Intraoperative Hemoadsorption (Cytosorb™) during Open Thoracoabdominal Aortic Repair: A Pilot Randomized Controlled Trial

Doukas, Panagiotis; Hellfritsch, Gabriel; Wendt, Daniel; Magliani, Mirko; Barbati, Mohammad E.; Jalaie, Houman; Jacobs, Michael J.; Gombert, Alexander

doi:10.3390/jcm12020546

Cited by 11 publications

(14 citation statements)

References 36 publications

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“…11 On the other hand, several recent RCTs including intraoperative haemoadsorption in medium-to high-risk cardiac surgical patients reported controversial data on the post-operative need for vasoactive support. 10,[25][26][27][28] The results of our RCT are in line with earlier observational studies confirming a clear relationship between intraoperative haemoadsorption and the moderate manifestation of post-operative vasoplegia. Most likely, the discrepancies among these results can be explained by the inhomogeneity of the examined patient populations in terms of perioperative risk for severe vasoplegia.…”

Section: Discussionsupporting

confidence: 91%

“…Similarly, in a propensity score matched analysis of high‐risk infective endocarditis patients, the median vasopressor dose on post‐operative day 1 was found to be significantly lower in the haemoadsorption group than in controls 11 . On the other hand, several recent RCTs including intraoperative haemoadsorption in medium‐ to high‐risk cardiac surgical patients reported controversial data on the post‐operative need for vasoactive support 10,25–28 . The results of our RCT are in line with earlier observational studies confirming a clear relationship between intraoperative haemoadsorption and the moderate manifestation of post‐operative vasoplegia.…”

Section: Discussionsupporting

confidence: 89%

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Use of intraoperative haemoadsorption in patients undergoing heart transplantation: a proof‐of‐concept randomized trial

Nemeth,

Soltesz,

Kovacs

et al. 2023

ESC Heart Failure

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AimsThe aim of this trial was to compare the clinical effects of intraoperative haemoadsorption versus standard care in patients undergoing orthotopic heart transplantation (OHT).Methods and resultsIn a randomized, controlled trial, OHT recipients were randomized to receive intraoperative haemoadsorption or standard care. Outcomes were vasoactive‐inotropic score (VIS), frequency of vasoplegic syndrome (VS) in the first 24 h; post‐operative change in procalcitonin (PCT) and C‐reactive protein (CRP) levels; intraoperative change in mycophenolic acid (MPA) concentration; frequency of post‐operative organ dysfunction, major complications, adverse immunological events and length of in‐hospital stay and 1‐year survival. Sixty patients were randomized (haemoadsorption group N = 30, control group N = 25 plus 5 exclusions). Patients in the haemoadsorption group had a lower median VIS and rate of VS (VIS: 27.2 [14.6–47.7] vs. 41.9 [22.4–63.2], P = 0.046, and VS: 20.0% vs. 48.0%, P = 0.028, respectively), a 6.4‐fold decrease in the odds of early VS (OR: 0.156, CI: 0.029–0.830, P = 0.029), lower PCT levels, shorter median mechanical ventilation (MV: 25 [19–68.8] hours vs. 65 [23–287] hours, P = 0.025, respectively) and intensive care unit stay (ICU stay: 8.5 [8.0–10.3] days vs. 12 [8.5–18.0] days, P = 0.022, respectively) than patients in the control group. Patients in the haemoadsorption versus control group experienced lower rates of acute kidney injury (AKI: 36.7% vs. 76.0%, P = 0.004, respectively), renal replacement therapy (RRT: 0% vs. 16.0%, P = 0.037, respectively) and lower median per cent change in bilirubin level (PCB: 2.5 [−24.6 to 71.1] % vs. 72.1 [11.2–191.4] %, P = 0.009, respectively) during the post‐operative period. MPA concentrations measured at pre‐defined time points were comparable in the haemoadsorption compared to control groups (MPA pre‐cardiopulmonary bypass: 2.4 [1.15–3.60] μg/mL vs. 1.6 [1.20–3.20] μg/mL, P = 0.780, and MPA 120 min after cardiopulmonary bypass start: 1.1 [0.58–2.32] μg/mL vs. 0.9 [0.45–2.10] μg/mL, P = 0.786). The rates of cardiac allograft rejection, 30‐day mortality and 1‐year survival were similar between the groups.ConclusionsIntraoperative haemoadsorption was associated with better haemodynamic stability, mitigated PCT response, lower rates of post‐operative AKI and RRT, more stable hepatic bilirubin excretion, and shorter durations of MV and ICU stay. Intraoperative haemoadsorption did not show any relevant adsorption effect on MPA. There was no increase in the frequency of early cardiac allograft rejection related to intraoperative haemoadsorption use.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 89%

Use of intraoperative haemoadsorption in patients undergoing heart transplantation: a proof‐of‐concept randomized trial

Nemeth,

Soltesz,

Kovacs

et al. 2023

ESC Heart Failure

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“…Of note, the investigators analyzed complex aortic surgery patients including selective cerebral perfusion with hypothermic circulatory arrest. A small pilot study from India [ 26 ] mainly included elective aortic root replacements and a pilot RCT from Germany [ 27 ] enrolled patients who underwent open thoracoabdominal aortic aneurysm (TAAA) repair on CPB. This subgroup contains 186 patients treated with hemoadsorption who were compared to 193 control patients.…”

