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BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. FUNDING: EU Horizon 2020.
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Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/cirugía , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/cirugía , Estudios Prospectivos , Trombectomía/métodos , Hemorragias Intracraneales/etiología , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/cirugía , Procedimientos Endovasculares/métodos , Infarto/complicaciones , Alberta , Resultado del TratamientoRESUMEN
OBJECTIVES: Photon-counting detector computed tomography (PCD-CT) is a promising new technique for CT imaging. The aim of the present study was the in vitro comparison of coil-related artifacts in PCD-CT and conventional energy-integrating detector CT (EID-CT) using a comparable standard brain imaging protocol before and after metal artifact reduction (MAR). METHODS: A nidus-shaped rubber latex, resembling an aneurysm of the cerebral arteries, was filled with neurovascular platinum coils and inserted into a brain imaging phantom. Image acquisition and reconstruction were repeatedly performed for PCD-CT and EID-CT (n = 10, respectively) using a standard brain imaging protocol. Moreover, linear interpolation MAR was performed for PCD-CT and EID-CT images. The degree of artifacts was analyzed quantitatively (standard deviation in a donut-shaped region of interest) and qualitatively (5-point scale analysis). RESULTS: Quantitative and qualitative analysis demonstrated a lower degree of metal artifacts in the EID-CT images compared to the total-energy PCD-CT images (e.g., 82.99 ± 7.89 Hounsfield units (HU) versus 90.35 ± 6.28 HU; p < 0.001) with no qualitative difference between the high-energy bin PCD-CT images and the EID-CT images (4.18 ± 0.37 and 3.70 ± 0.64; p = 0.575). After MAR, artifacts were more profoundly reduced in the PCD-CT images compared to the EID-CT images in both analyses (e.g., 2.35 ± 0.43 and 3.18 ± 0.34; p < 0.001). CONCLUSION: PCD-CT in combination with MAR have the potential to provide an improved option for reduction of coil-related artifacts in cerebral imaging in this in vitro study. KEY POINTS: ⢠Photon-counting detector CT produces more artifacts compared to energy-integrating detector CT without metal artifact reduction in cerebral in vitro imaging after neurovascular coil-embolization. ⢠Spectral information of PCD-CT provides the potential for new post-processing techniques, since the coil-related artifacts were lower in PCD-CT images compared to EID-CT images after linear interpolation metal artifact reduction in this in vitro study.
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Artefactos , Tomografía Computarizada por Rayos X , Humanos , Tomografía Computarizada por Rayos X/métodos , Encéfalo/diagnóstico por imagen , Fantasmas de Imagen , Fotones , NeuroimagenRESUMEN
BACKGROUND: Air embolism (AE), especially when affecting the brain, is an underrated and potentially life-threatening complication in various endovascular interventions. This study aims to investigate experimental AEs using a new model to generate micro air bubbles (MAB), to assess the impact of a catheter on these MAB, and to demonstrate the applicability of this model in vivo. MATERIALS AND METHODS: Micro air bubbles were created using a system based on microfluidic channels. The MAB were detected and analyzed automatically. Micro air bubbles, with a target size of 85 µm, were generated and injected through a microcatheter. The MAB diameters proximal and distal to the catheter were assessed and compared. In a subsequent in vivo application, 2000 MAB were injected into the aorta (at the aortic valve) and into the common carotid artery (CCA) of a rat, respectively, using a microcatheter, resembling AE occurring during cardiovascular interventions. RESULTS: Micro air bubbles with a highly calibrated size could be successfully generated (median: 85.5 µm, SD 1.9 µm). After passage of the microcatheter, the MAB were similar in diameter (median: 86.6 µm) but at a lower number (60.1% of the injected MAB) and a substantially higher scattering of diameters (SD 29.6 µm). In vivo injection of MAB into the aorta resulted in cerebral microinfarctions in both hemispheres, whereas injection into the CCA caused exclusively ipsilateral microinfarctions. CONCLUSION: Using this new AE model, MAB can be generated precisely and reproducibly, resulting in cerebral microinfarctions. This model is feasible for further studies on the pathophysiology and prevention of AE in cardiovascular procedures.
