PMID- 36205769 OWN - NLM STAT- MEDLINE DCOM- 20230202 LR - 20230202 IS - 1432-1084 (Electronic) IS - 0938-7994 (Linking) VI - 33 IP - 2 DP - 2023 Feb TI - Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. PG - 988-995 LID - 10.1007/s00330-022-09108-4 [doi] AB - OBJECTIVES: We aimed to evaluate the safety of the ultrasound contrast agent sulfur hexafluoride microbubbles in a large group of patients referred for routine contrast-enhanced ultrasound (CEUS). METHODS: A retrospective assessment was made of all patients that received sulfur hexafluoride microbubbles intravenously for CEUS at 24 centers between January 2006 and April 2019. Patient demographic details, examination type, and the dose of sulfur hexafluoride microbubbles administered were recorded with specific adverse events (AEs) documentation tools at each center. All AEs were recorded as serious or non-serious. Non-serious AEs were classified by intensity as mild, moderate, or severe according to ACR criteria. The frequencies of AEs across patient subgroups were compared using the chi-square test. RESULTS: A total of 463,434 examinations were evaluated. Overall, 157 AEs (153 [0.033%] non-serious; 4 [0.001%] serious) were reported after sulfur hexafluoride microbubbles administration, giving an AE frequency of 0.034% (157/463,434). Among the non-serious AEs, 66 (0.014%) were mild, 70 (0.015%) moderate, and 17 (0.004%) severe in intensity. The liver was the most common examination site, presenting an AE frequency of 0.026%. The highest AE frequency (0.092%) was for patients undergoing CEUS for vascular disease. There were no significant gender differences in either the total number or the severity of non-serious AEs (chi-square = 2.497, p = 0.287). The onset of AEs occurred within 30 min of sulfur hexafluoride microbubbles administration in 91% of cases. CONCLUSION: The frequency of AEs to sulfur hexafluoride microbubbles is very low and severe reactions are rare, confirming that sulfur hexafluoride microbubbles are appropriate for routine CEUS applications. KEY POINT: * The frequency of AEs to sulfur hexafluoride microbubbles is very low and severe reactions are rare. CI - (c) 2022. The Author(s), under exclusive licence to European Society of Radiology. FAU - Shang, Yongning AU - Shang Y AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China. FAU - Xie, Xiaoyan AU - Xie X AD - Department of Medical Ultrasonics, Division of Interventional Ultrasound, Institute for the Study of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. FAU - Luo, Yan AU - Luo Y AD - Department of Medical Ultrasound, West China Hospital of Sichuan University, Chengdu, China. FAU - Nie, Fang AU - Nie F AD - Department of Medical Ultrasonics, Lanzhou University Second Hospital, Lanzhou, China. FAU - Luo, Yukun AU - Luo Y AD - Department of Ultrasound, Chinese PLA General Hospital, Beijing, China. FAU - Jing, Xiang AU - Jing X AD - Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China. FAU - Liao, Jintang AU - Liao J AD - Department of Medical Ultrasonics, Xiang Ya Hospital, Central South University, Changsha, China. FAU - Zheng, Rongqin AU - Zheng R AD - Department of Ultrasound, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. FAU - Wu, Rong AU - Wu R AD - Department of Ultrasound in Medical, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Luo, Xiaomao AU - Luo X AD - Department of Medical Ultrasound, Yunnan Cancer Hospital, Kunming, China. FAU - Chen, Zhiyi AU - Chen Z AD - Department of Ultrasound Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. FAU - Xu, Youfeng AU - Xu Y AD - Department of Ultrasound, Ningbo First Hospital, Ningbo, China. FAU - Zhang, Ruifang AU - Zhang R AD - Department of Medical Ultrasonics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wang, Hui AU - Wang H AD - Department of Ultrasound, China-Japan Union Hospital, Jilin University, Changchun, China. FAU - Yuan, Jianjun AU - Yuan J AD - Department of Ultrasonography, The People's Hospital of Zhengzhou University, Zhengzhou, China. FAU - Zhang, Hongxia AU - Zhang H AD - Department of Ultrasound, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. FAU - Zhu, Jiaan AU - Zhu J AD - Department of Ultrasound, Peking University People's Hospital, Beijing, China. FAU - Zhang, Wei AU - Zhang W AD - Department of Ultrasound, The Third Affiliated Hospital of Guangxi Medical University, Nanjing, China. FAU - Ruan, Litao AU - Ruan L AD - Department of Ultrasound Medicine, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, China. FAU - Yang, Min AU - Yang M AD - Department of Ultrasound, Beijing Shijitan Hospital, Capital Medical University, Beijing, China. FAU - Li, Zhiyan AU - Li Z AD - Department of Ultrasound, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Luo, Hong AU - Luo H AD - Department of Ultrasound, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. FAU - Chen, Qin AU - Chen Q AD - Department of Ultrasonic Medicine, West China Second University Hospital, Sichuan University, Chengdu, China. FAU - Yan, Jiping AU - Yan J AD - Department of Ultrasound, People's Hospital of Shanxi Province, Taiyuan, China. FAU - Tang, Chunlin AU - Tang C AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China. FAU - Liu, Deng AU - Liu D AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China. FAU - Fang, Kejing AU - Fang K AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China. FAU - Guo, Yanli AU - Guo Y AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China. guoyanli71@aliyun.com. AD - Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Gaotanyan street No.30, Shapingba Distract, Chongqing, China. guoyanli71@aliyun.com. FAU - He, Wen AU - He W AD - Department of Ultrasound, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. ttyyus@sina.com. AD - Department of Ultrasound, Beijing Tiantan Hospital, Capital Medical University, Tiantan Xili No.6, Dongcheng District, Beijing, China. ttyyus@sina.com. LA - eng GR - No. 2015DFA30920/International Science and Technology Cooperation Programme/ GR - No. 81771856/National Natural Science Foundation of China/ GR - No. SWH2016ZDCX4101/the Major Field Technical Innovation Program Project of the Affiliated Hospital of Army Medical University/ PT - Journal Article DEP - 20221007 PL - Germany TA - Eur Radiol JT - European radiology JID - 9114774 RN - WS7LR3I1D6 (Sulfur Hexafluoride) RN - 0 (Contrast Media) RN - 0 (Phospholipids) SB - IM MH - Humans MH - *Sulfur Hexafluoride/adverse effects MH - *Microbubbles MH - Retrospective Studies MH - Contrast Media/adverse effects MH - Ultrasonography MH - Administration, Intravenous MH - Phospholipids OTO - NOTNLM OT - Contrast-enhanced sonography OT - Safety, adverse reactions OT - Sulfur hexafluoride microbubbles OT - Ultrasound-enhancing agent EDAT- 2022/10/08 06:00 MHDA- 2023/02/03 06:00 CRDT- 2022/10/07 11:07 PHST- 2022/04/14 00:00 [received] PHST- 2022/08/04 00:00 [accepted] PHST- 2022/07/03 00:00 [revised] PHST- 2022/10/08 06:00 [pubmed] PHST- 2023/02/03 06:00 [medline] PHST- 2022/10/07 11:07 [entrez] AID - 10.1007/s00330-022-09108-4 [pii] AID - 10.1007/s00330-022-09108-4 [doi] PST - ppublish SO - Eur Radiol. 2023 Feb;33(2):988-995. doi: 10.1007/s00330-022-09108-4. Epub 2022 Oct 7.