Risk-Reduction by direct thrombin antagonism during ECMO therapy

Background: ECMO-patients can develop heparin (Hep)-induced-thrombocytopenia Type II (HITII). Approval for direct thrombin-antagonism is lacking. We analyze if direct thrombin antagoism feasible, save and not inferior to heparin. Methods: 254 multicenter prospective patients (vv- or va-ECMO) were analyzed in 4 different cardiothoracic, pulmonary, or anesthesiological intensive care units at university hospitals in XXXXXXX from 2020 to 2022. Results: 153 va-ECMO / 101 vv-ECMO patients always received heparin (95/43), only DTA (8/6) or a switch (50/52) from heparin to direct thrombin antagonism (DTA) in cases of suspected HITII and reduced platelet count (reduction: p =0.017). ICU morbidity, survival, therapeutic stability of anticoagulation, bleeding, thrombosis and technical integrity was analyzed regarding non inferiority and superiority of DTA versus heparin. Patients who changed anticoagulation showed increased infection levels before the change. Before switching from heparin to DTA, there was only a moderate increase in the INR, a decrease in the Quick and no therapeutic increase in the PTT with heparin. With regard to thrombosis and system occlusions, there is no difference between heparin and DTA. Weaning rates from extracorporal support and survival analysis did show non-inferiority of DTA. After switching a clear superiority of DTA in terms of (A) overall complication rate CI((0.6479/0.7871/0.9546)) (defined as bleeding from any cause, stroke, amputation, thrombosis and device-occlusion) and (B) bleeding from any cause alone CI((0.6432/0.7829/0.9513)) and a NON inferiority in terms of preventing strokes exists. Conclusions: DTA is not inferior to heparin in ECLS/ECMO therapy. Regarding all complications, stroke, thromboembolism, amputation DTA is superior.