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OBJECTIVE: The Contour Neurovascular System (CNS) is a novel intrasaccular flow-disrupting device for the treatment of intracranial aneurysms. This study presents the authors' institutional experience and midterm follow-up results with this device. METHODS: Seventy-six consecutive patients (mean ± SD age 58.9 ± 12.4 years) were treated with the CNS for 76 aneurysms (63 unruptured, 10 recurrent, and 3 ruptured). Aneurysm characteristics, procedural details, and clinical/angiographic outcomes were retrospectively evaluated. RESULTS: The most common aneurysm locations were the basilar tip in 25 (32.9%) cases and the anterior communicating artery in 22 (28.9%). There were 18 (23.7%) sidewall aneurysms. The mean ± SD aneurysm width was 5.6 ± 2.5 mm, and 68 (89.5%) aneurysms were wide-necked. The CNS was successfully implanted in 68 (89.5%) aneurysms, with 11 cases of additional coiling and 1 case each of additional stent and balloon. There were 3 (3.9%) thromboembolic events, of which 1 (1.3%) was symptomatic (a major ischemic stroke) and resulted in morbidity. There were no hemorrhagic events or deaths. At last available follow-up (mean 12 months), 32/56 (57.1%) aneurysms were completely occluded, 16/56 (28.6%) had neck remnants, and 8/56 (14.3%) had an aneurysm remnant. Three (5.4%) aneurysms were retreated. CONCLUSIONS: The use of the CNS was safe and feasible but proper aneurysm selection appears to be required, which may be facilitated with increasing operator experience and further study of this device. Similar to other intrasaccular flow disrupters, midterm complete occlusion rates are moderate but may increase with longer follow-up.
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OBJECTIVE: The Contour Neurovascular System (CNS) is a novel intrasaccular flow disrupting device with a semi-3D cup-like shape for the treatment of intracranial aneurysms. This study investigates the potential and limitations of the CNS for embolization of aneurysm remnants after previous treatment. METHODS: Ten cases of aneurysm recurrence treatment with the CNS were analyzed from a single-center database. Technical success, procedural aspects, complications, and angiographic results were evaluated. RESULTS: The aneurysms (median width: 5.3â mm, median neck width: 3.8â mm) were located in the anterior communicating artery (4), basilar tip (3), internal carotid artery (1), middle cerebral artery (1), and superior cerebellar artery (1). The aneurysms were initially treated endovascularly (9) and by clipping (1). Retreatment failed in one case where the smallest available CNS proved to be too small and had to be removed. Adjunctive coiling was performed in two large remnants of partially thrombosed basilar tip aneurysms. There were no procedural complications or morbidity. At a median follow-up of nine months, 4/8 (50%) aneurysms were completely occluded, 2/8 (25%) had neck remnants, and 2/8 (25%) had aneurysm remnants. The two aneurysm remnants were retreated with coiling and stent-assisted coiling, respectively. CONCLUSIONS: CNS treatment of aneurysm remnants may be feasible, especially for shallow, wide-necked aneurysm geometries. Further studies are needed to identify aneurysm subsets that benefit from CNS retreatment and to define mid- and long-term occlusion rates.
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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: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017â³ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. OBJECTIVE: To evaluate angiographic stability at 1 year. METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.
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OBJECTIVE: The Pipeline Vantage Embolization Device (PVED) is a novel coated flow diverter with reduced wire diameters to improve neoendothelialization and stent porosity. This systematic review evaluates the safety and efficacy of the PVED based on the current literature. METHODS: Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a thorough literature search was conducted using PubMed, EMBASE, and Cochrane. The random effects model was used to calculate estimates with major neurological complications within 30 days of treatment as the primary safety endpoint and ≤1-year complete occlusion rate as the primary efficacy endpoint. RESULTS: Six single-arm studies (5 retrospective, 1 prospective) with 392 patients and 439 aneurysms (6.8% ruptured) were included. Antiplatelet regimens varied, but dual antiplatelet therapy was administered in the majority. The pooled technical success rate was 99.0% (95%CI, 98.0%-100%) with an average of 1.2 devices implanted per procedure. Balloon angioplasty was performed in 17.0% (95%CI, 6.4-27.6%) and adjunctive coiling in 28.0% (95%CI, 17.8-38.2%), with significant heterogeneity for both variables. Pooled estimates for major neurological complications were 3.5% (95%CI, 1.7%-5.2%) with total ischemic events in 4.1% (95% CI, 1.6%-6.6%) and hemorrhagic events in 1.0% (95% CI, 0.0%-1.9%). The rate of complete angiographic occlusion was 75.7% (95%CI, 70.7%-80.6%) at a mean follow-up of 7 months, with in-stent stenoses in 8.1% (95%CI, 4.5%-11.8%). CONCLUSIONS: The safety and efficacy profile of the PVED appears comparable to competing devices, with potentially fewer complications than first-generation flow diverters. Long-term and comparative studies are needed to further confirm these results.
