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"New Devices and Techniques"
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Correspondence on ‘Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data’ by Rodriguez-Erazú et al
2025
The comprehensive analysis of 141 patients with wide-necked aneurysms ≤12 mm in size, and the systematic evaluation of braid deformations such as fish mouthing, foreshortening, braid bump, and braid collapse, contribute to the robustness of the study. [...]we would like to inquire about the long-term implications of braid deformations on patient outcomes beyond the 2-year follow-up period. [...]the study by Rodriguez-Erazú et al is a valuable addition to the literature on PED braid stability.
Journal Article
The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study
by
Coon, Alexander L
,
Cekirge, Saru
,
Delgado Almandoz, Josser E
in
Aneurysms
,
Braided composites
,
Laboratories
2019
IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration number NCT02191618
Journal Article
Middle meningeal artery embolization for chronic subdural hematoma: a systematic review and meta-analysis
2021
Middle meningeal artery (MMA) embolization has been proposed as a minimally invasive treatment for chronic subdural hematoma (cSDH). The aim of this systematic review and meta-analysis is to compare outcomes after MMA embolization versus conventional management for cSDH. We performed a systematic review of PubMed, Embase, Oxford Journal, Cochrane, and Google Scholar databases from April 1987 to October 2020 in accordance with PRISMA guidelines. Studies reporting outcomes after MMA embolization for ≥3 patients with cSDH were included. A meta-analysis comparing MMA embolization with conventional management was performed. The analysis comprised 20 studies with 1416 patients, including 718 and 698 patients in the MMA embolization and conventional management cohorts, respectively. The pooled recurrence, surgical rescue, and in-hospital complication rates in the MMA embolization cohort were 4.8% (95% CI 3.2% to 6.5%), 4.4% (2.8% to 5.9%), and 1.7% (0.8% to 2.6%), respectively. The pooled recurrence, surgical rescue, and in-hospital complication rates in the conventional management cohort were 21.5% (0.6% to 42.4%), 16.4% (5.9% to 27.0%), and 4.9% (2.8% to 7.1%), respectively. Compared with conservative management, MMA embolization was associated with lower rates of cSDH recurrence (OR=0.15 (95% CI 0.03 to 0.75), p=0.02) and surgical rescue (OR=0.21 (0.07 to 0.58), p=0.003). In-hospital complication rates were comparable between the two cohorts (OR=0.78 (0.34 to 1.76), p=0.55). MMA embolization is a promising minimally invasive therapy that may reduce the need for surgical intervention in appropriately selected patients with cSDH. Additional prospective studies are warranted to determine the long-term durability of MMA embolization, refine eligibility criteria, and establish this endovascular approach as a viable definitive treatment for cSDH.
Journal Article
Artificial intelligence to diagnose ischemic stroke and identify large vessel occlusions: a systematic review
by
Hui, Ferdinand K
,
Unberath, Mathias
,
Hager, Gregory D
in
Algorithms
,
Artificial intelligence
,
Classification
2020
Background and purposeAcute stroke caused by large vessel occlusions (LVOs) requires emergent detection and treatment by endovascular thrombectomy. However, radiologic LVO detection and treatment is subject to variable delays and human expertise, resulting in morbidity. Imaging software using artificial intelligence (AI) and machine learning (ML), a branch of AI, may improve rapid frontline detection of LVO strokes. This report is a systematic review of AI in acute LVO stroke identification and triage, and characterizes LVO detection software.MethodsA systematic review of acute stroke diagnostic-focused AI studies from January 2014 to February 2019 in PubMed, Medline, and Embase using terms: ‘artificial intelligence’ or ‘machine learning or deep learning’ and ‘ischemic stroke’ or ‘large vessel occlusion’ was performed.ResultsVariations of AI, including ML methods of random forest learning (RFL) and convolutional neural networks (CNNs), are used to detect LVO strokes. Twenty studies were identified that use ML. Alberta Stroke Program Early CT Score (ASPECTS) commonly used RFL, while LVO detection typically used CNNs. Image feature detection had greater sensitivity with CNN than with RFL, 85% versus 68%. However, AI algorithm performance metrics use different standards, precluding ideal objective comparison. Four current software platforms incorporate ML: Brainomix (greatest validation of AI for ASPECTS, uses CNNs to automatically detect LVOs), General Electric, iSchemaView (largest number of perfusion study validations for thrombectomy), and Viz.ai (uses CNNs to automatically detect LVOs, then automatically activates emergency stroke treatment systems).ConclusionsAI may improve LVO stroke detection and rapid triage necessary for expedited treatment. Standardization of performance assessment is needed in future studies.
