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Ajit S Puri - One of the best experts on this subject based on the ideXlab platform.

  • anatomic snuffbox distal radial artery and radial artery access for treatment of intracranial aneurysms with fda approved flow Diverters
    American Journal of Neuroradiology, 2021
    Co-Authors: Anna Luisa Kuhn, Matthew J Gounis, Sudhakar R Satti, T Eden, K De Macedo Rodrigues, J Singh, Francesco Massari, Ajit S Puri
    Abstract:

    BACKGROUND AND PURPOSE: Transradial access for neurointerventional procedures has been proved a safer and more comfortable alternative to femoral artery access. We present our experience with transradial (distal radial/anatomic snuffbox and radial artery) access for treatment of intracranial aneurysms using all 3 FDA-approved flow Diverters. MATERIALS AND METHODS: This was a high-volume, dual-center, retrospective analysis of each institution’s data base between June 2018 and June 2020 and a collection of all patients treated with flow diversion via transradial access. Patient demographic information and procedural and radiographic data were obtained. RESULTS: Seventy-four patients were identified (64 female patients) with a mean age of 57.5 years with a total of 86 aneurysms. Most aneurysms were located in the anterior circulation (93%) and within the intracranial ICA (67.4%). The mean aneurysm size was 5.5 mm. Flow Diverters placed included the Pipeline Embolization Device (Flex) (PED, n = 65), the Surpass Streamline Flow Diverter (n = 8), and the Flow-Redirection Endoluminal Device (FRED, n = 1). Transradial access was successful in all cases, but femoral crossover was required in 3 cases (4.1%) due to tortuous anatomy and inadequate support of the catheters in 2 cases and an inability to navigate to the target vessel in a patient with an aberrant right subclavian artery. All 71 other interventions were successfully performed via the transradial approach (95.9%). No access site complications were encountered. Asymptomatic radial artery occlusion was encountered in 1 case (3.7%). CONCLUSIONS: Flow Diverters can be successfully placed via the transradial approach with high technical success, low access site complications, and a low femoral crossover rate.

  • acute thrombus burden on coated flow Diverters assessed by high frequency optical coherence tomography
    CardioVascular and Interventional Radiology, 2020
    Co-Authors: Hans Henkes, Robert M King, Ajit S Puri, Erin T Langan, Giovanni J Ughi, Christopher M Raskett, Matthew J Gounis
    Abstract:

    The implantation of flow Diverters requires administration of dual anti-platelet therapy, posing the potential for complications. The p48MW HPC (phenox, Bochum, Germany) hydrophilic-coated flow diverting stent is designed to be anti-thrombotic, thus opening the potential for single anti-platelet therapy. We deploy a novel intravascular high-resolution imaging technique, high-frequency optical coherence tomography (HF-OCT), to study in an animal model the acute thrombus formation on coated p48MW devices versus uncoated control devices. Three pigs were implanted with 4 flow Diverters each, two test hydrophilic-coated devices, and two control uncoated devices (p48MW). Each pig was treated with a different anti-platelet regime: no anti-platelet therapy, aspirin only, aspirin and clopidogrel. Twenty minutes after the flow diverter was implanted, an HF-OCT data set was acquired. Acute clot formed on the flow diverter at each covered side branch was measured from the HF-OCT slices. Factors considered to be important were the device type (pHPC versus bare metal), aspirin, clopidogrel, and vessel location. A linear model was constructed from the significant factors. Both coating (p < 0.001) and aspirin (p = 0.003) were significantly related to reduction in clot burden, leading to an approximate 100-fold and 50-fold reduction in clot, respectively. This study shows the power of HF-OCT not only in the detection of clot but also the quantification of clot burden. In an animal model, the pHPC-coated p48MW significantly reduced acute thrombus formation over jailed side branches as compared to the bare metal p48MW that was nearly eliminated when combined with aspirin administration.

