How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals

Fiorella, David; Gache, Larry; Frame, Diana; Arthur, Adam S

doi:10.1136/neurintsurg-2019-015535

Cited by 30 publications

(30 citation statements)

References 20 publications

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“…10–14 Our results compare favorably with series using different flow diverters. 15–22 In a meta-analysis comprising 2614 patients treated with other flow diverters, 22 the occlusion rate was 75% at 12 months, and the permanent event rate was 7.8%. Our occlusion rate was with 80% better at a shorter interval of six months, and our complication rate was with less than 2% remarkably lower.…”

Section: Discussionmentioning

confidence: 99%

p64 flow diverter: Results in 108 patients from a single center

et al. 2020

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Background and purpose Flow diverters are increasingly used to treat intracranial aneurysms. We report the safety and efficacy of the p64 flow diverter, a resheathable and detachable device for intracranial aneurysms. Materials and methods We retrospectively reviewed 108 patients with 109 aneurysms treated with the p64 between March 2014 and July 2019. There were 87 women and 21 men, mean age 57 years. Of 109 aneurysms, 74 were discovered incidentally, 12 were symptomatic, 18 were previously treated, and five were ruptured dissection aneurysms. A total of 10 aneurysms were located in the posterior circulation. The mean aneurysm or remnant size was 8.1 mm. Results Hemorrhage by perforation with the distal guidewire occurred in two patients with permanent neurological deficits in one. In one patient, acute in-stent occlusion caused infarction with a permanent deficit. Permanent morbidity was 1.9% (2 of 108, 95%CI 0.1–6.9%); there was no mortality. During follow-up, three in-stent occlusions occurred, all asymptomatic. There were no delayed hemorrhagic complications. At six months, 77 of 96 aneurysms (80.2%) were completely occluded, and at last follow-up, this increased to 93 of 96 aneurysms (96.9%). In-stent stenosis at any degree occurred in 11 patients, progressing to asymptomatic complete occlusion in one. In the other patients, stenosis resolved or improved at further follow-up. Conclusion The p64 offers an effective and safe treatment option. Aneurysm occlusion rate was 97% at last follow-up, mostly achieved with a single device. There were no delayed hemorrhagic complications. Delayed in-stent stenosis infrequently progresses to occlusion but remains a matter of concern.

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Section: Discussionmentioning

confidence: 99%

p64 flow diverter: Results in 108 patients from a single center

et al. 2020

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“…With the ongoing transition from a fee-for-service to a quality-based healthcare system, the use of "big data" in neurosurgical clinical research has become increasingly popular. [9][10][11][12][13][14][15][16] One method of capturing outcomes has been through the use of administrative databases. A previous study in 2018 from the US showed that a total of 324 articles were identified since 2000 with an exponential increase since 2011.…”

Section: The Jnd As An Infrastructure Of Multicenter Clinical Researchmentioning

confidence: 99%

“…Since 2014, several study groups in collaboration with the JNS and other relevant societies have published papers on various aspects of real-world neurosurgical and stroke practices. [9][10][11]13,15,16,18) Unlike such administrative databases, the JND data are unique in that this database was created by the database committee of the JNS for specific purposes as reported previously. 1) Although no central review of the registered data has been conducted, the registered data are validated by neurosurgeons.…”

Section: The Jnd As An Infrastructure Of Multicenter Clinical Researchmentioning

confidence: 99%

The Japan Neurosurgical Database: Statistics Update 2018 and 2019

Iihara

Saito

Suzuki

et al. 2021

Neurol. Med. Chir.(Tokyo)