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PURPOSE: Cardiopulmonary exercise testing (CPET) is considered the gold standard for assessing cardiorespiratory fitness. To ensure consistent performance of each test, it is necessary to adapt the power increase of the test protocol to the physical characteristics of each individual. This study aimed to use machine learning models to determine individualized ramp protocols based on non-exercise features. We hypothesized that machine learning models will predict peak oxygen uptake ( V Ë O2peak) and peak power output (PPO) more accurately than conventional multiple linear regression (MLR). METHODS: The cross-sectional study was conducted with 274 (â168, â106) participants who performed CPET on a cycle ergometer. Machine learning models and multiple linear regression were used to predict V Ë O2peak and PPO using non-exercise features. The accuracy of the models was compared using criteria such as root mean square error (RMSE). Shapley additive explanation (SHAP) was applied to determine the feature importance. RESULTS: The most accurate machine learning model was the random forest (RMSE: 6.52 ml/kg/min [95% CI 5.21-8.17]) for V Ë O2peak prediction and the gradient boosting regression (RMSE: 43watts [95% CI 35-52]) for PPO prediction. Compared to the MLR, the machine learning models reduced the RMSE by up to 28% and 22% for prediction of V Ë O2peak and PPO, respectively. Furthermore, SHAP ranked body composition data such as skeletal muscle mass and extracellular water as the most impactful features. CONCLUSION: Machine learning models predict V Ë O2peak and PPO more accurately than MLR and can be used to individualize CPET protocols. Features that provide information about the participant's body composition contribute most to the improvement of these predictions. TRIAL REGISTRATION NUMBER: DRKS00031401 (6 March 2023, retrospectively registered).
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BACKGROUND: Silent MRA has shown promising results in evaluating the stents used for intracranial aneurysm treatment. A deep learning-based denoising and deranging algorithm was recently introduced by GE HealthCare. The purpose of this study was to compare the performance of several MRA techniques regarding lumen visibility in silicone models with flow diverter stents. METHODS: Two Surpass Evolve stents of different sizes were implanted in two silicone tubes. The tubes were placed in separate boxes in the straight position and in two different curve configurations and connected to a pulsatile pump to construct a flow loop. Using a 3.0T MRI scanner, TOF and silent MRA images were acquired, and deep learning reconstruction was applied to the silent MRA dataset. The intraluminal signal intensity in the stent (SIin-stent), in the tube outside the stent (SIvessel), and of the background (SIbg) were measured for each scan. RESULTS: The SIin-stent/SIbg and SIin-stent/SIv ratios were higher in the silent scans and DL-based reconstructions than in the TOF images. The stent tips created severe artefacts in the TOF images, which could not be observed in the silent scans. CONCLUSIONS: Our study demonstrates that the DL reconstruction algorithm improves the quality of the silent MRA technique in evaluating the flow diverter stent patency.
