• Rainer Zbinden, Christian Wollmann, Johannes Brachmann, Jochen Michaelsen, Clemens Steinwender, Pramesh Kovoor, Sebastian Kelle, Andrew D McGavigan, Chi Keong Ching, Gemma A Figtree, Jan Schmidt, Tobias Timmel, and Joachim Lotz.
• Klinik für Kardiologie, Stadtspital Triemli, Birmensdorferstrasse 497, Zurich, Switzerland.
• Europace. 2019 Nov 1; 21 (11): 1678-1685.

AimsThere have been no published studies on the safety of magnetic resonance imaging (MRI) at 3 Tesla (3 T) in patients with MRI-conditional implantable cardioverter-defibrillators (ICDs). The aim of this study was to assess clinical safety of the Biotronik ProMRI ICD system during non-diagnostic head and lower lumbar scans under 3 T MRI conditions.Methods And ResultsThe study enrolled 129 patients at 12 sites in Australia, Singapore, and Europe. Predefined head and lower lumbar MR scans (total duration ≈30 min) were performed in 112 patients. Three primary endpoints were evaluated from the pre-MRI to the 1-month post-MRI visit: (i) freedom from serious adverse device effects (SADEs) related to MRI (hypothesized to be >90%); (ii) pacing threshold invariance for all leads (geometric mean of the patient-wise ratios for 1 month vs. pre-MRI was hypothesized to be <1.07); and (iii) sensing amplitude invariance (geometric mean of the ratios was hypothesized to be >0.993). No MRI-related SADE occurred (SADE-free rate 100%, 95% confidence interval 95.98-100%). Pacing threshold and sensing amplitudes fulfilled the invariance hypotheses with high statistical significance (P < 0.0013). No threshold increase >0.5 V or sensing amplitude decrease by >50% was observed (secondary endpoints). Lead impedances, battery capacity, and detection and treatment of arrhythmias by ICDs were not affected by MRI scans.ConclusionThe head and lower lumbar scans under specific 3 T MRI conditions were safe in the investigated MR-conditional ICD systems. There was no evidence of harm to the patients or any negative influence of the MRI scan on the implanted systems.© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.

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