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

Abstract

BackgroundExperience 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.Methods40 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.ResultsComplete 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.ConclusionsEndovascular 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.

Postprocedural, midterm, and long-term results of cerebral aneurysms treated with flow-diverter devices: 7-year experience at a single center

“…1,2,[4][5][6][7][8]10,11,13 In addition, recent cost-effectiveness analyses have favored flow diversion over alternative endovascular treatments, particularly for large or giant aneurysms. 11 However, consensus has not been reached as regards the long-term stability of treatment and complication rates.…”

“…Furthermore, morbidity and mortality rates are similar to those reported in other series in the literature. 5,17,18,23 Finally, it is worth noting that the retrospective study design, small number of included cases, and prevalence of aneurysms of the ICA siphon (83%) and small aneurysms (78%) could represent certain limitations.…”

Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study

“…To address these limitations, FDDs are continuously being revised technically and novel devices such as the Flow Re-Direction Endoluminal Device (FRED, Microvention, Tustin, California, USA),10 the Pipeline Flex (Covidien),11 and the p64 (Phenox, Bochum, Germany)12 have been introduced to the market. However, while experience with the PED has been extensively reported in the literature, evidence for newer FDDs is still limited.…”

The Fate of Side Branches Covered by Flow Diverters–Results from 140 Patients

“…A C C E P T E D ACCEPTED MANUSCRIPT 3 We sought to determine the fate of covered branches in our institution.…”

“…Flow diverter stents (FDS) have gained increasing acceptance amongst the interventional and neurosurgical communities as an alternative treatment options for saccular intra-cranial aneurysms [1][2][3][4][5][6][7][8][9][10][11][12][13] . Similarly they have also shown benefit in previously difficult to treat diseases such as posterior circulation nonsaccular aneurysms 14 .…”