Key result
Sacubitril/valsartan initiation in patients with heart failure and reduced ejection fraction was followed by ventricular arrhythmic storm in 5.6% of patients.
Why the study?
Does sacubitril/valsartan initiation trigger ventricular arrhythmic storm in patients with HFrEF?
Observational (n=108)
No
Does sacubitril/valsartan initiation trigger ventricular arrhythmic storm in patients with HFrEF?
Initiation of sacubitril/valsartan in HFrEF patients may be associated with an early risk of ventricular arrhythmic storm, warranting further investigation into potential proarrhythmic effects.
May signal early arrhythmic risk after sacubitril/valsartan in HFrEF; leaves open proarrhythmic effects pending prospective trials.
OBJECTIVES: Sacubitril/valsartan was approved recently for the treatment of patients with heart failure and reduced ejection fraction. We present 6 cases of ventricular arrhythmia, that occurred shortly after sacubitril/valsartan initiation, that required drug withdrawal. Other potential triggering factors of electrical storm were ruled out and, from the arrhythmic perspective, all of the patients were stable in the previous year. Our aim is to describe the possible association of sacubitril/valsartan with arrhythmic storm. METHODS: This was an observational monocentric study performed in the first 7 months of sacubitril/valsartan commercialization in Spain (October 2016). All patients were included in the SUMA (Sacubitril/Varsartan Usado Ambulatoriamente en Madrid [Sacubitril/Valsartan Used in Outpatients in Madrid]) registry. Patients were consecutively enrolled on the day they started the drug. Ventricular arrhythmic storm was defined as ≥2 episodes of sustained ventricular arrhythmia or defibrillator therapy application in 24 h. RESULTS: From 108 patients who received the drug, 6 presented with ventricular arrhythmic storm (5.6%). Baseline characteristics were similar in the patients with and without ventricular arrhythmic storm. The total number of days that sacubitril/valsartan was administered to each patient was 5, 6, 44 (8 since titration), 84, 93, and 136 (105 since titration), respectively. CONCLUSIONS: Our data are not enough to infer a cause-and-effect relationship. Further investigations regarding a potential proarrhythmic effect of sacubitril/valsartan are probably needed.
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Vicent et al. (2018) conducted an observational in Heart failure and reduced ejection fraction (n=108). Sacubitril/valsartan was evaluated on Ventricular arrhythmic storm (≥2 episodes of sustained ventricular arrhythmia or defibrillator therapy application in 24 h). Sacubitril/valsartan initiation in patients with heart failure and reduced ejection fraction was followed by ventricular arrhythmic storm in 5.6% of patients.
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