Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5

• Published in: Artificial organs Vol. 47; no. 2; pp. 361 - 369
• Main Authors: Bashline, Michael, DiBridge, Julie, Klass, Wyatt J., Morelli, Brian, Kaczorowski, David, Schmidhofer, Mark, Horn, Edward T., Gomez, Hernando, Ramanan, Raj, Hickey, Gavin W., Rivosecchi, Ryan M.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-02-2023
• Subjects: Anticoagulants; Anticoagulants - adverse effects; antithrombotic therapy; Bleeding; cardiac assist and artificial heart; cardiac surgery; cardiothoracic surgery; Dextrose; Hemorrhage - chemically induced; Heparin; Heparin - adverse effects; Hirudins - adverse effects; Humans; Ischemia; Patients; Peptide Fragments - adverse effects; purge solution; Recombinant Proteins - adverse effects; Retrospective Studies; Sodium; Sodium Bicarbonate; Stroke; t-Plasminogen activator; Thrombocytopenia; Thromboembolism; Thrombosis; Tissue Plasminogen Activator - adverse effects; Treatment Outcome; VAD axial flow; purge solution; cardiothoracic surgery; cardiac surgery; VAD axial flow; antithrombotic therapy; cardiac assist and artificial heart
• ISSN: 0160-564X; 1525-1594
• DOI: 10.1111/aor.14428

Background
Impella 5.5 (Abiomed; Danvers, MA) (IMP5) is a commonly used, surgically implanted, tMCS device that requires systemic anticoagulation and purge solution to avoid pump failure. To avoid heparin‐induced thrombocytopenia (HIT) from unfractionated heparin (UFH) use, our program has explored the utility of bivalirudin (BIV) for systemic anticoagulation and sodium bicarbonate‐dextrose purge solution (SBPS) in IMP5.5.
Methods
This single center, retrospective study included 34 patients supported on IMP5.5 with BIV based AC and SBPS between December 1st 2020 to December 1st 2021.The efficacy and safety end points were incidence of development of HIT, Tissue Plasminogen Activator (tPA) use for suspected pump thrombosis, stroke, and device failure as well as clinically significant bleeding.
Results
The median duration of IMP5.5 support was 9.8 days (IQR: 6–15). Most patients were bridged to HTX (58%) followed by recovery (27%) and LVAD implantation (15%). Patients were therapeutic on bivalirudin for 64% of their IMP5.5 support. One patient (2.9%) suffered from ischemic stroke and 26.5% (9) patients developed clinically significant bleeding. tPA was administered to 7(21%) patients. One patient in the entire cohort developed HIT.
Conclusions
Our experience supports the use of systemic BIV and SBPS as a method to avoid heparin exposure in a patient population predisposed to the development of HIT.