Comparison of bicarbonate-based versus heparin-based Impella(R) purge solution

BackgroundThe Impella(R) is a continuous axial flow pump that utilizes a purge solution to create a positive pressure barrier and prevent pump thrombosis. Both the bicarbonate-based (BBPS) and heparin-based purge solutions (HBPS) are FDA-approved, but solution choice varies in clinical practice. This study aims to compare the efficacy and safety of the BBPS versus HBPS when BBPS is used as the standard of care. MethodsThis study was a retrospective analysis at two tertiary academic medical centers within the same health-system. Adult patients were included if they required an Impella(R) device and received either the BBPS or HBPS for at least 72 hours between July 2022 and October 2023. The major endpoint was a composite outcome of pump thrombosis, stroke, and bleeding events defined by International Society on Thrombosis and Haemostasis criteria. Pump thrombosis was defined as incidence of two or more purge pressures greater than 800 mmHg, the use of thrombolytic purge solution, or thrombus noted on imaging. Minor endpoints included intensive care unit (ICU) mortality, ICU length of stay, and vascular complications. ResultsA total of 178 patients were evaluated of which 66 were included. The composite outcome occurred in 23 of 38 patients (60.5%) in the BBPS group and 17 of 28 patients (60.7%) in the HBPS group (p=0.99). There was no difference in pump thrombosis, stroke or bleeding events between cohorts. Vascular events were noted in 5 (17.9%) of HBPS and 13 (34.2%) of BBPS group (p=0.14). Additional minor endpoints were not significantly different between the groups. ConclusionsThis study found no differences in pump thrombosis, stroke, and bleeding events in the BBPS versus HBPS group. Although these findings are supportive of utilizing BBPS as standard of care, larger, multi-center studies are needed to confirm differences in bleeding or thrombotic outcomes.