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J Thorac Cardiovasc Surg 1996;112:154-161
© 1996 Mosby, Inc.
CARDIOPULMONARY BYPASS, |
From the Departments of Anesthesia and Hematology, Montreal Heart Institute, Montreal, Quebec, Canada.
Presented in part at the Seventeenth Annual Meeting of the Society of Cardiovascular Anesthesiologists, Philadelphia, Pa., May 1995.
Received for publication Oct. 23, 1995 revisions requested Jan. 4, 1996; revisions received March 19, 1996 Accepted for publication March 21, 1996. Address for reprints: Jean-François Hardy, MD, FRCPC, Montreal Heart Institute, 5000 Belanger St., Montreal, Quebec, Canada H1T 1C8.
Abstract
Measurement of circulating heparin concentration has been suggested to optimize anticoagulation during cardiopulmonary bypass. The Hepcon/HMS device (Medtronic HemoTec, Inc., Parker, Colo.) uses heparin/protamine titration to quantitatively determine heparin concentration. Extensive validation of this instrument is still lacking. Methods:Agreement between heparin concentrations measured by the Hepcon/HMS system and by laboratory determination was evaluated in 16 patients undergoing cardiac operations. For laboratory determinations, plasma heparin concentration was derived from the measure of anti-Xa activity by means of a chromogenic substrate technique. The Hepcon/HMS instrument and cartridges measured whole blood heparin concentration. Samples were analyzed 5 minutes after administration of heparin, 15 and 30 minutes after the start of cardiopulmonary bypass, 5 minutes after aortic unclamping, at the end of cardiopulmonary bypass, and after administration of protamine. Data were plotted and interpreted according to the method of Bland and Altman: First, a difference less than 1.4 U/ml (i.e., ±0.7 U/ml) was chosen as acceptable, because it would not cause major difficulties in clinical interpretation; second, the difference between the two measurement techniques was plotted against the mean of the two measures. Results:The mean difference (bias) between heparin concentrations derived by the Hepcon/HMS device and those obtained by laboratory determination was as expected for measures performed on whole blood versus plasma (1.45 U/ml). Nevertheless, heparin concentrations derived by the Hepcon/HMS device may be as much as 2.76 U/ml above or 6.17 U/ml below the concentrations measured in the laboratory, differences well outside the predetermined limits of agreement and clearly unacceptable for clinical purposes. Conclusion:We conclude that heparin concentrations determined with the Hepcon/HMS instrument do not agree with laboratory determination of heparin concentration. Monitoring of heparin concentrations during bypass with the Hepcon/HMS device cannot be recommended. (J THORACCARDIOVASCSURG1996;112:154-61)
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