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A.k. Wakhloo - One of the best experts on this subject based on the ideXlab platform.

  • grading of regional apposition after Flow Diverter treatment graft a comparative evaluation of vasoct and intravascular oct
    Journal of NeuroInterventional Surgery, 2016
    Co-Authors: Kajo Van Der Marel, Robert M King, Matthew J Gounis, Olivia W Brooks, A.k. Wakhloo, John P Weaver, Antonius M De Korte, Jennifer M Arends, Ajit S Puri
    Abstract:

    Background Poor vessel wall apposition of Flow Diverter (FD) stents poses risks for stroke-related complications when treating intracranial aneurysms, necessitating long-term surveillance imaging. To facilitate quantitative evaluation of deployed devices, a novel algorithm is presented that generates intuitive two-dimensional representations of wall apposition from either high-resolution contrast-enhanced cone-beam CT (VasoCT) or intravascular optical coherence tomography (OCT) images. Methods VasoCT and OCT images were obtained after FD implant (n=8 aneurysms) in an experimental sidewall aneurysm model in canines. Surface models of the vessel wall and FD device were extracted, and the distance between them was presented on a two-dimensional flattened map. Maps and cross-sections at potential locations of malapposition detected on VasoCT-based maps were compared. The performance of OCT-based apposition detection was evaluated on manually labeled cross-sections using logistic regression against a thresholded (≥0.25 mm) apposition measure. Results VasoCT and OCT acquisitions yielded similar Grading of Regional Apposition after Flow-Diverter Treatment (GRAFT) apposition maps. GRAFT maps from VasoCT highlighted 16 potential locations of malapposition, of which two were found to represent malapposed device struts. Logistic regression showed that OCT could detect malapposition with a sensitivity of 98% and a specificity of 81%. Conclusions GRAFT delivered quantitative and visually convenient representations of potential FD malapposition and occasional acute thrombus formation. A powerful combination for future neuroendovascular applications is foreseen with the superior resolution delivered by intravascular OCT.

  • successful treatment of a giant pediatric fusiform basilar trunk aneurysm with surpass Flow Diverter
    Journal of NeuroInterventional Surgery, 2015
    Co-Authors: Peter Kan, Ajit S Puri, Maxim Mokin, A.k. Wakhloo
    Abstract:

    Fusiform aneurysms present a unique challenge to traditional microsurgical and endovascular treatment because of the lack of a discernible neck and the involvement of parent vessel. Flow diversion has increasingly become the treatment of choice for fusiform aneurysms in the anterior circulation, but its results in the posterior circulation are variable. We report successful treatment of a giant fusiform upper basilar trunk aneurysm with the Surpass Flow Diverter in an adolescent, and discuss the potential advantages of this emerging technology in the treatment of fusiform posterior circulation aneurysms.

  • Surpass Flow Diverter in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study
    American Journal of Neuroradiology, 2015
    Co-Authors: A.k. Wakhloo, J De Vries, A Biondi, P Lylyk, C. Taschner, J. Lundquist, M. Hartmann, I. Szikora, L. Pierot, N. Sakai
    Abstract:

    BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass Flow Diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful Flow-Diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at ≤30 days, SAH at ≤7 days, and intraparenchymal hemorrhage at ≤7 days were encountered in 3.7%, 2.5%, and 2.5% of subjects, respectively. No disabling ischemic strokes at >30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass Flow Diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high rate of intracranial aneurysm occlusion.

  • new generation of Flow Diverter surpass for unruptured intracranial aneurysms a prospective single center study in 37 patients
    Stroke, 2013
    Co-Authors: Joost De Vries, Jeroen Boogaarts, Anouk G W Van Norden, A.k. Wakhloo
    Abstract:

    Background and Purpose—In patients harboring intracranial aneurysms, the major goal in treatment is to prevent bleeding. A new generation of an endoluminal device (Surpass Flow Diverter [Surpass]) ...

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.

