Severe neck angulation
Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.
During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.
“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.
Dr. Brinster reported having no conflicts regarding his presentation.