  • introduction history and development of flow diverter technology and evolution
    Neurosurgery, 2020
    Co-Authors: Anna Luisa Kuhn, Matthew J Gounis, Ajit S Puri
    Abstract:

    : The introduction of flow diverter technology to the field of neurointervention has revolutionized the treatment of intracranial aneurysms. The therapy approach has shifted from intrasaccular aneurysm treatment to exclusion of the aneurysm from the blood circulation with remodeling of the parent artery. Previously, "difficult"-to-treat aneurysms including fusiform and blister aneurysms, but also aneurysms arising from a diseased vessel segment, can now be safely and permanently treated with flow Diverters.  A little over a decade ago, after extensive bench testing and refinement of the flow diverter concept, the device was eventually available for clinical use and today it has become a standard treatment for intracranial aneurysms. Currently, United States Food and Drug Administration (FDA)-approved flow Diverters are the Pipeline Embolization Device (Medtronic) and the Surpass Streamline Flow Diverter (Stryker).  The devices can either be delivered or deployed via a standard femoral artery approach or a radial artery approach. Other considerations for catheter setup and device deployment strategies depending on aneurysm location or vessel anatomy are described.

  • communicating malapposition of flow Diverters assessed with optical coherence tomography correlates with delayed aneurysm occlusion
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Robert M King, John Wainwright, Frédéric Clarençon, Jildaz Caroff, Matthew J Gounis, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Miklos Marosfői, Ajit S Puri
    Abstract:

    Background Optical coherence tomography (OCT) is a high resolution intravascular imaging method that allows visualization of flow diverter struts and the vessel wall. In this study, malapposition of the flow diverter that continues into the neck of the aneurysm, named communicating malapposition (CM), was investigated as a potential factor for delayed aneurysm healing. Methods 40 New Zealand White rabbits underwent elastase induced aneurysm creation, and were subsequently assigned to one of four treatment groups based on flow diverter type and administration of antiplatelet therapy. All animals underwent post device deployment balloon angioplasty and subsequent OCT to assess device/vessel apposition. The incidence of CM seen on OCT was assessed with a binary scoring system: 0–CM present; 1–CM absent. At 30 days, DSA was acquired to assess aneurysm healing. Aneurysm healing on terminal DSA was measured using a previously developed 5 point scale, with a score of 3 or 4 considered a positive outcome. Results All animals were grouped into a single cohort for analysis as no difference in the rate of CM or healing was seen in the four treatment groups. Significant interaction between the absence of CM and a positive outcome was confirmed by Fisher exact test (P=0.0034). Angioplasty was shown to treat 33% of the cases of CM seen at implant, and these treated cases overwhelmingly had a positive outcome (P Conclusion The use of OCT to assess CM of flow Diverters has been shown to be predictive of the 30 day healing rate of an animal model of aneurysms.

  • acute thrombus formation on phosphorilcholine surface modified flow Diverters
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: M Marosfoi, John Wainwright, Frédéric Clarençon, Robert M King, Matthew J Gounis, Srinivasan Vedantham, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Ajit S Puri
    Abstract:

    Purpose Thromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow Diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED). Methods Elastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent. Results Following angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p Conclusion In the rabbit model, phosphorilcholine surface modified flow Diverters are associated with less thrombus formation on the surface of the device.

M Marosfoi - One of the best experts on this subject based on the ideXlab platform.

  • acute thrombus formation on phosphorilcholine surface modified flow Diverters
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: M Marosfoi, John Wainwright, Frédéric Clarençon, Robert M King, Matthew J Gounis, Srinivasan Vedantham, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Ajit S Puri
    Abstract:

    Purpose Thromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow Diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED). Methods Elastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent. Results Following angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p Conclusion In the rabbit model, phosphorilcholine surface modified flow Diverters are associated with less thrombus formation on the surface of the device.

  • phosphorylcholine surface modified flow diverter associated with reduced intimal hyperplasia
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Jildaz Caroff, John Wainwright, Frédéric Clarençon, Laurent Spelle, Robert M King, Takamitsu Tamura, P Lylyk, Erin T Langan, Olivia W Brooks, M Marosfoi
    Abstract:

