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Chen x, wang y, yu j.Intra- and post-operative acute hemorrhagic complications of onyx embolization of brain arteriovenous malformations: a single-center experience.Frontiers in neurology.2022;13:974954.Doi:10.3389/fneur.2022.974954.Medtronic literature review found a report of patient complications in association with onyx, echelon catheter, marathon catheter, and apollo catheter.The purpose of this article was to investigate cases of intra- and post-operative acute (within 72 h) hemorrhagic complications of endovascular treatment (evt) for a brain arteriovenous malformation (bavm).This was a retrospective study of 25 patients with consecutive bavm who were treated via evt with onyx embolization and suffered intra- and post-operative acute hemorrhage.Twenty-five patients were aged 11¿70 years (mean, 37.2 years), of whom 12 were female.Four patients had an unruptured bavm; among them, one complained of headache, and three were admitted for epilepsy.Twenty-one patients were admitted for intracranial hemorrhage, including eight patients with ich, six patients with ivh, five patients with sah, and two patients with both ich and ivh.The inclusion criteria were as follows: evt of bavm with onyx embolization; and hemorrhagic complication during or in the acute phase after evt, defined as within 72 h after evt.The exclusion criteria were as follows: hemorrhagic complication occurring more than 72 h post-operatively, and bavm embolization with an embolic agent other than onyx.All patients were treated under general anesthesia via a transfemoral approach.The marathon microcatheter, an apollo microcatheter with a detachable tip, or the echelon-10 microcatheter was used to access the nidus to achieve the wedge position via the feeding artery.Then, the onyx was cast.If further evt was needed, another feeding artery could be chosen to repeat the onyx casting.In evt for bavms, weak structures, such as associated aneurysms and fistulous components, should be given priority for treatment.If no weak structure is identified, the main purpose of evt is to reduce the blood flow of bavms to help reduce nidus/perinidal angiogenesis.Flow-related aneurysms on a feeding artery away from the nidus could be treated by coiling embolization; when those aneurysms were close to the nidus, casting onyx could be applied.For intranidal aneurysms, the bavm compartment containing the aneurysm can be embolized with onyx casting.For venous aneurysms on the draining vein, the blood flow of the bavm compartment draining to the vein with aneurysms can be embolized with onyx casting to reduce the blood flow.In evt for bavms, the pressure cooker technique can be used.First, a marathon or apollo microcatheter is placed in the wedge position in the feeding artery, and then a microcatheter for coiling is placed behind the marathon or apollo microcatheter.Before casting onyx, the feeding artery is coiled to produce the effect of a pressure cooker and avoid reflux during onyx casting.When intraoperative hemorrhage occurred, continuous evt was performed promptly to stop the bleeding.Evt cannot be performed for postoperative hemorrhage.For hemorrhage without an occupying effect, conservative treatment was given.For severe hemorrhage with an occupying effect, craniotomy for hematoma evacuation and/or external ventricular drainage (evd) was recommended accordingly. of the 25 bavms, 17 required a single evt procedure, and eight required two evt procedures; overall, 33 procedures were performed.Of them, the marathon was used in 28 procedures, an apollo detachable microcatheter was used in four procedures, and the echelon-10 was used in one procedure.The pressure cooker technique was applied in four procedures.The article states technical issues during use of the catheters and onyx: - selective microcatheter angiogram showed contrast agent extravasation during catheterization and penetration of the nidus - high pressure from onyx casting can result in intraoperative rupture of the bavm structure, presenting as onyx assembly outside the bavm structure and active contrast agent extravasation as illustrated in case 25 the following intra- or post-procedural outcomes were noted: - of the 25 hemorrhagic complications, 17 were intraoperative, and 8 were post-operative and occurred between 1 and 12 h after evt.The hemorrhagic complications included intracerebral hemorrhage (ich) in seven patients, intraventricular hemorrhage (ivh) in six, both ich and ivh in five, subarachnoid hemorrhage (sah) in two, both sah and ich in four, and sah, ich, and ivh in one - there were eight cases of mortality; the remaining 17 patients had follow-up data.Among them, 15 patients had good outcomes, with glasgow outcome scale scores of 5 and 4, accounting for 60% - of 17 intraoperative hemorrhages, 13 were due to high-pressure onyx casting and four were due perforating complications - of eight post-operative hemorrhages, six were attributed to normal perfusion pressure breakthrough; three were nidus ruptures, two were intranidal aneurysm ruptures, one was perinidal angiogenesis rupture, and two were draining vein system ruptures.- the degree of nidus onyx embolization was more than 2/3 or complete in seven (7/8)bavms. - draining vein occlusion was observed in eight of 25 bavms.- after hemorrhage, conservative treatment was administered in 12 cases, and surgical management was performed in other cases; external ventricular drainage (evd) was applied in seven patients, craniotomy was performed in three patients, and craniotomy and evd were performed in three patients.- post-operative ct showing venous edema.
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Chen x, wang y, yu j.Intra- and post-operative acute hemorrhagic complications of onyx embolization of brain arteriovenous malformations: a single-center experience.Frontiers in neurology.2022;13:974954.Doi:10.3389/fneur.2022.974954.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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