The initial results from the ANCHOR (Aneurysm treatment using the Heli-FX Aortic Securement System Global Registry) postmarket registry evaluating the use of the Heli-FX EndoAnchor (Aptus Endosystems) in endovascular aneurysm repair (EVAR) were presented at the recent VIVA conference in Las Vegas (October 8, 2013). The device achieved a high degree of technical success in the first 250 patients enrolled in both treatment arms — primary group and revision group. These outcomes substantiate the safety of the Heli-FX endoanchors as there have been no unanticipated device-related adverse events.
Heli-FX is a mechanical fastening device (“endostaple”) that securely attaches the endograft to the aortic wall and is designed to prevent migration and enhance long-term durability of the EVAR procedure. The currently ongoing ANCHOR study is a global, multicenter, prospective postmarket registry that evaluates the use of these endoanchors in EVAR and captures critical data on the use of the technology as well as acute and long-term procedural outcomes. The trial has two treatment arms: primary (endoanchors applied at the time of initial stent graft implantation) and revision (patients who present with type I endoleak from previous EVAR). The investigational plan calls for enrollment of 1,000 patients in each arm, and the study duration will be 5 years.
Endoanchors are undoubtedly a welcome addition to the endovascular armamentarium. They are safe and appear to work as intended. Best indications and uses remain somewhat unclear, but these will evolve and become better established as experience accumulates. Secure endograft attachment to the aortic wall is obviously their raison d’etre but the need for this has rapidly diminished in the recent past with newer generation stent-grafts that resist migration quite well and remain stable for the long haul in the great majority of cases when used on-label and in adherence to the instructions for use. On the other hand and to be totally realistic, off-label use is clearly on the rise and suboptimal outcomes are far more likely when EVAR devices are implanted in borderline unsuitable and complex aneurysm anatomies. The latter, together with new and perhaps not yet foreseen applications, may provide a better target for the use of endoanchor technologies moving forward.