Clinical evaluation of Duraflo II heparin treated extracorporeal circulation circuits (2nd version). The European Working Group on heparin coated extracorporeal circulation circuits.
OBJECTIVE
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.


CONCLUSIONS
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.
Wildevuur
C R
CR
Cardio Pulmonary Center Amsterdam, Netherlands.
Jansen
P G
PG
Bezemer
P D
PD
Kuik
D J
DJ
Eijsman
L
L
Bruins
P
P
De Jong
A P
AP
Van Hardevelt
F W
FW
Biervliet
J D
JD
Hasenkam
J M
JM
Kure
H H
HH
Knudsen
L
L
Bellaiche
L
L
Ahlburg
P
P
Loisance
D Y
DY
Baufreton
C
C
Le Besnerais
P
P
Bajan
G
G
Matta
A
A
Van Dyck
M
M
Renotte
M T
MT
Ponlot-Lois
A
A
Baele
P
P
McGovern
E A
EA
Ahlvin
E
E
D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000503:physiopathology / Q000517:prevention & control; D001026:Coronary Artery Bypass / Q000401:mortality; D003327:Coronary Disease / Q000401:mortality / Q000601:surgery*; D005112:Extracorporeal Circulation / Q000295:instrumentation*; D005260:Female; D006493:Heparin; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D013499:Surface Properties; D016019:Survival Analysis; D016896:Treatment Outcome
D006493:Heparin