ABSTRACT
INTRODUCTION: Several surveys demonstrated that cardiopulmonary bypass (CPB) is associated with incidents that negatively affect the outcome of cardiac surgery. OBJECTIVES: In 2004, the French "Haute Autorité de santé" (an independent public scientific authority) and the French "College of Perfusion" issued recommendations concerning safety and monitoring devices for CPB. The aims of the present study were to: 1) investigate the difference between the recommendations and the clinical practice of CPB shortly after publication of the recommendations; 1) investigate the type and rate of perfusion incidents and their outcome. STUDY DESIGN: Retrospective survey. METHODS: A 62 items questionnaire was sent to all 66 centres performing cardiac surgery in France. RESULTS: Fifty-seven centres totalling 34,496 CPB procedures (response rate 86%) returned the questionnaire. There was a wide difference between the recommendations and the reported use of safety and monitoring devices. An incident was reported for every 198 CPB procedures with death occurring 1:4,864 and permanent sequelae 1:11,349 procedures respectively (permanent injury or death 1:3,220 procedures). The most frequent perfusion incidents were adverse effects to protamine (1:1,702), dissection at the arterial canulation site (1:1,792) and coagulation of the circuit (1: 4,864). CONCLUSION: This survey demonstrates that an important effort must be made in order to fill the gap between the recommendations and clinical use of monitoring and safety devices. The analysis of CPB-related incidents suggests that, with the exception of protamine adverse effects, the majority of deaths and severe permanent injuries could probably be avoided by improved use of the monitoring and safety devices.
