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Clinical evaluation of SafeCEC® one-way valve in hemolysis during CPB: Pilot study
Henrique Madureira da Rocha Coutinho1, Joaquim Henrique de Souza Aguiar Coutinho1, José Hamilton Torres2
1Division 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 - Division of Cardiovascular Surgery of the Hospital das Clínicas de Teresópolis Costantino Ottaviano - UNIFESO, Avenida Alberto Torres, 111 - Alto, Teresópolis, RJ, 25964-004, Brazil.
Insights
SafeCEC®, a one-way valve, prevents arterial line reflux during cardiopulmonary bypass (CPB) without causing hemolysis. This pilot study confirms its safety and effectiveness in cardiac surgery, ensuring patient well-being.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- Cardiopulmonary bypass (CPB) is essential for cardiac surgery, often using centrifugal pumps.
- Centrifugal pumps carry a risk of blood reflux, potentially compromising patient safety.
- SafeCEC®, a novel one-way valve, aims to mitigate arterial line reflux during CPB.
Purpose of the Study:
- To evaluate the safety and efficacy of the SafeCEC® one-way valve during CPB.
- To assess hemolysis as a key indicator of blood damage and patient safety.
- To determine if SafeCEC® introduces additional hemolysis compared to conventional CPB circuits.
Main Methods:
- A pilot study involving 31 patients undergoing CPB with a centrifugal pump.
- Randomized allocation into two groups: SafeCEC® incorporated (Group A) versus conventional circuit (Group B).
- Plasma free hemoglobin levels were measured pre-CPB, post-CPB, and 24 hours after weaning to assess hemolysis.
Main Results:
- SafeCEC® effectively controlled blood reflux, negating the need for arterial line clamps.
- No significant differences in plasma free hemoglobin levels were observed between the SafeCEC® and conventional groups.
- The device demonstrated efficacy in preventing reflux without inducing additional hemolysis.
Conclusions:
- The SafeCEC® one-way valve is safe and effective for preventing arterial line reflux in CPB.
- The device does not contribute to blood damage, as evidenced by the lack of significant hemolysis.
- This pilot study supports the clinical utility of SafeCEC® in enhancing patient safety during cardiac surgery.
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®, 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® 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®.
Conclusion:
The SafeCEC® 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® is both safe and effective for its intended use.
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