Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study).

Alexandre Mansour, Antoine Beurton, Anne Godier, Bertrand Rozec, Diane Zlotnik, Fabienne Nedelec, Pascale Gaussem, Mathieu Fiore, Elodie Boissier, Nicolas Nesseler, Alexandre Ouattara

Journal: Anesthesiology 2023;139(3):287-297

PMID: 37294939

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Abstract

BACKGROUND

Centrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets. The authors tested the hypothesis that this new device could allow a red blood cell recovery exceeding 80% with a posttreatment hematocrit exceeding 40%, and would remove more than 90% of heparin and 75% of free hemoglobin.

METHODS

Adults undergoing on-pump elective cardiac surgery were included in a noncomparative multicenter trial. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. The primary outcome was a composite of cell recovery performance, assessed in the device by red blood cell recovery and posttreatment hematocrit, and of biologic safety assessed in the device by the washout of heparin and free hemoglobin expressed as removal ratios. Secondary outcomes included platelet recovery and function and adverse events (clinical and device-related adverse events) up to 30 days after surgery.

RESULTS

The study included 50 patients, of whom 18 (35%) underwent isolated coronary artery bypass graft, 26 (52%) valve surgery, and 6 (12%) aortic root surgery. The median red blood cell recovery per cycle was 86.1% (25th percentile to 75th percentile interquartile range, 80.8 to 91.6) with posttreatment hematocrit of 41.8% (39.7 to 44.2). Removal ratios for heparin and free hemoglobin were 98.9% (98.2 to 99.7) and 94.6% (92.7 to 96.6), respectively. No adverse device effect was reported. Median platelet recovery was 52.4% (44.2 to 60.1), with a posttreatment concentration of 116 (93 to 146) · 109/l. Platelet activation state and function, evaluated by flow cytometry, were found to be unaltered by the device.

CONCLUSIONS

In this first-in-human study, the same™ device was able to simultaneously recover and wash both platelets and red blood cells. Compared with preclinical evaluations, the device achieved a higher platelet recovery of 52% with minimal platelet activation while maintaining platelet ability to be activated in vitro.

Address: Department of Anesthesia and Critical Care, Pontchaillou, University Hospital of Rennes, National Institute of Health and Medical Research, Center of Clinical Investigation, Research Institute for Environmental and Occupational Health, Mixed Research Unit S1085, University Hospital Federation Survival Optimization in Organ Transplantation, Univ Rennes, Rennes, France.; CHU Bordeaux, Department of Cardiovascular Anaesthesia and Critical Care, Haut-Lévêque hospital, University Bordeaux, National Institute of Health and Medical Research, Mixed Research Unit 1034, Biology of Cardiovascular Diseases, Pessac, France.; Université Paris Cité, Department of Anesthesiology and Critical Care, European Hospital Georges Pompidou, Public Hospitals of Paris, National Institute of Health and Medical Research, Mixed Research Unit S1140, Innovative Therapies in Haemostasis, Paris, France.; Department of Anesthesia and Critical Care, University Hospital of Nantes, France, CHU Nantes.; Paris Cité University, Department of Anaesthesiology and Critical Care, Hospital Georges Pompidou, Public Hospitals of Paris, Paris, France.; Department of Hematology, Pontchaillou, University Hospital of Rennes, France; Univ Rennes, Rennes, France.; Paris Cité University, Innovative Therapies in Haemostasis, Department of Hematology, National Institute of Health and Medical Research, Mixed Research Unit S1140, European Hospital Georges Pompidou, Public Hospitals of Paris, Paris, France.; Hematology Laboratory, Reference Centre for Platelet Disorders, Haut-Lévêque Hospital, University Hospital of Bordeaux, Pessac, France; National Institute of Health and Medical Research U1034, Biology of Cardiovascular Diseases, Bordeaux University, Pessac, France.; Department of Hematology, University Hospital of Nantes, France, CHU Nantes.; Department of Anesthesia and Critical Care, Pontchaillou, University Hospital of Rennes, France; Univ Rennes, CHU Rennes, National Institute of Health and Medical Research, Center of Clinical Investigation, Nutrition, Metabolism, Cancer, Mixed Research Unit S1241, University Hospital Federation Survival Optimization in Organ Transplantation), Univ Rennes, Rennes, France.; University Hospital of Bordeaux, CHU Bordeaux, Department of Cardiovascular Anaesthesia and Critical Care, Haut-Lévêque Hospital, National Institute of Health and Medical Research, Mixed Research Unit 1034, Biology of Cardiovascular Diseases, Pessac, France.

DOI: 10.1097/ALN.0000000000004642

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MeSH Terms: Adult, Humans, Blood Transfusion, Autologous, Blood Platelets, Erythrocytes, Cardiac Surgical Procedures, Hemoglobins, Heparin