14 research outputs found

    Woven EndoBridge (WEB) Width at the Aneurysm Neck Level Affects Early Angiographic Aneurysm Occlusion

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    Purpose!#!Endovascular therapy with the Woven EndoBridge (WEB) device is a safe treatment approach, whereby neoendothelialization at the neck area is a crucial element for aneurysm occlusion. We hypothesized that WEB sizing at the aneurysmal neck level has an impact on early aneurysm occlusion.!##!Methods!#!Patients with short-term follow-up digital subtraction angiography following WEB treatment of unruptured aneurysms were included. Aneurysms were categorized according to the Bicêtre Occlusion Scale Score (BOSS) as adequately (BOSS 0, 0', 1) or partially occluded (BOSS 2, 3, 1 + 3). The WEB device dimensions, including the average aneurysm diameter (AADi) and the average neck diameter (ANDi) as well as baseline patient characteristics were documented.!##!Results!#!In this study 75 patients with 76 aneurysms were included and 65 aneurysms showed adequate occlusion at short-term follow-up (86%). In univariable logistic regression analysis, smaller differences in WEB size to ANDi (D-ANDi) were significantly associated with adequate aneurysm occlusion (odds ratio, OR = 0.41, 95% confidence interval, CI 0.23-0.71, p = 0.002). Receiver operating characteristic (ROC) curve analyses displayed higher discriminative power for the D‑ANDi (AUC = 0.77, 95% CI 0.66-0.86, cut-off ≤2.9 mm) compared to the difference in WEB size to the average aneurysm diameter (D-AADi, AUC = 0.65, 95% CI 0.53-0.75, cut-off ≤1.0 mm).!##!Conclusion!#!Smaller differences between the WEB width and ANDi were associated with adequate early aneurysm occlusion and might thus have a higher impact on the results than the traditional device sizing considering the mean aneurysm diameter. D‑ANDi ≤2.9 mm served as an optimal cut-off to classify occlusion after WEB treatment at the short-term follow-up. Further external validation is warranted

    Intra-aneurysmal flow disruption after implantation of the Medina® Embolization Device depends on aneurysm neck coverage.

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    Flow disruption achieved by braided intrasaccular implants is a novel treatment strategy for cerebrovascular aneurysms. We hypothesized that the degree of intra-aneurysmal flow disruption can be quantified in vitro and is influenced by device position across the aneurysm neck. We tested this hypothesis using the Medina® Embolization Device (MED).Ten different patient-specific elastic vascular models were manufactured. Models were connected to a pulsatile flow circuit, filled with a blood-mimicking fluid and treated by two operators using a single MED. Intra-aneurysmal flow velocity was measured using conventional and high-frequency digital subtraction angiography (HF-DSA) before and after each deployment. Aneurysm neck coverage by the implanted devices was assessed with flat detector computed tomography on a three-point Likert scale.A total of 80 individual MED deployments were performed by the two operators. The mean intra-aneurysmal flow velocity reduction after MED implantation was 33.6% (27.5-39.7%). No significant differences in neck coverage (p = 0.99) or flow disruption (p = 0.84) were observed between operators. The degree of flow disruption significantly correlated with neck coverage (ρ = 0.42, 95% CI: 0.21-0.59, p = 0.002) as well as with neck area (ρ = -0,35, 95% CI: -0.54 --0.13, p = 0.024). On multiple regression analysis, both neck coverage and total neck area were independent predictors of flow disruption.The degree of intra-aneurysmal flow disruption after MED implantation can be quantified in vitro and varies considerably between different aneurysms and different device configurations. Optimal device coverage across the aneurysm neck improves flow disruption and may thus contribute to aneurysm occlusion

    Feasibility of a customizable training environment for neurointerventional skills assessment.

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    ObjectiveTo meet increasing demands to train neuroendovascular techniques, we developed a dedicated simulator applying individualized three-dimensional intracranial aneurysm models ('HANNES'; Hamburg Anatomic Neurointerventional Endovascular Simulator). We hypothesized that HANNES provides a realistic and reproducible training environment to practice coil embolization and to exemplify disparities between neurointerventionalists, thus objectively benchmarking operators at different levels of experience.MethodsSix physicians with different degrees of neurointerventional procedural experience were recruited into a standardized training protocol comprising catheterization of two internal carotid artery (ICA) aneurysms and one basilar tip aneurysm, followed by introduction of one framing coil into each aneurysm and finally complete coil embolization of one determined ICA aneurysm. The level of difficulty increased with every aneurysm. Fluoroscopy was recorded and assessed for procedural characteristics and adverse events.ResultsPhysicians were divided into inexperienced and experienced operators, depending on their experience with microcatheter handling. Mean overall catheterization times increased with difficulty of the aneurysm model. Inexperienced operators showed longer catheterization times (median; IQR: 47; 30-84s) than experienced operators (21; 13-58s, p = 0.011) and became significantly faster during the course of the attempts (rho = -0.493, p = 0.009) than the experienced physicians (rho = -0.318, p = 0.106). Number of dangerous maneuvers throughout all attempts was significantly higher for inexperienced operators (median; IQR: 1.0; 0.0-1.5) as compared to experienced operators (0.0; 0.0-1.0, p = 0.014).ConclusionHANNES represents a modular neurointerventional training environment for practicing aneurysm coil embolization in vitro. Objective procedural metrics correlate with operator experience, suggesting that the system could be useful for assessing operator proficiency

    DSA-based rating of aneurysm opacification.

