Stent Graft Fixation with the Heli-FX™ Aortic Endoanchor Device: A Single Institution Experience
Adam A Richter, Stacey Becker, Thomas C. Naslund
Vanderbilt University School of Medicine, Nashville, TN
The purpose of this study is to report experience with an endovascular aortic anchor device used to provide seal and fixation of stent grafts for endovascular aneurysm repair.
A retrospective chart review was carried out on 14 patients who had Heli-F X™ Aortic Endoanchors (Aptus Endosystems, Inc., Sunnyvale, CA) placed. Inclusion criteria were any patient who had Endoanchors placed in either an infrarenal endovascular aneurysm repair (EVAR) or thoracic endovascular aneurysm repair (TEVAR). Data regarding the anatomy of the aneurysm and the seal zones was collected as well as data regarding outcomes with regards to endoleak, migration, and decrease in the size of the aneurysm sac.
Average age was 73 years (range 62-81), and all but 3 patients were male. There were between 4 and 10 Endoanchors used in each patient. Seven patients had Endoanchors placed as part of a Phase II trial of the Aptus Endovascular Abdominal Aortic Aneurysm (AAA) Repair System (Aptus Endosystems, Inc.), which included an investigational infrarenal aortic stent graft routinely fixed to the neck with Endoanchors. The neck length was > 1.5 cm in all patients except one who had a neck length of 1.3 cm. Neck angulation was < 45 degrees in all patients but one who had an angulation of 69 degrees. No stent migrations or endoleaks were noted in this group at an average of 42 months (range 25-55) of follow-up. Seven patients had Endoanchors placed for hostile neck anatomy or Type 1a or 1b endoleak noted after stent graft deployment. Five underwent TEVAR for thoracoabdominal aortic aneurysms (1 Crawford Type I, 3 Type II, and 1 Type V). Three of these aneurysms represented degeneration of chronic Stanford Type B dissections, and three patients had TEVARs performed as part of a hybrid thoracoabdominal aneurysm repair after open debranching of the aortic arch or the visceral abdominal aorta. Two additional patients had Endoanchors placed during EVAR. Both patients had short necks (.9 cm and .75 cm), and one had an angulation of 51 degrees. After an average of 1.6 month follow-up (range 0 - 4.1 months), there was no evidence of stent migration or Type 1a or 1b endoleak noted in any of these seven patients. No perioperative mortalities or graft-related complications occurred except in one patient in the Aptus AAA Repair System Trial. This patient developed a limb thrombosis 6 months after his initial operation, which was successfully treated with mechanical thrombectomy and anticoagulation.
The Heli-FX™ Aortic Endoanchor device provides a feasible method of added fixation for endovascular aortic aneurysm repair. Durability of such fixation in patients with difficult neck anatomy remains unproven in long term follow up. This experience suggests the use of anchors provides effective fixation and seal of the proximal and/or distal ends of a stent graft, and their use appears safe with short follow up interval. Further long-term and comparative studies are needed to define the success of anchors in challenging anatomic situations.
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