Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads
Phase: NA
Conditions: Pacemaker Electrode Lead Fracture, ICD
Sponsor: Lancaster General Hospital

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Evaluating MRI Scanning in Patients with Fractured or Abandoned Endocardial Leads 
 
 
Principal Investigator: Sandeep Bansal, MD  
 
Background 
Millions of people in the United States and around the world have an implanted cardiac device. 
Between 1993 and 2009, overall pacemaker use increased by 50%, with 2.9 million permanent 
pacemakers implanted (Ferreira, et al, 2014). As of 2003, an estimated three million people met 
implant criteria for an implantable cardiac defibrillator (ICD) for either primary or secondary 
prevention (Nazarian, et al, 2006).  
It is further estimated that up to 75% of patients with a pacemaker or ICD will need medical 
magnetic resonance imaging (MRI) at some point following device implant (Nazarian, et al, 2006). 
Patients over 65 years of age comprise the majority of patients with implanted pacemakers or ICDs, 
and thus are extremely likely to require a MRI at some point after device implant.  
MRIs provide excellent spatial resolution and multi-plane 3-D analysis. MRI is particularly good for 
soft tissue imaging and is the preferred imaging method for many neurological and musculoskeletal 
conditions (Mollerus, Albin, Lipinski, & Lucca, 2008). In addition to its superior imaging 
characteristics, MRI does not expose patients to ionizing radiation.  
Pacemakers and ICDs have long been considered an absolute contraindication MRI due to concerns 
of the potential interactions between MRI and implantable cardiac devices including: 
 
• 
Tissue heating, especially at the lead tip/myocardial interface 
• 
Induction of ventricular arrhythmias such as ventricular tachycardia/fibrillation 
• 
Pacemaker reset 
• 
Reed switch closure, resulting in suspension of tachyarrhythmia detection/therapies 
• 
Inhibition of pacing 
• 
Increased pacing threshold/failure to capture 
• 
Damage to circuitry 
 
In recent years, however, several studies have concluded that MRI can be safe for patients with non-
MRI conditional pacemakers and/or ICDs (Nazarian, et al, 2006, 2011, 2017). In 2011, Nazarian et 
al. published the results of their study of patients with pacemakers (237) or ICDs (201) who 
underwent medically indicated MRI. The study indicated that MRI is safe for pacemaker and ICD 
patients when appropriate screening protocols are in place and followed, with no immediate or 

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long-term events requiring lead or system revision or reprogramming (Nazarian, et al., 2011). A 
2008 study determined that MRI scanning did not cause sufficient damage to the myocardium to 
produce a significant rise in troponin-I levels (Mollerus, Albin, Lipinski, & Lucca, 2008). In 2009, 
Mollerus et al also determined that device patients undergoing MRI did not have any increase in 
arrhythmic activity during the scan (Molerus, Albin, Lipinski, & Lucca, 2009). 
 
Previous MagnaSafe, Johns Hopkins, and Lancaster General Health (LGH) studies have shown that 
non-MRI-conditional cardiac implanted electronic device (CIED) patients without fractured or 
abandoned leads can safely be scanned with an MRI. The previous studies showed that accessibility 
to MRI allowed for diagnostic benefits in these patients that might not have been available with 
other imaging modalities. As a result of these studies, CMS changed restrictions for non-MRI 
conditional CIEDs in 2018. However, due to safety concerns and sparse data in the patient 
population with fractured or abandoned leads, these patients remain excluded from the current 
CMS coverage determination. These continued restrictions on MRI availability for patients with 
non-functional leads prevents accessibility to this important imaging technology and its potential 
impact on clinical management. In addition, physicians may alter management of these patients to 
avoid abandoning leads, often by choosing potentially dangerous lead extraction procedures, 
simply to allow for future MRIs.  
 
Data from the Mayo Clinic in which 90 MRI scans were performed on 80 patients with fractured or 
abandoned leads demonstrated no clinical adverse events, and no biochemical evidence of 
myocardial damage (Padmanabhan et al., 2017). The Hospital of the University of Pennsylvania 
similarly conducted 34 MRI scans on patients with fractured or abandoned leads, resulting in no 
clinical adverse events (Brunket at al., 2001). These studies suggest that MRI can be performed in 
this population with low risk and with the potential for significant clinical benefit. However, in 
addition to excluding these patients from its coverage determination, CMS also removed the option 
for centers to be reimbursed for such MRIs if conducted in research studies, thereby increasing the 
cost of any further research and decreasing its likelihood. 
 
