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预防心脏植入装置感染的抗菌封套
Antibacterial Envelope to Prevent Cardiac Implantable Device Infection


Khaldoun G. Tarakji ... 心脑血管疾病 • 2019.05.16
相关阅读
• 有心脏装置的患者进行磁共振成像的安全性

给心脏植入装置穿上抗菌封套,降低感染发生率

 

刘彤†*,谷云飞‡

†天津医科大学第二医院心脏科;‡郑州大学附属洛阳中心医院心内科

*通讯作者

 

全世界每年约有150万患者接受心脏植入式电子设备(CIED)1,中国心血管病报告2018中统计中国2017年约植入近8万台CIED装置2。伴随CIED装置植入数量的增多,以及植入患者合并疾病的增多,CIED装置相关感染问题也日益严重3

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摘要


背景

心脏植入式电子装置(CIED)植入后的感染与相当高的发病率和死亡率相关。除术前使用抗生素之外,关于此类感染预防策略的证据有限。

 

方法

我们开展了一项随机、对照临床试验,评估可吸收的抗生素洗脱封套在降低CIED植入相关感染发生率方面的安全性和有效性。我们以1∶1的比例将修正CIED囊袋、更换发生器或升级系统,或者初次植入心脏再同步治疗除颤器的患者随机分组,分别使用或不使用封套。对所有患者采用了预防感染的标准策略。主要终点是在CIED植入术后12个月内,导致系统移除或修正、长期抗生素治疗伴感染复发或死亡的感染。次要安全性终点是12个月内的手术相关或系统相关并发症。

 

结果

共有6,983例患者接受随机分组:封套组3,495例,对照组3,488例。封套组和对照组分别有25例患者和42例患者发生主要终点(12个月事件发生率的Kaplan-Meier估计值分别为0.7%和1.2%;风险比,0.60;95%置信区间[CI],0.36~0.98;P=0.04)。封套组和对照组分别有201例患者和236例患者发生安全性终点(12个月事件发生率的Kaplan-Meier估计值分别为6.0%和6.9%;风险比,0.87;95% CI,0.72~1.06;非劣效性P<0.001)。平均(±SD)随访时间为20.7±8.5个月。在整个随访期间,封套组和对照组分别有32例患者和51例患者发生主要CIED相关感染(风险比,0.63;95% CI,0.40~0.98)。

 

结论

与仅使用预防感染的标准策略相比,辅助使用抗菌封套实现了显著更低的主要CIED感染发生率,并且未出现更高的并发症发生率(由美敦力公司资助;WRAP-IT在ClinicalTrials.gov注册号为NCT02277990)。





作者信息

Khaldoun G. Tarakji, M.D., M.P.H., Suneet Mittal, M.D., Charles Kennergren, M.D., Ph.D., Ralph Corey, M.D., Jeanne E. Poole, M.D., Edward Schloss, M.D., Jose Gallastegui, M.D., Robert A. Pickett, M.D., Rudolph Evonich, M.D., François Philippon, M.D., Janet M. McComb, M.D., Steven F. Roark, M.D., Denise Sorrentino, M.D., Darius Sholevar, M.D., Edmond Cronin, M.B., B.Ch., B.A.O., Brett Berman, M.D., David Riggio, M.D., Mauro Biffi, M.D., Hafiza Khan, M.D., Marc T. Silver, M.D., Jack Collier, M.D., Zayd Eldadah, M.D., Ph.D., David J. Wright, M.D., Jeff D. Lande, Ph.D., Daniel R. Lexcen, Ph.D., Alan Cheng, M.D., and Bruce L. Wilkoff, M.D. for the WRAP-IT Investigators*
From the Cleveland Clinic, Cleveland (K.G.T., B.L.W.), and the Lindner Research Center, Cincinnati (E.S.) — both in Ohio; Valley Health System, Ridgewood (S.M.), and Lourdes Cardiology Services, Cherry Hill (D. Sholevar) — both in New Jersey; Sahlgrenska University Hospital, Göteborg, Sweden (C.K.); Duke Clinical Research Institute, Durham (R.C.), and WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh (M.T.S.) — both in North Carolina; University of Washington School of Medicine, Seattle (J.E.P.); Clearwater Cardiovascular and Interventional Consultants, Safety Harbor (J.G.), and Cardiology Associates of Gainesville, Gainesville (S.F.R.) — both in Florida; Saint Thomas Research Institute, Nashville (R.A.P.); Upper Michigan Cardiovascular Associates, Marquette (R.E.); Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC, Canada (F.P.); the Newcastle upon Tyne Hospitals, Newcastle upon Tyne (J.M.M.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) — both in the United Kingdom; Iowa Heart Center, West Des Moines (D. Sorrentino); Hartford Hospital, Hartford, CT (E.C.); Chula Vista Cardiac Center, Chula Vista, CA (B.B.); Arizona Arrhythmia Consultants, Scottsdale (D.R.); Policlinico Sant’ Orsola–Malpighi, Bologna, Italy (M.B.); Baylor Research Institute, Plano, TX (H.K.); Oklahoma Heart Hospital, Oklahoma City (J.C.); MedStar Heart and Vascular Institute, Washington, DC (Z.E.); and Medtronic, Mounds View, MN (J.D.L., D.R.L., A.C.). Address reprint requests to Dr. Tarakji at the Cleveland Clinic, 9500 Euclid Ave., J2-2, Cleveland, OH 44195, or at tarakjk@ccf.org. *A full list of the WRAP-IT investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009 — a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol 2011;34:1013-1027.

