心脏再同步治疗联合植入式心脏除颤器与单纯除颤器治疗的比较效果：一项队列研究。

Comparative effectiveness of cardiac resynchronization therapy with an implantable cardioverter-defibrillator versus defibrillator therapy alone: a cohort study.

出版信息

Ann Intern Med. 2014 May 6;160(9):603-11. doi: 10.7326/M13-1879.

Abstract

BACKGROUND

Trials comparing implantable cardioverter-defibrillator (ICD) therapy with cardiac resynchronization therapy with a defibrillator (CRT-D) are limited to selected patients treated at centers with extensive experience.

OBJECTIVE

To compare outcomes after CRT-D versus ICD therapy in contemporary practice.

DESIGN

Retrospective cohort study using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims.

SETTING

780 U.S. hospitals implanting both CRT-D and ICD devices.

PATIENTS

7090 propensity-matched patients older than 65 years with reduced left ventricular ejection fraction (<0.35) and prolonged QRS duration on electrocardiography (≥120 ms) having CRT-D or ICD implantation between 1 April 2006 and 31 December 2009.

MEASUREMENTS

Risks for death, readmission, and device-related complications over 3 years.

RESULTS

Compared with ICD therapy, CRT-D was associated with lower risks for mortality (cumulative incidence, 25.7% vs. 29.8%; adjusted hazard ratio [HR], 0.82 [99% CI, 0.73 to 0.93]), all-cause readmission (cumulative incidence, 68.6% vs. 72.8%; adjusted HR, 0.86 [CI, 0.81 to 0.93]), cardiovascular readmission (cumulative incidence, 45.0% vs. 52.4%; adjusted HR, 0.80 [CI, 0.73 to 0.88]), and heart failure readmission (cumulative incidence, 24.3% vs. 29.4%; adjusted HR, 0.78 [CI, 0.69 to 0.88]). It was also associated with greater risks for device-related infection (cumulative incidence, 1.9% vs. 1.0%; adjusted HR, 1.90 [CI, 1.07 to 3.37]). The lower risks for heart failure readmission associated with CRT-D compared with ICD therapy were most pronounced among patients with left bundle branch block or a QRS duration at least 150 ms and in women.

LIMITATIONS

Patients were not randomly assigned to treatment groups, and few patients could be propensity-matched. The findings may not extend to younger patients or those outside of fee-for-service Medicare.

CONCLUSION

In older patients with reduced left ventricular ejection fraction and prolonged QRS duration, CRT-D was associated with lower risks for death and readmission than ICD therapy alone.

PRIMARY FUNDING SOURCE

Agency for Healthcare Research and Quality.

摘要

背景

比较植入式心脏复律除颤器 (ICD) 治疗与带除颤器的心脏再同步治疗 (CRT-D) 的试验仅限于在经验丰富的中心接受治疗的选定患者。

目的

比较 CRT-D 与 ICD 治疗在当代实践中的结果。

设计

使用全国心血管数据注册中心的 ICD 注册与医疗保险索赔相关联的回顾性队列研究。

地点

在美国植入 CRT-D 和 ICD 设备的 780 家医院。

患者

2006 年 4 月 1 日至 2009 年 12 月 31 日期间，年龄大于 65 岁，左心室射血分数降低（<0.35）和心电图 QRS 持续时间延长（>=120 ms）的 7090 名患者接受 CRT-D 或 ICD 植入，采用倾向评分匹配。

测量

3 年内死亡、再入院和与设备相关的并发症风险。

结果

与 ICD 治疗相比，CRT-D 与死亡率降低相关（累积发生率，25.7% 对 29.8%；调整后的危险比 [HR]，0.82 [99%CI，0.73 至 0.93]）、全因再入院（累积发生率，68.6% 对 72.8%；调整后的 HR，0.86 [CI，0.81 至 0.93]）、心血管再入院（累积发生率，45.0% 对 52.4%；调整后的 HR，0.80 [CI，0.73 至 0.88]）和心力衰竭再入院（累积发生率，24.3% 对 29.4%；调整后的 HR，0.78 [CI，0.69 至 0.88]）。它还与设备相关感染的风险增加相关（累积发生率，1.9% 对 1.0%；调整后的 HR，1.90 [CI，1.07 至 3.37]）。与 ICD 治疗相比，CRT-D 治疗与心力衰竭再入院风险降低相关，这在左束支传导阻滞或 QRS 持续时间至少 150 ms 的患者和女性中最为明显。