Sex-Related Prognosis of VA-ECMO-Treated Cardiogenic Shock: A Post-Hoc Analysis of the HYPO-ECMO Trial.

Abstract

Background: The sex-related prognosis of patients with cardiogenic shock (CS) undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) remains unclear. Our analyses aim to assess sex-specific outcomes in patients with CS receiving VA-ECMO and explored whether the effect of moderate hypothermia (MH) on clinical outcomes was modified by sex. Methods: In this post-hoc analysis of the HYPO-ECMO trial, clinical outcomes were compared by sex. The primary outcome was 30-day all-cause mortality (ACM). Key secondary outcomes included ACM and a composite outcome of ACM, heart transplant, escalation to left ventricular assist device implantation, or stroke at 30, 60 and 180 days. Results: Among the 334 patients enrolled in the trial, 81 (24%) were female. At 30 days, 45.7% of female and 46.6% of male patients experienced the primary outcome, with no sex differences (adjusted OR, 1.01 [0.57 - 1.78], p=0.98 and log-rank test, p=0.93). No significant sex differences were observed in all-cause mortality at 60 and 180 days (adjusted OR, 0.87 [0.49 - 1.52], p=0.61 and 0.83 [0.47 - 1.46], p=0.51, respectively) or in the composite outcome up to 180 days (p>0.2 for all). The effect of MH on the primary outcome (aOR, 0.73 [0.43 - 1.25], p=0.25 and 0.67 [0.26 - 1.76], p=0.41, in male and female respectively, interaction p-value = 0.88) and secondary outcomes (interaction p-value >0.3 for all) was not modified by sex. Conclusions: In this post-hoc analysis of the HYPO-ECMO trial, male and female experienced similar outcomes in CS treated with VA-ECMO. Sex did not significantly modify the effect of moderate hypothermia on outcomes. Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02754193.