Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: The safety issue of the ESTIMATE study

Journal of Cardiovascular Magnetic Resonance

Volumn 16, Issue 1, 2014, Pages

  Wollmann, Christian G ^a,b   Thudt, Karin ^a,b   Kaiser, Bernd ^a   Salomonowitz, Erich ^a   Mayr, Harald ^a,b   Globits, Sebastian ^a,b  

^a Hospital of St Pölten Lilienfeld   (Austria)

^b Karl Landsteiner Society   (Austria)

Author keywords

Complications; Heart MR; Magnet resonance; MR conditional; Permanent pacemaker

Indexed keywords

LEAD;

AGED; ARTICLE; CARDIOVASCULAR MAGNETIC RESONANCE; CLINICAL ARTICLE; CONTROLLED STUDY; DEVICE MALFUNCTION; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HEART ATRIUM PACING; HUMAN; IMPEDANCE; IMPLANTED HEART PACEMAKER; MALE; MEDICAL DEVICE COMPLICATION; NUCLEAR MAGNETIC RESONANCE SCANNER; PACEMAKER ELECTRODE; PILOT STUDY; PRIORITY JOURNAL; SECOND DEGREE ATRIOVENTRICULAR BLOCK;

AGED; AGED, 80 AND OVER; ATRIOVENTRICULAR BLOCK; AUSTRIA; CARDIAC PACING, ARTIFICIAL; EQUIPMENT DESIGN; FEMALE; HEART VENTRICLES; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; PACEMAKER, ARTIFICIAL; PILOT PROJECTS; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; VENTRICULAR FUNCTION, LEFT; VENTRICULAR FUNCTION, RIGHT;

EID: 84901234499     PISSN: 10976647     EISSN: 1532429X     Source Type: Journal    
DOI: 10.1186/1532-429X-16-30     Document Type: Article

References (26)

