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  • 1
    In: Frontiers in Cardiovascular Medicine, Frontiers Media SA, Vol. 9 ( 2022-9-16)
    Abstract: The treatment of complex cerebrovascular diseases (CCVDs) at the skull base, such as complex intracranial aneurysms, carotid-cavernous sinus fistulas, and intracranial artery traumatic injuries, is a difficult clinical problem despite advances in endovascular and surgical therapies. Covered stents or stent graft insertion is a new concept for endovascular treatment that focuses on arterial wall defect reconstruction, differing from endovascular lesion embolization or flow diverter therapies. In recent years, covered stents specifically designed for cerebrovascular treatment have been applied in the clinical setting, allowing thousands of patients with CCVDs to undergo intraluminal reconstruction treatment and achieving positive results, even in the era of flow diverters. Since there is no unified reference standard for the application of covered stents for treating CCVDs, it is necessary to further standardize and guide the clinical application of this technique. Thus, we organized authoritative experts in the field of neurointervention in China to write an expert consensus, which aims to summarize the results of covered stent insertion in the treatment of CCVDs and propose suitable standards for its application in the clinical setting. Based on the contents of this consensus, clinicians can use individualized intraluminal reconstruction treatment techniques for patients with CCVDs.
    Type of Medium: Online Resource
    ISSN: 2297-055X
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2781496-8
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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: 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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  • 6
    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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  • 7
    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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  • 8
    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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  • 9
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 92, No. 5 ( 2023-05), p. 971-978
    Abstract: Pipeline embolization devices (PEDs) have been increasingly used for the treatment of posterior circulation aneurysms. OBJECTIVE: To investigate the safety and efficacy of PED in the treatment of small to medium unruptured vertebral artery intracranial aneurysms (VAIAs). METHODS: Data from 76 patients with 78 unruptured small and medium (≤12 mm) VAIAs were analyzed. Data for this study come from the PLUS study, which was conducted at 14 centers in China from 2014 to 2019. Univariate analyses were performed to evaluate predictors of the occlusion and complication. RESULTS: Seventy-eight aneurysms in 76 patients were treated with PED. The mean aneurysm size was 8.28 ± 2.13 mm, and all PEDs were successfully placed. The median follow-up was 7 months and available for 67 (85.9%) aneurysms. Complete occlusion was seen in 60 (89.6%) aneurysms, which 86.6% met the primary efficacy outcome. All patients received clinical follow-up, the combined major morbidity and mortality was 2.6%, and 98.7% of patients had a good prognosis. Ischemic stroke occurred in 10.5% of patients, and adjuvant coil and successful after adjustment were predictors of ischemic stroke in the early postoperative and follow-up, respectively. There was no significant difference in the occlusion rate of aneurysm involving posterior inferior cerebellar artery ( P = .78). In cases where posterior inferior cerebellar artery was covered by PED, there was no significant difference in ischemic stroke. CONCLUSION: In the treatment of unruptured ≤12 mm VAIAs, PED has a high surgical success rate, a high degree of occlusion, and low morbidity and mortality. PED may be a promising endovascular technique.
    Type of Medium: Online Resource
    ISSN: 0148-396X , 1524-4040
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 1491894-8
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  • 10
    In: Stroke and Vascular Neurology, BMJ
    Abstract: Unruptured intracranial aneurysm treatment aims to reduce the risk of aneurysm rupture and bleeding, relieves symptoms and improve the quality of life for patients. This study aimed to assess the safety and efficacy of Pipeline Embolization Device (PED, Covidien/Medtronic, Irvine, CA) treatment for intracranial aneurysms presenting with mass effect in real-world settings. Methods We selected patients from the PED in China Post-Market Multi-Center Registry Study with mass effect presentation. The study endpoints included postoperative mass effect deterioration and mass effect relief at follow-up (3–36 months). We conducted multivariate analysis to identify factors associated with mass effect relief. Subgroup analyses by aneurysm location, size and form were also performed. Results This study included 218 patients with a mean age of 54.3±11.8 years and a female predominance of 74.0% (162/218). The postoperative mass effect deterioration rate was 9.6% (21/218). During a median follow-up period of 8.4 months, the mass effect relief rate was 71.6% (156/218). Notably, immediate aneurysm occlusion following treatment was significantly associated with mass effect relief (OR 0.392, 95% CI, 0.170 to 0.907, p=0.029). Subgroup analysis demonstrated that adjunctive coiling contributed to mass effect relief in cavernous aneurysms, while dense embolism impeded symptom relief in aneurysms 〈 10 mm and saccular aneurysms. Conclusions Our data confirmed the efficacy of PED in relieving mass effect. The findings of this study provide support for endovascular treatment to alleviate mass effect in unruptured intracranial aneurysms. Trial registration number NCT03831672 .
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2847692-X
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