Comparison of minimally invasive closed circuit versus standard extracorporeal circulation for aortic valve replacement: a randomized study.

To evaluate the clinical results of aortic valve replacement performed with a miniaturized closed circuit extracorporeal circulation (MECC) system and to compare it to standard cardiopulmonary bypass (CPB). One hundred and twenty consecutive patients undergoing isolated aortic valve replacement were randomly assigned to either a miniaturized closed circuit CPB with the maquet-cardiopulmonary MECC System (study group, n=60) or to a standard CPB (control group, n=60). Demographic characteristic and operative data were similar in the two groups. No hospital death occurred in either group and no difference in intensive care unit (ICU) stay and in-hospital stay was observed. Patients in the study group showed lower chest tube drainage (212+/-62 ml vs. 420+/-219 ml, P<0.05) and lower need for blood products (6.1% vs. 40.4%, P<0.05) than patients in the control group. Platelet count at ICU arrival was significantly higher in the study group (139+/-40 x 10(9)/l vs. 164+/-75 x 10(9)/l, P=0.05). Peak postoperative troponin I release was significantly lower in the MECC group (3.81+/-2.7 ng/dl vs. 6.6+/-6.8 ng/dl, P<0.05). In this randomized study the MECC system has demonstrated best postoperative clinical results in terms of need for transfusion, platelets consumption and myocardial damage as compared to standard CPB.

RCT Entities:   Population Interventions Outcomes