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Effects of Sacubitril/Valsartan in Patients with High Arrhythmic Risk and an ICD: A Longitudinal Study

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Abstract

Purpose

Patients affected by heart failure with reduced ejection fraction (HFrEF) receive clinical and functional beneficial effects from treatment with sacubitril/valsartan. However previous studies have shown that patients with an implantable cardioverter defibrillator (ICD) could obtain even greater benefit, but only make up a only a small proportion of patients. In the current study we evaluated the effect of sacubitril/valsartan in patients with an ICD.

Methods

Thirty-five outpatients with HFrEF (aged 60 ± 11 years, 28 were males), on optimal medical therapy were studied. All patients received an ICD at least 6 months before enrollment or were non-responders to ICD plus resynchronization (CRT-D). An open-label sacubitril/valsartan treatment was established at the maximum tolerated dose. Clinical assessment, 6-min walk test (6MWT) and echocardiography, were performed during follow-up at 90, 180, and 360 days. Quality of life score and perceived fatigue on exercise were assessed.

Results

Clinical conditions dramatically improved in most patients, especially within the first 6 months of therapy (76 % were in NYHA-I and 24 % in NYHA-II at the end of study vs 71 % NYHA-II and 29 % NYHA III at enrollment, p < 0.001). Quality of life and exercise performance significantly improved according to N-terminal pro-brain natriuretic peptide (NT-proBNP) serum levels lowering. Walking distance at 6MWT increased from 274 ± 97 to 389 ± 53 m and walking speed from 0.74 ± 0.27 to 1.07 ± 0.15 m/s (p < 0.001), while oxygen saturation did not differ significantly (from 90 ± 1 % to 91 ± 2 %). More gradual was left ventricular reverse remodeling. Ejection fraction improved mildly (+ 5 points %, p < 0.001). Global longitudinal strain and diastolic function were also assessed over time.

Conclusion

Sacubitril/valsartan therapy for HFrEF may lead to significant clinical and functional improvements even in patients with ICD at greater arrhythmic risk. Clinical improvement is obtained within the first 6 months of treatment while reverse remodeling needs more time.

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Authors and Affiliations

  1. Operative Unit of ICCU and Cardiology, Hospital “S. Maria della Misericordia”, ASUR Marche-Area Vasta 1, Urbino, Italy

    Matteo Casale

  2. Operative Unit of Cardiology, University Hospital “Policlinico Riuniti”, Foggia, Italy

    Michele Correale

  3. Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

    Giulia Laterra, Vittoria Vaccaro, Claudia Morabito, Pasquale Crea, Francesco Luzza, Cesare de Gregorio & Giuseppe Dattilo

  4. Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy

    Salvatore Santo Signorelli

  5. Second Department of Propaedeutic Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece

    Niki Katsiki

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  1. Matteo Casale
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Corresponding author

Correspondence to Michele Correale.

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This research received no external funding.

Conflict of interest

The authors declare no conflict of interest.

Author contributions

Conceptualization, GD and CG; methodology, GD and CG; formal analysis, MC and GD; investigation, GL, VV, CM; data curation, MC and MC; writing—original draft preparation, MC and MC; writing—review and editing, MC and MC; visualization, SSS, FL and NK; supervision, FL; project administration, GD and CG. All authors have read and agreed to the published version of the manuscript.

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Casale, M., Correale, M., Laterra, G. et al. Effects of Sacubitril/Valsartan in Patients with High Arrhythmic Risk and an ICD: A Longitudinal Study. Clin Drug Investig 41, 169–176 (2021). https://doi.org/10.1007/s40261-020-00995-3

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