Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology: a retrospective cohort analysis.

BACKGROUND

The Pipeline Flex embolization device with Shield technology (PED Shield) is the first flow diverter for brain aneurysm treatment approved in the United States using surface-modified technology. The effect of PED Shield on decreasing perioperative diffusion-weighted imaging positive (DWI+) hits, as a marker for in-human decrease thrombogenicity, is unclear.

OBJECTIVE

To determine if the number of periprocedural DWI+ lesions differs between patients with an aneurysm treated with PED Flex and PED Shield.

METHODS

This retrospective study compares the outcomes of consecutive patients with an aneurysm treated with PED Flex and PED Shield. The primary outcome of interest was the occurrence of DWI+ lesions. We also assessed potential predictors of DWI+ lesions and compared the outcomes between on-label and off-label treatment indications.

RESULTS

89 patients were included, 48 (54%) treated with PED Flex and 41 (46%) with PED Shield. After matching, the incidence of DWI+ lesions was 61% and 62% for the PED Flex and PED Shield groups, respectively. Results were consistent across each model with no significant differences in DWI+ lesions between treatment groups, and effect sizes ranging from OR=1.08 (95% CI 0.41 to 2.89) after propensity score matching to OR=1.84 (95% CI 0.65 to 5.47) after multivariable regression. Multivariable models demonstrated reduced DWI+ lesions with balloon-assisted therapies and posterior circulation treatment, while a significant linear relationship was encountered with fluoroscopy time.

CONCLUSION

There was no significant difference in the incidence of perioperative DWI+ lesions between patients with an aneurysm treated with PED Flex and PED Shield. Larger cohorts are likely needed to demonstrate differences between the devices.