PRAETORIAN-DFT 试验的原理和设计：皮下植入式心脏复律除颤器植入与不进行除颤测试的前瞻性随机比较试验。
Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing.
机构信息
Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands.
Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands.
出版信息
Am Heart J. 2019 Aug;214:167-174. doi: 10.1016/j.ahj.2019.05.002. Epub 2019 May 16.
In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. STUDY DESIGN: The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. CONCLUSION: The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.
在经静脉植入式心脏复律除颤器（TV-ICD）植入中，常规除颤测试（DFT）不能提高电击效果或降低心律失常性死亡风险，但患者会面临与 DFT 相关的并发症风险。皮下 ICD（S-ICD）的 DFT 转换率较高，首次电击效果与 TV-ICD 效果率相似。研究设计：PRAETORIAN-DFT 试验是一项由研究者发起的、随机的、对照的、多中心的前瞻性双臂试验，旨在证明在接受 S-ICD 植入的患者中，省略 DFT 不劣于 S-ICD 系统组件最佳定位的患者。S-ICD 的定位将使用 PRAETORIAN 评分进行评估。PRAETORIAN 评分是为了系统地评估 S-ICD 系统组件的植入位置而开发的，这些组件决定了术后胸部 X 光片上的除颤阈值。共有 965 名患者计划接受新的 S-ICD 植入，没有 DFT 策略的禁忌症，将被随机分为标准护理 S-ICD 植入加 DFT，或 S-ICD 植入无 DFT，但使用 PRAETORIAN 评分评估植入位置。该研究的目的是声称在新的 S-ICD 患者中，无 DFT 的 S-ICD 植入在自发性心律失常发作的主要终点方面不劣于有 DFT 的 S-ICD 植入。在该研究的干预臂中，PRAETORIAN 评分（≥90）较高的患者将根据与对照臂相同的 DFT 方案进行 DFT。结论：PRAETORIAN-DFT 试验是一项随机试验，旨在获得科学证据，以在正确的设备定位下安全地省略 S-ICD 植入后的常规 DFT。
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