Ricci Renato Pietro, Quesada Aurelio, Almendral Jesus, Arribas Fernando, Wolpert Christian, Adragao Pedro, Zoni-Berisso Massimo, Navarro Xavier, DeSanto Tiziana, Grammatico Andrea, Santini Massimo
Heart Diseases Department, San Filippo Neri Hospital, Via Martinotti 20, 00135 Rome, Italy.
Europace. 2009 May;11(5):587-93. doi: 10.1093/europace/eup072.
The aim of the present analysis of the DATAS study was to compare the impact of dual- vs. single-chamber defibrillators on atrial fibrillation (AF) occurrence and AF-related clinical events in patients with Class I indication for implantable cardioverter defibrillators (ICDs) and no indication for dual-chamber pacing.
Three hundred and thirty-four patients were randomized, through a centralized assignment, to single-chamber ICDs, dual-chamber ICDs programmed as single-chamber ICDs, and dual ICDs with full diagnostics and AF prevention and therapy capabilities. The latter two groups in the first 8 months of the study, when the study design was that of a randomized parallel trial, were compared in the present analysis. The primary endpoint was composed by the following AF-related clinical events: permanent AF, AF-related hospitalizations, cardiac-embolic events, and inappropriate ICD shocks due to AF misclassification. Two hundred and twenty-three patients were available for this analysis, of whom 111 in the single-chamber-simulated group and 112 in the dual-chamber true group. Atrial fibrillation-related composite endpoint raw incidence was 9 of 111 (8.1%) in the single-chamber group vs. 1 of 112 (0.9%) in the dual-chamber group (P = 0.0098 by Fisher's exact test). Single-chamber ICDs were associated with a significantly higher risk to develop the AF-related composite endpoint by Cox regression analysis (hazard ratio 8.25, 95% CI 1.03-65.96, P = 0.047) and by the Kaplan-Meier survival analysis (log-rank test, P = 0.047).
Dual-chamber ICDs compared with single-chamber ICDs reduced the incidence of an endpoint composed by permanent AF, AF-related hospitalizations, and ICD shocks deemed inappropriate due to AF misclassification.
本项对DATAS研究的分析旨在比较双腔与单腔除颤器对有植入式心脏复律除颤器（ICD）I类适应症且无双腔起搏适应症患者房颤（AF）发生情况及AF相关临床事件的影响。
334例患者通过集中分配随机分为单腔ICD组、程控为单腔ICD的双腔ICD组以及具有完整诊断及AF预防和治疗功能的双腔ICD组。在本分析中，比较了研究设计为随机平行试验时前两组在前8个月的情况。主要终点由以下AF相关临床事件组成：永久性AF、AF相关住院、心脏栓塞事件以及因AF误分类导致的不适当ICD电击。223例患者可用于此次分析，其中单腔模拟组111例，双腔真实组112例。单腔组AF相关复合终点原始发生率为111例中的9例（8.1%），双腔组为112例中的1例（0.9%）（Fisher精确检验P = 0.0098）。通过Cox回归分析（风险比8.25，95%CI 1.03 - 65.96，P = 0.047）和Kaplan - Meier生存分析（对数秩检验，P = 0.047），单腔ICD与发生AF相关复合终点的风险显著更高相关。
与单腔ICD相比，双腔ICD降低了由永久性AF、AF相关住院以及因AF误分类导致的不适当ICD电击组成的终点发生率。
