From the Feinberg School of Medicine, Northwestern University, Chicago, IL (S.S., D.M.L.-J.; Tufts University School of Medicine, Boston, MA (M.V.O.); University of Minnesota Medical School, Minneapolis (D.G.B.); University of Virginia, Charlottesville (J.P.D.); St. Jude Medical, Sunnyvale, CA (E.K., F.Q., M.T.); Baystate Medical Center, Tufts University School of Medicine, Springfield, MA (M.T.S.); and Case Western Reserve University/University Hospitals Case Medical Center, Cleveland, OH (A.L.W.).
Circulation. 2016 Oct 18;134(16):1130-1140. doi: 10.1161/CIRCULATIONAHA.115.020252.
The RATE Registry (Registry of Atrial Tachycardia and Atrial Fibrillation Episodes) is a prospective, outcomes-oriented registry designed to document the prevalence of atrial tachycardia and/or fibrillation (AT/AF) of any duration in patients with pacemakers and implantable cardioverter defibrillators (ICDs) and evaluate associations between rigorously adjudicated AT/AF and predefined clinical events, including stroke. The appropriate clinical response to brief episodes of AT/AF remains unclear.
Rigorously adjudicated electrogram (EGM) data were correlated with adjudicated clinical events with logistic regression and Cox models. Long episodes of AT/AF were defined as episodes in which the onset and/or offset of AT/AF was not present within a single EGM recording. Short episodes of AT/AF were defined as episodes in which both the onset and offset of AT/AF were present within a single EGM recording.
We enrolled 5379 patients with pacemakers (N=3141) or ICDs (N=2238) at 225 US sites (median follow-up 22.9 months). There were 359 deaths. There were 478 hospitalizations among 342 patients for clinical events. We adjudicated 37 531 EGMs; 50% of patients had at least one episode of AT/AF. Patients with clinical events were more likely than those without to have long AT/AF (31.9% vs. 22.1% for pacemaker patients and 28.7% vs. 20.2% for ICD patients; P<0.05 for both groups). Only short episodes of AT/AF were documented in 9% of pacemaker patients and 16% of ICD patients. Patients with clinical events were no more likely than those without to have short AT/AF (5.1% vs. 7.9% for pacemaker patients and 11.5% vs. 10.4% for ICD patients; P=0.21 and 0.66, respectively).
In the RATE Registry, rigorously adjudicated short episodes of AT/AF, as defined, were not associated with increased risk of clinical events compared with patients without documented AT/AF.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00837798.
RATE 注册研究(房性心动过速和心房颤动发作登记研究)是一项前瞻性、以结局为导向的登记研究,旨在记录起搏器和植入式心脏复律除颤器(ICD)患者任何持续时间的房性心动过速和/或心房颤动(AT/AF)的发生率,并评估经过严格裁决的 AT/AF 与预先设定的临床事件(包括中风)之间的相关性。对于短暂的 AT/AF 发作,适当的临床应对方法仍不清楚。
对经过严格裁决的心电图(EGM)数据进行分析,并与经过裁决的临床事件进行相关性分析,采用逻辑回归和 Cox 模型。长程 AT/AF 定义为 AT/AF 的起始和/或终止不在单个 EGM 记录内的发作。短程 AT/AF 定义为 AT/AF 的起始和终止均在单个 EGM 记录内的发作。
我们在 225 个美国地点招募了 5379 名起搏器(N=3141)或 ICD(N=2238)患者(中位随访时间 22.9 个月)。共有 359 人死亡。342 名患者中有 478 人因临床事件住院。我们裁决了 37531 个 EGM;50%的患者至少有一次 AT/AF 发作。与无临床事件的患者相比,有临床事件的患者更有可能发生长程 AT/AF(起搏器患者中为 31.9%比 22.1%,ICD 患者中为 28.7%比 20.2%;两组均 P<0.05)。仅有 9%的起搏器患者和 16%的 ICD 患者记录了短程 AT/AF。与无临床事件的患者相比,有临床事件的患者发生短程 AT/AF 的可能性没有增加(起搏器患者中为 5.1%比 7.9%,ICD 患者中为 11.5%比 10.4%;P=0.21 和 0.66)。
在 RATE 登记研究中,与未记录 AT/AF 的患者相比,严格裁决的短程 AT/AF 发作与临床事件风险增加无关。