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World Neurosurgery Oct 2022The Pipeline Embolization Device (PED) has been the only flow-diverting device (FDD) approved by the Food and Drug Administration (FDA) in the U.S. market for nearly a...
BACKGROUND
The Pipeline Embolization Device (PED) has been the only flow-diverting device (FDD) approved by the Food and Drug Administration (FDA) in the U.S. market for nearly a decade, with more FDD choices in the United States following recent FDA approval of the Flow Redirection Endoluminal Device and Surpass. We sought to explore the integration patterns of these devices into practice by U.S. neurointerventionalists.
METHODS
A 34-question electronic survey was distributed to the U.S. neurointerventional community from different backgrounds (neurosurgery, neurology, radiology) through different organizational links, focusing on technical aspects of device selection and personal preferences/experiences regarding FDD in aneurysms treatment.
RESULTS
Responses were collected from 120 neurointerventionalists across the United States; operators from a neurosurgery background constituted the majority of respondents (47.5%; 85% of dual-trained). The largest age block was early-to mid-career operators (70.8% aged 36-50 years). Most participants (78.8%) treated a range of 25-100 aneurysms/year with FDDs, with 49.2% of respondents having all the FDA-approved FDDs available in their centers (80.8% academic practice). Femoral access was used by the 67.7% of respondents, without impact of FDD-device on access-type (89.2%). PED was the most commonly used device (70.9%), with 66.7% of respondents reporting using different FDD based on case specifics. Comparing devices preferences by training backgrounds, more neurosurgical operators endorsed PED as their most commonly used device, whereas more interventional neuroradiologists/neurologists reported Surpass and Flow Redirection Endoluminal Device as their most commonly used devices.
CONCLUSIONS
The results of this survey identify common themes in FDD choices among neurointerventionalists in the U.S. market, along with their integration patterns of the newly introduced devices into clinical practice.
Topics: Blood Vessel Prosthesis; Embolization, Therapeutic; Endovascular Procedures; Humans; Intracranial Aneurysm; Neurosurgical Procedures; Stents; Treatment Outcome; United States
PubMed: 35953041
DOI: 10.1016/j.wneu.2022.07.144 -
Neurosurgery Jan 2020Over the past decade, flow diverter technology for endocranial aneurysms has seen rapid evolution, with the development of new devices quickly outpacing the clinical... (Review)
Review
Over the past decade, flow diverter technology for endocranial aneurysms has seen rapid evolution, with the development of new devices quickly outpacing the clinical evidence base. However, flow diversion has not yet been directly compared to surgical aneurysm clipping or other endovascular procedures. The oldest and most well-studied device is the Pipeline Embolization Device (PED; Medtronic), recently transitioned to the Pipeline Flex (Medtronic), which still has sparse data regarding outcomes. To date, other flow diverting devices have not been shown to outperform the PED, although information comes primarily from retrospective studies with short follow-up, which are not always comparable. Because of this lack of high-quality outcome data, no reliable recommendations can be made for choosing among flow diversion devices yet. Moreover, the decision to proceed with flow diversion should be individualized to each patient. In this work, we wish to provide a comprehensive overview of the technical specifications of all flow diverter devices currently available, accompanied by a succinct description of the evidence base surrounding each device.
Topics: Blood Vessel Prosthesis; Embolization, Therapeutic; Endovascular Procedures; Humans; Intracranial Aneurysm; Retrospective Studies; Treatment Outcome
PubMed: 31838536
DOI: 10.1093/neuros/nyz323 -
Turkish Neurosurgery 2020To investigate the safety and efficacy of Derivo® embolisation device (DED), a new-generation flow diverter designed to treat cerebrovascular aneurysms, and its...
AIM
To investigate the safety and efficacy of Derivo® embolisation device (DED), a new-generation flow diverter designed to treat cerebrovascular aneurysms, and its long-term clinical outcomes.
MATERIAL AND METHODS
In total, 146 patients with 182 aneurysms were treated with DED. The mean age of the participants was 51.5 years; among them, 46 (31.5%) presented with acute subarachnoid haemorrhage. The mean aneurysm size was 8.3 mm, and 12 aneurysms were involved the vertebrobasilar system. Ophthalmic aneurysms account for most internal carotid artery (ICA) aneurysms.
RESULTS
The Glasgow Coma Scale (GCS) score of 12 patients was < 15. DED was associated with a mortality rate of 2.7% and permanent morbidity rate of 3.4%, and a complete aneurysm occlusion rate was achieved in 78.7% of cases after 7.02 months.
CONCLUSION
The DED device is a new-generation flow diverter with excellent opening behaviour and navigational benefits. Our results indicated a safe aneurysm occlusion with optimum morbidity and mortality values despite the fact that almost one-third of the patients presented with subarachnoid haemorrhage.
