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New devices and techniques
Original research
Evaluation of a novel flow diverter, the DiVeRt system, in an animal model
  1. Clemens Hufnagl1,
  2. Erasmia Broussalis1,2,
  3. Christophe Cognard3,
  4. Jochen Grimm4,
  5. Constantin Hecker1,2,
  6. Andreas Oellerer1,4,
  7. Muhammed Abdallah1,5,
  8. Christoph J Griessenauer1,6,
  9. Monika Killer-Oberpfalzer1,2
  1. 1 Institute of Neurointervention, Paracelsus Medical University, Salzburg, Austria
  2. 2 Department of Neurology, University Hospital Salzburg, Salzburg, Austria
  3. 3 Diagnostic and Therapeutic Neuroradiology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  4. 4 Department of Neuroradiology, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria
  5. 5 Department of Vascular and Endovascular Surgery, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria
  6. 6 Department of Neurosurgery, Geisinger, Danville, Pennsylvania, USA
  1. Correspondence to Professor Monika Killer-Oberpfalzer, Department of Neurology, Paracelsus Medical University Salzburg, Salzburg 5020, Austria; m.killer{at}salk.at

Abstract

Background Using a surgical aneurysm model, this study assessed the performance of a new flow diverter (FD), the DiVeRt, and evaluated the angiographic and histologic features at different periods after stent deployment.

Methods Fifteen New Zealand White rabbits were treated 3 days prior to intervention and until euthanization with dual antiplatelets. DiVeRt was implanted in bilateral carotid aneurysms (n=30) as well as in the aorta (n=15). The rate of technical success, assessment of aneurysm occlusion (measured by the O'Kelly–Marotta grading (OKM) scale), and stent patency were examined using angiography and histologic examinations in three groups at 1, 3, and 6 months follow-up (FU). In each FU group one control animal was included and treated with the XCalibur stent (n=3).

Results Overall, DiVeRt placement was successful and without apparent intraprocedural complications. In total, four stents in the carotid artery were occluded and in-stent stenosis was registered in two carotid (7%) and one aortic (6%) vessels. Complete or near complete aneurysm occlusion (OKM scale D1 and C3) was seen in 100% in the 1-month FU group, 70% in the 2-month FU group, and 100% in the 3-month FU group. Histology showed loose, organizing fibrous tissue matrix within the sac and adequate neck endothelialization in all vessels. All branches covered by the DiVeRt remained patent.

Conclusions The DiVeRt system appears to be feasible and effective for the treatment of aneurysms with high rates of complete aneurysm occlusion, excellent vessel patency, and evidence of high biocompatibility. Occurrences of parent artery occlusion at follow-up did not result in clinical consequences.

  • flow diverter
  • aneurysm
  • intervention

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/neurintsurg-2021-017430

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Twitter @cgriessenauer

    • Contributors CHu, EB, JG, CHe, AO, and MA performed the measurements and analyzed the data. MKO supervised the work. CHe and BE processed the experimental data, performed the analysis, drafted the manuscript and designed the figures. CHu, EB, and MKO performed the calculations. CC, JG, and CJG supported the interpretation of the results. All authors discussed the results and commented on the manuscript.

    • 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 None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.