A prospective randomised multicentre clinical comparison of a minimised perfusion circuit versus conventional cardiopulmonary bypass

Objective: Minimised perfusion circuits (MPCs) are expected to reduce the side effects of conventional cardiopulmonary bypass (CCPB); however, conclusive data from sufficiently powered clinical trials are lacking. The purpose of this study was to evaluate the safety and efficacy of the ROCsafeRX™ minimised perfusion circuit. Methods: A randomised, controlled, multicentre clinical trial comparing both perfusion circuits in patients subjected to elective coronary artery bypass and/or aortic valve replacement is described. The primary end points of safety, defined as procedure success without device-related complications, and secondary end point of efficacy, including reduction of transfusion requirement and incidence of atrial fibrillation, are analysed. Results: To date, 291 patients have been enrolled and randomised (146 MPC vs 145 CCPB). With the exception of a significantly higher male population in the MPC group (83.6% vs 71.0%, p = 0.01), both groups were well matched for demographic data and type of surgery. There were no device-related complications but a hard-shell reservoir had to be integrated in one MPC because of a tear in the right atrium that was managed uneventfully. Total transfusion requirement (329 ± 599 ml vs 783 ± 1638 ml, p ≤ 0.001) and erythrocyte transfusion (181 ± 341 ml vs 434 ± 798 ml, p ≤ 0.001) were significantly reduced in the MPC group. The incidence of atrial fibrillation was significantly lower in the MPC group (7.1% vs 19.5%, p ≤ 0.01), while freedom of major adverse events showed no significant difference. Conclusions: Lack of device-related complications combined with a significant reduction in postoperative atrial fibrillation and transfusion requirements have shown the ROCsafeRX™ MPC to be both safe and efficient for large-scale use in cardiac patients. Additional data are expected to confirm these initial findings.