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PURPOSE: The WEB 17 system represents the fifth generation of Woven Endobridge (WEB) flow disruptors and features a low profile with fewer wires than its predecessor, the WEB 21. The present study compares the safety and efficacy of the WEB 17 and WEB 21 for the treatment of unruptured cerebral aneurysms with 4-7â¯mm device sizes, which were available for both systems. METHODS: Patient and aneurysm characteristics, complications, clinical outcome and angiographic results were retrospectively analysed. 1:1 propensity score matching was performed to adjust for minor baseline differences between the groups. RESULTS: Sixty aneurysms treated with WEB 21 and 90 with WEB 17 were included. The overall failure rate (deployment failure and adjunctive stent) was significantly higher with WEB 21 (16.7%) than with WEB 17 (3.3%, pâ¯< 0.01). The rates of neurological events between WEB 21 (6.7%) and WEB 17 treatment (1.1%) were not significantly different (pâ¯= 0.08). Also, procedural morbidity was comparably low in both groups (WEB 21: 3.3%, WEB 17: 0%, pâ¯= 0.16). The rates of complete/adequate occlusion at follow up were 69.7%/86.4% for WEB 17 vs. 80.4%/91.3% for WEB 21 at short-term (pâ¯= 0.27), and 64.5%/83.9% vs. 75.9%/86.2% at mid-term (pâ¯= 0.41), respectively. Propensity score matching confirmed the results of the unmatched series. CONCLUSION: WEB 17 and WEB 21 had a similar safety and efficacy profile, but WEB 17 was associated with an improved feasibility. Prospective studies with long-term follow-up will define the full potential of the WEB 17 system.
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BACKGROUND/PURPOSE: Several periprocedural adjuncts for elective surgical aneurysm treatment have been introduced over the last 20 years to increase safety and efficacy. Besides the introduction of IONM in the late-1990s, ICG-videoangiography (ICG-VAG) since the mid-2000s and intraoperative CT-angiography/-perfusion (iCT-A/-P) since the mid-2010s are available. We aimed to clarify whether the introduction of ICG-VAG and iCT-A/-P resulted in our department in a stepwise improvement in the rate of radiologically detected postoperative ischemia, complete aneurysm occlusion and postoperative new deficits. METHODS: Patients undergoing microsurgical clip occlusion for unruptured anterior circulation aneurysms between 2000 and 2019 were included, with ICG-VAG since 2009 and iCT-A/-P (for selected cases) since 2016. Baseline characteristics and treatment-related morbidity/outcome focusing on differences between the three distinct cohorts (cohort-I: pre-ICG-VAG-era, cohort-II: ICG-VAG-era, cohort-III: ICG-VAG&iCT-A/-P-era) were analyzed. RESULTS: 1391 patients were enrolled (n = 74 were excluded), 779 patients were interventionally treated, 538 patients were surgically clipped by a specialized vascular team (cohort-I n = 167, cohort-II n = 284, cohort-III n = 87). Aneurysm size was larger in cohort-I (8.9 vs. 7.5/6.8 mm; p < 0.01) without differences concerning age (mean:55years), gender distribution (m: f = 1:2.6) and aneurysm location (MCA:61%, ICA:18%, ACA/AcomA:21%). There was a stepwise improvement in the rate of radiologically detected postoperative ischemia (16.2vs.12.0vs.8.0%; p = 0.161), complete aneurysm occlusion (68.3vs.83.6vs.91.0%; p < 0.01) and postoperative new deficits (10.8vs.7.7vs.5.7%; p = 0.335) from cohort-I to -III. After a mean follow-up of 12months, a median modified Rankin scale of 0 was achieved in all cohorts. DISCUSSION: Associated with periprocedural technical achievements, surgical outcome in elective anterior circulation aneurysm surgery has improved in our service during the past 20 years.
