Safety of myocardial flash-contrast echocardiography in combination with dobutamine stress testing for the detection of ischaemia in 5250 studies.

OBJECTIVE: The purpose of the present study was to provide evidence regarding the safety of real-time flash-contrast echocardiography combined with dobutamine-atropine stress echo (DASE).
BACKGROUND: The combination of perfusion assessment using myocardial contrast echocardiography (MCE) with DASE has shown very promising results for the diagnosis of coronary artery disease. Concerns have, however, been expressed regarding the safety of the use of echo-contrast agents in echocardiography.
DESIGN: 5250 individuals (70.8% men, aged 64.6 years (SD 10.6)) were submitted to DASE, with concurrent MCE using a low mechanical index technique with the administration of high-energy impulses in order to assess replenishment time.
RESULTS: No deaths or myocardial infarctions were observed. Sustained ventricular tachycardia (VT) or fibrillation requiring resuscitation occurred in two cases (0.04%). The incidence of other arrhythmic events was: sustained VT not requiring resuscitation, 10 (0.18%); non-sustained VT, 18 (0.34%); atrial tachycardia, 4 (0.08%); atrial fibrillation, 25 (0.48%). Other observed adverse events included: intense headache, 52 (1%); intense back pain, 26 (0.5%). Vagal reactions with marked systolic blood pressure falls were observed in 45 cases (0.9%). Hypersensitivity reactions were reported in 23 cases (0.44%), although no serious cases of hypersensitivity requiring hospitalisation were recorded. The sensitivity, specificity and overall accuracy of DASE/MCE were 92%, 61% and 85%, respectively.
CONCLUSIONS: This report of safety data regarding stress-contrast echocardiography in a large series of subjects suggests that this is an exceptionally safe technique, given that in 5250 studies no study-related deaths or myocardial infarctions were encountered, whereas serious adverse events requiring hospitalisation were extremely rare (one in 2625 studies).