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

Sebastian Globits²  Harald Mayr²  Erich Salomonowitz¹  Bernd Kaiser¹  Karin Thudt²  Christian G Wollmann² 

[1] Department of Radiology and Interventional Angiology, Hospital of St. Pölten-Lilienfeld, St. Pölten, Austria;Karl Landsteiner Society, Institute of Cardiovascular Research, St. Pölten, Austria

关键词: Complications;    Heart MR;    Magnet resonance;    MR conditional;    Permanent pacemaker;   

Others  :  801335
DOI  :  10.1186/1532-429X-16-30

 received in 2014-01-02, accepted in 2014-03-28,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Wollmann et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [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 webcite
• [2]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.
• [3]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.
• [4]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.
• [5]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.
• [6]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.
• [7]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.
• [8]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.
• [9]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.
• [10]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.
• [11]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.
• [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 webcite
• [13]EnRhythm MRI SureScan Pacing System Medtronic, Inc. 2011 [Internet]. Technical manual. Available from: http://manuals.medtronic.com/manuals/main/us/en_US/manual webcite
• [14]Biotronik SE&Co KG: Press Release August 29,2013 [Internet]. Available from: http://www.biotronik.com/wps/wcm/connect/int_web/biotronik/newsroom/press_releases/#jump webcite
• [15]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.
• [16]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. BioMed Central Full Text
• [17]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 : 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.
• [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 webcite
• [19]CapSureFix MRI™ SureScan™ 5086MRI Medtronic, Inc. 2012 [Internet]. Technical manual. Available from: http://manuals.medtronic.com/manuals/main/us/en_US/manual webcite
• [20]Medtronic News Release 2008 [Internet] Available from: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1226935170803&lang=de_DE webcite
• [21]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.
• [22]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.
• [23]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.
• [24]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.
• [25]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. BioMed Central Full Text
• [26]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.