Analysis of Outcomes Using Low-Dose and Early Administration of Recombinant Activated Factor VII in Cardiac Surgery

Abstract

Although not currently approved for postoperative cardiac surgical bleeding, recombinant activated factor VII (rFVIIa) has been used for this purpose. This study sought to analyze outcomes in patients who had cardiac surgical bleeding and received low-dose and early administration of rFVIIa versus outcomes in patients who had cardiac surgical bleeding and did not receive rFVIIa. Fifty-one patients receiving rFVIIa were matched, using The Society of Thoracic Surgeons morbidity and mortality scores, with 51 patients who underwent cardiac surgical procedures and met criteria for surgical bleeding. Primary outcomes were ventilator hours and intensive care unit length of stay. Secondary outcomes included 30-day mortality, acute kidney injury, postoperative hospital length of stay, thromboembolic events, postoperative pneumonia, and sternal wound infections. Reoperations for bleeding were analyzed for each group to assess for achievement of hemostasis. The median total dose of rFVIIa was 12 mcg/kg. rFVIIa was given as the first and only treatment for bleeding in 7 of 51 (13%) patients, whereas 13 of 51 patients receiving rFVIIa (25%) also received up to 1 unit of anyblood product. Patients who received rFVIIa had increased duration of mechanical ventilation (p= 0.002) and increased length of stay in the intensive care unit (p=0.02). There were no differences in hospital length ofstay, 30-day mortality, acute kidney injury, postoperative pneumonia, sternal wound infections, postoperative thromboembolic events, or rate of reoperations for bleeding. Low-dose and early administration of rFVIIa (median total dose 12 mcg/kg) for cardiac surgical bleeding shows potential in achieving hemostasis without increased risk of thromboembolism or acute kidney injury.