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标准化ICD编程协议引入的影响:来自单一中心的真实世界数据。

Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre.

作者信息

Sunderland Nicholas, Kaura Amit, Li Anthony, Kamdar Ravi, Petzer Ed, Dhillon Para, Murgatroyd Francis, Scott Paul A

机构信息

King's College Hospital, Denmark Hill, London, UK.

出版信息

J Interv Card Electrophysiol. 2016 Sep;46(3):335-43. doi: 10.1007/s10840-016-0151-4. Epub 2016 Jun 3.

Abstract

PURPOSE

Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a "real-world" setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients.

METHODS

We analysed 270 consecutive ICD recipients implanted in a single centre-135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death.

RESULTS

At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group, n = 31 vs. standardised group, n = 16). There was a 47 % risk reduction in any device therapy (p = 0.04) and an 86 % risk reduction in inappropriate therapy (p = 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (p = 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death.

CONCLUSIONS

In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.

摘要

目的

随机试验表明,采用长检测时间和高检测区间的经验性植入式心律转复除颤器(ICD)程控,可减少ICD植入患者的设备治疗。然而,关于其在“现实世界”环境中的有效性的数据较少,尤其是二级预防患者。我们的目的是评估在未选择的ICD植入患者的现实世界环境中引入标准化程控方案的情况。

方法

我们分析了在单一中心连续植入ICD的270例患者,其中135例在方案实施前植入(医生主导组),135例在方案实施后植入(标准化组)。该方案包括长心律失常检测时间(30/40或等效)和高心率检测区间(一级预防较低治疗区间为200次/分钟)。医生主导组的程控由植入者自行决定。主要终点是首次接受任何治疗(抗心动过速起搏或电击)的时间。次要终点是不适当治疗时间和适当治疗时间。安全终点是晕厥发作、住院和死亡。

结果

在12个月的随访中,47例患者接受了任何ICD治疗(医生主导组,n = 31;标准化组,n = 16)。与医生主导组相比,标准化组的任何设备治疗风险降低了47%(p = 0.04),不适当治疗风险降低了86%(p = 0.009)。适当治疗风险降低了30%,差异无统计学意义(p = 0.32)。一级和二级预防患者的结果一致。晕厥、住院和死亡率无显著差异。

结论

在现实世界环境中的未选择患者中,采用长检测时间和高检测区间引入标准化程控方案,可显著减轻ICD治疗负担,且不会增加不良后果。

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