Purpose: To report the midterm results of a new vascular endostapling system in the endovascular treatment of abdominal aortic aneurysms (EVAR).
Methods: A prospective single-center study was performed to evaluate the feasibility and safety of the Anson Refix Endostapler, which implants a nitinol clip to provide transmural stent-graft fixation to the adventitia. Eight patients (6 men; mean age 71 years, range 59-82) underwent EVAR with endostaple fixation between November 2007 and March 2008. Follow-up evaluation consisted of plain radiography, duplex sonography at 6 months, and computed tomography after the procedure, at 12 months, and then annually. In addition to evaluating safety and feasibility, the study assessed device integrity and freedom from endoleaks, rupture, and migration in follow-up.
Results: Attempts to implant 29 endostaples (range 3-7, median 3) were successful in 20 (70%) instances; 9 clips did not fully penetrate the graft and tissue due to severe calcification of the wall. They were successfully retracted; no endostaple migrated or was lost. The delivery time from insertion of the Refix delivery catheter to its withdrawal was a mean 57 minutes (range 20-120) over and above the regular stent-graft procedure. The delivery time improved as the learning curve was passed (mean 27.5 minutes in the last 4 cases). During the mean 18.2+/-2.2 months of follow-up, there were no device failures, migrations, endoleaks, conversions, or secondary procedures.
Conclusion: The midterm results of this prospective study document the safety and feasibility of the Anson Refix endostapling system. However, further evaluation is mandatory to draw robust conclusions about the utility of this new aortic stent-graft fixation modality.