TY - JOUR
T1 - MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads
T2 - Randomized trial results
AU - Shenthar, Jayaprakash
AU - Milasinovic, Goran
AU - Al Fagih, Ahmed
AU - Götte, Marco
AU - Engel, Gregory
AU - Wolff, Steven
AU - Tse, Hung-Fat
AU - Herr, Julie
AU - Carrithers, John
AU - Cerkvenik, Jeffrey
AU - Nähle, Claas Philip
PY - 2015/4/1
Y1 - 2015/4/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84925356848&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/25556038
U2 - https://doi.org/10.1016/j.hrthm.2014.12.035
DO - https://doi.org/10.1016/j.hrthm.2014.12.035
M3 - Article
C2 - 25556038
SN - 1547-5271
VL - 12
SP - 759
EP - 765
JO - Heart Rhythm
JF - Heart Rhythm
IS - 4
ER -