Safety of Contemporary Heart Failure Therapy in Patients with Continuous-Flow Left Ventricular Assist Devices
Section snippets
General Approach
The project was approved by the local ethics committee of the Charité–Universitätsmedizin Berlin (EA2/236/17) and was conducted in accordance with the ethical principles of the 2013 Declaration of Helsinki.8 This research project was also registered in the German Clinical Trials Register (DRKS-ID: DRKS00018074). Because it was a retrospective analysis, written informed consent was not necessary. All authors had full access to the complete (raw) data set.
Pharmacological Therapy and Pump Settings
The intensified medical HF therapy was
Baseline Characteristics
After LVAD implantation, 257 patients were discharged from the regular ward and were included in the subsequent analysis (Table 1). Patients who were transferred from the intensive care unitn to an affiliated center with different medical standards were excluded.
The 257 patients in the overall cohort who had end-stage HF due mainly to dilated cardiomyopathy or ischemic heart disease underwent LVAD implantation. Prior to LVAD implantation, 121 patients (47%) were in cardiogenic shock or
Discussion
The safety profile of contemporary HF medication was found to be acceptable in our cohort because no severe, life-threatening side effects occurred during our observational study. The most common adverse event at FU was symptomatic and asymptomatic hypotension in ARNI- and BB-treated patients and elevated creatinine in patients on MRA. We found no significant reduction in rehospitalization rates due to right HF, ventricular tachycardia, or ICD shocks in the ARNI group. No significant difference
Conclusions
Based on the results of this study, the use of medical HF therapy, including ARNI, appears to be safe for patients with LVADs. With ARNI medication, no serious adverse events occurred in our cohort of patients, but hypotension had to be monitored closely. No significant difference in survival rates was seen between the groups (P= 0.06). Especially in patients with DCM, an additional effect of neurohormonal blockade on reverse cardiac remodeling beyond the effects of mechanical unloading alone
Acknowledgments
We thank all patients who participated in the project.
Sources of funding
This work was supported by a research grant from Novartis Pharma (# 039A1001).
Disclosures
LR received a research grant of the German Heart Foundation under the Kaltenbach scholarship for doctoral candidates; VF has relevant (institutional) financial activities outside the submitted work, with the following commercial entities: Medtronic, Biotronik, Abbott, Boston Scientific, Edwards Lifesciences, Berlin Heart, Novartis Pharma, JOTEC, and Zurich Heart in the form of educational grants (including travel support), fees for lectures and speeches, fees for professional consultation, as
Authors’ Contributions
All authors contributed to the conception and design of the study and approved of the revisions of the article. JS, LR, PP, and FS provided administrative support; LR, MM, JM, JK, EP, and FS provided study materials or patients; JS, LR, IJ, and FS collected and assembled data; JS, PP, JS, and FS performed statistical data analysis and interpretation.
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