title: 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.
authors.affiliation: Cardiac Surgery Unit, San Vincenzo Hospital, Messina, Italy. sasha.agati@tiscali.it
authors.forename: Salvatore
authors.initials: S
authors.lastname: Agati
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ciccarello
authors.forename: Eugenio Santo
authors.initials: ES
authors.lastname: Trimarchi
authors.forename: Daniela
authors.initials: D
authors.lastname: Grasso
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Trimarchi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Di Stefano
authors.forename: Mignosa
authors.initials: M
authors.lastname: Carmelo
mesh_terms: D000368:Aged; D002097:C-Reactive Protein / Q000032:analysis; D002315:Cardiopulmonary Bypass / Q000009:adverse effects* / Q000295:instrumentation*; D004869:Equipment Safety; D017707:Erythrocyte Transfusion; D015199:Extracorporeal Membrane Oxygenation / Q000009:adverse effects* / Q000295:instrumentation*; D005260:Female; D006400:Hematocrit; D006801:Humans; D006836:Hydro-Lyases / Q000097:blood; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine; D010865:Pilot Projects; D010976:Platelet Count
chemical_list: D010767:Phosphorylcholine; D002097:C-Reactive Protein; D006836:Hydro-Lyases; C045581:lactate dehydratase