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Abstract
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.
- Stroke
- Flow Diverter
- Aneurysm
- Angiography
- Device
Data availability statement
Data are available upon reasonable request. The data and R code that support the findings are available from the corresponding author upon reasonable request.
Statistics from Altmetric.com
Data availability statement
Data are available upon reasonable request. The data and R code that support the findings are available from the corresponding author upon reasonable request.
Footnotes
Twitter @victorhbenalia, @drnimajax
Contributors All authors have substantially contributed to the conception and design of the study and/or data acquisition. GMC was responsible for conceptualizing the initial draft, and RAH for its critical revision. JMP performed the statistical analysis. All the authors revised the manuscript and approved the final version of the manuscript. RAH acts as guarantor and had full access to data analysis and final responsibility for the decision to submit for publication.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical, and Corindus. Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX, and Balt. Investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. AA is on an advisory board for iSchema View. JMP is employed by, and holds equity in, Superior Medical Experts and Nested Knowledge. All other authors have nothing to disclose.
Provenance and peer review Not commissioned; externally peer reviewed.
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