Definity Approved for Use in Pediatric Patients With Suboptimal Echocardiograms

The Food and Drug Administration (FDA) has expanded the approval of Definity^® (perflutren lipid microsphere) to include use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Previously, the ultrasound contrast agent was only approved for use in adults.

The expanded approval was supported by data from 3 trials that evaluated the effectiveness of Definity in 189 pediatric patients:

• Golding study: 40 patients 1 month to 17 years of age with significant cardiovascular disorders, including heart transplant, Kawasaki disease or congenital cardiovascular anomaly.  
• Fine study: 36 patients 10 to 21 years of age who had previously undergone a heart transplant. 
• Kutty study: 113 patients 5 to 21 years of age with a diagnosis of known congenital or acquired heart disease or suspected cardiac disease.

Findings from these trials showed left ventricular opacification with Definity was successful and provided important information to guide patient management. In Golding, the ability to detect wall motion abnormalities and to perform ejection fraction determinations was improved in the majority of patients (70% and 80%, respectively). 

In the Kutty study, wall motion and/or myocardial perfusion wall motion abnormalities were identified in 11.5% (13/113) of patients. Across all patients, the number of left ventricular segments visualized improved from 13 ± 1 per patient without contrast to 16 ± 1 segments per patient with contrast.

In the Fine study, regional wall motion abnormalities were detected in 8.3% (3/36) of patients, while myocardial perfusion imaging was successful in 89% (32/36). 

With regard to adverse reactions in pediatric patients, no new safety signals were observed in clinical trials.

For pediatric patients, Definity is administered by an intravenous bolus injection only.