  • comparison of the Flow Diverter and stent assisted coiling in large and giant aneurysms safety and efficacy based on a propensity score matched analysis
    European Radiology, 2016
    Co-Authors: Yongxin Zhang, Jianmin Liu, Yu Zhou, Pengfei Yang, Bo Hong, Wenyuan Zhao, Qi Chen, Qinghai Huang
    Abstract:

    The Flow Diverter (FD) is a device aimed at reconstructing the parent artery and occluding an aneurysm. We performed a propensity score-matched analysis to compare safety and efficacy between the FD and stent-assisted coiling. A database review was conducted to identify patients with large and giant unruptured aneurysms (aneurysms located in the ACA, MCA, or PCA were excluded) treated with the FD or stent-assisted coiling. A propensity score, representing the probability of using the FD, was generated for each aneurysm using the relevant patient and aneurysmal variables. Angiographic results, complications, and clinical outcomes were compared. Forty-five aneurysms treated with the FD (FD alone: 32; FD+Coils: 13) and 45 treated with stent-assisted coiling were matched. The rate of complete occlusion was significantly (P = 0.0002) higher in the FD cohort than the conventional stent cohort at the 6-month follow-up. The FD cohort achieved greater improvement (P < 0.0001) and a lower rate of recurrence (P = 0.0001). The rate of periprocedural complications was similar, as was the proportion of patients who attained mRS ≤ 2 at discharge and at the 6-month follow-up. Our findings provide reliable evidence demonstrating that the FD may be a preferred treatment option for large and giant unruptured aneurysms. • Flow Diverter provided a higher complete occlusion rate at 6-month follow-up. • Flow Diverter achieved more progress occlusion and less recurrence. • Compared with the conventional stents, procedure-related morbidity of Flow Diverter was similar. • Flow Diverter is a preferred treatment for large and giant unruptured aneurysms.

  • 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

Hui Meng - One of the best experts on this subject based on the ideXlab platform.

  • compacting a single Flow Diverter versus overlapping Flow Diverters for intracranial aneurysms a computational study
    American Journal of Neuroradiology, 2017
    Co-Authors: Robert J Damiano, Vincent M Tutino, Nikhil Paliwal, Jason M Davies, Adnan H Siddiqui, Hui Meng
    Abstract:

    BACKGROUND AND PURPOSE: Locally compacting the mesh of a Flow Diverter by a dynamic push-pull technique can accelerate intracranial aneurysm healing. We asked how this deployment strategy compares with overlapping 2 Flow Diverters for aneurysmal Flow reduction. MATERIALS AND METHODS: Using a high-fidelity virtual stent placement method, we simulated 3 Flow-Diverter strategies (single noncompacted, 2 overlapped, and single compacted) in 3 aneurysms (fusiform, large saccular, and medium saccular). Computational fluid dynamics analysis provided posttreatment hemodynamic parameters, including time-averaged inFlow rate, aneurysm-averaged velocity, wall shear stress, total absolute circulation, and turnover time. We examined the relationship between the achieved degree of compaction and aneurysm orifice area. RESULTS: Flow-Diverter compaction resulted in a compaction coverage of 57%, 47%, and 22% over the orifice of the fusiform, large, and medium saccular aneurysm, respectively. Compaction coverage increased linearly with orifice area. In the fusiform aneurysm, the single compacted Flow Diverter accomplished more aneurysmal Flow reduction than the other 2 strategies, as indicated by all 5 hemodynamic parameters. In the 2 saccular aneurysms, the overlapped Flow Diverters achieved the most Flow reduction, followed by the single compacted and the noncompacted Flow Diverter. CONCLUSIONS: Compacting a single Flow Diverter can outperform overlapping 2 Flow Diverters in aneurysmal Flow reduction, provided that the compaction produces a mesh denser than 2 overlapped Flow Diverters and this denser mesh covers a sufficient portion of the aneurysm orifice area, for which we suggest a minimum of 50%. This strategy is most effective for aneurysms with large orifices, especially fusiform aneurysms.

  • hemodynamic effect of Flow Diverter and coils in treatment of large and giant intracranial aneurysms
    World Neurosurgery, 2016
    Co-Authors: Linkai Jing, Nikhil Paliwal, Hui Meng, Jingru Zhong, Jian Liu, Xinjian Yang, Shengzhang Wang, Ying Zhang
    Abstract:

