Chung Eugene S, Leon Angel R, Tavazzi Luigi, Sun Jing-Ping, Nihoyannopoulos Petros, Merlino John, Abraham William T, Ghio Stefano, Leclercq Christophe, Bax Jeroen J, Yu Cheuk-Man, Gorcsan John, St John Sutton Martin, De Sutter Johan, Murillo Jaime
Lindner Clinical Trial Center, Cincinnati, OH 45219, USA.
Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
Data from single-center studies suggest that echocardiographic parameters of mechanical dyssynchrony may improve patient selection for cardiac resynchronization therapy (CRT). In a prospective, multicenter setting, the Predictors of Response to CRT (PROSPECT) study tested the performance of these parameters to predict CRT response.
Fifty-three centers in Europe, Hong Kong, and the United States enrolled 498 patients with standard CRT indications (New York Heart Association class III or IV heart failure, left ventricular ejection fraction < or = 35%, QRS > or = 130 ms, stable medical regimen). Twelve echocardiographic parameters of dyssynchrony, based on both conventional and tissue Doppler-based methods, were evaluated after site training in acquisition methods and blinded core laboratory analysis. Indicators of positive CRT response were improved clinical composite score and > or = 15% reduction in left ventricular end-systolic volume at 6 months. Clinical composite score was improved in 69% of 426 patients, whereas left ventricular end-systolic volume decreased > or = 15% in 56% of 286 patients with paired data. The ability of the 12 echocardiographic parameters to predict clinical composite score response varied widely, with sensitivity ranging from 6% to 74% and specificity ranging from 35% to 91%; for predicting left ventricular end-systolic volume response, sensitivity ranged from 9% to 77% and specificity from 31% to 93%. For all the parameters, the area under the receiver-operating characteristics curve for positive clinical or volume response to CRT was < or = 0.62. There was large variability in the analysis of the dyssynchrony parameters.
Given the modest sensitivity and specificity in this multicenter setting despite training and central analysis, no single echocardiographic measure of dyssynchrony may be recommended to improve patient selection for CRT beyond current guidelines. Efforts aimed at reducing variability arising from technical and interpretative factors may improve the predictive power of these echocardiographic parameters in a broad clinical setting.
单中心研究数据表明,机械性不同步的超声心动图参数可能有助于改善心脏再同步治疗(CRT)患者的选择。在一项前瞻性多中心研究中,CRT反应预测因素(PROSPECT)研究对这些参数预测CRT反应的性能进行了测试。
欧洲、中国香港和美国的53个中心纳入了498例符合标准CRT适应证的患者(纽约心脏协会III或IV级心力衰竭、左心室射血分数≤35%、QRS≥130 ms、药物治疗稳定)。在对采集方法进行现场培训并经盲法核心实验室分析后,基于传统方法和组织多普勒方法评估了12个不同步的超声心动图参数。CRT阳性反应的指标为临床综合评分改善以及6个月时左心室收缩末期容积减少≥15%。426例患者中有69%临床综合评分得到改善,而在有配对数据的286例患者中,56%的患者左心室收缩末期容积减少≥15%。12个超声心动图参数预测临床综合评分反应的能力差异很大,敏感性范围为6%至74%,特异性范围为35%至91%;预测左心室收缩末期容积反应时,敏感性范围为9%至77%,特异性范围为31%至93%。对于所有参数,CRT临床或容积阳性反应的受试者工作特征曲线下面积≤0.62。不同步参数分析存在很大差异。
尽管进行了培训和集中分析,但在这种多中心环境中敏感性和特异性一般,因此除当前指南外,不建议使用单一的超声心动图不同步测量方法来改善CRT患者的选择。旨在减少技术和解释因素引起的变异性的努力可能会提高这些超声心动图参数在广泛临床环境中的预测能力。