Journal Article
How to WEB: a practical review of methodology for the use of the Woven EndoBridge
2020
Wide-necked bifurcation aneurysms (WNBAs) make up 26–36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.
Journal Article
Review of current intracranial aneurysm flow diversion technology and clinical use
by
Arat, Anil
,
Pereira, Vitor M
,
Derakhshani, Shahram
in
aneurysm
,
Aneurysms
,
Biomedical Technology - instrumentation
2021
Endovascular treatment of intracranial aneurysms (IAs) has evolved considerably over the past decades. The technological advances have been driven by the experience that coils fail to completely exclude all IAs from the blood circulation, the need to treat the diseased parent vessel segment leading to the aneurysm formation, and expansion of endovascular therapy to treat more complex IAs. Stents were initially developed to support the placement of coils inside wide neck aneurysms. However, early work on stent-like tubular braided structure led to a more sophisticated construct that then later was coined as a flow diverter (FD) and found its way into clinical application. Although FDs were initially used to treat wide-neck large and giant internal carotid artery aneurysms only amenable to surgical trap with or without a bypass or endovascular vessel sacrifice, its use in other types of IAs and cerebrovascular pathology promptly followed. Lately, we have witnessed an explosion in the application of FDs and subsequently their modifications leading to their ubiquitous use in endovascular therapy. In this review we aim to compile the available FD technology, evaluate the devices’ peculiarities from the authors’ perspective, and analyze the current literature to support initial and expanded indications, recognizing that this may be outdated soon.
Journal Article
Transradial approach for neurointerventions: a systematic review of the literature
by
Joshi, Krishna C
,
Crowley, R Webster
,
Beer-Furlan, André
in
Aneurysms
,
angiography
,
Angioplasty
2020
BackgroundDespite the recent increase in the number of publications on diagnostic cerebral angiograms using transradial access (TRA), there have been relatively few regarding TRA for neurointerventional cases. Questions of feasibility and safety may still exist among physicians considering TRA for neurointerventional procedures.MethodsA systematic literature review was performed following PRISMA guidelines. Three online databases (MedLine via PubMed, Scopus and Embase) were searched for articles published between January 2000 and December 2019. Search terms included “Transradial access”, “Radial Access”, “Radial artery” AND “Neurointerventions\". The reference lists of selected articles and pertinent available non-systematic analysis were reviewed for other potential citations. Primary outcomes measured were access site complications and crossover rates.ResultsTwenty-one studies (n=1342 patients) were included in this review. Two of the studies were prospective while the remaining 19 were retrospective. Six studies (n=616 patients) included TRA carotid stenting only. The rest of the studies included treatment for cerebral aneurysms (n=423), mechanical thrombectomy (n=127), tumor embolization (n=22), and other indications (n=154) such as angioplasty and stenting for vertebrobasilar stenosis, balloon test occlusion, embolization of dural arteriovenous fistula and arteriovenous malformation, chemotherapeutic drug delivery, intra-arterial thrombolysis, and arterial access during a venous stenting procedure. Two (0.15%) major complications and 37 (2.75%) minor complications were reported. Sixty-four (4.77%) patients crossed over to transfemoral access for completion of the procedure. Seven (0.52%) patients crossed over due to access failure and 57 (4.24%) patients crossed over to TFA due to inability to cannulate the target vessel.ConclusionThis systematic review demonstrates that TRA has a relatively low rate of access site complications and crossovers. With increasing familiarity, development of TRA-specific neuroendovascular devices, and the continued reports of its success in the literature, TRA is expected to become more widely used by neurointerventionalists.
