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双束支阻滞伴不明原因晕厥患者的永久性心脏起搏预防晕厥:PRESS 研究。

Prevention of syncope through permanent cardiac pacing in patients with bifascicular block and syncope of unexplained origin: the PRESS study.

机构信息

Azienda Ospedaliera S. Filippo Neri, Roma, Italy.

出版信息

Circ Arrhythm Electrophysiol. 2013 Feb;6(1):101-7. doi: 10.1161/CIRCEP.112.975102. Epub 2013 Feb 6.

Abstract

BACKGROUND

Syncope in patients with bifascicular block (BFB) is a common event whose causes might be difficult to assess.

METHODS AND RESULTS

Prevention of syncope through permanent cardiac pacing in patients with bifascicular block (PRESS) is a multicenter, prospective, randomized, single-blinded study designed to demonstrate a reduction in symptomatic events in patients with bifascicular block and syncope of undetermined origin implanted with permanent pacemaker. Device programming mode (NASPE/BPEG code) at DDD with a lower rate of 60 ppm is compared with backup pacing at DDI with a lower rate of 30 ppm. The end point consisted of (1) syncope, (2) symptomatic presyncopal episodes associated with a device intervention (ventricular pacing), and (3) symptomatic episodes associated with intermittent or permanent atrioventricular block (any degree). One hundred one patients were enrolled and randomized. Primary end point events at 2 years were observed in 23 patients, with a significant lower incidence in the study group (hazard ratio, 0.32; 95% confidence interval [CI], 0.10-0.96; P=0.042). Reduction of any symptoms, associated or not with device intervention, was superior in DDD60 compared with DDI30 (hazard ratio, 0.4; 95% confidence interval, 0.25-0.78; P=0.0053). Fourteen patients developed other rhythm diseases and met class I indication for pacing. The annual incidence of rhythm disease development was 7.4%.

CONCLUSIONS

In patients with bifascicular block and syncope of undetermined origin, the use of a dual chamber pacemaker programmed to DDD60 led to a significant reduction of syncope or symptomatic events associated with a cardioinhibitory origin, compared with DDI30 programming. Symptoms associated with a new onset of rhythm disease were found in 15% of the population at 2 years.

摘要

背景

双束支阻滞(BFB)患者发生晕厥较为常见,其病因可能难以评估。

方法和结果

预防双束支阻滞伴不明原因晕厥患者发生晕厥的心脏永久起搏(PRESS)是一项多中心、前瞻性、随机、单盲研究,旨在证明植入永久起搏器的双束支阻滞伴不明原因晕厥患者的症状性事件减少。与备用起搏的 DDI(下限率 30ppm)相比,装置程控模式(DDD,下限率 60ppm,NASPE/BPEG 编码)比较。终点包括(1)晕厥;(2)与器械干预(心室起搏)相关的有症状先兆晕厥发作;(3)与间歇性或永久性房室传导阻滞(任何程度)相关的有症状发作。共纳入 101 例患者并进行随机分组。2 年时观察到主要终点事件发生在 23 例患者中,研究组发生率显著降低(风险比,0.32;95%置信区间[CI],0.10-0.96;P=0.042)。与 DDI30 相比,DDD60 降低任何症状(与器械干预相关或不相关)的效果更优(风险比,0.4;95%CI,0.25-0.78;P=0.0053)。14 例患者发生其他节律性疾病并符合起搏 I 类适应证。节律性疾病的年发生率为 7.4%。

结论

在双束支阻滞伴不明原因晕厥患者中,与 DDI30 程控相比,程控为 DDD60 的双腔起搏器可显著降低心因性晕厥或症状性事件的发生率。在 2 年时,有 15%的人群发现与新发节律性疾病相关的症状。

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