A recent editorial in JAMA Cardiology (Kramer et al., 2018) decries the restrictions in the CMS 
coverage determination and concludes that a large multi-center study should be conducted. The 
study aims to collect data to demonstrate the safety of MRI. 
 
Objectives 
The primary aim of this study is to determine if MRIs can be safely performed in patients with 
abandoned or fractured leads.  
The secondary aim of this study is to assess the impact of MRI availability by surveying ordering 
physicians about the impact of MRI availability on patient care, in the population of patients 
excluded from current CMS reimbursement for MRI due to device lead characteristics. 
 
The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with 
fractured or abandoned endocardial leads. Specifically, the investigators aim to provide 
community-acquired data that can be used in Medicare and Medicaid coverage determinations and 
to investigate whether patients with fractured or abandoned leads can safely be scanned using an 
MRI and to evaluate the impact of MRI availability on patient care in this population. This study also 
aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of 

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Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient 
population.   
 
Methods 
This study is a prospective descriptive single-site study that will take place at Lancaster General 
Hospital.  
 
Inclusion:  
• 
Patients implanted with an ICD or pacemaker with an abandoned or non-functional 
endocardial lead, and who have a clinical need for MR imaging  
• 
Patients are English or Spanish speaking and able to review and sign the consent 
 
Exclusion:  
• 
Patients who meet current CMS approved indications for MRI with cardiac implanted 
electronic device 
• 
Patients who complete the MRI standard screening form and are deemed inappropriate 
for MRI for any reason other than abandoned or fractured endocardial, or epicardial 
lead.  
• 
Patients less than 18 years of age 
 
Any patients with fractured or abandoned endocardial leads with or without a pacemaker or ICD 
implanted after 2001 who meet the all of the inclusion and none of the exclusion criteria and who 
require a medically indicated MRI will be eligible to enroll in the study. MRI scans will be performed 
utilizing institutional protocols and appropriate settings for the patient population. The EP 
physician/Advanced Practice Provider will monitor participant heart rhythms and symptoms 
during, before, and after the MRI scan. The ordering physician will be surveyed to assess how the 
availability of MRI impacted patient care. We propose to screen 60 but enroll 30 participants at the 
site over a period of 2 years.  
 
All studies will be done in the existing MRI units at the MRI Group. MRI scan sequences, field 
intensity and fields of exposure will be given no special consideration given the presence of the 
pacemaker or ICD. ECG monitoring pads will be placed on the participants for the duration of the 
study. An external defibrillator and ACLS drugs will be on hand. Heart rate, heart rhythm, blood 
pressure, O2 saturation will also be monitored non-invasively throughout the study by a doctor, 
registered nurse, or technician trained in devices and ACLS. Symptoms will be assessed during and 
after completion of the MRI. 
All devices will undergo a complete interrogation and testing prior to imaging and following 
imaging. Parameters such as atrial and ventricular pacing thresholds, R and P wave amplitudes, 
lead impedance, and battery status will be measured and recorded. PPMs will be programmed to an 
asynchronous mode if dependent and to an inhibited mode in participants without pacemaker 
dependence, as per current protocols for MRI with cardiac implanted electronic devices.  

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After the appropriate MRI protocol for each MRI participant is completed, the device will be re-
programmed to its original settings and completely interrogated and retested to detect any changes 
in device performance. 
 
All MRI’s are clinically indicated and therefore standard of care. The participants’ participation in 
the study will terminate when they complete the MRI and device check. 
 
Participants or their insurance companies will be responsible for the cost of the MRI. 
 
Participant information that will be collected includes name, medical record number, name of 
ordering physician, device data and any symptoms experienced during MRI.  
 
Data Collection and Management 
Data collection is under the supervision of the PI. Data will be managed by the Research Institute.  
All study relevant data will be entered into REDCap (Harris, 2009), a 21 CFR Part 11-compliant data 
capture system provided and maintained by the Research Institute.   
 
Data Monitoring Safety Plan 
The Data Safety Monitoring Board (DSMB) for this Registry will be comprised of three individuals 
who work at LGH, and will include a statistician, a radiologist specializing in MRI procedures, and 
an EP cardiologist or other technical staff familiar with cardiac device parameters and 
programming. Sandeep Bansal, M.D. will not be a member of the DSMB but may attend the 
meetings. 
 
The DSMB will meet quarterly to review study data and all adverse events as described in the 
Registry protocol. If the DSMB identifies a safety issue, enrollment may be suspended until the issue 
has been satisfactorily resolved.  
 
