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• W4213348580 abstract "Ultrasound-enhancing agents (UEAs) are an indispensable component of state-of-the-art echocardiography. They also have an excellent safety profile, with serious adverse events (SAEs) occurring in approximately one in 10,000 administrations,1Wei K. Mulvagh S.L. Carson L. Davidoff R. Gabriel R. Grimm R.A. et al.The safety of Definity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses.J Am Soc Echocardiogr. 2008; 21: 1202-1206Google Scholar the most common of which are hypersensitivity reactions. Based on experience with nanotherapeutics composed of liposomes or lipid emulsions, serious hypersensitivity and other nonserious adverse events (AEs) from lipid-stabilized UEAs have been attributed to complement activation-related pseudoanaphylaxis (CARPA).2Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity.Toxicology. 2005; 216: 106-121Google Scholar Ordinarily, blood complement proteins of the immune system interact with microbubble shells and mediate the usually uneventful clearance of UEAs from the circulation.3Lindner J.R. Coggins M.P. Kaul S. Klibanov A.L. Brandenburger G.H. Ley K. Microbubble persistence in the microcirculation during ischemia/reperfusion and inflammation is caused by integrin- and complement-mediated adherence to activated leukocytes.Circulation. 2000; 101: 668-675Google Scholar,4Fisher N.G. Christiansen J.P. Klibanov A. Taylor R.P. Kaul S. Lindner J.R. Influence of microbubble surface charge on capillary transit and myocardial contrast enhancement.J Am Coll Cardiol. 2002; 40: 811-819Google Scholar CARPA or nonanaphylactic pain responses occur from an exaggerated complement anaphylatoxin response. In early 2021, the MedWatch arm of the United States Food and Drug Administration issued a report on a small number of presumed type I hypersensitivity reactions to UEAs in patients with known allergy to polyethyleneglycol (PEG), thereby suggesting a second mechanism involving adaptive immunity. For some lipid-stabilized UEAs, PEG is a component of the excipient alone (Lumason or Sonovue, Bracco Diagnostics) or is incorporated in the microbubble shell (Definity, Lantheus Medical Imaging). Polyethyleneglycol is also component of many drugs, laxatives, and cosmetics. It is also in the cationic lipid excipient used to stabilize and augment transduction of mRNA COVID-19 vaccines (Pfizer-BioNTech, Moderna). Recent expert consensus statements have outlined new safety recommendations for PEG-containing UEAs and highlighted that the MedWatch report did not change information on the incidence of SAEs.5Lindner J.R. Belcik T. Main M.L. Montanaro A. Mulvagh S.L. Olson J. et al.Expert consensus statement from the American Society of Echocardiography on hypersensitivity reactions to ultrasound enhancing agents in patients with allergy to polyethylene glycol.J Am Soc Echocardiogr. 2021; 34: 707-708Google Scholar Yet anecdotal reports have raised concern that hypersensitivity reactions to UEAs may have increased after the introduction of COVID-19 vaccines.6Soni M. McGovern M. Jacob R. Weiss R. Adusumalli S. Litwin S. et al.Ultrasound enhancing agents and associated adverse reactions: a potential connection to the COVID-19 vaccines?.J Am Soc Echocardiogr. 2022; 35: 241-242Google Scholar While it is possible that exposure to PEGylated lipid vaccines could increase type I hypersensitivity to UEAs or CARPA,7Krantz M.S. Liu Y. Phillips E.J. Stone Jr., C.A. Anaphylaxis to PEGylated liposomal echocardiogram contrast in a patient with IgE-mediated macrogol allergy.J Allergy Clin Immunol Pract. 2020; 8: 1416-1419.e3Google Scholar scientific evidence is lacking and was the aim of this study. According to power calculations, a prospective study powered at 0.90 to detect a five-fold increase in SAEs to UEAs (α = 0.05) based on vaccination status would require a study size of 80,000 subjects. Because of the urgency of the question, we instead examined cross-reactivity through a retrospective survey to assess for mRNA vaccine hypersensitivity in patients exposed to PEG-containing lipid-stabilized UEA within the previous 7 years who either did or did not have a documented reaction to UEAs. A programmed search script of the electronic health record using Cogito Slicer-Dicer (EPIC, Madison, WI) identified subjects with documented AE to Definity or Lumason. Age- and sex-matched control subjects who received UEAs without reaction were identified and recruited in an approximately 2:1 ratio to those with reactions. A scripted phone interview was conducted, and only those with completed COVID-19 vaccination were included. Adverse events were characterized according to symptoms, severity, and need for therapy with SAEs defined using Food and Drug Administration criteria. Vaccine-related AEs qualified only if they occurred within 6 hours. The search identified 204 subjects with documented AE related to lipid-based UEAs, of whom 62 were alive, could be reached, had completed COVID-19 vaccination, and agreed to participate. Clinical and demographic information is shown in Table 1. The most common AEs to UEAs were nociceptive, followed by dermatologic, dyspnea/throat tightness/lip or tongue swelling, and chest pain/tachycardia. Only six (10%) reactions were classified as SAEs. Vaccine-related AEs occurred in 15 (24%) subjects with a history of UEA reactions and in five (4%) of the control subjects (n = 120; χ2, P = .0001, odds ratio = 6.1 [95% CI, 2.4-16.3]). In the former