RATIONALE AND OBJECTIVES:To analyze the complications and mid-to-long-term results of Pipeline embolization device (PED, Covidien/Medtronic) treatment for giant intracranial aneurysms (GIAs), and identify predictors of outcomes. MATERIALS AND METHODS:We retrospectively analyzed the data from the PLUS registry and identified all patients with GIAs for further evaluation. RESULTS:A total of 137 patients (137 GIAs) were included in this study. Of these, 118 (86.1%) were saccular, and 13 (9.5%) were located in the posterior circulation. PED-assisted coiling was performed in 96 patients (70.1%), and 20 patients (14.6%) received overlapping PED deployment. Early postoperative complications occurred in 15 patients (10.9%). The median duration of clinical follow-up was 15.0 months (IQR, 12.0-24.0). The overall complication rate was 13.1% (18/137), including 12 ischemic events and 6 hemorrhagic events. The mortality rate was 2.2% (3/137). At the final follow-up, 123 of 130 patients (94.6%) were functioning independently. Multivariable logistic regression analysis identified posterior circulation aneurysms [OR, 6.01, 95% CI: 1.40-25.78; P=0.016], PED deployment adjustment [OR, 4.96, 95% CI: 1.35-18.25; P=0.016] and diabetes [OR, 10.34, 95% CI: 1.02-104.42; P=0.048] as factors independently associated with overall complications. Angiographic follow-up was available for 97 patients (70.8%), with a median follow-up duration of 7.0 months (IQR, 5.0-9.0). The complete occlusion rate was 75.3% (73/97). CONCLUSION:In this retrospective multicenter study, PED treatment for unruptured GIAs was associated with favorable angiographic and clinical outcomes. Posterior circulation aneurysms, comorbid diabetes, and PED adjustment were significantly associated with a higher risk of overall complications.

BACKGROUND:Approximately 25% of aneurysms treated with Pipeline remain incompletely occluded at 6 months. This study aimed to develop and externally validate a novel preoperative scoring system to predict the risk of incomplete occlusion. METHODS:This retrospective multicenter study developed a model using data from 588 patients (659 aneurysms) (PLUS study, 2014-2019). An external validation cohort consisted of 189 patients with 235 aneurysms from a single participating center (2020-2022). Feature selection was performed using the least absolute shrinkage and selection operator (LASSO) regression, followed by multivariable logistic regression modeling. Model performance was assessed by the Area Under the Curve (AUC), calibration, and bootstrap validation. A points-based Pre-scope score was derived and compared with the DIANES score (DeLong test; R software v4.2.0). RESULTS:Eight predictors were identified, including aneurysm diameter, stent diameter, stent-parent diameter ratio, branch artery involvement, coil assistance, aneurysm type, and location. The model shows good discriminative power with an AUC of 0.802 and good calibration. The model also provided good discrimination (AUC of 0.795) and good calibration in the validation cohort. After conversion into a points-based system, the Pre-scope score showed good discriminative ability, with AUCs of 0.775 and 0.794 in the training and validation cohorts, respectively. Compared with the DIANES score, this score has good discriminative ability (verification cohort AUC: 0.794 vs. 0.651, P ＜0.05). CONCLUSION:The Pre-scope score, based on a large multicenter dataset with independent temporal validation, is a practical preoperative tool with superior predictive ability. It may support individualized surgical strategies and improve patient outcomes.

