ObjectivesTo investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.MethodsGARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.ResultsMedian gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications.ConclusionsThe GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population.Key points• Gadobutrol at recommended dose shows low rates of adverse drug reactions
• Gadobutrol demonstrates a uniform safety profile across diverse patient groups
• Gadobutrol provides excellent contrast quality in routine practice
ObjectiveTo assess the suitability of deep medullary vein visibility in susceptibility weighted imaging—magnetic resonance imaging studies as a method for the diagnosis and evaluation of cerebral small vessel disease progression.MethodsA total of 92 patients with CSVD were enrolled and baseline clinical and imaging data were reviewed retrospectively. Neuroimaging biomarkers of CSVD including high-grade white matter hyperintensity (HWMH), cerebral microbleed (CMB), enlarged perivascular space (PVS), and lacunar infarct (LI) were identified and CSVD burden was calculated. Cases were grouped accordingly as mild, moderate, or severe. The DMV was divided into six segments according to the regional anatomy. The total DMV score (0–18) was calculated as the sum of the six individual segmental scores, which ranged from 0 to 3, for a semi-quantitative assessment of the DMV based on segmental continuity and visibility.ResultsThe DMV score was independently associated with the presence of HWMH, PVS, and LI (P < 0.05), but not with presence and absence of CMB (P > 0.05). Correlation between the DMV score and the CSVD burden was significant (P < 0.05) [OR 95% C.I., 1.227 (1.096–1.388)].ConclusionThe DMV score was associated with the presence and severity of CSVD.
Objective: To explore the relationships of asymmetric deep medullary veins (ADMV) to asymmetric cortical veins (ACV), leptomeningeal collaterals and prognosis in patients with occlusion of a large cerebral artery.Methods: Clinical and imaging data of 56 patients with occlusion of a large cerebral artery were collected and reviewed. We assessed the time delayed between stroke onset and MR imaging (within 24 h of stroke onset), extension of cerebral infarction using the Alberta stroke program early CT score based on diffusion-weighted imaging (ASPECTs). ADMV and ACV were assessed using susceptibility-weighted imaging. The presence of ADMV (ACV) was defined as deep medullary veins (cortical veins) of the affected hemisphere that were greater in number and diameter than in the contralateral hemisphere. To evaluate leptomeningeal collaterals, the hyperintense vessel sign (HVS) was detected using T2 weighted fluid attenuated inversion recovery images. At 90 days, a modified Rankin scale score (mRS) was assessed to evaluate the clinical outcome.Results: Of 56 patients, 27 presented with ADMV. Those patients who presented with and without ADMV differed significantly in HVS and ACV (P < 0.05) but not in time delayed between stroke onset and MR imaging, age, gender, stroke risk factors, baseline NIHSS score, or modified Rankin scale score at 3 months (P > 0.05). Logistic regression analysis found that the presence of ADMV was independently related to HVS and ACV (ACV: OR 95% C.I., 1.287–4.368; HVS: OR 95% C.I., 1.132–4.887).Conclusions: The presence of ADMV on SWI was associated with prominent ACV and good leptomeningeal collateral flow but was not related to prognosis in patients with occlusion of a large cerebral artery.
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