دورية أكاديمية

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice.

التفاصيل البيبلوغرافية
العنوان: Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice.
المؤلفون: Ali MT; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Johnson M; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Irwin T; University of South Dakota, Yankton Medical Clinic, Yankton, South Dakota., Henry S; Department of Cardiology, Northwell Health, Manhasset, New York., Sugeng L; Department of Cardiology, Northwell Health, Manhasset, New York., Kansal S; WellStar Center for Cardiovascular Medicine, WellStar Health System, Atlanta, Georgia., Allison TG; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Department of Pediatric and Adolescent Medicine, Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota., Bremer ML; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Jones VR; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Martineau MD; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Wong C; Department of Cardiology, Northwell Health, Manhasset, New York., Marecki G; Department of Cardiology, Northwell Health, Manhasset, New York., Stebbins J; WellStar Center for Cardiovascular Medicine, WellStar Health System, Atlanta, Georgia., Michelena HI; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., McCully RB; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Svatikova A; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Padang R; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Scott CG; Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota., Kanuga MJ; Division of Allergic Diseases, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota., Arsanjani R; Division of Cardiac Imaging and Stress Testing, Department of Cardiovascular Medicine, Mayo Clinic, Phoenix, Arizona., Pellikka PA; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Kane GC; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota., Thaden JJ; Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: thaden.jeremy@mayo.edu.
المصدر: Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography [J Am Soc Echocardiogr] 2024 Mar; Vol. 37 (3), pp. 276-284.e3. Date of Electronic Publication: 2023 Oct 24.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Mosby-Year Book Country of Publication: United States NLM ID: 8801388 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6795 (Electronic) Linking ISSN: 08947317 NLM ISO Abbreviation: J Am Soc Echocardiogr Subsets: MEDLINE
أسماء مطبوعة: Publication: St. Louis Mo : Mosby-Year Book
Original Publication: St. Louis, Mo. : C.V. Mosby Co., [c1988-
مواضيع طبية MeSH: COVID-19 Vaccines* , Drug-Related Side Effects and Adverse Reactions*/diagnosis , Drug-Related Side Effects and Adverse Reactions*/epidemiology , Fluorocarbons*, Humans ; Retrospective Studies ; Prospective Studies ; Incidence ; Echocardiography ; Headache ; Back Pain
مستخلص: Objectives: Prior data indicate a very rare risk of serious adverse drug reaction (ADR) to ultrasound enhancement agents (UEAs). We sought to evaluate the frequency of ADR to UEA administration in contemporary practice.
Methods: We retrospectively reviewed 4 US health systems to characterize the frequency and severity of ADR to UEA. Adverse drug reactions were considered severe when cardiopulmonary involvement was present and critical when there was loss of consciousness, loss of pulse, or ST-segment elevation. Rates of isolated back pain and headache were derived from the Mayo Clinic Rochester stress echocardiography database where systematic prospective reporting of ADR was performed.
Results: Among 26,539 Definity and 11,579 Lumason administrations in the Mayo Clinic Rochester stress echocardiography database, isolated back pain or headache was more frequent with Definity (0.49% vs 0.04%, P < .0001) but less common with Definity infusion versus bolus (0.08% vs 0.53%, P = .007). Among all sites there were 201,834 Definity and 84,943 Lumason administrations. Severe and critical ADR were more frequent with Lumason than with Definity (0.0848% vs 0.0114% and 0.0330% vs 0.0010%, respectively; P < .001 for each). Among the 3 health systems with >2,000 Lumason administrations, the frequency of severe ADR with Lumason ranged from 0.0755% to 0.1093% and the frequency of critical ADR ranged from 0.0293% to 0.0525%. Severe ADR rates with Definity were stable over time but increased in more recent years with Lumason (P = .02). Patients with an ADR to Lumason since the beginning of 2021 were more likely to have received a COVID-19 vaccination compared with matched controls (88% vs 75%; P = .05) and more likely to have received Moderna than Pfizer-Biotech (71% vs 26%, P < .001).
Conclusion: Severe and critical ADR, while rare, were more frequent with Lumason, and the frequency has increased in more recent years. Additional work is needed to better understand factors, including associations with recently developed mRNA vaccines, which may be contributing to the increased rates of ADR to UEA since 2021.
Competing Interests: Conflicts of Interest None.
(Copyright © 2023 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Keywords: Adverse drug reaction; Echocardiography; Imaging; Ultrasound enhancement agent
المشرفين على المادة: CK0N3WH0SR (perflutren)
0 (COVID-19 Vaccines)
0 (Fluorocarbons)
تواريخ الأحداث: Date Created: 20231025 Date Completed: 20240305 Latest Revision: 20240305
رمز التحديث: 20240305
DOI: 10.1016/j.echo.2023.10.010
PMID: 37879379
قاعدة البيانات: MEDLINE
الوصف
تدمد:1097-6795
DOI:10.1016/j.echo.2023.10.010