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1.
J Neurointerv Surg ; 15(8): 776-780, 2023 Aug.
Article in English | MEDLINE | ID: mdl-35705359

ABSTRACT

BACKGROUND: Flow diversion is the first-line treatment for several types of intracranial aneurysms. We report on a large series of patients treated with the Derivo Embolization Device who underwent a 1-year angiographic control follow-up. METHODS: We performed a multicenter retrospective analysis of prospectively collected data, designed to evaluate the clinical and angiographic results of treatment of intracranial aneurysms with the Derivo Flow Diverter. The primary endpoint was complete occlusion of the aneurysm within 12 months, which was evaluated using DSA. The secondary endpoint was the absence of any serious adverse events. Univariate and multivariate logistic regression analyses were performed to analyze the data. RESULTS: The study was conducted from December 2016 to September 2019 and enrolled 127 patients with 177 intracranial aneurysms, treated at three different centers. Efficacy at 6 months was 70.1% (122/174) for total occlusion and 87.3% (152/174) for favorable occlusion and, at 12 months, it was 83.3% (145/174) for total occlusion and 97.7% (170/174) for favorable occlusion. Regarding safety concerns, 97.6% (124/127) of patients did not experience severe adverse effects during the follow-up period of 12 months, and there was no procedure-related mortality. CONCLUSIONS: The Derivo Embolization Device, achieving a total occlusion rate of 83.3% and a favorable occlusion rate of 97.7% in a 1-year angiographic control study of 174 aneurysms with minor morbidity and no intervention-related mortality, is a safe and effective treatment for intracranial aneurysms.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Intracranial Aneurysm/complications , Retrospective Studies , Cerebral Angiography/methods , Treatment Outcome , Embolization, Therapeutic/methods , Stents , Follow-Up Studies
2.
Cochrane Database Syst Rev ; 7: CD013690, 2022 07 20.
Article in English | MEDLINE | ID: mdl-35857365

