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Randomized Controlled Trial Multicenter Study
MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results.
- Jayaprakash Shenthar, Goran Milasinovic, Ahmed Al Fagih, Marco Götte, Gregory Engel, Steven Wolff, Hung-Fat Tse, Julie Herr, John Carrithers, Jeffrey Cerkvenik, and Claas Philip Nähle.
- Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, India. Electronic address: jshenthar@yahoo.com.
- Heart Rhythm. 2015 Apr 1; 12 (4): 759-65.
BackgroundMagnetic resonance imaging (MRI) can be safely performed in patients with magnetic resonance (MR)-conditional pacemaker systems but remains relatively contraindicated with non-MR-conditional pacemaker systems.ObjectiveThe purpose of this study was to evaluate the safety of MRI without positioning restrictions in patients with an MR-conditional pacemaker and currently a non-MR-conditional Medtronic CapSureFix Novus 5076 lead(s).MethodsThe study randomized 266 patients in a 2:1 ratio to the MRI group (177 patients) or to the control group (89 patients). At 9-12 weeks postimplant, the MRI group underwent MRI at 1.5 T. Primary end points were MRI-related complication-free rate and noninferiority of the MRI group compared to the control group with regard to the proportion of patients with an increase of ≤0.5 V in right atrial (RA) and right ventricular (RV) pacing capture thresholds from immediately before MRI to 1-month after MRI.ResultsNo MRI-related complications occurred in 156 MRI-scanned patients who were followed through 1-month post-MRI. Differences in the proportion of patients with ≤0.5 V pacing capture threshold changes from pre-MRI to 1-month post-MRI were minimal between the groups for RA (proportions of 100% in both groups; a P value cannot be calculated) and RV leads (proportions of 99.3% in the MRI group and 100% in the control group; noninferiority test, P < .0001). Proportions of patients with acceptable sensing amplitude changes from pre-MRI to 1-month post-MRI were also similar between the 2 groups for RA and RV leads (noninferiority test, P < .0001 and P = .0004, respectively). No arrhythmias occurred during MRI.ConclusionMRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
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