Linfante, i., andreone, v., ravelo, n., starosciak, a.K., arif, b., shallwani, h., tze man kan, p., mcdermott, m.W., dabus, g.(2020).Endovascular treatment of giant intracranial aneurysms.Cureus, 12(5), e8290.Https://doi.Org/10.7759/cureus.8290 abstract objective: giant intracranial aneurysms (gias) are associated with a high risk of rupture and have a high mortality rate when they rupture (65-100%).The traditional microsurgical approach to secure these lesions is challenging, and as such endovascular embolization has been increasingly selected as a treatment option.Methods: we performed a retrospective analysis of consecutive patients with ruptured and unruptured gias at three medical centers from october 2008 to april 2016.Clinical follow-up and digital subtraction angiography were conducted at six months post-treatment.Chi-square analysis was used to determine differences in outcomes between anterior and posterior circulation aneurysms and if a pipeline embolization device (ped) provided favorable outcomes in unruptured gias.Results: a total of 45 consecutive patients (mean/median age = 57/59; range: 16-82 years) were included.The mean/median aneurysm size was 29.9/28.3 mm (range: 25-50 mm).Eight (18%) patients presented with aneurysmal subarachnoid hemorrhage and 37 (82%) with unruptured gias.Twenty-eight (62%) were treated with a ped: 11 (24.4%) with one ped, 1 (2.2%) with ped + coils, 11 (24.4%) with more than one ped, and 5 (13.5%) with multiple ped + coils.The overall mortality rate was 3/45 (6.7%).No deaths were procedure-related.Five (11.1%) patients experienced ischemic stroke but only 2 had a 90-day modified rankin scale (mrs) score of =3.Of 33 patients available for six-month angiography, raymond scale (rs) scores were 1, 2, and 3 for 23/45 (70%), 7/45 (20.9%), and 3/45 (9.1%), respectively.Chi-square test demonstrated that overall, anterior circulation gias had better clinical (mrs score) and radiographic (rs score) outcomes than posterior gias.Ped alone provided similar clinical mrs outcomes but had a higher rate of complete occlusion at six months compared with ped + coils and coils alone in unruptured gias (p <(><<)> 0.05).Conclusions: endovascular embolization using ped or ped + coils appears to be a moderately safe and effective treatment option for patients with gias.3 patients included in the study and all of whom were treated with implantation of multiple ped's experienced stroke which resulted in symptoms and/or increased mrs.The first patient was treated for an unruptured 25.3mm aneurysm of the right middle cerebral artery and had two ped's implanted and coiling.This patient developed completed ped occlusion and right lentiform and caudate nucleus infarct with clinical worsening demonstrated by report of pre-procedure mrs score of 2 and 90-day mrs score of 4, but 6 month mrs score was 1.The patient was treated with mechanical thrombectomy of the embolism and medication; treatment was successful.The second patient was treated with three implanted ped's and coiling to treat an unruptured 30mm basilar and left ventricular artery.The pre-procedure mrs score was 3, which worsened to 4 at 90 days.The third patient was treated for an unruptured 30mm aneurysm of the left ventricular artery with 9 ped's implanted.This patient experienced a left thalamic stroke which caused right hand weakness, but the mrs score at 90 days was 3, which was the same as pre-procedure.Another patient, treated for an unruptured 50mm aneurysm of the right internal carotid artery (r-ica) with 2 ped's and coiling, developed a pseudoaneurysm of the femoral artery.Additional treatment was provided to evacuate the hematoma from the femoral artery pseudoaneurysm with a drain.Two patients had an intraoperative transient ischemic attack (tia) which was treated with integrillin.One of these patients also developed post-operative subarachnoid and intraparenchymal hemorrhage which were treated with craniectomy and clot evacuation; 2 additional ped's were also implanted for residual aneurysm.This patient presented with a mrs score of 2; at 90 days, the mrs score was 4 and at 6 months the patient was recovered with an mrs score of 1.Another patient treated for an unruptured 27mm aneurysm of the r-ica with implantation of a ped had residual aneurysm; 2 additional ped's were implanted.There was also a patient treated for an unruptured 27.9mm aneurysm of the l-ica which had incomplete coverage of the aneurysm.A follow-up procedure was planned for implantation of multiple additional ped's.
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H6: device code updated to a25, patient code updated to e2403, health impact code updated to f26.H10: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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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