Uhlig Johannes, Al-Bourini Omar, Salgado Rodrigo, Francone Marco, Vliegenthart Rozemarijn, Bremerich Jens, Lotz Joachim, Gutberlet Matthias
Department of Diagnostic and Interventional Radiology, University Medical Center Goettingen, Robert-Koch-Strasse 40, 37075 Goettingen, Germany (J.U., O.A.B., J.L.); Section of Interventional Radiology, Yale School of Medicine, New Haven, Conn (J.U.); Department of Radiology, Antwerp University Hospital, Antwerp, Belgium (R.S.); Department of Radiology, Holy Heart Hospital, Lier, Belgium (R.S.); Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, Rome, Italy (M.F.); Department of Radiology, Center for Medical Imaging, University Medical Center Groningen, Groningen, the Netherlands (R.V.); Radiology Department, University Hospital Basel, Basel, Switzerland (J.B.); German Cardiovascular Research Center (DZHK), Partner site Goettingen, Germany (J.L.); and Department of Diagnostic and Interventional Radiology, University of Leipzig-Heart Centre, Leipzig, Germany (M.G.).
Radiol Cardiothorac Imaging. 2020 Oct 29;2(5):e200102. doi: 10.1148/ryct.2020200102. eCollection 2020 Oct.
To assess current use and acute safety profiles of gadolinium-based contrast agents (GBCAs) in cardiac MRI given recent suspensions of GBCA approval.
Patients were retrospectively included from the multinational multicenter European Society of Cardiovascular Radiology (ESCR) MR/CT Registry collected between January 2013 and October 2019. GBCA-associated acute adverse events (AAEs) were classified as mild (self-limiting), moderate (pronounced AAE requiring medical management), and severe (life threatening). Multivariable generalized linear mixed-effect models were used to assess AAE likelihood.
A total of 154 779 patients (average age, 53 years ± 19 [standard deviation]; 99 106 men) who underwent cardiac MRI were included, the majority of whom underwent administration of GBCAs (94.2% [ = 145 855]). While linear GBCAs were used in 15.2% of examinations through 2011, their use decreased to less than 1% in 2018 and 2019. Overall, 0.36% ( = 556) of AAEs were documented (mild, 0.12% [ = 178]; moderate, 0.21% [ = 331]; severe, 0.03% [ = 47]). For nonenhanced cardiac MRI, examination-related events were reported in 2.59% (231 of 8924) of cases, the majority of which were anxiety (0.98% [ = 87]) and dyspnea (0.93% [ = 83]). AAE rates varied significantly by pharmacologic stressor, GBCA molecular structure (macrocyclic vs linear GBCA: multivariable odds ratio, 0.634; 95% confidence interval: 0.452, 0.888; = .008), GBCA subtype, and imaging indication.
Gadolinium-based contrast agent administration changed according to recent regulatory decisions, with use of macrocyclic agents almost exclusively in 2018 and 2019; these agents also demonstrated a favorable acute safety profile.© RSNA, 2020.
鉴于钆对比剂（GBCA）近期获批情况的暂停，评估其在心脏磁共振成像（MRI）中的当前使用情况和急性安全性。
回顾性纳入2013年1月至2019年10月期间收集的多国多中心欧洲心血管放射学会（ESCR）MR/CT登记处的患者。GBCA相关的急性不良事件（AAE）分为轻度（自限性）、中度（需要医疗处理的明显AAE）和重度（危及生命）。采用多变量广义线性混合效应模型评估AAE发生的可能性。
共纳入154779例接受心脏MRI检查的患者（平均年龄53岁±19[标准差]；男性99106例），其中大多数接受了GBCA注射（94.2%[=145855]）。2011年之前，线性GBCA在15.2%的检查中使用，到2018年和2019年其使用比例降至不到1%。总体而言，记录到0.36%（=556）的AAE（轻度，0.12%[=178]；中度，0.21%[=331]；重度，0.03%[=47]）。对于非增强心脏MRI，在2.59%（8924例中的231例）的病例中报告了与检查相关的事件，其中大多数是焦虑（0.98%[=87]）和呼吸困难（0.93%[=83]）。AAE发生率因药物应激源、GBCA分子结构（大环GBCA与线性GBCA：多变量优势比，0.634；95%置信区间：0.452，0.888；=0.008）、GBCA亚型和成像指征而有显著差异。
根据近期的监管决定，钆对比剂的使用发生了变化，2018年和2019年几乎仅使用大环对比剂；这些对比剂也显示出良好的急性安全性。©RSNA，2020。
