Real-world outcomes of hemostatic matrices in cardiac surgery
Scott M Tackett1, Domenico Calcaterra2, Glenn Magee3
1Baxter Healthcare Corporation, Westlake Village, CA.
Objective:
While 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.
Design:
Retrospective database analysis of cardiac surgical cases from 2006 to 2012.
Setting:
Data were extracted from Premier's United States (US) Perspective Database, developed for quality and utilization benchmarking and containing approximately 25% of US hospital discharges.
Participants:
Coronary artery bypass grafting (CABG), aortic, valve, or valvular with CABG surgery cases in which FLOSEAL or SURGIFLO was included.
Interventions:
Three 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 Results:
Group 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.
Conclusions:
These retrospective outcomes suggested FLOSEAL was associated with fewer negative consequences than SURGIFLO in this surgical population.
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