The Safety Profile of Perflutren Microsphere Contrast Echocardiography During Rest and Stress Imaging: Results from an Australian Multicentre Cohort

Abstract

CEE is a safe investigation in a broad range of indications and clinical scenarios. AR are very rare, mild and transient.

Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database

“…Subsequent observational studies refined (i.e., substantially weakened) the signal for the major events of death, myocardial infarction, and arrhythmias but supported a low risk of anaphylactoid reactions [12,[14][15][16][17][18][19][20][21][22][23][24][25][26][27]. The product label evolved dynamically in response to this accumulating information.…”

“…Multiple studies [12,[14][15][16][17][18][19][20][21][22][23][24][25][26][27] have demonstrated the safety of perflutren, focusing on death, cardiac arrhythmias, and myocardial infarction, including three studies that were specifically requested by the FDA [12][13][14]. The first was the CaRES (Contrast Echocardiography Registry for Safety Surveillance) study [12].…”

“…Subsequent observational studies and meta-analysis evaluating the aforementioned signal provide important information [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27]. The multiple observational studies failed to detect an increased risk of the major cardiovascular events of death, myocardial infarction, and arrhythmia due to perflutren [12,[14][15][16][17][18][19][20][21][22][23][24][25][26][27]. However, studies supported the rare occurrence of anaphylactoid reactions due to perflutren [21,26].…”

Myocardial Perfusion Imaging Using Contrast Echocardiography

“…35 Minor adverse effects include back pain, headache, nausea and rash and can occur in 0.27-3.5% of cases. 36,37 Physical injury may be provoked by the heat released from microbubble destruction -indeed, this is the mechanism that is thought to underpin sonothrombolysis (see below). Although some investigators showed ventricular ectopy in association with microbubble destruction, arrhythmia has never been reported as a consequence of contrast use.…”

“…40 More recent studies have echoed this safety profile including a prospective phase 4 study of contrast agent (Definity). 36,37 The groups causing the greatest consternation included the critically ill cohort, those with an ACS and those with pulmonary hypertension. Given the prevalence of multiple comorbidities in an aging population, these groups stand to gain the greatest benefit from MCE.…”