    Background Optical coherence tomography (OCT) is a high-resolution, intra-vascular diagnostic technique widely used for the characterization of vascular pathologies and optimization of stent implantation during percutaneous coronary intervention. OCT was used to investigate the in vivo vascular response to a new phosphorylcholine surface modified flow diverter (sPED). Methods In an in vivo rabbit aneurysmal model, we used two different types of flow Diverters (classic Pipeline – cPED; and sPED) with or without dual antiplatelet therapy (four groups, n=10 per group). OCT cross-sectional area measurements were compared with histology in all animals. Neointimal hyperplasia (NIH) ratio was compared between OCT and histology at five different levels for each stent. The severity of NIH was also compared between the different stents, antiplatelet protocols, and vessel locations. Results OCT was used to calculate in-stent hyperplasia in 227 different locations corresponding to histology sections. OCT measurement strongly correlated with gold standard histology (r 2 =0.83; slope=0.988; P Conclusion OCT is a promising technique for immediate and long-term evaluation of flow diverter stent treatments. In an animal model, phosphorylcholine surface modified flow Diverters induces less NIH after stent implant without reducing aneurysm occlusion rates.

  • evolution of flow diverter endothelialization and thrombus organization in giant fusiform aneurysms after flow diversion a histopathologic study
    American Journal of Neuroradiology, 2015
    Co-Authors: Istvan Szikora, E Turanyi, M Marosfoi
    Abstract:

    BACKGROUND AND PURPOSE: Treatment of giant fusiform aneurysms with flow Diverters has been associated with a relatively high rate of complications. Our goal was to study the evolution of flow-diverter endothelialization and thrombus organization at different time points after flow-diverter treatment in giant fusiform aneurysms to better understand reasons for flow-diverter thrombosis and delayed aneurysm ruptures. MATERIALS AND METHODS: Two giant anterior and 2 posterior circulation aneurysms, all of which had partially thrombosed before treatment, were studied. An unruptured, untreated posterior circulation aneurysm was used as a control. Each specimen was removed at 7 days or at 6, 9, or 13 months after flow-diverter treatment. The 3 patients who survived longer than 7 days were followed up by angiography and MR imaging. Formaldehyde-fixed paraffin-embedded sections were stained by using H&E, Van Gieson elastic, CD34, h-Caldesmon, and Picrosirius stains and studied by light microscopy. RESULTS: According to angiography, aneurysms were found to be obliterated partially at 6 and 9 months and completely at 13 months. MR imaging revealed that mass effect remained unchanged in each case. Sections of the flow diverter within the normal parent artery were covered by an endothelialized fibrous layer as early as 6 months, but there was no tissue coverage or endothelialization seen even at 13 months inside the aneurysm itself. Each treated aneurysm had a thin wall with complete lack of smooth muscle cells. No signs of thrombus organization were found at any of the time points studied. CONCLUSIONS: Endothelialization of the flow diverter in giant fusiform aneurysms may not occur and thrombus organization may not be initiated inside these aneurysms for as long as 1 year, which explains delayed flow-diverter thrombosis and the possibility of delayed ruptures.

John Wainwright - One of the best experts on this subject based on the ideXlab platform.

  • thrombogenicity assessment of pipeline flex pipeline shield and fred flow Diverters in an in vitro human blood physiological flow loop model
    Journal of Biomedical Materials Research Part A, 2018
    Co-Authors: Gaurav Girdhar, Arielle Andersen, Elizabeth Pangerl, Reza Jahanbekam, Kevin Nguyen, John Wainwright, Michael F Wolf
    Abstract:

    : Endovascular treatment of intracranial aneurysms with endoluminal flow Diverters (single or multiple) has proven to be clinically safe and effective, but is associated with a risk of thromboembolic complications. Recently, a novel biomimetic surface modification with covalently bound phosphorylcholine (Shield Technology™) has shown to reduce the material thrombogenicity of the Pipeline flow diverter. Thrombogenicity of Pipeline Flex, Pipeline Shield, and Flow Redirection Endoluminal Device (FRED) in the presence of human blood under physiological flow conditions-in addition to relative increase in thrombogenicity with multiple devices-remains unknown and was investigated here. Thrombin generation (mean ± SD; μg/mL; thrombin-antithrombin complex or TAT) was measured as FRED (30.3 ± 2.9), Pipeline (13.9 ± 4.4), Pipeline Shield (0.4 ± 0.3), and negative control (no device; 0.1 ± 0.0). Platelet activation (mean ± SD; IU/μL; beta-thromboglobulin or βTG) was measured as FRED (148 ± 45), Pipeline (92.8 ± 41), Pipeline Shield (16.2 ± 3.5), and negative control (2.70 ± 0.16). FRED was significantly more thrombogenic than Pipeline and Pipeline Shield (p 0.05). TAT and βTG scaled proportionately with multiple Pipeline devices (N = 6) but was unaffected by multiple Pipeline Shield (N = 6) devices-the latter being statistically similar to negative control (p > 0.05). © 2018 The Authors. Journal Of Biomedical Materials Research Part A Published By Wiley Periodicals, Inc. J Biomed Mater Res Part A: 106A: 3195-3202, 2018.

