J Extra Corpor Technol 2025, 57, 105 – 112 Ó The Author( s), published by EDP Sciences, 2025 https:// doi. org / 10.1051 / ject / 2025010
Available online at: ject. edpsciences. org
ORIGINAL ARTICLE
Clinical evaluation of SafeCEC Ò one-way valve in hemolysis during CPB: Pilot study
Henrique Madureira da Rocha Coutinho( MD, MSc) 1, 2,* Joaquim Henrique de Souza Aguiar Coutinho( MD, MSc) 1, 2, José Hamilton Torres 1, Rafaela Mourão Casanova 1, Gustavo Kikuta( MD) 1, 2, and Edison Emídio Reis 1
1 Division of Cardiovascular Surgery of the Hospital Universitário Pedro Ernesto – UERJ, Rua Boulevard 28 de Setembro, 77 – Vila Isabel, Rio de Janeiro, RJ, 20551-030, Brazil 2 Division of Cardiovascular Surgery of the Hospital das Clínicas de Teresópolis Costantino Ottaviano – UNIFESO,
Avenida Alberto Torres, 111 – Alto, Teresópolis, RJ, 25964-004, Brazil Received 6 January 2025, Accepted 31 March 2025
Abstract – Introduction: In cardiopulmonary bypass( CPB), blood circulation is temporarily maintained by an artificial blood-pumping device during cardiac surgery. Worldwide, approximately half of the CPB procedures utilize either centrifugal or roller pumps( Wu P et al. Front Physiol 12, 699891). Centrifugal pumps, while non-occlusive, pose a risk of blood reflux if there is a system failure, which endangers patient safety( Souza MHL, Elias DO. Fundamentos da Circulação Extracorpórea 2006; 186 – 192). SafeCEC Ò, a one-way valve, offers a potential solution to this risk by preventing arterial line reflux. This pilot study aims to evaluate patient safety by analyzing hemolysis as an evaluation parameter. Plasma free hemoglobin is chosen to measure patient safety with the use of the product, ensuring it does not cause additional hemolysis during extracorporeal circulation. Materials and methods: After approval by the Ethics Committee, 31 patients undergoing CPB with a centrifugal pump were included in the study. The patients were randomly divided into two groups: group A, where SafeCEC Ò was incorporated into the arterial line, and group B, which used the conventional circuit. Hemolysis was assessed by analyzing plasma free hemoglobin in blood samples collected before CPB, after CPB, and 24 h after weaning from CPB. Results: This device has been shown to be effective in controlling blood reflux, eliminating the need for arterial line clamps. Analysis of plasma free hemoglobin levels revealed no significant differences between the groups with or without SafeCEC Ò. Conclusion: The SafeCEC Ò one-way valve effectively prevents reflux without contributing to blood damage, as indicated by the absence of significant hemolysis. This pilot study demonstrates that the SafeCEC Ò is both safe and effective for its intended use.
Key words: Cardiopulmonary bypass, One-way valve, Centrifugal pump, Retrograde flow.
Introduction
In cardiopulmonary bypass( CPB), blood circulation is artificially driven by a blood pumping device that temporarily replaces cardiac function by maintaining blood circulation during cardioplegic arrest [ 1 ]. Currently, centrifugal pumps are widely used for CPB due to their non-occlusive mechanism, which reduces the risk of excessive hemolysis and high afterload [ 2 ]. However, for procedures lasting less than 3 h, there is no conclusive evidence demonstrating their superiority over roller pumps, which maintain consistent flow and pressure but may be associated with higher hemolysis rates due to their occlusive nature [ 3, 4 ].
During the preparation of this work the authors did not use any AI-assisted technology. * Corresponding author: henricoutinho @ gmail. com
Centrifugal pumps are characterized by a non-occlusive nature and sensitivity to flow resistance, that is, the flow generated by the pump varies inversely with variation of flow resistance; if the resistance is equal to the outlet pressure of the pump, no flow occurs. Conversely, if the flow resistance is greater than the pump outlet pressure, retrograde flow will occur [ 5 ], which may result in blood volume loss, hypotension, surgical exsanguination of the patient and other consequences if the event is not immediately detected and controlled [ 6 ]. Retrograde flow is a serious risk to patient safety without an anti-reflux valve.
Retrograde flow detection in centrifugal pumps is performed through continuous monitoring of flowmeter, but the control of retrograde flow depends solely on the actions of the perfusionist, who must occlude the line through clamping to avoid reflux by accelerating the rotation the centrifugal pump drive unit until it reaches 1200 – 1500 rpm [ 7 ]. At this point, the perfusionist must end the flow. Likewise, in weaning form
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