ObjectiveTo evaluate whether intraoperative fractional flow reserve (FFR) pressure wire measurements combined with FLOW800 imaging analysis effectively predict postoperative cerebral perfusion abnormalities following superficial temporal artery to middle cerebral artery (STA–MCA) bypass surgery in patients with Moyamoya disease (MMD).MethodsA retrospective analysis was conducted on 26 patients diagnosed with MMD who underwent STA–MCA bypass at our institution between November 2023 and January 2025. Intraoperative graft pressures were assessed using FFR pressure wires. Concurrently, FLOW800 imaging provided quantitative microcirculatory parameters, including delay time (DT), flow velocity, rise time (RT), and fluorescence intensity. Postoperative cerebral perfusion-related complications were documented. ROC analyses were reported with 95% confidence intervals to evaluate the predictive value of intraoperative parameters.ResultsPostoperative cerebral perfusion abnormalities occurred in 9 out of 26 patients (34.6%). Among them, 3 patients (11.5%) had diffusion-weighted MRI (DWI)-confirmed acute ischemic lesions (major complications), whereas the remaining 6 patients experienced transient neurological symptoms that completely resolved within 2 weeks to 1 month without radiographic infarction. A higher pressure gradient across the bypass graft (ΔP) and prolonged rise time (RT) in the proximal recipient artery significantly correlated with postoperative perfusion abnormalities (p < 0.05). A ΔP cutoff >32 mmHg showed a sensitivity of 77.8% and a specificity of 64.7%. The combined predictive capability of ΔP and RT yielded an area under the receiver operating characteristic (ROC) curve (AUC) of 0.82 (95% CI, 0.61–0.99), surpassing the predictive value of either parameter alone (AUC 0.79 for ΔP and 0.79 for RT).ConclusionsIntraoperative monitoring with FFR pressure wire combined with FLOW800 imaging may help identify MMD patients at increased risk of early postoperative cerebral perfusion abnormalities after STA–MCA bypass. The integration of ΔP and RT appears to improve predictive accuracy and may support perioperative risk stratification, although larger prospective studies are required before routine decision-making can be recommended.

BACKGROUND:The impact of parent artery stenosis on the treatment of intracranial aneurysms by using flow diversion (FD) remains unknown. This multicenter retrospective study aimed to evaluate the clinical and radiological outcomes of patients with intracranial aneurysms accompanied by parent artery stenosis of different etiologies after FD implantation. METHODS:The study cohort included patients who received FD treatment at four comprehensive centers from March 2013 to June 2024. The etiological factors underlying intracranial arterial stenosis were categorized as intracranial atherosclerosis (ICAS), intracranial arterial dissection (ICAD), and matricidal aneurysms (MA). RESULTS:A total of 161 patients with intracranial aneurysms accompanied by parent artery stenosis were ultimately included for in-depth analysis. The procedures were successfully performed in all patients, with a low incidence of periprocedural complications. In the clinical and angiographic follow-up, all patients had a favorable outcome (modified Rankin Scale score 0-2), and the complete occlusion rate of aneurysms was 64.0% at median 8.0 months (IQR 6-13.5 months). A comparative analysis revealed that, in contrast to the ICAD and MA groups, the ICAS group exhibited a significantly higher rate of in-stent restenosis (28% vs 16.7% vs 5.5%, p = 0.020). CONCLUSIONS:FDs demonstrated satisfactory performance in terms of periprocedural complications, favorable clinical outcomes, and complete occlusion on follow-up imaging in the management of intracranial aneurysms accompanied by parent artery stenosis. Notably, ICAS exerted a substantially greater influence on in-stent restenosis and entailed a higher requirement for repeat angioplasty compared with ICAD and MA.

Background:Delayed ischemic stroke (DIS) is a rare complication that may occur in patients with cerebral aneurysms treated with the Pipeline Embolization device (PED). This study aims to evaluate the characteristics of DIS following PED placement and to investigate the optimal duration of dual antiplatelet therapy (DAPT) in relation to the incidence of DIS. Methods:We conducted a multicenter retrospective cohort study on consecutive cases of intracranial aneurysms treated with PED. Patients were divided into two groups based on the timing of DAPT switching to monotherapy: early (<6 months) and late (≥6 months). To adjust for potential biases between the groups, inverse probability of treatment weighting (IPTW) was applied. Kaplan-Meier survival analysis and multivariate Cox regression were used to calculate cumulative DIS rates, and risk factors for DIS. Results:A total of 1,146 consecutive patients with 1,296 aneurysms were included, of whom 12 (0.96%) who received PED developed DIS. The late-switch group had a lower DIS rate compared to the early-switch group [0.5% (4 of 752 patients) vs. 2.0% (8 of 394 patients), p = 0.018], even after IPTW. Hypertension [hazard ratio (HR) 3.47, 95% CI: 1.045-11.552] and complete occlusion immediately post-procedure (HR 5.48, 95% CI: 3.048-9.868) were significant risk factors for DIS. Conclusion:DIS is a rare complication among patients treated with PED for cerebral aneurysms. Extending the duration of DAPT to at least six months may safer for the patients with hypertension and immediate complete occlusion.

