Safety of echocardiographic contrast in hospitalized patients with pulmonary hypertension: a multi-center study.

AIMS: Echocardiographic contrast (EC) improves the diagnostic accuracy of suboptimal echocardiograms. In October 2007, the Food and Drug Administration (FDA) placed a black box warning on the label of the perflutren-based agents Definity and Optison, contraindicating their use in patients with pulmonary hypertension (PHT) and unstable cardiopulmonary status, after serious cardiopulmonary reactions occurred in temporal relation to EC administration. In 2008 and 2011, the FDA revised the black box warning allowing their use in this same population. However, limited data exist regarding the safety profile of these agents in patients with PHT. METHODS AND
RESULTS: Consecutive hospitalized patients with PHT who were referred for echocardiographic evaluation, but required the use of EC, were included. All our patients received the EC agent Definity. We evaluated these patients for serious adverse events (respiratory decompensation, hypotension, syncope, convulsions, arrhythmias, anaphylactic reactions, or death) occurring within 24 h of EC administration. The study group included 1513 patients (age 69 ± 14 years, 55% males, BMI 33 ± 9 kg/m(2)), of which 911 (60%) had mild PHT, 515 (34%) had moderate PHT, and 87 (6%) had severe PHT. The mean pulmonary artery systolic pressures (PASP) in the groups with mild, moderate, and severe PHT were 41 ± 4 (range 35-49) mmHg, 55 ± 5 (range 50-69) mmHg, and 78 ± 9 (range 70-122) mmHg, respectively. The incidence of adverse events in all subgroups was rare (0.002%) and they were not attributed to EC because of temporal and clinical considerations.
CONCLUSION: The use of the EC agent Definity is safe in hospitalized patients with PHT.