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皮下除颤器治疗效果不逊于经静脉除颤器
作者:小柯机器人 发布时间:2020/8/9 22:23:59

荷兰阿姆斯特丹大学Reinoud E. Knops课题组比较了皮下或经静脉的除颤器治疗效果。2020年8月6日,该成果发表在《新英格兰医学杂志》上。

皮下植入式心脏复律除颤器(ICD)的设计,通过完全胸腔外放置来避免与静脉ICD导联相关的并发症。比较这些系统的证据主要是基于观察研究。

研究组进行了一项非劣效性试验,招募了849名有ICD适应症但无起搏适应症的患者,将其随机分组,其中426名接受皮下ICD,423名接受静脉ICD。主要终点是与设备相关的并发症和不适当电击的综合结局。

中位随访49.1个月后,皮下ICD组中有68例患者发生主要终点事件,静脉ICD组亦有68例,两组48个月Kaplan–Meier估计的累积发生率分别为15.1%和15.7%,风险比为0.99,符合非劣效性标准。

皮下ICD组中有31例患者发生设备相关并发症,静脉ICD组中有44例,风险比为0.69;两组分别有41例和29例患者发生不适当电击,风险比为1.43。皮下ICD组有83例患者死亡,静脉ICD组中有68例,风险比为1.23;两组分别对83例和57例患者进行了适当电击,风险比为1.52。

总之,对于有ICD征兆但无起搏征兆的患者,就设备相关并发症和不适当电击而言,皮下ICD不逊于经静脉ICD。

附:英文原文

Title: Subcutaneous or Transvenous Defibrillator Therapy

Author: Reinoud E. Knops, M.D., Ph.D.,, Louise R.A. Olde Nordkamp, M.D., Ph.D.,, Peter-Paul H.M. Delnoy, M.D., Ph.D.,, Lucas V.A. Boersma, M.D., Ph.D.,, Jürgen Kuschyk, M.D.,, Mikhael F. El-Chami, M.D.,, Hendrik Bonnemeier, M.D., Ph.D.,, Elijah R. Behr, M.D.,, Tom F. Brouwer, M.D., Ph.D.,, Stefan Kb, M.D., Ph.D.,, Suneet Mittal, M.D.,, Anne-Floor B.E. Quast, M.D., Ph.D.,, Lonneke Smeding, Ph.D.,, Willeke van der Stuijt, M.D.,, Anouk de Weger, M.Sc.,, Koen C. de Wilde, M.D.,, Nick R. Bijsterveld, M.D., Ph.D.,, Sergio Richter, M.D.,, Marc A. Brouwer, M.D., Ph.D.,, Joris R. de Groot, M.D., Ph.D.,, Kirsten M. Kooiman, M.P.A.,, Pier D. Lambiase, M.D., Ph.D.,, Petr Neuzil, M.D., Ph.D.,, Kevin Vernooy, M.D., Ph.D.,, Marco Alings, M.D., Ph.D.,, Tim R. Betts, M.D., Ph.D.,, Frank A.L.E. Bracke, M.D., Ph.D.,, Martin C. Burke, D.O.,, Jonas S.S.G. de Jong, M.D., Ph.D.,, David J. Wright, M.D.,, Jan G.P. Tijssen, Ph.D.,, and Arthur A.M. Wilde, M.D., Ph.D.

Issue&Volume: 2020-08-05

Abstract: 

Background

The subcutaneous implantable cardioverter–defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.

Methods

We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.

Results

A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan–Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P=0.01 for noninferiority; P=0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).

Conclusions

In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.

DOI: 10.1056/NEJMoa1915932

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915932

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home