心肌梗死后的可穿戴式心脏除颤器。
Wearable Cardioverter-Defibrillator after Myocardial Infarction.
机构信息
From the Division of Cardiology, Department of Medicine, the UCSF Center for the Prevention of Sudden Death (J.E.O., C.M., B.K.L.) and the Department of Epidemiology and Biostatistics (M.J.P., E.V., T.F.H., F.L., J.A.S., S.H.), University of California, San Francisco, San Francisco; the Department of Electrocardiology, Medical University of Lodz, Lodz, Poland (J.W.); McLeod Regional Medical Center, Florence, SC (R.M.); Ochsner Medical Center and Ochsner Clinical School, University of Queensland School of Medicine, New Orleans (D.P.M.); Hartford Healthcare Heart and Vascular Institute and University of Connecticut School of Medicine, Hartford (S.Z.); Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (A.E.B.); Gill Heart Institute, University of Kentucky, and Veterans Affairs Medical Center, Lexington (C.S.E.); the Department of Internal Medicine, University of Michigan, Michigan Medicine, Ann Arbor (E.H.C.); Stony Brook Medicine, Stony Brook, NY (E.R.); and First Department of Medicine-Cardiology, University Medical Center Mannheim, Mannheim, and DZHK (German Center for Cardiovascular Research), Heidelberg - both in Germany (M.B.).
出版信息
N Engl J Med. 2018 Sep 27;379(13):1205-1215. doi: 10.1056/NEJMoa1800781.
BACKGROUND
Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear.
METHODS
We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death.
RESULTS
Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock.
CONCLUSIONS
Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).
背景
尽管射血分数较低的心肌梗死患者发生心源性猝死的发生率很高，但植入式心脏复律除颤器在心肌梗死后 40 至 90 天内仍被禁用。可穿戴式除颤器是否会降低这段高危期内心源性猝死的发生率尚不清楚。
方法
我们以 2:1 的比例随机分配急性心肌梗死后射血分数低于或等于 35%的患者接受可穿戴式除颤器加指南指导的治疗（装置组）或仅接受指南指导的治疗（对照组）。主要终点是 90 天内心源性猝死或室性心动过速性心律失常所致死亡的复合终点（心律失常性死亡）。次要终点包括任何原因导致的死亡和非心律失常性死亡。
结果
在 2302 名参与者中，1524 名被随机分配至装置组，778 名被分配至对照组。装置组参与者每天佩戴装置的中位数时间为 18.0 小时（四分位距 3.8 至 22.7）。装置组中有 1.6%的参与者发生心律失常性死亡，对照组中有 2.4%（相对风险 0.67；95%置信区间 0.37 至 1.21；P=0.18）。装置组中有 3.1%的参与者死亡，对照组中有 4.9%（相对风险 0.64；95%置信区间 0.43 至 0.98；未校正 P=0.04），非心律失常性死亡分别为 1.4%和 2.2%（相对风险 0.63；95%置信区间 0.33 至 1.19；未校正 P=0.15）。装置组中 48 名死亡的参与者中有 12 名在死亡时佩戴了装置。共有 20 名装置组患者（1.3%）接受了适当的电击，9 名（0.6%）接受了不适当的电击。
结论
在近期心肌梗死后射血分数为 35%或更低的患者中，与对照组相比，可穿戴式除颤器并未显著降低心律失常性死亡的主要终点发生率。（由美国国立卫生研究院和 Zoll 医疗公司资助；VEST ClinicalTrials.gov 编号，NCT01446965）。
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