The role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms.
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ABSTRACT:
SUBMITTER: de Barros Faria M
PROVIDER: S-EPMC7964407 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and purposeFlow-diverting stents, such as the PED, have emerged as a novel means of treating complex intracranial aneurysms. This retrospective analysis of the initial Canadian experience provides insight into technical challenges, clinical and radiographic outcomes, and complication rates after the use of flow-diverting stents for unruptured aneurysms.Materials and methodsCases were compiled from 7 Canadian centers between July 2008 and December 2010. Each center prospectively tracked their initial experience; these data were retrospectively updated and pooled for analysis.ResultsDuring the defined study period, 97 cases of unruptured aneurysm were treated with the PED, with successful stent deployment in 94 cases. The overall complete or near-complete occlusion rate was 83%, with a median follow-up at 1.25 years (range 0.25-2.5 years). Progressive occlusion was witnessed over time, with complete or near-complete occlusion in 65% of aneurysms followed through 6 months, and 90% of aneurysms followed through 1 year. Multivariate analysis found previous aneurysm treatment and female sex predictive of persistent aneurysm filling. Most patients were stable or improved (88%), with the most favorable outcomes observed in patients with cavernous carotid aneurysms. The overall mortality rate was 6%. Postprocedural aneurysm hemorrhage occurred in 3 patients (3%), while ipsilateral distal territory hemorrhage was observed in 4 patients (3.4%).ConclusionsFlow-diverting stents represent an important tool in the treatment of complex intracranial aneurysms. The relative efficacy and morbidity of this treatment must be considered in the context of available alternate interventions.
| S-EPMC7965091 | biostudies-literature
Project description:BackgroundUnruptured 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.MethodsWe 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.ResultsThis 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.ConclusionsOur 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 numberNCT03831672.
| S-EPMC10956105 | biostudies-literature
Project description:Background and purposeRisk factors for acute ischemic stroke following flow-diverter treatment of intracranial aneurysms are poorly understood. Using the International Retrospective Study of Pipeline Embolization Device (IntrePED) registry, we studied demographic, aneurysm, and procedural characteristics associated with postoperative acute ischemic stroke following Pipeline Embolization Device (PED) treatment.Materials and methodsWe identified patients in the IntrePED registry with post-PED-treatment acute ischemic stroke. The rate of postoperative acute ischemic stroke was determined by demographics, comorbidities, aneurysm characteristics, and procedure characteristics (including anticoagulation use, platelet testing, number of devices used, sheaths, and so forth). Categoric variables were compared with χ(2) testing, and continuous variables were compared with the Student t test. Odds ratios and 95% confidence intervals were obtained by using univariate logistic regression. Multivariate logistic regression analysis was used to determine which factors were independently associated with postoperative stroke.ResultsOf 793 patients with 906 aneurysms, 36 (4.5%) patients had acute ischemic stroke. Twenty-six (72.2%) strokes occurred within 30 days of treatment (median, 3.5 days; range, 0-397 days). Ten patients died, and the remaining 26 had major neurologic morbidity. Variables associated with higher odds of acute ischemic stroke on univariate analysis included male sex, hypertension, treatment of MCA aneurysms, treatment of fusiform aneurysms, treatment of giant aneurysms, and use of multiple PEDs. However, on multivariate analysis, the only one of these variables independently associated with stroke was treatment of fusiform aneurysms (OR, 2.74; 95% CI, 1.11-6.75; P = .03). Fusiform aneurysms that were associated with stroke were significantly larger than those not associated with stroke (mean, 24.5 ± 12.5 mm versus 13.6 ± 6.8 mm; P < .001).ConclusionsIschemic stroke following PED treatment is an uncommon-but-devastating complication. Fusiform aneurysms were the only variable independently associated with postoperative stroke.
| S-EPMC7984677 | biostudies-literature
Project description:During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3-36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672.
| S-EPMC8423892 | biostudies-literature
Project description:Background and purposeAneurysm treatment by intrasaccular packing has been associated with a relatively high rate of recurrence. The use of mesh tubes has recently gained traction as an alternative therapy. This article summarizes the midterm results of using an endoluminal sleeve, the PED, in the treatment of aneurysms.Materials and methodsA total of 19 wide-neck aneurysms were treated in 18 patients: 10 by implantation of PEDs alone and 9 by a combination of PED and coils. Angiographic and clinical results were recorded immediately and at 6 months following treatment.ResultsImmediate angiographic occlusion was achieved in 4 and flow reduction, in another 15 aneurysms. Angiography at 6 months demonstrated complete occlusion in 17 and partial filling in 1 of 18 patients. There was no difference between coil-packed and unpacked aneurysms. Of 28 side branches covered by > or =1 device, the ophthalmic artery was absent immediately in 1 and at 6 months in another 2 cases. One patient experienced abrupt in-stent thrombosis resulting in a transient neurologic deficit, and 1 patient died due to rupture of a coexisting aneurysm. All giant aneurysms treated with PED alone were demonstrated by follow-up cross-sectional imaging to have involuted by 6 months.ConclusionsTreatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flow-modifying devices with or without adjunctive use of intrasaccular coil packing.
