Key result
1.5T MRI scanning with the Advisa pacemaker system yields 0 complications and stable pacing thresholds.
Why the study?
Does the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system allow safe 1.5 T MRI scanning without complications or changes in pacing capture threshold in patients with standard dual-chamber pacing indications?
Population
263 patients with standard dual-chamber pacing indications
Comparison
16 chest and head MRI scans at 1.5 T between 9… vs No MRI scans post-implant in patients implanted…
Design
RCT, 2:1 ratio
Follow-up
1-month post-MRI
Authors
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Supports safe 1.5 T MRI without restrictions in dual-chamber pacemaker patients; confirms threshold stability for the Advisa MRI system.
RCT (n=263)
2:1
Does the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system allow safe 1.5 T MRI scanning without complications or changes in pacing capture threshold in patients with standard dual-chamber pacing indications?
The Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective for 1.5 T MRI scanning without positioning restrictions.
Gimbel et al. (2013) conducted an RCT in Standard dual-chamber pacing indications (n=263). 1.5 T MRI scanning vs. No MRI was evaluated on MRI-related complication-free rate and pacing capture threshold. 1.5 T MRI scanning with the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system resulted in no MRI-related complications (0/148) and minimal changes in pacing capture thresholds.
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