Safety and efficacy of a new transpulmonary echo contrast agent in echocardiographic studies in patients

Abstract

Objectives: This study was designed to investigate in patients the effect of a new transpulmonary echo contrast agent, made from 5% human serum albumin (Albunex), on systemic and pulmonary hemodynamics and the influence of the contrast doses on left ventricular opacification.

Background: New intravenous transpulmonary echo contrast agents are promising, allowing contrast stress echocardiography and myocardial contrast echocardiography. Nevertheless, some shortcomings still remain. Thus, the pulmonary hypertension observed in pigs after Albunex injection should be investigated in humans, and the optimal dose of contrast agent remains to be determined because previous experiments indicated that the left ventricular opacification and attenuation are dose dependent.

Methods: Albunex in doses of 0.08 and 0.22 ml/kg was successively injected intravenously in 20 catheterized patients; in 11 of them, anti-inflammatory drugs were withdrawn to avoid the blocking of an eventual thromboxane-mediated pulmonary artery hypertension. Systemic blood pressure and pulmonary artery, capillary wedge and right atrial pressures were continuously monitored. Cardiac output, left ventricular fractional shortening and blood gases were determined 5 min before and 5 and 10 min after each injection. The left ventricular opacification was qualitatively assessed by three independent observers using a grading scale from 0 to 3, with 0 indicating an absence of contrast effect and 3 indicating full opacification.

Results: No clinical, hemodynamic or respiratory adverse reactions were observed in any patient. Irrespective of doses, a left ventricular opacification grade > or = 2 was observed in 74% of the 35 injections that could be evaluated. This percentage increased to 94% when the higher dose group was considered alone.

Conclusions: This first report of the effect of Albunex injected intravenously on pulmonary artery pressures in humans demonstrates that this contrast agent appears to be safe. The significant left ventricular opacification obtained in a majority of patients without an important increase in attenuation supports the use of the higher dose of the contrast agent.