Prof Dr Daniel Wendt on: Use of intraoperative haemoadsorption in patients undergoing heart transplantation: A proof-of-concept randomized trial
Nemeth E, et al. ESC HeartFailure 2023; epub DOI: 10.1002/ehf2.14632

Heart transplant surgery is a complex journey that goes beyond the operating table and it is seen as the royal discipline in cardiac surgery. The challenges during the postoperative phase, like vasoplegia or multi-organ dysfunction, can overshadow the success of the transplantation. A recent groundbreaking randomized controlled trial, explored a new approach by using intraoperative hemoadsorption by CytoSorb® during orthotopic heart transplant surgery.

This important study was performed from April 2018 to December 2021 at the prestigious Semmelweis university in Budapest. The authors specifically focused on adult heart transplantation candidates presenting with UNOS status 6, which is the least urgent medical status according to the United Network for Organ Sharing criteria. Having said that, the study had strict exclusion criteria to ensure a similar patient group, excluding urgent cases, re-transplantations, pre-operative mechanical circulatory support or inotropic dependence.

Out of the initially randomized 60 patients, 30 received CytoSorb® during surgery, while 25 served as the control group after excluding five patients for various reasons. Both groups had comparable baseline characteristics, except for a difference in pre-transplant amiodarone use, which influenced the baseline risk for postoperative vasoplegia. The primary trial outcome focused on post-operative hemodynamic instability, measured by the vasoactive-inotropic score (VIS), frequency of vasoplegic syndrome, and duration of vasopressor requirement. The CytoSorb®-treated group showed significantly lower VIS during the initial 24 hours post-surgery, a reduced incidence of vasoplegic syndrome, and a shorter duration of vasopressor support compared to the control group.

Importantly, the CytoSorb® intervention had no device-related adverse events, comparable 30-day mortality rates, no mycophenolic acid removal or an impact on immunosuppressive drugs and no reported cardiac allograft rejection. Moreover, shorter times on the ventilator in line with shorter ICU-stay in the CytoSorb® treated patients might not only impact clinical, but also economical outcomes. These findings align with earlier observational studies, supporting the connection between intraoperative hemoadsorption and reduced post-operative vasoplegia as one of the major findings. It is therefore important to clearly define homogeneous patient populations including appropriate endpoints what the authors obviously considered. By doing so, such results as shown in the study by Nemeth et al. (reduced vasoplegia and less inotropic support) might be transferable to other indications.

Since the authors could show that intraoperative hemoadsorption did not impact immunosuppressive therapy, one could speculate that hemoadsorption could be also applied e.g. in septic patients following solid organ transplantation (e.g. liver, kidney etc.).

The significance of this randomized controlled trial extends beyond its outcomes to its methodology—a structured approach aligned with evidence-based medicine. By focusing specifically on Status 6 heart transplantation patients, the study progresses strategically from retrospective analysis to randomized controlled trial validation, confirming the clinical benefits of CytoSorb® as an adjunctive therapy in heart transplantation.

In conclusion, this pioneering randomized controlled trial presents a promising direction supported by empirical evidence for integrating CytoSorb® into the interventions during heart transplant surgeries. It calls for further exploration, potentially reshaping the path of post-transplant care and enhancing the lives of patients undergoing this life-changing procedure.

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About the Author

Prof Dr. Wendt, a cardiac surgeon based in Essen, formerly served as the co-director of the Westgerman Heart and Vascular Center in Essen until 2021. From January 1st 2022, he was appointed as Vice President (cardiovascular) of the company CytoSorbents. His medical expertise covers the whole field of adult cardiac surgery, and he is also specialized in intensive care medicine. Moreover, he is member of numerous medical societies, and he serves as Editorial Board member for many scientific journals. So far, he published more than 150 peer-reviewed articles.