Use of intraoperative haemoadsorption in patients undergoing heart transplantation: a proof-of-concept randomized trial.
Nemeth, E., et al.ESC heart failure 2023 [record in progress].
Aims
This study aimed to investigate the role of intraoperative haemoadsorption in orthotopic heart transplant patients.
Interventions
Participants were randomised to receive either intraoperative haemoadsorption or standard care.
Participants
60 patients undergoing orthotopic heart transplantation.
Outcomes
The primary endpoint was early post-operative haemodynamic instability. Secondary endpoints were changes in procalcitonin (PCT) and C-reactive protein (CRP) levels post-operation, intraoperative change in mycophenolic acid (MPA) concentration, early allograft rejection, frequency of post-operative organ dysfunction, adverse immunological events, major complications, duration of ICU and in-hospital stay, and 1-year survival.
Follow-up
1 year
CET Conclusions
This is a very interesting, novel, RCT in heart transplantation. Heart recipients were randomised to standard care or to receive additional therapy with intra-operative hemoadsorption with the Cytosorb system from CytoSorbents, NJ, USA. The hemoadsorption cartridge was integrated into the cardiopulmonary bypass system and has been shown previously to remove cytokines, chemokines, bilirubin, myoglobin and plasma free haemoglobin. Patients were blinded to the treatment allocation, but clinical professionals were not. No sample size calculation could be done due to a lack of prior data on which to base it. The study found statistically significant differences across a range of outcomes, including the primary outcomes. Patients receiving hemoadsorption had a lower vasoactive-inotropic score, frequency of vasoplegic syndrome, risk of AKI, shorter median mechanical ventilation and median intensive care stay (by 3.5 days). The rates of cardiac allograft rejection, 30-day mortality and 1-year survival were similar between the groups, although it may have been too small to show differences in these outcomes. There were no device related complications.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT03145441