OBJECTIVES: To compare costs and effectiveness of using two different hemostatic matrices (Hemopatch vs. dry or wet gauze compression or similar standard of care (SOC)) in cardiac surgery from the Italian hospital perspective.

METHODS: Using clinical outcomes from a published randomized control trial (Weltert 2016), a costing framework was utilized to model the economic impact of using Hemopatch in 170 cardiac surgeries. In this trial, patients treated with Hemopatch had a 97.6% hemostasis success rate (defined as reaching hemostasis in three minutes) which was statistically significantly better than 65.8% with SOC (p<0.001). Additional clinically significant endpoints studied in the trial (blood transfusions and surgical revisions) were also analyzed. It was assumed that each surgery utilized 2 units of Hemopatch (dimensions of 4.5 x 9 cm) and 2 units of SOC. The Italian product acquisition costs for Hemopatch and SOC were included along with outcome-related costs derived from the literature and adjusted to 2017 EUR using standard inflation estimates. One-way sensitivity analysis (OWSA) and probabilistic sensitivity analyses (PSA) were performed by varying all variables within the 95% confidence interval (CI) of the point estimate or ±20% when CI was not available.

RESULTS: Considering only product acquisition cost, Hemopatch had an incremental cost effectiveness ratio (ICER) of €619.81 per hemostasis success when compared to SOC. However, when considering the cost and potential difference in the frequency of transfusions and revisions compared to SOC, the ICER reduced to €474.27 and Hemopatch was associated with a reduction of 1.87 revisions and 17.85 transfusions, saving €3,901.74 and €3,966.27, respectively. Sensitivity analysis demonstrated model robustness.

CONCLUSIONS: This analysis supports the use of Hemopatch over standard of care in cardiac surgery in Italian hospitals, as it offers a statistically significant higher hemostasis success rate and may lead to sizable cost savings from reduced transfusions and surgical revisions.