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[CRJ]MASTER研究:微伏T波交替试验在应用预防性除颤器的缺血性心肌病患者中预测室性快速型心律失常

Does Microvolt T-Wave Alternans Testing Predict Ventricular Tachyarrhythmias in Patients With Ischemic Cardiomyopathy and Prophylactic Defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) Trial

作者:  ChowT,KeriakesDJ,OnuferJ   来源:Am J Cardiol 2008;10script>   日期:2008/12/11 16:55:00

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MASTER研究是一项前瞻性、多中心试验,目的在于探讨微伏T波交替(MTWA)是否为心肌梗死后危险分层的可靠方法。研究入选575例平均年龄65岁、心肌梗死后射血分数(EF)≤30% (平均EF为24%)的患者,在植入埋藏式复律除颤器(ICD)之前行MTWA试验。试验结果分为阴性或非阴性(阳性或不确定性),随访2~4年,主要终点为室性心动过速事件(VTE),定义为心源性猝死或适当的ICD放电。研究结果提示MTWA试验并不能从有缺血性心肌病的心肌梗死后患者中,准确筛选出致死性心律失常的低危患者。

Objectives: The purpose of this trial was to determine whether microvolt T-wave alternans (MTWA) predicts ventricular tachyarrhythmic events (VTEs) in post-myocardial infarction patients with left ventricular ejection fraction (LVEF) 30%.

Background: Previous studies have established MTWA as a predictor for total and arrhythmic mortality, but its ability to identify prophylactic implantable cardioverter-defibrillator (ICD) recipients most likely to experience VTEs remains uncertain.

Methods: This prospective trial was conducted at 50 U.S. centers. Patients were eligible if they met MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II) indications for device implant. All patients underwent MTWA testing followed by ICD implantation, with pre-specified programming to minimize the likelihood of therapies for non–life-threatening VTE. Minimum follow-up was 2 years with annual MTWA testing. Initially indeterminate MTWA tests were repeated.

Results: Analyses were conducted on 575 patients (84% male; average age ± SD = 65 ± 11 years; average LVEF ± SD = 0.24 ± 0.05). The final distribution of MTWA results were: MTWA positive in 293 (51%), MTWA negative in 214 (37%), and indeterminate in 68 patients (12%). Over an average follow-up of 2.1 ± 0.9 years, there were 70 VTEs. A VTE occurred in 48 of 361 (13%, 6.3%/year) MTWA non-negative and 22 of 214 (10%, 5.0%/year) MTWA negative patients. A non-negative MTWA test result was not associated with VTE (hazard ratio: 1.26; 95% confidence interval: 0.76 to 2.09; p = 0.37), although total mortality was significantly increased (hazard ratio: 2.04; 95% confidence interval: 1.10 to 3.78; p = 0.02).

Conclusions: In MADIT-II–indicated ICD-treated patients, the risk of VTE does not differ according to MTWA classification, despite differences in total mortality.

问题:微伏T波电交替(MTWA)是心肌梗死后危险分层的可靠方法吗?

方法:MASTER研究是一项前瞻性、多中心试验,575例心肌梗死后射血分数(EF)≤30% (平均EF为24%)的患者(平均年龄65岁)在植入埋藏式心律转复除颤器(ICD)之前行MTWA试验。MTWA试验被分为阴性和非阴性(阳性或不确定性)。随访时间为2~4年,主要终点为室性心动过速事件(VTE),定义为心源性猝死或适当的ICD放电。

结果:MTWA试验在63%患者中为非阴性,在37%患者中为阴性。一年VTE发生率在非阴性和阴性试验患者中(分别为6.3%和5.0%)没有显著差异。MTWA不是VTE的预测因素。总死亡率在MTWA试验非阴性患者中比阴性患者高2倍。

结论:MTWA试验不能从有缺血性心肌病的心肌梗死后患者中,准确筛选出致死性心律失常的低危患者。

评论:此研究中ICD的植入符合MADIT-II标准。之前的回顾性研究提示MTWA试验阴性表明患者发生致死性心律失常的风险极低,按照MADIT-II标准的ICD备选者不需要植入ICD。如果真是这样,将会显著改善心肌梗死后预防性植入ICD的性价比。然而,这项研究表明,MTWA试验阴性并不意味着植入ICD对于改善MADIT-II型患者的预后无效。

出处:J Am Coll Cardiol 2008;52:1607-1615.

 

版面编辑:张家程



微伏T波交替MASTER研究缺血性心肌病

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