The Use of Flow Diversion for the Treatment of Intracranial Aneurysms: Expansion of Indications.
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ABSTRACT:
SUBMITTER: Brouillard AM
PROVIDER: S-EPMC4772997 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and purposeFlow diversion is a recent endovascular treatment for intracranial aneurysms. We compared the safety and efficacy of flow diversion with the alternative standard management options.Materials and methodsA parallel group, prerandomized, controlled, open-label pragmatic trial was conducted in 3 Canadian centers. The trial included all patients considered for flow diversion. A Web-based platform 1:1 randomly allocated patients to flow diversion or 1 of 4 alternative standard management options (coiling with/without stent placement, parent vessel occlusion, surgical clipping, or observation) as prespecified by clinical judgment. Patients ineligible for alternative standard management options were treated with flow diversion in a registry. The primary safety outcome was death or dependency (mRS > 2) at 3 months. The composite primary efficacy outcome included the core lab-determined angiographic presence of a residual aneurysm, aneurysm rupture, progressive mass effect during follow-up, or death or dependency (mRS > 2) at 3-12 months.ResultsBetween May 2011 and November 2020, three hundred twenty-three patients were recruited: Two hundred seventy-eight patients (86%) had treatment randomly allocated (139 to flow diversion and 139 to alternative standard management options), and 45 (14%) received flow diversion in the registry. Patients in the randomized trial frequently had unruptured (83%), large (52% ≥10 mm) carotid (64%) aneurysms. Death or dependency at 3 months occurred in 16/138 patients who underwent flow diversion and 12/137 patients receiving alternative standard management options (relative risk, 1.33; 95% CI, 0.65-2.69; P = .439). A poor primary efficacy outcome was found in 30.9% (43/139) with flow diversion and 45.6% (62/136) of patients receiving alternative standard management options, with an absolute risk difference of 14.7% (95% CI, 3.3%-26.0%; relative risk, 0.68; 95% CI, 0.50-0.92; P = .014).ConclusionsFor patients with mostly unruptured, large, anterior circulation (carotid) aneurysms, flow diversion was more effective than the alternative standard management option in terms of angiographic outcome.
| S-EPMC9451626 | biostudies-literature
Project description:BackgroundTransradial access for neurointerventions offers advantages of fewer access-site complications, reduced procedure time, and greater patient comfort over transfemoral access. Data about transradial access for flow diversion are limited. We share our early experience with transradial access for flow diversion in a relatively large case series.MethodsConsecutive patients who underwent Pipeline embolization device (Medtronic) deployment via transradial access were included in the study, irrespective of location and laterality of the intracranial aneurysm. The cases were performed between July 2016 and October 2019. Demographics, aneurysm characteristics, and procedure-related details (including catheter systems used) were recorded and statistically evaluated.ResultsThirty-five transradial flow diversion procedures were attempted in 32 patients, of which 33 procedures were successful. In two cases involving left common carotid artery and internal carotid artery access, guide catheter herniation into the aortic arch led to abandonment of transradial access in favor of transfemoral access. The most common aneurysm locations in the transradial access procedures were the posterior communicating artery (n = 7), ophthalmic artery (n = 7), and superior hypophyseal artery (n = 7). Most transradial access procedures (66.7%) were performed using a biaxial catheter system. 6-French Benchmark (Penumbra) and Phenom 27 (Medtronic) were the most commonly utilized guide- and microcatheters, respectively. One patient had intraprocedural subarachnoid hemorrhage. No access-site complications occurred.ConclusionThis study demonstrates safety and feasibility of transradial access for Pipeline embolization device deployment and shows the versatility of this approach for different catheter systems. Tortuosity and acute angulation of the left common carotid artery and internal carotid artery were associated with approach failure.
| S-EPMC7903544 | biostudies-literature
Project description:BackgroundThe use of antithrombotic medication following acute flow diversion for a ruptured intracranial aneurysm (IA) is challenging with no current guidelines. We investigated the incidence of treatment-related complications and patient outcomes after flow diversion for a ruptured IA before and after the implementation of a standardized antithrombotic medication protocol.MethodsWe conducted a single-center retrospective study including consecutive patients treated for acutely ruptured IAs with flow diversion during 2015-2023. We divided the patients into two groups: those treated before the implementation of the protocol (pre-protocol) and those treated after the implementation of the protocol (post-protocol). The primary outcomes were hemorrhagic and ischemic complications. A secondary outcome was clinical outcome using the modified Ranking Scale (mRS).ResultsTotally 39 patients with 40 ruptured IAs were treated with flow diversion (69% pre-protocol, 31% post-protocol). The patient mean age was 55 years, 62% were female, 63% of aneurysms were in the posterior circulation, 92% of aneurysms were non-saccular, and 44% were in poor grade on admission. Treatment differences included the use of glycoprotein IIb/IIIa inhibitors (pre-group 48% vs. post-group 100%), and the use of early dual antiplatelets (pre-group 44% vs. 92% post-group). The incidence of ischemic complications was 37% and 42% and the incidence of hemorrhagic complications was 30% and 33% in the pre- and post-groups, respectively, with no between-group differences. There were three (11%) aneurysm re-ruptures in the pre-group and none in the post-group. There were no differences in mortality or mRS 0-2 between the groups at 6 months.ConclusionWe found no major differences in the incidence of ischemic or hemorrhagic complications after the implementation of a standardized antithrombotic protocol for acute flow diversion for ruptured IAs. There is an urgent need for more evidence-based guidelines to optimize antithrombotic treatment after flow diversion in the setting of subarachnoid hemorrhage.
