Dataset Information

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

ABSTRACT:

Background

The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.

Methods

PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.

Results

As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.

Conclusions

The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.

Trial registration

NCT02186561.

SUBMITTER: Hanel RA

PROVIDER: S-EPMC9985759 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

Hanel Ricardo A RA Cortez Gustavo M GM Lopes Demetrius Klee DK Nelson Peter Kim PK Siddiqui Adnan H AH Jabbour Pascal P Mendes Pereira Vitor V István Istvan Szikora IS Zaidat Osama O OO Bettegowda Chetan C Colby Geoffrey P GP Mokin Maxim M Schirmer Clemens M CM Hellinger Frank R FR Given Curtis C Krings Timo T Taussky Philipp P Toth Gabor G Fraser Justin F JF Chen Michael M Priest Ryan R Kan Peter P Fiorella David D Frei Donald D Aagaard-Kienitz Beverly B Diaz Orlando O Malek Adel M AM Cawley C Michael CM Puri Ajit S AS Kallmes David F DF

Journal of neurointerventional surgery 20220315 3

<h4>Background</h4>The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.<h4>Methods</h4>PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) i ...[more]

PMID: 35292570

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Project description:BackgroundEndovascular therapy is the primary treatment modality for intracranial aneurysms (IA). The objective of this study was to assess the effectiveness and safety of a pipeline embolization device (PED) for the treatment of IA.MethodsThis retrospective study was conducted at a single center. Data were collected for all patients who underwent PED treatment at the Fourth Affiliated Hospital of Xinjiang Medical University between December 2018 and January 2022. Clinical characteristics, aneurysm-related characteristics, treatment details, and clinical and imaging outcomes were collected and analyzed.ResultsA total of 60 consecutive patients with 60 IAs were treated with a PED. The mean age of the participants was 61.8 years, with 53% being female. The average size of the aneurysms was 14.7 mm, with 54 located in the anterior circulation and six in the posterior circulation. The median last follow-up time was 13.0 months (range, 11-24 months). All patients underwent final digital subtraction angiography (DSA) for angiographic follow-up, and 50 aneurysms (83.3%) were completely occluded. The overall complication rate was 3.3%, and there were no reported mortalities. Among the 12 cases of ruptured aneurysms, all of which underwent adjunctive coil embolization, the complete occlusion rate was 91.7% with a complication rate of 16.6% [ischemic complication and modified Rankin scale (mRS) deteriorated]. In the 6 cases of posterior circulation aneurysms (2 in the basilar artery), 5 cases achieved complete occlusion and 1 case achieved near-complete occlusion, with no reported complications or mortality.ConclusionsThe use of PEDs appears to be an effective treatment option for IA, demonstrating high occlusion rates and low complication rates. While the application of PEDs for the treatment of ruptured aneurysms did not increase the risk of secondary aneurysm rupture, caution is still warranted due to a higher complication rate. In the treatment of aneurysms of the vertebrobasilar artery using PEDs, this study achieved favorable efficacy outcomes without complications nor patient mortality. However, further studies are needed to validate these findings.

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.

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.

Project description:IntroductionIn recent years, the Pipeline embolization device (PED) has been widely used in the embolization of intracranial aneurysms, but there are some inconsistent findings on whether its efficacy and safety are superior to those of traditional coils embolization (coils alone, stent-assisted coils and balloon-assisted coils). The purpose of this meta-analysis was to evaluate the safety and efficacy of PED in intracranial aneurysm embolization by comparing with traditional coils.MethodsWe systematically searched PubMed, Embase, Web of Science, and The Cochrane Library databases for randomized controlled trials and observational studies (case-control studies and cohort studies) comparing the efficacy of PED with traditional coils in intracranial aneurysm embolization published before April 1, 2022. The endpoints observed in this meta-analysis were procedure-related intracranial hemorrhage, procedure-related intracranial ischemia, other procedure-related complications (e.g., aneurysm rupture, neurological impairment, etc.), retreatment rate, complete occlusion (100%) of the aneurysm at the last follow-up, and favorable functional outcome (MRS ≤ 2).ResultsA total of 10 studies with a total of 1,400 patients (PED group: 576 and Traditional coils: 824) were included in this meta-analysis. A comprehensive analysis of the included literature showed that the PED group had a higher rate of complete aneurysm occlusion [OR = 2.62, 95% Cl (1.94, 3.55), p < 0.00001] and Lower re-treatment rate [OR = 0.20, 95% Cl (0.12, 0.34 p < 0.00001)] compared with the traditional coil embolization group at the last follow-up. In terms of procedure-related intracranial hemorrhage [OR = 3.04, 95% Cl (1.08, 8.57), p = 0.04] and other procedure-related complications [OR = 2.91, 95% Cl (1.48, 5.57), p = 0.002], the incidence of PED was higher than that of the traditional coil embolization group. Moreover, in terms of favorable functional outcome [OR = 0.4, 95% Cl (0.22, 0.71), p = 0.002] of patients at the last follow-up, the PED group was lower than the traditional coil embolization group. There was no statistically significant between the two groups in terms of surgery-related intracranial ischemia complications [OR = 0.88, 95% Cl (0.47, 1.64), p = 0.68].ConclusionPED had higher rates of complete aneurysm occlusion and lower rates of aneurysm retreatment compared with traditional coils, but traditional coils was superior to the PED group in terms of procedure-related intracranial hemorrhage complication and other procedure-related complications (aneurysm rupture, neurological impairment), and favorable functional outcome (mRS ≤ 2). This result still needs to be further confirmed by additional large-sample, multicenter, prospective randomized controlled trials.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022325673.

Dataset Information

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

Background

Methods

Results

Conclusions

Trial registration

Publications

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

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