BACKGROUND: Cardiac surgery is occasionally complicated by massive blood loss that is refractory to standard hemostatic interventions. Recombinant factor VIIa (rF-VIIa) is being increasingly used as rescue therapy in such cases, but little information is available on its safety and efficacy for this indication. STUDY DESIGN AND METHODS: The outcomes of the first 51 cardiac surgery patients who received rF-VIIa for intractable blood loss (from November 2002 to February 2004) at a single institution according to a standardized clinical guideline were compared to 51 matched control patients, with the control patients identified from a large database and matched based on the propensity for massive blood loss. RESULTS: Blood loss and blood product usage were significantly decreased after 2.4 to 4.8 mg of rF-VIIa. In those treated after sternal closure (n = 32), there was a significant reduction in blood loss from the hour before to the hour after treatment: 100 (70, 285) mL (median [25th, 75th percentiles]; p < 0.0001). Except for a slower postoperative recovery and higher incidence of acute renal dysfunction, the adverse event rates were similar between the rF-VIIa-treated patients and their matched controls. CONCLUSIONS: These results suggest that rF-VIIa may be an effective rescue therapy for patients with intractable hemorrhage after cardiac surgery. A clinically important risk of stroke or other major thrombotic complications could not be ruled out by our study. Controlled clinical trials with adequate power to detect the impact of rF-VIIa therapy on morbidity and mortality therefore are necessary before one can recommend its routine use in patients undergoing cardiac surgery who have excessive bleeding.
BACKGROUND: Cardiac surgery is occasionally complicated by massive blood loss that is refractory to standard hemostatic interventions. Recombinant factor VIIa (rF-VIIa) is being increasingly used as rescue therapy in such cases, but little information is available on its safety and efficacy for this indication. STUDY DESIGN AND METHODS: The outcomes of the first 51 cardiac surgery patients who received rF-VIIa for intractable blood loss (from November 2002 to February 2004) at a single institution according to a standardized clinical guideline were compared to 51 matched control patients, with the control patients identified from a large database and matched based on the propensity for massive blood loss. RESULTS:Blood loss and blood product usage were significantly decreased after 2.4 to 4.8 mg of rF-VIIa. In those treated after sternal closure (n = 32), there was a significant reduction in blood loss from the hour before to the hour after treatment: 100 (70, 285) mL (median [25th, 75th percentiles]; p < 0.0001). Except for a slower postoperative recovery and higher incidence of acute renal dysfunction, the adverse event rates were similar between the rF-VIIa-treated patients and their matched controls. CONCLUSIONS: These results suggest that rF-VIIa may be an effective rescue therapy for patients with intractable hemorrhage after cardiac surgery. A clinically important risk of stroke or other major thrombotic complications could not be ruled out by our study. Controlled clinical trials with adequate power to detect the impact of rF-VIIa therapy on morbidity and mortality therefore are necessary before one can recommend its routine use in patients undergoing cardiac surgery who have excessive bleeding.
Authors: Nicholas D Andersen; Syamal D Bhattacharya; Judson B Williams; Emil L Fosbol; Evelyn L Lockhart; Mayur B Patel; Jeffrey G Gaca; Ian J Welsby; G Chad Hughes Journal: Ann Thorac Surg Date: 2012-05-01 Impact factor: 4.330