The p48_HPC antithrombogenic flow diverter: initial human experience using single antiplatelet therapy

Abstract

The p48 is a low-profile, intermediate-porosity flow diverter. phenox GmbHtrademarked hydrophilic polymer coating (pHPC) is a hydrophilic coating that has been shown in vitro to reduce the thrombogenicity of nitinol device surfaces. We performed the present study to determine whether the p48_HPC can be implanted using prasugrel alone. Methods: We retrospectively identified all patients who were treated with the p48_HPC from January 2017 to December 2018 (n ¼ 5) and underwent single antiplatelet therapy (SAPT) with prasugrel. P2Y12 inhibition was confirmed by the VerifyNow assay. The occurrence of thromboembolic and haemorrhagic complications was recorded alongside the occlusion rates of the treated aneurysms. Results: All patients achieved adequate occlusion (Raymond-Roy Occlusion Classification I or II) during the follow-up period. No thromboembolic complications occurred. One patient developed a contained haematoma within the Sylvian fissure from the treated aneurysm 2 weeks postoperatively without clinical sequelae. Conclusions: In this small series, no thromboembolic complications occurred in patients treated with the surface modified p48_HPC flow diverter and SAPT. Further studies with longer follow-up periods and larger cohorts should be performed.

The p48 Flow Modulation Device with Hydrophilic Polymer Coating (HPC) for the Treatment of Acutely Ruptured Aneurysms: Early Clinical Experience Using Single Antiplatelet Therapy

“…pHPC has no pharmaceutical effect, is biocompatible with no evidence of acute inflammatory response, and does not interact with the physical properties of the metallic implant [10,11]. Bhogal et al [5] recently reported on the use of the p48MW HPC under SAPT in treating five patients with unruptured aneurysms and reported no thromboembolic complications, with just one patient experiencing a minor hemorrhage from the treated aneurysm 2 weeks postoperatively. However, only prasugrel was used for SAPT, and there were no ruptured aneurysms treated in this series.…”

“…Its hydrophilic polymer coating (pHPC, phenox, Bochum, Germany) is a novel glycan-based multilayer polymer that has been shown to have significant anti-thrombogenic properties when tested in vitro [4]. A recently published study concluded that the p48MW HPC appears both safe and efficacious under single antiplatelet therapy (SAPT) using prasugrel in selected cases of unruptured aneurysms [5]. However, no publications have yet focused on the use of this surface-modified FDS in the setting of aSAH.…”

Use of the pCONus HPC as an adjunct to coil occlusion of acutely ruptured aneurysms: early clinical experience using single antiplatelet therapy

“…Bhogal et al reported the use of the p48MW HPC in treating five patients with unruptured aneurysms using only prasugrel as SAPT. They reported no thromboembolic complications while one patient experienced a minor hemorrhage from the treated aneurysm 2 weeks postoperatively 30…”

The p48 MW flow modulation device for treatment of unruptured, saccular intracranial aneurysms: a single center experience from 77 consecutive aneurysms

“…The reported experience with the p48 MW Flow Modulation Device is still very limited (Bhogal et al, 2019 ; Bhogal et al, 2020 ; Aguilar-Perez et al, 2020 ). The Buenos Aires experience with the uncoated version based on 25 patients with 25 aneurysms reported an adequate occlusion rate of 79.2% and a procedure-related complication rate of 4% with no permanent morbidity (Bhogal et al, 2019 ).…”