    Background This study aimed to investigate the hemodynamic changes induced by a Flow Diverter (FD) and coils in the treatment of internal carotid artery aneurysms, as well as to evaluate the effect of this treatment by using angiographic follow-up data. Methods Six large and giant aneurysms were treated by the Tubridge FD and loose packing coils between June 2013 and May 2015. Patient-specific models were constructed and analyzed using a computational fluid dynamics (CFD) method. The virtual FD deployment method was used to implant the Tubridge stent into a 3-dimensional digital subtraction angiographic image of the aneurysms, and the coils were simulated by a porous medium model. Results Tubridge FD alone can significantly reduce the intra-aneurysmal Flow velocity (0.17 ± 0.05 m/s–0.11 ± 0.06 m/s, P P  = 0.001) and increase the low wall shear area (LSA, 6.38% ± 1.49%–34.60% ± 28.90%, P  = 0.047). Coils, as a supplementary measure, further reduced the velocity (0.11 ± 0.06 m/s–0.08 ± 0.05 m/s, P  = 0.03) and WSS (0.77 ± 0.34 Pa–0.47 ± 0.35 Pa, P  = 0.04) and increased the LSA (34.60% ± 28.90%–63.33% ± 34.82%, P  = 0.044). Aneurysm with sustained strong inFlow after treatment (case 3, 25% reduction in velocity, 12% reduction in WSS, and 16% increment in LSA) showed partial patency, whereas others with a weaker inFlow jet (mean 56% reduction in velocity, 74% reduction in WSS, and 1081% increment in LSA) showed complete occlusion at follow-up. Conclusions On the basis of using the CFD method, adjunctive coiling with the Tubridge FD placement may significantly reduce intra-aneurysmal Flow velocity and WSS, promoting thrombosis formation and occlusion of aneurysms.

  • increasing Flow diversion for cerebral aneurysm treatment using a single Flow Diverter
    Neurosurgery, 2014
    Co-Authors: Jianping Xiang, Adnan H Siddiqui, Kenneth V Snyder, Elad I Levy, Hui Meng
    Abstract:

    BACKGROUND A neurovascular Flow Diverter (FD), aiming at inducing embolic occlusion of cerebral aneurysms through hemodynamic changes, can produce variable mesh densities owing to its flexible mesh structure. OBJECTIVE To explore whether the hemodynamic outcome would differ by increasing FD local compaction across the aneurysm orifice. METHODS We investigated deployment of a single FD using 2 clinical strategies: no compaction (the standard method) and maximum compaction across the aneurysm orifice (an emerging strategy). Using an advanced modeling technique, we simulated these strategies applied to a patient-specific wide-necked aneurysm model, resulting in a relatively uniform mesh with no compaction (C1) and maximum compaction (C2) at the aneurysm orifice. Pre- and posttreatment aneurysmal hemodynamics were analyzed using pulsatile computational fluid dynamics. Flow-stasis parameters and blood shear stress were calculated to assess the potential for aneurysm embolic occlusion. RESULTS Flow streamlines, isovelocity, and wall shear stress distributions demonstrated enhanced aneurysmal Flow reduction with C2. The average intra-aneurysmal Flow velocity was 29% of pretreatment with C2 compared with 67% with C1. Aneurysmal Flow turnover time was 237% and 134% of pretreatment for C2 and C1, respectively. Vortex core lines and oscillatory shear index distributions indicated that C2 decreased the aneurysmal Flow complexity more than C1. Ultrahigh blood shear stress was observed near FD struts in inFlow region for both C1 and C2. CONCLUSION The emerging strategy of maximum FD compaction can double aneurysmal Flow reduction, thereby accelerating aneurysm occlusion. Moreover, ultrahigh blood shear stress was observed through FD pores, which could potentially activate platelets as an additional aneurysmal thrombosis mechanism.

  • computer modeling of deployment and mechanical expansion of neurovascular Flow Diverter in patient specific intracranial aneurysms
    Journal of Biomechanics, 2012
    Co-Authors: G F Dargush, Adnan H Siddiqui, Elad I Levy, Sabareesh K Natarajan, Hui Meng
    Abstract:

    Flow Diverter (FD) is an emerging neurovascular device based on self-expandable braided stent for treating intracranial aneurysms. Variability in FD outcome has underscored a need for investigating the hemodynamic effect of fully deployed FD in patient-specific aneurysms. Image-based computational fluid dynamics, which can provide important hemodynamic insight, requires accurate representation of FD in deployed states. We developed a finite element analysis (FEA) based workFlow for simulating mechanical deployment of FD in patient-specific aneurysms. We constructed FD models of interlaced wires emulating the Pipeline Embolization Device, using 3D finite beam elements to account for interactions between stent strands, and between the stent and other components. The FEA analysis encompasses all steps that affect the final deployed configuration including stent crimping, delivery and expansion. Besides the stent, modeling also includes key components of the FD delivery system such as microcatheter, pusher, and distal coil. Coordinated maneuver of these components allowed the workFlow to mimic clinical operation of FD deployment and to explore clinical strategies. The workFlow was applied to two patient-specific aneurysms. Parametric study indicated consistency of the deployment result against different friction conditions, but excessive intra-stent friction should be avoided. This study demonstrates for the first time mechanical modeling of braided FD stent deployment in cerebral vasculature to produce realistic deployed configuration, thus paving the way for accurate CFD analysis of Flow Diverters for reliable prediction and optimization of treatment outcome.

