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(Circulation. 2004;109:2755-2760.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Double-Blind, Randomized Controlled Trial on the Effect of Leukocyte-Depleted Erythrocyte Transfusions in Cardiac Valve Surgery

Y.M. Bilgin, MD; L.M.G. van de Watering, MD; L. Eijsman, MD, PhD; M.I.M. Versteegh, MD; R. Brand, PhD; M.H.J. van Oers, MD, PhD; A. Brand, MD, PhD

From the Department of Hematology (Y.M.B., M.H.J.v.O.) and the Department of Cardiothoracic Surgery (L.E.), Academic Medical Center, Amsterdam, The Netherlands; and the Department of Immnunohematology and Blood Transfusion and Sanquin Bloodbank Southwest (L.M.G.v.d.W, A.B.), the Department of Cardiothoracic Surgery (M.I.M.V.), and the Department of Medical Statistics (R.B.), Leiden University Medical Center, Leiden, The Netherlands.

Correspondence to Dr Yavuz Bilgin, Department Immunohematology and Blood Transfusion, E-3-Q, Leiden University Medical Center, Albinusdreef 2, PO Box 9600, 2300 RC Leiden, The Netherlands. E-mail m.y.bilgin{at}lumc.nl

Received September 3, 2003; revision received December 23, 2003; accepted February 26, 2004.

Background— Leukocytes in allogeneic blood transfusions are believed to be the cause of immunomodulatory events. A few trials on leukocyte removal from transfusions in cardiac surgery have been conducted, and they showed inconclusive results. We found in a previous study a decrease in mortality rates and number of infections in a subgroup of more heavily transfused patients.

Methods and Results— Patients (n=496) undergoing valve surgery (with or without CABG) were randomly assigned in a double-blind fashion to receive standard buffy coat–depleted (PC) or prestorage, by filtration, leukocyte-depleted erythrocytes (LD). The primary end point was mortality at 90 days, and secondary end points were in-hospital mortality, multiple organ dysfunction syndrome, infections, intensive care unit stay, and hospital stay. The difference in mortality at 90 days was not significant (PC 12.7% versus LD 8.4%; odds ratio [OR], 1.52; 95% confidence interval [CI], 0.84 to 2.73). The in-hospital mortality rate was almost twice as high in the PC group (10.1% versus 5.5% in the LD group; OR, 1.99; 95% CI, 0.99 to 4.00). The incidence of multiple organ dysfunction syndrome in both groups was similar, although more patients with multiple organ dysfunction syndrome died in the PC group. LD was associated with a significantly reduced infection rate (PC 31.6% versus LD 21.6%; OR, 1.64; 95% CI, 1.08 to 2.49). In both groups, intensive care unit stay and hospital stay were similar, and postoperative complications increased with the number of transfused units.

Conclusions— Mortality at 90 days was not significantly different; however, a beneficial effect of LD in valve surgery was found for the secondary end points of in-hospital mortality and infections.

Key Words: leukocytes • infection • mortality • bypass • valves

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