背景:和目标:尽管全球范围内心脏骤停(SCA)的负担,植入式心脏复律除颤器(ICD)未得到充分利用,尤其是在亚洲,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)患者受益于ICD或心脏再同步治疗除颤器(CRT-D)。我们旨在比较符合ICD治疗指南指征并植入ICD/CRT-D的缺血性和非缺血性心肌病(ICM和NICM)PP患者的器械治疗率和死亡率。
方法:改善SCA是一种前瞻性的,非随机化,纳入上述地区患者的非盲多中心试验.通过心肌病(ICMvsNICM)和植入状态检查全因死亡率和器械治疗。使用Cox比例风险方法,调整影响死亡风险的因素。
结果:在1,848名PPNICM患者中,1,007(54.5%)获得了ICD/CRT-D,581名PPICM患者中有302名(52.1%)接受了ICD/CRT-D。有或没有ICD/CRT-D的NICM患者3年的全因死亡率分别为13.1%和18.3%,分别为(HR0.51,95%CI0.38-0.68,p<0.001)。同样,使用ICD/CRT-D的ICM患者3年全因死亡率为13.8%,未使用ICD/CRT-D的患者为19.9%(HR0.54,95%CI0.33-.0.88,p=0.011).第一次设备治疗的时间,第一次震惊的时间,首次抗心动过速起搏(ATP)治疗的时间在组间无显著差异(p≥0.263).
结论:在这个基于指南的PPICD适应症患者的大数据集中,除颤器装置植入对NICM和ICM患者均有显著的死亡率获益.两组的适当装置治疗的比率也相似。
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.
BACKGROUND: ClinicalTrials.gov ID: NCT02099721.