提示: 手机请竖屏浏览!

置入起搏器或除颤器的患者接受MRI检查的相关危险评估
Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator


Robert J. Russo ... 心脑血管疾病 • 2017.02.23
相关阅读
• 关于植入式装置患者接受MRI检查安全性的更多数据 • 有心脏装置的患者进行磁共振成像的安全性 • 置入型心脏装置成功通过了MRI检查

摘要


背景

长期以来,有心血管置入型电子器械都是进行磁共振成像(MRI)的禁忌证。我们进行了一项前瞻性注册研究,用于确定安装有“非MRI兼容型”(即未获美国食品药品监督管理局[Food and Drug Administration,FDA]批准进行MRI)起搏器或置入型心脏复律除颤器(ICD)的患者接受磁场强度为1.5 T的MRI检查所面临的危险。

 

方法

注册研究中的患者被转诊去接受具有临床指征的、磁场强度为1.5 T的非胸部MRI。使用标准化方案在MRI前后检查(interrogate)器械情况,并且扫描前对器械进行适当的重新程控。主要终点是在扫描期间死亡、脉冲发生器或电极故障、诱发心律失常、失夺获或电重设。次要终点是器械设置改变。

 

结果

我们对1,000个有起搏器的患者病例和500个有ICD的患者病例进行了MRI。MRI期间,没有患者发生死亡、电极故障、失夺获或室性心律失常。1例ICD脉冲发生器在MRI后无法正常检测到信号,需要紧急更换;该器械在MRI前没有根据方案进行适当程控。我们观察到6例自行终止的房颤或房扑和6例部分电重设。小部分患者出现电极阻抗、起搏阈值、电池电压及超过预设阈值的P波和R波幅值的变化。重复MRI没有引起不良事件增加。

 

结论

在本研究中,经过适当筛选,有非MRI兼容型起搏器或ICD,且器械根据预设方案进行过重新程控的任何患者,在接受磁场强度为1.5 T、有临床适应证的非胸部MRI检查后均没有发生器械或电极故障(由圣犹达医疗公司[St. Jude Medical]等资助;MagnaSafe在ClinicalTrials.gov注册号为NCT00907361)。





作者信息

Robert J. Russo, M.D., Ph.D., Heather S. Costa, Ph.D., Patricia D. Silva, M.S., Jeffrey L. Anderson, M.D., Aysha Arshad, M.D., Robert W.W. Biederman, M.D., Noel G. Boyle, M.D., Ph.D., Jennifer V. Frabizzio, M.D., Ulrika Birgersdotter-Green, M.D., Steven L. Higgins, M.D., Rachel Lampert, M.D., Christian E. Machado, M.D., Edward T. Martin, M.D., Andrew L. Rivard, M.D., Jason C. Rubenstein, M.D., Raymond H.M. Schaerf, M.D., Jennifer D. Schwartz, M.D., Dipan J. Shah, M.D., Gery F. Tomassoni, M.D., Gail T. Tominaga, M.D., Allison E. Tonkin, M.D., Seth Uretsky, M.D., and Steven D. Wolff, M.D., Ph.D.
From the Scripps Research Institute (R.J.R.), the La Jolla Cardiovascular Research Institute (R.J.R., P.D.S.), University of California, San Diego (U.B.-G.), and Scripps Memorial Hospital (S.L.H., G.T.T.), La Jolla, the University of California, Los Angeles, Los Angeles (N.G.B.), and Providence St. Joseph Medical Center, Burbank (R.H.M.S.) — all in California; the Department of Entomology, University of Arizona, Tucson (H.S.C.); Intermountain Medical Center, Salt Lake City (J.L.A., A.E.T.); Inova Heart and Vascular Institute, Falls Church, VA (A.A.); Allegheny General Hospital, Pittsburgh (R.W.W.B.), and Abington Memorial Hospital, Abington (J.V.F.) — both in Pennsylvania; Yale University School of Medicine, New Haven, CT (R.L.); Providence Heart Institute, Southfield, MI (C.E.M.); Oklahoma Heart Institute, Tulsa (E.T.M.); University of Mississippi Medical Center, Jackson (A.L.R.); Medical College of Wisconsin, Milwaukee (J.C.R.); Bassett Medical Center, Cooperstown (J.D.S.), and Advanced Cardiovascular Imaging, Carnegie Hill Radiology, New York (S.U., S.D.W.) — both in New York; Methodist DeBakey Heart and Vascular Center, Houston (D.J.S.); and Baptist Health, Lexington, KY (G.F.T.). Address reprint requests to Dr. Russo at the Department of Molecular and Experimental Medicine, Scripps Research Institute, 10550 N. Torrey Pines Rd., La Jolla, CA 92037, or at russo@scripps.edu.

