Skip to main content
Top
Published in: Journal of Cardiovascular Magnetic Resonance 1/2014

Open Access 01-12-2014 | Research

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

Authors: Christian G Wollmann, Karin Thudt, Bernd Kaiser, Erich Salomonowitz, Harald Mayr, Sebastian Globits

Published in: Journal of Cardiovascular Magnetic Resonance | Issue 1/2014

Login to get access

Abstract

Background

No published data exist about the safety of diagnostic magnetic resonance (MR) of the heart performed in a larger series of patients implanted with MR conditional pacemakers (PM). The purpose of our study is to analyse safety and potential alterations of electrical lead parameters in patients implanted with the EnRhythm/Advisa MRI SureScan PM with 5086MRI leads (Medtronic Inc.) during and after MR of the heart at 1.5 Tesla.

Methods

Patients enrolled in this single center pilot study who underwent non-clinically indicated diagnostic MR of the heart were included in this analysis. Heart MR was performed for analyses of potential changes in right and left ventricular functional parameters under right ventricular pacing at 80 and 110 bpm. Atrial/ventricular sensing, atrial/ventricular pacing capture threshold [PCT], and pacing impedances were assessed immediately before, during, and immediately after MR, as well at 3 and 15 months post MR.

Results

Thirty-six patients (mean age 69 ± 13 years; high degree AV block 18 [50%]) underwent MR of the heart. No MR related adverse events occurred during MR or thereafter. Ventricular sensing differed significantly between the FU immediately after MR (10.3 ± 5.3 mV) and the baseline FU (9.8 ± 5.3 mV; p < 0.05). Despite PCT [V/0.4ms] was not significantly different between the FUs (baseline: 0.84 ± 0.27; in-between MR scans: 0.82 ± 0.27; immediately after MR: 0.84 ± 0.24; 3-month: 0.85 ± 0.23; 15-month: 0.90 ± 0.67; p = ns), 7 patients (19%) showed PCT increases by 100% (max. PCT measured: 1.0 V) at the 3-month FU compared to baseline. RV pacing impedance [Ω/5V] differed significantly at the FU in-between MR scans (516 ± 47), and at the 15-month FU (482 ± 58) compared to baseline (508 ± 75).