Section: Resultsmentioning

confidence: 99%

The role of hemoadsorption in cardiac surgery – a systematic review

Matejic-Spasic,

Lindstedt,

Lebreton

et al. 2024

BMC Cardiovasc Disord

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Background Extracorporeal blood purification has been widely used in intensive care medicine, nephrology, toxicology, and other fields. During the last decade, with the emergence of new adsorptive blood purification devices, hemoadsorption has been increasingly applied during CPB in cardiac surgery, for patients at different inflammatory risks, or for postoperative complications. Clinical evidence so far has not provided definite answers concerning this adjunctive treatment. The current systematic review aimed to critically assess the role of perioperative hemoadsorption in cardiac surgery, by summarizing the current knowledge in this clinical setting. Methods A literature search of PubMed, Cochrane library, and the database provided by CytoSorbents was conducted on June 1st, 2023. The search terms were chosen by applying neutral search keywords to perform a non-biased systematic search, including language variations of terms “cardiac surgery” and “hemoadsorption”. The screening and selection process followed scientific principles (PRISMA statement). Abstracts were considered for inclusion if they were written in English and published within the last ten years. Publications were eligible for assessment if reporting on original data from any type of study (excluding case reports) in which a hemoadsorption device was investigated during or after cardiac surgery. Results were summarized according to sub-fields and presented in a tabular view. Results The search resulted in 29 publications with a total of 1,057 patients who were treated with hemoadsorption and 988 control patients. Articles were grouped and descriptively analyzed due to the remarkable variability in study designs, however, all reported exclusively on CytoSorb® therapy. A total of 62% (18/29) of the included articles reported on safety and no unanticipated adverse events have been observed. The most frequently reported clinical outcome associated with hemoadsorption was reduced vasopressor demand resulting in better hemodynamic stability. Conclusions The role of hemoadsorption in cardiac surgery seems to be justified in selected high-risk cases in infective endocarditis, aortic surgery, heart transplantation, and emergency surgery in patients under antithrombotic therapy, as well as in those who develop a dysregulated inflammatory response, vasoplegia, or septic shock postoperatively. Future large randomized controlled trials are needed to better define proper patient selection, dosing, and timing of the therapy.

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“…The most extensive study (23) included various surgical interventions involving the thoracic aorta while patients were in hypothermic circulatory arrest, comprising elective and acute procedures. A small pilot study from India (24) mainly included elective aortic root replacements and a pilot RCT from Germany (25) Overall, less need for vasopressor therapy and blood product transfusions was observed compared to controls, and there was a lower incidence of acute respiratory distress syndrome (ARDS) in the TAAA patients. Mechanical ventilation-related outcomes were notably better within the intervention groups.…”

Section: Aortic Surgerymentioning

confidence: 99%

The role of hemoadsorption in cardiac surgery – a systematic review

Matejic-Spasic,

Lindstedt,

Lebreton

et al. 2024

Preprint

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Background Despite advancements, cardiopulmonary bypass-assisted cardiac surgery still carries a significant risk for morbidity and mortality, often related to postoperative hyperinflammation. Hemoadsorption of cytokines and various exogenous and endogenous inflammation triggers has been increasingly used in cardiac surgery to mitigate the risk of inflammation-mediated complications. Clinical evidence so far has not provided definite answers concerning this adjunctive treatment. The current systematic review aimed to assess the role of perioperative hemoadsorption in cardiac surgery critically. Methods A PubMed literature search with predefined criteria was conducted. The screening and selection process followed rigorous scientific principles (PRISMA statement). The search resulted in 29 publications that were grouped and descriptively analyzed due to the remarkable variability in study designs, however, they all reported exclusively on CytoSorb® therapy. Results CytoSorb® use was proven feasible and safe with no unanticipated device-related adverse events reported in the retrieved articles. The most frequently reported clinical outcome associated with hemoadsorption was reduced vasopressor demand resulting in better hemodynamic stability. Conclusions The role of hemoadsorption in cardiac surgery seems to be justified in selected high-risk cases in infective endocarditis, aortic surgery, heart transplantation, and emergency surgery of patients under antithrombotic therapy, as well as in those who develop a dysregulated inflammatory response, vasoplegia, or septic shock postoperatively. Current evidence suggests limited value from CytoSorb® use in routine elective surgery and low-risk patients. Further evaluation in more extensive prospective trials is required concerning proper patient selection and postoperative timing and administration.

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Intraoperative Hemoadsorption (Cytosorb™) during Open Thoracoabdominal Aortic Repair: A Pilot Randomized Controlled Trial

Cited by 11 publications

References 36 publications

Use of intraoperative haemoadsorption in patients undergoing heart transplantation: a proof‐of‐concept randomized trial

Use of intraoperative haemoadsorption in patients undergoing heart transplantation: a proof‐of‐concept randomized trial

The role of hemoadsorption in cardiac surgery – a systematic review

The role of hemoadsorption in cardiac surgery – a systematic review

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