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  • 1
    In: Frontiers in Aging Neuroscience, Frontiers Media SA, Vol. 14 ( 2022-6-13)
    Abstract: The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial primarily demonstrated the safety and efficacy of the implantation of multiple pipeline embolization devices (multi-PEDs) for large/giant intracranial aneurysms. However, no study has focused on when, why, or how to apply multi-PEDs. Objective The purpose of this study was to investigate the indications and strategies of using multi-PEDs for complex intracranial aneurysms. Methods Patients who had been treated with two or more PEDs were included in the post-market multicenter registry study from 2014 to 2019, across 14 centers in China. Indications, strategies, perioperative safety, and clinical outcomes were retrospectively analyzed. The modified Rankin scale (mRS) score was used to evaluate clinical outcomes comprehensively, and the O’Kelly–Marotta (OKM) grading scale was used to evaluate aneurysm healing results. Results A total of 55 intracranial aneurysms were treated with multi-PEDs. There were 20 fusiform aneurysms with a large range, 25 large/giant saccular aneurysms, six aneurysms with failed treatment, and four aneurysms with greatly varied diameters of the parent artery. The strategies included telescope techniques in 40 patients and overlap techniques in 15 patients. In total, 120 stents were deployed in 55 patients. The operation styles included 25 patients (55.6%) with two PEDs, 21 patients (38.2%) with two PEDs combined with coiling, four patients (7.3%) with three PEDs, four patients (7.3%) with three PEDs combined with coiling, and one patient (1.8%) with four PEDs. Angiography revealed OKM D in two, OKM C in seven, and OKM A and B in 46 cases after surgery. During the perioperative period, eight patients developed neurological dysfunction, three of whom died. A total of thirty-four patients were followed up with digital subtraction angiography for 2–45 (8.2 ± 8.0) months. Angiography revealed OKM D in 26, OKM C in five, and OKM B in three. At the last follow-up, the mRS score was 0–1 in 52 patients. Conclusion The treatment of anterior circulation aneurysms with multi-PEDs is safe and effective. The implantation of multi-PEDs could be considered for large-scale fusiform aneurysms, large/giant saccular aneurysms with a jet-sign, salvage of failed PED treatments, and in cases where the diameter of the parent artery varies greatly.
    Type of Medium: Online Resource
    ISSN: 1663-4365
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2558898-9
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  • 2
    In: Clinical Neuroradiology, Springer Science and Business Media LLC
    Type of Medium: Online Resource
    ISSN: 1869-1439 , 1869-1447
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2232347-8
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  • 3
    In: Stroke and Vascular Neurology, BMJ, Vol. 7, No. 4 ( 2022-08), p. 345-352
    Abstract: The aim of this study was to compare complications and outcomes between intracranial aneurysms treated with the Pipeline embolisation device (PED) alone or with PED combined with coiling for different-sized aneurysms. Method Patients with aneurysms treated by PED were collected from the PED in China postmarket multicentre registry study. We performed a propensity match analysis to compare the efficacy and safety between PED alone and PED combined with coiling treatment, and then aneurysms were organised into three groups based on their size: small (≤7 mm), medium (≤15 mm to 〉 7 mm) and large/giant ( 〉 15 mm). Complications and aneurysm occlusion rates in the aneurysm size groups were compared between PED alone and PED combined with coiling patients. Result A total of 1171 patients with 1322 aneurysms were included. All patients received clinical follow-up, while angiographic follow-up was available in 967 aneurysms. For small aneurysms, there was no difference in the aneurysm occlusion rate between two groups (79.1% vs 88.4%, respectively), while there was a significant increase in the ischaemic complication rate (8.3% vs 19.3%, respectively, p=0.0001). For medium and large/giant saccular aneurysms, PED combined with coiling significantly improved the occlusion rate (medium aneurysms: 74.7% vs 88.8%, respectively, p 〈 0.0001; large/giant saccular aneurysms: 72.9% vs 86.9%, respectively, p=0.018), while there were no differences in the total complication rate. For large/giant non-saccular aneurysms, two groups showed no differences. Conclusion Use of the PED with adjunctive coils can significantly improve the occlusion rate of medium aneurysms, without increasing the total complication rate.
