Europace Advance Access published February 6, 2016
LETTER TO THE EDITOR
doi:10.1093/europace/euv275
Leadless pacemakers and MRI compatibility: authors’ reply
Sincerely, Johannes Sperzel
References 1. Cay S, Ozeke O, Ozcan F, Topaloglu S, Aras D. An important advantage of the leadless pacemakers: magnetic resonance imaging compatibility. Europace 2015; doi:10.1093/europace/euv246. 2. Sperzel J, Burri H, Gras D, Tjong FVY, Knops RE, Hindricks G, Steinwender C, Defaye P. State of the art of leadless pacing. Europace 2015;17: 1508 –13. 3. Ritter P, Duray GZ, Steinwender C, Soejima K, Omar R, Mont L et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J 2015;36: 2510 – 19. 4. Knops RE, Tjong FVY, Neuzil P, Sperzel J, Miller MA, Petru J et al. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol 2015;65:1497 –504.
Johannes Sperzel* Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany *Corresponding author. Tel: +49 6032 9960; fax: +49 6032 996 3236. E-mail address: j.sperzel@ kerckhoff-klinik.de
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2016. For permissions please email: [email protected].
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Thank you for the opportunity to comment on the letter by Dr Cay et al.1 regarding our review ‘State of the art of leadless pacing’. 2 The authors raise an important consideration related to the magnetic resonance imaging (MRI) conditionality of pacemakers. As indicated by Cay et al. the Micraw Transcatheter Pacing System (Medtronic, Inc.) is compatible with full-body 1.5 and 3.0 T MRI scanning. It should be noted that the NanostimTM Leadless Pacemaker (St Jude Medical, Inc.) is also designed to be MRI compatible for full-body MRI scans. According to information provided from St Jude Medical, bench testing for MRI conditionality has been successfully completed and appropriate data have been
submitted for regulatory approval in the EU. The MRI conditional labelling for the NanostimTM leadless pacemaker is expected shortly in the EU. While MRI conditionality is important, the data on safety and effectiveness for both the Micraw Transcatheter Pacing System and the Nanostim TM Leadless Pacemaker are more important at this early stage of clinical use. The data available for both leadless pacemaker systems are promising and show that safety is similar to transvenous pacemakers.3,4 However, data across a larger patient population with longer term follow-up will be key in order for leadless pacemakers to fully replace transvenous pacemakers, which have been around for over 50 years and have vast amounts of data to support their safety profile.
LETTER TO THE EDITOR
doi:10.1093/europace/euv275
Leadless pacemakers and MRI compatibility: authors’ reply
Sincerely, Johannes Sperzel
References 1. Cay S, Ozeke O, Ozcan F, Topaloglu S, Aras D. An important advantage of the leadless pacemakers: magnetic resonance imaging compatibility. Europace 2015; doi:10.1093/europace/euv246. 2. Sperzel J, Burri H, Gras D, Tjong FVY, Knops RE, Hindricks G, Steinwender C, Defaye P. State of the art of leadless pacing. Europace 2015;17: 1508 –13. 3. Ritter P, Duray GZ, Steinwender C, Soejima K, Omar R, Mont L et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J 2015;36: 2510 – 19. 4. Knops RE, Tjong FVY, Neuzil P, Sperzel J, Miller MA, Petru J et al. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol 2015;65:1497 –504.
Johannes Sperzel* Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany *Corresponding author. Tel: +49 6032 9960; fax: +49 6032 996 3236. E-mail address: j.sperzel@ kerckhoff-klinik.de
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2016. For permissions please email: [email protected].
Downloaded from by guest on February 6, 2016
Thank you for the opportunity to comment on the letter by Dr Cay et al.1 regarding our review ‘State of the art of leadless pacing’. 2 The authors raise an important consideration related to the magnetic resonance imaging (MRI) conditionality of pacemakers. As indicated by Cay et al. the Micraw Transcatheter Pacing System (Medtronic, Inc.) is compatible with full-body 1.5 and 3.0 T MRI scanning. It should be noted that the NanostimTM Leadless Pacemaker (St Jude Medical, Inc.) is also designed to be MRI compatible for full-body MRI scans. According to information provided from St Jude Medical, bench testing for MRI conditionality has been successfully completed and appropriate data have been
submitted for regulatory approval in the EU. The MRI conditional labelling for the NanostimTM leadless pacemaker is expected shortly in the EU. While MRI conditionality is important, the data on safety and effectiveness for both the Micraw Transcatheter Pacing System and the Nanostim TM Leadless Pacemaker are more important at this early stage of clinical use. The data available for both leadless pacemaker systems are promising and show that safety is similar to transvenous pacemakers.3,4 However, data across a larger patient population with longer term follow-up will be key in order for leadless pacemakers to fully replace transvenous pacemakers, which have been around for over 50 years and have vast amounts of data to support their safety profile.
