Background Flow diverters have been widely used in clinical practice for more than a decade. However, most outcome data are limited to 1 year timepoints. This study aims to offer meta-analysis data on long-term (>1 year) safety and effectiveness results for patients with aneurysms treated with flow diverters. Methods PubMed, Web of Science, Embase, and SCOPUS were searched up to February 24, 2022 using the AutoLit platform. We included primary studies assessing the long-term outcomes for flow diverter devices to manage unruptured internal carotid artery aneurysms with a follow-up period of >1 year. The meta-analysis was carried out using Comprehensive Meta-Analysis software (CMA). Results Eleven studies were included in the meta-analysis. The pooled occlusion rates after flow diversion treatment for unruptured intracranial brain aneurysms were 77%, 87.4%, 84.5%, 89.4%, 96% for 1 year, 1–2 years, 2 years, 3 years, and 5 years follow-up, respectively. The in-stent stenosis rate was 4.8% and the retreatment rate for the long-term follow-up period was 5%. No delayed rupture of the aneurysm was reported, and there was one case of delayed ischemic stroke. The sensitivity analysis of the prospective studies showed a complete occlusion rate of 83.5% and 85.2% for 1 and 3 years of follow-up, respectively. Conclusion Flow diverters are safe and effective in short- and long-term follow-up and rarely cause serious delayed side effects.

Long-term outcomes of flow diversion for unruptured intracranial aneurysms: a systematic review and meta-analysis

Background To report the 3-year safety and effectiveness of the Surpass Streamline flow diverter in the SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms). Methods The Surpass Streamline flow diverter device was evaluated in a multicenter, prospective, single-arm, non-randomized interventional trial including patients with uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery. 3-year outcomes were tabulated with descriptive statistics and compared with 1-year outcomes. Results Of 180 patients in the modified intent-to-treat (mITT) cohort, 36-month clinical and angiographic follow-up was available in 134 and 117 cases, respectively. Effectiveness endpoint of complete aneurysm occlusion without clinically significant stenosis or retreatment was met in 71.8% (79/110, 95% CI 62.4% to 80.0%) of cases. Safety composite endpoint was 12.2% (22/180) over the 3-year period, with two major safety events (ipsilateral ischemic strokes) occurring between 12–36 months. Complete aneurysm occlusion was noted in 77.8% (91/117), and 99.1% (116/117) of the patients demonstrated adequate aneurysm occlusion (complete occlusion or neck residual). There were four cases (2.2%) of aneurysm rupture, all occurring within the first month of the index procedure. Target aneurysm retreatment rate was 2.8% (5/180). Conclusion The present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device. Trial registration NCT01716117 . 

Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms – SCENT: 3-year outcomes

BACKGROUND
Flow diverters (FDs) have demonstrated a safe and effective profile. However, the use of FDs for posterior communicating artery (PComA) aneurysms remains controversial.


OBJECTIVE
To evaluate the safety and effectiveness of FDs for PComA aneurysms using a systematic review and meta-analysis of the literature.


METHODS
We performed a systematic search from inception until June 2022 for flow diversion in PComA aneurysms. Primary effectiveness was the rate of complete aneurysm occlusion defined by Raymond-Roy class 1. Primary safety outcomes were treatment-related ischemic/hemorrhagic (composite) events causing morbidity and mortality. Secondary safety was PComA patency at follow-up. Random-effects meta-analyses were used to calculate proportions, and statistical heterogeneity was assessed.


RESULTS
A total of 13 studies with 397 patients harboring 403 aneurysms were included. Mean age was 48 years, and the mean aneurysm size was 5.3 mm. Most aneurysms were unruptured (65%). Complete occlusion at final follow-up was 73% (CI 66%-79%), and adjunctive coils were used in 10% of aneurysms. Retreatment rate was 2% (CI 0%-9%). The primary safety composite outcome was 4% (CI 3%-7%), and mortality was 1%. PComA patency at final follow-up was 76% (CI 57%-89%). Subgroup analysis, patients with fetal PComAs had a lower complete occlusion rate (42% fetal PComA vs 77%, psubgroupdifference = <.01).


CONCLUSION
The performance of FDs in PComA aneurysms is comparable with outcomes found in other subtypes of supraclinoid aneurysms. Effectiveness was acceptable and safety favorable. However, effectiveness was suboptimal in patients with fetal-type PComAs; alternative treatments should be considered in these cases.