| S-EPMC10927838 | biostudies-literature
Project description:Delayed aneurysm rupture and delayed intraparenchymal hemorrhages (DIPH) are poorly understood and often fatal complications of flow diversion (FD) for intracranial aneurysms. The purpose of this study was to identify risk factors for these complications.We performed a systematic review on post-FD delayed aneurysm rupture and DIPH. For each reported case, we collected the following information: aneurysm location, size and rupture status, type of flow diverter used, timing of the hemorrhage, and neurological outcome. We reported descriptive statistics of patients suffering DIPH and delayed aneurysm rupture to determine if there were any characteristics consistently present among patients with these complications.We identified 81 delayed aneurysm ruptures and 101 DIPH. Of the delayed ruptures, 76.6% (45/58) occurred within 1 month. The prognosis of delayed ruptures was poor, with 81.3% (61/75) experiencing death or poor neurological outcome. Giant aneurysms accounted for 46.3% of ruptures (31/67). Of these aneurysms, 80.9% (55/68) were initially unruptured. Of the delayed ruptured aneurysms, 17.8% (13/73) had prior or concomitant coiling. DIPHs were ipsilateral to the treated aneurysm in 82.2% (60/73) of cases. Of the DIPH, 86.0% (43/50) occurred within 1 month after FDS. Combined morbidity/mortality rate was 68.5% (50/73) following DIPH. Of DIPHs, 23.0% (14/61) occurred in patients with giant aneurysms.Our study demonstrates that giant aneurysms represent almost 50% of delayed aneurysm ruptures in the flow diverter literature. About 2% of delayed ruptures occurred despite associated coiling. A substantial proportion of DIPHs occur early following FDS treatment of giant aneurysms.
| S-EPMC4849277 | biostudies-literature
Project description:ObjectiveDelayed aneurysm rupture is a fatal complication after flow diversion treatment for large and giant intracranial aneurysms. This study aimed to investigate the feasibility and safety of coiling first and followed by planned flow diversion to prevent delayed aneurysm rupture.MethodsFrom January 2017 to December 2021 in two institutions, patients with unruptured intracranial aneurysms treated by coiling first and planned flow diversion were retrospectively collected. Data on demographic and aneurysmal characteristics, procedural details, and clinical and angiographic outcomes were reviewed.ResultsThirty patients were included (7 Males and 23 Females; Median age 57 years). Aneurysmal size ranged from 11.8 to 26.8 mm, with a median value of 18.5 mm. All aneurysms were located within the intradural segment of internal carotid arteries. Coiling and planned flow diversion were successfully performed in all patients. The time interval between coiling and flow diversion was 3.9-6.7 weeks, with a median value of 5.2 weeks. No hemorrhagic or ischemic complications occurred during the procedures and follow-up. Complete or subtotal occlusion was achieved in 86.7% (26/30) at the last angiographic follow-up (median 6.7 months).ConclusionThe preliminary data suggested that coiling unruptured intracranial aneurysms followed by planned flow diversion is both safe and effective. Further studies with larger cohorts are needed to verify the effect of this new strategy in preventing delayed rupture after flow diversion.
| S-EPMC9751354 | biostudies-literature
Project description:Flow diversion prostheses represent a new endovascular approach aimed at treating patients with large wide-neck aneurysms. Our objective is to present this new technology, to review the clinical studies on efficacy, and to emphasize its current limits. Flow diversion prostheses consist of a cylinder made of a large number of braided microfilaments providing a large metallic surface when deployed and inducing a blood flow diversion outside the aneurysm. Two different brands are currently available. Clinical data supporting their efficacy are currently limited to six non comparative cohort studies that included between 18 and 107 patients. Procedural implantation was shown to be feasible in more than 90% and safe with a thirty-day mortality between 2.8 and 5.5%. Complete occlusion rates at twelve months varied between 85.7 and 100%. Even though promising, the current status of flow diversion prostheses needs further evaluation with randomized, prospective, clinical trials with comparison to conventional strategies including endovascular coiling or surgical clipping.
