Efficacy and safety of a new mechanical balloon-based flow diverter in the treatment of intracranial aneurysms.

Abstract

Flow diverters (FDs) are the first-line treatment of intracranial aneurysms (IAs). A groundbreaking mechanical balloon-based FD device was developed to enhance the precise landing and deployment efficiency for FDs. To investigates the efficacy and safety of this innovative device in a prospective cohort. This study was a prospective multicenter observational study conducted between September 2019 and November 2021. Patients diagnosed with unruptured IAs and treated with this innovative FD device alone were included. The immediate implantation success rate, the successful aneurysm occlusion rate (Raymond I-II or OKM C-D), the complete occlusion rate (Raymond I or OKM D), and the parent artery stenosis rate (>50%) at follow-up were evaluated as the evaluation index of efficacy. The mortality rate, adverse events (AEs), neurological AEs, and serious adverse events (SAEs) were evaluated as the evaluation index of safety. A total of 128 patients were included, and all of the FD deployments were successful (success rate reached 100%). At the 12-month mark, 91.4% (117/128) of patients achieved successful occlusion, 85.9% (110/128) achieved complete occlusion, and only 0.8% (1/128) exhibited parent artery stenosis >50% (without need for additional treatment). During the follow-up, there were no reported mortalities or cerebral hemorrhage, while 6 neurological adverse events (4.69%) and 4 SAEs (3.1%) were observed. The mechanical balloon-based FD showed a remarkable occlusion rate alongside minimal ischemic and hemorrhagic adverse events compared with existing FDs. This innovative mechanical balloon-based design may be an important direction for future FD design.