Background and Purpose Cavernous carotid aneurysms can cause pain and ophtalmoplegia from mass effect, but they rarely rupture or cause life threatening complications. Treatment options include observation, parent vessel occlusion, coil embolization, or in the last decade flow-diversion (FD). We aimed to compare the results of FD with more conventional treatments in patients with cavernous aneurysms recruited in the Flow Diverter in the Treatment of Aneurysms trial (FIAT).
Materials and methods FIAT, conducted in 3 Canadian hospitals, proposed randomized allocation to flow diversion or standard management options (observation, coil embolization, parent vessel occlusion, or clip placement), and a registry of nonrandomized patients treated with flow diversion. The primary safety outcome was death or dependency (modified Rankin Scale score >2) at 3 months, to be determined for all patients who received flow diversion at any time. The primary efficacy outcome was angiographic occlusion at 3–12 months combined with an independent clinical outcome.
Results Forty-two patients with cavernous aneurysms were included in the FIAT study. In 31 patients, treatment was randomly allocated: 17 were treated with FD, 14 using best standard treatment (BST). Eleven patients treated with FD were judged untreatable otherwise. An hemorrhagic complication occurred in 3/28 patients treated with FD (11%; 3.7%–27.2%), as compared to 0/14 with BST (0%–21.5%) Overall, we had a 3% mortality rate and a 7% major neurologic complication rate.
Conclusion Flow diversion in CCAs was not safe as hypothesized. We observed unusual and potentially fatal hemorrhagic complications in patients treated with FD that need to be attentively analyzed, especially considered that CCAs hemorrhagic presentation is a rare event. More randomized trials are needed to determine the role of flow diversion in the management of cavernous carotid aneurysms.
Disclosures L. Nico: 1; C; Medtronic-Covidien. A. Weill: None. D. Roy: None. J. Raymond: None.
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