Division of Cardiology, Duke University Hospital, Durham, North Carolina2Duke Clinical Research Institute, Durham, North Carolina.
Yale University School of Medicine, New Haven, Connecticut.
JAMA Cardiol. 2016 Nov 1;1(8):900-911. doi: 10.1001/jamacardio.2016.2782.
Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described.
To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD.
Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients.
Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001).
The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities.
在美国,皮下植入式心律转复除颤器(S-ICD)早期应用的趋势及其院内结局尚未被描述。
描述 S-ICD 在美国的早期使用情况,并比较 S-ICD 与经静脉(TV)-ICD 植入患者的院内结局。
设计、设置和参与者:对 2012 年 9 月 28 日(美国食品药品监督管理局批准 S-ICD 之日)至 2015 年 3 月 31 日期间向全国心血管数据注册 ICD 登记处报告的 393734 例 ICD 植入的回顾性分析,这是一个具有全国代表性的美国 ICD 登记处。对 5760 例患者进行了 1:1:1 的倾向匹配分析,以比较 S-ICD 患者与单腔(SC)-ICD 和双腔(DC)-ICD 患者的院内结局。
分析 S-ICD 作为总 ICD 植入物的函数的采用趋势,并比较 S-ICD 和 TV-ICD 接受者的院内结局(死亡、并发症和除颤阈值[DFT]测试)。
在研究期间评估的 393734 例 ICD 植入中,有 3717 例为 S-ICD(0.9%)。共有 109445 例(27.8%)患者为女性;平均(SD)年龄为 67.03(13.10)岁。ICD 的使用从 2012 年第四季度的 0.2%增加到 2015 年第一季度的 1.9%。与 SC-ICD 和 DC-ICD 接受者相比,S-ICD 接受者更年轻、女性、黑人、接受透析治疗,且曾经历过心脏骤停。在 2791 例接受 DFT 测试的 S-ICD 患者中,分别有 2588(92.7%)、2629(94.2%)、2635(94.4%)和 2784(99.7%)例患者成功除颤(分别为≤65、≤70、≤75 和≤80 J)。在对 5760 例患者进行的倾向匹配分析中,S-ICD 相关的院内并发症发生率(0.9%)与 SC-ICD(0.6%)(P = .27)和 DC-ICD 率(1.5%)(P = .11)相当。S-ICD 植入后平均(SD)住院时间与 SC-ICD 植入后相似(1.1[1.5]与 1.0[1.2]天;P = .77),短于 DC-ICD 植入后(1.1[1.5]与 1.2[1.5]天;P < .001)。
在美国,S-ICD 的使用正在迅速增加。尽管经常在患有多种合并症的患者中使用,但早期采用 S-ICD 与低并发症发生率和高 DFT 测试成功率相关。