Sex differences on the effect of hemoadsorption during cardiac surgery - A REMOVE trial post-hoc analysis

Abstract

Objectives: Multi-organ failure is one of the leading causes of mortality after cardiac surgery for infective endocarditis (IE). Although the randomized evidence does not support the use of hemoadsorption during cardiac surgery for IE, observational studies suggest a beneficial effect in selected patient groups. We aimed to analyze the effect of sex differences on hemoadsorption in patients with IE.

Methods: This is a post-hoc analysis of the REMOVE-trial that randomized patients with IE who underwent cardiac surgery with hemoadsorption using CytoSorb® or control. The primary endpoint was variation of Sequential Organ Failure Assessment (ΔSOFA), defined as the difference between the mean total postoperative and baseline SOFA score within 24 h of surgery. The secondary endpoints were 30-day mortality and other usual postoperative outcomes.

Results: Among 282 patients, 73 (25.9 %) were females (38 and 35 patients in the hemoadsorption and control group, respectively) and 209 (74.1 %) were males (98 and 111 patients in the hemoadsorption and control group, respectively). The overall ΔSOFA did not differ significantly between the intervention groups in both female and male subgroups (MD: -2.13, 95 % CI -5.20 to 0.93, p = 0.163; MD: 0.31, 95 % CI -0.91 to 1.53, p = 0.612, respectively) and neither did 30-day mortality (HR = 0.54, 95 % CI 0.23 to 1.24, p = 0.132; HR 1.17, 95 % CI 0.61 to 2.21, p = 0.634, respectively). No significant differences were observed concerning the other secondary outcomes.

Conclusion: The intraoperative use of hemoadsorption was not associated with reduction of postoperative organ dysfunction, 30-day mortality, or other major clinical endpoints in both sex subgroups.

Keywords: Heart surgery; Hemoadsorption; Infective endocarditis; Inflammation.