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European Journal of Cardio-Thoracic Surgery, Vol 11, 616-623, Copyright © 1997 by European Association for Cardio-thoracic Surgery
CR Wildevuur, PG Jansen, PD Bezemer, DJ Kuik, L Eijsman, P Bruins, AP De Jong, FW Van Hardevelt, JD Biervliet, JM Hasenkam, HH Kure, L Knudsen, L Bellaiche, P Ahlburg, DY Loisance, C Baufreton, P Le Besnerais, G Bajan, A Matta, M Van Dyck, MT Renotte, A Ponlot-Lois, P Baele, EA McGovern and E Ahlvin
OBJECTIVES: To evaluate whether the application of heparin treated circuits
for elective coronary artery surgery improves postoperative recovery, a
European multicenter randomised clinical trial was carried out. METHODS: In
11 European heart centers, 805 low-risk patients underwent cardiopulmonary
bypass (CPB) with either an untreated circuit (n = 407) or an identical but
heparin treated circuit (n = 398, Duraflo II). RESULTS: Significant
differences were found among participating centers with respect to patient
characteristics, blood handling procedures and postoperative care. The use
of heparin treated circuits revealed no overall changes in blood loss,
blood use, time on ventilator, occurrence of adverse events, morbidity,
mortality, and intensive care stay. These results did not change after
adjustment for centers and (other) prognostic factors as analysed with
logistic regression. In both groups no clinical or technical (patient or
device related) side effects were reported. Because female gender and
aortic cross clamp time appeared as prognostic factors in the logistic
regression analysis, a subgroup analysis with these variables was
performed. In a subpopulation of females (n = 99), those receiving heparin
treated circuits needed less blood products, had a lower incidence of
rhythm disturbances and were extubated earlier than controls. In another
subgroup of patients with aortic cross clamp time exceeding 60 min (n =
197), the amount of patients requiring prolonged intensive care treatment
(> 24 h) was significantly lower when they received heparin treated
circuits versus controls. CONCLUSION: These findings suggest that improved
recovery can be expected with heparin treated circuits in specific higher
risk patient populations (e.g. females) and when prolonged aortic cross
clamp time is anticipated. Further investigations are recommended to
analyses the clinical benefit of heparin treated circuits in studies with
patients in different well defined risk categories and under better
standardised circumstances.
ARTICLES
Clinical evaluation of Duraflo II heparin treated extracorporeal circulation circuits (2nd version). The European Working Group on heparin coated extracorporeal circulation circuits
Cardio Pulmonary Center Amsterdam, Netherlands.
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