Real-World Outcomes of Hemostatic Matrices in Cardiac Surgery

Abstract

ObjectiveWhile hemostatic matrices are efficacious in achieving hemostasis, outcomes research is limited; therefore, this study analyzed clinical outcomes of flowable hemostatic matrices in a real-world cardiac surgical population.DesignRetrospective database analysis of cardiac surgical cases from 2006 to 2012.SettingData were extracted from Premier’s United States (US) Perspective Database, developed for quality and utilization benchmarking and containing approximately 25% of US hospital discharges.ParticipantsCoronary artery bypass grafting (CABG), aortic, valve, or valvular with CABG surgery cases in which FLOSEAL or SURGIFLO was included.InterventionsThree study groups were formed, given usage of hemostatic matrices: (1) FLOSEAL or SURGIFLO, exclusively; (2) FLOSEAL or SURGIFLO, with fibrin sealants, sealants, or powder hemostats; and (3) FLOSEAL or SURGIFLO, with nonflowable hemostats with or without thrombin. Outcomes included complications, transfusions, surgical revisions, mortality, length of stay (LOS) and surgery time.Measurements and Main ResultsGroup A included 4,480 FLOSEAL and 326 SURGIFLO cases. Results suggested SURGIFLO cases were associated with significantly higher risk of multiple adverse outcomes, including major (odds Ratio [OR] 2.12; 95% CI 1.34-3.35; p = 0.001) and minor complications (OR 1.84; 95% CI 1.33-2.55; p<0.001); surgical revisions (OR 2.01; 95% CI 1.03- 3.94; p = 0.042); transfusions for any blood products (OR 4.90; 95% CI 3.50-6.87; p<0.001); and longer surgery times (adjusted mean difference = 64 minutes, p<0.001) than the FLOSEAL group. There were no significant differences in mortality and LOS. Results were similar in groups B and C.ConclusionsThese retrospective outcomes suggested FLOSEAL was associated with fewer negative consequences than SURGIFLO in this surgical population