Cardiovascular Implantable Electronic Devices -> Monitoring & Outcomes: -> Monitoring & Follow-up
D-PO05 - Poster Session V (ID 39)
Poster
D-PO05-093 - Utilization And Safety Of 3T Magnetic Resonance Imaging (MRI) For Patients With Transvenous Cardiac Implantable Electronic Devices (ID 546)
Abstract
Background: Patients with cardiac implantable electronic device systems (CIEDs) often need MRI studies. Prior to MR-conditional devices, CIEDs were a contraindication to MRI. Available data support the safe use of 1.5T MRI with MR-conditional CIEDs. In recent years, some CIEDs have also been approved for 3T imaging, but adoption of 3T MRI for CIED patients appears slow and safety data are limited.
Objective: To report the change in pacing capture threshold (ΔPCT) and MRI-related adverse events (AEs) following on-label 3T MRI of transvenous CIEDs.
Methods: Since approval in 2016, patients with a Medtronic 3T MR-conditional CIED and consented to enroll were prospectively followed in the Product Surveillance Registry, Medtronic’s active surveillance platform. Pre- to post-MRI ΔPCT and MRI-related AEs are summarized. Pre-MRI PCT is the mean PCT within 4 weeks preceding the scan, and post-MRI PCT is the maximum value between 4 - 7 weeks post-scan.
Results: Among 5015 patients with eligible CIEDs from 154 sites in 14 countries with mean follow-up of 16±14.8 months, there were 293 MRI scans and 24 were 3T MR (1 Pacer, 10 ICD and 13 CRT). The 3T imaging was mostly of brain (37.5%) and lumbar region (20.8%). Top reasons for scans were neuro (33.3%), joint (20.8%) and cancer (20.8%). Forty-six of 54 3T-exposed leads had available ΔPCT data and no change was clinically significant. The mean ΔPCT was 0.026±0.133V, with a maximum increase of 0.469V (Table). There were no MRI-related AEs.
Conclusion: In a real-world setting, 3T MRI of various device types, lead types and scan sites did not result in clinically relevant PCT changes or AEs. These data provide reassurance for the safe use of on-label 3T MRI for CIED patients.
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Objective: To report the change in pacing capture threshold (ΔPCT) and MRI-related adverse events (AEs) following on-label 3T MRI of transvenous CIEDs.
Methods: Since approval in 2016, patients with a Medtronic 3T MR-conditional CIED and consented to enroll were prospectively followed in the Product Surveillance Registry, Medtronic’s active surveillance platform. Pre- to post-MRI ΔPCT and MRI-related AEs are summarized. Pre-MRI PCT is the mean PCT within 4 weeks preceding the scan, and post-MRI PCT is the maximum value between 4 - 7 weeks post-scan.
Results: Among 5015 patients with eligible CIEDs from 154 sites in 14 countries with mean follow-up of 16±14.8 months, there were 293 MRI scans and 24 were 3T MR (1 Pacer, 10 ICD and 13 CRT). The 3T imaging was mostly of brain (37.5%) and lumbar region (20.8%). Top reasons for scans were neuro (33.3%), joint (20.8%) and cancer (20.8%). Forty-six of 54 3T-exposed leads had available ΔPCT data and no change was clinically significant. The mean ΔPCT was 0.026±0.133V, with a maximum increase of 0.469V (Table). There were no MRI-related AEs.
Conclusion: In a real-world setting, 3T MRI of various device types, lead types and scan sites did not result in clinically relevant PCT changes or AEs. These data provide reassurance for the safe use of on-label 3T MRI for CIED patients.
