Background In patients with conventional pacemakers or ICD's, MRI is infrequently performed due to safety concerns. Recent reports have allayed many of these concerns. However, the additive clinical value of scanning patients with cardiac implants has not been established. Objective Assessing the additive value of thoracic and non-thoracic MRI in patients with implantable cardiac devices. Methods and results Prospective data were analyzed in 500 patients with implanted cardiac devices that underwent MRI over a 12 year period at a single institution (Allegheny General Hospital, Pittsburgh, PA). A set of three questions were answered following scan interpretation by both the MRI technologist and interpreting MRI physician(s): 1) Did the primary diagnosis change? 2) Did MRI provide additional information to the existing diagnosis? 3) Did patient management change? If 'Yes' was answered to any of the above questions, it was considered that the MRI scan was of value to patient diagnosis and/or guiding therapy. Scans encountered were neurological/neurosurgical 354 (70.8%), cardiac 98 (19.6%) and orthopedic 48 (9.6%) in nature. In 431 (86%) MRI added additional information to the primary diagnosis and in 277 (55.4%) MRI changed the primary diagnosis. In 304 (60.8%) cases management changed, 265 (53%) due to a change in diagnosis and in 39 (7.8%) due to providing additional information. No safety issues were encountered and no adverse effects of MRI scan were noted. Conclusions MRI in patients with implanted cardiac devices was of additive value to diagnosis and management thereby informing risk-benefit considerations. Condensed abstract 500 patients with implanted cardiac devices who underwent a MRI examination over a 12 year period were followed prospectively. Imaging primarily focus on three anatomical regions (neurological/neurosurgical, cardiac and orthopedic) providing added information to the primary diagnosis in 431 (86%) cases and changing the primary diagnosis in 277 (55.4%) cases. In 304 (60.8%) cases management changed with 265 (53%) being due to a change of diagnosis and in 39 (7.8%) due to providing additional information. No safety issues were encountered using a defined protocol. Conclusions: MR imaging retains its diagnostic yield in patients with implanted devices.

MRI is infrequently performed on patients with conventional pacemakers and ICDs. While many studies have documented MRI safety, the clinical value has not been considered. Yet, the recent CMS-NCD supported more widespread considerations. We propose that MRI in pts with a PM/ICD is crucial to the

Introduction: While many studies have unequivocally demonstrated MRI safety in pts with thoracic devices, the clinical value is rarely considered. Yet, recent CMS-NCD supports more widespread considerations providing a unique opportunity for improved care. Hypothesis: We propose that MRI in pts with PM/ICDs are crucial to existing diagnosis and often substantially alters diagnosis and subsequent care. Methods: An evaluation of 1145 PM/ICDs pts who underwent MRI (GE 1.5T,WI) over 12 yrs (95% <5yrs) was performed. The devices consisted of 665 PMs, 418 ICDs, 30 retained leads and 18 Loop/Linqs (some pts >1). Specific criteria were followed to objectively determine if MRI diagnosis altered pt care. Accordingly, 4 Boolean Logic Construct questions were posed within 1 week of MRI by technologist/MD: 1) Did primary diagnosis change? 2) Did MRI provide additional diagnoses? 3) Was pre-MRI (tentative) diagnosis confirmed? 4) Did pt care change? If 'Yes' was answered to any question, MRI was considered of value to pt diagnosis and/or impending therapy. Result: Avg MRI: 34±21min. In 1145 pts: 819 (72%) were neuro/neurosurgery (NS), 110 (10%) were musculoskeletal (MK) and 216 (19%) were cardiac (CV) pts. On review, NS-MRI's, 669 (87%) provided additional information. The diagnoses changed in 553 (73%) and medical therapy changed in 536 (70%). In only 73(10%) did MRI simply confirm original diagnosis. In 216 CV cases, MRI provided additional data. In 178 pts (82%), MRI changed the original diagnosis and in 138 (64%), pt care. MRI was uninterpretable in 29 (11%; ICD artifact) while in 41 (19%) pts there was no diagnostic change. In essence, 174 (81%) of the CV cases benefited by MRI. Finally, in 110 MK cases, MRI provided additional data in 103 (96%), in 95 (88%) changed pt care and in 1 pt simply confirmed the diagnosis. Importantly, with careful attention to device reprogramming and scanner sequences, no safety/device issues occured. Conclusion: In 1145 pts with devices, MRI adds substantial clinical value to diagnosis and subsequent management justifying any residual risk. We believe, this is the largest study to focus solely on diagnostic value and efficacy under the assumption that safety can be routinely accomplished; a new paradigm in the error of a generation of non-CIED devices.

