Biton Yitschak, Rosero Spencer, Moss Arthur, Zareba Wojciech, Kutyifa Valentina, Baman Jayson, Barsheshet Alon, McNitt Scott, Polonsky Bronislava, Goldenberg Ilan
Division of Cardiology, Heart Research Follow-Up Program, Department of Medicine, University of Rochester Medical Center, Rochester, New York; Heart Institute, Sheba Medical Center, Ramat Gan, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Division of Cardiology, Heart Research Follow-Up Program, Department of Medicine, University of Rochester Medical Center, Rochester, New York.
Am J Cardiol. 2018 Mar 1;121(5):615-620. doi: 10.1016/j.amjcard.2017.11.032. Epub 2017 Dec 11.
The ACC/AHA/HRS (American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society) guidelines recommend implantable cardioverter-defibrillator (ICD) therapy primary prevention in all patients with severely reduced left ventricular ejection fraction (≤30%) regardless of New York Heart Association (NYHA) functional class, whereas recent European guidelines limit the indication to those with symptomatic heart failure (NYHA ≥ II). We therefore aimed to evaluate the long-term survival benefit of primary ICD therapy among postmyocardial infarction patients with and without heart failure (HF) symptoms who were enrolled in MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II). We classified 1,164 MADIT-II patient groups according to the baseline NYHA class (NYHA I [n = 442], NYHA II [n = 425], and NYHA III [n = 297]); patients with NYHA IV were excluded. Multivariate Cox proportional hazards regression modeling was performed to compare the mortality reduction with ICD versus non-ICD therapy during 8 years of follow-up between the 3 NYHA groups. The median (interquartile range) follow-up time was 7.6 (3.5 to 9) years. At 8 years of follow-up, the cumulative probability of mortality in the non-ICD treatment arm was 57% for NYHA I, 57% for NYHA II, and 76% for NYHA III (p <0.001). Multivariate models demonstrated similar long-term mortality risk reduction with ICD compared with the non-ICD treatment arm regardless of HF symptoms: NYHA I (HR = 0.63, 0.46 to 0.85, p = 0.003), NYHA II (HR = 0.68, 0.50 to 0.93, p = 0.017), and NYHA III (HR = 0.68, 0.50 to 0.94, p = 0.018); p for NYHA class by treatment arm interaction >0.10. In conclusion, primary ICD therapy provides consistent long-term survival benefit among patients with previous myocardial infarction and severe left ventricular dysfunction, regardless of HF symptoms.
美国心脏病学会/美国心脏协会临床实践指南工作组及心律协会（ACC/AHA/HRS）发布的指南推荐，对于所有左心室射血分数严重降低（≤30%）的患者，无论其纽约心脏协会（NYHA）心功能分级如何，均应进行植入式心律转复除颤器（ICD）一级预防治疗；而欧洲最近发布的指南则将适应证限制在有症状性心力衰竭（NYHA≥II级）的患者。因此，我们旨在评估心肌梗死后有或无症状性心力衰竭（HF）的患者接受ICD一级预防治疗的长期生存获益，这些患者均纳入了多中心自动除颤器植入试验II（MADIT-II）。我们根据基线NYHA分级（NYHA I级[n = 442]、NYHA II级[n = 425]和NYHA III级[n = 297]）对1164例MADIT-II患者进行分组；NYHA IV级患者被排除。采用多变量Cox比例风险回归模型，比较3个NYHA组在8年随访期间ICD治疗与非ICD治疗的死亡率降低情况。中位（四分位间距）随访时间为7.6（3.5至9）年。在8年随访时，非ICD治疗组的累积死亡概率在NYHA I级为57%，NYHA II级为57%，NYHA III级为76%（p<0.001）。多变量模型显示，无论有无HF症状，与非ICD治疗组相比，ICD治疗均能降低相似的长期死亡风险：NYHA I级（HR = 0.63，0.46至0.85，p = 0.003）、NYHA II级（HR = 0.68，0.50至0.93，p = 0.017）和NYHA III级（HR = 0.68，0.50至0.94，p = 0.018）；治疗组与NYHA分级的交互作用p>0.10。总之，对于既往有心肌梗死且左心室功能严重不全的患者，无论有无HF症状，ICD一级预防治疗均能提供一致的长期生存获益。