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    <p>Diagram shows receiver operating characteristic curves for classification of dichotomized neck coverage ratings based on early, intermediate and late phase DSA images. Intrasaccular stasis observed on late phase images had the highest area under the curve for discriminating favorable from unfavorable neck coverage.</p

    Design for Mass Adaptation of the Neurointerventional Training Model HANNES with Patient-Specific Aneurysm Models

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    A neurointerventional training model called HANNES (Hamburg ANatomical NEurointerventional Simulator) has been developed to replace animal models in catheter-based aneurysm treatment training. A methodical approach to design for mass adaptation is applied so that patient-specific aneurysm models can be designed recurrently based on real patient data to be integrated into the training system. HANNES’ modular product structure designed for mass adaptation consists of predefined and individualized modules that can be combined for various training scenarios. Additively manufactured, individualized aneurysm models enable high reproducibility of real patient anatomies. Due to the implementation of a standardized individualization process, order-related adaptation can be realized for each new patient anatomy with modest effort. The paper proves how the application of design for mass adaptation leads to a well-designed modular product structure of the neurointerventional training model HANNES, which supports quality treatment and provides an animal-free and patient-specific training environment

    Model fabrication.

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    <p>A, Digital subtraction angiography from a patient with a left-sided internal carotid artery aneurysm originating at the posterior communicating artery origin. B, Hollowed surface data after postprocessing, before manufacturing. C, Photograph of the model after manufacturing. D, A single frame from high-frequency digital subtraction angiography in the model, obtained with a MED framer device deployed in the aneurysm sac.</p

    Intra-aneurysmal flow disruption after implantation of the Medina<sup>®</sup> Embolization Device depends on aneurysm neck coverage

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    <div><p>Background and purpose</p><p>Flow disruption achieved by braided intrasaccular implants is a novel treatment strategy for cerebrovascular aneurysms. We hypothesized that the degree of intra-aneurysmal flow disruption can be quantified in vitro and is influenced by device position across the aneurysm neck. We tested this hypothesis using the Medina<sup>®</sup> Embolization Device (MED).</p><p>Methods</p><p>Ten different patient-specific elastic vascular models were manufactured. Models were connected to a pulsatile flow circuit, filled with a blood-mimicking fluid and treated by two operators using a single MED. Intra-aneurysmal flow velocity was measured using conventional and high-frequency digital subtraction angiography (HF-DSA) before and after each deployment. Aneurysm neck coverage by the implanted devices was assessed with flat detector computed tomography on a three-point Likert scale.</p><p>Results</p><p>A total of 80 individual MED deployments were performed by the two operators. The mean intra-aneurysmal flow velocity reduction after MED implantation was 33.6% (27.5–39.7%). No significant differences in neck coverage (p = 0.99) or flow disruption (p = 0.84) were observed between operators. The degree of flow disruption significantly correlated with neck coverage (ρ = 0.42, 95% CI: 0.21–0.59, p = 0.002) as well as with neck area (ρ = -0,35, 95% CI: -0.54 –-0.13, p = 0.024). On multiple regression analysis, both neck coverage and total neck area were independent predictors of flow disruption.</p><p>Conclusions</p><p>The degree of intra-aneurysmal flow disruption after MED implantation can be quantified in vitro and varies considerably between different aneurysms and different device configurations. Optimal device coverage across the aneurysm neck improves flow disruption and may thus contribute to aneurysm occlusion.</p></div

    Neck coverage.

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    <p>Upper row shows volume reconstructions from VasoCT of two different MED configurations after implantation in the same aneurysm model (aneurysm 2), viewed from the direction of the aneurysm ostium. Incomplete neck coverage is appreciated in the first configuration (A, top), corresponding to moderate flow velocity reduction (41%) on high-frequency DSA (A, bottom). A different configuration showing better coverage of the neck by the MED petals (B, top) was accompanied by a higher degree of intra-aneurysmal flow velocity reduction (73%, B, bottom).</p

    Relationship between the degree of recanalization and functional outcome in acute ischemic stroke is mediated by penumbra salvage volume

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    Background!#!The presence of metabolically viable brain tissue that may be salvageable with rapid cerebral blood flow restoration is the fundament rationale for reperfusion therapy in patients with large vessel occlusion stroke. The effect of endovascular treatment (EVT) on functional outcome largely depends on the degree of recanalization. However, the relationship of recanalization degree and penumbra salvage has not yet been investigated. We hypothesized that penumbra salvage volume mediates the effect of thrombectomy on functional outcome.!##!Methods!#!99 acute anterior circulation stroke patients who received multimodal CT and underwent thrombectomy with resulting partial to complete reperfusion (modified thrombolysis in cerebral infarction scale (mTICI) ≥ 2a) were retrospectively analyzed. Penumbra volume was quantified on CT perfusion and penumbra salvage volume (PSV) was calculated as difference of penumbra and net infarct growth from admission to follow-up imaging.!##!Results!#!In patients with complete reperfusion (mTICI ≥ 2c), the median PSV was significantly higher than the median PSV in patients with partial or incomplete (mTICI 2a-2b) reperfusion (median 224 mL, IQR: 168-303 versus 158 mL, IQR: 129-225; p &amp;lt; 0.01). A higher degree of recanalization was associated with increased PSV (+ 63 mL per grade, 95% CI: 17-110; p &amp;lt; 0.01). Higher PSV was also associated with improved functional outcome (OR/mRS shift: 0.89; 95% CI: 0.85-0.95, p &amp;lt; 0.0001).!##!Conclusions!#!PSV may be an important mediator between functional outcome and recanalization degree in EVT patients and could serve as a more accurate instrument to compare treatment effects than infarct volumes
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