Stiles Martin K, Fauchier Laurent, Morillo Carlos A, Wilkoff Bruce L
Waikato Hospital Hamilton New Zealand.
Centre Hospitalier Universitaire Trousseau Université François Rabelais Tours France.
J Arrhythm. 2019 May 14;35(3):485-493. doi: 10.1002/joa3.12178. eCollection 2019 Jun.
The provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.
本文提供了关于植入式心脏复律除颤器（ICD）患者治疗中缓慢性心律失常程控、快速性心律失常检测、快速性心律失常治疗以及除颤测试的指导意见。这32条建议代表了编写组的共识意见，并根据推荐类别和证据水平进行了分级。此外，附录B提供了这些建议针对各制造商的临床实践翻译版本，与母文档中的建议保持一致。在某些情况下，根据从某些制造商的设备研究中获得的高质量证据进行的程控被翻译后，使其在另一个制造商的ICD程控设置中得以近似。作者发现，这些数据虽然未经过正式测试，但具有较强的说服力、一致性，并且可以推广到特定制造商和型号的ICD之外。正如预期的那样，由于这些建议代表了平衡风险的战略选择，已有报告记录了按照附录B建议进行ICD程控时出现的不良后果。这些建议已经过审查和更新，以尽量减少此类不良事件。值得注意的是，未接受不必要ICD治疗的患者并未意识到自己避免了潜在的伤害，而ICD未能治疗危及生命心律失常的患者，其事件会被详细记录。修订后的建议采用的原则是，随机试验和大型注册数据应比轶事证据更能指导程控。这些建议不应取代治疗医生通过共同临床决策过程考虑患者临床状况和预期结果后的意见。