MRI is infrequently performed on pts with conventional PM/ICDs. While many studies have unequivocally documented safety, the clinical value has not been considered. We propose that MRI in pts with PM/ICDs is crucial to the existing diagnosis and many times, substantially alters the diagnosis and

Introduction: MRI is infrequently performed on patients with conventional pacemakers/ICDs. While many studies have unequivocally documented MRI safety in pts with implanted devices, the clinical va...

Today, MRI is infrequently performed in pts with conventional PM/lCDs. While MagnaSafe, published in NEJM for non-thoracic MRI, unequivocally documented safety, the clinical value remains unconsidered. A myopic, potentially prohibitive, focus on safety continues. MRI in PM/lCDs pts is crucial to

Introduction: MRI is infrequently performed in patients with conventional PM/ICD’s. While recent studies such as MagnaSafe have unequivocally documented MRI safety in those with implanted devices, ...

OBJECTIVES:The objective of this study was to assess the diagnostic usefulness of thoracic and nonthoracic magnetic resonance imaging (MRI) imaging in patients with implantable cardiac devices (permanent pacemaker or implantable cardioverter-defibrillators [ICDs]) to determine if there was a substantial benefit to patients with regard to diagnosis and/or management.BACKGROUND:MRI is infrequently performed on patients with conventional pacemakers or ICDs. Multiple studies have documented the safety of MRI scans in patients with implanted devices, yet the diagnostic value of this approach has not been established.METHODS:Evaluation data were acquired in 136 patients with implanted cardiac devices who underwent MRIs during a 10-year period at a single institution. Specific criteria were followed for all patients to objectively define if the diagnosis by MRI enhanced patient care; 4 questions were answered after scan interpretation by both MRI technologists and MRI physicians who performed the scan. 1) Did the primary diagnosis change? 2) Did the MRI provide additional information to the existing diagnosis? 3) Was the pre-MRI (tentative) diagnosis confirmed? 4) Did patient management change? If "Yes" was answered to any of the preceding questions, the MRI scan was considered to be of value to patient diagnosis and/or therapy.RESULTS:In 97% (n = 132) of patients, MR added value to patient diagnosis and management. In 49% (n = 67) of patients, MRI added additional valuable information to the primary diagnosis, and in 30% (n = 41) of patients, MRI changed the principle diagnosis and subsequent management of the patient. No safety issues were encountered, and no adverse effects of undergoing the MRI scan were noted in any patient.CONCLUSIONS:MRI in patients with implanted pacemakers and defibrillators added value to patient diagnosis and management, which justified the risk of the procedure.

Background: MRI is infrequently performed on patients with conventional pacemakers/ICD’s. While many studies have unequivocally documented MRI safety in pts with implanted devices, the clinical value has never been considered. Hypothesis: We propose that MRI in pts with a PM/ICD is crucial to the existing diagnosis and in many instances, substantially alters diagnosis and pt management. Methods: An evaluation of 250 consecutive pts with PM/ICD’s who underwent MRI (GE 1.5T,WI) over 10 yrs (95% <5 yrs) was performed. The devices consisted of 222 PM, 4 BiV PM while 150 had PM/ICD and 8 BiV ICD. Specific criteria were followed to objectively determine if the diagnosis via MRI altered pt care. Accordingly, four questions were answered within 1 week of MRI by both MRI technologist and MRI physician(s): 1) Did the primary diagnosis change? 2) Did MRI provide additional information to existing diagnosis? 3) Was the pre-MRI (tentative) diagnosis confirmed? 4) Did pt management change? If ’Yes’ was answered to any ...

