Aim: The purpose of this study was to report the outcome of EVAR using EXCLUDER endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz.) with low-porosity polytetrafluoroethylene (PTFE) in the medium term. We reviewed a 10-year-experience with this device to document the outcome of 100 consecutive elective EVARs with Excluder-Device performed at a single centre.
Methods: From 01.2006 to 01.2009 all elective abdominal aortic aneurysm (AAA) cases (N=100) with an abdominal aortic aneurysm (AAA; mean diameter 5.61 cm; range 4.2-7.3 cm) that were treated electively with the EXCLUDER Bifurcated Endoprosthesis were entered in an index. Anatomical and clinical evaluations and radiological results have been analyzed. Mean aortic neck length was 12.24 mm, mean proximal aortic diameter was 24.39 mm. Primary outcome that has been examined, include operative mortality, aneurysm rupture, aneurysm-related mortality, open surgical conversion, and late survival rates. The incidence of endoleak, migration, aneurysm enlargement, and graft patency have also been determined. Finally, the need for reinterventions and success of such secondary procedures were evaluated. Endoleaks were diagnosed from contrast-enhanced computed tomography, the rate of type II endoleaks was analyzed after 1, 3 and 12 months.
Results: Mean patient age was 74.1 years (range 44-91 years); 91% were male. Mean follow-up was 20 months; 78 % of the patients had 2 or more major comorbidities, and 32 % were categorized as inappropriate for open repair. On an intent-to-treat basis, device deployment was successful in 100%. Thirty-day mortality was 0%; freedom from AAA rupture was 100%. Type II endoleak appeared directly after the procedure in 24%, after 3 months in 15% and after 12 months in 7%. The initial technical success defined as endovascular aneurysm exclusion and absence of type I endoleak was 99%. Proximal type I early endoleak occurred (detected by intraoperative DSA) in 3 patients, in 2 cases intraoperative proximal aortic cuffs were needed to seal proximal type I endoleaks. In one case we performed a proximal bending via a retroperitoneal access and sealed the endoprosthesis. Postoperatively, the size of the AAA decreased or remained unchanged in 93% after 12 months. Freedom from reinterventions was 94% after 2 years.
Conclusion: EVAR using the EXCLUDER-Device is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application within a wide spectrum of patients.