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Embolia Aérea , Ratas , Animales , Embolia Aérea/diagnóstico por imagen , Embolia Aérea/etiología , Embolia Aérea/prevención & control , Resultado del Tratamiento , Encéfalo , Aorta/diagnóstico por imagen , Arteria Carótida ComúnRESUMEN
PURPOSE: To assess the effectiveness, safety, and predictors of outcomes and adverse events for percutaneous sclerotherapy using polidocanol for the treatment of venous malformations (VMs). METHODS: A retrospective single-center analysis was performed, including patients with VMs who were treated with sclerotherapy using polidocanol between January 2011 and November 2021 at a tertiary center. Demographic characteristics, clinical data, and radiologic features were analyzed, and the influence of patient- and VM-related factors on the subjective clinical outcome and adverse events were investigated using a multivariate logistic regression analysis. RESULTS: In total, 167 patients who received 325 treatment sessions were included in this study. Overall symptom improvement was observed in 67.5%, stable symptoms were observed in 25.0%, and worsening was reported in 7.5% (clinical follow-up, 1.04 ± 1.67 years). The total adverse event rate was 10.2%, with an overall rate of 4.2% for permanent adverse events within the cohort. In multivariate analysis, the clinical outcome was worse in children (P = .01; 57.1% symptom improvement in children [age, <18 years] and 79.7% in adults), and adverse events were more frequently observed after the treatment of VMs located at the extremities (P < .01; 8.4% for VMs of the extremities and 1.2% for VMs in other locations). CONCLUSIONS: Sclerotherapy using polidocanol can be an effective treatment option for VMs with an acceptable safety profile. However, it can be less effective in children, and adverse events can be more frequently expected for VMs of the extremities.
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Escleroterapia , Malformaciones Vasculares , Niño , Adulto , Humanos , Adolescente , Polidocanol/efectos adversos , Escleroterapia/efectos adversos , Soluciones Esclerosantes , Estudios Retrospectivos , Malformaciones Vasculares/diagnóstico por imagen , Malformaciones Vasculares/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: The pressure cooker technique (PCT) was developed to enable safer and more extensive embolization of hypervascular lesions by simultaneously minimizing backflow of liquid embolic materials and thus reduce the risk of non-target embolization of adjacent healthy vessels. We report our experience in applying the PCT to cerebral arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs) and additionally suggest our technical adjustments. METHODS: We retrospectively reviewed all patients suffering from AVMs or DAVFs that were treated with the PCT between 2018 and 2020 in two university hospitals. The endpoints of the study were clinical safety and the technical efficacy. The endpoints of the study were clinical safety and the technical efficacy. Clinical safety was the absence of death, major or minor symptomatic stroke, TIA and procedure-related intracranial bleeding (SAH) in the peri-procedural period until dismission. Good clinical outcome was defined as no deterioration of the modified Rankin Scale (mRS) score (comparing the pre- and post-procedural mRS evaluated by a trained neurologist at admission and dismission). The technical efficacy was considered as the complete embolization occlusion of the target vessels of the lesion documented on the final control angiogram. Long-term follow-up evaluation was not intended for this study as it was not available for all patients. RESULTS: Fifteen consecutive patients (6 women; mean age 55 y; range 20-82 y) with seven AVMs and eight DAVFs met the inclusion criteria. The primary clinical safety end point was obtained in all cases as no intraprocedural complications were encountered. All patients had a good clinical outcome with no difference between the pre- and post-mRS scores. The primary efficacy end point was reached in all cases. CONCLUSION: The PCT is a safe and effective technique in the treatment of cerebral AVMs and DAVFs. Adding an easy and fast step to the procedure, namely the injection of contrast media to test the complete obstruction by the plug, the risk of reflux seems to additionally be reduced.
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Malformaciones Vasculares del Sistema Nervioso Central , Embolización Terapéutica , Malformaciones Arteriovenosas Intracraneales , Humanos , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Malformaciones Arteriovenosas Intracraneales/diagnóstico por imagen , Malformaciones Arteriovenosas Intracraneales/terapia , Malformaciones Vasculares del Sistema Nervioso Central/patología , Malformaciones Vasculares del Sistema Nervioso Central/terapia , Embolización Terapéutica/métodosRESUMEN
PURPOSE: Diabetes is associated with vascular dysfunction potentially impairing collateral recruitment in acute ischemic stroke. This retrospective study aimed at analyzing the impact of diabetes on collateralization assessed on dynamic CTA. METHODS: Collaterals were retrospectively assessed on CT perfusion-derived dynamic CTA according to the mCTA score by Menon in a cohort of patients with an acute occlusion of the M1 segment or carotid T. The extent of collateral circulation was related to the history of diabetes and to admission blood glucose and HbA1c levels. RESULTS: Two hundred thirty-nine patients were included. The mCTA collateral score was similar in patients with diabetes (median 3, interquartile range 3-4) and without diabetes (median 4, interquartile range 3-4) (P = 0.823). Diabetes was similarly frequent in patients with good (18.8%), intermediate (16.1%), and poor collaterals (16.0%) (P = 0.355). HbA1c was non-significantly higher in patients with poor collaterals (6.3 ± 1.5) compared to patients with intermediate (6.0 ± 0.9) and good collaterals (5.8 ± 0.9) (P = 0.061). Blood glucose levels were significantly higher in patients with poor compared to good collaterals (mean 141.6 vs. 121.8 mg/dl, P = 0.045). However, there was no significant difference between good and intermediate collaterals (mean 121.8 vs. 129.5 mg/dl, P = 0.161) as well as between intermediate and poor collaterals (129.5 vs. 141.6 mg/dl, P = 0.161). CONCLUSION: There was no statistically significant difference among patients with good, intermediate, and poor collaterals regarding the presence of diabetes or HbA1c level on admission. However, stroke patients with poor collaterals tend to have higher blood glucose and HbA1c levels.