Background: MRI is infrequently performed on patients with conventional pacemakers/ICD’s. Multiple recent studies and registries (MagnaSafe) have documented the safety of MRI in these patients, yet the diagnostic value of this approach has not been established remaining a critical issue to advance this field in an era of progressive MRI useage. Objective: 1) to examine a protocol to assess the diagnostic utility of thoracic and non-thoracic MRI in patients with implantable devices and 2) to determine if there is substantial benefit to the pt with regard to diagnosis and/or management. Methods: Over 8 years, 134 pts with PM/AICD’s underwent MRI (GE, 1.5T Milwaukee, WI) at a single institution. Specific criteria were followed for all pts to objectively define whether final diagnosis by MRI imaging enhanced patient care. A checklist of three questions was answered following scan interpretation by both the technologist and performing MRI physician(s):1) Did the primary diagnosis change? 2) Did the MRI provide additional information to the existing diagnosis? 3) Did patient management change? If ’Yes’ was answered to any of the above questions, it was considered that the MRI scan was of value to patient diagnosis and/or therapy. Results: All 134 pts underwent MRI/CMR without complications: avg scan time 24±9min including 42 pts with ICD’s, 5 pts with a retained lead and 87 non-MR conditional pacemakers. In 83% (n=112) MR added value to patient diagnosis and management. In 64% (n=86) MRI added additional valuable information to the primary diagnosis and in 19% (n=26) MRI was life-saving, changing the principal diagnosis and subsequent management of the pt. There were no deaths, arrhythmias or power-on-resets encountered and no adverse effects were noted in any pt. No post-procedure revisions or reimplantations of generator/lead were required. Conclusions: MR imaging in patients with implanted cardiac devices adds substantial value to patient diagnosis and management justifying the risk of the procedure. In this real-world patient population, we have shown that MR imaging retains its very high diagnostic yield. Risk-benefit ratios clearly justify the performance of MRI even in this higher risk population, that is, until such time as MR-conditional devices are universal.

Background Pacemaker/ AICD imaging is currently clincally performed in the MRI environment. A vigilant team consisting of Cardiologist, EP staff, and technologists with close patient monitoring and supervision has evolved this heretofore risky endeavor into a procedure with established safety if done properly. However, once safety is established, does such add valuable irrefutable information to merit that risk?

Background Pacemaker/AICD use may no longer be prohibitive in the MRI environment. Seminal work by us and others has pointed towards increasing safety and specifically, the marked additive clinical value. Historically, only extraordinarily high-risk patients with acute life-threatening diagnoses were imaged. However, over time, we began to note an interesting trend as our understanding, science and comfort level admixed with zero-event rate almost imperceptibly causes us to ‘relax’ the mandate for ‘acuity’. We wondered, “Has imaging a patient with a pacemaker that was once considered a last resort procedure started to evolve into a ‘routine’ study?

Background Pacemaker/AICD use may no longer be prohibitive in the MRI environment. Seminal work by us and others has pointed towards increasing safety and specifically, the marked additive clinical value. Historically, on only extraordinarily high-risk patients with acute diagnoses were imaged. However, over time, we began to note an interesting trend as our understanding, science and comfort level admixed with zero-event rate almost imperceptibly causes us to ‘relax’ the mandate for acuity. We wondered, “Has imaging a patient with a pacemaker that was once considered a last resort procedure started to evolve into a routine study? What have we learned from performing these procedures?

A 54-year-old male patient with bilateral metal-on-metal hip prosthesis and recently diagnosed cobalt toxicity presented with gradually worsening symptoms of heart failure. Serum cobalt (120 μg/l; normal <1 μg/l) and chromium (108.8 μg/l; normal <1.4 μg/l) levels were significantly elevated.

We propose that not only are Pacemakers/AICD's no longer forbidden in the MRI environment but they can be markedly efficient with lifealtering and life-saving consequences.