Multicenter Study of Pipeline Flex for Intracranial Aneurysms

Area of Science:

• Neuroendovascular surgery
• Cerebrovascular disease management
• Medical device technology

Background:

• The Pipeline Flex (PED Flex) device was engineered to improve upon its predecessor, aiming for easier deployment and navigation.
• These design enhancements are intended to decrease the incidence of technical complications during neurovascular procedures.

Purpose of the Study:

• To evaluate the 30-day neurological morbidity and mortality rates associated with the PED Flex device.
• To assess the safety and efficacy of the PED Flex in treating intracranial aneurysms.

Main Methods:

• A retrospective analysis of 205 patients with 223 intracranial aneurysms treated across 9 neurovascular centers.
• Data collected included patient and aneurysm characteristics, periprocedural events, and clinical/angiographic outcomes.
• Multivariate logistic regression was used to identify predictors of unfavorable clinical outcomes (modified Rankin Scale > 2).

Main Results:

• The 30-day neurological morbidity and mortality rates were low at 1.9% and 0.5%, respectively.
• Intraprocedural events without neurological compromise occurred in 6.8% of patients.
• Favorable clinical outcomes (mRS 0-2) were achieved in 94.5% of patients at 30 days.

Conclusions:

• The PED Flex device is associated with low 30-day neurological morbidity and mortality rates for intracranial aneurysm treatment.
• Technical events related to device deployment were infrequent, likely due to design modifications.
• The study supports the safety and effectiveness of the PED Flex in a multicenter setting.