Vicent Lourdes, Juárez Miriam, Martín Irene, García Jorge, González-Saldívar Hugo, Bruña Vanesa, Devesa Carolina, Sousa-Casasnovas Iago, Fernández-Avilés Francisco, Martínez-Sellés Manuel
Cardiology Department, Hospital General Universitario Gregorio Marañón, CIBERCV, Madrid, Spain.
Universidad Complutense, Madrid, Spain.
Cardiology. 2018;139(2):119-123. doi: 10.1159/000486410. Epub 2018 Jan 16.
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.
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.
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.
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.
沙库巴曲缬沙坦最近被批准用于治疗射血分数降低的心力衰竭患者。我们报告6例在开始使用沙库巴曲缬沙坦后不久发生的室性心律失常病例，这些病例需要停药。排除了电风暴的其他潜在触发因素，从心律失常的角度来看，所有患者在前一年病情稳定。我们的目的是描述沙库巴曲缬沙坦与心律失常风暴之间可能的关联。
这是一项在西班牙沙库巴曲缬沙坦商业化的前7个月（2016年10月）进行的单中心观察性研究。所有患者均纳入SUMA（马德里门诊使用的沙库巴曲/缬沙坦）登记册。患者在开始用药当天连续入组。室性心律失常风暴定义为24小时内≥2次持续性室性心律失常发作或应用除颤器治疗。
在108例接受该药治疗的患者中，6例出现室性心律失常风暴（5.6%）。有和没有室性心律失常风暴的患者基线特征相似。每位患者使用沙库巴曲缬沙坦的总天数分别为5天、6天、44天（自滴定起8天）、84天、93天和136天（自滴定起105天）。
我们的数据不足以推断因果关系。可能需要进一步研究沙库巴曲缬沙坦潜在的促心律失常作用。
