Key result
The Medtronic Affinity NT oxygenator performed similarly to the Cobe Optima XP regarding blood components and O2 transfer, but had a significantly lower transmembrane pressure drop (p < 0.001).
Why the study?
Does the Medtronic Affinity NT oxygenator improve blood component preservation, O2 transfer, or blood loss compared to the Cobe Optima XP oxygenator in patients undergoing cardiac surgery with CPB?
RCT (n=256)
Randomly assigned
Does the Medtronic Affinity NT oxygenator improve blood component preservation, O2 transfer, or blood loss compared to the Cobe Optima XP oxygenator in patients undergoing cardiac surgery with CPB?
The Medtronic Affinity NT and Cobe Optima XP oxygenators perform similarly regarding blood component preservation and oxygen transfer during cardiopulmonary bypass, though the Affinity NT operates with a lower transmembrane pressure drop.
Supports Affinity NT as equivalent alternative to Cobe Optima XP; extends device options by pressure-drop advantage in CPB.
Open-heart surgery (OHS) requires cardiopulmonary bypass (CPB) in most patients. Membrane oxygenators are a critical component of the CPB system. Despite advancements in CPB technology, injury to blood components during CPB still occurs and may result in complications after surgery. The purpose of the present study was to evaluate the performance of the Medtronic Affinity NT with Trillium coating and the Cobe Optima XP oxygenators and compare their influence on blood components. Two hundred and fifty-six male and female patients scheduled for urgent or elective cardiac surgery with CPB were randomly assigned to either the Affinity NT or the Optima XP oxygenators. Outcomes included platelets, hemoglobin, leukocyte counts, and O2 transfer, measured preoperatively and at 15, 45 and 75 min of CPB time. Blood loss was measured at six and 12 hours postoperatively. A modified intention-to-treat analysis was conducted. The two groups were similar for age, sex, height, weight, body surface area, and blood components at baseline. There were no differences between the Affinity NT and Optima XP for any outcome measure, although a significant change with time was seen in platelets, hemoglobin, hematocrit and leukocytes, as well as O2 transfer for both groups (p < 0.001). The Affinity NT oxygenator had a significantly lower difference in pressure across the membrane (p < 0.001) compared with the Optima XP. In conclusion, the two oxygenators performed similarly with respect to their impact on blood components, O2 transfer, and blood loss postoperatively during OHS with CPB. The Affinity NT had the smaller transmembrane pressure drop of the two.
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Noora et al. (2003) conducted an RCT in Open-heart surgery with cardiopulmonary bypass (n=256). Medtronic Affinity NT oxygenator vs. Cobe Optima XP oxygenator was evaluated on Platelets, hemoglobin, leukocyte counts, O2 transfer, and blood loss. The Medtronic Affinity NT oxygenator performed similarly to the Cobe Optima XP regarding blood components and O2 transfer, but had a significantly lower transmembrane pressure drop (p < 0.001).
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