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Isquemia Encefálica , Diabetes Mellitus , Accidente Cerebrovascular Isquémico , Glucemia , Isquemia Encefálica/diagnóstico por imagen , Angiografía Cerebral , Circulación Colateral , Angiografía por Tomografía Computarizada , Diabetes Mellitus/diagnóstico por imagen , Hemoglobina Glucada , Humanos , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Perfusión , Estudios Retrospectivos , Tomografía Computarizada por Rayos XRESUMEN
PURPOSE: To investigate whether intra-arterial injection of lidocaine enhances irreversible electroporation (IRE) in a liver model. MATERIALS AND METHODS: Conventional IRE (C-IRE) and lidocaine-enhanced IRE (L-IRE) were performed in 8 pig livers. Protocol 1 (tip exposure and electrode distance of 2.0 cm each) and protocol 2 (increased tip exposure and electrode distance 2.5 cm each) were used. Animals were sacrificed 3 hours after IRE. Study goals included electrical tissue properties (eg, current, conductivity) during IRE, geometry of IRE zones analyzed using computed tomography and magnetic resonance imaging (eg, volume and sphericity index), degree of acute liver damage, and irreversible cell death analyzed using microscopy (hematoxylin and eosin staining and terminal deoxynucleotidyl transferase deoxyuridine 5-triphosphate nick end labeling). Statistical comparisons were performed using the paired t test and Wilcoxon test. RESULTS: All treatments were performed without adverse events. Electrical tissue properties were not significantly different between C-IRE and L-IRE. For protocol 1, the diameter of the largest sphere within the IRE zone was significantly larger for L-IRE than for C-IRE (25.0 ± 4.7 mm vs 18.4 ± 3.1 mm [P = .013]). For protocol 2, the volume of IRE zone was significantly larger for L-IRE compared with C-IRE (46.0 ± 5.4 cm3 vs 22.6 ± 6.4 cm3 [P = .018]), as well as the diameter of the largest sphere within the IRE zone (27.1 ± 2.2 mm vs 19.8 ± 2.3 mm [P = .020]). For protocol 1, a significantly higher degree of irreversible cell death was noted for L-IRE than for C-IRE (1.8 ± 1.0 vs 0.8 ± 1.0 [P = .046]). CONCLUSIONS: Intra-arterial injection of lidocaine can enhance IRE in terms of larger IRE zones and an increase of irreversible cell death.
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Técnicas de Ablación , Electroporación , Lidocaína/administración & dosificación , Hígado/efectos de los fármacos , Hígado/cirugía , Animales , Muerte Celular , Conductividad Eléctrica , Femenino , Inyecciones Intraarteriales , Hígado/patología , Sus scrofa , Factores de TiempoRESUMEN
Objectives: To compare image quality between filtered back projection (FBP) and iterative reconstruction algorithm and dedicated metal artifact reduction (iMAR) algorithms during antenna positioning for computed tomography-guided microwave ablation (MWA).Materials and methods: An MWA antenna was positioned in the liver of five pigs under CT guidance. Different exposure settings (120kVp/200mAs-120kVp/50mAs) and image reconstruction techniques (FBP, iterative reconstruction with and without iMAR) were applied. Quantitative image analysis included density measurements in six positions (e.g., liver in extension of the antenna [ANTENNA] and liver >3 cm away from the antenna [LIVER-1]). Qualitative image analysis included assessment of overall quality, image noise, artifacts at the antenna tip, artifacts in liver parenchyma bordering antenna tip and newly generated artifacts. Two independent observers performed the analyses twice and interreader agreement was compared with Bland-Altman analysis.Results: For all exposure and reconstruction settings, density measurements for ANTENNA were significantly higher for the I30-1 iMAR compared with FBP and I30-1 (e.g., 8.3-17.2HU vs. -104.5 to 155.1HU; p ≤ 0.01, respectively). In contrast, for all exposure settings, density measurements for LIVER-1 were comparable between FBP and I30-1 iMAR (e.g., 49.4-50.4HU vs. 50.1-52.5U, respectively). For all exposure and reconstruction settings, subjective image quality for LIVER-1 was better for the I30-1 iMAR algorithm compared with FBP and I30-1. Bland-Altman interobserver agreement was from -0.2 to 0.2 for FBP and iMAR, and Cohen's kappa was 0.74.Conclusion: Iterative algorithms I30-1 with iMAR algorithm improves image quality during antenna positioning and placement for CT-guided MWA and is applicable over a range of exposure settings.
