Crossley George H, Aonuma Kazutaka, Haffajee Charles, Shoda Morio, Meijer Albert, Bauer Alexander, Boriani Giuseppe, Svendsen Jesper, Thomas Shelley, Wiggenhorn Christopher, Unterberg-Buchwald Christina
St. Thomas Research Institute, and Division of Cardiology, University of Tennessee, College of Medicine, Nashville, Tennessee 37203, USA.
Pacing Clin Electrophysiol. 2009 Jan;32(1):13-23. doi: 10.1111/j.1540-8159.2009.02171.x.
Atrial fibrillation (AF) is a major cause of morbidity and mortality, especially in patients with congestive heart failure.
The purposes of this international, prospective multicenter study were to evaluate the efficacy of atrial shock therapy in patients with a cardiac resynchronization therapy defibrillator (CRT-D) and to evaluate the safety of the new CRT-D. The effectiveness of a new wireless telemetry system was also evaluated.
A total of 282 patients, without permanent AF, who had indications for a CRT-D were included. Atrial shock therapy was tested on both spontaneous and induced AF episodes. The effectiveness of the Medtronic wireless telemetry system (Conexus; Medtronic Inc., Minneapolis, MN, USA) was also tested. Secondary endpoints included the heart failure Clinical Composite Response, system performance evaluation, and adverse event summary.
Atrial shock therapy was successful in 168 of 171 episodes (98.2%). Of these, 138 episodes were induced and 33 were spontaneous. Successful cardioversion occurred in 137 of the 138 induced-AF episodes (86.1% with 12 joule (J), 13.1% with 24 J, and 0.7% with 35 J). During the first 3 months of implant, there were 43 system-related complications in 37 subjects out of 278 subjects. There were 1,999 Conexus telemetry uses recorded during this study. This includes 282 uses during the implant procedure. There were no cases of complete loss of telemetry or any adverse events reported using this system.
We achieved an atrial shock efficacy of 98.2% in patients who met standard CRT-D indications. The wireless telemetry performed well with no reported unanticipated adverse device effects.
心房颤动(AF)是发病和死亡的主要原因,尤其是在充血性心力衰竭患者中。
这项国际前瞻性多中心研究的目的是评估心房电击疗法对植入心脏再同步化治疗除颤器(CRT-D)患者的疗效,并评估新型CRT-D的安全性。还评估了一种新型无线遥测系统的有效性。
共纳入282例无永久性AF且有CRT-D植入指征的患者。对自发和诱发的AF发作均进行了心房电击疗法测试。还测试了美敦力无线遥测系统(Conexus;美敦力公司,美国明尼苏达州明尼阿波利斯)的有效性。次要终点包括心力衰竭临床综合反应、系统性能评估和不良事件总结。
171次发作中有168次(98.2%)心房电击疗法成功。其中,138次为诱发性发作,33次为自发性发作。138次诱发性AF发作中有137次成功转复(12焦耳(J)时为86.1%,24 J时为13.1%,35 J时为0.7%)。在植入后的前3个月,278例患者中有37例出现43例与系统相关的并发症。本研究期间记录了1999次Conexus遥测使用情况。这包括植入过程中的282次使用。使用该系统未报告遥测完全丢失或任何不良事件的病例。
在符合标准CRT-D指征的患者中,我们实现了98.2%的心房电击疗效。无线遥测性能良好,未报告意外的不良设备影响。