The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional pacemaker system at 1.5 tesla

Thuy D. Nguyen, MD; Sarah A. Sandberg, MD; Amir K. Durrani, MD; Kevin W. Mitchell, BS; Matthew D. Keith, MS; Marye J. Gleva, MD, FHRS; Pamela K. Woodard, MD

Heart Rhythm O2 (Feb 2021)

The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional pacemaker system at 1.5 tesla

Thuy D. Nguyen, MD,
Sarah A. Sandberg, MD,
Amir K. Durrani, MD,
Kevin W. Mitchell, BS,
Matthew D. Keith, MS,
Marye J. Gleva, MD, FHRS,
Pamela K. Woodard, MD

Affiliations

Thuy D. Nguyen, MD: Divisions of Cardiovascular Medicine and Mallinckrodt Institute of Radiology, Washington University, Saint Louis, Missouri
Sarah A. Sandberg, MD: Divisions of Cardiovascular Medicine and Mallinckrodt Institute of Radiology, Washington University, Saint Louis, Missouri; Brookwood Baptist Health, Birmingham, Alabama
Amir K. Durrani, MD: Divisions of Cardiovascular Medicine and Mallinckrodt Institute of Radiology, Washington University, Saint Louis, Missouri; Division of Cardiovascular Medicine, Washington Permanente, Seattle, Washington
Kevin W. Mitchell, BS: Clinical Studies Division at Biotronik, Inc, Lake Oswego, Oregon
Matthew D. Keith, MS: Clinical Studies Division at Biotronik, Inc, Lake Oswego, Oregon
Marye J. Gleva, MD, FHRS: Divisions of Cardiovascular Medicine and Mallinckrodt Institute of Radiology, Washington University, Saint Louis, Missouri
Pamela K. Woodard, MD: Divisions of Cardiovascular Medicine and Mallinckrodt Institute of Radiology, Washington University, Saint Louis, Missouri; Address reprint requests and correspondence: Dr Pamela K. Woodard, Washington University School of Medicine, Department of Radiological Sciences, Mallinckrodt Institute of Radiology, 510 S. Kingshighway Blvd, St. Louis, MO 63110.

Journal volume & issue: Vol. 2, no. 1
pp. 73 – 79

Abstract

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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.

Published in Heart Rhythm O2

ISSN: 2666-5018 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the circulatory (Cardiovascular) system
Website: https://www.journals.elsevier.com/heart-rhythm-o2

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