Background High-frequency optical coherence tomography (HF-OCT) is an intravascular imaging method that allows for volumetric imaging of flow diverters in vivo.
Objective To examine the hypothesis that a threshold for both volume and area of communicating malapposition can be predictive of early aneurysm occlusion.
Methods Fifty-two rabbits underwent elastase aneurysm formation, followed by treatment with a flow diverter. At the time of implant, HF-OCT was acquired to study the rate and degree of communicating malapposition. Treated aneurysms were allowed to heal for either 90 or 180 days and euthanized following catheter angiography. Healing was dichotomized into aneurysm remnant or neck remnant/complete occlusion. Communicating malapposition was measured by HF-OCT using a semi-automatic algorithm able to detect any points where the flow diverter was more than 50 µm from the vessel wall. This was then summed across image slices to either a volume or area. Finally, a subsampled population was used to train a statistical classifier for the larger dataset.
Results No difference in occlusion rate was found between device type or follow-up time (p=0.28 and p=0.67, respectively). Both volume and area of malapposition were significantly lower in aneurysms with a good outcome (p<0.001, both). From the statistical model, a volume of less than 0.56 mm3 or a normalized area less than 0.69 as quantified by HF-OCT was predictive of occlusion (p<0.001, each).
Conclusions HF-OCT allows for measurements of both volume and area of malapposition and, from these measurements, an accurate prediction for early aneurysm occlusion can be made.
- Flow Diverter
Data availability statement
Data are available upon reasonable request. Data are available by contacting the corresponding author.
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Contributors RMK, MSS: responsible for data acquisition, data analysis, and statistical analysis. Drafted the manuscript. They are guarantors of the report. AP, CMR: responsible for data acquisition and analysis. VA, JMA, HGD, and MJG: responsible for planning, conception and design of the study, acquisition of data, and revising the manuscript. GJU and ASP: major contributions to high-frequency optical coherence tomography technology and data interpretation. Provided critical editing of the manuscript. All authors approved the final version of this manuscript to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This study was sponsored by Stryker Neurovascular and a Bits-2-Bytes grant from the Massachusetts Life Sciences Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the sponsors.
Competing interests ASP: consultant for Medtronic Neurovascular, Stryker Neurovascular, Balt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc, and Arsenal Medical; research grants from NIH, Microvention, Cerenovus, Medtronic Neurovascular, and Stryker Neurovascular; holds stocks in InNeuroCo, Agile, Perfuze, Galaxy and NTI. JMA and HGD are employees of Stryker Neurovascular. GJU is an employee of Gentuity. MJG: has been a consultant on a fee-per-hour basis for Alembic LLC, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, phenox GMbH, Q’Apel, Route 92 Medical, Scientia, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics and Neurogami; and has received research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Agile, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc LLC, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute and Xtract Medical. MJG is associate editor of Basic Science on the JNIS editorial board. MSS: has been a consultant on a fee-per-hour basis for Sanofi; and has research support from Sio Gene Therapies, Inozyme, the National Institutes of Health (NIH), Gilbert Foundation, and Massachusetts Life Science Center.
Provenance and peer review Not commissioned; externally peer reviewed.
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