  • communicating malapposition of flow Diverters assessed with optical coherence tomography correlates with delayed aneurysm occlusion
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Robert M King, John Wainwright, Frédéric Clarençon, Jildaz Caroff, Matthew J Gounis, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Miklos Marosfői, Ajit S Puri
    Abstract:

    Background Optical coherence tomography (OCT) is a high resolution intravascular imaging method that allows visualization of flow diverter struts and the vessel wall. In this study, malapposition of the flow diverter that continues into the neck of the aneurysm, named communicating malapposition (CM), was investigated as a potential factor for delayed aneurysm healing. Methods 40 New Zealand White rabbits underwent elastase induced aneurysm creation, and were subsequently assigned to one of four treatment groups based on flow diverter type and administration of antiplatelet therapy. All animals underwent post device deployment balloon angioplasty and subsequent OCT to assess device/vessel apposition. The incidence of CM seen on OCT was assessed with a binary scoring system: 0–CM present; 1–CM absent. At 30 days, DSA was acquired to assess aneurysm healing. Aneurysm healing on terminal DSA was measured using a previously developed 5 point scale, with a score of 3 or 4 considered a positive outcome. Results All animals were grouped into a single cohort for analysis as no difference in the rate of CM or healing was seen in the four treatment groups. Significant interaction between the absence of CM and a positive outcome was confirmed by Fisher exact test (P=0.0034). Angioplasty was shown to treat 33% of the cases of CM seen at implant, and these treated cases overwhelmingly had a positive outcome (P Conclusion The use of OCT to assess CM of flow Diverters has been shown to be predictive of the 30 day healing rate of an animal model of aneurysms.

  • acute thrombus formation on phosphorilcholine surface modified flow Diverters
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: M Marosfoi, John Wainwright, Frédéric Clarençon, Robert M King, Matthew J Gounis, Srinivasan Vedantham, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Ajit S Puri
    Abstract:

    Purpose Thromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow Diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED). Methods Elastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent. Results Following angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p Conclusion In the rabbit model, phosphorilcholine surface modified flow Diverters are associated with less thrombus formation on the surface of the device.

  • phosphorylcholine surface modified flow diverter associated with reduced intimal hyperplasia
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Jildaz Caroff, John Wainwright, Frédéric Clarençon, Laurent Spelle, Robert M King, Takamitsu Tamura, P Lylyk, Erin T Langan, Olivia W Brooks, M Marosfoi
    Abstract:

    Background Optical coherence tomography (OCT) is a high-resolution, intra-vascular diagnostic technique widely used for the characterization of vascular pathologies and optimization of stent implantation during percutaneous coronary intervention. OCT was used to investigate the in vivo vascular response to a new phosphorylcholine surface modified flow diverter (sPED). Methods In an in vivo rabbit aneurysmal model, we used two different types of flow Diverters (classic Pipeline – cPED; and sPED) with or without dual antiplatelet therapy (four groups, n=10 per group). OCT cross-sectional area measurements were compared with histology in all animals. Neointimal hyperplasia (NIH) ratio was compared between OCT and histology at five different levels for each stent. The severity of NIH was also compared between the different stents, antiplatelet protocols, and vessel locations. Results OCT was used to calculate in-stent hyperplasia in 227 different locations corresponding to histology sections. OCT measurement strongly correlated with gold standard histology (r 2 =0.83; slope=0.988; P Conclusion OCT is a promising technique for immediate and long-term evaluation of flow diverter stent treatments. In an animal model, phosphorylcholine surface modified flow Diverters induces less NIH after stent implant without reducing aneurysm occlusion rates.