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Isquemia Encefálica , Aneurisma Intracraniano , Complicações Pós-Operatórias , Humanos , Aneurisma Intracraniano/cirurgia , Aneurisma Intracraniano/diagnóstico por imagem , Masculino , Feminino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Idoso , Isquemia Encefálica/prevenção & controle , Isquemia Encefálica/etiologia , Isquemia Encefálica/diagnóstico por imagem , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Neurocirúrgicos/métodos , Instrumentos Cirúrgicos , Adulto , Resultado do Tratamento , Angiografia Cerebral/métodos , Estudos Retrospectivos , Microcirurgia/métodos , Angiografia por Tomografia Computadorizada/métodosRESUMO
BACKGROUND: Endovascular treatment has become the standard care for acute basilar artery occlusion (BAO). Uncertainty persists about the optimal thrombectomy technique. OBJECTIVE: To compare aspiration thrombectomy with stent retriever thrombectomy in patients with BAO in a multicenter real-world patient population. METHODS: We analyzed data from the German Stroke Registry-Endovascular Treatment (GSR-ET). Patients with isolated BAO who underwent either aspiration or stent retriever thrombectomy were compared, including propensity score matching (PSM). The primary outcome measure was the modified Rankin Scale shift analysis at 90 days. Secondary outcomes included symptomatic intracranial hemorrhage (sICH), procedure complications, and metrics. RESULTS: Of 13 082 patients in the GSR-ET, 387 patients (mean age 72.0±13.1 years; 45.0% female) fulfilled the inclusion criteria. The thrombectomy technique was aspiration only in 195 (50.4%) and stent retriever only in 192 (49.6%) patients. Functional outcome did not differ between the groups, either before (common OR (cOR) 0.94; 95% CI 0.64 to 1.38) or after PSM (cOR=1.37; 95% CI 0.90 to 2.09). There was no significant difference in sICH (2.6 vs 5.5%; P=0.231; OR=0.46; 95% CI 0.14 to 1.47), but aspiration thrombectomy demonstrated fewer procedure-related complications (4.6% vs 12.5%; P=0.017), a shorter procedure duration (24 vs 48 min; P<0.001), and higher first pass recanalization rates (75.1% vs 44.8%; P<0.001). CONCLUSIONS: In this study both aspiration and stent retriever thrombectomy showed equal efficacy in terms of functional outcome in patients with BAO. However, procedure complications and metrics might favor aspiration over stent retriever thrombectomy.
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BACKGROUND: Intrasaccular devices have become increasingly popular in the treatment of cerebral aneurysms, particularly at the bifurcation. Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study, the largest to the best of our knowledge. METHODS: Consecutive patients with intracranial aneurysms treated with the Contour Neurovascular System between February 2017 and October 2022 at 10 European neurovascular centers were prospectively collected and retrospectively reviewed. Patient and aneurysm characteristics, procedural details, and angiographic and clinical outcomes were evaluated. RESULTS: During the study period, 279 aneurysms (median age of patients 60 years, IQR 52-68) were treated with Contour. In 83.2% of patients the device was placed electively, whereas the remaining patients were treated in the setting of acute subarachnoid hemorrhage. The most common locations were the middle cerebral artery (26.5%) followed by the anterior communicating region (26.2%). Median aneurysm dome and neck size were 5.2 mm (IQR 4.2-7) and 3.9 mm (IQR 3-5). Contour size 7 (39%) and 9 (25%) were most used. Thromboembolic and hemorrhagic complications occurred in 6.8% and 0.4% of aneurysms, respectively. Raymond-Roy 1 and 2 occlusions at last follow-up were achieved in 63.2% and 28.3%, respectively, resulting in adequate occlusion of 91.5% of aneurysms. CONCLUSION: This is the largest multicenter study reporting the outcome on the Contour Neurovascular System. At 1 year, the self-evaluated data on safety and efficacy are comparable to data of existing intrasaccular devices. Contour is a promising technology in the treatment of cerebral aneurysms.
