Type III Endoleaks with Endologix Abdominal Aortic Aneurysm Endovascular Graft Platforms after Recent Revision of the Instruction for Use
Heepeel Chang, MD, Neal C. Hadro, MD, Marc A. Norris, MD, Sang Won Rhee, MD, Marvin E. Morris, MD.
Baystate Medical Center, University of Massachusetts Medical School, Springfield, MA, USA.
OBJECTIVE:
The Endologix abdominal aortic aneurysm (AAA) endovascular graft platform (Endologix Inc, Irvine, CA) has undergone recent modifications due to concerns of separation of the bifurcated unibody and proximal stent grafts at the points of overlap. Post-market surveillance revealed significantly higher rate of type III endoleaks in this cohort of patients. A revision in the instruction for use (IFU), requiring a minimum component overlap of at least 30mm to 40mm was mandated in 2013. To date, no type III endoleaks have been reported since the IFU revision. We present two cases of type III component separation and AFX® device failure despite strict adherence to the IFU guidelines.
METHODS:
A single center retrospective review of patients treated for type III endoleaks after Endologix graft placement was performed from a database of clinical surveillance from 2013 to 2017. For our analysis, we compared the aortic neck length, neck diameter, maximal AAA size during initial implant, extent of overlap and time-to-treatment failure.
RESULTS:
A total of 7 patients required intervention for type III endoleaks since the IFU modification in 2013. Despite fulfilling all the requirements of current IFU, two patients (mean aortic neck diameter 25mm, mean neck length 22mm, mean maximal AAA diameter 6cm, and mean extent of overlap 45mm) developed component separation after a mean of 33 months. The two type III endoleaks were successfully treated by realigning an existing graft with deployment of AFX® bifurcated main-body graft with aortic cuff and a Zenith® AAA endovascular graft (Cook Inc, Bloomington, IN), respectively.
CONCLUSIONS:
Type III endoleaks following Endologix AAA device implantation is an evolving problem. Unlike recent literature emphasizing inadequate graft overlap and large aneurysms as major factors leading to type III endoleaks, we have identified that adequate component overlap with small aneurysms (6cm) can still have a type III device failure. This leads to the possibility of an intrinsic design failure of the Endologix AFX® device and the need for further investigation to identify additional predisposing factors to the component separation and graft failure.
FIGURES:
A. Adequate overlap (arrow) at index operation based on current IFU. B. Type III device failure (arrow).
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