The Efficacy, Safety and Cost-Effectiveness of Intra-Operative Cell Salvage in High-Bleeding-Risk Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Randomized and Controlled Trial

Objective: Intra-operative cell salvage (CS) was reported to be ineffective, safe and not cost-effective in low-bleeding-risk cardiac surgery with cardiopulmonary bypass (CPB), but studies in high-bleeding-risk cardiac surgery are limited. The objective of this study is to evaluate the efficacy, safety and cost-effectiveness of intra-operative CS in high-bleeding-risk cardiac surgery with CPB. Methods: One hundred and fifty patients were randomly assigned to either with intra-operative CS group (Group CS) or without intra-operative CS group (Group C). Study endpoints were defined as perioperative allogeneic red blood cell (RBC) transfusion, perioperative impairment of blood coagulative function, postoperative adverse events and costs of transfusion-related. Results: Both the proportion and quantity of perioperative allogeneic RBC transfusion were significantly lower in Group CS than that in Group C (p=0.0002, <0.0001, respectively). The incidence of residual heparin and total impairment of blood coagulative function in the 24 hours after surgery, the incidence of postoperative excessive bleeding, were significantly higher in Group CS than that in Group C (p=0.018, 0.042, 0.034, respectively). Cost of both allogeneic RBC transfusion and total allogeneic blood transfusion were significantly lower in Group CS than that in Group C (p<0.001, =0.002, respectively). Cost of total blood transfusion was significantly higher in Group CS than that in Group C (p =0.001). Conclusion: Intra-operative CS in high-bleeding-risk cardiac surgery with CPB is effective, generally safe, and cost-effective in developed countries but not in China.