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Técnicas de Ablación/métodos , Artefactos , Metales/química , Tomografía Computarizada por Rayos X/métodos , Algoritmos , Animales , Femenino , Humanos , Masculino , PorcinosRESUMEN
INTRODUCTION: This study focuses on long-term outcomes after aneurysm treatment with either the Flow Re-Direction Endoluminal Device (FRED) or the FRED Jr. to investigate the durability of treatment effect and long-term complications. METHODS: This study is based on a retrospective analysis of a prospectively maintained patient data base. Patients treated with either FRED or FRED Jr. between 2013 and 2017 at our institution, and thus a possibility for ≥â¯5 years of follow-up, were included. Aneurysm occlusion rates, recurrence rates, modified Rankin scale score shifts to baseline, and delayed complications were assessed. RESULTS: In this study 68 patients with 84 aneurysms had long-term follow-up with a mean duration of 57.3 months and 44 patients harboring 52 aneurysms had a follow-up ≥â¯5 years with a mean follow-up period of 69.2 months. Complete occlusion was reached in 77.4% at 2 years and increased to 84.9% when the latest available imaging result was considered. Younger age and the absence of branch involvement were predictors for aneurysm occlusion in linear regression analysis. After the 2year threshold, there were 3 reported symptomatic non-serious adverse events. Of these, one patient had a minor stroke, one a transitory ischemic attack and one had persistent mass effect symptoms due to a giant aneurysm, none of these resulted in subsequent neurological disability. CONCLUSION: This long-term follow-up study demonstrates that the FRED and FRED Jr. are safe and effective for the treatment of cerebral aneurysms in the long term, with high rates of complete occlusion and low rates of delayed adverse events.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Estudios de Seguimiento , Resultado del Tratamiento , Estudios Retrospectivos , Procedimientos Endovasculares/métodos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Embolización Terapéutica/métodos , StentsRESUMEN
PURPOSE: Cerebral infarctions caused by air embolisms (AE) are a feared risk in endovascular procedures; however, the relevance and pathophysiology of these AEs is still largely unclear. The objective of this study was to investigate the impact of the origin (aorta, carotid artery or right atrium) and number of air bubbles on cerebral infarctions in an experimental in vivo model. METHODS: In 20 rats 1200 or 2000 highly calibrated micro air bubbles (MAB) with a size of 85⯵m were injected at the aortic valve (group Ao), into the common carotid artery (group CA) or into the right atrium (group RA) using a microcatheter via a transfemoral access, resembling endovascular interventions in humans. Magnetic resonance imaging (MRI) using a 9.4T system was performed 1â¯h after MAB injection followed by finalization. RESULTS: The number (5.5 vs. 5.5 median) and embolic patterns of infarctions did not significantly differ between groups Ao and CA. The number of infarctions were significantly higher comparing 2000 and 1200 injected MABs (6 vs. 4.5; pâ¯< 0.001). The infarctions were significantly larger for group CA (median infarction volume: 0.41â¯mm3 vs. 0.19â¯mm3; pâ¯< 0.001). In group RA and in the control group no infarctions were detected. Histopathological analyses showed early signs of ischemic stroke. CONCLUSION: Iatrogenic AEs originating at the ascending aorta cause a similar number and pattern of cerebral infarctions compared to those with origin at the carotid artery. These findings underline the relevance and potential risk of AE occurring during endovascular interventions at the aortic valve and ascending aorta.
