Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram. / Segurança do Agente de Contraste SF6 (SonoVueⓇ) no Ecocardiograma sob Estresse Farmacológico.

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.

Early impairment of myocardial deformation assessed by regional speckle-tracking echocardiography in the indeterminate form of Chagas disease without fibrosis detected by cardiac magnetic resonance.

Chagas disease (CD) will account for 200,000 cardiovascular deaths worldwide over the next 5 years. Early detection of chronic Chagas cardiomyopathy (CCC) is a challenge. We aimed to test if speckle-tracking echocardiography (STE) can detect incipient myocardial damage in CD. METHODS: Among 325 individuals with positive serological tests, 25 (age 55±12yrs) were selected to compose the group with indeterminate form of Chagas disease (IFCD), based on stringent criteria of being asymptomatic and with normal EKG/X-ray studies. This group was compared with a group of 20 patients with CCC (55±11yrs) and a group of 20 non-infected matched control (NC) subjects (48±10yrs). CD patients and NC were submitted to STE and CD patients were submitted to cardiac magnetic resonance (CMR) with late gadolinium administration to detect cardiac fibrosis by the late enhancement technique. Global longitudinal strain (GLS), circumferential (GCS) and radial strain (GRS) were defined as the average of segments measured from three apical view (GLS) and short axis views (GRS and GCS). Regional left ventricular (LV) longitudinal strain (Reg LS) was measured from each of the 17 segments. Twist was measured as systolic peak difference between basal and apical rotation and indexed to LV length to express torsion. RESULTS: STE global indices (GLS, GCS, twist and torsion) were reduced in CCC vs NC (GLS: -14±6.3% vs -19.3±1.6%, p = 0.001; GCS: -13.6±5.2% vs -17.3 ±2.8%; p = 0.008; twist: 8±7° vs 14±7°, p = 0.01 and torsion: 0.96±1°/cm vs 1.9±1°/cm, p = 0.005), but showed no differences in IFCD vs NC. RegLS was reduced in IFCD vs NC in four LV segments: basal-inferior (-16.3±3.3% vs -18.6±2.2%, p = 0.013), basal inferoseptal (-13.1±3.4 vs -15.2±2.7, p = 0.019), mid-inferoseptal (-17.7±3.2 vs -19.4±2, p = 0.032) and mid-inferolateral (-15.2±3.5 vs -17.8±2.8, p = 0.014). These abnormalities in RegLS occurred in the absence of myocardial fibrosis detectable with CMR in nearly 92% of subjects with IFCD, while myocardial fibrosis was present in 65% with CCC. CONCLUSION: RegLS detects early regional impairment of myocardial strain that is independent from fibrosis in IFCD subjects.

Segurança do Agente de Contraste SF6 (SonoVueⓇ) no Ecocardiograma sob Estresse Farmacológico / Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram

Resumo 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.

Abstract 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.