Stambler Bruce S, Ellenbogen Kenneth A, Orav E John, Sgarbossa Elena B, Estes N A Mark, Rizo-Patron Carlos, Kirchhoffer James B, Hadjis Tom A, Goldman Lee, Lamas Gervasio A
University Hospitals of Cleveland, Cleveland VA Medical Center, Case Western Reserve University, Cleveland, Ohio 44106, USA.
Pacing Clin Electrophysiol. 2003 Oct;26(10):2000-7. doi: 10.1046/j.1460-9592.2003.00309.x.
The Pacemaker Selection in the Elderly (PASE) trial was a prospective, multicenter, single blind, randomized comparison of single chamber, rate adaptive, ventricular pacing (VVIR) with dual chamber, rate adaptive pacing (DDDR) in 407 patients aged > or =65 years(mean 76 +/- 7 years, 60% male)with standard bradycardia indications for dual chamber pacemaker implantation. The incidence, predictors, and clinical consequences of atrial fibrillation (AF) developing after pacemaker implantation in the PASE trial were studied prospectively. During a median follow-up of 18 months, AF developed in 73 (18%) patients. Kaplan-Meier estimated cumulative incidences of AF in patients with sinus node dysfunction (n=176) at 18 months were 28% in the VVIR and 16% in the DDDR groups (P=0.08). After adjustment for other clinical variables using a Cox multivariate regression model, randomization to VVIR compared with DDDR pacing mode among patients with sinus node dysfunction was independently associated with a 2.6-fold increased relative risk (RR) of developing AF after pacemaker implantation (P=0.01). Other independent clinical risk factors for development of postimplant AF included a preimplant history of hypertension (P=0.02) or supraventricular tachyarrhythmias(P<0.04). Patients who developed AF had similar health related quality of life scores and cardiovascular functional status after 18 months of pacing as patients who remained free of AF. The RR of death, stroke, or heart failure hospitalization was not increased in patients who developed AF. Thus, in the elderly patients with sinus node dysfunction requiring permanent pacing, DDDR pacing mode protected against the development of AF. However, development of AF after pacemaker implantation in this population was not associated with a significant impact on quality-of-life, functional status, or other clinical endpoints during 18 months of follow-up.
老年患者起搏器选择(PASE)试验是一项前瞻性、多中心、单盲、随机对照试验,在407例年龄≥65岁(平均76±7岁,60%为男性)、有双腔起搏器植入标准心动过缓指征的患者中,比较单腔频率适应性心室起搏(VVIR)与双腔频率适应性起搏(DDDR)。前瞻性研究了PASE试验中起搏器植入后房颤(AF)发生的发生率、预测因素及临床后果。在中位随访18个月期间,73例(18%)患者发生房颤。18个月时,窦房结功能障碍患者(n = 176)中,VVIR组房颤的Kaplan-Meier估计累积发生率为28%,DDDR组为16%(P = 0.08)。在使用Cox多变量回归模型对其他临床变量进行校正后,窦房结功能障碍患者中,随机分配至VVIR起搏模式与DDDR起搏模式相比,起搏器植入后发生房颤的相对风险(RR)独立增加2.6倍(P = 0.01)。植入后房颤发生的其他独立临床危险因素包括植入前有高血压病史(P = 0.02)或室上性快速心律失常病史(P < 0.04)。发生房颤的患者在起搏18个月后的健康相关生活质量评分和心血管功能状态与未发生房颤的患者相似。发生房颤的患者死亡、中风或心力衰竭住院的RR未增加。因此,在需要永久起搏的老年窦房结功能障碍患者中,DDDR起搏模式可预防房颤的发生。然而,该人群起搏器植入后房颤的发生在18个月随访期间对生活质量、功能状态或其他临床终点无显著影响。