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Original research
Acute thrombus formation on phosphorilcholine surface modified flow diverters
  1. Miklos Marosfoi1,
  2. Frederic Clarencon2,
  3. Erin T Langan1,
  4. Robert M King1,
  5. Olivia W Brooks1,
  6. Takamisu Tamura1,
  7. John M Wainwright3,
  8. Matthew J Gounis1,
  9. Srinivasan Vedantham4,
  10. Ajit S Puri1
  1. 1 New England Center for Stroke Research, Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  2. 2 Department of Interventional Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France
  3. 3 Research and Development, Medtronic Neurovascular, Irvine, California, USA
  4. 4 Department of Medical Imaging, The University of Arizona – Banner University Medical Center, Tucson, Arizona, USA
  1. Correspondence to Dr Matthew J Gounis, Department of Radiology Director, New England Center for Stroke Research University of Massachusetts, 55 Lake Ave N, SA-107R, Worcester, MA 01655, USA; matthew.gounis{at}umassmed.edu

Abstract

Purpose Thromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED).

Methods Elastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent.

Results Following angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p<0.0001), but not with DAPT (p=0.3872) or aneurysm neck size (p=0.8555). The incidence rate for clots with cPED was 1.72 times more than with sPED. The clots on the flow diverter at the location corresponding to side branch ostia was significantly lower with sPED than with cPED (OR 0.180; 95% CI 0.044 to 0.734; p=0.0168), but was not associated with DAPT (p=0.3198).

Conclusion In the rabbit model, phosphorilcholine surface modified flow diverters are associated with less thrombus formation on the surface of the device.

  • optical coherence tomography
  • flow diverters
  • intracranial aneurysms
  • dual antiplatelet therapy

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors Study design: MM, JMW, MJG ASP. Data acquisition: MM, FC, ETL, RMK, OWB, TT. Literature research: MM, MJG, SV, ASP. Data analysis and interpretation: MM, SV, MJG, ASP. Manuscript preparation: MM MJG, SV. Revision of manuscript for important intellectual content: ASP. Approval of final version of manuscript: all authors.

  • Funding This work was supported by Medtronic Neurovascular. The content is solely the responsibility of the authors, and does not represent the official views of Medtronic.

  • Competing interests MM, FC, ETL, RMK, OWB, TT, SV: None. JMW: Employed by Medtronic Neurovascular. MJG: Has been a consultant on a fee-per-hour basis for Codman Neurovascular, InNeuroCo and Stryker Neurovascular; holds stock in InNeuroCo; and has received research support from the National Institutes of Health (NIH), CereVasc LLC, Codman Neurovascular, Gentuity, Microvention, Medtronic Neurovascular, Neuravi, Philips Healthcare, InNeuroCo, Rapid Medical, Stryker Neurovascular, and the Wyss Institute. ASP: Has been a consultant on a fee-per-hour basis for Medtronic Neurovascular and Stryker Neurovascular; and has received research grants from Medtronic Neurovascular and Stryker Neurovascular.

  • Provenance and peer review Not commissioned; externally peer reviewed.