Duke University Hospital, Durham, NC.
Duke University Hospital, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Am Heart J. 2019 Nov;217:131-139. doi: 10.1016/j.ahj.2019.08.010. Epub 2019 Aug 17.
The subcutaneous implantable cardioverter defibrillator (S-ICD) is a completely extrathoracic device that has recently been FDA approved for the prevention of sudden cardiac death in select populations. Although the transvenous implantable cardioverter defibrillator (TV-ICD) has a proven mortality benefit in multiple patient populations, there are significant risks both with implantation and years after its placement. The S-ICD may help prevent some of these complications. Currently, the S-ICD is typically implanted in patients with prior device infection or at an increased risk for an infection, younger patients with difficult venous access related to either hemodialysis or difficult cardiac anatomy, patients who live active lifestyles, and those who may outlive the TV-ICD leads. There is an absolute contraindication for S-ICD implantations for patients who need pacing either for ventricular tachycardia or bradycardia because this device cannot perform these functions. To date, there are no randomized controlled trial (RCT) data evaluating the safety and efficacy of this relatively new device. Observational studies of both the S-ICD alone and in comparison with the TV-ICD have showed promising results, including a decrease in lead-related and periprocedural complications as well as a high level of effectiveness at terminating ventricular arrhythmias. These analyses over time may have contributed to the evolution and comfortability with the S-ICD system, as physicians are more often referring for and/or implanting this device for patients with appropriate indications. Furthermore, inappropriate shock rates with the S-ICD have decreased over time especially with dual zone programming. This review summarizes the results of a multitude of observational studies with respect to patient selection for the S-ICD, complication rates, appropriate and inappropriate shock rates, and programming. This review also tackles current ongoing randomized trials. Although the results of ongoing trials will be helpful, there is still a continued need to evaluate the efficacy of the S-ICD in broader patient populations including patients with several comorbidities and older patients so that more patients can be considered for this potentially lifesaving device.
皮下植入式心律转复除颤器(S-ICD)是一种完全体外的设备,最近已获得美国食品和药物管理局(FDA)批准,用于预防某些特定人群的心脏性猝死。尽管经静脉植入式心律转复除颤器(TV-ICD)在多种患者群体中具有已证实的死亡率益处,但在植入和放置多年后,它存在显著风险。S-ICD 可能有助于预防其中一些并发症。目前,S-ICD 通常植入以前有器械感染或感染风险增加、因血液透析或心脏解剖结构困难而静脉通路困难的年轻患者、生活方式活跃的患者以及可能比 TV-ICD 导联寿命更长的患者。对于需要起搏治疗的患者,S-ICD 植入存在绝对禁忌症,因为该设备不能执行这些功能,这些患者包括因室性心动过速或心动过缓需要起搏的患者。迄今为止,尚无评估该相对较新设备的安全性和有效性的随机对照试验(RCT)数据。单独使用 S-ICD 以及与 TV-ICD 进行比较的观察性研究均显示出有希望的结果,包括降低了与导联相关和围手术期并发症的发生率,以及终止室性心律失常的高有效性。随着时间的推移,这些分析可能有助于 S-ICD 系统的发展和使用舒适度的提高,因为医生更常将其推荐给有适当适应证的患者,并为其植入该设备。此外,随着时间的推移,S-ICD 的不适当电击率尤其是通过双区编程降低。本综述总结了多项观察性研究的结果,涉及 S-ICD 的患者选择、并发症发生率、适当和不适当电击率以及编程。本综述还涉及当前正在进行的随机试验。尽管正在进行的试验的结果将有所帮助,但仍需要在更广泛的患者群体中评估 S-ICD 的疗效,包括患有多种合并症和老年患者的患者,以便更多的患者可以考虑使用这种有潜在救命作用的设备。