2. Baddour LM, Epstein AE, Erickson CC, et al. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation 2010;121:458-477.

3. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC guidelines for the management of infective endocarditis: the Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Eur Heart J 2015;36:3075-3128.

4. Baman TS, Gupta SK, Valle JA, Yamada E. Risk factors for mortality in patients with cardiac device-related infection. Circ Arrhythm Electrophysiol 2009;2:129-134.

5. Deckx S, Marynissen T, Rega F, et al. Predictors of 30-day and 1-year mortality after transvenous lead extraction: a single-centre experience. Europace 2014;16:1218-1225.

6. Tarakji KG, Wazni OM, Harb S, Hsu A, Saliba W, Wilkoff BL. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490-1495.

7. Sohail MR, Henrikson CA, Jo Braid-Forbes M, Forbes KF, Lerner DJ. Increased long-term mortality in patients with cardiovascular implantable electronic device infections. Pacing Clin Electrophysiol 2015;38:231-239.

8. Kay G, Eby EL, Brown B, et al. Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection. J Med Econ 2018;21:294-300.

9. Bloom HL, Constantin L, Dan D, et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. Pacing Clin Electrophysiol 2011;34:133-142.

10. Henrikson CA, Sohail MR, Acosta H, et al. Antibacterial envelope is associated with low infection rates after implantable cardioverter-defibrillator and cardiac resynchronization therapy device replacement: results of the Citadel and Centurion studies. JACC Clin Electrophysiol 2017;3:1158-1167.

11. Kolek MJ, Dresen WF, Wells QS, Ellis CR. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. Pacing Clin Electrophysiol 2013;36:354-361.

12. Kolek MJ, Patel NJ, Clair WK, et al. Efficacy of a bio-absorbable antibacterial envelope to prevent cardiac implantable electronic device infections in high-risk subjects. J Cardiovasc Electrophysiol 2015;26:1111-1116.

13. Mittal S, Shaw RE, Michel K, et al. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm 2014;11:595-601.

14. Shariff N, Eby E, Adelstein E, et al. Health and economic outcomes associated with use of an antimicrobial envelope as a standard of care for cardiac implantable electronic device implantation. J Cardiovasc Electrophysiol 2015;26:783-789.

15. Tarakji KG, Mittal S, Kennergren C, et al. Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT). Am Heart J 2016;180:12-21.

16. Polyzos KA, Konstantelias AA, Falagas ME. Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. Europace 2015;17:767-777.

17. Head SJ, Kaul S, Bogers AJ, Kappetein AP. Non-inferiority study design: lessons to be learned from cardiovascular trials. Eur Heart J 2012;33:1318-1324.

18. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm 2017;14(12):e503-e551.

19. Brunner MP, Cronin EM, Wazni O, et al. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm 2014;11:419-425.

20. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010;55:579-586.

21. de Oliveira JC, Martinelli M, Nishioka SA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol 2009;2:29-34.

22. Krahn AD, Longtin Y, Philippon F, et al. Prevention of Arrhythmia Device Infection Trial: the PADIT Trial. J Am Coll Cardiol 2018;72:3098-3109.

23. Romeyer-Bouchard C, Da Costa A, Dauphinot V, et al. Prevalence and risk factors related to infections of cardiac resynchronization therapy devices. Eur Heart J 2010;31:203-210.

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