ABSTRACT
Background: Impella 5.5® with Smart Assist is a minimally invasive Left Ventricular Assist Devices (LVAD) approved by the Food and Drug Administration (FDA) for treating ongoing cardiogenic shock for up to 14 days. The Impella® intends to reduce ventricular workload and provide the circulatory support necessary for myocardial recovery.Research Question: Compared to standard practice, does adding an extension piece to the purge tube side arm of the Impella® Device decrease the incidence of device failure and positively impact the health outcome of adult patients receiving Impella® support?Study Design and Methods: A retrospective chart review of ICU patients was done at a tertiary care center from August 2018 to August 2022 to assess the differences in patient outcomes related to Impella® Device utilization before and after the implementation of the extension piece to the purge tube sidearm. Among patients reviewed, a total of 20 were included in our review, with seven not having the purge tube side arm extension added, while 13 patients had the extension.Results: The two study groups had no significant difference in patient health outcomes. Additionally, there were no instances of device failure requiring explanation without the extension tubing. However, there were no cases of the purge cassette cracking with the addition of the extension tubing.Conclusion: The addition of extension tubing to the purge cassette of the Impella® Device did not impact patient health outcomes or the incidence of device failure. There was a complete reduction in the incidence of the purge cassette cracking, which could reduce the potential for infection or device failure over a long period of mechanical support. There is a need for long-term prospective studies to confirm the results.
ABSTRACT
BACKGROUND/OBJECTIVE: Antithrombotic therapy is administered after left ventricular assist device (LVAD) implantation to prevent thromboembolic events. Intracranial hemorrhage (ICH) is a life-threatening adverse event requiring immediate discontinuation of antithrombotics. We investigated the timing of antithrombotic resumption after ICH in patients with LVADs and the association between timing and risk of recurrent hemorrhage and thrombotic events. METHODS: We performed a multicenter, retrospective analysis of patients with ICH occurrence during LVAD antithrombotic regimen with subsequent resumption of antithrombotics from January 1, 2010, to December 31, 2017. Covariates included age, international normalized ratio, antithrombotic dosing, timing of resumption, modified Rankin score, and subsequent hemorrhagic and thrombotic events within 1 year post-ICH. Patients who did not resume anticoagulation were excluded. RESULTS: Of 673 patients with LVADs, 85 (12.6%) developed ICH while being treated with antithrombotics. Forty-three were excluded due to death prior to resumption and one due to lack of resumption. The remaining 41 patients were on antithrombotics with a median (interquartile range [IQR]) international normalized ratio at ICH onset of 2.6 (1.8-3.6). Aspirin and warfarin were resumed at a median (IQR) of 5.5 (1.3-8.8) and 6.5 (4.0-15.5) days post-ICH, respectively. A continuous unfractionated heparin infusion was initiated in 16 (39.0%) patients at a median (IQR) of 2.5 (1.0-7.8) days post-ICH. During the 1-year follow-up after anticoagulation resumption, 11 (26.8%) patients suffered secondary hemorrhages and two (4.9%) suffered secondary thrombotic events. Using Kaplan-Meier method and log-rank test, we compared all patients who resumed anticoagulation by 6 days post-ICH to those who resumed after 6 days. There was no difference in freedom from secondary hemorrhagic event between the two groups (P = 0.75). CONCLUSION: Despite timing of resumption of antithrombotic therapy after ICH, recurrent hemorrhagic events can be expected in one-quarter of these patients over the subsequent year.
