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双腔闭环刺激对倾斜诱导血管迷走性心抑制性晕厥健康患者晕厥复发的影响:前瞻性、随机、单盲、交叉研究。

The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study.

机构信息

Department of Cardio-Thoracic and Respiratory Sciences, Syncope Unit, Second University of Naples, Italy.

出版信息

Heart. 2013 Nov;99(21):1609-13. doi: 10.1136/heartjnl-2013-303878. Epub 2013 May 30.

Abstract

BACKGROUND

The closed-loop stimulation (CLS) pacemaker algorithm is a system that permanently monitors the contractile state of the myocardium and converts the intrinsic information into rate regulation. The role that the CLS algorithm plays in the prevention of syncope recurrences still remains unclear. The aim of our prospective, randomised, single-blind, crossover study was to evaluate the effect of dual-chamber CLS in the prevention of syncope recurrence in patients with refractory vasovagal syncope (VVS) and a cardioinhibitory response to head-up tilt test (HUT) during a 36 months follow-up.

METHOD SAND RESULTS

We studied 50 patients (mean age 53 ± 5.1; 33 male) with the indication for permanent dual-chamber cardiac pacing for HUT-induced vasovagal cardioinhibitory syncope. They were randomised after 1 month of stabilisation period to CLS algorithm features programmed OFF or ON for 18 months each, using a crossover design. The number of syncopal and presyncopal episodes during active treatment was lower than those registered during no treatment (n syncopal episodes: 2 vs 15; p=0.007; n presincopal episodes: 5 vs 30; p = 0.004). Lead parameters remained stable over time, and there were no lead-related complications.

CONCLUSIONS

Based on these 36 months follow-up data, it is concluded that dual-chamber CLS is an effective algorithm for preventing syncope recurrences in healthy patients with tilt-induced vasovagal cardioinhibitory syncope.

摘要

背景

闭环刺激(CLS)起搏器算法是一种永久监测心肌收缩状态并将内在信息转化为心率调节的系统。CLS 算法在预防晕厥复发中的作用尚不清楚。我们前瞻性、随机、单盲、交叉研究的目的是评估双腔 CLS 在预防难治性血管迷走性晕厥(VVS)和直立倾斜试验(HUT)中出现心脏抑制反应的患者晕厥复发中的作用,随访时间为 36 个月。

方法和结果

我们研究了 50 名(平均年龄 53±5.1;33 名男性)因 HUT 引起的血管迷走性心脏抑制性晕厥而需要永久性双腔心脏起搏的患者。他们在稳定期 1 个月后随机分为 CLS 算法特征编程关闭或开启各 18 个月,采用交叉设计。在积极治疗期间,晕厥和先兆晕厥发作的次数少于无治疗期间(晕厥发作次数:2 次与 15 次;p=0.007;先兆晕厥发作次数:5 次与 30 次;p=0.004)。导联参数随时间保持稳定,且无导联相关并发症。

结论

根据这 36 个月的随访数据,得出结论,双腔 CLS 是预防健康患者因倾斜诱导的血管迷走性心脏抑制性晕厥而发生晕厥复发的有效算法。

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