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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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PURPOSE: Evaluation of the effectiveness of CT-guided drainage (CTD) placement in managing symptomatic postoperative fluid collections in liver transplant patients. The assessment included technical success, clinical outcomes, and the occurrence of complications during the peri-interventional period. METHODS: Analysis spanned the years 2005 to 2020 and involved 91 drain placement sessions in 50 patients using percutaneous transabdominal or transhepatic access. Criteria for technical success (TS) included (a) achieving adequate drainage of the fluid collection and (b) the absence of peri-interventional complications necessitating minor or prolonged hospitalization. Clinical success (CS) was characterized by (a) a reduction or normalization of inflammatory blood parameters within 30 days after CTD placement and (b) the absence of a need for surgical revision within 60 days after the intervention. Inflammatory markers in terms of C-reactive protein (CRP), leukocyte count and interleukin-6, were evaluated. The dose length product (DLP) for various intervention steps was calculated. RESULTS: The TS rate was 93.4%. CS rates were 64.3% for CRP, 77.8% for leukocytes, and 54.5% for interleukin-6. Median time until successful decrease was 5.0 days for CRP and 3.0 days for leukocytes and interleukin-6. Surgical revision was not necessary in 94.0% of the cases. During the second half of the observation period, there was a trend (p = 0.328) towards a lower DLP for the entire intervention procedure (median: years 2013 to 2020: 623.0 mGy·cm vs. years 2005 to 2012: 811.5 mGy·cm). DLP for the CT fluoroscopy component was significantly (p = 0.001) lower in the later period (median: years 2013 to 2020: 31.0 mGy·cm vs. years 2005 to 2012: 80.5 mGy·cm). CONCLUSIONS: The TS rate of CT-guided drainage (CTD) placement was notably high. The CS rate ranged from fair to good. The reduction in radiation exposure over time can be attributed to advancements in CT technology and the growing expertise of interventional radiologists.
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MR perfusion imaging is important in the clinical evaluation of primary brain tumors, particularly in differentiating between true progression and treatment-induced change. The utility of velocity-selective ASL (VSASL) compared to the more commonly utilized DSC perfusion technique was assessed in routine clinical surveillance MR exams of 28 patients with high-grade gliomas at 1.5T. Using RANO criteria, patients were assigned to two groups, one with detectable residual/recurrent tumor ("RT", n = 9), and the other with no detectable residual/recurrent tumor ("NRT", n = 19). An ROI was drawn to encompass the largest dimension of the lesion with measures normalized against normal gray matter to yield rCBF and tSNR from VSASL, as well as rCBF and leakage-corrected relative CBV (lc-rCBV) from DSC. VSASL (rCBF and tSNR) and DSC (rCBF and lc-rCBV) metrics were significantly higher in the RT group than the NRT group allowing adequate discrimination (p < 0.05, Mann-Whitney test). Lin's concordance analyses showed moderate to excellent concordance between the two methods, with a stronger, moderate correlation between VSASL rCBF and DSC lc-rCBV (r = 0.57, p = 0.002; Pearson's correlation). These results suggest that VSASL is clinically feasible at 1.5T and has the potential to offer a noninvasive alternative to DSC perfusion in monitoring high-grade gliomas following therapy.
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BACKGROUND: Chest radiographs (CXRs) are still of crucial importance in primary diagnostics, but their interpretation poses difficulties at times. RESEARCH QUESTION: Can a convolutional neural network-based artificial intelligence (AI) system that interprets CXRs add value in an emergency unit setting? STUDY DESIGN AND METHODS: A total of 563 CXRs acquired in the emergency unit of a major university hospital were retrospectively assessed twice by three board-certified radiologists, three radiology residents, and three emergency unit-experienced nonradiology residents (NRRs). They used a two-step reading process: (1) without AI support; and (2) with AI support providing additional images with AI overlays. Suspicion of four suspected pathologies (pleural effusion, pneumothorax, consolidations suspicious for pneumonia, and nodules) was reported on a five-point confidence scale. Confidence scores of the board-certified radiologists were converted into four binary reference standards of different sensitivities. Performance by radiology residents and NRRs without AI support/with AI support were statistically compared by using receiver-operating characteristics (ROCs), Youden statistics, and operating point metrics derived from fitted ROC curves. RESULTS: NRRs could significantly improve performance, sensitivity, and accuracy with AI support in all four pathologies tested. In the most sensitive reference standard (reference standard IV), NRR consensus improved the area under the ROC curve (mean, 95% CI) in the detection of the time-critical pathology pneumothorax from 0.846 (0.785-0.907) without AI support to 0.974 (0.947-1.000) with AI support (P < .001), which represented a gain of 30% in sensitivity and 2% in accuracy (while maintaining an optimized specificity). The most pronounced effect was observed in nodule detection, with NRR with AI support improving sensitivity by 53% and accuracy by 7% (area under the ROC curve without AI support, 0.723 [0.661-0.785]; with AI support, 0.890 [0.848-0.931]; P < .001). Radiology residents had smaller, mostly nonsignificant gains in performance, sensitivity, and accuracy with AI support. INTERPRETATION: We found that in an emergency unit setting without 24/7 radiology coverage, the presented AI solution features an excellent clinical support tool to nonradiologists, similar to a second reader, and allows for a more accurate primary diagnosis and thus earlier therapy initiation.
