Jayaprakash Shenthar1, Goran Milasinovic2, Ahmed Al Fagih3, Marco Götte4, Gregory Engel5, Steven Wolff6, Hung-Fat Tse7, Julie Herr8, John Carrithers8, Jeffrey Cerkvenik8, Claas Philip Nähle9. 1. Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, India. Electronic address: jshenthar@yahoo.com. 2. Pacemaker Center, Clinical Center of Serbia, Belgrade, Serbia. 3. Prince Sultan Cardiac Center, Riyadh, Saudi Arabia. 4. Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands. 5. Silicon Valley Cardiology, East Palo Alto, California. 6. Carnegie Hill Radiology, New York, New York. 7. Queen Mary Hospital, Hong Kong, China. 8. Medtronic, Inc, Minneapolis, Minnesota. 9. Department of Radiology, University of Bonn, Bonn, Germany.
Abstract
BACKGROUND:Magnetic 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. OBJECTIVE: The 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). METHODS: The 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. RESULTS: No 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. CONCLUSION: MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.
RCT Entities:
BACKGROUND: Magnetic 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. OBJECTIVE: The 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). METHODS: The 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. RESULTS: No 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. CONCLUSION: MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.
Authors: Pierpaolo Lupo; Riccardo Cappato; Giovanni Di Leo; Francesco Secchi; Giacomo D E Papini; Sara Foresti; Hussam Ali; Guido M G De Ambroggi; Antonio Sorgente; Gianluca Epicoco; Paola M Cannaò; Francesco Sardanelli Journal: Eur Radiol Date: 2018-01-09 Impact factor: 5.315
Authors: Wolfgang Rudolf Bauer; Dennis H Lau; Christian Wollmann; Andrew McGavigan; Jacques Mansourati; Theresa Reiter; Simone Frömer; Mark E Ladd; Harald H Quick Journal: Sci Rep Date: 2019-12-03 Impact factor: 4.379