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Does Standardizing Extracorporeal Circuit Design for Cardiopulmonary Bypass Affect Outcomes? Results from a National
Alfred H Stammers1, Linda B Mongero1, Eric A Tesdahl1
1SpecialtyCare, Brentwood, Tennessee.
Insights
Standardizing extracorporeal circuits (ECCs) in cardiopulmonary bypass (CPB) reduced device variation, improving clinician familiarity and continuity. While prime volume slightly increased, safety outcomes like red blood cell transfusions remained stable.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Healthcare Standardization
Background:
- Numerous extracorporeal circuit (ECC) designs complicate cardiopulmonary bypass (CPB) conduct and increase costs.
- Variation in ECCs poses challenges, particularly for clinicians working across multiple centers.
- Standardization efforts aim to reduce variability and enhance patient safety in clinical practice.
Purpose of the Study:
- To evaluate the impact of standardizing ECCs using new-generation devices through a Pack Enhancement Project (PEP).
- To determine if ECC standardization affects key perfusion outcomes such as prime volume, hematocrit drift, and red blood cell (RBC) transfusions.
- To assess the effect of a unified ECC design on clinical practice within a national perfusion provider.
Main Methods:
- The Pack Enhancement Project (PEP) involved standardizing ECCs by incorporating new-generation oxygenators across adult cardiac surgery centers.
- Data from 12 months before and after the PEP implementation were analyzed.
- Outcome measures included ECC prime volume, hematocrit (HCT) drift, and intraoperative red blood cell (RBC) transfusions.
Main Results:
- ECC configurations reduced by 83.0% from 47 to eight standardized packs across 91 hospitals.
- Net prime volume slightly increased (733-750 mL, p < .001) in the PEP group.
- No significant variation in RBC transfusions was observed; however, a small reduction in nadir HCT (28.0 vs. 27.5, p < .001) and HCT drift (-9.6 vs. -10.25, p < .001) occurred.
Conclusions:
- Standardization of ECCs, despite minor changes in prime volume, successfully reduced device variation.
- The primary benefit was increased familiarity and continuity of circuit design among clinicians across different sites.
- The initiative demonstrated that ECC standardization can be implemented without negatively impacting critical safety outcomes like RBC transfusion rates.
Abstract:
Standardization of clinical practice is an effective means of reducing unwanted variation and improving safety. There are numerous extracorporeal circuit (ECC) designs in clinical practice which both complicates the conduct of cardiopulmonary bypass (CPB) and increases costs, especially in situations where clinicians may conduct perfusion at more than one center. The current study was undertaken to determine the effect of standardizing ECCs by incorporating new generation devices as part of a pack enhancement project (PEP). Standardization of ECCs in cardiac centers within a national perfusion provider was undertaken to incorporate new generation oxygenators to reduce variation and improve safety among clinicians. The PEP was carried out in adult centers performing cardiac surgery across America. Data were analyzed for 12 months before the change and compared with those of an equal time thereafter. The outcome measures were ECC prime volume, hematocrit (HCT) drift, and transfusion of intraoperative red blood cells (RBCs). The transition time frame took just less than 12 months and included soliciting input from end-users, pack redesign, and education and implementation. Before the PEP, 91 hospitals used 47 different ECC configurations, which was reduced by 83.0% to eight packs. Regression analysis comparing outcomes between PEP and non-PEP patients showed statistically significant but subtle changes. The net prime volume increased slightly in the PEP group (733-750 mL, p < .001), whereas RBC transfusions did not vary, and the PEP group had a small reduction in nadir HCT (28.0 vs. 27.5, p < .001) and HCT drift (-9.6 vs. -10.25, p < .001). A concurrent analysis of 50,135 patients not in the PEP conducted over the same time period showed no change in RBC transfusions. Although small changes in the net prime volume and transfusion rates were seen with the standardization of ECCs, the primary benefit of this initiative was the increased familiarity and continuity of circuit design across sites.
