TY - JOUR
T1 - Impact of magnetic resonance imaging on ventricular tachyarrhythmia sensing
T2 - Results of the Evera MRI Study
AU - Gold, Michael R.
AU - Sommer, Torsten
AU - Schwitter, Juerg
AU - Kanal, Emanuel
AU - Bernabei, Matthew A.
AU - Love, Charles J.
AU - Surber, Ralf
AU - Ramza, Brian
AU - Cerkvenik, Jeffrey
AU - Merkely, Béla
N1 - Funding Information:
Dr Gold has received research grants from Boston Scientific and St. Jude Medical. Dr Sommer has received consulting fees from Medtronic. Dr Schwitter has received consulting fees from Medtronic. Dr Kanal has received consulting fees from Medtronic, Boston Scientific, and St. Jude Medical. Dr Love has received research grants from Medtronic and consulting fees from Medtronic, St. Jude Medical, and Spectranetics. Dr Surber has received consulting fees from Biotronik, Medtronic, St. Jude Medical, and Boston Scientific. Dr Ramza has received research support from Medtronic and Boston Scientific and consulting fees from Medtronic. Mr Cerkvenik is employed by Medtronic. Dr Merkely has received speaker’s fees from Medtronic. The Evera MRI Study was funded by Medtronic, plc (Minneapolis, MN). The sponsor was involved in the study design and managed the collection of data as well as data analysis.
Publisher Copyright:
© 2016 Heart Rhythm Society
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Background Studies have shown that magnetic resonance imaging (MRI) conditional pacemakers experience no significant effect from MRI on device function, sensing, or pacing. More recently, similar safety outcomes were demonstrated with MRI conditional defibrillators (implantable cardioverter-defibrillator [ICD]), but the impact on ventricular arrhythmias has not been assessed. Objective The purpose of this study was to assess the effect of MRI on ICD sensing and treatment of ventricular tachyarrhythmias. Methods The Evera MRI Study was a worldwide trial of 156 patients implanted with an ICD designed to be MRI conditional. Device-detected spontaneous and induced ventricular tachycardia/ventricular fibrillation (VT/VF) episodes occurring before and after whole body MRI were evaluated by a blinded episode review committee. Detection delay was computed as the sum of RR intervals of undersensed beats. A ≥5-second delay in detection due to undersensing was prospectively defined as clinically significant. Results Post-MRI, there were 22 polymorphic VT/VF episodes in 21 patients, with 16 of these patients having 17 VT/VF episodes pre-MRI. Therapy was successful for all episodes, with no failures to treat or terminate arrhythmias. The mean detection delay due to undersensing pre- and post-MRI was 0.60 ± 0.59 and 0.33 ± 0.63 seconds, respectively (P = .17). The maximum detection delay was 2.19 seconds pre-MRI and 2.87 seconds post-MRI. Of the 17 pre-MRI episodes, 14 (82%) had some detection delay as compared with 11 of 22 (50%) post-MRI episodes (P = .03); no detection delay was clinically significant. Conclusion Detection and treatment of VT/VF was excellent, with no detection delays or significant impact of MRI observed.
AB - Background Studies have shown that magnetic resonance imaging (MRI) conditional pacemakers experience no significant effect from MRI on device function, sensing, or pacing. More recently, similar safety outcomes were demonstrated with MRI conditional defibrillators (implantable cardioverter-defibrillator [ICD]), but the impact on ventricular arrhythmias has not been assessed. Objective The purpose of this study was to assess the effect of MRI on ICD sensing and treatment of ventricular tachyarrhythmias. Methods The Evera MRI Study was a worldwide trial of 156 patients implanted with an ICD designed to be MRI conditional. Device-detected spontaneous and induced ventricular tachycardia/ventricular fibrillation (VT/VF) episodes occurring before and after whole body MRI were evaluated by a blinded episode review committee. Detection delay was computed as the sum of RR intervals of undersensed beats. A ≥5-second delay in detection due to undersensing was prospectively defined as clinically significant. Results Post-MRI, there were 22 polymorphic VT/VF episodes in 21 patients, with 16 of these patients having 17 VT/VF episodes pre-MRI. Therapy was successful for all episodes, with no failures to treat or terminate arrhythmias. The mean detection delay due to undersensing pre- and post-MRI was 0.60 ± 0.59 and 0.33 ± 0.63 seconds, respectively (P = .17). The maximum detection delay was 2.19 seconds pre-MRI and 2.87 seconds post-MRI. Of the 17 pre-MRI episodes, 14 (82%) had some detection delay as compared with 11 of 22 (50%) post-MRI episodes (P = .03); no detection delay was clinically significant. Conclusion Detection and treatment of VT/VF was excellent, with no detection delays or significant impact of MRI observed.
KW - Implantable cardioverter-defibrillator
KW - Magnetic resonance imaging
KW - Ventricular arrhythmias
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U2 - 10.1016/j.hrthm.2016.05.014
DO - 10.1016/j.hrthm.2016.05.014
M3 - Article
C2 - 27196818
AN - SCOPUS:84991492551
SN - 1547-5271
VL - 13
SP - 1631
EP - 1635
JO - Heart Rhythm
JF - Heart Rhythm
IS - 8
ER -