Department of Cardiology, Thoraxcenter, Erasmus Medical Center Rotterdam, Dr. Molewaterplein 40, Rotterdam, 3015 GD, The Netherlands.
Department of Epidemiology, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
ESC Heart Fail. 2021 Oct;8(5):3656-3662. doi: 10.1002/ehf2.13506. Epub 2021 Aug 1.
While the efficacy of the intracardiac defibrillators (ICDs) for primary prevention is not disputed, the relevant studies were carried out a long time ago. Most pertinent trials, including MADIT-II, SCD-Heft, and DEFINITE, recruited patients more than 20 years ago. Since then, improved therapeutic modalities including, in addition to cardiac resynchronization therapy, mineralocorticoid receptor antagonists, angiotensin receptor-neprilysin inhibitors, and, most recently, inhibitors of sodium-glucose cotransporter 2, have lowered present-day rates of mortality and of sudden cardiac death. Thus, nowadays, ICD therapy may be less effective than previously reported, and not as beneficial as many people currently believe. However, criteria for ICD implantation remain very inclusive. The patient must (only) be symptomatic and have ejection fraction (EF) ≤ 35%. The choice of EF 35% is notable because the average EF in all large trials was much lower, and clinical benefit was mainly limited to EF ≤ 30%. This EF cut-off value defines a substantial portion of potential ICD recipients. It seems therefore reasonable to limit ICD eligibility criteria in the EF range 30-35% to patients at highest risk only. We discuss and present some rational criteria to assist the clinician in improving risk stratification for preventive ICD implantation.
尽管心脏内除颤器 (ICD) 用于一级预防的疗效并无争议,但相关研究是很久以前进行的。大多数相关试验,包括 MADIT-II、SCD-Heft 和 DEFINITE,都是在 20 多年前招募的患者。从那时起,除了心脏再同步治疗、盐皮质激素受体拮抗剂、血管紧张素受体-脑啡肽酶抑制剂,以及最近的钠-葡萄糖共转运体 2 抑制剂等治疗方法的改进,降低了当今的死亡率和心源性猝死率。因此,如今 ICD 治疗的效果可能不如以前报告的那么有效,也不像许多人目前认为的那么有益。然而,ICD 植入的标准仍然非常广泛。患者必须(仅)有症状且射血分数 (EF)≤35%。选择 EF 35%是值得注意的,因为所有大型试验的平均 EF 要低得多,临床获益主要限于 EF≤30%。这个 EF 截止值定义了相当一部分潜在的 ICD 接受者。因此,似乎有理由将 EF 在 30-35%范围内的 ICD 资格标准限制在仅风险最高的患者。我们讨论并提出了一些合理的标准,以帮助临床医生改善预防性 ICD 植入的风险分层。