持续性心房颤动和充血性心力衰竭患者的导管消融与最佳药物治疗:随机AMICA试验

K. Kuck, B. Merkely, R. Zahn, T. Arentz, K. Seidl, M. Schlüter, R. Tilz, C. Piorkowski, L. Gellér, T. Kleemann, G. Hindricks
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引用次数: 108

摘要

背景:持续性心房颤动(AF)和心力衰竭(HF)患者左心室射血分数(LVEF)降低的最佳治疗方法和内部除颤器治疗的适应症存在争议。方法将LVEF≤35%的持续性/长期持续性房颤患者随机分配到房颤导管消融组或最佳药物治疗组(BMT)。主要研究终点是1年时LVEF从基线的绝对增加。次要终点包括6分钟步行测试、生活质量和NT-proBNP (n端脑利钠肽前体)。肺静脉隔离是主要的消融途径;BMT包括速率或节奏控制。所有患者在植入心律转复除颤器或心脏再同步化治疗除颤器后住院后出院。这项研究因无效而提前终止了。结果140例患者(65±8岁,126例[90%]男性)可用于终点分析,68例和72例患者分别被分配到消融术和BMT。1年时,消融患者的LVEF增加了8.8% (95% CI, 5.8%-11.9%), BMT患者的LVEF增加了7.3% (4.3%-10.3%;P = 0.36)。61/83例消融患者(73.5%)和42/84例BMT患者(50%)在1年12导联心电图上记录窦性心律。在28/39例消融患者(72%)和16/36例BMT患者(44%)中,设备记录的1年房颤负担为0%或最多5%。消融患者和BMT患者的次要终点结局无差异。结论AMICA试验(充血性心力衰竭伴消融的心房颤动管理)未显示导管消融对房颤和晚期心衰患者有任何益处。这主要是因为在1年时,消融患者的LVEF增加的程度与BMT患者相似。心衰患者房颤导管消融的效果可能受到基线时心衰程度的影响,严重晚期心衰患者的消融获益相当有限。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT00652522。
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Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.
BACKGROUND Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. METHODS Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. RESULTS Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%; P=0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. CONCLUSIONS The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.
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