Journal Article
Motor neuroprosthesis implanted with neurointerventional surgery improves capacity for activities of daily living tasks in severe paralysis: first in-human experience
by
Burkitt, Anthony N
,
Campbell, Bruce C V
,
Ronayne, Stephen M
in
Activities of daily living
,
Activities of Daily Living - psychology
,
Aged
2021
BackgroundImplantable brain–computer interfaces (BCIs), functioning as motor neuroprostheses, have the potential to restore voluntary motor impulses to control digital devices and improve functional independence in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction. However, reports to date have had limited clinical translation.MethodsTwo participants with amyotrophic lateral sclerosis (ALS) underwent implant in a single-arm, open-label, prospective, early feasibility study. Using a minimally invasive neurointervention procedure, a novel endovascular Stentrode BCI was implanted in the superior sagittal sinus adjacent to primary motor cortex. The participants undertook machine-learning-assisted training to use wirelessly transmitted electrocorticography signal associated with attempted movements to control multiple mouse-click actions, including zoom and left-click. Used in combination with an eye-tracker for cursor navigation, participants achieved Windows 10 operating system control to conduct instrumental activities of daily living (IADL) tasks.ResultsUnsupervised home use commenced from day 86 onwards for participant 1, and day 71 for participant 2. Participant 1 achieved a typing task average click selection accuracy of 92.63% (100.00%, 87.50%–100.00%) (trial mean (median, Q1–Q3)) at a rate of 13.81 (13.44, 10.96–16.09) correct characters per minute (CCPM) with predictive text disabled. Participant 2 achieved an average click selection accuracy of 93.18% (100.00%, 88.19%–100.00%) at 20.10 (17.73, 12.27–26.50) CCPM. Completion of IADL tasks including text messaging, online shopping and managing finances independently was demonstrated in both participants.ConclusionWe describe the first-in-human experience of a minimally invasive, fully implanted, wireless, ambulatory motor neuroprosthesis using an endovascular stent-electrode array to transmit electrocorticography signals from the motor cortex for multiple command control of digital devices in two participants with flaccid upper limb paralysis.
Journal Article
Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms
2023
BackgroundThe Contour Neurovascular System is a novel device designed to treat intracranial aneurysms by intrasaccular flow disruption. We report our experience and mid-term follow-up in a series of patients treated with the Contour.MethodsThe patients were divided into an intention to treat and a per protocol population, the latter defined by the successful implantation of the Contour device. The intention to treat population included 53 patients (30 women, mean age 56 years) with 60 unruptured intracranial aneurysms (53 in the anterior circulation and seven in the posterior circulation). There was clinical and angiographic follow-up immediate postoperatively and at 24 hours, 3 months and 1 year using the Raymond–Roy classification and the O’Kelly–Marotta grading scale.ResultsThe Contour was successfully implanted in 54/60 (90%) aneurysms. With regard to the angiographic follow-up, there was adequate occlusion (defined as complete occlusion or presence of a neck remnant) in 31.5% of 54 aneurysms immediately postoperatively, 62.3% (in 53/54 aneurysms) at 24 hours, 81.4% (in 43/54 aneurysms) at 3 months, and 89.3% (in 28/54 aneurysms) at 1 year. Technical complications in 60 aneurysms of the intention to treat population included two (3.3%) inadvertent detachments of the device. Thromboembolic events were observed in four of the 60 aneurysms (6.7%), with no clinical symptoms in three patients and transient morbidity in one (1.7%). No aneurysm bleeding was observed and no patient was retreated during the 1-year follow-up period. There was no permanent morbidity or mortality.ConclusionsThe Contour device is effective and safe in the treatment of intracranial aneurysms. However, more experience and long-term follow-up are needed.
Journal Article