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Inteligência Artificial , Serviço Hospitalar de Emergência , Radiografia Torácica , Humanos , Radiografia Torácica/métodos , Estudos Retrospectivos , Masculino , Feminino , Competência Clínica , Pessoa de Meia-Idade , Curva ROC , Adulto , IdosoRESUMO
INTRODUCTION: Two recent studies showed clinical benefit for endovascular treatment (EVT) in basilar artery occlusion (BAO) stroke up to 12 h (ATTENTION) and between 6 and 24 h from onset (BAOCHE). Our aim was to investigate the cost-effectiveness of EVT from a U.S. healthcare perspective. MATERIALS AND METHODS: Clinical input data were available for both trials, which were analyzed separately. A decision model was built consisting of a short-run model to analyze costs and functional outcomes within 90 days after the index stroke and a long-run Markov state transition model (cycle length of 12 months) to estimate expected lifetime costs and outcomes from a healthcare and a societal perspective. Incremental cost-effectiveness ratios (ICER) were calculated, deterministic (DSA) and probabilistic (PSA) sensitivity analyses were performed. RESULTS: EVT in addition to best medical management (BMM) resulted in additional lifetime costs of $32,063 in the ATTENTION trial and lifetime cost savings of $7690 in the BAOCHE trial (societal perspective). From a healthcare perspective, EVT led to incremental costs and effectiveness of $37,389 and 2.0 QALYs (ATTENTION) as well as $3516 and 1.9 QALYs (BAOCHE), compared to BMM alone. The ICER values were $-4052/QALY (BAOCHE) and $15,867/QALY (ATTENTION) from a societal perspective. In each trial, PSA showed EVT to be cost-effective in most calculations (99.9%) for a willingness-to-pay threshold of $100,000/QALY. Cost of EVT and age at stroke represented the greatest impact on the ICER. DISCUSSION: From an economic standpoint with a lifetime horizon, EVT in addition to BMM is estimated to be highly effective and cost-effective in BAO stroke.
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Artéria Basilar , Acidente Vascular Cerebral , Humanos , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Atenção à Saúde , Acidente Vascular Cerebral/terapiaRESUMO
PURPOSE: To develop and validate an artificial intelligence algorithm for the positioning assessment of tracheal tubes (TTs) and central venous catheters (CVCs) in supine chest radiographs (SCXRs) by using an algorithm approach allowing for adjustable definitions of intended device positioning. MATERIALS AND METHODS: Positioning quality of CVCs and TTs is evaluated by spatially correlating the respective tip positions with anatomical structures. For CVC analysis, a configurable region of interest is defined to approximate the expected region of well-positioned CVC tips from segmentations of anatomical landmarks. The CVC/TT information is estimated by introducing a new multitask neural network architecture for jointly performing type/existence classification, course segmentation, and tip detection. Validation data consisted of 589 SCXRs that have been radiologically annotated for inserted TTs/CVCs, including an experts' categorical positioning assessment (reading 1). In-image positions of algorithm-detected TT/CVC tips could be corrected using a validation software tool (reading 2) that finally allowed for localization accuracy quantification. Algorithmic detection of images with misplaced devices (reading 1 as reference standard) was quantified by receiver operating characteristics. RESULTS: Supine chest radiographs were correctly classified according to inserted TTs/CVCs in 100%/98% of the cases, thereby with high accuracy in also spatially localizing the medical device tips: corrections less than 3 mm in >86% (TTs) and 77% (CVCs) of the cases. Chest radiographs with malpositioned devices were detected with area under the curves of >0.98 (TTs), >0.96 (CVCs with accidental vessel turnover), and >0.93 (also suboptimal CVC insertion length considered). The receiver operating characteristics limitations regarding CVC assessment were mainly caused by limitations of the applied CXR position definitions (region of interest derived from anatomical landmarks), not by algorithmic spatial detection inaccuracies. CONCLUSIONS: The TT and CVC tips were accurately localized in SCXRs by the presented algorithms, but triaging applications for CVC positioning assessment still suffer from the vague definition of optimal CXR positioning. Our algorithm, however, allows for an adjustment of these criteria, theoretically enabling them to meet user-specific or patient subgroups requirements. Besides CVC tip analysis, future work should also include specific course analysis for accidental vessel turnover detection.
