RESUMO
BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.
Assuntos
Prótese Vascular , Embolização Terapêutica/métodos , Procedimentos Endovasculares/métodos , Aneurisma Intracraniano/terapia , Adulto , Idoso , Embolização Terapêutica/instrumentação , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
PURPOSE: We describe safety and efficacy aspects of mechanical thrombectomy with the novel stent-type clot retrieval device EmboTrap for revascularization of large-artery occlusions in acute ischemic stroke. MATERIALS AND METHODS: A total of 40 patients with acute ischemic stroke due to large-artery occlusion were treated in five European centers. Clinical and procedural data were collected; self-reported angiographic results and neurologic outcome (discharge and 90 days) were assessed in a standardized manner. RESULTS: The median National Institutes of Health Stroke Scale at admittance was 16; no patient was treated after 12 h. Intravenous thrombolysis (IVT) was received by 65 % of patients. The territorial distribution was as follows: 87.5 % in the anterior circulation: 62.5 % middle cerebral artery and 25 % internal carotid artery (ICA) terminus, comprising 20 % tandem occlusions; and 12.5 % in the posterior circulation, all of which were vertebrobasilar. Revascularization of TICI 2b-3 was achieved in 38 of 40 (95 %) treatments. Additional devices were utilized in 11 of 40 (28 %) cases after a mean of 2.6 passes with EmboTrap prior to switching. The mean number of EmboTrap passes needed was 1.8, with a mean procedural time to reperfusion of 54 min. One patient (2.5 %), who had not received IVT, experienced symptomatic intracranial hemorrhage post-interventionally. Procedural complications were encountered in 2 of 40 cases (5 %); both patients exhibited ICA dissection that was treated conservatively without clinical sequelae. There were no device-related complications. Of 23 available patients, 8 (35 %) had a good outcome after 90 days. CONCLUSION: The procedural results from these five centers suggest that EmboTrap is technically safe. Successful recanalization rates can be expected to be within the range of other stent retrievers.
Assuntos
Hemorragia Cerebral/etiologia , Revascularização Cerebral/efeitos adversos , Revascularização Cerebral/instrumentação , Trombólise Mecânica/efeitos adversos , Trombólise Mecânica/instrumentação , Acidente Vascular Cerebral/terapia , Hemorragia Cerebral/diagnóstico , Hemorragia Cerebral/prevenção & controle , Desenho de Equipamento , Análise de Falha de Equipamento , Europa (Continente) , Feminino , Humanos , Masculino , Projetos Piloto , Radiografia Intervencionista , Acidente Vascular Cerebral/diagnóstico por imagem , Resultado do TratamentoRESUMO
Cerebral arteriovenous malformations (AVM) are vascular lesions that occur either congenitally or arise in early childhood. AVM are characterised by arteriovenous shunts through a nidus of coiled and tortuous vascular connections that connect feeding arteries to draining veins. Generally, AVM become evident through intracranial haemorrhage in patients aged 20-40 years. Especially, in the young adult presenting with epileptic seizures or focal neurological deficits AVM needs to be considered as an important differential diagnosis. Treatment modalities for the occlusion of symptomatic AVM include microneurosurgery, endovascular embolisation, or radiosurgery. These can be performed each on its own or in combination with the others. Incidentally diagnosed AVM require a thorough and individual consideration of treatment indications. This review deals with the current recommendations for the treatment of AVM in the adult patient.