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New devices and techniques
Original research
First clinical multicenter experience with the new Pipeline Vantage flow diverter
  1. Dominik F Vollherbst1,
  2. H Saruhan Cekirge2,
  3. Isil Saatci2,
  4. Feyyaz Baltacioglu3,
  5. Baran Onal4,
  6. Osman Koc5,
  7. Riitta Rautio6,
  8. Matias Sinisalo6,
  9. Alejandro Tomasello7,
  10. Pedro Vega8,
  11. Mario Martínez-Galdámez9,
  12. Jeremy Lynch10,
  13. Vitor Mendes Pereira11,
  14. Martin Bendszus1,
  15. Markus A Möhlenbruch1
  1. 1 Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany
  2. 2 Interventional Neuroradiology Department, Koru Hospital, Ankara, Turkey
  3. 3 Department of Radiology, Marmara University School of Medicine, Istanbul, Turkey
  4. 4 Radiology Department, School of Medicine, Gazi University, Ankara, Turkey
  5. 5 Radiology Department, Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Turkey
  6. 6 Department of Interventional Radiology, Turku University Hospital, Turku, Finland
  7. 7 Interventional Neuroradiology Section, Department of Radiology, Vall d’Hebron University Hospital, Barcelona, Spain
  8. 8 Interventional Neuroradiology, Department of Radiology, Hospital Universitario Central de Asturias, Oviedo, Spain
  9. 9 Department of Interventional Neuroradiology/Endovascular Neurosurgery, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
  10. 10 Neuroradiology, Toronto Western Hospital, Toronto, Ontario, Canada
  11. 11 Department of Neurosurgery, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Prof Dr Markus A Möhlenbruch, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany; markus.moehlenbruch{at}med.uni-heidelberg.de

Abstract

Background Flow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD.

Methods Patients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed.

Results 60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure.

Conclusions The new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.

  • aneurysm
  • flow diverter
  • angiography
  • 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-2021-018480

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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 @pedrovegavaldes, @Doctorgaldamez, @VitorMendesPer1

    • Contributors All listed authors contributed to the work. DFV and MAM acquired, analyzed, and interpreted data for the work; designed the study; drafted the manuscript and approved the final manuscript. DFV and MAM are guarantors of this work. IS and MB acquired, analyzed, and interpreted data for the work; drafted the manuscript and approved the final manuscript. SC, FB, BO, OK, RR, MS, AT, PV, MMG, JL and VMP acquired and analyzed data for the work and approved the final 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 DFV has received travel support outside this work from MicroVention and Stryker GmbH & Co. KG. SC is shareholder of NDI Technologies and Vesalio LLC, non-paid member of Siemens Senior Advisory Board, and reports consultancy proctorship agreements with Medtronic and MicroVention. IS reports consultancy and proctorship agreements with Medtronic and MicroVention, and is Associate Editor for JNIS. RR is consultant for Stryker Neurovascular, Medtronic, MicroVention and Acandis. MMG is consultant and proctor for Medtronic. VMP is consultant for Medtronic. MB reports board membership: DSMB Vascular Dynamics; consultancy: Roche, Guerbet, Codman; grants/grants pending: DFG, Hopp Foundation, Novartis, Siemens, Guerbet, Stryker, Covidien; payment for lectures (including service on speakers bureaus): Novartis, Roche, Guerbet, Teva, Bayer, Codman. MM has received consulting honoraria, speaker honoraria, and travel support outside this work from Codman, Covidien/Medtronic, MicroVention, Phenox, and Stryker.

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