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探讨一种新型的左心室同步起搏算法和心脏再同步治疗的动态优化:适应性 CRT 试验结果。

Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: results of the adaptive CRT trial.

机构信息

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio 44195, USA.

出版信息

Heart Rhythm. 2012 Nov;9(11):1807-14. doi: 10.1016/j.hrthm.2012.07.009. Epub 2012 Jul 14.

DOI:10.1016/j.hrthm.2012.07.009
PMID:22796472
Abstract

BACKGROUND

In patients with sinus rhythm and normal atrioventricular conduction, pacing only the left ventricle with appropriate atrioventricular delays can result in superior left ventricular and right ventricular function compared with standard biventricular (BiV) pacing.

OBJECTIVE

To evaluate a novel adaptive cardiac resynchronization therapy ((aCRT) algorithm for CRT pacing that provides automatic ambulatory selection between synchronized left ventricular or BiV pacing with dynamic optimization of atrioventricular and interventricular delays.

METHODS

Patients (n = 522) indicated for a CRT-defibrillator were randomized to aCRT vs echo-optimized BiV pacing (Echo) in a 2:1 ratio and followed at 1-, 3-, and 6-month postrandomization.

RESULTS

The study met all 3 noninferiority primary objectives: (1) the percentage of aCRT patients who improved in their clinical composite score at 6 months was at least as high in the aCRT arm as in the Echo arm (73.6% vs 72.5%, with a noninferiority margin of 12%; P = .0007); (2) aCRT and echo-optimized settings resulted in similar cardiac performance, as demonstrated by a high concordance correlation coefficient between aortic velocity time integrals at aCRT and Echo settings at randomization (concordance correlation coefficient = 0.93; 95% confidence interval 0.91-0.94) and at 6-month postrandomization (concordance correlation coefficient = 0.90; 95% confidence interval 0.87-0.92); and (3) aCRT did not result in inappropriate device settings. There were no significant differences between the arms with respect to heart failure events or ventricular arrhythmia episodes. Secondary end points showed similar benefit, and right-ventricular pacing was reduced by 44% in the aCRT arm.

CONCLUSIONS

The aCRT algorithm is safe and at least as effective as BiV pacing with comprehensive echocardiographic optimization.

摘要

背景

在窦性节律和正常房室传导的患者中,仅起搏左心室并适当调整房室延迟可改善左心室和右心室功能,优于标准双心室(BiV)起搏。

目的

评估一种新型自适应心脏再同步治疗(aCRT)算法用于 CRT 起搏,该算法可提供左心室同步或 BiV 起搏的自动活动选择,并动态优化房室和室间延迟。

方法

将需要 CRT-除颤器的患者随机分为 aCRT 组和超声优化 BiV 起搏(Echo)组,比例为 2:1,并在随机分组后 1、3 和 6 个月进行随访。

结果

该研究达到了所有 3 个非劣效性主要终点:(1)6 个月时,aCRT 患者的临床综合评分改善率在 aCRT 组至少与 Echo 组一样高(73.6% vs 72.5%,非劣效性边界为 12%;P =.0007);(2)aCRT 和超声优化设置导致相似的心脏功能,这表现在随机分组时 aCRT 和 Echo 设置的主动脉速度时间积分之间具有很高的一致性相关系数(一致性相关系数 = 0.93;95%置信区间 0.91-0.94)和 6 个月随访时(一致性相关系数 = 0.90;95%置信区间 0.87-0.92);(3)aCRT 不会导致设备设置不当。两组在心力衰竭事件或室性心律失常发作方面无显著差异。次要终点显示出相似的益处,aCRT 组右心室起搏减少了 44%。

结论

aCRT 算法安全且至少与全面超声优化的 BiV 起搏一样有效。

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