Background 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.

Background Epstein-Barr virus (EBV) infection has been associated with the development of glial fibrillary acidic protein astrocytopathy (GFAP-A), with most cases responding favorably to steroids and/or intravenous immunoglobulin (IVIG). We report a case of EBV-related GFAP-A exhibiting a poor response to conventional immunotherapy. Case presentation A 62-year-old Chinese male presented with dysuria, fever, and headache, rapidly progressing to paraparesis. Initial investigations indicated pulmonary infection and viral encephalitis. Despite intensive care and antiviral treatment, his condition deteriorated, necessitating tracheostomy and intubation. Upon transfer to a tertiary neurology center, he had reduced tone, power, and areflexia in the lower limbs, and a loss of sensation below the T6 level. Cerebrospinal fluid (CSF) analysis revealed markedly elevated cell counts and protein levels. MRI showed leptomeningeal enhancement in the left frontal lobe, cervical and thoracic spines. EBV DNA and GFAP-IgG were detected in the CSF, suggesting a diagnosis of EBV-related GFAP-A. Treatment with IV acyclovir, high-dose steroids, and IVIG was administered with no clinical improvement. Conclusions This report presents a case of EBV-related GFAP-A refractory to treatments with steroids and IVIG. It suggests that higher levels of CSF protein and cell count may predict worse outcomes and a poorer prognosis.

OBJECTIVE:The burr-hole technique is a minimally invasive transcranial approach designed to minimize the surgical incision size and reduce disruption to brain tissue. We aimed to share our experience with the burr-hole technique for removing brain lesions and to evaluate its effectiveness in treating appropriately sized intra-axial brain lesions. METHODS:In this retrospective cohort study, we analyzed the clinical features, radiological characteristics, surgical techniques, and outcomes of patients who underwent burr-hole surgery for intra-axial brain lesions between January 2019 and December 2023. RESULTS:A total of 81 patients were included in the study. Gross total resection was achieved in 74 patients (91.4%), whereas subtotal resection was performed in 7 patients (8.6%). There were no perioperative deaths, cerebrospinal fluid leaks, or wound infections. The median follow-up duration was 40.5 months (range, 4.1-63.7 months). At the end of the follow-up period, 14 patients (17.3%) experienced recurrence, including 6 with glioma and 8 with primary cerebral lymphoma. Among these patients, 10 died due to lesion recurrence. CONCLUSIONS:The burr-hole approach using a retractable tubular device is a safe and effective method for the removal of brain lesions. As a novel minimally invasive technique, it significantly facilitates and accelerates the evolution of microsurgical outcomes.

Background 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.

目的 探讨pipeline栓塞装置(PED)治疗大脑中动脉(MCA)动脉瘤的临床效果.方法 回顾性分析2014年11月至2019年10月我国14个临床中心采用PED治疗的33例MCA动脉瘤的临床资料、影像学资料和随访资料.结果 33例共39个动脉瘤,使用37个PED.33例完成临床随访,30例(36个动脉瘤)完成影像随访;随访时间4～22个月,平均(10.6±6.3)个月;动脉瘤完全或近全闭塞30个(83.3％,30/36);相对于单纯PED治疗组(71.4％),PED辅助弹簧圈栓塞组动脉瘤闭塞率更高(100％;P= 0.031);预后不良(mRS评分>2分)3例(9.1％),预后良好(mRS评分≤2分)30例(90.9％);术后并发症发生率为24.2％(8/33),术前规律服用双抗药物3d以上病人术后并发症发生率明显低于未规律服用双抗药物的病人(P=0.033).结论 MCA动脉瘤可以采用PED治疗,疗效较满意.对于直径大、形态不规则的MCA动脉瘤,可使用PED结合弹簧圈栓塞治疗以获得更高的闭塞率.术前、术后应规范应用双抗药物以减少缺血、出血并发症.

