AI Article Synopsis
- The study confirmed that MRI-conditional permanent pacemakers (PPMs) are safe for patients even after multiple MRI scans across different body regions.
- No serious adverse events were reported in a cohort of 81 patients who underwent multiple MRIs, indicating strong device safety.
- Although there were statistically significant changes in some PPM performance metrics post-MRI, these changes were not clinically significant, supporting the ongoing use of these devices for patients requiring serial imaging.
Article Abstract
Background: Studies have demonstrated magnetic resonance imaging (MRI) safety in the presence of MRI-conditional permanent pacemakers (PPM). However, since patients' care may require serial MRIs, it is necessary to evaluate device safety and performance after multiple scans.
Objectives: We evaluated safety and performance of MRI-conditional PPMs after serial MRIs over various anatomic regions performed during a multicenter, prospective, single-arm study (ProMRI).
Methods: ProMRI was a multiphase observational study designed to evaluate PPM performance after MRI scans. Our study evaluated PPM function in a cohort of patients who underwent multiple 1.5-T MRI scans. Selected patients underwent separate head, chest, and lumbar spine MRIs. Pacing capture threshold (PCT), lead impedance (LI), sensing amplitude, and battery capacity were collected before and after scanning. Freedom from serious adverse device effects (SADE) through 1 month post MRI served as a primary endpoint. Changes in PPM function parameters, including threshold success rate and sensing attenuation, were analyzed for statistical significance and clinical relevance.
Results: In 81 patients no adverse events or SADE occurred. Statistically significant changes in ventricular PCT (0.034 ± 0.15 V) immediately after, ventricular LI immediately after (-18.7 ± 44.2 Ω) and 1 month post phase B (-19.8 ± 44.9 Ω), and atrial sensing attenuation immediately after (-0.27 ± 0.92 mV) and 1 month post phase B (-0.22 ± 0.92 mV) were noted. However, these changes were not clinically relevant in degree.
Conclusion: These results demonstrate the safety and performance of the ProMRI PPM in patients undergoing 3 serial MRIs over various anatomic regions.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183850 | PMC |
| http://dx.doi.org/10.1016/j.hroo.2020.12.018 | DOI Listing |
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