1. American College of Radiology: Practice Guidelines and Technical Standards [Internet]. Available from: http://www.acr.org/Quality-Safety/ Standards-Guidelines/Practice-Guidelines-by-Modality/MRI
2. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Roguin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, Auricchio A, Priori S, Sommer T, Europace 2008 10 336 46 10.1093/europace/eun021 18308754 (Pubitemid 351773738)
3. 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. Sommer T, Naehle CP, Yang A, Zeijlemaker V, Hackenbroch M, Schmiedel A, Meyer C, Strach K, Skowasch D, Vahlhaus C, Litt H, Schild H, Circulation 2006 114 1285 92 10.1161/ CIRCULATIONAHA.105.597013 16966587 (Pubitemid 44402054)
4. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR, Ann Intern Med 2011 155 415 24 10.7326/0003-4819-155-7-201110040-00004 21969340
5. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. Martin ET, Coman JA, Shellock FG, Pulling CC, Fair R, Jenkins K, J Am Coll Cardiol 2004 43 1315 24 10.1016/j.jacc.2003.12.016 15063447 (Pubitemid 38452612)
6. Safety, feasibility, and diagnostic value of cardiac magnetic resonance imaging in patients with cardiac pacemakers and implantable cardioverters/ defibrillators at 1.5 T. Naehle CP, Kreuz J, Strach K, Schwab JO, Pingel S, Luechinger R, Fimmers R, Schild H, Thomas D, Am Heart J 2011 161 1096 105 10.1016/j.ahj.2011.03.007 21641356
7. Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla. Naehle CP, Zeijlemaker V, Thomas D, Meyer C, Strach K, Fimmers R, Schild H, Sommer T, Pacing Clin Electrophysiol 2009 32 1526 35 10.1111/j.1540-8159.2009.02570.x 19793358
8. 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. Russo RJ, Am Heart J 2013 165 266 72 10.1016/j.ahj.2012.12.004 23453091
9. - 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA). Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE, European Society of Cardiology (ESC), Europace 2013 15 1070 118 23801827
10. Impact of imaging landmark on the risk of MRI-related heating near implanted medical devices like cardiac pacemaker leads. Nordbeck P, Ritter O, Weiss I, Warmuth M, Gensler D, Burkard N, Herold V, Jakob PM, Ertl G, Ladd ME, Quick HH, Bauer WR, Magn Reson Med 2011 65 44 50 10.1002/mrm.22592 20806352
11. Cardiac pacemakers and implantable cardioverter defibrillators: in vitro magnetic resonance imaging evaluation at 1.5-Tesla. Shellock FG, Fischer L, Fieno DS, J Cardiovasc Magn Reson 2007 9 21 31 10.1080/10976640600897237 17178677 (Pubitemid 46018480)
12. Revo MRI SureScan Pacing System MRI Technical Manual. Medtronic, Inc. 2013 [Internet]. Available from: http://manuals.medtronic.com/manuals/main/us/ en-US/manual
13. EnRhythm MRI SureScan Pacing System. Medtronic, Inc. 2011 [Internet]. Technical manual. Available from: http://manuals.medtronic.com/manuals/main/us/ en-US/manual
14. Press Release August 29,2013 [Internet]. Biotronik SE&Co KG, Available from: http://www.biotronik.com/wps/wcm/connect/int-web/biotronik/ newsroom/press-releases/#jump
15. Initial experience with magnetic resonance imaging-safe pacemakers. A review. Jung W, Zvereva V, Hajredini B, Jäckle S, J Interv Card Electrophysiol 2011 32 213 9 10.1007/s10840-011-9610-0 21993594
16. Magnetic resonance imaging in patients with cardiac pacemakers: era of "MR Conditional" designs. Shinbane JS, Colletti PM, Shellock FG, J Cardiovasc Magn Reson 2011 13 63 10.1186/1532-429X-13-63 22032338
17. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, al. et, J Am Coll Cardiol 2008 51 1 62 10.1016/j.jacc.2008.02.032 18498951
18. Advisa DR MRI SureScan Pacing System. MRI procedural information for Advisa DR MRI SureScan.A2DR01 digital dual chamber pacemaker and SureScan leads. Medtronic, Inc. 2013 [Internet]. Technical manual. Available from: http://manuals.medtronic.com/manuals/main/us/en-US/manual
19. CapSureFix MRI™ SureScan™ 5086MRI. Medtronic, Inc. 2012 [Internet]. Technical manual. Available from: http://manuals.medtronic.com/ manuals/main/us/en-US/manual
20. Medtronic News Release 2008 [Internet]. Available from: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId= 1226935170803&lang=de-DE
21. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Wilkoff BL, Bello D, Taborsky M, Vymazal J, Kanal E, Heuer H, Hecking K, Johnson WB, Young W, Ramza B, Akhtar N, Kuepper B, Hunold P, Luechinger R, Puererfellner H, Duru F, Gotte MJ, Sutton R, Sommer T, EnRhythm MRI SureScan Pacing System Study Investigators, Heart Rhythm 2011 8 65 73 10.1016/j.hrthm.2010.10.002 20933098
22. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E, MRI Advisa System Study Investigators, Heart Rhythm 2013 10 685 91 10.1016/j.hrthm.2013.01.022 23333721
23. Magnetic resonance imaging of pacemakers and implantable cardioverter defibrillators without specific absorption rate restrictions. Mollerus M, Albin G, Lipinski M, Lucca J, Europace 2010 12 947 51 10.1093/europace/euq092 20353963
24. Cardiac magnetic resonance imaging at 1.5 T in patients with cardiac rhythm devices. Buendía F, Cano Ó Sánchez-Gómez JM, Igual B, Osca J, Sancho-Tello MJ, Olagüe J, Salvador A, Europace 2011 13 533 8 10.1093/europace/euq501 21227955
25. Monocenter feasibility study of the MRI compatibility of the Evia Pacemaker in combination with Safio S Pacemaker Lead. Wollmann CG, Steiner E, Vock P, Mayr H, J Cardiovasc Magn Reson 2012 14 67 10.1186/1532-429X-14-67 23009683
26. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Tóth A, Chang Y, van Osch D, Sommer T, Advisa MRI System Study Investigators, Heart Rhythm 2013 6 864 72