Conclusion

The results of our study suggest MR of the heart to be safe in patients with the MR conditional EnRhythm/Advisa system, albeit although noticeable but clinically irrelevant ventricular PCT changes were observed.
Appendix
Available only for authorised users
Literature
2.
go back to reference Roguin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, Auricchio A, Priori S, Sommer T: Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace. 2008, 10: 336-46. 10.1093/europace/eun021.CrossRefPubMed Roguin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, Auricchio A, Priori S, Sommer T: Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace. 2008, 10: 336-46. 10.1093/europace/eun021.CrossRefPubMed
3.
go back to reference Sommer T, Naehle CP, Yang A, Zeijlemaker V, Hackenbroch M, Schmiedel A, Meyer C, Strach K, Skowasch D, Vahlhaus C, Litt H, Schild H: 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: 1285-92. 10.1161/CIRCULATIONAHA.105.597013.CrossRefPubMed Sommer T, Naehle CP, Yang A, Zeijlemaker V, Hackenbroch M, Schmiedel A, Meyer C, Strach K, Skowasch D, Vahlhaus C, Litt H, Schild H: 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: 1285-92. 10.1161/CIRCULATIONAHA.105.597013.CrossRefPubMed
4.
go back to reference 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: A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011, 155: 415-24. 10.7326/0003-4819-155-7-201110040-00004.PubMedCentralCrossRefPubMed 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: A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011, 155: 415-24. 10.7326/0003-4819-155-7-201110040-00004.PubMedCentralCrossRefPubMed
5.
go back to reference 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: 1315-24. 10.1016/j.jacc.2003.12.016.CrossRefPubMed 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: 1315-24. 10.1016/j.jacc.2003.12.016.CrossRefPubMed
6.
go back to reference Naehle CP, Kreuz J, Strach K, Schwab JO, Pingel S, Luechinger R, Fimmers R, Schild H, Thomas D: Safety, feasibility, and diagnostic value of cardiac magnetic resonance imaging in patients with cardiac pacemakers and implantable cardioverters/defibrillators at 1.5 T. Am Heart J. 2011, 161: 1096-105. 10.1016/j.ahj.2011.03.007.CrossRefPubMed Naehle CP, Kreuz J, Strach K, Schwab JO, Pingel S, Luechinger R, Fimmers R, Schild H, Thomas D: Safety, feasibility, and diagnostic value of cardiac magnetic resonance imaging in patients with cardiac pacemakers and implantable cardioverters/defibrillators at 1.5 T. Am Heart J. 2011, 161: 1096-105. 10.1016/j.ahj.2011.03.007.CrossRefPubMed
7.
go back to reference Naehle CP, Zeijlemaker V, Thomas D, Meyer C, Strach K, Fimmers R, Schild H, Sommer T: Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla. Pacing Clin Electrophysiol. 2009, 32: 1526-35. 10.1111/j.1540-8159.2009.02570.x.CrossRefPubMed Naehle CP, Zeijlemaker V, Thomas D, Meyer C, Strach K, Fimmers R, Schild H, Sommer T: Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla. Pacing Clin Electrophysiol. 2009, 32: 1526-35. 10.1111/j.1540-8159.2009.02570.x.CrossRefPubMed
8.
go back to reference 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: 266-72. 10.1016/j.ahj.2012.12.004.CrossRefPubMed 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: 266-72. 10.1016/j.ahj.2012.12.004.CrossRefPubMed
9.
go back to reference 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): 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). Europace. 2013, 15: 1070-118.CrossRefPubMed 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): 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). Europace. 2013, 15: 1070-118.CrossRefPubMed
10.
go back to reference Nordbeck P, Ritter O, Weiss I, Warmuth M, Gensler D, Burkard N, Herold V, Jakob PM, Ertl G, Ladd ME, Quick HH, Bauer WR: Impact of imaging landmark on the risk of MRI-related heating near implanted medical devices like cardiac pacemaker leads. Magn Reson Med. 2011, 65: 44-50. 10.1002/mrm.22592.CrossRefPubMed Nordbeck P, Ritter O, Weiss I, Warmuth M, Gensler D, Burkard N, Herold V, Jakob PM, Ertl G, Ladd ME, Quick HH, Bauer WR: Impact of imaging landmark on the risk of MRI-related heating near implanted medical devices like cardiac pacemaker leads. Magn Reson Med. 2011, 65: 44-50. 10.1002/mrm.22592.CrossRefPubMed
11.
go back to reference Shellock FG, Fischer L, Fieno DS: Cardiac pacemakers and implantable cardioverter defibrillators: in vitro magnetic resonance imaging evaluation at 1.5-Tesla. J Cardiovasc Magn Reson. 2007, 9: 21-31. 10.1080/10976640600897237.CrossRefPubMed Shellock FG, Fischer L, Fieno DS: Cardiac pacemakers and implantable cardioverter defibrillators: in vitro magnetic resonance imaging evaluation at 1.5-Tesla. J Cardiovasc Magn Reson. 2007, 9: 21-31. 10.1080/10976640600897237.CrossRefPubMed
