Performance of the subcutaneous implantable cardioverter-defibrillator in patients with a primary prevention indication with and without a reduced ejection fraction versus patients with a secondary prevention indication
Performance of the subcutaneous implantable cardioverter-defibrillator in patients with a primary prevention indication with and without a reduced ejection fraction versus patients with a secondary prevention indication
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DOI：
10.1016/j.hrthm.2016.11.025
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发表时间：
2017-03-01
期刊：
影响因子：
5.5
通讯作者：
Gold, Michael R.
中科院分区：
文献类型：
--
作者：
Boersma, Lucas V.;Barr, Craig S.;Gold, Michael R.
背景皮下植入式除颤器（S-ICD）提供了经静脉ICD的替代方案，用于预防心脏性猝死，但尚未在最常治疗的经静脉ICD患者人群中进行充分研究，即，初级预防目的本研究的分析旨在比较PP患者的临床结局，方法包括来自S-ICD IDE研究和EFFORTLESS登记处的所有18岁及以上的患者，其具有截至2013年11月18日的可用数据（n = 856;平均随访持续时间644天）。在2项分析中评价结局：（1）将所有PP患者（n = 603，70.4%）与所有SP患者（n = 253，29.6%）进行比较;（2）将所有PP患者与EF？结果SP组与PP组在死亡率、并发症、治疗不当、转复室性心律失常能力等方面无差异。然而，SP患者的适当治疗发生率高于PP患者（11.9% vs 5.0%; P = 0.0004）。在PP亚组分析中，EF？35%的患者年龄较大，合并症较多，死亡率较高（每年3.0% vs 0.0%）。尽管有这些差异，设备相关的并发症，转换效率，和不适当的休克治疗的发生率之间没有显着差异PP subgroup.CONCLUSION S-ICD在保护患者无论是PP或SP植入适应症心脏猝死。在PP患者中，器械性能与EF无关。
BACKGROUND The subcutaneous implantable defibrillator (S-ICD) provides an alternative to the transvenous ICD for the prevention of sudden cardiac death, but has not been well studied in the most commonly treated transvenous ICD patient population, namely, primary prevention (PP) patients with left ventricular dysfunction.OBJECTIVE The analyses in the present study were designed to compare clinical outcomes for PP patients with and without a reduced ejection fraction (EF) and secondary prevention (SP) patients implanted with the S-ICD.METHODS All patients 18 years and older from the S-ICD IDE study and the EFFORTLESS Registry with available data as of November 18, 2013, were included (n = 856; mean follow-up duration 644 days). Outcomes were evaluated in 2 analyses: (1) comparing all PP patients (n = 603, 70.4%) with all SP patients (n = 253, 29.6%) and (2) comparing all PP patients with an EF ?35% (n = 379) with those with an EF >35% (n = 149, 17.4%).RESULTS No differences were observed in mortality, complications, inappropriate therapy, or ability to convert ventricular tachyarrhythmias between SP and PP patients. However, SP patients had a higher incidence of appropriate therapy than did PP patients (11.9% vs 5.0%; P = .0004). In the PP subanalysis, the cohort with an EF ?35% had significantly older patients with more comorbidities and higher mortality (3.0% annually vs 0.0%). Despite these differences, device-related complications, conversion efficacy, and incidence of inappropriate shock therapies were not significantly different between PP subgroups.CONCLUSION The S-ICD performs well in protecting patients with either PP or SP implant indications from sudden cardiac death. Within PP patients, device performance was independent of EF.