  • thrombogenicity of flow Diverters in an ex vivo shunt model effect of phosphorylcholine surface modification
    Journal of NeuroInterventional Surgery, 2017
    Co-Authors: Matthew W Hagen, Gaurav Girdhar, John Wainwright, Monica T. Hinds
    Abstract:

    Background Flow Diverters offer a promising treatment for cerebral aneurysms. However, they have associated thromboembolic risks, mandating chronic dual antiplatelet therapy (DAPT). Shield Technology is a phosphorylcholine surface modification of the Pipeline Embolization Device (PED) flow diverter, which has shown significant reductions in material thrombogenicity in vitro. Objective To compare the thrombogenicity of PED, PED with Shield Technology (PED+Shield), and the Flow-Redirection Endoluminal Device (FRED)—with and without single antiplatelet therapy and DAPT—under physiological flow. Methods An established non-human primate ex vivo arteriovenous shunt model of stent thrombosis was used. PED, PED+Shield, and FRED were tested without antiplatelet therapy, with acetylsalicylic acid (ASA) monotherapy, and with DAPT. Radiolabeled platelet deposition was quantified over 1 hour for each device and total fibrin deposition was also quantified. Results Cumulative statistical analysis showed significantly lower platelet deposition on PED compared with FRED. The same statistical model showed significant decreases in platelet deposition when ASA, clopidogrel, or Shield Technology was used. Direct comparisons of device performances within antiplatelet conditions showed consistent significant decreases in platelet accumulation on PED+Shield relative to FRED. PED+Shield showed significant reductions in platelet deposition compared with unmodified PED without antiplatelet therapy and with DAPT. PED accumulated minimal fibrin with and without Shield Technology. Conclusions In this preclinical model, we have shown that the Shield Technology phosphorylcholine modification reduces the platelet-specific thrombogenicity of a flow diverter under physiologically relevant flow with and without DAPT. We have further identified increased fibrin-driven thrombogenicity associated with FRED relative to PED.

Robert M King - One of the best experts on this subject based on the ideXlab platform.

  • acute thrombus burden on coated flow Diverters assessed by high frequency optical coherence tomography
    CardioVascular and Interventional Radiology, 2020
    Co-Authors: Hans Henkes, Robert M King, Ajit S Puri, Erin T Langan, Giovanni J Ughi, Christopher M Raskett, Matthew J Gounis
    Abstract:

    The implantation of flow Diverters requires administration of dual anti-platelet therapy, posing the potential for complications. The p48MW HPC (phenox, Bochum, Germany) hydrophilic-coated flow diverting stent is designed to be anti-thrombotic, thus opening the potential for single anti-platelet therapy. We deploy a novel intravascular high-resolution imaging technique, high-frequency optical coherence tomography (HF-OCT), to study in an animal model the acute thrombus formation on coated p48MW devices versus uncoated control devices. Three pigs were implanted with 4 flow Diverters each, two test hydrophilic-coated devices, and two control uncoated devices (p48MW). Each pig was treated with a different anti-platelet regime: no anti-platelet therapy, aspirin only, aspirin and clopidogrel. Twenty minutes after the flow diverter was implanted, an HF-OCT data set was acquired. Acute clot formed on the flow diverter at each covered side branch was measured from the HF-OCT slices. Factors considered to be important were the device type (pHPC versus bare metal), aspirin, clopidogrel, and vessel location. A linear model was constructed from the significant factors. Both coating (p < 0.001) and aspirin (p = 0.003) were significantly related to reduction in clot burden, leading to an approximate 100-fold and 50-fold reduction in clot, respectively. This study shows the power of HF-OCT not only in the detection of clot but also the quantification of clot burden. In an animal model, the pHPC-coated p48MW significantly reduced acute thrombus formation over jailed side branches as compared to the bare metal p48MW that was nearly eliminated when combined with aspirin administration.

