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心脏再同步治疗长期持续性心房颤动患者的节律与心率控制策略:随机Pilot-CRAfT研究结果

Rhythm and rate control strategies in patients with long-standing persistent atrial fibrillation treated with cardiac resynchronization: the results of the randomized Pilot-CRAfT study.

作者信息

Ciszewski Jan B, Tajstra Mateusz, Kowalik Ilona, Maciąg Aleksander, Chwyczko Tomasz, Jankowska Agnieszka, Smolis-Bąk Edyta, Firek Bohdan, Zając Dariusz, Karwowski Jarosław, Szwed Hanna, Pytkowski Mariusz, Gąsior Mariusz, Sterliński Maciej

机构信息

2nd Department of Cardiac Arrhythmia, Centre of Cardiac Arrhythmia, National Institute of Cardiology (Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy), 42 Alpejska Street, 04-628, Warsaw, Poland.

3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Silesian Center for Heart Diseases, Medical University of Silesia, Zabrze, Katowice, Poland.

出版信息

Clin Res Cardiol. 2024 Oct 10. doi: 10.1007/s00392-024-02541-z.

Abstract

BACKGROUND

Atrial fibrillation (AF) is common in cardiac resynchronization therapy (CRT) recipients. It is a marker of impaired CRT response mainly mediated by the reduction of effectively captured biventricular paced beats (BiVp). There are no randomized trials comparing strategies to maintain high BiVp percentage.

OBJECTIVE

To compare the efficacy of rhythm vs rate control strategies in CRT recipients with long-standing persistent AF.

METHODS

We performed a randomized trial including CRT recipients with persistent AF resulting in low BiVp%. All patients received amiodarone, the rhythm control group received external electrical cardioversion (EC), and the rate control group received atrioventricular node ablation, if needed. The primary end-point was 12-month BiVp% (NCT).

RESULTS

43 patients were included in the analysis. The mean age was 68.4 (SD: ± 8.3) years and the mean BiVp% 82.4% ± 9.7%. AF lasted 25 ± 19 months. The mean baseline left ventricular ejection fraction (LVEF), left atrium area, and the maximal oxygen uptake (VO2max) were: 30 ± 8%, 33 ± 7 cm, and 14 ± 5 mL/(kg*min), respectively. The EC success rate was 58%. 38% patients remained in sinus rhythm (SR) after 12 months. BiVp% increased similarly in both arms reaching 99% [95% CI 97.3-99.8] and 98% [94.0-99.0], P = 0.14 in rhythm and rate control groups, respectively. LVEF raised significantly only in the rhythm control group (ΔLVEF 4.1 (± 7.3), P = 0,018) which was driven by the patients who maintained SR. No differences in VO2max, QoL, clinical and safety end-points were observed.

CONCLUSION

Despite comparable BiVp% in both groups, only restoration of SR led to improved left ventricular ejection fraction in CRT patients with long-standing AF.

TRIAL REGISTRATION

NCT01850277 registered on 22/04/2013.

摘要

背景

心房颤动(AF)在接受心脏再同步治疗(CRT)的患者中很常见。它是CRT反应受损的一个标志物,主要由有效捕获的双心室起搏搏动(BiVp)减少介导。尚无比较维持高BiVp百分比策略的随机试验。

目的

比较节律控制与心率控制策略在长期持续性AF的CRT患者中的疗效。

方法

我们进行了一项随机试验,纳入持续性AF导致BiVp%低的CRT患者。所有患者均接受胺碘酮治疗,节律控制组接受体外电复律(EC),心率控制组根据需要接受房室结消融。主要终点为12个月时的BiVp%(NCT)。

结果

43例患者纳入分析。平均年龄为68.4(标准差:±8.3)岁,平均BiVp%为82.4%±9.7%。AF持续25±19个月。平均基线左心室射血分数(LVEF)、左心房面积和最大摄氧量(VO2max)分别为:30±8%、33±7 cm和14±5 mL/(kg·min)。EC成功率为58%。12个月后38%的患者维持窦性心律(SR)。两组的BiVp%均有相似增加,分别达到99%[95%可信区间97.3 - 99.8]和98%[94.0 - 99.0],节律控制组和心率控制组的P值分别为0.14。仅节律控制组的LVEF显著升高(LVEF变化值4.1(±7.3),P = 0.018),这是由维持SR的患者驱动的。在VO2max、生活质量、临床和安全性终点方面未观察到差异。

结论

尽管两组的BiVp%相当,但在长期AF的CRT患者中,仅恢复SR可改善左心室射血分数。

试验注册

NCT01850277于2013年4月22日注册。

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