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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
Italian Journal of Vascular and Endovascular Surgery 2013 September;20(3):157-63
Endovascular aortic sealing with the Nellix sac-anchoring endoprosthesis: update of technique and results
De Vries J. P. P. M., Kropman R. H. J., Wille J., Van De Mortel R. H. W., Van De Pavoordt H. D. W. M. ✉
Department of Vascular Surgery, St. Antonius Hospital Nieuwegein, The Netherlands
Aim: The use of current modular endografts for endovascular aortic aneurysm repair has been associated with substantial adverse events during follow-up, including migration, obstruction, and endoleaks. A new sac-anchoring endoprosthesis (Nellix System, Endologix Inc., Irvine, CA, USA) has been designed to seal the entire aortic aneurysm from the inside and to stabilize the position of the endoprosthesis during long-term follow-up. This article presents results of an update of the implantation technique and a review of in vitro and clinical results.
Methods: The Nellix System consists of bilateral cobalt chromium alloy ePTFE covered balloon-expandable stent grafts that are surrounded by nonporous endobags. During implantation, each endobag is filled with a biostable polymer that crosslinks to form a hydrogel. This hydrogel anchors the Nellix System and seals the entire aneurysm lumen, including proximal and distal landing zones. The endograft is designed to withstand the lateral displacement forces that act on other modular endografts, while effectively sealing lumbar or visceral arteries, and minimizing the risk of type II endoleaks.
Results: Mechanical durability and structural integrity of all Nellix system components have been proven in in vitro studies, including sheep explants after 4 years. The initial technical success in a multicenter prospective trial was 94% (1 temporary type IA endoleak, 1 type IB endoleak). Short-term clinical outcome was very promising, with no device-related adverse events (no migration, obstruction, or new-onset endoleaks) during follow-up.
Conclusion: Short-term clinical outcome of the Nellix EVAS System is promising, with high initial technical success and very low need for reinterventions.