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2847692-X
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  • 4
    In: Journal of NeuroInterventional Surgery, BMJ
    Abstract: The Pipeline Embolization Device (PED) is reported to be a safe treatment tool for aneurysms. However, mortality occurs in a few cases, and this has not been clearly studied. We conducted a multicenter study to retrospectively evaluate the causes of, and risk factors for, mortality in patients with intracranial aneurysms treated with the PED. Methods We retrospectively reviewed the prospectively maintained databases of patients with intracranial aneurysms treated by PED placement at 14 academic institutions from 2014 to 2019. Patients’ data, including clinical and radiographic information, were analyzed with an emphasis on mortality-related complications. Results A total of 1171 consecutive patients underwent 1319 PED procedures to treat 1322 intracranial aneurysms. The mortality rate was 1.5% (17/1171), and in 1.3% of the patients (15/1171), deaths were caused by delayed aneurysmal rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms associated with PED procedures. Multivariate analysis showed that previous treatment (OR, 12.657; 95% CI, 3.189 to 50.227; P 〈 0.0001), aneurysm size ≥10 mm (OR, 4.704; 95% CI, 1.297 to 17.068; P=0.019), aneurysm location (basilar artery) (OR, 10.734; 95% CI, 2.730 to 42.207; P=0.001), and current subarachnoid hemorrhage (OR, 4.505; 95% CI, 0.991 to 20.474; P=0.051) were associated with neurological complications resulting in mortality. Conclusions Delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression were the main causes of mortality in patients with intracranial aneurysms treated with the PED. Large basilar aneurysms are associated with an increased risk of postoperative death and require increased attention and caution.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2506028-4
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  • 5
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 14 ( 2021-01), p. 175628642110393-
    Abstract: Although grading scales for angiography outcomes following cerebral aneurysm treatment with flow diversion have been published, physicians have not widely adopted these scales in practice. The aim of this study is to propose and validate a novel Flow diversion Predictive Score (4F-FPS) grading scale based on previously established scales that is simple and reliable. Methods: We retrospectively analyzed consecutive patients who underwent endovascular treatment for cerebral aneurysms with flow diversion between January 2014 and September 2019. The included patients were randomly divided into the derivation and validation group in a 70/30 ratio, respectively. Aneurysms were classified as incomplete or complete occlusion based on final angiography outcomes. 4F-FPS was derived to predict aneurysm occlusion from multivariate logistic regression analyses in the derivation group and validated with previously published grading scales in the validation group. Results: Overall, 662 patients [mean age, 53.8 years; 72.5% (480/662) female] with 662 aneurysms treated with the Pipeline TM flow diverter were included [69.9% (463/662) derivation group, 30.1% (199/662) validation group]. The incidence of aneurysm occlusion was 82.7%. 4F-FPS demonstrated significant discrimination in 10-fold cross validation [mean receiver operating characteristic (ROC) area, 0.862 ± 0.055] and calibration (Cox & Snell R 2 , 0.251; Nagelkerke R 2 , 0.413) in the derivation group. The ROC area of 4F-FPS score in both the derivation and validation groups is the largest compared with previously published grading scales/scores ( p  〈  0.05), which shows better sensitivity and specificity. The 4F-FPS score showed excellent prediction, discrimination, and calibration properties. Conclusion: The 4F-FPS score is a simple and reliable tool to predict angiography outcome after flow diversion treatment. If widely adopted, it may provide a common language to be used in future reporting of flow diversion results for clinical trials and daily practice. Clinical trial registration: http://www.clinicaltrials.gov . Unique identifier: NCT03831672
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2442245-9
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  • 6
    In: Neurotherapeutics, Springer Science and Business Media LLC, Vol. 18, No. 2 ( 2021-04), p. 1198-1206
    Type of Medium: Online Resource
    ISSN: 1933-7213 , 1878-7479
