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Effects of Sacubitril/Valsartan in Patients with High Arrhythmic Risk and an ICD: A Longitudinal Study
Matteo Casale1, Michele Correale2, Giulia Laterra3
1Operative Unit of ICCU and Cardiology, Hospital "S. Maria della Misericordia", ASUR Marche-Area Vasta 1, Urbino, Italy.
Insights
Sacubitril/valsartan significantly improves heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverter defibrillators (ICDs). Clinical benefits emerge within six months, while cardiac remodeling takes longer.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Heart failure with reduced ejection fraction (HFrEF) impacts millions globally.
- Sacubitril/valsartan offers clinical and functional benefits for HFrEF patients.
- Patients with implantable cardioverter defibrillators (ICDs) may experience enhanced benefits from sacubitril/valsartan.
Purpose of the Study:
- To evaluate the efficacy of sacubitril/valsartan in HFrEF patients who have an ICD.
- To assess clinical, functional, and echocardiographic changes in HFrEF patients with ICDs treated with sacubitril/valsartan.
Main Methods:
- A study of 35 HFrEF outpatients (mean age 60 years, 28 males) with ICDs.
- Patients received optimal medical therapy and were initiated on open-label sacubitril/valsartan at maximum tolerated dose.
- Clinical assessments, 6-minute walk tests (6MWT), echocardiography, quality of life, and fatigue were evaluated at 90, 180, and 360 days.
Main Results:
- Significant improvements in New York Heart Association (NYHA) functional class were observed (76% NYHA-I, 24% NYHA-II at study end vs. 71% NYHA-II, 29% NYHA-III at enrollment).
- Quality of life and exercise performance improved, evidenced by increased 6MWT distance (274m to 389m) and walking speed (0.74m/s to 1.07m/s).
- Left ventricular ejection fraction showed a mild improvement (+5 points %), with global longitudinal strain and diastolic function also assessed.
Conclusions:
- Sacubitril/valsartan therapy provides significant clinical and functional improvements in HFrEF patients with ICDs.
- Clinical benefits are evident within the first six months, whereas cardiac reverse remodeling requires a longer treatment duration.
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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