Peter Osypka Herzzentrum München, Internistisches Klinikum München Süd, Munich, Germany.
Klinik für Kardiologie, Klinikum Nürnberg, Nuremberg, Germany.
Clin Res Cardiol. 2020 Jan;109(1):115-123. doi: 10.1007/s00392-019-01503-0. Epub 2019 Jun 24.
The DANISH trial raised doubts about the effectiveness of primary prevention of sudden cardiac death by ICD implantation among patients with non-ischemic heart failure. We sought to analyse data from the EVITA-HF registry to give an answer from real-world registry data to the DANISH trial.
1804 patients were identified from the EVITA-HF registry with chronic heart failure (CHF) due to ischemic or dilated heart disease and reduced left ventricular ejection fraction of ≤ 35%. The patients were divided into two groups: Patients with newly implanted cardioverter-defibrillator (ICD group; mean age 66 ± 12 years, 77% male) and without ICD (no-ICD group; mean age 66 ± 14 years, 77% male). The subgroups were compared with regard to mortality and predictive parameters affecting survival.
Cardiovascular risk factors were similar among patients in the non-ICD group (n = 1473) compared to ICD group (n = 331). After 1-year follow-up patients with ischemic heart disease showed a significant improved survival in the ICD group compared to non-ICD group [92.1% vs. 80.6%, HR 0.37 (0.22-0.62)]. Patients with non-ischemic cardiomyopathy did not show a difference with regard to survival between the ICD and the non-ICD group [93.7% vs. 93.1%, HR 0.92 (0.43-1.97)]. The data were stable in a Cox-regression model.
In a real-world setting, no benefit was evident for patients with non-ischemic cardiomyopathy and reduced left ventricular ejection fraction by adding ICD therapy in a short-term follow-up of 12 months in contrast to patients with ischemic cardiomyopathy.
DANISH 试验对 ICD 植入术在非缺血性心力衰竭患者中的心脏性猝死一级预防效果提出了质疑。我们试图从 EVITA-HF 登记处分析数据,从真实世界的登记处数据中为 DANISH 试验提供答案。
从 EVITA-HF 登记处确定了 1804 例患有缺血性或扩张型心脏病和左心室射血分数≤35%的慢性心力衰竭(CHF)的患者。患者分为两组:植入式心脏复律除颤器(ICD)组(平均年龄 66±12 岁,77%为男性)和无 ICD 组(无 ICD 组;平均年龄 66±14 岁,77%为男性)。比较了两组的死亡率和影响生存的预测参数。
与 ICD 组(n=331)相比,无 ICD 组(n=1473)的非 ICD 组患者的心血管危险因素相似。在 1 年随访后,与无 ICD 组相比,缺血性心脏病患者的 ICD 组生存率显著提高[92.1%比 80.6%,HR 0.37(0.22-0.62)]。非缺血性心肌病患者在 ICD 和无 ICD 组之间的生存率无差异[93.7%比 93.1%,HR 0.92(0.43-1.97)]。Cox 回归模型中的数据稳定。
在真实世界环境中,与缺血性心肌病患者相比,在 12 个月的短期随访中,添加 ICD 治疗对非缺血性心肌病和左心室射血分数降低的患者没有明显益处。