Federico Cagnazzo - One of the best experts on this subject based on the ideXlab platform.

  • treatment of unruptured distal anterior circulation aneurysms with Flow Diverter stents a meta analysis
    Journal of Neuroradiology, 2020
    Co-Authors: Federico Cagnazzo, D Di Carlo, Pierrehenri Lefevre, Paolo Perrini, Cyril Dargazanli, G Gascou, C Riquelme, Riccardo Morganti, Imad Derraz, Alain Bonafe
    Abstract:

    Background The safety and efficacy of FD among distal AC aneurysms must be proved. Purpose To analyze the outcomes after FD among MCA, AcomA, and DACA aneurysms. Data sources A systematic search of three databases was performed for studies published from 2005 to 2018. Study selection According to PRISMA guidelines, we included studies reporting FD of distal AC aneurysms. Data analysis Random-effects meta-analysis was used to pool aneurysm occlusion and complication rates. From the individual patient data, univariate and multivariate analysis were used to test predictors of occlusion and complications. Data synthesis We included 27 studies (484 aneurysms). Long-term adequate occlusion rate (OKM C-D) was 82.7 % (295/364, 95 % CI = 77.4 %–87.9 %, I2 = 52 %). Treatment-related complications were 12.5 % (63/410, 95 % CI = 9 %–16 %%, I2 = 18.8 %), with 5.4 % (29/418, 95 % CI = 3.2–7.5 %, I2 = 0 %) of morbidity. MCA location was an independent factor associated with lower occlusion (OR = 0.5, P = 0.03) and higher complication rates (OR = 1.8, P = 0.02), compared to AcomA and DACA aneurysms. PED (vs other stents) gave better occlusion rates (OR = 2.6, P = 0.002), whereas large/giant aneurysms were associated with higher odds of complications (OR = 2.2, P = 0.03). The rates of occlusion and narrowing of arteries covered by Flow-Diverter stents were 6.3 % (29/283, 95 % CI = 3.5 %–9.1 %, I2 = 4.2 %) and 23.8 % (69/283, 95 % CI = 15.7 %–32 %, I2 = 80 %), respectively. Symptoms related to occlusion and narrowing of the jailed arteries were 3.5 % (6/269, 95 % CI = 1.1 %–5 %, I2 = 0 %) and 3 % (6/245, 95 % CI = 1 %–4 %, I2 = 0 %), respectively. Limitations Small and retrospective series. Conclusions FD among distal AC aneurysms is effective, leading to adequate aneurysm occlusion in 83 % of cases. However, this strategy presents some limitations among MCA, and for larger lesions especially related to the higher rate of complications. Compared to the other devices, PED seems to be associated with a higher occlusion rate.

  • Treatment of Unruptured Distal Anterior Circulation Aneurysms With Flow-Diverter Stents: A Meta-Analysis
    American Journal of Neuroradiology, 2019
    Co-Authors: Federico Cagnazzo, Pierrehenri Lefevre, Paolo Perrini, G Gascou, Riccardo Morganti, Imad Derraz, Cyril Darganzali, D.t. Di Carlo, Carlos Riquelme Bareiro, Alain Bonafe
    Abstract:

