Cell salvage has proven a reduction in the need for perioperative allogeneic blood transfusion in cardiac surgery. However, current centrifugation-based autotransfusion devices can only salvage red blood cells while blood platelets are removed during the process. The same™ by i-SEP device (Smart Autotransfusion for ME, i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets without significant impact on cell integrity and function¹. Our objective was to evaluate the safety and performance of the same™ device during on-pump cardiac surgery.
In a prospective, multicenter, single-arm study, we included adult patients undergoing on-pump elective cardiac surgery (isolated coronary artery bypass graft, valve replacement or aortic root surgery) without anemia and thrombocytopenia. Patients receiving uninterrupted P2Y12 inhibitors, vitamin K antagonists or direct oral anticoagulants were excluded. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. Samples from the collection reservoir and the concentrated blood were analyzed for each device treatment cycle. Primary performance endpoints were a red blood cell minimal recovery of 80% and a minimal hematocrit of 40%. Primary safety endpoints were a minimal heparin and free hemoglobin removal ratios of 90% and 75% respectively. Secondary performance and safety endpoints included platelet recovery and function (flow cytometric analysis of platelet glycoproteins), post-operative bleeding, transfusion and adverse events up to 30 days. All safety data were independently reviewed by a Data Safety Monitoring Board.
Twenty-six patients were included in this first interim analysis. Mean age was 68.3±8.7 years, 89% were men. Cardiac procedures included isolated coronary artery bypass graft (27%), isolated valve replacement (62%) and aortic root surgery (11%). Mean reinfused blood volume was 577±278 mL, corresponding to 1714±683 mL of salvaged blood. Mean processing time was 6±2 min for each 500mL of salvaged blood. Red blood cell recovery was 85.7±6.8 % with post-treatment hematocrits of 42.4±4.9 %. Removal ratios were 99.9±0.3 % and 94.6±14.4% for heparin and free hemoglobin, respectively. Platelet recovery was 49.4±15.6 % with post-treatment counts of 119±42 G/L. Platelet function, evaluated by flow cytometric analysis, was found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin pathway stimulation. Mean 24-hour chest tube output was 493±228 mL. No plasma or platelet transfusion was reported, while early postoperative (<24h) packed red blood cell transfusion was needed for one patient. No adverse device effect was reported.
This first interim analysis demonstrated the performance and safety of the same™ by i-SEP device during on-pump cardiac surgery. For the first time, both platelets and red blood cells were salvaged with a fast processing time, without significant impact on platelet function. At the same time, the washing performance of the device prevented reinfusion of high concentration of heparin.
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