Abstract 601: An Observational Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
Background: Reports of ultrasound contrast agent safety have been derived from retrospective databases, and not from studies designed to assess safety. We report the results of the first large, multicenter, study designed to evaluate the safety of Optison during echocardiography (2DE).
Methods: Patients referred for routine rest or stress 2DE who had indications for ultrasound contrast were enrolled. Vital signs were obtained at baseline and at intervals up to 1 h after dosing of Optison, and patients were followed for any serious adverse event (SAE), defined as an event causing death, is life threatening, requires or prolongs hospitalization, causes persistent or significant disability, is teratogenic, or causes another important event, for 24 h after Optison.
Results: A total of 1039 patients were enrolled, and 76% had 24h follow-up. The median age was 60 yrs (20 – 97 yrs) and 62% were male. The mean body mass index was 33±9 kg•m2. Patient co-morbidities included hypertension (73%), hyperlipidemia (64%), smoking (52%), and diabetes (37%). Vital signs after Optison are shown Table 1⇓. Increases in systolic blood pressure, heart rate and respiratory rate were expected as a proportion of the studies were stress 2DE. SAEs are shown in Table 2⇓. Although 2 events were classified as SAEs, the hospitalizations were appropriate for pathology that would have been missed without Optison use. None of the SAEs were felt to be related to Optison.
Conclusions: In this large, prospective, safety study of Optison during routine resting and stress echocardiography, no SAEs related to Optison developed. Optison helped to define abnormalities that required further management.