    Background: The safety and efficacy of Flow diversion among distal anterior circulation aneurysms must be proved. Purpose: Our aim was to analyze the outcomes after Flow diversion among MCA, anterior communicating artery, and distal anterior cerebral artery aneurysms. Data sources: A systematic search of 3 databases was performed for studies published from 2005 to 2018. Study selection: According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies reporting Flow diversion of distal anterior circulation aneurysms. Data analysis: Random-effects meta-analysis was used to pool aneurysm occlusion and complication rates. From the individual patient data, univariate and multivariate analyses were used to test predictors of occlusion and complications. Data synthesis: We included 27 studies (484 aneurysms). The long-term adequate occlusion rate (O'Kelly-Marotta scale, C-D) was 82.7% (295/364; 95% CI, 77.4%-87.9%; I2 = 52%). Treatment-related complications were 12.5% (63/410; 95% CI, 9%-16%%; I2 = 18.8%), with 5.4% (29/418; 95% CI, 3.2%-7.5%; I2 = 0%) morbidity. MCA location was an independent factor associated with lower occlusion (OR = 0.5, P = .03) and higher complication rates (OR = 1.8, P = .02), compared with anterior communicating artery and distal anterior cerebral artery aneurysms. The Pipeline Embolization Device (versus other stents) gave better occlusion rates (OR = 2.6, P = .002), whereas large/giant aneurysms were associated with higher odds of complications (OR = 2.2, P = .03). The rates of occlusion and narrowing of arteries covered by Flow-Diverter stents were 6.3% (29/283; 95% CI, 3.5%-9.1%; I2 = 4.2%) and 23.8% (69/283; 95% CI, 15.7%-32%; I2 = 80%), respectively. Symptoms related to occlusion and narrowing of the jailed arteries were 3.5% (6/269; 95% CI, 1.1%-5%; I2 = 0%) and 3% (6/245; 95% CI, 1%-4%; I2 = 0%), respectively. Limitations: We reviewed small and retrospective series. Conclusions: Flow diversion among distal anterior circulation aneurysms is effective, leading to adequate aneurysm occlusion in 83% of cases. However, this strategy has some limitations among MCA and larger lesions, especially related to the higher rate of complications. Compared with the other devices, the Pipeline Embolization Device seems to be associated with a higher occlusion rate

  • acutely ruptured intracranial aneurysms treated with Flow Diverter stents a systematic review and meta analysis
    American Journal of Neuroradiology, 2018
    Co-Authors: Federico Cagnazzo, D Di Carlo, M Cappucci, Pierrehenri Lefevre, Vincent Costalat, Paolo Perrini
    Abstract:

    BACKGROUND: The implantation of Flow-Diverter stents for the treatment of ruptured intracranial aneurysms required further investigation. PURPOSE: Our aim was to analyze the outcomes after Flow diversion of ruptured intracranial aneurysms. DATA SOURCES: A systematic search of 3 databases was performed for studies published from 2006 to 2018. STUDY SELECTION: According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies (from 2010 to 2018) reporting acutely ruptured intracranial aneurysms treated with Flow diversion. DATA ANALYSIS: Random-effects meta-analysis was used to pool the following: aneurysm occlusion rate, complications, rebleeding, and factors influencing the studied outcomes. DATA SYNTHESIS: We included 20 studies evaluating 223 patients with acutely ruptured intracranial aneurysms treated with Flow-Diverter stents. Immediate angiographic occlusion was obtained in 32% (29/86; 95% CI, 15.4%–48%; I 2 = 79.6%) of aneurysms, whereas long-term complete/near-complete aneurysm occlusion was 88.9% (162/189; 95% CI, 84%–93.5%; I 2 = 20.9%) (mean radiologic follow-up of 9.6 months). The treatment-related complication rate was 17.8% (42/223; 95% CI, 11%–24%; I 2 = 52.6%). Complications were higher in the posterior circulation (16/72 = 27%; 95% CI, 14%–40%; I 2 = 66% versus 18/149 = 11.7%; 95% CI, 7%–16%; I 2 = 0%) ( P = .004) and after treatment with multiple stents (14/52 = 26%; 95% CI, 14%–45%; I 2 = 59%) compared with a single stent (20/141 = 10%; 95% CI, 5%–15%; I 2 = 0%) ( P = .004). Aneurysm rebleeding after treatment was 4% (5/223; 95% CI, 1.8%–7%; I 2 = 0%) and was higher in the first 72 hours. LIMITATIONS: Small and retrospective series. CONCLUSIONS: Flow-diversion treatment of ruptured intracranial aneurysms yields a high rate of long-term angiographic occlusion with a relatively low rate of aneurysm rebleeding. However, treatment is associated with a complication rate of 18%. When coiling or microsurgical clipping are not feasible strategies, anterior circulation ruptured aneurysms can be effectively treated with a Flow-diversion technique, minimizing the number of stents deployed. Given the 27% rate of complications, Flow diversion for ruptured posterior circulation aneurysms should be considered only in selected cases not amenable to other treatments.