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Embolia Aérea , Procedimientos Endovasculares , Humanos , Ratas , Animales , Embolia Aérea/diagnóstico por imagen , Embolia Aérea/etiología , Infarto Cerebral/diagnóstico por imagen , Infarto Cerebral/etiología , Imagen por Resonancia Magnética , Procedimientos Endovasculares/efectos adversos , Enfermedad IatrogénicaRESUMEN
BACKGROUND: Flat detector computed tomography (FDCT) is frequently applied for periinterventional brain imaging within the angiography suite. Novel technical developments such as the Sine Spin FDCT (S-FDCT) may provide an improved cerebral soft tissue contrast. This study investigates the effect of S-FDCT on the differentiation between gray and white matter compared to conventional FDCT (C-FDCT) and multidetector computed tomography (MDCT). METHODS: A retrospective analysis of a prospectively maintained patient database was performed, including patients who underwent mechanical thrombectomy in our institution and received S-FDCT or C-FDCT as well as MDCT. Differentiation between gray and white matter on the contralateral hemisphere to the ischemic stroke was analyzed quantitatively by contrast-to-noise ratio (CNR) and qualitatively (5-point ordinal scale). RESULTS: In a cohort of 109 patients, MDCT demonstrated the best differentiation between gray and white matter compared to both FDCT techniques (p ≤ 0.001). Comparing both generations of FDCT, S-FDCT provided better visibility of the basal ganglia (p = 0.045) and the supratentorial cortex (p = 0.044) compared to C-FDCT both in quantitative and qualitative analyses. Median CNR were as follows: S-FDCT 2.41 (interquartile range [IQR] 1.66-3.21), C-FDCT 0.96 (0.46-1.70), MDCT 3.43 (2.83-4.17). For basal ganglia, median score and IQR were as follows: S-FDCT 2.00 (2.00-3.00), C-FDCT 1.50 (1.00-2.00), MDCT 5.00 (4.00-5.00). CONCLUSIONS: The novel S-FDCT improves the periinterventional imaging quality of cerebral soft tissue compared to C-FDCT. Thus, it may improve the diagnosis of complications within the angiography suite. MDCT provides the best option for x-ray-based imaging of the brain tissue. RELEVANCE STATEMENT: Flat detector computed tomography is a promising technique for cerebral soft tissue imaging, while the novel Sine Spin flat detector computed tomography technique improves imaging quality compared to conventional flat detector computed tomography and thus may facilitate periinterventional diagnosis of gray and white matter. KEY POINTS: ⢠Flat detector computed tomography (FDCT) is frequently applied for periinterventional brain imaging. ⢠The potential of novel Sine Spin FDCT (S-FDCT) is unknown so far. ⢠S-FDCT improves the visibility of cerebral soft tissue compared to conventional FDCT. ⢠Multidetector computed tomography is superior to both FDCT techniques. ⢠S-FDCT may facilitate the evaluation of brain parenchyma within the angiography suite.
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Encéfalo , Tomografía Computarizada Multidetector , Humanos , Encéfalo/diagnóstico por imagen , Tomografía Computarizada Multidetector/métodos , Estudios Retrospectivos , Trombectomía , Angiografía , NeuroimagenRESUMEN
BACKGROUND AND PURPOSE: The Pipeline Embolization Device is a safe and effective treatment option for intracranial aneurysms. The newer Pipeline generations have received structural refinements and a surface modification to improve deliverability, procedural safety, and angiographic outcomes. This multicenter study evaluated the clinical safety and efficacy of the 2 surface-modified Pipeline iterations, Pipeline Vantage and Pipeline Flex with Shield Technology (PFS). MATERIALS AND METHODS: Consecutive patients treated between 2017 and 2023 were retrospectively reviewed for aneurysm characteristics, procedural details, complications, and angiographic outcomes. The safety end point was the rate of procedural and postprocedural major neurologic events occurring during the hospital stay. The efficacy end point was the rate of complete occlusion at last follow-up. RESULTS: One hundred forty-one patients underwent 112 Pipeline Vantage procedures and 32 PFS procedures for 147 aneurysms with a mean size of 8.0 (SD, 5.9) mm (11% ruptured, 16% posterior circulation, 18% nonsaccular morphology). All procedures were technically successful with a mean of 1.2 devices implanted. Balloon angioplasty was required in 20/144 (13.9%) procedures. Major neurologic adverse events occurred in 6/144 (4.2%) procedures (all ischemic stroke), resulting in death in 2 (1.4%) patients. There were no hemorrhagic complications. At a mean of 11 months, complete occlusion was achieved in 85/112 (75.9%) aneurysms, 15/112 (13.4%) had an entry remnant, and 12/112 (10.7%) had an aneurysm remnant. CONCLUSIONS: The results demonstrate high feasibility, procedural safety, and efficacy of the surface-modified Pipeline flow diverters.
