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Observational Study
. 2021 Dec;117(6):1170-1178.
doi: 10.36660/abc.20200475.

Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram

[Article in English, Portuguese]
Rogerio Gomes Furtado  1   2 , Daniela do Carmo Rassi  1   2 , Luciano Henrique Melato  1 , Ana Caroline Reinaldo de Oliveira  1   2 , Paula Meneses Nunes  1 , Priscila Elias Baccelli  1 , Sara Camila de Oliveira Santos  1 , Victor Emanuel Santos  3 , Luiz Rassi Junior  1 , Colandy Godoy Nunes  1
Affiliations
Observational Study

Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram

[Article in English, Portuguese]
Rogerio Gomes Furtado et al. Arq Bras Cardiol. 2021 Dec.

Abstract
in English, Portuguese

Background: In 2007, the United States Food and Drug Administration mandated safety reviews of commercially available echocardiographic contrast agents (ECA), following reports of death. During the past years, different studies have proven the safety of ECA, but there have been few studies on SonoVue®.

Objectives: To evaluate the safety of SonoVue® during pharmacological stress echocardiography (PSE), by analyzing the incidence of allergic reactions and comparing groups regarding the appearance of arrhythmia, minor side effects and adverse events.

Methods: In this observational, prospective study, 2346 patients underwent PSE, and they were divided into the following 2 groups: group 1 with ECA (n = 1099) and group 2 without ECA (n = 1247). Patients were evaluated during PSE, at 24 hours, and at 30 days. Statistical significance was defined as p < 0.05.

Results: Group 1 had fewer minor side effects, such as headache (5/0.5% versus 19/1.5%, p = 0.012) and less reactive hypertension (3/0.3% versus 19/1.5%, p = 0.002); fewer arrhythmias, such as ventricular extrasystoles (180/16.4% versus 247/19.8%, p = 0.032) and paroxysmal supraventricular tachycardia (2/0.2% versus 15/1.2%, p = 0.003); and no adverse events, such as acute myocardial infarction (AMI) or death. In group 2, 1 patient had AMI in < 24 hours (1/01%), and there were 2 deaths in < 30 days (2/0.1%). SonoVue®-related urticaria was seen in 3 (0.3%) patients, without anaphylactic reaction.

Conclusion: SonoVue® demonstrated safety during PSE. No cases of death, AMI, or anaphylactic reaction were observed. There was a lower incidence of minor side effects and arrhythmias in the group that received ECA, as well as a low incidence of mild allergic reactions.

Fundamento: Em 2007, a Food and Drug Administration (FDA) determinou revisões sobre segurança dos agentes de contraste ecocardiográfico (ACE) disponíveis no mercado após relatos de mortes. Ao longo desses anos, diversos estudos comprovaram a segurança dos ACE, porém com poucos estudos relacionados ao SonoVue®.

Objetivos: Avaliar a segurança do SonoVue® durante o ecocardiograma sob estresse farmacológico (EEF) por meio da análise da incidência de reações alérgicas e da comparação entre os grupos quanto ao surgimento de arritmia, efeitos colaterais menores e eventos adversos.

Métodos: Estudo observacional, prospectivo, no qual 2.346 pacientes foram submetidos ao EEF e divididos em dois grupos: grupo 1 com ACE (n=1.099) e grupo 2 sem ACE (n=1.247). Os pacientes foram avaliados durante o EEF – 24 horas e 30 dias. Foi definido p significativo quando <0,05.

Resultados: O grupo 1 apresentou efeitos colaterais mais leves, como cefaleia (5/0,5% vs. 19/1,5%, p=0,012) e hipertensão reativa (3/0,3% vs . 19/1,5%, p=0,002), menos arritmias como extrassístoles ventriculares (180/16,4% vs . 247/19,8%, p=0,032) e taquicardia paroxística supraventricular (2/0,2% vs . 15/1,2%, p=0,003), assim como nenhum evento adverso como infarto agudo do miocárdio (IAM) e óbito. No grupo 2, um paciente apresentou IAM <24h (1/01%) e dois óbitos <30 dias (2/0,1%). Urticária relacionada ao SonoVue® foi observada em 3 (0,3%) pacientes sem reação anafilática.

Conclusão: SonoVue® demonstrou segurança durante o EEF, não sendo observados morte, IAM ou reação anafilática. Observou-se menor incidência de efeitos colaterais mais leves e arritmias no grupo que utilizou o ACE, assim como baixa incidência de reações alérgicas leves.

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Conflict of interest statement

Potencial conflito de interesse

Não há conflito com o presente artigo

Figures

Figura 1
Figura 1. – Exemplo de uma paciente com reação alérgica/urticária com uso de SonoVue® e com melhora clínica após o uso do anti-histamínico oral.
Figura 2
Figura 2. – Paciente com janelas acústicas limitadas com melhora da imagem após o uso do agente de contraste ecocardiográfico.
Figure 1
Figure 1. – Example of a patient with allergic reaction/urticaria to use of SonoVue®, with clinical improvement after use of an oral antihistamine drug.
Figure 2
Figure 2. – Patient with limited acoustic windows, with improved imaged after use of the echocardiographic contrast agent.
See this image and copyright information in PMC

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