Thrombogenicity of the p48 and anti-thrombogenic p48 hydrophilic polymer coating low-profile flow diverters in an in vitro human thrombin generation model

Bhogal, Pervinder; Lenz-Habijan, Tim; Bannewitz, Catrin; Hannes, Ralf; Monstadt, Hermann; Brodde, Martin F.; Kehrel, Beate E.; Henkes, Hans

doi:10.1177/1591019920923817

Cited by 6 publications

(6 citation statements)

References 37 publications

(44 reference statements)

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“…In support of this hypothesis, initial in vitro experiments by Lenz-Habijan et al 2 showed a significant reduction of adherent CD61 þ platelets on pHPC nickel titanium surfaces compared to uncoated ones, thus paving the way for the development of antithrombogenic endovascular devices. Also, Bhogal et al 10 reported a reduction in thrombogenicity using a p48 HPC FDS in an in vitro model of human thrombin generation. On the other hand, a second investigation by Lenz-Habijan et al, 11 evaluating the effects of implantation of HPC FDS vs. uncoated FDS in rabbit carotid arteries, did not observe significant differences between the two devices with regard to implantation, foreign body response and endothelialization.…”

Section: Discussionmentioning

confidence: 99%

Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: Preliminary experience

et al. 2020

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Background The use of flow diverter stent (FDS) has limitations in cases of subarachnoid haemorrhage caused by ruptured aneurysm, due to the need for double antiplatelet therapy and the delay in the aneurysm occluding. The p48 MW and the p64 MW (Phenox) are available with Hydrophilic Polymer Coating (HPC), that reduces the risk of thrombus formation. Purpose of this study is to evaluate the safety and efficacy of p48 and p64 MW HPC with single antiplatelet therapy for the acute treatment of ruptured aneurysm. Methods We retrospectively evaluated all patients treated for acutely ruptured aneurysms with a p48 MW HPC or p64 MW HPC from October 2019 to April 2020 using single antiplatelet therapy. For each patient, we considered demographic and aneurysm-related data, clinical presentation, size and location of the implanted flow diverter stent, intra- and post-procedural complications, aneurysm occlusion. Results Seven patients were included. The ruptured aneurysms were four saccular, two blister-like and one dissecting, six in the anterior and one in posterior circulation. No intraprocedural stent thrombosis and rebleeding was observed. In two cases the aneurysm is completely excluded, in one patient it was found only neck perfusion, in three cases there were mild reduction of the sac and in one case there was a persistent perfusion. No patients needed retreatment in this series. Conclusion In our experience, FDS HPC appears a potential treatment option in selected cases. Our study is limited by small population and short-term follow-up. We report our preliminary data, but further investigations are necessary.

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Section: Discussionmentioning

confidence: 99%

Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: Preliminary experience

et al. 2020

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“…More recently a larger series, including the pCONUS2 HPC device was published. The pCONUS2 HPC device has a hydrophilic polymer coating that has shown reduced thrombogenicity when applied to nitinol [18][19][20][21][22][23][24][25] and cobalt-chromium surfaces [26]. Yeomans et al [16] reported the results of 20 aneurysms, 4 of which were ruptured, treated with the pCONUS2 (n = 13) or the pCONUS2 HPC (n = 7) with all of the ruptured aneurysms treated using the pCONUS2 HPC.…”

