Real-World Clinical and Economic Outcomes Associated with Surgiflo® vs Floseal in Cardiovascular Surgeries in the US.

Abstract

Background: Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo^®, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface.

Objective: To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries.

Methodology: A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups.

Results: The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by >2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44,146 vs $46,812), and lower odds of readmission at 30, 60, and 90 days post-discharge (all P < 0.05). Inpatient mortality and LOS were comparable between Surgiflo and Floseal (all P > 0.05).

Conclusion: In this large study of real-world clinical and economic outcomes after cardiovascular surgery involving the current formulation of Surgiflo vs Floseal, Surgiflo was associated with mostly similar clinical outcomes as compared with Floseal. Differences in selected economic/resource use outcomes were also observed, for which root-cause analysis in future research would be informative.