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皮下和经静脉植入型除颤器的比较
Subcutaneous or Transvenous Defibrillator Therapy


Reinoud E. Knops ... 心脑血管疾病 • 2020.08.06
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摘要


背景

皮下植入型心律转复除颤器(ICD)被设计为完全植入胸腔外,从而避免了与经静脉ICD导线相关的并发症。比较上述两种系统的证据主要是基于观察性研究。

 

方法

我们开展了一项非劣效性试验,试验中将有ICD适应证,但无起搏适应证的患者分组,两组分别采用皮下ICD或经静脉ICD。主要终点是由装置相关并发症和不适当电击构成的复合终点;风险比(皮下ICD vs.经静脉ICD)的95%置信区间[CI]上限的非劣效性界值为1.45。我们预先设定在证实非劣效性的情况下进行优效性分析。次要终点包括死亡和适当电击。

 

结果

共计849例患者(皮下ICD组426例,经静脉ICD组423例)被纳入分析。中位随访49.1个月时,皮下ICD组68例患者和经静脉ICD组68例患者发生了主要终点事件(48个月Kaplan-Meier估计累积发生率,分别为15.1%和15.7%;风险比,0.99;95% CI,0.71~1.39;非劣效性P=0.01;优效性P=0.95)。皮下ICD组31例患者和经静脉ICD组44例患者发生了装置相关并发症(风险比,0.69;95% CI,0.44~1.09);两组分别有41例和29例患者发生了不适当电击(风险比,1.43;95% CI,0.89~2.30)。皮下ICD组83例患者和经静脉ICD组68例患者死亡(风险比,1.23;95% CI,0.89~1.70);两组分别有83例和57例患者发生了适当电击(风险比,1.52;95% CI,1.08~2.12)。

 

结论

在有ICD适应证但无起搏适应证的患者中,在装置相关并发症和不适当电击方面,皮下ICD不劣于经静脉ICD(由波士顿科学公司[Boston Scientific]资助,PRAETORIAN在ClinicalTrials.gov注册号为NCT01296022)。





作者信息

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 Kääb, 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. for the PRAETORIAN Investigators*
From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) — all in the Netherlands; the First Department of Medicine–Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg–Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) — all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George’s, University of London and St. George’s University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) — all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.). Address reprint requests to Dr. Knops at the Department of Clinical and Experimental Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands, or at r.e.knops@amsterdamumc.nl. *A full list of the PRAETORIAN investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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