ABSTRACT

BACKGROUND: The use of mechanical thrombectomy to restore intracranial blood flow after proximal large artery occlusion by a thrombus has increased over time and led to better outcomes than intravenous thrombolytic therapy alone. Currently, the type of anaesthetic technique during mechanical thrombectomy is under debate as having a relevant impact on neurological outcomes. OBJECTIVES: To assess the effects of different types of anaesthesia for endovascular interventions in people with acute ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Specialised Register of Trials on 5 July 2022, and CENTRAL, MEDLINE, and seven other databases on 21 March 2022. We performed searches of reference lists of included trials, grey literature sources, and other systematic reviews.  SELECTION CRITERIA: We included all randomised controlled trials with a parallel design that compared general anaesthesia versus local anaesthesia, conscious sedation anaesthesia, or monitored care anaesthesia for mechanical thrombectomy in acute ischaemic stroke. We also included studies reported as full-text, those published as abstract only, and unpublished data. We excluded quasi-randomised trials, studies without a comparator group, and studies with a retrospective design. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. The outcomes were assessed at different time periods, ranging from the onset of the stroke symptoms to 90 days after the start of the intervention. The main outcomes were functional outcome, neurological impairment, stroke-related mortality, all intracranial haemorrhage, target artery revascularisation status, time to revascularisation, adverse events, and quality of life. All included studies reported data for early (up to 30 days) and long-term (above 30 days) time points. MAIN RESULTS: We included seven trials with 982 participants, which investigated the type of anaesthesia for endovascular treatment in large vessel occlusion in the intracranial circulation. The outcomes were assessed at different time periods, ranging from the onset of stroke symptoms to 90 days after the procedure. Therefore, all included studies reported data for early (up to 30 days) and long-term (above 30 up to 90 days) time points. General anaesthesia versus non-general anaesthesia(early) We are uncertain about the effect of general anaesthesia on functional outcomes compared to non-general anaesthesia (mean difference (MD) 0, 95% confidence interval (CI) -0.31 to 0.31; P = 1.0; 1 study, 90 participants; very low-certainty evidence) and in time to revascularisation from groin puncture until the arterial reperfusion (MD 2.91 minutes, 95% CI -5.11 to 10.92; P = 0.48; I² = 48%; 5 studies, 498 participants; very low-certainty evidence). General anaesthesia may lead to no difference in neurological impairment up to 48 hours after the procedure (MD -0.29, 95% CI -1.18 to 0.59; P = 0.52; I² = 0%; 7 studies, 982 participants; low-certainty evidence), and in stroke-related mortality (risk ratio (RR) 0.98, 95% CI 0.52 to 1.84; P = 0.94; I² = 0%; 3 studies, 330 participants; low-certainty evidence), all intracranial haemorrhages (RR 0.92, 95% CI 0.65 to 1.29; P = 0.63; I² = 0%; 5 studies, 693 participants; low-certainty evidence) compared to non-general anaesthesia. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia (RR 0.21, 95% CI 0.05 to 0.79; P = 0.02; I² = 71%; 2 studies, 229 participants; low-certainty evidence). General anaesthesia improves target artery revascularisation compared to non-general anaesthesia (RR 1.10, 95% CI 1.02 to 1.18; P = 0.02; I² = 29%; 7 studies, 982 participants; moderate-certainty evidence). There were no available data for quality of life. General anaesthesia versus non-general anaesthesia (long-term) There is no difference in general anaesthesia compared to non-general anaesthesia for dichotomous and continuous functional outcomes (dichotomous: RR 1.21, 95% CI 0.93 to 1.58; P = 0.16; I² = 29%; 4 studies, 625 participants; low-certainty evidence; continuous: MD -0.14, 95% CI -0.34 to 0.06; P = 0.17; I² = 0%; 7 studies, 978 participants; low-certainty evidence). General anaesthesia showed no changes in stroke-related mortality compared to non-general anaesthesia (RR 0.88, 95% CI 0.64 to 1.22; P = 0.44; I² = 12%; 6 studies, 843 participants; low-certainty evidence). There were no available data for neurological impairment, all intracranial haemorrhages, target artery revascularisation status, time to revascularisation from groin puncture until the arterial reperfusion, adverse events (haemodynamic instability), or quality of life. Ongoing studies We identified eight ongoing studies. Five studies compared general anaesthesia versus conscious sedation anaesthesia, one study compared general anaesthesia versus conscious sedation anaesthesia plus local anaesthesia, and two studies compared general anaesthesia versus local anaesthesia. Of these studies, seven plan to report data on functional outcomes using the modified Rankin Scale, five studies on neurological impairment, six studies on stroke-related mortality, two studies on all intracranial haemorrhage, five studies on target artery revascularisation status, four studies on time to revascularisation, and four studies on adverse events. One ongoing study plans to report data on quality of life. One study did not plan to report any outcome of interest for this review. AUTHORS' CONCLUSIONS: In early outcomes, general anaesthesia improves target artery revascularisation compared to non-general anaesthesia with moderate-certainty evidence. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia with low-certainty evidence. We found no evidence of a difference in neurological impairment, stroke-related mortality, all intracranial haemorrhage and haemodynamic instability adverse events between groups with low-certainty evidence. We are uncertain whether general anaesthesia improves functional outcomes and time to revascularisation because the certainty of the evidence is very low. However, regarding long-term outcomes, general anaesthesia makes no difference to functional outcomes compared to non-general anaesthesia with low-certainty evidence. General anaesthesia did not change stroke-related mortality when compared to non-general anaesthesia with low-certainty evidence. There were no reported data for other outcomes. In view of the limited evidence of effect, more randomised controlled trials with a large number of participants and good protocol design with a low risk of bias should be performed to reduce our uncertainty and to aid decision-making in the choice of anaesthesia.


Subject(s)
Brain Ischemia , Ischemic Stroke , Stroke , Anesthesia, General , Brain Ischemia/surgery , Humans , Intracranial Hemorrhages , Quality of Life , Randomized Controlled Trials as Topic , Retrospective Studies , Stroke/surgery
3.
Neurosurgery ; 87(1): 104-111, 2020 07 01.
Article in English | MEDLINE | ID: mdl-31504821

ABSTRACT

BACKGROUND: The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications. OBJECTIVE: To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield. METHODS: This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported. RESULTS: Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo. CONCLUSION: The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.