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Cateterismo Venoso Central , Cateteres Venosos Centrais , Humanos , Cateterismo Venoso Central/métodos , Inteligência Artificial , Radiografia , Radiografia Torácica/métodosRESUMO
OBJECTIVE: Several studies have demonstrated a high safety and efficacy profile of the Woven EndoBridge (WEB) for endovascular aneurysm treatment. However, contemporary large-scale studies of the WEB are rare. This multicenter study attempts to set a benchmark for state-of-the-art WEB treatment with consistent application of the WEB oversizing technique. METHODS: This is a retrospective, multicenter study of aneurysms (dome width 2-10 mm) treated with the WEB between 2015 and 2023. Patient and aneurysm characteristics, complications, and clinical and angiographic outcomes were analyzed. RESULTS: The study consisted of 247 patients treated for 251 aneurysms (25.5% ruptured, 5.6% recurrent). WEB implantation was feasible in 98.8%, achieving a mean WEB/dome ratio of 1.2 ± 0.1. The thromboembolic complication rate was 7.2%, which was higher in ruptured versus unruptured aneurysms (hazard ratio: 2.8, 95%CI: 1.0-7.6, P = 0.04), but lower in cases where WEB 17 was used (hazard ratio: 4.0, 95%CI: 1.4-11.2, P = 0.01). Neurological complications occurred in 8 procedures (3.2%), including 3 (1.2%) major, and 5 (2.0%) minor events. Procedural morbidity and mortality were 0.8% and 0%, respectively. Mid-term complete and adequate occlusion rates were 66.3% and 88.4%, respectively. The retreatment rate was 5.2%. Feasibility, complication, and occlusion rates were comparable between typical and atypical aneurysm locations. CONCLUSIONS: Oversizing the WEB and using currently available WEB types in this series resulted in slightly better treatment outcomes compared to early WEB studies, confirming the high safety, feasibility, and efficacy of this technique.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Estudos Retrospectivos , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Embolização Terapêutica/métodosRESUMO
OBJECTIVE: The Pipeline Vantage Embolization Device is a fourth-generation flow diverter with an antithrombotic coating and a reduced profile compared to previous Pipeline versions. The objective of this study was to evaluate the procedural feasibility, safety, and efficacy of this device. METHODS: The Pipe-VADER study was designed as a retrospective, observational study of consecutive patients treated with the Vantage at 3 neurovascular centers. Patient and aneurysm characteristics, procedural parameters, early complications, and extent of postinterventional contrast retention were analyzed on an intention-to-treat basis. RESULTS: Twenty-eight patients with 31 aneurysms (median size: 5.0 mm, posterior circulation: 4 [12.9%], ruptured: 5 [16.1%]) were included. The technical success rate was 100%, with multiple stents used in 4/30 (13.3%) procedures. Of the 30 procedures, adjunctive coiling was performed in 3 (10.0%) and balloon angioplasty in 2 (6.7%). Median procedure time was 62 minutes. Procedural ischemic stroke occured in 4 (13.3%) cases, whereof 2 were major strokes (6.6%). There were no hemorrhagic complications. Initial contrast retention was observed in 29/31 (93.5%) aneurysms. All 27 overstented side vessels were patent at the end of the procedure. Short-term follow-up (median: 5 months) showed complete and favorable occlusion rates of 70% (14/20) and 80% (16/20), respectively. CONCLUSIONS: The new Pipeline Vantage appears to be safe and feasible for the treatment of intracranial aneurysms and warrants further evaluation.
Assuntos
Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Embolização Terapêutica/métodos , Angiografia Cerebral/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Stents , Procedimentos Endovasculares/métodos , SeguimentosRESUMO
BACKGROUND: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.