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The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center

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Abstract

Background and Purpose

The p64 is a flow modulation device designed to be used in endovascular treatment of intracranial aneurysms. There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device.

Methods

A retrospective review of a prospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed.

Results

A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly–Marotta scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%).

Conclusion

Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complications.

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Author information

Authors and Affiliations

  1. Radiology department, University Hospital St. Ivan Rilski, Sofia, Bulgaria

    S. Sirakov, A. Sirakov & M. Penkov

  2. Neurosurgery department, University Hospital St. Ivan Rilski, Sofia, Bulgaria

    K. Minkin, K. Ninov, H. Hristov & V. Karakostov

  3. Department of Interventional Neuroradiology, The Royal London Hospital, London, UK

    P. Bhogal

  4. Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles David Geffen School of Medicine, Los Angeles, USA

    R. Raychev

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  1. S. Sirakov
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Correspondence to S. Sirakov.

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Conflict of interest

S. Sirakov, A. Sirakov, P. Bhogal, M. Penkov, K. Minkin, K. Ninov, H. Hristov, V. Karakostov and R. Raychev declare that they have no competing interests.

Ethical standards

All procedures performed in the 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. Informed consent was obtained from all individual participants included in the study.

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Sirakov, S., Sirakov, A., Bhogal, P. et al. The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center. Clin Neuroradiol 30, 471–480 (2020). https://doi.org/10.1007/s00062-019-00823-y

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