PubMed · 8402245
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M McGregor, B Dickens, D Roy. 1993. Informed consent.. https://pubmed.ncbi.nlm.nih.gov/8402245/
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OBJECTIVES: This systematic review and meta-analysis are aimed at evaluating the incidence of adverse drug reactions (ADRs) following administration of clinically approved ultrasound contrast agents (UCAs) in adults and children, to assess risks in patients with cardiovascular disease and in pregnancy, and to evaluate the effectiveness of emergency management of severe ADRs. MATERIALS AND METHODS: A PRISMA 2020 systematic review was conducted searching PubMed, Scopus, and Embase. Two reviewers independently screened, extracted data, and assessed quality. Incidence estimates were pooled when feasible, stratified by age group, contrast agent, and administration route. RESULTS: Seventy-four studies encompassing > 1 million adults and > 36,000 children were included, contributing multiple analytic cohorts to the quantitative synthesis. Severe acute ADRs were extremely rare (6 and 16 cases per 100,000 in adults and children, respectively) and absent following endocavitary administration in children. Non-severe acute ADRs occurred in 11 and 8 cases per 10,000 adults and children, respectively. Delayed reactions were very rare (< 1 case per million in adults). No significant safety differences emerged between UCA products. The incidence of ADRs in patients with cardiovascular disease was analogous to the general population. No ADRs were reported in pregnant women. Standard emergency management was effective in almost all serious cases, though rare fatalities occurred. CONCLUSION: UCAs show an excellent safety profile in adults and children, with very rare severe ADRs and few non-severe, typically self-limiting reactions. Strict adherence to recommended emergency management protocols mitigates the remaining risks, supporting safe use across a broad range of clinical indications. PROSPERO REGISTRATION: CRD42023432668. KEY POINTS: Question What is the incidence, type, and severity of acute and delayed ADRs associated with clinically approved UCAs across different patient populations? Findings Severe acute adverse reactions are very rare, and non-severe reactions are rare and self-limiting, with no significant safety differences between adults, children, or patients with cardiovascular disease. Clinical relevant UCAs show an excellent safety profile across populations. These findings support their safe clinical use as reliable alternatives to iodine-based and gadolinium-based contrast agents in routine diagnostic imaging.
BACKGROUND: Contrast echocardiography may be used to assess myocardial perfusion. However, gray scale assessment of myocardial contrast echocardiography (MCE) is difficult because of variations in regional backscatter intensity, difficulties in distinguishing varying shades of gray, and artifacts or attenuation. We sought to determine whether the assessment of rest myocardial perfusion by MCE could be improved with subtraction and color coding. METHODS AND RESULTS: MCE was performed in 31 patients with previous myocardial infarction with a 2nd generation agent (NC100100, Nycomed AS), using harmonic triggered or continuous imaging and gain settings were kept constant throughout the study. Digitized images were post processed by subtraction of baseline from contrast data and colorized to reflect the intensity of myocardial contrast. Gray scale MCE alone, MCE images combined with baseline and subtracted colorized images were scored independently using a 16 segment model. The presence and severity of myocardial contrast abnormalities were compared with perfusion defined by rest MIBI-SPECT. Segments that were not visualized by continuous (17%) or triggered imaging (14%) after color processing were excluded from further analysis. The specificity of gray scale MCE alone (56%) or MCE combined with baseline 2D (47%) was significantly enhanced by subtraction and color coding (76%, p<0.001) of triggered images. The accuracy of the gray scale approaches (respectively 52% and 47%) was increased to 70% (p<0.001). Similarly, for continuous images, the specificity of gray scale MCE with and without baseline comparison was 23% and 42% respectively, compared with 60% after post processing (p<0.001). The accuracy of colorized images (59%) was also significantly greater than gray scale MCE (43% and 29%, p<0.001). The sensitivity of MCE for both acquisitions was not altered by subtraction. CONCLUSION: Post-processing with subtraction and color coding significantly improves the accuracy and specificity of MCE for detection of perfusion defects.
This study shows an increase in von Willebrand factor antigen in blood collected from the coronary sinus shortly after coronary angiography with an ionic contrast agent (diatrizoate), but not a nonionic contrast agent (iohexol). These findings suggest that ionic contrast agents may cause more endothelial injury than nonionic contrast agents.