Privacy and Confidentiality Considerations 
The REDCap data system includes password protection, dual authentication sign-on, and internal 
quality checks, such as automatic range checks to identify data that appear inconsistent, incomplete 
or inaccurate.  Identifiers will be excluded in any reports that are exported from the secure data 
capture system. Information about study participants will be kept confidential and managed 
according to the requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Study documents will be retained for 6 years.  No records will be destroyed prior to that 
time. 
 
Potential Risks and Reporting of Adverse Events Involving Risks 
The primary risks are symptoms, arrhythmias, myocardial damage and data breach. All participants 
will undergo a device check and will be monitored during the MRI for adverse events, new or 
worsening symptoms. All participant data will be stored in a secure database created within 
REDCap, a HIPAA compliant data storage system.  Any participant identifiers will be destroyed after 
the study is completed. Any potential breach of confidentiality would be reported to the respective 

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participants who were at risk, in addition to the applicable HIPAA privacy officer, the IRB and the 
HRPP.  
 
Potential Benefits 
The direct benefit to those participating in the study is the opportunity to receive an MRI which 
would otherwise not be available, and which may facilitate and guide clinical care.  Indirect benefits 
to society may result from knowledge gained in this study.  
 
Risk/Benefit Ratio 
The potential benefits and knowledge to be gained by this study outweigh the potential risks to 
participants involved in this research study. 
 
Informed Consent and HIPAA 
Consent forms describing in detail the study intervention, study procedures and risks will be given 
to the participants and written documentation of informed consent is required prior to starting the 
intervention. The following consent materials will be submitted with this protocol: consent form 
with combined HIPAA authorization and advanced beneficiary notice.  
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will 
explain the research study to the participant and answer any questions that may arise. A verbal 
explanation will be provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask 
questions prior to signing. The participants should have the opportunity to discuss the study with 
their family or surrogates or think about it prior to agreeing to participate. The participant will sign 
the informed consent document prior to any procedures being done specifically for the study. 
Participants must be informed that participation is voluntary and that they may withdraw from the 
study at any time, without prejudice. A copy of the informed consent document will be given to the 
participants for their records. The informed consent process will be conducted and documented in 
the source document (including the date), and the form signed, before the participant undergoes 
any study-specific procedures. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this study. 
 
Sponsorship 
This study not funded. 
 
Conflict of Interest 
All Investigators will follow the Penn Medicine Lancaster General Health Policy on Conflicts of 
Interest Related to Research.  
 

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Publication Plan 
After completion of the study and analysis of the data, a manuscript for publication may be written 
with the principal investigator as lead author.  The manuscript will be targeted for publication in a 
clinical journal.   
References 
IRB application for Safety and Clinically Indicated Magnetic Resonance Imaging in Patients with 
Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICDs). Courtesy of Henry 
Halperin, MD, MA, Johns Hopkins Hospital, Baltimore, MD. 
 
Johns Hopkins Research Participant Informed Consent  and Privacy Authorization Form for the 
clinical trial Safety and Clinically Indicated Magnetic Resonance Imaging in Patients with 
Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICDs). Courtesy of Henry 
Halperin, MD, MA. Johns Hopkins Hospital, Baltimore, MD. 
 
Molerus, M., Albin, G., Lipinski, M., & Lucca, J. (2009). Ectopy in Patients with Permanent 
Pacemakers and Implantable Cardioverter-Defibrillators Undergoing MRI Scan. PACE, 772-778. 
 
Nazarian, S., Hansford, R., Roguiin, A., Goldsher, D., Zviman, M., Lardo, A., and Halperin, H. (2011). A 
prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted 
cardiac devices. Annals of Internal Medicine, 415-424. 
 
Nazarian, S., Roguin, A., et al. (2006). Clinical utility and safety of a protocol for noncardiac and 
cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable 
cardioverer defibrillators at 1.5 tesla. Circulation, 1277-1284. 
 
Nazarian, S, Beinart, R, & Halperin, HR. Magnetic resonance Imaging and implantable  
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Ferriera, A., Costa, F., et al. (2014). MRI-conditional pacemakers: current perspectives. Medical  
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Russo, RJ, et al (2017). Assessing the risks associated with MRI in patients with a pacemaker or 
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Padmanabhan D, Kella DK, Mehta R, et al. Safety of magnetic resonance imaging in patients with 
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Kramer DB, Lo B, Russo RJ. Implication of Medicare Coverage for magnetic Resonance Imaging in 
Patients With Capped or Epicardial Leads. JAMA Cardiology 2018;3(12):1139-40. 
 
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(MRI) (CAG-00399R4). https://www.cms.gov/medicare-coverage-database/details/nca-decision-
memo.aspx?NCAId=289. Accessed October 18, 2018