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BACKGROUND AND PURPOSE: The optimal antiplatelet regimen after flow diverter treatment of cerebral aneurysms is still a matter of debate. A single antiplatelet therapy might be advantageous in determined clinical scenarios. This study evaluated the efficacy and safety of prasugrel single antiplatelet therapy versus aspirin and clopidogrel dual antiplatelet therapy. MATERIALS AND METHODS: We performed a post hoc analysis of 4 retrospective multicenter studies including ruptured and unruptured aneurysms treated with flow diversion using either prasugrel single antiplatelet therapy or dual antiplatelet therapy. Primary end points were the occurrence of any kind of procedure- or device-related thromboembolic complications and complete aneurysm occlusion at the latest radiologic follow-up (mean, 18 months). Dichotomized comparisons of outcomes were performed between single antiplatelet therapy and dual antiplatelet therapy. Additionally, the influence of various patient- and aneurysm-related variables on the occurrence of thromboembolic complications was investigated using multivariable backward logistic regression. RESULTS: A total of 222 patients with 251 aneurysms were included, 90 (40.5%) in the single antiplatelet therapy and 132 (59.5%) in the dual antiplatelet therapy group. The primary outcome-procedure- or device-related thromboembolic complications-occurred in 6 patients (6.6%) of the single antiplatelet therapy and in 12 patients (9.0%) of the dual antiplatelet therapy group (P = .62; OR, 0.712; 95% CI, 0.260-1.930). The primary treatment efficacy end point was reached in 82 patients (80.4%) of the single antiplatelet therapy and in 115 patients (78.2%) of the dual antiplatelet therapy group (P = .752; OR, 1.141; 95% CI, 0.599-2.101). Logistic regression showed that non-surface-modified flow diverters (P = .014) and fusiform aneurysm morphology (P = .004) significantly increased the probability of thromboembolic complications. CONCLUSIONS: Prasugrel single antiplatelet therapy after flow diverter treatment may be as safe and effective as dual antiplatelet therapy and could, therefore, be a valid alternative in selected patients. Further prospective comparative studies are required to validate our findings.
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Aspirina , Clopidogrel , Aneurisma Intracraneal , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Clorhidrato de Prasugrel/uso terapéutico , Clorhidrato de Prasugrel/administración & dosificación , Femenino , Masculino , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Retrospectivos , Clopidogrel/uso terapéutico , Clopidogrel/administración & dosificación , Persona de Mediana Edad , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Anciano , Resultado del Tratamiento , Terapia Antiplaquetaria Doble/métodos , Tromboembolia/prevención & control , Tromboembolia/etiología , Adulto , StentsRESUMEN
BACKGROUND: Non-ischemic cerebral enhancing (NICE) lesions have been reported as a rare complication of various neuroendovascular procedures, but information on their incidence after flow diversion is scant. It is unclear if specific devices or novel coating technologies may impact their occurrence. METHODS: We conducted a multicenter study on the incidence of NICE lesions after flow diverter (FD) implantation for cerebral aneurysm treatment. RESULTS: Eight centers identified 15 patients and provided detailed data. The clinical presentation ranged from asymptomatic to hemiplegia and cognitive impairment. The mean time to diagnosis after treatment was 65.1±101.5 days. Five centers disclosed information on all of their 1201 FD procedures during the inclusion period (2015-2022), during which 12 patients were diagnosed with NICE lesions in these institutions-that is, an incidence of 1%. FD coatings did not increase the incidence (6/591 patients (1%) treated with surface-modified FD vs 6/610 patients (1%) treated with bare FD; P=1.00). Significantly increased rates of 3.7% (6 cases in 161 procedures; P<0.01) and 3.3% (5 cases in 153 procedures; P<0.01) were found with stents of two specific product lines. The use of one product line was associated with a significantly lower incidence (0 cases in 499 procedures (0%); P<0.01). CONCLUSIONS: Novel stent coatings are not associated with an increased incidence of NICE lesions. The incidence rate of 1% suggests that these lesions may occur more often after flow diversion than after other endovascular treatments. We found a concerning accumulation of NICE lesion cases when FDs from two product families were used.
