Prospective study to assess the tissue response to HPC-coated p48 flow diverter stents compared to uncoated devices in the rabbit carotid artery model

Lenz-Habijan, Tim; Bhogal, Pervinder; Bannewitz, Catrin; Hannes, Ralf; Monstadt, Hermann; Simgen, Andreas; Mühl-Benninghaus, Ruben; Reith, Wolfgang; Henkes, Hans

doi:10.1186/s41747-019-0128-z

Cited by 23 publications

(18 citation statements)

References 23 publications

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“…Growing efforts in this area besides the Pipeline Shield include the P48 and P64 hydrophilic polymer-coated devices with early preclinical data. 24 25 Early endothelial coverage of flow diverters could also mitigate thromboembolic complications if adequate wall apposition of the device with the parent artery is achieved. Optimization of pore density of flow diverters is important to achieve adequate stagnation inside the aneurysm, improve occlusion and thereby scaffolding at the neck of the aneurysm.…”

Section: Discussionmentioning

confidence: 99%

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

Starke

Thompson

Pagani

et al. 2020

J NeuroIntervent Surg

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BackgroundThe Pipeline Vantage Embolization Device with Shield Technology is a next generation flow diverter developed to improve aneurysm occlusion and implant endothelialization in addition to lowering thrombogenicity. We report here the in vivo biocompatibility and in vitro hemocompatibility performance of the Pipeline Vantage Embolization Device with Shield Technology (Vantage) compared with the Pipeline Flex Embolization Device (Flex).MethodsBiocompatibility (via histology), aneurysm occlusion and vessel patency (via angiography), and endothelial coverage (via scanning electron microscopy (SEM)) for the Vantage and Flex devices were assessed in the rabbit elastase aneurysm model at 90 days (n=29) and 180 days (n=27). In vitro thrombogenicity for Flex and Vantage (n=16) was assessed using a human blood flow loop model at low heparin concentration (0.6 U/mL) with thrombin generation, platelet activation and thrombus visualization as outputs.ResultsRaymond Roy Occlusion Classification grade 1 was higher for Vantage (61%) compared with Flex (46%), but was not statistically significant (p>0.05). All branch vessels were patent. Histological measures for both devices were similar (p>0.05). Endothelial coverage of the implant was significantly better for Vantage compared with Flex (p<0.05). In vitro measurements of thrombin generation (thrombin-antithrombin complex (µg/mL): Vantage 0.49±0.45; Flex 10.57±9.84) and platelet activation (β-thromboglobulin (IU/µl): Vantage 0.41±0.19; Flex 4.14±2.38) were both statistically lower (p<0.05) for Vantage compared with Flex. High resolution microscopy showed less accumulation of thrombus on Vantage as compared with Flex.ConclusionVantage improved aneurysm occlusion and implant endothelialization and had significantly lower thrombogenicity as compared with Flex, while preserving the biocompatibility safety profile of Flex.

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Section: Discussionmentioning

confidence: 99%

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

Starke

Thompson

Pagani

et al. 2020

J NeuroIntervent Surg

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“…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. Preliminary in vivo canine experiments were also conducted using the p64 MW HPC device, which appeared to be biocompatible and unable to trigger acute inflammation.…”

Section: Discussionmentioning

confidence: 89%

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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“…It is designed to mimic the biological properties of the glycocalyx, the coverage that can be found on the luminal surface of the endothelium of the arterial wall, making the coated surface hydrophilic and, consequently, less thrombogenic 7. In vivo studies have shown that the pHPC has no pharmaceutical effect and is biocompatible in both dogs and rabbits, with no evidence of acute inflammatory response 27–29. These in vivo studies comparing coated and uncoated devices showed no difference in the rate of neo-endothelialization, which implies that pHPC reduces the thrombogenicity of the device but does not inhibit its endothelialization.…”

Section: Discussionmentioning

confidence: 99%

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

Aguilar-Pérez

AlMatter

Hellstern

et al. 2020

J NeuroIntervent Surg

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BackgroundCoil occlusion has become the standard treatment for many ruptured aneurysms. However, specific aneurysm structures pose technical difficulties and may require the use of adjunctive neck-bridging devices, which necessitate the use of dual antiplatelet therapy. The hydrophilic polymer coating (pHPC, phenox) is a surface modification that inhibits platelet adhesion.ObjectiveTo present initial experience with the pCONUS HPC device as an adjunct to coil embolization for ruptured aneurysms using single antiplatelet therapy (SAPT).MethodsAll patients who were treated with the pCONUS HPC for ruptured aneurysms using SAPT were retrospectively identified. The occurrence of thromboembolic and hemorrhagic complications was recorded together with the angiographic and clinical follow-up details.ResultsFifteen patients were identified (nine female) with a median age of 54 years (range 27–81). Six aneurysms were located at the anterior communicating artery, five at the middle cerebral artery bifurcation, two at the basilar artery bifurcation, one at the posterior communicating artery, and one involving the intradural internal carotid artery. Ten patients (66.6%) achieved modified Raymond–Roy classification I or II at post-treatment angiography, with 45.5% of patients having adequate occlusion (defined as complete occlusion or neck remnant) at follow-up. All patients received acetylsalicylic acid (ASA) as SAPT before and after the procedure. Intraprocedural thrombus formation was seen in three patients (20%), resolving in two patients after a bolus dose of eptifibatide, and one treated with mechanical aspiration. No clinical or radiological consequences were seen. There were no recurrent aneurysm ruptures. One patient died owing to cerebral vasospasm.ConclusionThis initial clinical experience highlights the possibility and limitations of using the pCONUS HPC device in the treatment of complex ruptured aneurysm with ASA as SAPT. Randomized trials with longer follow-up in larger cohorts are underway.

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Prospective study to assess the tissue response to HPC-coated p48 flow diverter stents compared to uncoated devices in the rabbit carotid artery model

Cited by 23 publications

References 23 publications

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

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

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

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