 

参考文献

1. Langman DA, Goldberg IB, Judy J, Paul Finn J, Ennis DB. The dependence of radiofrequency induced pacemaker lead tip heating on the electrical conductivity of the medium at the lead tip. Magn Reson Med 2012;68:606-613

2. Beinart R, Nazarian S. Effects of external electrical and magnetic fields on pacemakers and defibrillators: from engineering principles to clinical practice. Circulation 2013;128:2799-2809

3. Luechinger R, Zeijlemaker VA, Pedersen EM, et al. In vivo heating of pacemaker leads during magnetic resonance imaging. Eur Heart J 2005;26:376-383

4. American College of Radiology. Appropriateness criteria. 2016 (https://acsearch.acr.org/list).

5. Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm 2011;8:65-73

6. Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm 2013;10:685-691

7. Nazarian S, Hansford R, Roguin A, et al. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med 2011;155:415-424

8. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol 2005;28:326-328

9. Russo RJ. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Am Heart J 2013;165:266-272

10. Roguin A, Zviman MM, Meininger GR, et al. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnetic resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation 2004;110:475-482

11. Centers for Medicare & Medicaid Services. Decision memo for magnetic resonance imaging (MRI) (CAG-00399R2). February 24, 2011 (https://wwwNaNs.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=246&ver;=9&NcaName;=Magnetic+Resonance+Imaging+(MRI)&TimeFrame;=7&DocType;=All&bc;=AgAAQAAAEAAA&).

12. Danilovic D, Ohm OJ. Pacing threshold trends and variability in modern tined leads assessed using high resolution automatic measurements: conversion of pulse width into voltage thresholds. Pacing Clin Electrophysiol 1999;22:567-587

13. Chan CC, Lau CP, Leung SK, et al. Comparative evaluation of bipolar atrial electrogram amplitude during everyday activities: atrial active fixation versus two types of single pass VDD/R leads. Pacing Clin Electrophysiol 1994;17:1873-1877

14. Sharif MN, Wyse DG, Rothschild JM, Gillis AM. Changes in pacing lead impedance over time predict lead failure. Am J Cardiol 1998;82:600-603

15. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006;295:1901-1906

16. The R Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing, 2015 (https://www.R-project.org/).

17. Gimbel JR, Kanal E. Can patients with implantable pacemakers safely undergo magnetic resonance imaging? J Am Coll Cardiol 2004;43:1325-1327

18. Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol 2012;110:1631-1636

19. Gimbel JR, Wilkoff BL, Kanal E, Rozner MA. Safe, sensible, sagacious: responsible scanning of pacemaker patients. Eur Heart J 2005;26:1683-1684

20. Sommer T, Naehle CP, Schild H. Magnetic resonance imaging in patients with cardiac pacemakers. J Am Coll Cardiol 2005;46:561-562

21. Martin ET, Coman JA, Shellock FG, Pulling CC, Fair R, Jenkins K. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol 2004;43:1315-1324

22. Sommer T, Naehle CP, Yang A, et al. Strategy for safe performance of extrathoracic magnetic resonance imaging at 1.5 tesla in the presence of cardiac pacemakers in non-pacemaker-dependent patients: a prospective study with 115 examinations. Circulation 2006;114:1285-1292

23. Nazarian S, Roguin A, Zviman MM, et al. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation 2006;114:1277-1284

24. Naehle CP, Strach K, Thomas D, et al. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol 2009;54:549-555

25. Irnich W. Risks to pacemaker patients undergoing magnetic resonance imaging examinations. Europace 2010;12:918-920

26. Gimbel JR. Unexpected asystole during 3T magnetic resonance imaging of a pacemaker-dependent patient with a ‘modern’ pacemaker. Europace 2009;11:1241-1242

27. Anfinsen OG, Berntsen RF, Aass H, Kongsgaard E, Amlie JP. Implantable cardioverter defibrillator dysfunction during and after magnetic resonance imaging. Pacing Clin Electrophysiol 2002;25:1400-1402

28. Gimbel JR, Bailey SM, Tchou PJ, Ruggieri PM, Wilkoff BL. Strategies for the safe magnetic resonance imaging of pacemaker-dependent patients. Pacing Clin Electrophysiol 2005;28:1041-1046

29. Mollerus M, Albin G, Lipinski M, Lucca J. Cardiac biomarkers in patients with permanent PMs and ICDs undergoing an MR scan. Pacing Clin Electrophysiol 2008;31:1241-1245

30. Boilson BA, Wokhlu A, Acker NG, et al. Safety of magnetic resonance imaging in patients with permanent pacemakers: a collaborative clinical approach. J Interv Card Electrophysiol 2012;33:59-67

31. Burke PT, Ghanbari H, Alexander PB, Shaw MK, Daccarett M, Machado C. A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI). J Interv Card Electrophysiol 2010;28:59-66

32. Verma A, Ha AC, Dennie C, et al. Canadian Heart Rhythm Society and Canadian Association of Radiologists consensus statement on magnetic resonance imaging with cardiac implantable electronic devices. Can J Cardiol 2014;30:1131-1141

33. Blomström Lundqvist C, Auricchio A, Brugada J, et al. The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology. Europace 2013;15:927-936

34. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 2010;122:1553-1561

35. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction. Europace 2010;12:395-401

36. Jones SO IV, Eckart RE, Albert CM, Epstein LM. Large, single-center, single-operator experience with transvenous lead extraction: outcomes and changing indications. Heart Rhythm 2008;5:520-525

37. 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

38. Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of the Pacing Lead Extraction with the Excimer Sheath (PLEXES) trial. J Am Coll Cardiol 1999;33:1671-1676

服务条款 | 隐私政策 | 联系我们