complications have ben reported in 91 patients (9 1 %) with successful placement of the stent graft and complete exclusion of the AAA. There was one non-device-related death in the first postoperative day (1 %). Endoleaks occurred in 12 cases with spontaneous resolution in 5 cases at 1 and 6 months postoperatively and surgical seal at 1 month. In t wo patients one minor and one massive embolization occurred due to catheter and guidewire dislodgement of thrombi in the aneurysm (2 %). In four patients scheduled for endovascular repair, a conversion was requir ed due to excessive tortuosity and calcification of the access arteries (4 %). The average length of hospitalization was 5 days (3-11 days). Conclusions. The preliminary results achieved by our groups with the Medtro nic AneuRx modular system stent-graft have been very satisfactory. The conf ormability of this device makes it usable in a considerable number of cases of AAA. The superstructure area containing the bifurcation into the legs h as recently been converted from a single continuous stent configuration to a series of individual stent rings. This has numerous advantages, including increased conformability of the stent-graft body, increased delivery cathe ter flexibility and facilitation of nose cone/runner retraction. These adva ntages are accomplished without a decrement in hoop or column strength. In addition the "gate" area in the short pant leg has been lengthened to maxim ize the overlap as well as the modularity of the system. In conclusion, we believe that this device is a good alternative to open surgical AAA repair.