| S-EPMC3216267 | biostudies-other
Project description:Background and purposeAneurysms of the cavernous segment of the ICA are difficult to treat with standard endovascular techniques, and ICA sacrifice achieves a high rate of occlusion but carries an elevated level of surgical complications and risk of de novo aneurysm formation. We report rates of occlusion and treatment-related data in 44 patients with cavernous sinus aneurysms treated with flow diversion.Materials and methodsPatients with cavernous segment aneurysms treated with flow diversion were selected from a prospectively maintained data base of patients from 2009 to the present. Demographic information, treatment indications, number/type of flow diverters placed, outcome, complications (technical or clinical), and clinical/imaging follow-up data were analyzed.ResultsWe identified 44 patients (37 females, 7 males) who had a flow diverter placed for treatment of a cavernous ICA aneurysm (mean age, 57.2; mean aneurysm size, 20.9 mm). The mean number of devices placed per patient was 2.2. At final angiographic follow-up (mean, 10.9 months), 71% had complete occlusion, and of those with incomplete occlusion, 40% had minimal remnants (<3 mm). In symptomatic patients, complete resolution or significant improvement in symptoms was noted in 90% at follow-up. Technical complications (which included, among others, vessel perforation in 4 patients, groin hematoma in 2, and asymptomatic carotid occlusion in 1) occurred in approximately 36% of patients but did not result in any clinical sequelae immediately or at follow-up.ConclusionsOur series of flow-diversion treatments achieved markedly greater rates of complete occlusion than coiling, with a safety profile that compares favorably with that of carotid sacrifice.
| S-EPMC7964557 | biostudies-literature
Project description:Background and purposeThere is a paucity of data regarding antiplatelet management strategies in the setting of stent-assisted coiling/flow diversion for ruptured intracranial aneurysms. This study aimed to identify current challenges in antiplatelet management during stent-assisted coiling/flow diversion for ruptured intracranial aneurysms and to outline possible antiplatelet management strategies.Materials and methodsThe modified DELPHI approach with an on-line questionnaire was sent in several iterations to an international, multidisciplinary panel of 15 neurointerventionalists. The first round consisted of open-ended questions, followed by closed-ended questions in the subsequent rounds. Responses were analyzed in an anonymous fashion and summarized in the final manuscript draft. The statement received endorsement from the World Federation of Interventional and Therapeutic Neuroradiology, the Japanese Society for Neuroendovascular Therapy, and the Chinese Neurosurgical Society.ResultsData were collected from December 9, 2019, to March 13, 2020. Panel members achieved consensus that platelet function testing may not be necessary and that antiplatelet management for stent-assisted coiling and flow diversion of ruptured intracranial aneurysms can follow the same principles. Preprocedural placement of a ventricular drain was thought to be beneficial in cases with a high risk of hydrocephalus. A periprocedural dual, intravenous, antiplatelet regimen with aspirin and a glycoprotein IIb/IIIa inhibitor was preferred as a standard approach. The panel agreed that intravenous medication can be converted to oral aspirin and an oral P2Y12 inhibitor within 24 hours after the procedure.ConclusionsMore and better data on antiplatelet management of patients with ruptured intracranial aneurysms undergoing stent-assisted coiling or flow diversion are urgently needed. Panel members in this DELPHI consensus study preferred a periprocedural dual-antiplatelet regimen with aspirin and a glycoprotein IIb/IIIa inhibitor.
| S-EPMC7661082 | biostudies-literature
Project description:Flow diverters (pipeline embolization device, Silk flow diverter, and Surpass flow diverter) have been developed to treat intracranial aneurysms. These endovascular devices are placed within the parent artery rather than the aneurysm sac. They take advantage of altering hemodynamics at the aneurysm/parent vessel interface, resulting in gradual thrombosis of the aneurysm occurring over time. Subsequent inflammatory response, healing, and endothelial growth shrink the aneurysm and reconstruct the parent artery lumen while preserving perforators and side branches in most cases. Flow diverters have already allowed treatment of previously untreatable wide neck and giant aneurysms. There are risks with flow diverters including in-stent thrombosis, perianeurysmal edema, distant and delayed hemorrhages, and perforator occlusions. Comparative efficacy and safety against other therapies are being studied in ongoing trials. Antiplatelet therapy is mandatory with flow diverters, which has highlighted the need for better evidence for monitoring and tailoring antiplatelet therapy. In this paper we review the devices, their uses, associated complications, evidence base, and ongoing studies.
| S-EPMC4054970 | biostudies-other
Project description:Little is known about the hemodynamic disturbances induced by the cerebral aneurysms in the parent artery and the effect of flow diverter stents (FDS) on these latter. A better understanding of the aneurysm-parent vessel complex relationship may aid our understanding of this disease and to optimize its treatment. The ability of volumetric flow rate (VFR) waveform to reflect the arterial compliance modifications is well known. By analyzing the VFR waveform and the pulsatility in the parent vessel, this study aimed to test the hypotheses that (1) intracranial aneurysms might disrupt the blood flow of the parent vessel and (2) the treatment by FDS might have measurable corrective effect on these changes. Ten patients followed for unruptured intracranial aneurysms treated by FDS and ten healthy volunteers as control group were included in this study. Two-dimensional quantitative phase-contrast magnetic resonance imaging (MRI) was performed on each patient on the ICA artery upstream and downstream to the aneurysm, and on each volunteer at similar locations. The aneurysms altered significantly the parent vessel pulsatility and this effect was correlated to their volume. The aneurysms treatment by FDS allowed for the restoration of a normally modulated flow and pulsatility correction in the parent vessel.
| S-EPMC4671130 | biostudies-literature