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随机临床试验结果和/或植入式心脏复律除颤器编程推荐在多大程度上普及到临床实践中?

How Well Do Results From Randomized Clinical Trials and/or Recommendations for Implantable Cardioverter-Defibrillator Programming Diffuse Into Clinical Practice?.

机构信息

1 Cleveland Clinic Cleveland OH.

2 Boston Scientific St. Paul MN.

出版信息

J Am Heart Assoc. 2019 Feb 5;8(3):e007392. doi: 10.1161/JAHA.117.007392.

DOI:10.1161/JAHA.117.007392
PMID:30712432
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6405582/
Abstract

Background Inappropriate implantable cardioverter-defibrillator programming can be detrimental. Whether trials/recommendations informing best implantable cardioverter-defibrillator programming (high-rate cutoff and/or extended duration of detection) influence practice is unknown. Methods and Results We measured reaction to publication of MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy; 2012) and the Consensus Statement (2015) providing generic programming parameters, in a national cohort of implantable cardioverter-defibrillator recipients, using the ALTITUDE database (Boston Scientific). Yearly changes in programmed parameters to either trial-specified or class 1 recommended parameters (≥185 beats per minute or delay ≥6 seconds) were assessed in parallel. From 2008 to 2017, 232 982 patients (aged 67±13 years; 28% women) were analyzed. Prevalence of MADIT- RIT -specific settings before publication was <1%, increasing to 13.6% in the year following. Thereafter, this increased by <6% over 5 years. Among preexisting implants (91 171), most patients (58 739 [64.4%]) underwent at least 1 in-person device reprogramming after trial publication, but <2% were reprogrammed to MADIT - RIT settings. Notably, prevalence of programming to ≥185 beats per minute or delay ≥6 seconds was increased by MADIT - RIT (57.4% in 2013 versus 40.2% at baseline), but the following publication of recommendations had minor incremental effect (73.2% in 2016 versus 70.8% in 2015). High-rate cutoff programming was favored almost 2-fold compared with extended duration throughout the test period. Practice changes demonstrated large interhospital and interstate variations. Conclusions Trial publication had an immediate effect during 1 year postpublication, but absolute penetration was low, and amplified little with time. Consensus recommendations had a negligible effect. However, generic programming was exercised more widely, and increased after trial publication, but not following recommendations.

摘要

背景

不恰当的植入式心律转复除颤器编程可能会产生不利影响。目前尚不清楚告知最佳植入式心律转复除颤器编程(高心率截止值和/或延长检测时间)的试验/建议是否会影响实践。

方法和结果

我们使用波士顿科学公司的 ALTITUDE 数据库,对全国范围内植入式心律转复除颤器接受者的队列,测量了对 MADIT-RIT(多中心自动除颤器植入试验-降低不必要的治疗;2012 年)和共识声明(2015 年)发布后,对特定于试验或 1 类推荐(≥185 次/分钟或延迟≥6 秒)参数编程的反应。并行评估每年对试验指定或 1 类推荐参数(≥185 次/分钟或延迟≥6 秒)的编程参数变化。2008 年至 2017 年,共分析了 232982 例患者(年龄 67±13 岁;28%为女性)。在发布之前,MADIT-RIT 特定设置的患病率<1%,在发布后的一年中增加到 13.6%。此后,在 5 年内,这一比例增加了不到 6%。在现有植入物中(91171 例),大多数患者(58739[64.4%])在试验发布后至少进行了 1 次设备现场重新编程,但只有<2%的患者被重新编程为 MADIT-RIT 设置。值得注意的是,编程至≥185 次/分钟或延迟≥6 秒的比例因 MADIT-RIT 而增加(2013 年为 57.4%,而基线时为 40.2%),但随后发布的建议仅产生较小的增量效果(2016 年为 73.2%,2015 年为 70.8%)。在整个测试期间,高心率截止值编程几乎是延长检测时间编程的两倍。实践变化表明,各医院和各州之间存在较大差异。

结论

试验发布后 1 年内立即产生影响,但绝对渗透率较低,随着时间的推移增幅很小。共识建议的影响可以忽略不计。然而,通用编程的应用范围更广,在试验发布后增加,但在建议发布后没有增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/b39a5c01c09e/JAH3-8-e007392-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/441dbd79c3d4/JAH3-8-e007392-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/a0492828e4de/JAH3-8-e007392-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/ac602af86680/JAH3-8-e007392-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/b39a5c01c09e/JAH3-8-e007392-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/441dbd79c3d4/JAH3-8-e007392-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/a0492828e4de/JAH3-8-e007392-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/ac602af86680/JAH3-8-e007392-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dbd/6405582/b39a5c01c09e/JAH3-8-e007392-g006.jpg

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