Background High-frequency optical coherence tomography (HF-OCT) is an intra-vascular imaging technique capable of assessing device-vessel interactions at spatial resolution approaching 10 µm. We tested the hypothesis that adequately deployed Woven EndoBridge (WEB) devices as visualized by HF-OCT lead to higher aneurysm occlusion rates.
Methods In a leporine model, elastase-induced aneurysms (n=24) were treated with the WEB device. HF-OCT and digital subtraction angiography (DSA) were performed following WEB deployment and repeated at 4, 8, and 12 weeks. Protrusion (0-present, 1-absent) and malapposition (0-malapposed, 1-neck apposition >50%) were binary coded. A device was considered ‘adequately deployed’ by HF-OCT and DSA if apposed and non-protruding. Aneurysm healing on DSA was reported using the 4-point WEB occlusion score: A or B grades were considered positive outcome. Neointimal coverage was quantified on HF-OCT images at 12 weeks and compared with scanning electron microscopy (SEM).
Results Adequate deployment on HF-OCT correlated with positive outcome (P=0.007), but no statistically significant relationship was found between good outcome and adequate deployment on DSA (P=0.289). Absence of protrusion on HF-OCT correlated with a positive outcome (P=0.006); however, malapposition alone had no significant relationship (P=0.19). HF-OCT showed a strong correlation with SEM for the assessment of areas of neointimal tissue (R²=0.96; P<0.001). More neointimal coverage of 78%±32% was found on ‘adequate deployment’ cases versus 31%±24% for the ‘inadequate deployment’ cases (P=0.001).
Conclusion HF-OCT visualizes features that can determine adequate device deployment to prognosticate early aneurysm occlusion following WEB implantation and can be used to longitudinally monitor aneurysm healing progression.
Data availability statement
Data presented in the manuscript.
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Contributors All authors: designed and performed the experiments, analyzed the data, drafted the manuscript, approved the final manuscript.
Funding This research was funded by NINDS 2R44NS100163-02 (PIs: GJU and ASP) and the Massachusetts Life Science Center Bits Two Bytes Program (PIs: MJG and GJU). Per an investigator-initiated funding request, Microvention generously provided the WEB devices and ancillary devices for WEB delivery and detachment. The content is solely the responsibility of the authors and does not reflect the opinions of the sponsors.
Competing interests ZV, RMK, AK, CR, and VA declare no competing interest. ETL: has served as consultant on a fee-per-hour basis for InNeuroCo, Imperative Care, Mivi Neurosciences, Route 92 Medical, Stryker Neurovascular, and Neurovasc. LMP, BHD, and GJU: are employees and shareholders of Gentuity LLC. MJG: Has been a consultant on a fee-per-hour basis for Astrocyte Pharmaceuticals, Cerenovous, Imperative Care, Medtronic Neurovascular, Mivi Neurosciences, Phenox, Q’Apel, Route 92 Medical, Stryker Neurovascular; holds stock in Imperative Care, InNeuroCo, and Neurogami; and has received research support from the Research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Cerenovus, Ceretrieve, Cook Medical, Galaxy Therapeutics, Gentuity, Imperative Care, InNeuroCo, Insera, Magneto, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Omniox, Philips Healthcare, Rapid Medical, Route 92 Medical, Stryker Neurovascular, Syntheon, and the Wyss Institute. ASP: consultant for Medtronic Neurovascular and Stryker Neurovascular; research grants from Medtronic Neurovascular and Stryker Neurovascular.
Provenance and peer review Not commissioned; externally peer reviewed.