Flow Diverter Performance in Aneurysms Arising From the Posterior Communicating Artery: A Systematic Review and Meta-Analysis.

Background The Pipeline Flex embolization device with Shield technology (PED Shield) is the first flow diverter for brain aneurysm treatment approved in the United States using surface-modified technology. The effect of PED Shield on decreasing perioperative diffusion-weighted imaging positive (DWI+) hits, as a marker for in-human decrease thrombogenicity, is unclear. Objective To determine if the number of periprocedural DWI+ lesions differs between patients with an aneurysm treated with PED Flex and PED Shield. Methods This retrospective study compares the outcomes of consecutive patients with an aneurysm treated with PED Flex and PED Shield. The primary outcome of interest was the occurrence of DWI+ lesions. We also assessed potential predictors of DWI+ lesions and compared the outcomes between on-label and off-label treatment indications. Results 89 patients were included, 48 (54%) treated with PED Flex and 41 (46%) with PED Shield. After matching, the incidence of DWI+ lesions was 61% and 62% for the PED Flex and PED Shield groups, respectively. Results were consistent across each model with no significant differences in DWI+ lesions between treatment groups, and effect sizes ranging from OR=1.08 (95% CI 0.41 to 2.89) after propensity score matching to OR=1.84 (95% CI 0.65 to 5.47) after multivariable regression. Multivariable models demonstrated reduced DWI+ lesions with balloon-assisted therapies and posterior circulation treatment, while a significant linear relationship was encountered with fluoroscopy time. Conclusion There was no significant difference in the incidence of perioperative DWI+ lesions between patients with an aneurysm treated with PED Flex and PED Shield. Larger cohorts are likely needed to demonstrate differences between the devices.

Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology: a retrospective cohort analysis

Safety and efficacy of the pipeline embolization device for treatment of small vs. large aneurysms: a systematic review and meta-analysis

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.

/pdf/prospective-study-on-embolization-of-intracranial-aneurysms-3k4vptyn.pdf

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

<h3>Introduction</h3> Flow diverters proved to be a safe and efficacious approach for the management of large intracranial lesions. The PREMIER trial was the first prospective study to examine the efficacy of the pipeline embolization device (PED, Medtornic) for the management of small and medium size wide-necked aneurysms. Herein, we present the 3-year follow-up results from the PREMIER cohort. <h3>Methods</h3> The PREMIER was a prospective, single-arm study, including patients with a target wide-necked aneurysm of ≤ 12 mm, located in the internal carotid artery or vertebral artery. The primary effectiveness endpoint (complete aneurysm occlusion) and primary safety endpoint (major stroke in the supplied territory or neurologic death) were independently monitored and adjudicated. Additional angiographic evaluation to highlight the natural history of aneurysms treated with flow diverters was performed using the modified Cekirge-Saatci Classification (mCSC). <h3>Results</h3> According to CRL review, of 141 patients treated with PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. Three (12%) of these patients progressed to complete occlusion, resulting in a complete aneurysm occlusion rate at 3-year of 83.3% (115/138). Further angiographic evaluation using mCSC demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in all cases with consecutive available follow-ups (97.1%). Overall safety endpoint occurred in 2.8% (4/140) of the patients over the 3-year follow-up, with only one event occurring after the first year – which was non-disabling at 2-year follow-up. Retreatment rate since initial device implantation was 5.0% (7/138): 4 within the first year and 3 within the second year, all carried on with PED in elective procedures. There was one case of aneurysm recurrence (0.7%) in a patient with an initially occluded aneurysm who afterward demonstrated residual neck at a 3-year follow-up. Not a single case of aneurysm rupture occurred in the series. <h3>Conclusions</h3> A high rate of aneurysm occlusion, low morbidity, and absence of aneurysm rupture emphasize the PED as a safe treatment strategy for small and medium-sized aneurysms located along the ICA and VA in the long term. <h3>Disclosures</h3> R. Hanel: 1; C; Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. G. Cortez: None. D. Lopes: 2; C; Asahi, Medtronic, and Stryker; honoraria from Siemens, Medtronic, Stryker, and Phenox. P. Nelson: 2; C; Medtronic, Phenox, and GmbH. A. Siddiqui: 2; C; Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rap. 4; C; in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, I. P. Jabbour: 2; C; Medtronic, Cerenovus, and Microvention. V. Pereira: 1; C; Philips. 2; C; Stryker, Penumbra, Balt, Medtronic, and Neurovasc. I. István: 2; C; Medtronic. O. Zaidat: 2; C; Medtronic, Stryker, Penumbra, and Cerenovus. C. Bettegowda: 2; C; Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. G. Colby: 2; C; Medtronic, Microvention-Terumo, and Stryker. M. Mokin: 2; C; Cerebrotech, Imperative Care, and Penumbra; consulting fees form Medtronic, Cerenovus, and Canon Medical. C. Schirmer: 6; C; received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. F. Hellinger: None. C. Given II: 2; C; Medtronic and Stryker. 3; C; Medtronic and Stryker. T. Krings: 2; C; Stryker, Cerenovus, Penumbra, and Medtronic. P. Taussky: 2; C; Stryker Neurovascular, Cerenovus, and Medtronic. G. Toth: 2; C; Dynamed EBSCO and Microvention. J. Fraser: 2; C; Stream Biomedical, Penumbra, and Medtronic. 4; C; Fawkes Biotechnology, LLC, and Cerelux. M. Chen: 2; C; Medtronic, Stryker, Penumbra, Genentech, and GE. R. Priest: 2; C; Medtronic, Stryker, and Cerenovus. P. Kan: 2; C; Stryker Neurovascular, Medtronic, and Cerenovus. D. Fiorella: 1; C; Balt USA, Microvention, Penumbra, Siemens, and Stryker. 2; C; Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, Siemens. 6; C; honorarium from Qapel Medicine. D. Frei: 2; C; Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. B. Aagaard-Kienitz: None. O. Diaz: 6; C; proctor for Microvention/Terumo. A. Malek: 6; C; Cofounder, investor, and shareholder of CereVasc. C. Cawley: None. A. Puri: 1; C; Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus. 2; C; Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. D. Kallmes: 1; C; Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera. 6; C; President of Marblehead Medical and has patent pending in balloon catheter technologies.