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2279496-7
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  • 7
    In: International Journal of Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 109, No. 8 ( 2023-05-9), p. 2159-2167
    Abstract: Intracranial aneurysms pose a significant health issue, affecting 3–5% of the adult population. The pipeline embolization device (PED) has emerged as a promising treatment for these lesions. This study aimed to investigate the impact of operator experience on complication and poor outcome rates, as well as the learning curve for PED. Methods: A total of 217 patients were consecutively enroled from four eligible centres and divided into three groups based on the number of procedures performed: group 1 (first 10 procedures), group 2 (11–20 procedures), and group 3( 〉 20 procedures). Major complications include operation-related ischaemic or haemorrhagic events and mass effect deterioration. Poor outcome was defined as a modified Rankin Scale score greater than 2 at discharge. Cumulative summation (CUSUM) analysis was generated to assess the learning curve according to major complications and poor outcome. Results: The study found that major complications and poor outcomes occurred in 5.1% and 2.3% of cases, respectively. The rate of major complications decreased from 10.0% in group 1 to 2.9% in group 3 ( P =0.053), while the rate of poor outcomes decreased from 7.5% in group 1 to 0.7% in group 3 ( P =0.015). Multivariable regression analysis adjusted for covariates showed that operator experience was associated with a lower rate of poor outcomes ( P =0.034). CUSUM analysis demonstrated that the learning curve for avoiding major complications and poor outcomes required 27 (mean=13) and 40 (mean=20) cases, respectively. Conclusions: These findings suggest that PED treatment requires a learning curve of 40 cases to achieve reproducibility regarding complications and functional results. Additionally, major complications and poor outcomes significantly decreases after the first 20 procedures. CUSUM analysis can serve as a useful tool for monitoring and assessing surgical performance.
    Type of Medium: Online Resource
    ISSN: 1743-9159
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2201966-2
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  • 8
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 16 ( 2023-01), p. 175628642311705-
    Abstract: Several pharmacological pathways have revealed statin to have a positive role in patients with for intracranial aneurysms. However, prior studies regarding the association between statin use and patients’ outcomes after pipeline embolization device (PED) treatment were not completely supportive. Objectives: To investigate whether statin medication following PED treatment would improve the outcomes of intracranial aneurysm patients in a real-world setting. Design: A retrospective multicenter cohort study. Methods: Patients were selected from the PLUS registry study conducted from November 2014 to October 2019 across 14 centers in China. The population was divided into two groups: those who received statin medication after the PED treatment and those who did not receive statin medication after PED treatment. Study outcomes included angiographic evaluation of aneurysm occlusion, parent arteries stenosis, ischemic and hemorrhage complications, all-cause mortality, neurologic mortality, and functional outcome. Results: 1087 patients with 1168 intracranial aneurysms were eligible; 232 patients were in the statin user group and the other 855 were in the non-statin user group. For the statin user group versus the non-statin user group, no significant difference was found for the primary outcomes of complete occlusion of aneurysm (82.4% versus 84.2%; p = 0.697). Of the secondary outcomes, none had a significant difference including stenosis of parent arteries ≥ 50% (1.4% versus 2.3%; p = 0.739), total subarachnoid hemorrhage (0.9% versus 2.5%; p = 0.215), all-cause mortality (0.0% versus 1.9%; p = 0.204), neurologic mortality (0.0% versus 1.6%; p = 0.280), excellent (95.5% versus 97.2%; p = 0.877), and favorable (98.9% versus 98.4%; p = 0.933) functional outcomes. The total ischemic complication rate (9.0% versus 7.1%; p = 0.401) was higher but not significant in the statin user group. The propensity score-matched cohort showed similar results. Results of binary multivariable logistic regression analysis and propensity score-matched analysis both showed that statin usage was not independently associated with an increased rate of complete occlusion or any other secondary outcomes. Subgroup analysis found the same result in patients who did not use statin before the procedure. Conclusion: Among patients with intracranial aneurysms, statin use after the PED treatment was not significantly associated with better angiographic and clinical outcomes. Well-designed studies are needed to further confirm this finding.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2442245-9
