Background A new dual resolution imaging x-ray detector system (Canon Medical Systems Corporation, Tochigi, Japan) has a standard resolution 194 µm pixel conventional flat-panel detector (FPD) mode and a high-resolution 76 µm high-definition (Hi-Def) mode in a single unit. The Hi-Def mode enhances the visualization of the intravascular devices.
Objective We report the clinical experience and physician evaluation of this new detector system with Hi-Def mode for the treatment of intracranial aneurysms using a Pipeline embolization device (PED).
Methods During intervention at our institute, under large field of view (FOV) regular resolution FPD mode imaging, the catheter systems and devices were first guided to the proximity of the treatment area. Final placement and deployment of the PED was performed under Hi-Def mode guidance. A post-procedure 9-question physician survey was conducted to qualitatively assess the impact of Hi-Def mode visualization on physicians’ intraoperative decision-making. One-sample t-test was performed on the responses from the survey. Dose values reported by the x-ray unit were also recorded.
Results Twenty-five cases were included in our study. The survey results indicated that, for each of the nine questions, the physicians in all cases indicated that the Hi-Def mode improved visualization compared with the FPD mode. For the 25 cases, the mean cumulative entrance air kerma was 2.35 Gy, the mean dose area product (DAP) was 173.71 Gy.cm2, and the mean x-ray exposure time was 39.30 min.
Conclusions The Hi-Def mode improves visualization of flow diverters and may help in achieving more accurate placement and deployment of devices.
- pipeline embolization device
- physician survey
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Contributors Conception and design: SVSN, KV, AHS, SR. Data acquisition: SVSN, KV. Data analysis and interpretations: All authors. Drafting the manuscript: SVSN. Critically revising the manuscript: All authors. Final approval of the manuscript: All authors.
Funding This work was supported by National Institutes of Health grant number R01EB2873. AHS is the primary clinical investigator and SR is the primary non-clinical investigator.
Competing interests DRB: Research Grant and Intellectual Property License through UB STOR, with Canon (formerly Toshiba) Medical Systems Corp. JMD: Research grant: National Center for Advancing Translational Sciences of the National Institutes of Health under award number KL2TR001413 to the University at Buffalo. Speakers’ bureau: Penumbra; Honoraria: Neurotrauma Science; shareholder/ownership interests: RIST Neurovascular. KVS: Consulting and teaching for Canon Medical Systems Corp, Penumbra, Medtronic, and Jacobs Institute. Co-Founder: Neurovascular Diagnostics. MM: Consultant, Canon (formerly Toshiba) Medical Systems Corp, Medtronic; stock options: Serenity Medical, VICIS. Primary Investigator, NIH grant 1R21NS109575. SR: Primary non-clinical investigator: National Institutes of Health grant number R01EB2873; Research grant: Canon (formerly Toshiba) Medical Systems Corp. EIL: Shareholder/ownership interests: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care (formerly the Stroke Project), Rebound Therapeutics, StimMed, Three Rivers Medical; National Principal Investigator/Steering Committees: Medtronic (merged with Covidien Neurovascular) SWIFT Prime and SWIFT Direct Trials. Fees: Medtronic (training and lectures); Consultant: Claret Medical, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, Rebound, StimMed; Advisory Board: Stryker (AIS Clinical Advisory Board), NeXtGen Biologics, MEDX, Cognition Medical, Endostream Medical; Site Principal Investigator: CONFIDENCE study (MicroVention), STRATIS Study—Sub I (Medtronic). AHS: NIH/NINDS 1R01NS091075 as a co-investigator for “Virtual Intervention of Intracranial Aneurysms;” financial interest/investor/stock options/ownership: Amnis Therapeutics, Apama Medical, Blink TBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Rebound Therapeutics Corp, Rist Neurovascular, Serenity Medical, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, Viseon Spine Consultant/advisory board: Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra LifeSciences Corp, Medtronic, MicroVention, Northwest University–DSMB Chair for HEAT Trial, Penumbra, Q’Apel Medical, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, W L Gore & Associates; Principal investigator/steering committee of the following trials: Cerenovus LARGE and ARISE II; Medtronic SWIFT PRIME and SWIFT DIRECT; MicroVention FRED & CONFIDENCE; MUSC POSITIVE; and Penumbra 3D Separator, COMPASS, and INVEST.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data sharing not applicable as no datasets generated and/or analysed for this study. All data relevant to the study are included in the article or uploaded as supplementary information.