Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region.
Masahiko Goya, Seung-Jung Park, Kenji Ando, Reece Holbrook, Rowan Iskandar, Luke Jacobsen, Joseph D Mozingo, Boyoung Joung
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引用次数: 0
Abstract
Background: Antitachycardia pacing (ATP) therapy, available in modern implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), aims to terminate ventricular arrhythmias without administering high energy shocks. The intrinsic ATP (iATP) algorithm automates ATP programming in real-time, tailoring therapy based on previous ATP attempts. This study evaluated the safety, efficacy, and clinical outcomes of iATP in patients from Japan and South Korea.
Methods: This study was a prospective, observational, multi-site registry that enrolled patients from Japan and South Korea implanted with an ICD or CRT-D device with the iATP algorithm. Patients were followed for a minimum of 12 months. Outcomes included ATP termination success, appropriate shocks, acceleration, arrhythmia-related syncope, and mortality. A post hoc unanchored matching-adjusted indirect comparison (uMAIC) was performed to compare iATP with standard ATP using published literature.
Results: A total of 800 patients were enrolled. The iATP success rate for terminating all episodes was 89.2% (86.2% Generalized Estimating Equation [GEE] estimated) and 82.2% for episodes in the fast VT zone (80.9% GEE estimated). Acceleration occurred in 2.0% of episodes, and arrhythmia-related syncope was observed in 0.5% of patients. The 1-year survival rate was 96.1%, with no device-related deaths or abnormal battery depletions. The uMAIC showed iATP had higher termination efficacy across all episodes (88.1% vs. 79.3%, p < 0.001), a lower probability of appropriate shocks per episode (iATP 14.7% and ATP 31.3%, p < 0.001), and fewer accelerations per episode (2.1% vs. 4.8%, p = 0.02), with similar probability of arrhythmia-related syncope per patient (0.5% vs 0.9%, p = 0.35) and mortality (12-month Kaplan Meyer survival estimate iATP 95.4%, ATP 95.3%, p = 0.43).
Conclusions: iATP exhibited a high ventricular arrhythmia termination efficacy and a favorable safety profile. Comparison of iATP to standard ATP provides initial evidence of higher termination success, lower incidence of accelerations and appropriate shocks, and similar rates of mortality and arrhythmia-related syncope.
Trial registration: ClinicalTrials.gov Identifier: NCT01524276; Japan Registry of Clinical Trials Identifier: jRCT1042200049.
背景:抗心动过速起搏(ATP)治疗可用于现代植入式心律转复除颤器(ICD)和心脏再同步治疗除颤器(CRT-D),旨在终止室性心律失常而无需给予高能量冲击。内在ATP (iATP)算法实时自动ATP编程,根据先前的ATP尝试定制治疗。本研究评估了日本和韩国患者使用itp的安全性、有效性和临床结果。方法:本研究是一项前瞻性、观察性、多地点注册的研究,招募了来自日本和韩国的植入itp算法的ICD或CRT-D设备的患者。患者随访至少12个月。结果包括ATP终止成功、适当的电击、加速、心律失常相关性晕厥和死亡率。使用已发表的文献,对iATP与标准ATP进行了非锚定匹配调整间接比较(uMAIC)。结果:共纳入800例患者。iATP终止所有发作的成功率为89.2%(广义估计方程[GEE]估计为86.2%),快速VT区发作的成功率为82.2% (GEE估计为80.9%)。2.0%的发作发生加速,0.5%的患者发生心律失常相关性晕厥。1年生存率为96.1%,无设备相关死亡或异常电池耗尽。uMAIC显示,在所有发作中,iATP具有更高的终止疗效(88.1% vs. 79.3%)。结论:iATP具有较高的室性心律失常终止疗效和良好的安全性。iATP与标准ATP的比较提供了更高的终止成功率,更低的加速和适当的电击发生率,以及相似的死亡率和心律失常相关性晕厥的初步证据。试验注册:ClinicalTrials.gov标识符:NCT01524276;日本临床试验注册号:jRCT1042200049。
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