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  • 9
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 15, No. 4 ( 2023-04), p. 315-320
    Abstract: Intracranial fusiform aneurysms are less common than saccular aneurysms, but are associated with higher mortality and morbidity. We conducted this study to determine the safety and efficacy of the pipeline embolization device (PED) to treat intracranial fusiform aneurysms. Methods This was a multicenter, retrospective, and observational study. Data for this study came from the PLUS study conducted from 2014 to 2019 across 14 centers in China. Univariate and multivariable logistic regression analyses were performed to evaluate predictors of the occlusion rate and complication. Results A total of 1171 consecutive patients with 1322 intracranial aneurysms participated in this study. Among the participants, 104 patients with 109 fusiform aneurysms were eligible for this analysis (mean age 49 years, 36.5% women, aneurysm mean size 14.7 mm, 55% in the posterior circulation, and 6% in the basilar artery). Mean follow-up time was 9.0 months (range 3–36 months). The last DSA angiographic follow-up was available for 85 patients, and 58 aneurysms (68.2%) were completely occluded. The overall complication rate and mortality were 17.3% and 2.8%, respectively. Multivariate analysis demonstrated that age (OR=1.007, p=0.037) and cerebral atherosclerosis (OR=1.441, p=0.002) were associated with incomplete occlusion of fusiform aneurysms after PED treatment. Conclusion PEDs may be an effective treatment for intracranial fusiform aneurysms, with a favorable occlusion rate. However, because these treatments have a relatively high rate of complications, PED treatment for fusiform aneurysms should be carefully and strictly controlled. Our analysis showed that PEDs with adjunctive coiling did not significantly improve the occlusion rate of fusiform aneurysms.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2506028-4
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  • 10
    In: Frontiers in Neurology, Frontiers Media SA, Vol. 13 ( 2022-5-31)
    Abstract: The purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China. Methods Patients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller than 12 mm were selected. Radiographic outcomes were assessed using digital subtraction angiography. Clinical outcomes included functional outcomes (modified Rankin Scale, MRS) in the early postoperative period ( ≤ 30 days) and early postoperative complications associated with PED therapy. Results A total of 652 patients with a combined 754 aneurysms were included in this study (mean age of 53.9 ± 10.3 years, 68.7% women). Mean aneurysm diameter was 6.78 ± 2.67 mm. Of the 687 stents deployed, 99.7% (685/689) were successfully deployed. In this study, 64.7% (488/754) of aneurysms were treated with only the PED, whereas 35.3% (266/754) were subjected to PED-assisted therapy. Radiographic outcome at the last follow-up (median time: seven months) was available for 64.3% (485/754) of the aneurysms. 82.5% (400/485) of aneurysms demonstrated complete occlusion (Raymond Roy Grade I). 81.4% (395/485) of aneurysms were found to meet the study's primary effectiveness outcome. At the early postoperative period, the mRS score was determined to be 0–2 vs. 3-6 in 98.2% (640/652) vs. 1.8% (12/652) of the cases, respectively. The combined major morbidity and mortality rate was 3.2% (21/652). Conclusion In the largest study of PED therapy for small and medium-sized intracranial aneurysms to date, pipeline-assisted coil embolization was chosen more often than multiple stent implantation for aneurysm treatment, demonstrating good results, high surgical success rates, high occlusion rates, and low morbidity and mortality. Clinical Trial Registration www.ClinicalTrials.gov , identifier: NCT03831672.
    Type of Medium: Online Resource
    ISSN: 1664-2295
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2564214-5
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