Higgins Steven L, Hummel John D, Niazi Imran K, Giudici Michael C, Worley Seth J, Saxon Leslie A, Boehmer John P, Higginbotham Michael B, De Marco Teresa, Foster Elyse, Yong Patrick G
Scripps Memorial Hospital, La Jolla, California 92038-0028, USA.
J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.
This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy (CRT) when combined with an implantable cardioverter defibrillator (ICD).
Long-term outcome of CRT was measured in patients with symptomatic heart failure (HF), intraventricular conduction delay, and malignant ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]) requiring therapy from an ICD.
Patients (n = 490) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT (n = 245) or control (no CRT, n = 245) for up to six months. The primary end point was progression of HF, defined as all-cause mortality, hospitalization for HF, and VT/VF requiring device intervention. Secondary end points included peak oxygen consumption (VO(2)), 6-min walk (6 MW), New York Heart Association (NYHA) class, quality of life (QOL), and echocardiographic analysis.
A 15% reduction in HF progression was observed, but this was statistically insignificant (p = 0.35). The CRT, however, significantly improved peak VO(2) (0.8 ml/kg/min vs. 0.0 ml/kg/min, p = 0.030) and 6 MW (35 m vs. 15 m, p = 0.043). Changes in NYHA class (p = 0.10) and QOL (p = 0.40) were not statistically significant. The CRT demonstrated significant reductions in ventricular dimensions (left ventricular internal diameter in diastole = -3.4 mm vs. -0.3 mm, p < 0.001 and left ventricular internal diameter in systole = -4.0 mm vs. -0.7 mm, p < 0.001) and improvement in left ventricular ejection fraction (5.1% vs. 2.8%, p = 0.020). A subgroup of patients with advanced HF (NYHA class III/IV) consistently demonstrated improvement across all functional status end points.
The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay.
本研究旨在评估心脏再同步治疗(CRT)联合植入式心律转复除颤器(ICD)时的安全性和有效性。
对有症状性心力衰竭(HF)、室内传导延迟且需要ICD治疗的恶性室性快速心律失常(室性心动过速/心室颤动[VT/VF])患者进行了CRT的长期预后评估。
490例患者植入了能够提供CRT和ICD治疗的装置,并随机分为CRT组(n = 245)或对照组(无CRT,n = 245),为期6个月。主要终点是HF进展,定义为全因死亡率、HF住院以及需要装置干预的VT/VF。次要终点包括峰值耗氧量(VO₂)、6分钟步行距离(6MW)、纽约心脏协会(NYHA)心功能分级、生活质量(QOL)以及超声心动图分析。
观察到HF进展降低了15%,但这在统计学上无显著意义(p = 0.35)。然而,CRT显著改善了峰值VO₂(0.8 ml/kg/min对0.0 ml/kg/min,p = 0.030)和6MW(35米对15米,p = 0.043)。NYHA心功能分级(p = 0.10)和QOL(p = 0.40)的变化无统计学意义。CRT显示心室尺寸显著减小(舒张末期左心室内径 = -3.4毫米对 -0.3毫米,p < 0.001;收缩末期左心室内径 = -4.0毫米对 -0.7毫米,p < 0.001),左心室射血分数提高(5.1%对2.8%,p = 0.020)。一组晚期HF(NYHA III/IV级)患者在所有功能状态终点均持续显示出改善。
CRT改善了适合植入ICD且有症状性HF和室内传导延迟患者的功能状态。