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BACKGROUND: This multicenter study evaluated the safety and efficacy of coated flow diverters (cFDs) for the treatment of ruptured intracranial aneurysms. METHODS: Consecutive patients treated with different cFDs for ruptured aneurysms under tirofiban at eight neurovascular centers between 2016 and 2023 were retrospectively analyzed. The majority of patients were loaded with dual antiplatelet therapy after the treatment. Aneurysm occlusion was determined using the O'Kelly-Marotta (OKM) grading scale. Primary outcome measures were major procedural complications and aneurysmal rebleeding during hospitalization. RESULTS: The study included 60 aneurysms (posterior circulation: 28 (47%)) with a mean size of 5.8±4.7 mm. Aneurysm morphology was saccular in 28 (47%), blister-like in 12 (20%), dissecting in 13 (22%), and fusiform in 7 (12%). Technical success was 100% with a mean of 1.1 cFDs implanted per aneurysm. Adjunctive coiling was performed in 11 (18%) aneurysms. Immediate contrast retention was observed in 45 (75%) aneurysms. There was 1 (2%) major procedural complication (a major stroke, eventually leading to death) and no aneurysmal rebleeding. A good outcome (modified Rankin Scale 0-2) was achieved in 40 (67%) patients. At a mean follow-up of 6 months, 27/34 (79%) aneurysms were completely occluded (OKM D), 3/34 (9%) had an entry remnant (OKM C), and 4/34 (12%) had residual filling (OKM A or B). There was 1 (3%) severe in-stent stenosis during follow-up that was treated with balloon angioplasty. CONCLUSIONS: Treatment of ruptured aneurysms with cFDs was reasonably safe and efficient and thus represents a valid treatment option, especially for complex cases.
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BACKGROUND: Patients treated with mechanical thrombectomy (MT) for acute ischemic strokes from large vessel occlusion (LVO) have better outcomes with effective reperfusion. However, it is unknown which technique leads to better technical and clinical success. We aimed to determine which technique yields the most effective first pass reperfusion during MT. METHODS: In a prospective, multicenter global registry we enrolled patients treated with operator preferred MT technique at 71 hospitals from January 2019 to January 2022. Three techniques were assessed: SR Classic with stent retriever (SR) and balloon guide catheter (BGC); SR Combination which employed SR with contact aspiration with or without BGC; and direct aspiration (DA) with or without BGC. The primary outcome was achieving an expanded Thrombolysis In Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. RESULTS: A total of 1492 patients were enrolled. Patients treated with SR Classic or SR Combination were more likely to achieve first pass eTICI 2c or 3 reperfusion (P=0.01). There was no significant difference in mRS 0-2 (P=0.46) or safety endpoints. CONCLUSIONS: The use of SR Classic or SR Combination was more likely to achieve first pass eTICI 2c or 3 reperfusion. There were no significant differences in clinical outcomes and safety endpoints.
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BACKGROUND: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. METHODS: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. FINDINGS: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). INTERPRETATION: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. FUNDING: European Union Horizon 2020 Research and Innovation Programme.
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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Trombectomía , Humanos , Trombectomía/métodos , Masculino , Femenino , Procedimientos Endovasculares/métodos , Anciano , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Persona de Mediana Edad , Resultado del Tratamiento , Calidad de Vida , Anciano de 80 o más AñosRESUMEN
PURPOSE: Individual regions of the Alberta Stroke Programme Early CT Score (ASPECTS) may contribute differently to the clinical symptoms in large vessel occlusion (LVO). Here, we investigated whether the predictive performance on clinical outcome can be increased by considering specific ASPECTS subregions. METHODS: A consecutive series of patients with LVO affecting the middle cerebral artery territory and subsequent endovascular treatment (EVT) between January 2015 and July 2020 was analyzed, including affected ASPECTS regions. A multivariate logistic regression was performed to assess the individual impact of ASPECTS regions on good clinical outcome (defined as modified Rankin scale after 90 days of 0-2). Machine-learning-driven logistic regression models were trained (trainingâ¯= 70%, testingâ¯= 30%) to predict good clinical outcome using i) cumulative ASPECTS and ii) location-specific ASPECTS, and their performance compared using deLong's test. Furthermore, additional analyses using binarized as well as linear clinical outcomes using regression and machine-learning techniques were applied to thoroughly assess the potential predictive properties of individual ASPECTS regions and their combinations. RESULTS: Of 1109 patients (77.3 years⯱ 11.6, 43.8% male), 419 achieved a good clinical outcome and a median NIHSS after 24â¯h of 12 (interquartile range, IQR 4-21). Individual ASPECTS regions showed different impact on good clinical outcome in the multivariate logistic regression, with strongest effects for insula (odds ratio, OR 0.56, 95% confidence interval, CI 0.42-0.75) and M5 (OR 0.53, 95% CI 0.29-0.97) regions. Accuracy (ACC) in predicting good clinical outcome of the test set did not differ between when considering i) cumulative ASPECTS and ii) location-specific ASPECTS (ACCâ¯= 0.619, 95% CI 0.58-0.64 vs. ACCâ¯= 0.629, 95% CI 0.60-0.65; pâ¯= 0.933). CONCLUSION: Cumulative ASPECTS assessment in LVO remains a stable and reliable predictor for clinical outcome and is not inferior to a weighted (location-specific) ASPECTS assessment.
