Extracorporeal Circulation, Optimized: A Pilot Study

Abstract

We designed a pilot study to assess as primary end point the safety and efficacy of a new phosphorylcholine-coated, closed cardiopulmonary bypass (CPB) system (extracorporeal circulation, optimized [ECC.O], Dideco, Mirandola, Italy). The secondary end point was to compare results with two retrospectively matched cohorts of patients who underwent isolated coronary artery by-pass graft (CAGB) with nonphosphorylcholine-bonded circuits and cardiotomy suction (Group II, n = 32) and off-pump coronary artery by-pass (OPCAB) (Group III, n = 26). In January 2005, 30 patients (Group I) undergoing first-time CABG were assigned to the ECC.O group. Five minutes after CPB, initial hematocrit levels were significantly and consistently highest in Group I relative to Group II (Group I, 29.7 +/- 4.4 vs. Group II, 22.7 +/- 4.1; P < 0.001). Red blood cell transfusion rate was reduced drastically in Group I versus Group II (P < 0.001). High differences were also observed in C-reactive protein levels at 24 h after surgery (Group I vs. Group II-P < 0.001 and vs. Group III-P < 0.001) and at 72-h peak value (Group I vs. Group II-P < 0.001 and vs. Group III-P < 0.001). The routine clinical use of the ECC.O system has been demonstrated to be both clinically safe and efficacious. An intensive training program for surgeons, perfusionists, and anesthesiologists is required.