Abstract 4139380: A Report of <u>2000</u> Consecutive Patients Undergoing Imaging with Pacemakers and ICDs in the MRI Environment; the Additive Value of a Large, Prospective ~20-Year Observational Study

Background: Imaging of conventional PM’s and ICDs are infrequently performed via MRI. While many studies, including the MagnaSafe Trial have unequivocally supported MRI safety in patients with such devices, the added clinical value has rarely been considered. Accordingly, we performed an observational, IRB-approved, prospective study to determine the 'Additive Value' beyond safety for patients with conventional PM/ICD's undergoing clinical MRI. We hypothesize that MRI in PM/ICD patients is critical to an existing diagnosis and often markedly alters diagnosis and subsequent downstream patient management. Methods: An MRI Device exam (GE 1.5T,WI) pioneered by cardiologists (&gt;90% over 10 yrs; 100% over 20 years) was performed. Subsequently, a series of prospective defining questions using Boolean Logic Construct were answered within 1 week of MRI by both MRI technologist and MRI physicians. Questions : 1) Did the primary diagnosis change? 2) Did the MRI provide additional information to existing diagnosis? 3) Was the pre-MRI (tentative) diagnosis confirmed? 4) Did subsequent patient management change? If 'Yes' was answered to any of the above questions, it was considered that MRI was of value to pt diagnosis and/or impending therapy. Results: Average MRI: 25±14min for 2,008 consecutive patients of which 1,526 (76%) were neuro/neurosurgery, 141 (7%) were musculoskeletal and 341(17%) were CV cases. Upon review: of the N euro/neurosurgery MRIs, 1,376 (89%) provided additional information. The diagnosis changed in 1018 (74%), while medical therapy changed in 977 (71%). In only 124 (9%) did MRI simply confirm original diagnosis. For Cardiac patients, MRI changed the original diagnosis in 235 (69%). MRI did not contribute in 42 (12%) as it was uninterpretable (ICD artifact), while in 64 pts, the diagnosis did not change. Finally, in 146 Orthopedic pts, MRI provided additional information in 143 (98%) and in 130 (89%), changed pt care, and in 4 pts (3%), simply confirmed the diagnosis. Importantly, with careful attention to device reprogramming and scanner sequences, no safety or device issues were encountered in any patient all with tracking for &gt;1 year. Conclusion: Via a dedicated program of MRI in PM/ICD patients adds substantial clinical value to diagnosis and subsequent management justifying ant inherent risk(s). Herein, we propose that yet another impediment to the advancement of CMR-PM/ICD strategies can become routine and often life-changing.