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| Administration of Recombinant Activated Factor VII in the Intensive Care Unit After Complex Cardiovascular Surgery: Clinical and Economic Outcomes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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John M. Toole1, Jason S. Haney2, Martha R. Stroud1, John Lazarchick3, Fred A. Crawford1, Walt Uber2, John S. Ikonomidis1; 1Cardiothoracic Surgery, Medical University of South Carolina, Charleston, SC; 2Pharmacy Services, Medical University of South Carolina, Charleston, SC; 3Pathology and Laboratory Medicince, Medical University of South Carolina, Charleston, SC Objective: Reoperation for bleeding following complex cardiovascular surgery is associated with increased morbidity and mortality. Recombinant activated factor VII (rFVIIa) can reverse intraoperative coagulopathy in patients undergoing cardiovascular surgery. However, its high cost and potential thrombotic risk are concerning. This study evaluated the clinical and economic impact of rFVIIa administration in the intensive care unit (ICU) to avoid reoperation for bleeding following high-risk cardiovascular procedures. Methods: From December 2003 to September 2007, 421 patients undergoing high-risk procedures (cardiac transplant, aortic surgery, redo operations, multiple cardiac procedures) were evaluated for post-operative bleeding defined as chest tube output >3 mL/kg/hr for >2 consecutive hours and their need for rFVIIa in the ICU following the primary surgery for refractory bleeding or reoperation for refractory bleeding in the first 24 hours. Patients with post-operative bleeding but who did not receive rFVIIa or undergo reoperation were included to determine post-operative bleeding incidence. Patients who received rFVIIa in the ICU were compared to patients who did not receive rFVIIa but underwent reoperation for bleeding with regard to demographics, risk assessment, blood product use, reoperation rates, OR time, ventilator time, ICU and hospital length of stay, mediastinitis, thrombotic events, renal failure, survival, and hospital cost/reimbursement. Results: The incidence of post-operative bleeding, indication for reoperation, and reoperation were 5.9% (25/421), 5.7% (24/421), and 3.6% (15/421), respectively. In this cohort, 12 patients, who all met criteria for reoperation, received rFVIIa in the ICU after their primary operation and 12 patients underwent reoperation for bleeding without receiving rFVIIa. In the rFVIIa group, hemostasis was achieved in 9 (75%) patients with a significant decrease in chest tube output (5.3 vs. 1.8 mL/kg/hr, p=0.002). Reoperation for bleeding was required in 3 patients in the rFVIIa group. Total OR time was significantly decreased in the rFVIIa group (444 vs. 599 min, p=0.001). Hospital survival was 100% in both groups. There were no discernable differences for efficacy, safety, and cost endpoints (Table). Conclusion: In high-risk cardiovascular surgery patients, rFVIIa can control refractory non-surgical post-operative hemorrhage and may reduce reoperation for bleeding with no appreciable increase in cost.
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