Background: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.

BackgroundManaging fusiform aneurysms of the proximal (M1) segment of the middle cerebral artery (MCA) is challenging due to difficulties in both surgical and endovascular treatment. In this study, we present our experience using flow diverter stents for managing unruptured M1 segment fusiform aneurysms.MethodsWe conducted a retrospective review of the database of our institution to identify all patients who underwent flow diversion treatment for unruptured M1 segment fusiform aneurysms. We collected data on patient demographics, aneurysm characteristics, complications, angiographic follow-up results, and clinical outcomes.ResultsA total of 10 patients (five male and five female patients) with 10 unruptured M1 segment fusiform aneurysms were included in the study. The average age of the patients was 48 years (range: 16–64 years); five patients had aneurysms smaller than 10 mm, four had aneurysms measuring between 10 and 25 mm, and one patient had an aneurysm larger than 25 mm. The successful deployment of flow-diverting stents was achieved in all cases. Procedure-related morbidity was observed in 10% of patients, but there were no deaths. All patients showed good outcomes (modified Rankin Scale score of 0–1); eight out of 10 patients had available follow-up angiography results with a mean follow-up period of 11.6 months (range: 6–24 months). Complete occlusion occurred in six out of eight reviewed cases (75%).ConclusionOur preliminary findings suggest that using flow diversion for treating unruptured fusiform aneurysms in the proximal MCA is feasible and safe, with a satisfactory rate of complete occlusion. However, further studies involving larger case series are needed to validate the durability and efficacy of this treatment approach.

Background: 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.

初步观察Pipeline栓塞装置(PED)治疗大脑中动脉M1段未破裂夹层动脉瘤的临床疗效和安全性.回顾性分析2015年1月至2021年1月上海冬雷脑科医院神经外科采用PED治疗的6例(7个动脉瘤)大脑中动脉M1段未破裂夹层动脉瘤患者的临床资料.3例患者行弹簧圈辅助PED治疗,3例患者单纯行PED治疗.6例患者共置入6个PED,支架均释放成功.1例患者术后出现手术同侧脑实质血肿.6例患者随访时间的中位数为36个月(12～80个月).至末次随访,无动脉血栓栓塞事件,改良Rankin量表评分0分5例,1分1例;5例患者的6个动脉瘤O'Kelly-Marotta(OKM)分级D级愈合,1例患者的单发动脉瘤OKM分级B级愈合.

BACKGROUND: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.

目的 明确Pipeline血流导向装置(PED)治疗颅内大型和巨大型夹层动脉瘤的安全性和有效性.方法 回顾性分析2014年11月至2019年10月首都医科大学附属北京天坛医院等14家临床中心进行的PLUS研究中的临床和影像学资料,提取其中接受PED治疗的颅内大型(最大直径为15～＜25 mm)和巨大型(最大直径为≥25 mm)未破裂夹层动脉瘤患者的数据,总结其临床特征和治疗情况.术后即刻动脉瘤的闭塞程度采用O'Kelly-Marotta(OKM)分级进行评价,治疗结局通过临床随访获得的改良Rankin量表评分(mRS)以及影像学随访结果评估.结果 研究纳入36例患者(36个动脉瘤),共置入44枚PED.仅使用PED治疗18例(50.0％),PED结合弹簧圈栓塞治疗18例(50.0％);使用多枚PED治疗7例(19.4％).支架贴壁良好率为100.0％(44/44),支架调整后的释放成功率为88.9％(32/36).术后即刻造影结果显示,OKM分级A级20例(55.6％),B级12例(33.3％),C级3例(8.3％),D级1例(2.8％).围手术期1例(2.8％)患者出现缺血性并发症,1例(2.8％)死亡.35例患者完成临床随访,28例完成影像学随访.随访时间为(11.7±5.3)个月(3～24个月).末次随访时,86.1％(31/36)的患者神经功能恢复良好(mRS为0～1分).OKM分级为D级的比率为92.9％(26/28),1例动脉瘤复发.总的并发症发生率为11.1％(4/36),总病死率为5.6％(2/36).结论 使用PED治疗颅内大型和巨大型夹层动脉瘤安全、有效,短中期随访可以观察到良好的临床结局.

