![]() ![]() We categorized AAEs according to the ACR Manual on Contrast Media, version 10.3 ( 17). The use of GBCA was descriptively assessed as the frequency of contrast-enhanced cardiac MRI after the EMA’s decision in July 2017 to suspend approval of linear GBCAs for cardiac imaging ( 15). The study reported herein adds data from 3 years, with an additional 81 940 patients. Patients were excluded if they were reported to have “back pain” or “other/unspecified” AAEs, as these were not classifiable according to the American College of Radiology (ACR).Ī total of 72 839 included patients were reported in an earlier study that focused on AAE patterns across different GBCA subtypes and pharmacologic stressors ( 4). Patient inclusion was irrespective of patient demographics, cardiac MRI protocol, and imaging indication. Patients were included if data were submitted to the MR/CT Registry at one of the participating centers. The MR/CT Registry of the ESCR was queried for cardiac MRI studies submitted between January 2013 and October 2019. The ESCR MR/CT Registry received unrestricted educational funding from Siemens Healthcare (Erlangen, Germany), Bayer HealthCare (Leverkusen, Germany), Philips Healthcare (Franklin, Tenn), and Bracco Imaging (Milan, Italy). Integrated plausibility checks provided immediate feedback to submitting physicians and ensured data consistency. The ESCR MR/CT Registry uses a standardized online questionnaire to acquire mandatory information on patient characteristics, indication, diagnosis, imaging technique, contrast media application, and occurrence of AAEs (reported as the most severe event for each patient) from the submitting physician. All participating centers underwent initial audit by the ESCR office in Vienna, Austria, to ensure data quality. In some countries, submission of cases to the MR/CT Registry is part of the national certification and accreditation process in cardiovascular radiology. Participation of individual centers in the registry is voluntary and is not restricted to ESCR members. The data source for this analysis was the European Society of Cardiovascular Radiology (ESCR) MR/CT Registry, a multinational multicenter database on cardiac CT and MRI. Patient consent was waived by the institutional review board owing to analyses of anonymized multicenter data. This retrospective study was approved by the institutional review board (Leipzig University, No 131/17-ek) and was conducted according to the Declaration of Helsinki. This study assesses the contemporary effect of the EMA regulatory decision on use of GBCAs in cardiac MRI and the associated safety profile of GBCAs with regard to AAEs using a multinational registry. To our knowledge, there are currently no data on the effects of these regulatory changes on case numbers or on the cardiac MRI safety profile. As a preventive measure, in late 2017, the European Medicines Agency (EMA) suspended the marketing authorization of linear GBCA types (except for hepatic imaging), and this suspension was ratified by the European Commission ( 15). There have been growing concerns about cerebral gadolinium depositions after repeated GBCA administration, with some studies suggesting that the molecular GBCA structure affected these depositions, with higher likelihood for deposit with linear compounds compared with macrocyclic GBCAs ( 13, 14). Based on the type of ligand, GBCAs can be generally classified as linear or macrocyclic ( 12). GBCAs can be considered safe for the referred population in general and the cardiac MRI population in particular, with reported acute adverse event (AAE) rates between 0.04% and 2.2% ( 4– 11).īecause of the toxicity of free gadolinium 3+ ions, ligands are used to create gadolinium chelates for safe use of GBCAs in humans. According to international registries, intravenous gadolinium-based contrast agents (GBCAs) are used in most cardiac MRI examinations for indications ranging from myocarditis and cardiomyopathy imaging to myocardial viability assessment ( 2, 3). Cardiac MRI is a well-established cardiac imaging modality and is considered the reference standard for several diseases ( 1). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |