The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging

Clinical Medicine Insights. Cardiology
Arnaud SavouréArnaud Lazarus

Abstract

The impact of magnetic resonance imaging (MRI) on pacemakers is potentially hazardous. We present clinical results from a novel MRI conditional pacing system with the capability to switch automatically to asynchronous mode in the presence of a strong magnetic field. The IKONE (Assessment of the MRI solution: KORA 100™ and Beflex™ pacing leads system) study is an open-label, prospective, multicenter study aimed at confirming the safety and effectiveness of the system, when used in patients undergoing MRI of anatomical regions excluding the chest. Primary eligibility criteria included patients implanted with the system, with or without a clinically indicated MRI. The primary endpoint was to confirm no significant change in pacing capture thresholds at 1 month after an MRI, with an absolute difference of ≤0.75 V between the pre- and 1-month post-MRI for both atrial and ventricular capture thresholds. Out of 33 patients enrolled (mean age: 72.8 ± 11.4 years, 70% male, implant indication or device), 29 patients implanted with the MRI conditional system underwent an MRI 6-8 week postimplant. The study reached its primary endpoint: the mean absolute difference in pacing capture threshold at 1-month post-MRI versus pre-MRI was less tha...Continue Reading

References

Oct 2, 2009·Pacing and Clinical Electrophysiology : PACE·Claas P NaehleTorsten Sommer
Apr 1, 2010·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Michael MollerusJill Lucca
Jan 14, 2011·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Francisco BuendíaAntonio Salvador
Jan 13, 2012·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Werner JungSebastian Jäckle

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Citations

Apr 1, 2018·Pacing and Clinical Electrophysiology : PACE·Iwan S NyotowidjojoJulia H Indik
Sep 27, 2018·Radiology·Rahul G MuthalalyArthur Nasis
Dec 8, 2020·Pacing and Clinical Electrophysiology : PACE·Saurabh DeshpandeDeepak Padmanabhan
Jun 1, 2020·Archives of Cardiovascular Diseases·Estelle GandjbakhchUNKNOWN Working Group of Pacing, Electrophysiology of the French Society of Cardiology, the French Society of Diagnostic, Interventi

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Clinical Trials Mentioned

NCT02175797

Software Mentioned

SAS
AutoMRI
IKONE

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