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  • 1
    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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  • 2
    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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  • 3
    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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  • 4
    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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  • 5
    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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  • 6
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 91, No. 6 ( 2022-12), p. 943-951
    Type of Medium: Online Resource
    ISSN: 0148-396X , 1524-4040
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1491894-8
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  • 7
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 13 ( 2020-01), p. 175628642096782-
    Abstract: The Pipeline Embolization Device (PED, Covidien/Medtronic) is widely used to treat intracranial aneurysms. This PED in China post-market multi-center registry study (PLUS) investigated safety and effectiveness of the PED for intracranial aneurysms in the Chinese population. Methods: This was a panoramic, consecutive, real-world cohort registry study. Patients treated with PED with or without coils between November 2014 and October 2019 at 14 centers in China were included, and those treated by parent vessel occlusion or other stents were excluded. Study outcomes included angiographic evaluation of aneurysm occlusion, complications, in-stent stenosis, and predictors of aneurysm occlusion. A central committee reviewed all imaging and endpoint events. Results: In total, 1171 patients with 1322 intracranial aneurysms were included. The total occlusion rate was 81.4% (787/967) at mean follow-up of 8.96 ± 7.50 months, with 77.1% (380/493) occlusion in the PED alone and 85.9% (407/474) in the PED plus coiling group. On multi-variate analysis, female sex, hyperlipidemia, vertebral aneurysms, PED plus coiling, and blood flow detained to venous phase were significant predictors of aneurysm occlusion. In posterior circulation cohort, there was no variable associated with aneurysm occlusion. In-stent stenosis predictors included current smoking and cerebral sclerosis/stenosis. Conclusion: In the largest series on PED of multi-center date of China, data suggest that treatment with the flow-diverting PED in intracranial aneurysms was efficacious. The treatment of PED combined coiling and blood flow detained to venous phase after PED implant were associated with aneurysmal occlusion. The occlusion rate of vertebral aneurysms was higher than other location aneurysms. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03831672.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2442245-9
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  • 8
    In: Frontiers in Neurology, Frontiers Media SA, Vol. 12 ( 2021-9-16)
    Abstract: Background and Purpose: The utilization of flow diversion for ruptured intracerebral aneurysms (IAs) is still limited. We aimed to demonstrate our multicenter experience using the pipeline embolization device (PED) for ruptured IAs that were difficult to treat by clipping and coiling. Methods: Thirty-eight patients with ruptured IAs who underwent PED treatment from 2015 to 2020 were retrospectively reviewed. Factors associated with procedure-related stroke (ischemic and hemorrhagic) and clinical and angiography outcomes were analyzed. Results: There were 14 (36.8%) saccular IAs, 12 (31.6%) blister-like IAs, and 12 (31.6%) dissecting IAs. Perforator involvement was noted in 10 (26.3%) IAs. Early PED placement ( ≤ 15 days) and adjunctive coiling treatment were performed in 27 (71.1%) and 22 (57.9%) cases, respectively. The overall rate of stroke-related complications was 31.6% (12/38) (including rates of 10.5% for procedure-related hemorrhagic complications and 15.8% for procedure-related infarction). The mortality rate was 13.2% (5/38), and 84.2% of patients (32/38) had favorable outcomes. Thirty-two (84.2%) patients underwent follow-up angiographic evaluations; of these, 84.4% (27 patients) had complete occlusion and 15.6% had incomplete obliteration. Multivariate analysis revealed that early PED placement was not associated with a high risk of procedure-related stroke or an unfavorable outcome. Adjunctive coiling exhibited an association with procedure-related stroke ( p = 0.073). Procedure-related hemorrhagic complications were significantly associated with an unfavorable outcome ( p = 0.003). Immediate contrast stasis in the venous phase was associated with complete occlusion during follow-up ( p = 0.050). Conclusion: The PED is a feasible and effective treatment to prevent rebleeding and achieve aneurysm occlusion, but it is associated with a substantial risk of periprocedural hemorrhage and ischemic complications in acute ruptured IAs. Therefore, the PED should be used selectively for acutely ruptured IAs. Additionally, adjunctive coiling might increase procedure-related stroke; however, it may reduce aneurysm rebleeding in acutely ruptured IAs. Patients with immediate contrast stasis in the venous phase were more likely to achieve total occlusion. A prospective study with a larger sample size should be performed to verify our results.
    Type of Medium: Online Resource
    ISSN: 1664-2295
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2564214-5
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  • 9
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 14, No. 4 ( 2022-04), p. 371-375
    Abstract: Although coiling with a flow diverter may provide immediate dome protection, no studies have evaluated the effect on complications of postoperative occlusion degree immediately postoperatively. The purpose of this study was to determine whether postoperative occlusion degree immediately after flow-diverter placement with adjunctive coiling was associated with complications. Methods All patients’ data were collected from the post-market multi-center cohort study of embolization of intracranial aneurysms with a pipeline embolization device (PED) in China (PLUS) registry. We divided patients into those treated with a PED alone (PED-only (PO) group), those treated with a PED with coils and incomplete occlusion (PED + coils + incomplete occlusion (PCIO) group), and those treated with a PED with coils and complete occlusion (PED + coils + complete occlusion (PCCO) group). Results We evaluated 1171 consecutive patients with 1322 aneurysms treated with a PED: 685 aneurysms were treated with PO, 444 with PCIO, and 193 with PCCO. The PCCO group had a higher rate of aneurysm occlusion at the last follow-up than the PCIO and PO groups (P 〈 0.0001). Multivariate analysis of the predictors of ischemic stroke and modified Rankin Scale score (mRS) deterioration showed that PCCO was an independent predictor of ischemic stroke (HR, 2.03; 95% CI, 1.12 to 3.67; P=0.019) and mRS deterioration (HR, 2.59; 95% CI, 1.57 to 4.26; P 〈 0.0001). Conclusions Although postoperative complete occlusion with a PED and adjunctive coiling can increase the rate of aneurysm occlusion, this approach may also increase the risk of ischemic stroke and lead to poor postoperative functional outcomes.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2506028-4
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  • 10
    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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