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Published on: June 12, 2021
Analysis of Bicarbonate-Based Purge Solution in Patients With Cardiogenic Shock Supported Via Impella Ventricular
Kyle Bergen1, Shashank Sridhara1, Nicholas Cavarocchi2
1Department of Pharmacy, AdventHealth, Orlando, FL, USA.
Insights
Bicarbonate-based purge solutions for Impella devices may reduce bleeding and anticoagulation needs compared to heparin. This study found similar pump thrombosis rates, suggesting a safe alternative for hemodynamic support.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- The Impella device is a continuous axial flow pump for hemodynamic support.
- Manufacturer guidelines recommend heparin-based purge solutions.
- Bicarbonate-based purge solutions are an alternative with limited supporting data.
Purpose of the Study:
- To evaluate the impact of bicarbonate-based purge solutions on Impella pump thrombosis and bleeding outcomes.
- To compare the safety and efficacy of bicarbonate-based versus heparin-based purge solutions.
Main Methods:
- A single-center, retrospective study of cardiogenic shock patients using Impella.
- Patients were divided into bicarbonate-based or heparin-based purge solution groups.
- Primary outcome: Impella pump thrombosis; Secondary outcomes: bleeding and supratherapeutic anticoagulation.
Main Results:
- Pump thrombosis rates were similar between bicarbonate (16.3%) and heparin (12.2%) groups (P=0.58).
- Bleeding events were significantly lower in the bicarbonate group (27.9% vs. 65.3%, P<0.05).
- Supratherapeutic anticoagulation was higher in the heparin group (65.3% vs. 27.9%, P<0.05).
Conclusions:
- Bicarbonate-based purge solutions may reduce bleeding complications and laboratory monitoring.
- These solutions appear to maintain Impella device durability.
- Nonanticoagulant purge alternatives show promise for improved patient outcomes.
Background:
The Impella device is a continuous axial flow pump which provides hemodynamic support by expelling blood into the aorta. The manufacturer recommends using dextrose-based heparin containing solutions as the default purge. As an alternative to anticoagulant solutions, a bicarbonate-based purge solution has been proposed with limited data substantiating adequate protection and durability.
Objective:
To assess the impact of a bicarbonate-based purge solution on Impella pump thrombosis and bleeding outcomes.
Methods:
Single-center, retrospective study of cardiogenic shock patients who received an Impella between December 2020 through September 2021. Patients were evaluated based on whether they received bicarbonate-based purge solutions or remained on heparin-based purge solutions. The primary outcome was the rate of Impella pump thrombosis, defined as multiple purge pressures greater than 800 mm Hg. Secondary outcomes included incidence of bleeding defined as a drop in Hgb of at least 2 g/dL along with use of blood products and supratherapeutic anticoagulation defined as an aPTT of greater than 70 seconds.
Results:
Forty-three patients received bicarbonate-based purge solutions and 49 controls received heparin. The incidence of purge thrombosis by purge pressure threshold was similar between the two groups (16.3% vs 12.2%, P = 0.58). The rate of bleeding was lower with bicarbonate-based purge (27.9% vs 65.3%, P < 0.05) driven by a drop in Hgb of more than 2 g/dL. The rate of supratherapeutic anticoagulation was higher in the heparin arm (65.3% vs 27.9%, P < 0.05).
Conclusion And Relevance:
Nonanticoagulant purge alternatives offer the potential to reduce bleeding complications and laboratory monitoring burden while maintaining durability.
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