  • communicating malapposition of flow Diverters assessed with optical coherence tomography correlates with delayed aneurysm occlusion
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Robert M King, John Wainwright, Frédéric Clarençon, Jildaz Caroff, Matthew J Gounis, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Miklos Marosfői, Ajit S Puri
    Abstract:

    Background Optical coherence tomography (OCT) is a high resolution intravascular imaging method that allows visualization of flow diverter struts and the vessel wall. In this study, malapposition of the flow diverter that continues into the neck of the aneurysm, named communicating malapposition (CM), was investigated as a potential factor for delayed aneurysm healing. Methods 40 New Zealand White rabbits underwent elastase induced aneurysm creation, and were subsequently assigned to one of four treatment groups based on flow diverter type and administration of antiplatelet therapy. All animals underwent post device deployment balloon angioplasty and subsequent OCT to assess device/vessel apposition. The incidence of CM seen on OCT was assessed with a binary scoring system: 0–CM present; 1–CM absent. At 30 days, DSA was acquired to assess aneurysm healing. Aneurysm healing on terminal DSA was measured using a previously developed 5 point scale, with a score of 3 or 4 considered a positive outcome. Results All animals were grouped into a single cohort for analysis as no difference in the rate of CM or healing was seen in the four treatment groups. Significant interaction between the absence of CM and a positive outcome was confirmed by Fisher exact test (P=0.0034). Angioplasty was shown to treat 33% of the cases of CM seen at implant, and these treated cases overwhelmingly had a positive outcome (P Conclusion The use of OCT to assess CM of flow Diverters has been shown to be predictive of the 30 day healing rate of an animal model of aneurysms.

  • acute thrombus formation on phosphorilcholine surface modified flow Diverters
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: M Marosfoi, John Wainwright, Frédéric Clarençon, Robert M King, Matthew J Gounis, Srinivasan Vedantham, Takamitsu Tamura, Erin T Langan, Olivia W Brooks, Ajit S Puri
    Abstract:

    Purpose Thromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow Diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED). Methods Elastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent. Results Following angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p Conclusion In the rabbit model, phosphorilcholine surface modified flow Diverters are associated with less thrombus formation on the surface of the device.

  • phosphorylcholine surface modified flow diverter associated with reduced intimal hyperplasia
    Journal of NeuroInterventional Surgery, 2018
    Co-Authors: Jildaz Caroff, John Wainwright, Frédéric Clarençon, Laurent Spelle, Robert M King, Takamitsu Tamura, P Lylyk, Erin T Langan, Olivia W Brooks, M Marosfoi
    Abstract:

    Background Optical coherence tomography (OCT) is a high-resolution, intra-vascular diagnostic technique widely used for the characterization of vascular pathologies and optimization of stent implantation during percutaneous coronary intervention. OCT was used to investigate the in vivo vascular response to a new phosphorylcholine surface modified flow diverter (sPED). Methods In an in vivo rabbit aneurysmal model, we used two different types of flow Diverters (classic Pipeline – cPED; and sPED) with or without dual antiplatelet therapy (four groups, n=10 per group). OCT cross-sectional area measurements were compared with histology in all animals. Neointimal hyperplasia (NIH) ratio was compared between OCT and histology at five different levels for each stent. The severity of NIH was also compared between the different stents, antiplatelet protocols, and vessel locations. Results OCT was used to calculate in-stent hyperplasia in 227 different locations corresponding to histology sections. OCT measurement strongly correlated with gold standard histology (r 2 =0.83; slope=0.988; P Conclusion OCT is a promising technique for immediate and long-term evaluation of flow diverter stent treatments. In an animal model, phosphorylcholine surface modified flow Diverters induces less NIH after stent implant without reducing aneurysm occlusion rates.

Jianmin Liu - One of the best experts on this subject based on the ideXlab platform.

  • parent artery reconstruction for large or giant cerebral aneurysms using the tubridge flow diverter a multicenter randomized controlled clinical trial parat
    American Journal of Neuroradiology, 2018
    Co-Authors: Jianmin Liu, Yu Zhou, B Leng, P Zhang, G Liang, Q H Huang, Pengfei Yang, H Shi, John H Zhang, J Wan
    Abstract:

