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房室结消融治疗永久性心房颤动患者的心脏再同步治疗:一项随机试验。

Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial.

机构信息

Arrhythmologic Centre, Department of Cardiology, Ospedali del Tigullio, 16033 Lavagna, Italy.

出版信息

Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23.

DOI:10.1093/eurheartj/ehr162
PMID:21606084
Abstract

AIMS

On the basis of the current knowledge, cardiac resynchronization therapy (CRT) cannot be recommended as a first-line treatment for patients with severely symptomatic permanent atrial fibrillation undergoing atrioventricular (AV) junction ablation. We examined whether CRT was superior to conventional right ventricular (RV) pacing in reducing heart failure (HF) events.

METHODS AND RESULTS

In this prospective, multi-centre study, we randomly assigned 186 patients, in whom AV junction ablation and CRT device implantation had been successfully performed, to receive optimized echo-guided CRT (97 patients) or RV apical pacing (89 patients). The data were analysed according to the intention-to-treat principle. During a median follow-up of 20 months (interquartile range 11-24), the primary composite endpoint of death from HF, hospitalization due to HF, or worsening HF occurred in 11 (11%) patients in the CRT group and 23 (26%) patients in the RV group [CRT vs. RV group: sub-hazard ratio (SHR) 0.37 ( 95% CI 0.18-0.73), P = 0.005]. In the CRT group, compared with the RV group, fewer patients had worsening HF [SHR 0.27 (95% CI 0.12-0.58), P = 0.001] and hospitalizations for HF [SHR 0.20 (95% CI 0.06-0.72), P = 0.013]. Total mortality was similar in both groups [hazard ratio (HR) 1.57 (95% CI 0.58-4.27), P = 0.372]. The beneficial effects of CRT were consistent in patients who had ejection fraction ≤35%, New York Heart Association Class ≥III and QRS width ≥120 and in those who did not. At multi-variable Cox regression, only CRT mode remained an independent predictor of absence of clinical failure during the follow-up [HR = 0.23 (95% CI 0.08-0.66), P = 0.007].

CONCLUSIONS

In patients undergoing 'Ablate and Pace' therapy for severely symptomatic permanent atrial fibrillation, CRT is superior to RV apical pacing in reducing the clinical manifestations of HF. (ClinicalTrials.gov number: NCT00111527).

摘要

目的

根据现有知识,心脏再同步治疗(CRT)不能作为严重症状性永久性心房颤动患者房室(AV)结消融后的一线治疗。我们研究了 CRT 是否优于传统的右心室(RV)起搏以减少心力衰竭(HF)事件。

方法和结果

在这项前瞻性、多中心研究中,我们随机分配了 186 名成功接受 AV 结消融和 CRT 设备植入的患者,分别接受优化的超声引导 CRT(97 名患者)或 RV 心尖起搏(89 名患者)。根据意向治疗原则对数据进行分析。在中位随访 20 个月(四分位距 11-24)期间,CRT 组中有 11 名(11%)患者发生 HF 死亡、HF 住院或 HF 恶化的主要复合终点,而 RV 组中有 23 名(26%)患者[CRT 组与 RV 组:亚危险比(SHR)0.37(95% CI 0.18-0.73),P = 0.005]。在 CRT 组中,与 RV 组相比,较少的患者出现 HF 恶化[SHR 0.27(95% CI 0.12-0.58),P = 0.001]和 HF 住院[SHR 0.20(95% CI 0.06-0.72),P = 0.013]。两组的总死亡率相似[风险比(HR)1.57(95% CI 0.58-4.27),P = 0.372]。在射血分数≤35%、纽约心脏协会(NYHA)分级≥III 级和 QRS 宽度≥120 且不伴这些特征的患者中,CRT 的有益效果是一致的。在多变量 Cox 回归分析中,只有 CRT 模式仍然是随访期间无临床失败的独立预测因素[HR = 0.23(95% CI 0.08-0.66),P = 0.007]。

结论

在接受严重症状性永久性心房颤动“消融和起搏”治疗的患者中,CRT 可减少心力衰竭的临床表现,优于 RV 心尖起搏。(临床试验编号:NCT00111527)。

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