| S-EPMC7963954 | biostudies-literature
Project description:Background and purposeThe published results of treating internal carotid artery aneurysms with the PED do not necessarily apply to its use in the posterior circulation because disabling brain stem infarcts can be caused by occlusion of a single perforator. In this multicenter study, we assessed the safety of PED placement in the posterior circulation.Materials and methodsA prospective case registry was maintained of all posterior circulation aneurysms treated with PEDs at 3 Australian neurointerventional centers during a 27-month period. The objective was to assess the complications and aneurysm occlusion rates associated with posterior circulation PEDs.ResultsThirty-two posterior circulation aneurysms were treated in 32 patients. No deaths or poor neurologic outcomes occurred. Perforator territory infarctions occurred in 3 (14%) of the 21 patients with basilar artery aneurysms, and in all 3, a single PED was used. Two asymptomatic intracranial hematomas were recorded. No aneurysm rupture or PED thrombosis was encountered. The overall rate of permanent neurologic complications was 9.4% (3/32); all 3 patients had very mild residual symptoms and a good clinical outcome. Aneurysm occlusion was demonstrated in 85% of patients with >6 months of follow-up and 96% of patients with >1 year of follow-up.ConclusionsThe PED is effective in the treatment of posterior circulation aneurysms that are otherwise difficult or impossible to treat with standard endovascular or surgical techniques, and its safety is similar to that of stent-assisted coiling techniques. A higher clinical perforator infarction rate may be associated with basilar artery PEDs relative to the internal carotid artery.
| S-EPMC7965498 | biostudies-literature
Project description:Flow diversion is an evolving endovascular modality for treating intracranial aneurysms. Although rare, serious adverse events following flow diversion may include ischemic stroke, intracranial hemorrhage, or delayed rupture of the treated aneurysm. This dataset describes 141 flow diversion procedures performed with the Pipeline Embolization Device, Pipeline Flex, or Surpass Streamline on 126 subjects with intracranial aneurysms [1]. The retrospective data were collected from electronic medical records at two large tertiary centers. Baseline patient data included age, sex, and medical comorbidities. The dataset also describes aneurysm characteristics including laterality, anatomic location, morphology, dome height, and neck width. In addition, digital subtraction images showing the internal carotid artery tortuosity were included for aneurysms in the anterior cerebral circulation [2]. Procedural data include case duration, radiation exposure, number of flow diverters deployed, and complications encountered during deployment. In addition, data related to the duration of hospitalization and postoperative adverse events are included. Finally, time to follow up and rates of total aneurysm obliteration at first and second postoperative visits are included. This data is propensity score matching are included. This data is presented as a starting point for future prospective comparisons in the safety and efficacy of flow diverters as more devices become approved and commercially available.
| S-EPMC9163419 | biostudies-literature
Project description:Background and purposeThe 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.MethodsThis 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.ResultsIn 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.ConclusionIn 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 registrationClinicalTrials.gov identifier: NCT03831672.
| S-EPMC7649855 | biostudies-literature
Project description:BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.
| S-EPMC6996098 | biostudies-literature
Project description:Background and purposePostinterventional rupture of intracranial aneurysms (IAs) remains a severe complication after flow diverter treatment. However, potential hemodynamic mechanisms underlying independent predictors for postinterventional rupture of IAs remain unclear. In this study, we employed arteriography-derived radiomic features to predict this complication.MethodsWe included 64 patients who underwent pipeline flow diversion for intracranial aneurysms, distinguishing between 16 patients who experienced postinterventional rupture and 48 who did not. We performed propensity score matching based on clinical and morphological factors to match these patients with 48 patients with postinterventional unruptured IAs at a 1:3 ratio. Postinterventional digital subtraction angiography were used to create five arteriography-derived perfusion parameter maps and then radiomics features were obtained from each map. Informative features were selected through the least absolute shrinkage and selection operator method with five-fold cross-validation. Subsequently, radiomics scores were formulated to predict the occurrence of postinterventional IA ruptures. Prediction performance was evaluated with the training and test datasets using area under the curve (AUC) and confusion matrix-derived metrics.ResultsOverall, 1,459 radiomics features were obtained, and six were selected. The resulting radiomics scores had high efficacy in distinguishing the postinterventional rupture group. The AUC and Youden index were 0.912 (95% confidence interval: 0.767-1.000) and 0.847 for the training dataset, respectively, and 0.938 (95% confidence interval, 0.806-1.000) and 0.800 for the testing dataset, respectively.ConclusionRadiomics scores generated using arteriography-derived radiomic features effectively predicted postinterventional IA ruptures and may aid in differentiating IAs at high risk of postinterventional rupture.
| S-EPMC10954779 | biostudies-literature