Section: Discussionmentioning

confidence: 99%

The pCONUS2 and pCONUS2 HPC Neck Bridging Devices

et al. 2022

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Introduction Bifurcation aneurysms represent an ongoing endovascular challenge with a variety of techniques and devices designed to address them. We present our multicenter series of the pCONUS2 and pCONUS2 HPC devices when treating bifurcation aneurysms. Methods We performed a retrospective review of our prospectively maintained databases at 3 tertiary neurointerventional centers to identify all patients who underwent coil embolization with the pCONUS2 or pCONUS2 HPC device between February 2015 and August 2021. We recorded baseline demographics, aneurysm data, complications, immediate and delayed angiographic results. Results We identified 55 patients with 56 aneurysms, median age 63 years (range 42–78 years), 67.3% female (n = 37). The commonest aneurysm location was the MCA bifurcation (n = 40, 71.4%). Average dome height was 8.9 ± 4.2 mm (range 3.2–21.5 mm), average neck width 6.4 ± 2.5 mm (range 2.6–14 mm), and average aspect ratio 1.3 ± 0.6 (range 0.5–3.3). The pCONUS2 was used in 64.3% and the pCONUS2 HPC in 35.7%. The procedural technical success rate was 98.2%. Intraoperative complications occurred in 5 cases (8.9%), 4 of which were related to the coils with partial thrombus formation on the pCONUS2 HPC seen in 1 case that was resolved with heparin. In relation to the procedure and treatment of the aneurysm the overall permanent morbidity was 1.8% (n = 1/55) and mortality 0%. Delayed angiographic follow-up (48 aneurysms) at median 12 months postprocedure (range 3–36 months) demonstrated adequate occlusion of 83.4% of aneurysms. Conclusion The pCONUS2 and pCONUS2 HPC devices carry a high technical success rate, low complication and retreatment rate, and good rates of adequate occlusion. Larger prospective confirmatory studies are required.

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“… 37 Similarly, in vitro flow model tests demonstrated that the thrombogenicity of coated p48MW HPC flow diverters was significantly lower than that of uncoated p48MW flow diverters. 30 , 33 In vivo studies have shown that the coating elicits neither an acute nor chronic inflammatory reaction in the arterial walls after implantation with biocompatibility shown across different species (canines and rabbits). 31 , 32 , 35 Of equal importance there was no evidence from these in vivo studies to suggest that the coating impaired neo-endothelialisation and hence the initial in vitro and in vivo results suggested that the coating did limit the thrombogenicity of coated devices but without any evidence of causing either a slowing in the neo-endothelialisation process, that could impair aneurysm exclusion, or an inflammatory reaction.…”

Section: Discussionmentioning

confidence: 99%

“… 28 , 29 The Hydrophilic Polymer Coating (HPC, phenox, Bochum, Germany) was developed to limit the need for dual antiplatelet therapy (DAPT) and can be applied to flow diverters as well as other nitinol surfaces. 30 – 37 This glycan polymer simulates the features of the glycocalyx and thereby limits the thrombogenicity of the coated devices hence allowing the use of SAPT.…”

Section: Introductionmentioning

confidence: 99%

Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment

Bhogal

Петров

Rentsenkhu³

et al. 2021

Interv Neuroradiol

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Background The p64MW HPC and p48MW HPC flow diverters have reduced thrombogenicity due to hydrophilic coating. The purpose of this study was to evaluate its safety and efficacy in Mongolian patients under single antiplatelet therapy (SAPT) with prasugrel. Materials and methods We performed a retrospective review of patients enrolled into our prospectively maintained database to identify all patients treated with either the p48MW HPC or p64MW HPC under SAPT. We recorded baseline demographics, aneurysm size and location, procedural complications, angiographic and clinical results. Results 24 patients, (female = 21, 87.5%), age 48.2 ± 11.6 years (range 25–63) underwent treatment of 30 aneurysms with either p64MW HPC or p48MW HPC. All aneurysms were saccular with dome width 8.2 ± 6.5 (range 1.6–26.0 mm) and dome height 7.6 ± 6.7 (range 1.6–30.0 mm). None of the aneurysms were previously treated. The average PRU was 54.6 ± 31.2 (range 1–127) on pre-operative VerifyNow testing. Angiographic follow-up was available for 13 patients (17 aneurysms), 183 ± 36 days post-procedure, at which point 64.7% of aneurysms (n = 11/17) were completely occluded and 11.8% (n = 2/17) had only neck remnants resulting in 76.5% of aneurysms being adequately occluded A single intra-operative complication (4.2%) occurred however all patients were mRS ≤1 at last follow-up. There were two post-operative complications neither of which resulted in permanent neurological morbidity. There were no instances of post-operative aneurysmal rupture or delayed parenchymal haemorrhage. The overall mortality was 0%. Conclusion The efficacy and safety of p64MW HPC coated devices under SAPT is similar to uncoated flow diverters that require DAPT.

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Thrombogenicity of the p48 and anti-thrombogenic p48 hydrophilic polymer coating low-profile flow diverters in an in vitro human thrombin generation model

Cited by 6 publications

References 37 publications

Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: Preliminary experience

Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: Preliminary experience

The pCONUS2 and pCONUS2 HPC Neck Bridging Devices

Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment

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