Elsevier

Journal of Cardiac Failure

Volume 27, Issue 12, December 2021, Pages 1328-1336
Journal of Cardiac Failure

Safety of Contemporary Heart Failure Therapy in Patients with Continuous-Flow Left Ventricular Assist Devices

https://doi.org/10.1016/j.cardfail.2021.06.007Get rights and content

Highlights

  • Uniform administration of medical therapy in patients with LVADs is aimed .

  • Standardized administration of medical heart failure therapie in patients with LVADs is aimed.

  • Use of heart failure medication in patients with LVADs, including angiotensin receptor neprilysin inhibitors (ARNIs), is safe.

  • Conditional 1-year survival in groups with and without ARNIs is 97% vs 88%; P = 0.06.

ABSTRACT

Background

Limited data are available concerning the safety, optimal administration and benefits of contemporary heart failure therapy in patients after left ventricular assist device (LVAD) implantation.

Methods

: Between 2015 and 2019, 257 patients underwent LVAD implantation and were included in this observational study. Oral heart failure therapy was initiated and uptitrated during the further course. After propensity matching and excluding patients with immediate postoperative treatment in an affiliated center with different medical standards, hospitalization rates and mortality within 12 months after LVAD implantation were compared between 83 patients who received medical therapy including an angiotensin receptor neprilysin inhibitor (ARNI) and 83 patients who did not receive an ARNI.

Results

The overall use of heart-failure medications after 12 months was high: prescriptions: beta-blockers, 85%; angiotensin inhibiting drugs, 90% (angiotensin-converting-enzyme inhibitors 30%, angiotensin receptor blockers 23%, ARNI 37%); mineralocorticoid receptor antagonists, 80%. No serious drug-related adverse events occurred. The conditional 1-year survival in the group with ARNIs was 97% (95% CI: 94%-100%) compared to 88% in the group without an ARNI (95% CI: 80%-96%); P = 0.06.

Conclusions

Contemporary heart failure therapy is safe in patients with LVADs. No increase in serious adverse events was seen in patients receiving ARNIs. No significant difference in the conditional 1-year survival was seen between the ARNI group and the nonARNI group.

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.

References (30)

  • AB Catino et al.

    Clinical and histopathological effects of heart failure drug therapy in advanced heart failure patients on chronic mechanical circulatory support

    Eur J Heart Fail

    (2018)
  • EV Potapov et al.

    2019 EACTS expert consensus on long-term mechanical circulatory support

    Eur J Cardiothorac Surg

    (2019)
  • CW Yancy et al.

    2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America

    Circulation

    (2017)
  • World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects

    JAMA

    (2013)
  • P Ponikowski et al.

    2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC), developed with the special contribution of the Heart Failure Association (HFA) of the ESC

    Eur Heart J

    (2016)
  • Cited by (7)

    • Sacubitril/Valsartan Off-Label Uses for Heart Failure

      2022, Journal of Cardiac Failure
      Citation Excerpt :

      Overall, S/V improves MAP and NT-proBNP values in patients with LVADs, but MAP should be monitored closely. The study by Schnettler et al. revealed that the 1-year survival rate in the S/V group was nonsignificantly but numerically lower than the non-S/V group (97% vs 88%; P= 0.06).68 However, the sample size of this study was small, and nonsignificance in the 1-year survival rate between S/V and non-S/V groups could be due to type 2 error.

    View all citing articles on Scopus
    View full text