Intracranial vertebral artery dissecting aneurysm (IVADA) is a rare type of aneurysm with high morbidity and mortality. Recently, the application of pipeline embolization devices (PEDs) has been extended to IVADAs. Here, we aim to investigate the safety and effectiveness of PEDs for IVADAs. We retrospectively reviewed the PLUS database to identify patients who had IVADAs and were treated with PEDs from 2014 to 2019 at 14 centers across China. Data including patient and aneurysm characteristics, procedure details, angiographic and clinical results, relationship with the ipsilateral posterior inferior cerebellar artery (PICA), and patency of the PICA following PED coverage were analyzed. In this study 52 consecutive patients with 52 IVADAs were included. The mean age was 52.33 years and 82.7 http://www.clinicaltrials.gov . Unique identifier: NCT03831672

本研究旨在探索血流导向装置（FD）治疗颅内支架辅助栓塞复发动脉瘤（rSACAN）的技术可行性、安全性及有效性。本研究对《Pipeline治疗动脉瘤的中国上市后多中心回顾性研究（PLUS）》中使用Pipeline血流导向装置（PED）治疗rSACAN患者亚组数据进行回顾性分析。结果表明，在使用PED治疗15例rSACAN患者过程中，PED植入技术成功14例，围手术期发生缺血并发症1例，占位效应1例，死亡1例。10例患者（10个动脉瘤）有效影像学随访，随访期为（8.8±3.2）个月，9例闭塞，与PLUS研究总体闭塞率相当（81.4%）。本研究结果表明，FD治疗rSACAN技术上可行，具有较高的安全性和有效性，但受限于小样本及低随访率，研究结论尚需进一步证实。

ObjectiveThe 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.MethodsPatients 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.ResultsA 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).ConclusionIn 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 Registrationwww.ClinicalTrials.gov, identifier: NCT03831672.

BACKGROUND:In-stent stenosis (ISS) is a delayed complication that can occur after pipeline embolization device use when treating intracranial aneurysms (IAs).OBJECTIVE:To assess the incidence, predictors, and outcomes of ISS.METHODS:This was a retrospective, multicenter, observational study. All patient data were collected from a PLUS registry study. We collected data from patients with IA who completed digital subtraction angiography at follow-up and divided patients into "non-ISS," "mild ISS," or "severe ISS" groups. Multivariate logistic regression analysis was conducted to determine predictors of ISS.RESULTS:A total of 1171 consecutive patients with 1322 IAs participated in this study. Angiographic follow-up was available for 662 patients with 728 IAs, and the mean follow-up time was 9 months. ISS was detected in 73 cases (10.03%), including 61 mild ISS cases and 12 severe ISS cases. Univariate and multivariable analysis demonstrated that current smoking history (mild ISS: OR 2.15, 95% CI 1.122-4.118, P = .021; severe ISS: OR 5.858, 95% CI 1.186-28.93, P = .030) and cerebral atherosclerosis (mild ISS: OR 5.694, 95% CI 3.193-10.15, P = .001; severe ISS: OR 6.103, 95% CI 1.384-26.91, P = .017) were independent predictors of ISS. Compared with the other groups, the severe ISS group had higher rate of ischemic stroke (33.3%).CONCLUSION:ISS occurs in approximately 10.03% of cases at a mean follow-up of 9 months. Statistically, current smoking history and cerebral atherosclerosis are the main predictors of ISS. Severe ISS may be associated with higher risk of neurological ischemic events in patients with IA after pipeline embolization device implantation.