De Ferrari Gaetano M, Sanzo Antonio
Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Heart Rhythm. 2009 Mar;6(3 Suppl):S29-35. doi: 10.1016/j.hrthm.2008.10.008. Epub 2008 Oct 10.
Prophylactic implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF), but the absolute risk reduction is relatively small. Thus, there is a strong need to identify reliable risk stratifiers, particularly among patients with nonischemic cardiomyopathy (NIDCM), in whom the search for risk predictors has been particularly frustrating.
This study sought to review data regarding T-wave alternans (TWA) in patients with NIDCM and to discuss its potential role.
We included in a meta-analysis clinical trials that enrolled > or =50 NICDM patients, had a follow-up of > or =1 year, and provided detailed data on NIDCM patients, in case of mixed population. Relative risks were derived from absolute numbers of events in abnormal (positive + indeterminate test whenever possible) TWA versus normal (negative) TWA group.
Eight studies with 1,456 patients (mean age 56 years, LVEF 30%, follow-up 25 months) were included. A negative TWA test occurred in 33%, and was indeterminate in 21% of the patients. The primary end point (VT+VF+sudden or all-cause death) occurred in 14.7% abnormal versus 3.8% normal TWA patients. The relative risk for the cumulative data was found to be 2.99 (95% confidence interval: 1.88 to 4.75). The negative predictive value was 96.2%.
A normal TWA test identifies one-third of NIDCM patients who have a very good prognosis and are unlikely to significantly benefit from ICD therapy. A randomized clinical trial evaluating the utility of TWA in guiding therapy seems warranted, possibly a noninferiority trial of medical therapy only versus ICD in TWA-negative patients.
预防性植入式心脏复律除颤器(ICD)治疗可降低心力衰竭(HF)且左心室射血分数(LVEF)降低患者的死亡率,但绝对风险降低相对较小。因此,迫切需要识别可靠的风险分层指标,尤其是在非缺血性心肌病(NIDCM)患者中,在此类患者中寻找风险预测指标一直特别困难。
本研究旨在回顾关于NIDCM患者T波电交替(TWA)的数据,并讨论其潜在作用。
我们纳入了一项荟萃分析,该分析纳入了≥50例NICDM患者、随访时间≥1年且在混合人群情况下提供了NIDCM患者详细数据的临床试验。相对风险来自异常(尽可能为阳性+不确定试验)TWA组与正常(阴性)TWA组的事件绝对数。
纳入了八项研究,共1456例患者(平均年龄56岁,LVEF 30%,随访25个月)。33%的患者TWA试验为阴性,21%的患者结果不确定。主要终点(室性心动过速+心室颤动+猝死或全因死亡)在异常TWA患者中的发生率为14.7%,在正常TWA患者中的发生率为3.8%。累积数据的相对风险为2.99(95%置信区间:1.88至4.75)。阴性预测值为96.2%。
TWA试验正常可识别三分之一预后非常好且不太可能从ICD治疗中显著获益的NIDCM患者。评估TWA在指导治疗中的效用的随机临床试验似乎是必要的,可能是一项仅对TWA阴性患者进行药物治疗与ICD治疗的非劣效性试验。