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Each year, the Japan Neurosurgical Society (JNS) reports up-to-date statistics from the Japan Neurosurgical Database regarding case volume, patient demographics, and in-hospital outcomes of the overall cohort and neurosurgical subgroup according to the major classifications of main diagnosis. We hereby report patient demographics, in-hospital mortality, length of hospital stay, purpose of admission, number of medical management, direct surgery, endovascular treatment, and radiosurgery of the patients based on the major classifications and/or main diagnosis registered in 2018 and 2019 in the overall cohort (523283 and 571143 patients, respectively) and neurosurgical subgroup (177184 and 191595 patients, respectively). The patient demographics, disease severity, proportion of purpose of admission (e.g., operation, 33.9–33.5%) and emergent admission (68.4–67.8%), and in-hospital mortality (e.g., cerebrovascular diseases, 6.3–6.5%; brain tumor, 3.1–3%; and neurotrauma, 4.3%) in the overall cohort were comparable between 2018 and 2019. In total, 207783 and 225217 neurosurgical procedures were performed in the neurosurgical subgroup in 2018 and 2019, respectively, of which endovascular treatment comprised 19.1% and 20.3%, respectively. Neurosurgical management of chronic subdural hematoma (19.4–18.9%) and cerebral aneurysm (15.4–14.8%) was most common. Notably, the proportion of management of ischemic stroke/transient ischemic attack, including recombinant tissue plasminogen activator infusion and endovascular acute reperfusion therapy, increased from 7.5% in 2018 to 8.8% in 2019. The JNS statistical update represents a critical resource for the lay public, policy makers, media professionals, neurosurgeons, healthcare administrators, researchers, health advocates, and others seeking the best available data on neurosurgical practice.

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“…Serial imaging using Computed Tomography (CT) will be utilized to determine the rate of radiological HT after edoxaban initiation. Incident radiological HT rates will be assessed as objective performance criteria for the safety of early vs. delayed edoxaban initiation (15)(16)(17). We also hypothesize that RNA expressed in leukocytes at time of stroke can stratify risk of HT in patients treated with edoxaban.…”

Section: Introductionmentioning

confidence: 99%

Protocol for LASER: A Randomized Evaluation and an Associated Registry of Early Anticoagulation With Edoxaban After Ischemic Stroke in Patients With Atrial Fibrillation

et al. 2021

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Background: The optimal timing of anticoagulation after stroke in patients with atrial fibrillation (AF) is unknown.Aim and Hypothesis: Our primary aim is to demonstrate the safety of edoxaban initiation within 5 days of AF related stroke. Our secondary aim is to determine predictors of hemorrhagic transformation (HT) after AF related stroke. We hypothesize that the rate of radiological HT will not be increased in patients starting edoxaban within 5 days of AF related stroke, relative to those in whom initiation is delayed. We hypothesize that the risk of HT in patients treated with edoxaban can be predicted using RNA expressed in leukocytes at time of stroke.Methods and Design: LASER (Lixiana Acute Stroke Evaluation Registry) is a randomized controlled trial with an associated registry (clinicaltrials.gov NCT03494530). One hundred and fifty patients with ischemic stroke and AF will undergo baseline Computed Tomography (CT) scan and will be randomized 2:1 within 5 days of symptom onset to early (≤5 days, n = 100) or delayed (6–14 days, n = 50) edoxaban initiation. Participants will undergo clinical assessment and repeat CT at 7 days and clinical assessment at 90 days.Study Outcomes: The primary outcome is the rate of incident radiological HT. Secondary outcomes include symptomatic HT, recurrent ischemic stroke, recurrent sub-clinical infarcts on follow up CT, systemic hemorrhagic complication rate, National Institute of Health Stroke Scale and modified Rankin Scale at day 7 and 90, mortality within 90 days, quality of life assessments at day 90, and predictors of HT, including RNA expression by 6 pre-selected candidate genes.Discussion: Event rates for both HT and recurrent ischemic events, in patients treated with early vs. delayed edoxaban initiation are unknown. The primary study endpoint of LASER is an objective performance criterion relevant to clinical decision making in patients with AF related stroke. This study will provide data required for a definitive safety/efficacy study sample size power calculation.

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How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals

Cited by 30 publications

References 20 publications

p64 flow diverter: Results in 108 patients from a single center

p64 flow diverter: Results in 108 patients from a single center

The Japan Neurosurgical Database: Statistics Update 2018 and 2019

Protocol for LASER: A Randomized Evaluation and an Associated Registry of Early Anticoagulation With Edoxaban After Ischemic Stroke in Patients With Atrial Fibrillation

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