    BACKGROUND AND PURPOSE: Although flow Diverters have been reported with favorable clinical and angiographic outcomes in various literatures, randomized trials determining their true effectiveness and safety are still in lack. The Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter (PARAT) trial was designed to evaluate the safety and efficacy of the Tubridge flow diverter in the treatment of large or giant aneurysms in comparison with Enterprise stent-assisted coiling. MATERIALS AND METHODS: This prospective, multicenter, randomized trial was conducted at 12 hospitals throughout China. Enrolled adults with unruptured large/giant intracranial aneurysms were randomly assigned (1:1) to receive either Enterprise stent-assisted coiling or Tubridge flow diverter implantation. The primary end point was complete occlusion at 6-month follow-up, while secondary end points included technical success, mortality, target vessel–related stroke, aneurysm bleeding, in-stent stenosis, parent artery occlusion, and the frequency of all adverse events. RESULTS: Among 185 enrolled subjects, 41 withdrew before procedure initiation. Overall, 82 subjects underwent Tubridge implantation, and 62 subjects were primarily treated with stent-assisted coiling. The results of 6-month follow-up imaging included complete occlusion rates of 75.34% versus 24.53% for the Tubridge and stent-assisted coiling groups, respectively, with a calculated common odds ratio of 9.4 (95% confidence interval, 4.14–21.38; P P value ( P = .051). CONCLUSIONS: This trial showed an obviously higher rate of large and giant aneurysm obliteration with the Tubridge FD over Enterprise stent-assisted coiling. However, this higher obliteration rate came at the cost of a nonsignificantly higher rate of complications. Investigational site comparisons suggested that a learning curve for flow-diverter implantation should be recognized and factored into trial designs.

  • parent artery reconstruction for large or giant cerebral aneurysms using a tubridge flow diverter parat study protocol for a multicenter randomized controlled clinical trial
    BMC Neurology, 2014
    Co-Authors: Yu Zhou, Pengfei Yang, Bo Hong, Wenyuan Zhao, Qinghai Huang, Yibin Fang, Rui Zhao, Jianmin Liu
    Abstract:

    Background: The treatment of large (10-25 mm) or giant (≥25 mm) cerebral aneurysms remains technically challenging, with a much higher complication and recanalization rate than that is observed for smaller aneurysms. The use of a flow diverter seems to facilitate the treatment of this special entity. In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration (CFDA), we obtained promising results, showing remarkable safety and effectiveness for the Tubridge flow diverter. Nevertheless, the previous study may have been limited by biases due to its single-center design and limited number of subjects. Furthermore, although various articles have reported durable results from treating aneurysms using flow Diverters, increasing questions have arisen about this form of treatment. Thus, prospective, multiple-center, randomized trials containing more subjects are needed. Methods/Design: This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion rate at 6-month follow-up. Secondary endpoints include the immediate technique success rate, overall mortality, adverse events (ischemic stroke or intracranial bleeding) within 30 days, 90 days and 1 year post-operation, and the rate of intra-stent stenosis and thrombosis 6 months post-operation. Discussion: This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms. Trial registration: The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-13003127

  • parent artery reconstruction for large or giant cerebral aneurysms using a tubridge flow diverter parat study protocol for a multicenter randomized controlled clinical trial
    BMC Neurology, 2014
    Co-Authors: Yu Zhou, Pengfei Yang, Bo Hong, Wenyuan Zhao, Qinghai Huang, Yibin Fang, Rui Zhao, Jianmin Liu
    Abstract:

    The treatment of large (10-25 mm) or giant (≥25 mm) cerebral aneurysms remains technically challenging, with a much higher complication and recanalization rate than that is observed for smaller aneurysms. The use of a flow diverter seems to facilitate the treatment of this special entity. In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration (CFDA), we obtained promising results, showing remarkable safety and effectiveness for the Tubridge flow diverter. Nevertheless, the previous study may have been limited by biases due to its single-center design and limited number of subjects. Furthermore, although various articles have reported durable results from treating aneurysms using flow Diverters, increasing questions have arisen about this form of treatment. Thus, prospective, multiple-center, randomized trials containing more subjects are needed. This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion rate at 6-month follow-up. Secondary endpoints include the immediate technique success rate, overall mortality, adverse events (ischemic stroke or intracranial bleeding) within 30 days, 90 days and 1 year post-operation, and the rate of intra-stent stenosis and thrombosis 6 months post-operation. This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-13003127