Preliminary Experience with the TransForm Occlusion Balloon Catheter: Safety and Potential Advantages.

PURPOSE: Balloon-assisted coiling (BAC) has made the treatment of aneurysms with complex shape and broad neck possible, especially during the acute phase of hemorrhage. The authors present a prospective series of their preliminary experience with the TransForm occlusion balloon catheter (TOBC).

METHODS: Between September 2015 to February 2016 a total of 20 patients underwent endovascular treatment assisted by TOBC of which 19 had 20 untreated aneurysms and 1 patient harboring a meningioma was submitted to balloon test occlusion (BTO). The TOBC was used to perform BAC and BTO for the treatment of vasospasms and to cross the neck of giant aneurysms (anchor technique). All data regarding the feasibility and safety of treatment with the device were collected prospectively.

RESULTS: All patients completed treatment according to the modality previously chosen. The balloon was employed solely for remodeling in 17 patients, for anchor technique in 2, for both remodeling and vasospasm angioplasty in 1 and for BTO in 1 patient. The balloon could be navigated to the target aneurysm in all cases. Evaluation of postoperative anatomical results indicated total occlusion in 13 (72.2 %) aneurysms, neck remnants in 4 (22.2 %) and residual sac filling in 1 (5.5 %). There were two (9.5 %) complications related to treatment, all thromboembolic. No technical complications were observed.

CONCLUSION: The TOBC was shown to be safe and effective for the treatment of intracranial aneurysms with BAC. In addition, it was successfully employed to perform angioplasty for vasospasm and BTO. Finally, it was used in the balloon anchor technique for the first time.