15.
go back to reference Jung W, Zvereva V, Hajredini B, Jäckle S: Initial experience with magnetic resonance imaging-safe pacemakers. A review. J Interv Card Electrophysiol. 2011, 32: 213-9. 10.1007/s10840-011-9610-0.PubMedCentralCrossRefPubMed Jung W, Zvereva V, Hajredini B, Jäckle S: Initial experience with magnetic resonance imaging-safe pacemakers. A review. J Interv Card Electrophysiol. 2011, 32: 213-9. 10.1007/s10840-011-9610-0.PubMedCentralCrossRefPubMed
16.
go back to reference Shinbane JS, Colletti PM, Shellock FG: Magnetic resonance imaging in patients with cardiac pacemakers: era of “MR Conditional” designs. J Cardiovasc Magn Reson. 2011, 13: 63-10.1186/1532-429X-13-63.PubMedCentralCrossRefPubMed Shinbane JS, Colletti PM, Shellock FG: Magnetic resonance imaging in patients with cardiac pacemakers: era of “MR Conditional” designs. J Cardiovasc Magn Reson. 2011, 13: 63-10.1186/1532-429X-13-63.PubMedCentralCrossRefPubMed
17.
go back to reference Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, 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, 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 : 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. J Am Coll Cardiol. 2008, 51: e1-62. 10.1016/j.jacc.2008.02.032.CrossRefPubMed Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, 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, 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 : 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. J Am Coll Cardiol. 2008, 51: e1-62. 10.1016/j.jacc.2008.02.032.CrossRefPubMed
21.
go back to reference 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: Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. 2011, 8: 65-73. 10.1016/j.hrthm.2010.10.002.CrossRefPubMed 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: Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. 2011, 8: 65-73. 10.1016/j.hrthm.2010.10.002.CrossRefPubMed
22.
go back to reference 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: Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013, 10: 685-91. 10.1016/j.hrthm.2013.01.022.CrossRefPubMed 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: Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013, 10: 685-91. 10.1016/j.hrthm.2013.01.022.CrossRefPubMed
23.
go back to reference Mollerus M, Albin G, Lipinski M, Lucca J: Magnetic resonance imaging of pacemakers and implantable cardioverter defibrillators without specific absorption rate restrictions. Europace. 2010, 12: 947-51. 10.1093/europace/euq092.CrossRefPubMed Mollerus M, Albin G, Lipinski M, Lucca J: Magnetic resonance imaging of pacemakers and implantable cardioverter defibrillators without specific absorption rate restrictions. Europace. 2010, 12: 947-51. 10.1093/europace/euq092.CrossRefPubMed
24.
go back to reference Buendía F, Cano Ó, Sánchez-Gómez JM, Igual B, Osca J, Sancho-Tello MJ, Olagüe J, Salvador A: Cardiac magnetic resonance imaging at 1.5 T in patients with cardiac rhythm devices. Europace. 2011, 13: 533-8. 10.1093/europace/euq501.CrossRefPubMed Buendía F, Cano Ó, Sánchez-Gómez JM, Igual B, Osca J, Sancho-Tello MJ, Olagüe J, Salvador A: Cardiac magnetic resonance imaging at 1.5 T in patients with cardiac rhythm devices. Europace. 2011, 13: 533-8. 10.1093/europace/euq501.CrossRefPubMed
25.
go back to reference Wollmann CG, Steiner E, Vock P, Mayr H: Monocenter feasibility study of the MRI compatibility of the Evia Pacemaker in combination with Safio S Pacemaker Lead. J Cardiovasc Magn Reson. 2012, 14: 67-10.1186/1532-429X-14-67.PubMedCentralCrossRefPubMed Wollmann CG, Steiner E, Vock P, Mayr H: Monocenter feasibility study of the MRI compatibility of the Evia Pacemaker in combination with Safio S Pacemaker Lead. J Cardiovasc Magn Reson. 2012, 14: 67-10.1186/1532-429X-14-67.PubMedCentralCrossRefPubMed
26.
go back to reference 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: 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. Heart Rhythm. 2013, 6: 864-72.CrossRef 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: 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. Heart Rhythm. 2013, 6: 864-72.CrossRef
Metadata
Title
Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study
Authors
Christian G Wollmann
Karin Thudt
Bernd Kaiser
Erich Salomonowitz
Harald Mayr
Sebastian Globits
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Journal of Cardiovascular Magnetic Resonance / Issue 1/2014
Electronic ISSN: 1532-429X
DOI
https://doi.org/10.1186/1532-429X-16-30

Other articles of this Issue 1/2014

Journal of Cardiovascular Magnetic Resonance 1/2014 Go to the issue