Topics: Aged; Embolization, Therapeutic; Female; Humans; Intracranial Aneurysm; Male; Middle Aged; Retrospective Studies; Treatment Outcome
PubMed: 31049921
DOI: 10.5137/1019-5149.JTN.25776-19.2 -
The Neuroradiology Journal Dec 2020The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises...
BACKGROUND AND PURPOSE
The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre.
MATERIALS AND METHODS
This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications.
RESULTS
The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10-25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond-Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence.
CONCLUSION
The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.
Topics: Angiography, Digital Subtraction; Blood Vessel Prosthesis; Cerebral Angiography; Embolization, Therapeutic; Female; Humans; Intracranial Aneurysm; Magnetic Resonance Angiography; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design
PubMed: 33092461
DOI: 10.1177/1971400920966749 -
World Neurosurgery Sep 2020Endovascular embolization of cerebral arteriovenous malformations (AVMs) originally entailed delivery of N-butyl cyanoacrylate glue to the nidus via a flow-directed... (Review)
Review
Endovascular embolization of cerebral arteriovenous malformations (AVMs) originally entailed delivery of N-butyl cyanoacrylate glue to the nidus via a flow-directed microcatheter. Within the past decade, several new liquid embolic agents and novel microcatheter technologies have become available that have improved the ease of use and efficacy of endovascular therapies for AVMs. Nonadhesive copolymers, such as Onyx and Precipitating Hydrophobic Injectable Liquid, have largely replaced N-butyl cyanoacrylate given a lower risk of catheter entrapment. The emergence of balloon microcatheters has allowed for improved protection of the normal cerebral vasculature and has improved the penetration of liquid embolics into large AVMs, ultimately reducing procedure times and radiation exposure. Finally, several detachable tip microcatheters have been developed to facilitate removal of the catheter from hardened liquid embolic cast, preventing the morbidity associated with distal catheter entrapment. This article reviews the embolic agents and microcatheters currently available for the treatment of cerebral AVMs in the United States as well as the data demonstrating the safety and efficacy of these devices.
Topics: Arteriovenous Fistula; Catheters; Dimethyl Sulfoxide; Embolization, Therapeutic; Enbucrilate; Humans; Intracranial Arteriovenous Malformations; Treatment Outcome
PubMed: 32592963
DOI: 10.1016/j.wneu.2020.06.118 -
Stroke and Vascular Neurology 2020Endovascular coil embolisation continues to evolve and remains a valid modality in managing ruptured and unruptured cerebral aneurysms. Technological advances in coil... (Review)
Review
Endovascular coil embolisation continues to evolve and remains a valid modality in managing ruptured and unruptured cerebral aneurysms. Technological advances in coil properties, adjunctive devices and interventional techniques continue to improve long-term aneurysm occlusion rates. This review elaborates on the latest advances in next-generation endovascular coils and adjunctive coiling techniques for treating cerebral aneurysms.
Topics: Cerebrovascular Circulation; Embolization, Therapeutic; Endovascular Procedures; Equipment Design; Hemodynamics; Humans; Intracranial Aneurysm; Treatment Outcome
PubMed: 32411403
DOI: 10.1136/svn-2019-000303 -
Journal of Neurointerventional Surgery Jul 2021High-frequency optical coherence tomography (HF-OCT) is an intra-vascular imaging technique capable of assessing device-vessel interactions at spatial resolution...
BACKGROUND
High-frequency optical coherence tomography (HF-OCT) is an intra-vascular imaging technique capable of assessing device-vessel interactions at spatial resolution approaching 10 µm. We tested the hypothesis that adequately deployed Woven EndoBridge (WEB) devices as visualized by HF-OCT lead to higher aneurysm occlusion rates.
METHODS
In a leporine model, elastase-induced aneurysms (n=24) were treated with the WEB device. HF-OCT and digital subtraction angiography (DSA) were performed following WEB deployment and repeated at 4, 8, and 12 weeks. Protrusion (0-present, 1-absent) and malapposition (0-malapposed, 1-neck apposition >50%) were binary coded. A device was considered 'adequately deployed' by HF-OCT and DSA if apposed and non-protruding. Aneurysm healing on DSA was reported using the 4-point WEB occlusion score: A or B grades were considered positive outcome. Neointimal coverage was quantified on HF-OCT images at 12 weeks and compared with scanning electron microscopy (SEM).
RESULTS
Adequate deployment on HF-OCT correlated with positive outcome (P=0.007), but no statistically significant relationship was found between good outcome and adequate deployment on DSA (P=0.289). Absence of protrusion on HF-OCT correlated with a positive outcome (P=0.006); however, malapposition alone had no significant relationship (P=0.19). HF-OCT showed a strong correlation with SEM for the assessment of areas of neointimal tissue (R²=0.96; P<0.001). More neointimal coverage of 78%±32% was found on 'adequate deployment' cases versus 31%±24% for the 'inadequate deployment' cases (P=0.001).
