Comparison of Bicarbonate-Based Versus Heparin-Based Impella® Purge Solution

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Pharmacology

Background:

• The Impella® device uses a purge solution to prevent pump thrombosis.
• Bicarbonate-based purge solution (BBPS) is FDA-approved for patients with heparin contraindications.
• Clinical practice varies in choosing between BBPS and heparin-based purge solution (HBPS).

Purpose of the Study:

• To compare the efficacy and safety of BBPS versus HBPS when BBPS is used as standard of care.
• To evaluate the composite outcome of pump thrombosis, stroke, and bleeding events.
• To assess secondary outcomes including ICU mortality, ICU length of stay, and vascular complications.

Main Methods:

• Retrospective analysis of adult patients requiring Impella® devices at two academic medical centers.
• Inclusion criteria: use of BBPS or HBPS for at least 72 hours between July 2022 and October 2023.
• Primary endpoint: composite of pump thrombosis, stroke, and bleeding events. Secondary endpoints: ICU mortality, ICU length of stay, vascular complications.

Main Results:

• 66 patients were included (38 BBPS, 28 HBPS).
• The composite outcome occurred in 60.5% of BBPS patients and 60.7% of HBPS patients (P=0.99).
• No significant differences were observed in pump thrombosis, stroke, or bleeding events between the groups. Vascular events were more frequent in the BBPS group (34.2% vs 17.9%, P=0.14).

Conclusions:

• This study found no significant differences in pump thrombosis, stroke, or bleeding events between BBPS and HBPS.
• Findings support the use of BBPS as a standard of care.
• Larger, multi-center studies are required to confirm potential differences in bleeding or thrombotic outcomes.