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

Francesco Briganti, Giuseppe Leone, Lorenzo Ugga, Mariano Marseglia, Antonio Macera, Andrea Manto, Luigi Delehaye, Maurizio Resta, Mariachiara Resta, Nicola Burdi, Nunzio Paolo Nuzzi, Ignazio Divenuto, Ferdinando Caranci, Mario Muto, Domenico Solari, Paolo Cappabianca, Francesco Maiuri, Francesco Briganti, Giuseppe Leone, Lorenzo Ugga, Mariano Marseglia, Antonio Macera, Andrea Manto, Luigi Delehaye, Maurizio Resta, Mariachiara Resta, Nicola Burdi, Nunzio Paolo Nuzzi, Ignazio Divenuto, Ferdinando Caranci, Mario Muto, Domenico Solari, Paolo Cappabianca, Francesco Maiuri

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.

Keywords: Aneurysm; Angiography; Flow Diverter.

Conflict of interest statement

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

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
A 70-year-old man with a fusiform right middle cerebral artery aneurysm. (A) Pretreatment time-of-flight MR angiogram. (B, C) Pretreatment three-dimensional digital subtraction angiogram with flow diverter device length and size evaluation. (D) Deployment of two p64 flow diverter devices. (E) Angiogram at the end of the procedure shows immediate contrast stasis (F) Three-month follow-up angiogram after p64 placement shows complete exclusion of the aneurysm.
Figure 2
Figure 2
A 58-year-old woman with a large fenestration basilar artery aneurysm with compression on the brainstem. (A) Left vertebral artery angiogram. (B) Non-subtracted image shows fully opened p64 and coiling of the sac. (C, D) Early angiogram after deployment of p64 flow diverter device. (E, F) Three-month follow-up shows persistent occlusion of the aneurysm (E) but also in-stent thrombosis (F). (G, H) MRI before (G) and 3 months after (H) the procedure shows reduced compression on the brainstem.
Figure 3
Figure 3
A 66-old-man with a large partially thrombosed aneurysm of the P2 tract of the right posterior cerebral artery. (A, B) Non-subtracted image (anteroposterior and oblique views). (C) Non-subtracted image showing deployment of the p64 device. (D) Three-month follow-up angiogram after p64 placement shows complete occlusion of the aneurysm.

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Source: PubMed

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