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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
Italian Journal of Vascular and Endovascular Surgery 2015 Dicembre;22(4):189-95
Long-term performance of Gore® EXCLUDER® AAA Endoprosthesis: a single center’s experience
Department of Vascular Surgery, Sana Kliniken Düsseldorf, Düsseldorf, Germany
AIM: The aim of this study was to assess the effectiveness of endovascular aneurysm repair (EVAR), specifically assessing the durability of EVAR utilizing the Gore® EXCLUDER® AAA Endoprosthesis by analyzing the long-term performance as it relates to reinterventions, patency and presence of aneurysm rupture.
METHODS: Patients undergoing elective endovascular AAA (abdominal aortic aneurysm) repair with the Gore® EXCLUDER® Endoprosthesis at the Sana Clinic in Düsseldorf, Germany were analyzed. Follow-up included routine contrast-enhanced computed tomography at 1, 6, and 12 months and annually thereafter. Average operating time was 116.2 minutes, with no difference noted between use of the EXCLUDER® featuring the Gore® SIM-PULL or C3 Delivery Systems (116.1 vs. 116.3 min respectively).
RESULTS: A total of 144 patients (122 men and 2 women) underwent EVAR with the Gore® Excluder® AAA Endoprosthesis between December 2004 and December 2012. The mean follow-up time was 13.8 months, and the longest recorded follow-up was 67.6 months. There was no migration nor type I or type III endoleaks during the follow-up period. Seven (5.8%) of the 121 patients required reintervention to treat a type II endoleak. Limb thrombosis was present in 1 (0.8%) patient. No patient was identified with aneurysmal rupture postimplant. Also, no patient presented with aneurysm diameter growth of more than 5 mm at any point during follow-up.
CONCLUSION: EVAR provides a safe and durable minimally invasive treatment method for the majority of patients presenting with AAA. Late failures of Gore® EXCLUDER® AAA Endoprosthesis are rare. Excellent patency, low reinterventions and consistent rupture prevention demonstrate long-term device durability.