心力衰竭合并心房颤动的导管消融治疗。
Catheter Ablation for Atrial Fibrillation with Heart Failure.
机构信息
From the Comprehensive Arrhythmia Research and Management Center, Division of Cardiovascular Medicine, School of Medicine, University of Utah Health, Salt Lake City (N.F.M.); Klinikum Coburg, Coburg (J.B.), Kardiologie an den Ev. Elisabeth-Kliniken (D.A.) and Biotronik (J.P., H.S.), Berlin, Klinik Rotes Kreuz, Frankfurt/Main (J.S.), Klinikum Links der Weser, Bremen (L.B.), Deutsches Herzzentrum München, Munich (H.C.), Institute of Medical Statistics and Computational Biology, Cologne (D.B.), and KMG Klinikum, Güstrow (J.V.) - all in Germany; Antonius Ziekenhuis Nieuwegein, Nieuwegein (L.J.), and the Erasmus University Medical Center, Rotterdam (B.M.) - both in the Netherlands; Semmelweis Medical University, Budapest, Hungary (E.P.); and the State Research Institute of Circulation Pathology, Novosibirsk, Russia (P.S.).
出版信息
N Engl J Med. 2018 Feb 1;378(5):417-427. doi: 10.1056/NEJMoa1707855.
BACKGROUND
Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment.
METHODS
We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure. All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure.
RESULTS
After a median follow-up of 37.8 months, the primary composite end point occurred in significantly fewer patients in the ablation group than in the medical-therapy group (51 patients [28.5%] vs. 82 patients [44.6%]; hazard ratio, 0.62; 95% confidence interval [CI], 0.43 to 0.87; P=0.007). Significantly fewer patients in the ablation group died from any cause (24 [13.4%] vs. 46 [25.0%]; hazard ratio, 0.53; 95% CI, 0.32 to 0.86; P=0.01), were hospitalized for worsening heart failure (37 [20.7%] vs. 66 [35.9%]; hazard ratio, 0.56; 95% CI, 0.37 to 0.83; P=0.004), or died from cardiovascular causes (20 [11.2%] vs. 41 [22.3%]; hazard ratio, 0.49; 95% CI, 0.29 to 0.84; P=0.009).
CONCLUSIONS
Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy. (Funded by Biotronik; CASTLE-AF ClinicalTrials.gov number, NCT00643188 .).
背景
与单纯心力衰竭患者相比，患有心房颤动和心力衰竭的患者的死亡率和发病率更高。对于接受适当治疗但仍有反应的心力衰竭患者，导管消融治疗心房颤动已被提议作为改善其预后的一种方法。
方法
我们随机分配了症状性阵发性或持续性心房颤动患者，这些患者对抗心律失常药物没有反应、有不可接受的副作用或不愿意服用这些药物，他们除了接受心力衰竭的基于指南的治疗外，还接受导管消融（179 名患者）或药物治疗（速率或节律控制）（184 名患者）。所有患者均有纽约心脏协会心功能 II、III 或 IV 级，左心室射血分数为 35%或更低，并且植入了除颤器。主要终点是任何原因导致的死亡或因心力衰竭恶化而住院的复合终点。
结果
在中位数为 37.8 个月的随访后，消融组中主要复合终点的患者明显少于药物治疗组（51 例[28.5%] vs. 82 例[44.6%]；风险比为 0.62；95%置信区间[CI]为 0.43 至 0.87；P=0.007）。消融组因任何原因死亡的患者明显少于药物治疗组（24 例[13.4%] vs. 46 例[25.0%]；风险比为 0.53；95%CI 为 0.32 至 0.86；P=0.01），因心力衰竭恶化而住院的患者也明显少于药物治疗组（37 例[20.7%] vs. 66 例[35.9%]；风险比为 0.56；95%CI 为 0.37 至 0.83；P=0.004），或死于心血管原因的患者也明显少于药物治疗组（20 例[11.2%] vs. 41 例[22.3%]；风险比为 0.49；95%CI 为 0.29 至 0.84；P=0.009）。
结论
与药物治疗相比，心力衰竭患者的心房颤动导管消融治疗与任何原因导致的死亡或因心力衰竭恶化而住院的复合终点发生率显著降低相关。（由 Biotronik 资助；CASTLE-AF ClinicalTrials.gov 编号，NCT00643188）。
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