The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging

Area of Science:

• Cardiology
• Biomedical Engineering
• Radiology

Background:

• Magnetic resonance imaging (MRI) poses risks to pacemaker patients.
• A novel MRI conditional pacing system automatically switches to asynchronous mode during MRI.
• This system aims to mitigate hazards associated with MRI in pacemaker recipients.

Purpose of the Study:

• To evaluate the safety and effectiveness of a new MRI conditional pacing system.
• To assess the impact of MRI on pacemaker function in patients undergoing scans outside the chest.
• The IKONE study confirmed the performance of the KORA 100™ and Beflex™ pacing leads system.

Main Methods:

• An open-label, prospective, multicenter study enrolled patients with the MRI conditional system.
• The primary endpoint measured the change in pacing capture thresholds at 1 month post-MRI.
• Thresholds were compared to pre-MRI values, with an acceptable difference of ≤0.75 V.

Main Results:

• The study met its primary endpoint, with mean absolute differences in atrial and ventricular capture thresholds below 0.75 V post-MRI.
• No adverse events related to the MRI procedure were reported.
• All patients achieved diagnostic quality MR images without symptoms or discomfort.

Conclusions:

• The novel MRI conditional pacing system is safe and effective for 1.5-T MRI scans outside the chest.
• Lead electrical performance, indicated by capture thresholds, remained unaffected by MRI.
• This evaluation supports the use of MRI conditional systems in pacemaker patients.