The effect of Definity on systemic and pulmonary hemodynamics in patients

The purpose of this study was to evaluate the pulmonary and systemic hemodynamic effects of Definity in patients with normal as well as those with elevated pulmonary artery pressure at baseline. Secondary objectives of the study were to evaluate safety and determine whether any potential immunologic reactions develop after Definity administration.

Patients with normal and elevated pulmonary artery systolic pressure undergoing right-heart catheterization received Definity (10 μL/kg) as a slow bolus over 30 to 60 sec. Multiple sequential measurements of right atrial pressure, pulmonary artery systolic pressure, pulmonary artery diastolic pressure, mean pulmonary artery pressure, cardiac output, and pulmonary capillary wedge pressure were made before and after Definity administration. Vital signs, electrocardiograms, and blood samples were taken at multiple time points. Patients were followed for the development of adverse events.

A total of 32 patients (16 with elevated pulmonary artery systolic pressure > 35 mm Hg) were enrolled. No significant changes in any pulmonary or systemic hemodynamic parameters, vital sign values, electrocardiographic data, or laboratory variables were found for data obtained before versus after receipt of Definity.

The administration of Definity at the approved dosage does not change pulmonary or systemic hemodynamics in control patients or those with mild to moderate pulmonary hypertension. No significant changes were noted in a wide array of clinical and laboratory safety assessments after patients were exposed to Definity.