An observational study of the occurrence of serious adverse reactions among patients who receive optison in routine medical practice

Abstract

Background: Reports of ultrasound contrast agent safety have been derived mainly from retrospective databases rather than from studies specifically designed to assess safety. The purpose of this study was to prospectively determine the safety of Optison (GE Healthcare, Princeton, NJ) in routine medical practice.

Methods: Patients referred for routine rest or stress two-dimensional echocardiography who had indications for contrast were enrolled. Vital signs were obtained at baseline and at intervals up to 1 hour after dosing of Optison. Patients were followed for the development of any serious adverse event (SAE), defined as an event that causes death, is life threatening, requires or prolongs hospitalization, or causes another important event, for 24 hours after Optison administration.

Results: A total of 1,039 patients were enrolled, and 76% had 24-hour follow-up. The median age was 60 years (range, 20-97 years), and 62% were men. The mean body mass index was 33 ± 9 kg/m(2). Patient comorbidities included hypertension (73%), hyperlipidemia (64%), smoking (52%), and diabetes (37%). There were significant increases in systolic blood pressure, heart rate, and respiratory rate between the baseline, 5- to 15-min, 30-min, and 60-min time points after the administration of Optison in patients undergoing stress studies but none in those undergoing rest studies. There was a total of six SAEs during the study, which were felt to be related not to Optison but rather to the stress test itself or to the patient's underlying pathology. Although two events were classified as SAEs because of hospitalization, the hospitalizations were appropriate for pathology that would have been missed without Optison use.

Conclusions: In this large, prospective safety study of Optison during routine resting and stress echocardiography, no SAEs related to Optison developed. Optison helped define abnormalities that required appropriate hospitalization for further management.

Keywords: Contrast agents; Echocardiography; Safety.