Bleeding-Related Complications and Readmission Rates Associated With Fibrin Sealant Use in Patients Undergoing Coronary Artery Bypass Graft Surgery in the United States

Abstract

Objectives: To compare the clinical and economic outcomes of EVICEL (Ethicon, Inc., Somerville, NJ) and TISSEEL (Baxter Healthcare Corporation, Westlake Village, CA) use in patients undergoing primary coronary artery bypass graft (CABG) surgery.

Design: Retrospective database analysis.

Setting: Premier prospective hospital database (June 2009 through March 2014) covering approximately 20% of hospital discharges in the United States.

Participants: Adults undergoing primary CABG surgery who received either EVICEL or TISSEEL on the day of surgery (index date).

Interventions: Two intervention groups were formed, EVICEL and TISSEEL. Clinical outcomes compared included postoperative bleeding complications (International Classification of Diseases, Ninth Revision, Clinical Modification code: 998.1) and number of blood transfusions received on the index day. Economic outcomes compared included hospital length of stay, hospital costs, and 30-day readmission rates. Propensity-score matching was used to control for patient and hospital characteristics.

Measurements and main results: A total of 129,014 primary CABG surgery patients were identified; 986 patients (mean age: 64 years, 73% male) received EVICEL and 6,340 patients (mean age: 65 years, 75% male) received TISSEEL on the index day. After propensity-score matching, patients who received EVICEL compared with TISSEEL had significantly fewer postoperative bleeding complications (3.0% v 5.0%, p = 0.0197), index-day blood transfusion rates (19% v 34%, p<0.0001), readmission rates (18% v 32%, p<0.0001), and costs ($40,736 [standard deviation $19,465] v $46,005 [standard deviation $24,049], p<0.0001). Results from a sensitivity analysis using a generalized linear model to control for other hemostatic agent use also favored EVICEL over TISSEEL.

Conclusion: Results from this real-world retrospective database analysis showed fewer bleeding complications and lower costs in patients undergoing primary CABG surgery who received EVICEL compared with TISSEEL.

Keywords: CABG surgery; bleeding complications; clotting; coagulation; fibrin sealants; hospital costs; transfusions.