/pdf/o-054-prospective-study-on-embolization-of-intracranial-3sefgrwg.pdf

O-054 Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a specific flow-diverter occlusion classification

Handle everyday research tasks with reliable, citation-backed results

Your personal Research Agent to handle research tasks with citation-backed results

Popular Tasks used by Researchers

How can I help with your research?

Meet SciSpace

Get more enhanced response by uploading the PDFs you want me to reference.

No relevant PDFs in your library

SciSpace is the AI research assistant for academics. Run systematic literature reviews on 280M+ papers, and write papers with cited sources. Trusted by 1M+ students, PhDs & researchers.

SciSpace | AI for Research

Analyze PDFs

Code & Manuscripts

Funding & Grants

Literature & Patents

Medical & Clinical Data

Systematic Review

Visualize & Present

Web & Data

Build a Google Scholar-like website for your research.

Build a website

Create charts and images for your research

Create a Chart

Write a paper for submission to a journal

Draft a manuscript

Patent Search

Design eye-catching scientific posters in minutes.

Scientific Poster Generation

Systematic Literature Review

One task is running at the moment. Your messages will be shown right after.

Drag and drop or click here to browse

Loved by <highlight>1 million+</highlight> researchers

Extract a list of specific topics and their sources from unstructured text

Topics

Compare and analyze relevant papers that matches with your search

Papers

Get insights from PDFs and bookmarked papers from your library

My library

Recent searches

Try searching for:

Catch AI-generated content in scholarly and non-scholarly content

{ai} Detector

Ai Writer

Get PDF Summaries, highlighted text explanations 

Chat with PDF

Effortlessly create in-text citations and bibliographies in APA and 2,500 other formats

Citation generator

Get explanations, summaries, and answers on academic papers

Ease up your research workflow with {scispace}'s cohort of exciting AI tools

Elevate your academic writing skills and convey your ideas the way you want

Paraphraser

Explore our range of reading and writing tools

Your file is being prepared and should be ready in a few minutes. If it's a large file, it might take a bit longer. You can close this window, and we'll email you the file when it's done.

You have reached a maximum limit of {limit} columns in the table. Remove at least 1 column to add or create another one.

I. István

Author Tools

Chat about Author

Papers

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

O-054 Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a specific flow-diverter occlusion classification