心脏转复除颤器降低了适合的缺血性和非缺血性心肌病患者的死亡率风险：多中心改善 SCA 研究的亚分析。
Cardioverter-defibrillator reduces mortality risk in eligible ischemic and non-ischemic cardiomyopathy patients: Sub-analysis of the multi-center Improve SCA study.
机构信息
Department of Cardiology, Pan Max Hospital, New Delhi, India.
Cardiovascular Center, Taichung Veterans General Hospital, Taichung, Taiwan; National Chung Hsing University School of Medicine, Taichung, Taiwan.
出版信息
Indian Heart J. 2023 Mar-Apr;75(2):115-121. doi: 10.1016/j.ihj.2023.01.010. Epub 2023 Feb 2.
BACKGROUND & OBJECTIVE: Despite the burden of sudden cardiac arrest (SCA) worldwide, implantable cardioverter-defibrillators (ICDs) are underutilized, particularly in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA trial demonstrated that primary prevention (PP) patients in these regions benefit from an ICD or a cardiac resynchronization therapy defibrillator (CRT-D). We aimed to compare the rate of device therapy and mortality among ischemic and non-ischemic cardiomyopathy (ICM and NICM) PP patients who met guideline indications for ICD therapy and had an ICD/CRT-D implanted.
METHODS
Improve SCA was a prospective, non-randomized, non-blinded multicenter trial that enrolled patients from the above-mentioned regions. All-cause mortality and device therapy were examined by cardiomyopathy (ICM vs NICM) and implantation status. Cox proportional hazards methods were used, adjusting for factors affecting mortality risk.
RESULTS
Of 1848 PP NICM patients, 1007 (54.5%) received ICD/CRT-D, while 303 of 581 (52.1%) PP ICM patients received an ICD/CRT-D. The all-cause mortality rate at 3 years for NICM patients with and without an ICD/CRT-D was 13.1% and 18.3%, respectively (HR 0.51, 95% CI 0.38-0.68, p < 0.001). Similarly, all-cause mortality at 3 years in ICM patients was 13.8% in those with a device and 19.9% in those without an ICD/CRT-D (HR 0.54, 95% CI 0.33-.0.88, p = 0.011). The time to first device therapy, time to first shock, and time to first antitachycardia pacing (ATP) therapy were not significantly different between groups (p ≥ 0.263).
CONCLUSIONS
In this large data set of patients with a guideline-based PP ICD indication, defibrillator device implantation conferred a significant mortality benefit in both NICM and ICM patients. The rate of appropriate device therapy was also similar in both groups.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov ID: NCT02099721.
背景与目的
尽管全球范围内突发心搏骤停（SCA）的负担沉重，但植入式心脏复律除颤器（ICD）的应用仍不充分，特别是在亚洲、拉丁美洲、东欧、中东和非洲。改善 SCA 试验表明，这些地区的一级预防（PP）患者从 ICD 或心脏再同步治疗除颤器（CRT-D）中获益。我们旨在比较符合 ICD 治疗指南适应证并植入 ICD/CRT-D 的缺血性和非缺血性心肌病（ICM 和 NICM）PP 患者的设备治疗率和死亡率。
方法
改善 SCA 是一项前瞻性、非随机、非盲的多中心试验，纳入了来自上述地区的患者。通过心肌病（ICM 与 NICM）和植入状态检查全因死亡率和设备治疗。使用 Cox 比例风险方法，调整影响死亡率风险的因素。
结果
在 1848 例 PP NICM 患者中，1007 例（54.5%）接受了 ICD/CRT-D，而 581 例 PP ICM 患者中，303 例（52.1%）接受了 ICD/CRT-D。未植入 ICD/CRT-D 的 NICM 患者 3 年全因死亡率为 13.1%，植入 ICD/CRT-D 的患者为 18.3%（HR 0.51，95%CI 0.38-0.68，p<0.001）。同样，ICM 患者的 3 年全因死亡率，植入设备的患者为 13.8%，未植入 ICD/CRT-D 的患者为 19.9%（HR 0.54，95%CI 0.33-0.88，p=0.011）。各组之间首次设备治疗时间、首次电击时间和首次抗心动过速起搏（ATP）治疗时间无显著差异（p≥0.263）。
结论
在这项基于指南的 PP ICD 适应证的大型患者数据集研究中，NICM 和 ICM 患者的 ICD 设备植入均显著降低死亡率。两组之间适当设备治疗的发生率也相似。
临床试验注册
ClinicalTrials.gov ID：NCT02099721。
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