  • treatment of distal anterior cerebral artery aneurysms with Flow Diverter stents a single center experience
    American Journal of Neuroradiology, 2018
    Co-Authors: Federico Cagnazzo, Pierrehenri Lefevre, Matteo Cappucci, Cyril Dargazanli, G Gascou, C Riquelme, Alain Bonafe, Vincent Costalat
    Abstract:

    BACKGROUND AND PURPOSE: Flow diversion for aneurysms beyond the circle of Willis is still debated. Our aim was to evaluate the safety and efficacy of Flow diversion treatment of distal anterior cerebral artery aneurysms. MATERIALS AND METHODS: Consecutive patients with distal anterior cerebral artery aneurysms treated from January 2014 to October 2017 were evaluated retrospectively with prospectively maintained data. Treatment was performed only for unruptured or recanalized aneurysms after coiling. Technical feasibility, procedural complications, aneurysm occlusion (O9Kelly-Marotta grading scale), and clinical outcome were evaluated. RESULTS: Fifteen patients were included in the study, with 17 distal anterior cerebral artery saccular aneurysms treated with Flow-Diverter stents. Mean aneurysm size was 4.25 ± 3.9 mm; range, 2–9 mm. Flow diversion was used as retreatment among 6 previously coiled aneurysms (5 ruptured and coiled in the acute phase, and 1 unruptured and recanalized). Stent deployment was technically successful in all cases. During the perioperative period, 1 patient experienced a transient minor stroke (6%), whereas 2 patients reported acute in-stent thrombosis with disabling ischemic complications (13%). Fourteen patients and 16 aneurysms were available during a mean radiologic follow-up of 12 months (range, 3–24 months). Overall, 12 (75%) aneurysms were completely occluded (O9Kelly-Marotta grading scale score D), 1 aneurysm (6%) showed near-complete occlusion (O9Kelly-Marotta grading scale score C), and 3 aneurysms (19%) were incompletely occluded (O9Kelly-Marotta grading scale, score B). All 6 aneurysms previously coiled were completely occluded after Flow diversion, whereas 70% of aneurysms treated with Flow Diverters alone showed complete/near-complete occlusion (O9Kelly-Marotta grading scale C–D). There were no cases of aneurysm rupture, in-stent occlusion, or retreatment during long-term follow-up. CONCLUSIONS: Treatment of distal anterior cerebral artery aneurysms with Flow-Diverter stents is feasible and effective, with high rates of aneurysm occlusion. Flow diversion plus coiling, in the retreatment of lesions previously coiled, allowed higher rates of occlusion compared with Flow Diverters alone. However, the risk of ischemic complications is not negligible, and Flow-diversion treatment should be evaluated only for aneurysms not amenable to simple coil embolization.

Yu Zhou - 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.

  • comparison of the Flow Diverter and stent assisted coiling in large and giant aneurysms safety and efficacy based on a propensity score matched analysis
    European Radiology, 2016
    Co-Authors: Yongxin Zhang, Jianmin Liu, Yu Zhou, Pengfei Yang, Bo Hong, Wenyuan Zhao, Qi Chen, Qinghai Huang
    Abstract:

    The Flow Diverter (FD) is a device aimed at reconstructing the parent artery and occluding an aneurysm. We performed a propensity score-matched analysis to compare safety and efficacy between the FD and stent-assisted coiling. A database review was conducted to identify patients with large and giant unruptured aneurysms (aneurysms located in the ACA, MCA, or PCA were excluded) treated with the FD or stent-assisted coiling. A propensity score, representing the probability of using the FD, was generated for each aneurysm using the relevant patient and aneurysmal variables. Angiographic results, complications, and clinical outcomes were compared. Forty-five aneurysms treated with the FD (FD alone: 32; FD+Coils: 13) and 45 treated with stent-assisted coiling were matched. The rate of complete occlusion was significantly (P = 0.0002) higher in the FD cohort than the conventional stent cohort at the 6-month follow-up. The FD cohort achieved greater improvement (P < 0.0001) and a lower rate of recurrence (P = 0.0001). The rate of periprocedural complications was similar, as was the proportion of patients who attained mRS ≤ 2 at discharge and at the 6-month follow-up. Our findings provide reliable evidence demonstrating that the FD may be a preferred treatment option for large and giant unruptured aneurysms. • Flow Diverter provided a higher complete occlusion rate at 6-month follow-up. • Flow Diverter achieved more progress occlusion and less recurrence. • Compared with the conventional stents, procedure-related morbidity of Flow Diverter was similar. • Flow Diverter is a preferred treatment for large and giant unruptured aneurysms.

  • 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