These results confirm both the safety and efficacy of the ROCsafeRX MPC for a large variety of cardiac patients. Minimized perfusion circuits should, therefore, play a greater role in daily practice so that as many patients as possible can benefit from their advantages.

Minimized perfusion circuits (MPC) were found to reduce side effects of standard extracorporeal circulation (ECC). We evaluated the safety and efficacy of the ROCsafe MPC for aortic valve and aortic root surgery. One hundred and seventy patients were randomized for surgery using either MPC [n = 85, 30 female/55 male, mean age: 69.8 +/- 11.8 years; aortic valve replacement (AVR): n = 40; AVR + coronary artery bypass graft (CABG): n = 31; David operation: n = 3; aortic root replacement (ARR): n = 11] or ECC [n = 85, 29 female/56 male, mean age: 67.7 +/- 9.5 years; AVR: n = 39; AVR+CABG: n = 35, David operation: n = 2; ARR: n = 9]. Neurological status, length of ICU stay, C-reactive protein (CRP), blood count, transfusion requirements and bleeding volume were analyzed. The MPC system provided ultrasound-controlled de-airing. A small roller pump and a flexible reservoir were used for left ventricular venting. As a control, we used a standard ECC with cardiotomy suction and hard-shell reservoir. Cross-clamp time (MPC: 76.5 +/- 29.5; ECC: 79.0 +/- 34.0 min) and bypass time (MPC: 103.0 +/- 37.9; ECC: 106.9 +/- 44.9 min) were comparable between groups. Transfusion requirements (red blood cells: MPC: 1.5 +/- 1.5 vs. ECC: 2.2 +/- 2.1 units [p = 0.05], frozen plasma: MPC: 1.2 +/- 1.8 vs. ECC: 1.9 +/- 2.4 units [p = 0.03]), postoperative bleeding (MPC: 521 +/- 283 vs. ECC: 615 +/- 326 ml/24 h, p = 0.09) were lower using MPC. ICU stay was shorter with MPC (1.6 +/- 1.6 days) compared to ECC (2.4 +/- 2.8 days, p = 0.001). One stroke occurred in each group. The ROCsafe MPC provides safe circulatory support for a wide range of aortic valve surgeries. Transfusion requirements, postoperative bleeding and length of ICU stay were markedly reduced compared to standard extracorporeal perfusion.

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.

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