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Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Masculino , Femenino , Alberta , Procedimientos Endovasculares/métodos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/terapia , Pronóstico , Resultado del Tratamiento , Trombectomía/métodos , Isquemia Encefálica/terapia , Estudios RetrospectivosRESUMEN
BACKGROUND: Endovascular embolization using liquid embolic agents (LEAs) is frequently applied for the treatment of intracranial vascular malformations. Appropriate visibility of LEAs during embolization is essential for visual control and to prevent complications. Since LEAs contain different radiopaque components of varying concentrations, our aim was the systematic assessment of the visibility of the most used LEAs in fluoroscopy. METHODS: A specifically designed in vitro model, resembling cerebral vessels, was embolized with Onyx 18, Squid 18, Squid 12, PHIL (precipitating hydrophobic injectable liquid) 25%, PHIL LV (low viscosity) and NBCA (n-butyl cyanoacrylate) mixed with iodized oil (n=3 for each LEA), as well as with contrast medium and saline, both serving as a reference. Fluoroscopic image acquisition was performed in accordance with clinical routine settings. Visibility was graded quantitatively (contrast to noise ratio, CNR) and qualitatively (five-point scale). RESULTS: Overall, all LEAs provided at least acceptable visibility in this in vitro model. Onyx and Squid as well as NBCA mixed with iodized oil were best visible at a comparable level and superior to the formulations of PHIL, which did not differ in quantitative and qualitative analyses (eg, Onyx 18 vs PHIL 25% along the 2.0 mm sector: mean CNR±SD: 3.02±0.42 vs 1.92±0.35; mean score±SD: 5.00±0.00 vs 3.75±0.45; p≤0.001, respectively). CONCLUSION: In this systematic in vitro study, relevant differences in the fluoroscopic visibility of LEAs in neurointerventional embolization procedures were demonstrated, while all investigated LEAs provided acceptable visibility in our in vitro model.
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Embolización Terapéutica , Malformaciones Arteriovenosas Intracraneales , Humanos , Dimetilsulfóxido , Embolización Terapéutica/métodos , Polivinilos , Fluoroscopía , Proyectos de Investigación , Malformaciones Arteriovenosas Intracraneales/terapia , Resultado del TratamientoRESUMEN
PURPOSE: The off-label use of flow diverting stents (FDS) for treating cerebral aneurysms in small distal vessels is increasing in clinical practice with encouraging results; however, data directly addressing the parent vessel size are still scarce. Our aim was to evaluate the safety and efficacy of FDS placement in anterior and posterior circulation aneurysms with parent arteries ≤â¯2â¯mm in a real-world representative setting. METHODS: We retrospectively reviewed patients treated with FDS at the three participating university hospitals between 2009 and 2021. The inclusion criteria were the placement of at least one FDS in a parent vessel with a maximum diameter of 2â¯mm or less. The primary clinical safety endpoint was the absence of death, major or minor symptomatic stroke, transient ischemic attack and procedure-related intracranial hemorrhage. Clinical outcome was assessed using the modified Rankin Scale (mRS) score at the follow-up visit at 1 year. The primary efficacy endpoint was defined as complete and near-complete occlusion at the 1year follow-up. RESULTS: We identified 55 patients harboring 56 aneurysms. The primary clinical safety endpoint was obtained in 93% of cases. The hemorrhagic and thromboembolic complication rates were 4% and 9%, respectively. No patient died or had a relevant discrepancy (>â¯1 point) at the pre-mRS and post-mRS. The primary efficacy endpoint was reached in 80% of cases. CONCLUSION: The use of FDS in vessels <â¯2â¯mm is technically feasible with good aneurysm occlusion rates and an acceptable safety profile. Nevertheless, it is essential to be aware of the of the main complications associated when operating in small diameter vessels.