Introduction
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.
Methods
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.
Results
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.
Discussion
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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© 2021 Published by Elsevier Inc.
