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  • Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience

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New devices
Case series
Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience
  1. Francesco Briganti1,
  2. Giuseppe Leone2,
  3. Lorenzo Ugga2,
  4. Mariano Marseglia2,3,
  5. Antonio Macera2,
  6. Andrea Manto3,
  7. Luigi Delehaye4,
  8. Maurizio Resta5,
  9. Mariachiara Resta6,
  10. Nicola Burdi5,
  11. Nunzio Paolo Nuzzi7,
  12. Ignazio Divenuto8,
  13. Ferdinando Caranci2,
  14. Mario Muto9,
  15. Domenico Solari10,
  16. Paolo Cappabianca10,
  17. Francesco Maiuri10
  1. 1Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, ‘Federico II’ University, Naples, Italy
  2. 2Department of Advanced Biomedical Sciences, ‘Federico II’ University, Naples, Italy
  3. 3Department of Neuroradiology, ‘Umberto I’ Hospital, Nocera Inferiore, Salerno, Italy
  4. 4Unit of Interventional Neuroradiology, San Giovanni Bosco Hospital, Naples, Italy
  5. 5Department of Radiology and Neuroradiology, ‘SS Annunziata’ Hospital, Taranto, Italy
  6. 6Unit of Neuroradiology, Aldo Moro University, Bari, Italy
  7. 7Unit of Neuroradiology, Humanitas Research Hospital, Rozzano, Milan, Italy
  8. 8Department of Radiology, Azienda Ospedaliero—Universitaria Maggiore della Carità, Novara, Italy
  9. 9Neuroradiology Department, Cardarelli Hospital, Naples, Italy
  10. 10Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, ‘Federico II’ University, Naples, Italy
  1. Correspondence to Professor Francesco Briganti, Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, Federico II University, Via S. Pansini 5, Naples 80131, Italy; frabriga{at}unina.it

Abstract

Background Experience with the endovascular treatment of cerebral aneurysms using the p64 Flow Modulation Device is still limited. This study discusses the results and complications of this new flow diverter device.

Methods 40 patients (30 women, 10 men) with 50 cerebral aneurysms treated in six Italian neurointerventional centers with the p64 Flow Modulation Device between April 2013 and September 2015 were retrospectively reviewed.

Results Complete occlusion was obtained in 44/50 aneurysms (88%) and partial occlusion in 3 (6%). In the other three aneurysms (6%), two cases of asymptomatic in-stent thrombosis and one intraprocedural occlusion of the parent vessel occurred. Technical complications were observed in eight procedures (16%). Permanent morbidity due to acute in-stent thrombosis and consequent ischemic stroke occurred in one patient (2.5%). No delayed aneurysm rupture, subarachnoid or intraparenchymal hemorrhage, or ischemic complications occurred and there were no deaths.

Conclusions Endovascular treatment with the p64 Flow Modulation Device is a safe treatment for unruptured cerebral aneurysms, resulting in a high rate of occlusion. As with other flow diverter devices, we recommend this treatment mainly for large-necked aneurysms of the internal carotid artery siphon. However, endovascular treatment with the p64 device should also be encouraged in difficult cases such as aneurysms of the posterior circulation and beyond the circle of Willis.

  • Aneurysm
  • Angiography
  • Flow Diverter

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/neurintsurg-2016-012502

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    Footnotes

    • Contributors FB designed data collection tools, monitored data collection, cleaned and analyzed the data, and drafted and revised the paper. He is the guarantor of the study. GL analyzed the data and drafted and revised the paper. LU monitored data collection, analyzed the data and drafted and revised the paper. MM, AM, LD, MR, NB and ID monitored data collection for the whole study and revised the draft paper. AM, MR NPN and MM designed data collection tools, monitored data collection, and revised the draft paper. FM, MM, PC, DS and FC analyzed the data and drafted and revised the paper.

    • Competing interests FB serves as proctor for Covidien. NPN serves as proctor for Sequent Medical, Covidien and as consultant for Covidien, MicroVention, Sequent Medical.

    • Patient consent Obtained.

    • Ethics approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or National Research Committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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

    • Data sharing statement Participants gave informed consent for data sharing.