group, vaccine-related reactions were reported in 21%, 17%, and 60% for subjects receiving the Pfizer-BioNTech (n = 33), Moderna (n = 23), or Johnston and Johnston (n = 5) vaccine, respectively. The most common vaccine-related AEs were dyspnea without lip or tongue edema, rash, and chest pain/tachycardia. Flank pain occurred in only one subject. All vaccine-related reactions were nonserious, self-limited, and did not require therapy. In subjects with AEs to both UEAs and vaccines, reaction manifestations to the two were similar in seven subjects, with only rash being perfectly matched when encountered (n = 3). In those subjects with UEA and vaccine reactions, 13 had received Definity and two had received Lumason, which is similar to the proportion receiving each agent in general. The median interval between UEA reaction and first vaccination dose was 245 weeks (95% CI, 173-284) and was not related to likelihood for vaccine reaction (Spearman rho = .62).Table 1Demographics, clinical characteristics, and AE data+AEs to lipid UEA (n = 62)Control subjects (n = 120)Age, years65 ± 1465 ± 12Gender, male/female32/3068/52Cancer history8 (13)11 (9)Chronic kidney disease2 (3)8 (7)Chronic liver disease6 (10)4 (3)Rheumatologic disease2 (3)5 (4)Autoimmune disease0 (0)3 (3)Chronic steroid use5 (8)14 (12)Biologic immunosuppressive use0 (0)2 (2)No. of drug or substance allergies, median (95% CI)2 (1, 2)2 (1, 2)Echocardiography type: Resting transthoracic34 (55)80 (67) Stress echocardiography26 (42)36 (30) Research (MCE perfusion)2 (3)4 (3)UEA: Definity58 (94)95 (79) Lumason4 (6)20 (17) Both0 (0)5 (4)Vaccine: Pfizer-BioNTech33 (53)61 (51) Moderna23 (37)49 (41) Johnston and Johnston5 (8)9 (8) Astra Zeneca0 (0)1 (1) Unknown1 (2)0 (0)AEs with UEAs: Total62 (100)— SAE23 (37)— Rash11 (18)— Nociceptive (nonchest pain)43 (69)— Dyspnea/throat tightness/lip or tongue edema10 (16)— Chest pain/tachycardia7 (11)— Fever/dizziness/other3 (5)—AEs with vaccine: Total15 (24)6 (5)∗P < .05 by vs + AE cohort. Serious AE0 (0)0 (0) Rash3 (5)0 (0) Nociceptive (nonchest pain)2 (3)4 (3) Dyspnea/throat tightness/lip or tongue edema9 (16)0 (0)∗P < .05 by vs + AE cohort. Chest pain/tachycardia3 (5)1 (1) Fever/dizziness/other1 (2)3 (3)MCE, myocardial contrast echocardiography.Data are reported as n (%) unless otherwise indicated.∗ P < .05 by vs + AE cohort. Open table in a new tab MCE, myocardial contrast echocardiography. Data are reported as n (%) unless otherwise indicated. The aim of this study was to examine whether a link exists between hypersensitivity reactions to lipid-based UEAs that contain PEG and COVID-19 vaccines, in particular the mRNA class of vaccines that have compositional similarity to lipid-stabilized UEAs. The mRNA in these vaccines is complexed with PEGylated cationic lipids, which reduce endonuclease digestion, promote cellular uptake by antigen-presenting cells, and increase translation. The UEAs and the vaccines studied differ in their specific amphipathic lipid moieties, net charge, molar amount of PEG, and whether PEG is incorporated into the lipid membrane. Yet all of them have the potential to stimulate complement activation and CARPA through “non-self” recognition and to sensitize for type I hypersensitivity to PEG through adaptive immunity.2Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity.Toxicology. 2005; 216: 106-121Google Scholar,7Krantz M.S. Liu Y. Phillips E.J. Stone Jr., C.A. Anaphylaxis to PEGylated liposomal echocardiogram contrast in a patient with IgE-mediated macrogol allergy.J Allergy Clin Immunol Pract. 2020; 8: 1416-1419.e3Google Scholar This study surveyed for AEs that occurred early after COVID-19 vaccination in subjects who previously received lipid-stabilized UEAs. A greater proportion of vaccine-related AEs were experienced in subjects who also had AEs to UEAs, indicating a modest pattern of cross-reactivity. An important caveat is that we have not investigated the opposite order of exposure, namely, whether those with unexpected AEs to COVID-19 vaccine reactions are more susceptible to UEA reactions. One limitation of our analysis is the inability to confidently differentiate CARPA from type I hypersensitivity reactions. We have also not established a mechanism of sensitization. The finding that vaccine reactions were most common in the few subjects receiving the Johnson and Johnson vaccine, which contains neither lipids nor PEG, implies that mechanisms apart from adaptive immunity can occur. As anticipated, most of the AEs with UEA administration were classified as nonsevere and were nociceptive. For vaccination-related AEs, all were classified as nonsevere. Accordingly, our data do not support the idea that patients with reactions to either lipid-stabilized UEAs or mRNA vaccines should be disqualified from receiving them. Instead, our findings simply raise awareness that cross-reactivity is possible. While our data indicate that most cross-reactions that occur are expected to be nonsevere, closer monitoring after vaccine or UEA administration is probably warranted in those who have had a prior AE to one or the other. Larger trials will be needed to study SAEs that are infrequent for both classes of agents and to test whether mRNA vaccine exposure increases the likelihood of UEA reactions." @default.
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• W4213348580 title "Hypersensitivity Cross-Reactivity for Ultrasound-Enhancing Agents and COVID-19 Vaccines" @default.
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