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

Abstract

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 bicarbonatedextrose 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.

Outcomes of Impella 5.0 and 5.5 for cardiogenic shock: A single‐center 137 patient experience

“…Our routine practice is to provide systemic anticoagulation using bivalirudin along with sodium bicarbonate-dextrose purge solution in patients who are supported on Impella. 26 From 2019 to 2021, we observed a 10-fold increase in the utilization of Impella 5.0 and 5.5 at our institution. Compared to the smaller Impella devices (2.5 and CP), the larger devices (5.0 and 5.5) have improved designs to allow longer support duration, which enhances their use as a bridging modality to transplantation.…”

“…Similar to other institutions, mechanical aortic valve and left ventricle thrombus preclude Impella utilization. Our routine practice is to provide systemic anticoagulation using bivalirudin along with sodium bicarbonate‐dextrose purge solution in patients who are supported on Impella 26 . From 2019 to 2021, we observed a 10‐fold increase in the utilization of Impella 5.0 and 5.5 at our institution.…”

“…This is not surprising as their use has significantly increased in patients with ADHF following the 2018 United States heart allocation policy change, which prioritized candidates who are bridged with temporary MCS devices. 26 The new allocation system was designed to address the limitations of the prior 3-tier allocation system by improving candidate risk stratification, especially the high-risk patients who are supported on temporary MCS. 24 Thus, there has been a nationwide trend of increasing transplants performed on patients with higher acuity following the 2018 allocation policy change, resulting in more frequent bridging to transplantation with temporary MCS devices over conventional durable LVAD therapy.…”

What the pediatric nurse needs to know about the Impella cardiac assist device

“…The bicarbonate-based purge solution (sodium bicarbonate 8.4% 25 mEq in 1 L dextrose 5%) has been approved by the Food and Drug Administration in US as an alternative to heparin in patients with HIT. 20 Bashline et al 21 showed in their single center retrospective study including 34 patients supported with Impella that the use of systemic bivalirudin and bicarbonate-dextrose purge solution was associated with a rate of adverse events similar to the one previously reported with heparin. Recently, Al-Ayoubi et al 20 also showed the successful use of the bicarbonate–dextrose purge solution and bivalirudin for systemic anticoagulation in two patients with cardiogenic shock who developed HIT.…”

“…In these cases, systemic anticoagulation can be achieved with the use of direct thrombin inhibitors (e.g., bivalirudin and argatroban), while intra-pump anticoagulation can be achieved using a bicarbonate-based purge solution. 20 , 21 The bicarbonate works by increasing the pH of the dextrose solution in the same way as heparin and prevents clot formation in the motor. The bicarbonate-based purge solution (sodium bicarbonate 8.4% 25 mEq in 1 L dextrose 5%) has been approved by the Food and Drug Administration in US as an alternative to heparin in patients with HIT.…”