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Objective: To evaluate the safety and efficacy of the SeparGate™ balloon-guiding catheter (BGC) for blocking flow and delivering devices in neurointerventional surgery. Method: This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy. The primary endpoint was immediate procedural success rate in flow arrest, device delivery, and withdrawal. The efficacy endpoints were intraoperative product performance, including rigidity, smoothness, fracture resistance of the catheter wall, catheter push performance, compatibility and radiopaque display, integrity, adhesion thrombus after withdrawal and balloon rupture. The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration. Result: A total of 129 patients were included; of them, 128 were analyzed in the full analysis set (FAS) and per protocol set (PPS). Immediate procedural success was achieved in 97.7% of patients with FAS and PPS. The lower bound of the 95% confidence interval was 94.6%, higher than the preset efficacy margin of 94%. Device-related adverse events occurred in 2 (1.6%) cases. One was mild adverse event of vasospasm, which resolved spontaneously. The other was serious adverse event of dissection aggravation, which was treated with stenting angioplasty. No device defects were observed. Conclusion: In neurointerventional surgery, the SeparGate™ BGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.
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Background: Hemorrhagic transformation (HT) of acute ischemic stroke (AIS) is associated with poor outcome. Previous studies only reported the association of mean ischemic severity or total infarct volume with HT after endovascular therapy (EVT). We aimed to investigate the predictive value of preoperative apparent diffusion coefficient (ADC) map for HT by combinated ischemic severity and corresponding volume in AIS after successful recanalization with EVT. Methods: We retrospectively analyzed 119 consecutive cases of AIS with large vessel occlusion of anterior circulation within 24 hours after symptom onset and successful recanalization after EVT. All cases had baseline magnetic resonance imaging (MRI), follow-up computed tomography (CT), and magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Volumes of ADC <0.6×10-3, 0.5×10-3, 0.4×10-3, and 0.3×10-3 mm2/s, baseline characteristics and outcomes of patients with and without HT identified by European Collaborative Acute Stroke Study (ECASS) were compared. The optimal ADC and volume threshold for predicting HT were analyzed using receiver operating characteristic (ROC) curve, and multivariate logistic regression analysis were performed with clinical characteristics and volumes of optimal ADC threshold to determine risk factors for HT. Results: Among 119 patients, 42 patients had HT on follow-up CT, including 24 hemorrhagic infarct (HI) cases and 18 parenchymal hematoma (PH) cases. The optimal volumes were 6.46 mL with ADC <0.4×10-3 mm2/s for predicting both HT and PH, with a larger area under curve (AUC) of 83.3% for HT than that for PH of 80%. In logistic regression analysis, intravenous tissue plasminogen activator (IV tPA) treatment, atrial fibrillation, and volume of ADC <0.4×10-3 mm2/s were identified as independent predictors for HT and volume of ADC <0.4×10-3 mm2/s had the highest odds ratio (OR) value. Conclusions: The combination of ischemic severity and corresponding volume in ADC map may predict HT after thrombectomy. In addition to the total infarct volume, volume with severe ischemia should be taken into consideration in preoperative patient selection.
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Background: Intracranial vertebrobasilar trunk large (≥10 mm) aneurysms (IVBTLAs) are rare and challenging to manage. In this study, we describe the natural prognosis and evaluate the safety and efficacy of endovascular treatment of IVBTLAs compared with conservative therapy. Methods: This prospective multicenter cohort study included patients with IVBTLAs, who chose either endovascular treatment (endovascular group) or conservative therapy (conservative group) after discussion with their doctors. The primary endpoint was the incidence of serious adverse events (SAEs) related to the target vessel, while secondary endpoints included target vessel-related mortality, major stroke, other serious adverse events, and aneurysm occlusion rate. Results: In total, 258 patients were referred to our two centers for the management of vertebrobasilar aneurysms, and 69 patients had IVBTLAs. Among them, 51 patients underwent endovascular treatment, and 18 patients received conservative therapy. The incidence of target vessel-related SAEs was 15.7% (8/51) in the endovascular group and 44.4% (8/18) in the conservative group (P = 0.031). The target vessel-related mortality was 2.0% (1/51) in the endovascular group and 38.9% (7/18) in the conservative group (P < 0.001). The cumulative survival rates in the endovascular group and conservative group within 1-year, 3-year, and 5-year were 98.0% vs. 83.3%, P = 0.020; 98.0% vs. 66.7%, P = 0.001; and 98.0% vs. 35.6%, P < 0.001, respectively. Multivariate analysis revealed conservative therapy, giant aneurysm, and ischemic onset as risks factor for SAEs. Conclusions: Compared with conservative treatment, endovascular treatment of the IVBTLAs may be associated with a lower incidence of SAEs, with higher 1-year, 3-year, and 5-year survival rates. Conservative therapy, giant aneurysm, and ischemic onset were associated with a high risk of SAEs.
Subject(s)
Conservative Treatment , Intracranial Aneurysm , Arteries , Cohort Studies , Humans , Intracranial Aneurysm/complications , Intracranial Aneurysm/therapy , Prospective Studies , Treatment OutcomeABSTRACT
OBJECTIVE: We aimed to characterize the occurrence of postoperative hematoma (POH) after neurosurgery overall and according to procedure type and describe the prevalence of possible confounders. METHODS: Patient data between 2010 and 2012 at the Department of Neurosurgery in Helsinki University Hospital were retrospectively analyzed. A data search was performed according to the type of surgery including craniotomies; shunt procedures, spine surgery, and spinal cord stimulator implantation. We analyzed basic preoperative characteristics, as well as data about the initial intervention, perioperative period, revision operation and neurologic recovery (after craniotomy only). RESULTS: The overall incidence of POH requiring reoperation was 0.6% (n = 56/8783) to 0.6% (n = 26/4726) after craniotomy, 0% (n = 0/928) after shunting procedure, 1.1% (n = 30/2870) after spine surgery, and 0% (n = 0/259) after implantation of a spinal cord stimulator. Craniotomy types with higher POH incidence were decompressive craniectomy (7.9%, n = 7/89), cranioplasty (3.6%, n = 4/112), bypass surgery (1.7%, n = 1/60), and epidural hematoma evacuation (1.6%, n = 1/64). After spinal surgery, POH was observed in 1.1% of cervical and 2.1% of thoracolumbar operations, whereas 46.7% were multilevel procedures. 64.3% of patients with POH and 84.6% of patients undergoing craniotomy had postoperative hypertension (systolic blood pressure >160 mm Hg or lower if indicated). Poor outcome (Glasgow Outcome Scale score 1-3), whereas death at 6 months after craniotomy was detected in 40.9% and 21.7%. respectively, of patients with POH who underwent craniotomy. CONCLUSIONS: POH after neurosurgery was rare in this series but was associated with poor outcome. Identification of risk factors of bleeding, and avoiding them, if possible, might decrease the incidence of POH.
