Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla

Wolfgang Rudolf Bauer,Simone Frömer,Theresa Reiter,Dennis H Lau,Mark E Ladd,Jacques Mansourati,Christian Wollmann,Harald H Quick,Andrew Mcgavigan

doi:10.1038/s41598-019-54342-4

Abstract

Magnetic resonance imaging (MRI) has long been contraindicated in patients with implanted pacemakers, defibrillators, and cardiac resynchronisation therapy (CRT) devices due to the risk of adverse effects through electromagnetic interference. Since many recipients of these devices will have a lifetime indication for an MRI scan, the implantable systems should be developed as ‘MRI-conditional’ (be safe for the MRI environment under predefined conditions). We evaluated the clinical safety of several Biotronik ProMRI (‘MRI-conditional’) defibrillator and CRT systems during head and lower lumbar MRI scans at 1.5 Tesla. The study enrolled 194 patients at 22 sites in Australia, Canada, and Europe. At ≥9 weeks after device implantation, predefined, non-diagnostic, specific absorption rate (SAR)-intensive head and lower lumbar MRI scans (total ≈30 minutes per patient) were performed in 146 patients that fulfilled pre-procedure criteria. Three primary endpoints were evaluated: freedom from serious adverse device effects (SADEs) related to MRI and defibrillator/CRT (leading to death, hospitalisation, life-threatening condition, or potentially requiring implanted system revision or replacement), pacing threshold increase, and sensing amplitude decrease, all at the 1-month post-MRI clinical visit. No MRI-related SADE occurred. Lead values remained stable, measured in clinic and monitored daily by the manufacturer home monitoring technology.

Highlights

Magnetic resonance imaging (MRI) has long been contraindicated in patients with pacemakers and implantable cardioverter-defibrillators (ICDs) due to the risk of adverse effects through electromagnetic interference[1,2]
Complex physical interactions between the electronic implants and the MRI environment necessitate testing on new pulse generator and lead combinations[1,9], especially of MRI-conditional ICD or cardiac resynchronisation therapy (CRT) defibrillator (CRT-D) and CRT pacemaker (CRT-P) systems[1,9], for which the available data are limited to a few device models[8,10,11,12]
One hundred ninety-four patients were enrolled from June 20, 2013, to September 26, 2014 at 22 sites in Australia, Canada, Germany, Austria, France, Switzerland, Czech Republic, and Hungary (Supplementary Information File)

Summary

Introduction

Magnetic resonance imaging (MRI) has long been contraindicated in patients with pacemakers and implantable cardioverter-defibrillators (ICDs) due to the risk of adverse effects through electromagnetic interference[1,2]. Another study[15] indicates that many scans are denied in patients with a clinical indication and that the presence of an MRI-conditional system does not seem to increase the rate of MRI procedures In light of these reports, it appears critical to increase the scientific literature on the safety and rate of adverse effects during MRI scans of patients with MRI-conditional cardiac devices. Complex physical interactions between the electronic implants and the MRI environment necessitate testing on new pulse generator and lead combinations[1,9], especially of MRI-conditional ICD or cardiac resynchronisation therapy (CRT) defibrillator (CRT-D) and CRT pacemaker (CRT-P) systems[1,9], for which the available data are limited to a few device models[8,10,11,12]. KG, Berlin, Germany) during non-diagnostic head and lower lumbar MRI scans at 1.5 Tesla (T)

Methods

Results

Discussion

Conclusion