Subject(s)
Blood Vessel Prosthesis , Embolization, Therapeutic/methods , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Patient Safety , Adult , Aged , Blood Vessel Prosthesis/adverse effects , Cerebral Angiography/methods , Embolization, Therapeutic/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome
4.
World Neurosurg ; 110: e907-e916, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29191528

ABSTRACT

OBJECTIVE: The aim of this study was to describe 27 patients with 32 web vessels (WVs) from our practice and provide a review of the literature regarding imaging diagnostics, clinical presentation, and treatment of WVs. METHODS: A MEDLINE search was performed using combinations of the following terms: "stroke in young adults," "web," "recurrent stroke," "diaphragm-like," "atypical fibromuscular hyperplasia," "atypical fibromuscular dysplasia," "septal fibromuscular dysplasia," "septa," "diaphragms," "pseudovalvular folds," and "carotid diaphragm." Our series was added in this review. RESULTS: According to location, there were 88 carotid WVs (91.66%), 7 vertebral WVs (7.3%), and 1 subclavian WV (1.04%). According to clinical presentation, the reported WVs caused stroke in 81 cases (84.38%). Treatment was supportive care in 46 cases (47.91%), surgery in 33 cases (35.41%), and an endovascular procedure through angioplasty and stenting in 17 cases (17.7%). Variables such as age (P = 0.7565), sex (P = 0.6912), and location (P = 0.7993) were not shown to be risk factors for stroke in these patients. CONCLUSIONS: Although few cases have been reported in the literature, the stroke rate in patients with WVs is high. Endovascular treatment is presented as an effective form of treatment with no associated morbidities or recurrences of ischemic events.


Subject(s)
Endovascular Procedures , Stroke/etiology , Vascular Diseases/complications , Vascular Diseases/surgery , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Stroke/diagnostic imaging , Stroke/surgery , Vascular Diseases/diagnostic imaging , Young Adult
5.
J Neurointerv Surg ; 10(5): 451-454, 2018 May.
Article in English | MEDLINE | ID: mdl-29212861

ABSTRACT

OBJECTIVE: Isolated dissecting spinal aneurysms are rare lesions that pose a therapeutic challenge. We report our experience in the management of four patients with dissecting spinal aneurysms. METHODS: After institutional review board approval was obtained, the neurointerventional databases of the two participating institutions were retrospectively reviewed. Aneurysms in the anterior spinal artery, posterior spinal artery, or in a radiculomedullary artery were included in the analysis. Flow-related aneurysms were excluded. Data on clinical presentation, hemorrhage location, aneurysm size, location, angiographic follow-up, re-hemorrhage, and clinical outcome were obtained and analyzed. RESULTS: Four patients with five spinal dissecting aneurysms met the inclusion criteria. There were two women and the mean age was 63 years (range 36-64). All patients presented with hemorrhage. Three radiculomedullary arteries in two different patients had one lesion each; the other two involved the anterior spinal artery and a posterior spinal artery in different patients. All four patients were managed conservatively. Follow-up angiography (5.5 months) demonstrated occlusion of all five aneurysms. There was no re-hemorrhage and all patients had a good outcome at the last follow-up (modified Rankin Scale score 0-2). CONCLUSIONS: Conservative management of ruptured spontaneous dissecting spinal aneurysms is a reasonable therapeutic option capable of achieving favorable angiographic and clinical outcomes.


Subject(s)
Aneurysm, Ruptured/diagnostic imaging , Aortic Dissection/diagnostic imaging , Conservative Treatment/methods , Spinal Cord/blood supply , Spinal Cord/diagnostic imaging , Adult , Aged , Aortic Dissection/therapy , Aneurysm, Ruptured/therapy , Cerebral Angiography/methods , Embolization, Therapeutic/methods , Female , Humans , Male , Middle Aged , Retrospective Studies , Vertebral Artery/diagnostic imaging
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