Data from the US Aorfix Endograft for EVAR with Highly-angulated Necks (Pythagoras) trial were presented by Dr Marc Fillinger at the recent ISET meeting. According to Fillinger, the results showed that the control of implant with Aorfix (Lombard Medical) is good, even in quite difficult anatomies, with an excellent rate of aneurysm sac regression.
The trial consists of two arms: endovascular treatment of 160 patients (40 with neck angle 0° to 60°, 120 with 60° to 90°) and an open surgery primary control arm of 323 patients, based upon data of the SVS Lifeline Registry including 60 patients added from this trial.
Fillinger presented the results of the first 21 patients. To date, they presented three groin wound infections, one femoral artery dissection, and two U transfusions. There was a graft thrombosis at three weeks, but the patient was found to have a prothrombotic state. During the operative completion, four presented type II endoleak and eight had type IV endoleak (“blush”).
Nine cases have reached six months of follow-up, and had the abdominal aortic aneurysms decreased 3.5mm (12% volume). The eight patients with intra-operative “blush” had a mean aneurysm decrease of 7mm dia, 19% volume (p=.08 vs. those with no “blush”). There was no enlargement by diameter or volume in any of the first 21 patients. “The implant has been used at multiple centres to treat highly angulated necks (>60°) and very tortuous anatomy with complete technical success”, said Fillinger.