Extracorporeal circulation, optimized: a pilot study

Artif Organs. 2007 May;31(5):377-83. doi: 10.1111/j.1525-1594.2007.00395.x.

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.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • C-Reactive Protein / analysis
  • Cardiopulmonary Bypass / adverse effects*
  • Cardiopulmonary Bypass / instrumentation*
  • Equipment Safety
  • Erythrocyte Transfusion
  • Extracorporeal Membrane Oxygenation / adverse effects*
  • Extracorporeal Membrane Oxygenation / instrumentation*
  • Female
  • Hematocrit
  • Humans
  • Hydro-Lyases / blood
  • Male
  • Middle Aged
  • Phosphorylcholine
  • Pilot Projects
  • Platelet Count

Substances

  • Phosphorylcholine
  • C-Reactive Protein
  • Hydro-Lyases
  • lactate dehydratase