Waikato Hospital, Hamilton, New Zealand.
Centre Hospitalier Universitaire Trousseau, Université François Rabelais, Tours, France.
Heart Rhythm. 2020 Jan;17(1):e220-e228. doi: 10.1016/j.hrthm.2019.02.034. Epub 2019 May 15.
The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing 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.
2015 年 HRS/EHRA/APHRS/SOLAECE 专家共识声明关于优化植入式心脏复律除颤器程控和测试,为植入式心脏复律除颤器 (ICD) 患者治疗提供了关于心动过缓程控、心动过速检测、心动过速治疗和除颤测试的指导。这 32 项建议代表了写作小组的共识意见,按推荐等级和证据水平进行分级。此外,附录 B 提供了制造商特定的翻译,将这些建议转化为与主要文件内建议一致的临床实践。在某些情况下,根据一些制造商的设备中进行的研究获得的高质量证据进行程控,将这种程控转化为另一个制造商的 ICD 程控设置。作者发现,这些数据虽然没有经过正式测试,但非常有力、一致且具有普遍性,超出了特定制造商和 ICD 型号的范围。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,因此在按照附录 B 建议程控的 ICD 中已经有报告记录了不良结果。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,接受附录 B 建议程控的患者不会意识到他们避免了潜在的伤害,而 ICD 未能治疗危及生命的心律失常的患者,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的意见,治疗医生通过共同的临床决策过程考虑了患者的临床状况和预期结果。