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Published on: June 12, 2021
Survey of Anticoagulation Practices with the Impella Percutaneous Ventricular Assist Device at High-Volume Centers
Brent N Reed1, Robert J DiDomenico2, J Erin Allender3
1University of Maryland School of Pharmacy, USA.
Insights
Anticoagulation practices for Impella percutaneous ventricular assist devices (pVAD) vary significantly among centers, often deviating from manufacturer guidelines. Further studies are needed to establish a standardized anticoagulation approach for Impella pVAD patients.
Area of Science:
- Cardiovascular Medicine
- Medical Device Technology
- Pharmacology
Background:
- Managing anticoagulation for Impella percutaneous ventricular assist devices (pVAD) presents unique challenges.
- These include the device's heparinized purge solution, concurrent systemic anticoagulation needs, and lack of alternatives for patients with heparin contraindications.
Purpose of the Study:
- To characterize current anticoagulation practices for Impella pVAD.
- To identify variations in practice across high-volume US centers.
- To compare practices against manufacturer recommendations.
Main Methods:
- A survey was conducted among high-volume Impella pVAD centers in the United States.
- Practices regarding purge solution concentration and systemic anticoagulation were assessed.
- Variations from manufacturer recommendations were a primary focus.
Main Results:
- Significant practice variations were observed in 35.7% of responding centers.
- About half of centers used the recommended UFH concentration in the purge solution; others used lower concentrations.
- Many centers lacked alternative strategies for patients with UFH contraindications, with most using argatroban or bivalirudin, contrary to guidelines.
Conclusions:
- Current anticoagulation practices for Impella pVAD are inconsistent and often deviate from established guidelines.
- There is a need for systematic studies to develop standardized anticoagulation protocols for Impella pVAD support.
Objectives:
To characterize anticoagulation practices with the Impella percutaneous ventricular assist device (pVAD).
Background:
Managing anticoagulation in patients being supported by the Impella pVAD is made challenging by several unique features of the device. These include the release of a dextrose-based purge solution containing unfractionated heparin (UFH), the need to concurrently administer systemic anticoagulation with intravenous UFH, and the lack of an alternative strategy in patients with contraindications to UFH.
Methods:
To characterize anticoagulation practices with the Impella pVAD, we conducted a survey of centers in the United States performing a high volume of Impella cases, which we defined as > 1 per month. Centers were contacted via email or phone and individuals who agreed to participate were provided with a link to complete the survey online. The primary measures of interest were variations in practice across centers and variations from the manufacturer's recommendations.
Results:
Practices varied considerably among respondents (65 of 182 centers, or 35.7%) and often diverged from manufacturer recommendations. Approximately half of centers (52.4%) reported using a UFH concentration of 50 units/mL in the purge solution, whereas most of the remaining centers (41.3%) reported using lower concentrations. Strategies for the initiation and adjustment of systemic therapy also varied, as did practices for routinely monitoring for hemolysis. Nearly one-fifth of centers (16.7%) had not developed an alternative strategy for the purge solution in patients with contraindications to UFH. Most centers (58.4%) reported using argatroban or bivalirudin in this scenario, a strategy that diverges from the manufacturer's recommendations.
Conclusions:
Given these findings, studies to determine a systematic approach to anticoagulation with the Impella device are warranted.
