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J Thorac Cardiovasc Surg 2006;132:909-917
© 2006 The American Association for Thoracic Surgery


Cardiopulmonary Support and Physiology

Aprotinin use in thoracic aortic surgery: Safety and outcomes

Artyom Sedrakyan, MD, PhDa,b,*, Albert Wu, MD, MPHb,c, George Sedrakyan, MDd, Marie Diener-West, PhDe, Maryann Tranquilli, RNa, John Elefteriades, MDa

a Department of Surgery, Yale University School of Medicine, New Haven, Conn
b Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md
c Health Services Research and Development Center, Johns Hopkins University, Baltimore, Md
d Nork-Marash Cardiac Surgery Hospital, Yerevan, Armenia
e Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.

Received for publication November 1, 2005; accepted for publication June 6, 2006.

* Address for reprints: Artyom Sedrakyan, MD, PhD, Department of Health Policy and Management, Johns Hopkins School of Public Health, 624 N. Broadway, PO Box 485, Baltimore, MD 21295. (Email: asedraky{at}jhsph.edu).

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.



Abbreviations and Acronyms ACT = activated clotting time; CABG = coronary artery bypass graft; ECM = extracellular matrix; DHCA = deep hypothermic cardiac arrest; KIU = kallikrein inactivation unit





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