CONCLUSION
HF-OCT visualizes features that can determine adequate device deployment to prognosticate early aneurysm occlusion following WEB implantation and can be used to longitudinally monitor aneurysm healing progression.
Topics: Angiography, Digital Subtraction; Animals; Embolization, Therapeutic; Intracranial Aneurysm; Male; Pancreatic Elastase; Rabbits; Self Expandable Metallic Stents; Tomography, Optical Coherence; Treatment Outcome
PubMed: 32989033
DOI: 10.1136/neurintsurg-2020-016447 -
Advanced Materials (Deerfield Beach,... Dec 2020Vascular embolization is a life-saving minimally invasive catheter-based procedure performed to treat bleeding vessels. Through these catheters, numerous metallic coils...
Vascular embolization is a life-saving minimally invasive catheter-based procedure performed to treat bleeding vessels. Through these catheters, numerous metallic coils are often pushed into the bleeding artery to stop the blood flow. While there are numerous drawbacks to coil embolization, physician expertise, availability of these coils, and their costs further limit their use. Here, a novel blood-derived embolic material (BEM) with regenerative properties, that can achieve instant and durable intra-arterial hemostasis regardless of coagulopathy, is developed. In a large animal model of vascular embolization, it is shown that the BEM can be prepared at the point-of-care within 26 min using fresh blood, it can be easily delivered using clinical catheters to embolize renal and iliac arteries, and it can achieve rapid hemostasis in acutely injured vessels. In swine arteries, the BEM increases cellular proliferation, angiogenesis, and connective tissue deposition, suggesting vessel healing and durable vessel occlusion. The BEM has significant advantages over embolic materials used today, making it a promising new tool for embolization.
Topics: Animals; Arteries; Biocompatible Materials; Blood; Catheters; Cell Proliferation; Embolization, Therapeutic; Neovascularization, Physiologic; Swine
PubMed: 33174305
DOI: 10.1002/adma.202005603 -
Neurosurgery Jan 2020Several studies have shown the efficacy and feasibility of flow diversion for the endovascular treatment of wide-necked and otherwise anatomically challenging... (Review)
Review
Several studies have shown the efficacy and feasibility of flow diversion for the endovascular treatment of wide-necked and otherwise anatomically challenging intracranial aneurysms (IA). Technological advances have led to successful long-term occlusion rates and a safety profile for flow-diverter stents that parallels other endovascular and open surgical options for these lesions. With growing indications for use of the Pipeline Embolization Device (PED, Medtronic, Dublin, Ireland) to include IAs up to the internal carotid artery (ICA) terminus, understanding the nuances of this technology is increasingly relevant. Furthermore, there is a growing body of literature on the use of flow diversion to treat distal (up to A2, M2, and P2), ruptured, and posterior circulation aneurysms, although these applications are "off-label" at present. In this manuscript, we discuss the expanding role of flow diversion in the ICA and compare this technique with other endovascular options for the treatment of ICA IAs. We also discuss technical nuances of the deployment of flow diverters for the treatment of challenging lesions and in difficult and tortuous anatomy.
Topics: Blood Vessel Prosthesis; Carotid Artery Diseases; Carotid Artery, Internal; Embolization, Therapeutic; Endovascular Procedures; Humans; Intracranial Aneurysm; Treatment Outcome
PubMed: 31838527
DOI: 10.1093/neuros/nyz315 -
Medecine Sciences : M/S Jan 2017During the last decade, the interest of degradable embolics has considerably grown as alternatives for the currently-used permanent embolics: no permanent foreign body,... (Review)
Review
During the last decade, the interest of degradable embolics has considerably grown as alternatives for the currently-used permanent embolics: no permanent foreign body, recanalisation for repeat embolization, complete drug delivery in chemoembolization. Their design is not trivial since a lot of requirements need to be satisfied. The degradable embolics should be easily suspended in physiological solutions and contrast media, injectable in catheters with small internal lumen and they have to recover their size and shape after injection, as for any embolic. Moreover, they need to be loadable with various drugs, and their degradation has to be achieved in a given time before the onset of a chronic inflammatory response and vessel wall remodeling. Various approaches have been tested on diverse materials over the last years and have produced interesting results that make it possible to claim that the revolution of the degradable embolic has begun.
Topics: Absorbable Implants; Biocompatible Materials; Drug Delivery Systems; Embolization, Therapeutic; History, 20th Century; History, 21st Century; Humans; Starch
PubMed: 28120752
DOI: 10.1051/medsci/20173301005