Primary Results From the SmartDelay Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV) Trial A Randomized Trial Comparing Empirical, Echocardiography-Guided, and Algorithmic Atrioventricular Delay Programming in Cardiac Resynchronization Therapy
Primary Results From the SmartDelay Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV) Trial A Randomized Trial Comparing Empirical, Echocardiography-Guided, and Algorithmic Atrioventricular Delay Programming in Cardiac Resynchronization Therapy
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DOI：
10.1161/circulationaha.110.992552
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发表时间：
2010-12-21
期刊：
影响因子：
37.8
通讯作者：
Stein, Kenneth M.
中科院分区：
文献类型：
--
作者：
Ellenbogen, Kenneth A.;Gold, Michael R.;Stein, Kenneth M.
一个可能影响心脏起搏治疗反应的变量是程控房室（AV）延迟。SmartDelay确定的AV优化：与心脏复苏治疗中使用的其他AV延迟方法的比较（SMART-AV）试验将患者前瞻性随机分配至固定的经验AV延迟（120毫秒）、超声心动图优化的AV延迟或使用SmartDelay（一种基于电描记图的算法）优化的AV延迟。（68%男性;平均年龄66 ± 11岁;平均左心室射血分数25 ± 7%）符合入组标准的患者接受心脏除颤治疗，980例患者按1：1：1的比例随机分组。所有患者均在植入后以及3个月和6个月后程控（DDD-60或DDDR-60）并进行评价。主要终点为左心室收缩末期容积。次要终点包括纽约心脏协会分级、生活质量评分、6分钟步行距离、左心室舒张末期容积和左心室射血分数。SmartDelay、超声心动图和固定组6个月时左心室收缩末期容积变化的中位数（四分位数1和3）分别为-21 mL（-45和6 mL）、-19 mL（-45和6 mL）和-15 mL（-41和6 mL）。在6个月时，SmartDelay组与超声心动图组（P=0.52）或SmartDelay组与固定组（P=0.66）的左心室收缩末期容积改善无差异。次要终点，包括结构（左心室舒张末期容积和左心室射血分数）和功能（6分钟步行，生活质量和纽约心脏协会分类）措施，没有显着差异arms. Conclusions，无论是SmartDelay还是超声心动图是上级到一个固定的AV延迟120毫秒。本试验中评估的AV优化技术的常规使用是不必要的。然而，这些数据并不排除在选定的对心脏起搏治疗无反应的患者中的可能效用。
Background-One variable that may influence cardiac resynchronization therapy response is the programmed atrioventricular (AV) delay. The SmartDelay Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV) Trial prospectively randomized patients to a fixed empirical AV delay (120 milliseconds), echocardiographically optimized AV delay, or AV delay optimized with SmartDelay, an electrogram-based algorithm.Methods and Results-A total of 1014 patients (68% men; mean age, 66 +/- 11 years; mean left ventricular ejection fraction, 25 +/- 7%) who met enrollment criteria received a cardiac resynchronization therapy defibrillator, and 980 patients were randomized in a 1:1:1 ratio. All patients were programmed (DDD-60 or DDDR-60) and evaluated after implantation and 3 and 6 months later. The primary end point was left ventricular end-systolic volume. Secondary end points included New York Heart Association class, quality-of-life score, 6-minute walk distance, left ventricular end-diastolic volume, and left ventricular ejection fraction. The medians (quartiles 1 and 3) for change in left ventricular end-systolic volume at 6 months for the SmartDelay, echocardiography, and fixed arms were -21 mL (-45 and 6 mL), -19 mL (-45 and 6 mL), and -15 mL (-41 and 6 mL), respectively. No difference in improvement in left ventricular end-systolic volume at 6 months was observed between the SmartDelay and echocardiography arms (P=0.52) or the SmartDelay and fixed arms (P=0.66). Secondary end points, including structural (left ventricular end-diastolic volume and left ventricular ejection fraction) and functional (6-minute walk, quality of life, and New York Heart Association classification) measures, were not significantly different between arms.Conclusions-Neither SmartDelay nor echocardiography was superior to a fixed AV delay of 120 milliseconds. The routine use of AV optimization techniques assessed in this trial is not warranted. However, these data do not exclude possible utility in selected patients who do not respond to cardiac resynchronization therapy.