Aprotinin use in thoracic aortic surgery: safety and outcomes.

OBJECTIVES: Previous studies of aprotinin use in thoracic aortic surgery, limited in size and design, reported minimal information regarding outcomes other than blood loss and transfusion. The evaluation of impact of aprotinin on surgical outcomes in a large sample is needed.
METHODS: Patients at Yale New Haven Hospital undergoing thoracic aortic surgery (aneurysm repair, dissections, penetrating ulcers, intramural hematomas) between 1995 and 2003 were considered for inclusion. Each patient receiving aprotinin was matched to a control per preoperative profile (age, gender, urgency of surgery, dissection/location of aortic disease). Data (surgical specifics, demographic variables, comorbidities, disease location-related variables, preoperative medications, intraoperative medications, surgical/operative data) were abstracted from the records of successfully matched aprotinin-treated patients and controls (n = 168). Comparison and determination of success of matching were performed using bivariate analyses. Outcome variables were compared using statistical tests for paired data. Supplementary unpaired and regression analyses were also performed.
RESULTS: Baseline demographics of groups were similar, although controls had reduced history of aortic disease, but greater intraoperative use of lysine analogs (P < .05). Aprotinin significantly reduced platelet transfusion (P < .05). Paired bivariate analyses showed a tendency toward reduced ventilation time, pulmonary complications, and permanent arrhythmias (P < .05) associated with aprotinin. Supplementary analyses were supportive only for pulmonary complications and permanent arrhythmias.
CONCLUSIONS: The current evaluation substantiates previous reports that aprotinin may be safe to use and likely to improve some outcomes of thoracic aortic surgery. However, further studies for rare safety and efficacy end points are warranted.