A Single Institution Registry Trial Evaluating the Safety of MRI for Patients With Non-MRI Conditional Pacemakers and ICD
Conditions: MRI Scans, Magnetic Resonance Imaging, Pacemaker, Implantable Cardioverter Defibrillator
Sponsor: Lancaster General Hospital

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A Single Institution Registry Trial Evaluating the Safety of MRI for Patients with  
Non-MRI Conditional Pacemakers and ICD 
 
Principal Investigator:  Sandeep Bansal, MD 
 
Co-Investigators:  
Ron Jacob, M.D., Paul Leslie, M.D., R. Ward Pulliam, M.D., Melissa 
McKernan-Pulliam, M.D., Matthew A. Bernabei, M.D.,  Douglas C. Gohn, M.D. 
 
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). In these studies, investigators limited 
the MRI scans to magnets generating a field of 1.5 Tesla. Initially, the specific absorption rate (SAR) was 
limited to ≤ 2.0 W/kg, but as investigators found no association between SAR and the device variables 
studied, that restriction was later removed (Nazaraian, 2011). 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 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).  
 
Registry Purpose 
 
This registry is a prospective single institution study of MRI examinations in patients with pacemakers or 
ICD’s who will undergo an MRI that is ordered for routine clinical care. The purpose of the registry is to 

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accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for 
patients with implantable devices. 
 
Registry data will add to existing data on the safety of MRI scans for patients with pacemakers and ICDs. 
This safety data may impact physicians’ diagnostic choices for this patient population. Patients with 
conditions for whom MRI is the best diagnostic modality but who have not been able to undergo MRI 
scanning may be able to do so through registry participation. The diagnostic information obtained from 
the scan may assist physicians’ treatment decisions and may ultimately affect patient outcomes.  
 
In addition, to our knowledge, previous registries of MRI’s in non-conditional cardiac devices have been 
limited to academic centers. This registry would be among the first to demonstrate the feasibility and 
safety of this approach in a community hospital setting. 
 
Study Methods 
 
The registry research involves acquiring and analyzing the data of device function and adverse events 
related to the MRI scan. 
 
The need for MRI will be determined on a case-by-case basis based on the patient’s medical history and 
treatment plan/goals, independent of the registry and research purposes. Only patients with implanted 
devices with orders for clinically indicated MRI scans will be considered for registry inclusion. Clinical 
review will be performed and the patient considered after determination that no other imaging modality 
would be appropriate.  
 
The appropriateness of the MRI study must be discussed, in person or via phone call, between a cardiac 
radiologist, as determined by Paul Leslie, M.D., and the requesting physician. The discussion should 
include consideration of alternative imaging modalities and diagnostic quality of MRI imaging of 
requested body region given implanted device(s).  The requesting physician is then responsible for 
discussing with the patient and/or their medical proxy the reasoning for the determination, based on the 
final decision made by a radiologist. 
 
All patients will be screened prior to enrollment. Any patient with any commercially available pacemaker 
or ICD system implanted after 2001 who meet all of the inclusion criteria and none of the exclusion 
criteria, and who require a medically-indicated MRI as described above will be eligible to enroll in the 
study. The presence/absence of capped/abandoned/epicardial leads/subcutaneous coil will be confirmed 
and documented by review of the most recent chest x-ray obtained.  The x-ray must post-date the most 
recent device/lead intervention, as determined by a review of the patient’s medical record. 
 
If an MRI procedure is deemed absolutely necessary, the MRI will be performed at the Lancaster 
General Hospital Lime Street MRI facility. MRI scan sequences, field intensity and field(s) of exposure 
will be selected to minimize risk to the patient while gaining needed diagnostic information for diagnosis 
or therapy management. 
 
The MRI will be performed with a 1.5 T scanner utilizing institutional protocols and the following settings: 
 
 
Normal operating mode 
 
SAR ≤ 2.0 W/kg per patient.  
 
Prior to the procedure, a pacemaker technologist or manufacturer clinical representative will interrogate 
the pacemaker or ICD and record the following parameters:  
 
 
Patient’s underlying rhythm 
 
Atrial and right/left ventricular pacing thresholds 
 
P-wave and R-wave amplitude 

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 
Lead impedance (atrial, ventricular, high voltage) 
 
Battery voltage 
 
Arrhythmia history 
 
Tachyarrhythmia therapy 
 
The following pacemaker/ICD parameters will be deactivated for the duration of the MRI:  
 
 
Magnet response (ICD) 
 
Rate response 
 
PVC response 
 
Noise reversion response 
 
Ventricular sense response 
 
Mode switching 
 
Tachycardia detection/therapies (ICD) 
 
EGM triggers 
 
Patients who are not pacemaker dependent will have their pacemaker/ICD programmed to AAI/VVI/DDI 
at 40 beats per minute for the duration of the MRI. Patients who are pacemaker dependent (pacing at 
programmed lower rate during the pre-scan interrogation) will have their pacemaker/ICD programmed to 
AOO/VOO/DOO at the programmed lower rate for the duration of the MRI. Emergency equipment, 
including a MRI compatible defibrillator and transcutaneous pacemaker, will be available throughout the 
procedure in the event of an adverse clinical event.  In addition to radiology staff, a pacemaker 
technologist or manufacturer clinical representative and an EP tech/RN with current ACLS will be present 
for the duration of the procedure. An EP physician/advanced practice provider (APP) must be 
immediately available (i.e., in the hospital) to provide medical intervention, such as placement of a 
temporary external pacemaker if required.  In the event that a code is called by the MRI staff, hospital 
protocol indicates that ER staff will respond to the code. 
 
Radiology staff and the electrophysiology (EP) technologist or nurse with current ACLS certification will 
monitor the following patient parameters at least every 5 minutes throughout the MRI scan: 
 
 
Heart rate 
 
Heart rhythm 
 
Non-invasive blood pressure 
 
Oxygen saturation 
 
Symptoms 
 
If any of the following adverse symptoms/events occur during the scan, the test will be immediately 
terminated: 
 
 
Burning/pulling sensation in device pocket/chest during MRI 
 
Potentially lethal/previously non-diagnosed arrhythmias during MRI 
 
Spontaneous and unanticipated pacing rate change 
 
SOB 
 
Chest pain 
 
Feeling of heat/pulling in the chest or device pocket 
 
The patient will be removed from the scanner to the holding area and the device interrogated and 
reprogrammed to original parameters or as indicated by interrogation. If needed, emergency treatment 
will be provided as per ACLS protocols or at the discretion of the monitoring physician. The following 
parameters will be compared to the pre-MRI results: 
 
 
Patient’s underlying rhythm 

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 
Atrial and right/left ventricular pacing thresholds 
 
P-wave and R-wave amplitude 
 
Lead impedance (atrial, ventricular, high voltage) 
 
Battery voltage 
 
All device-related adverse events/symptoms will be documented on the data collection form and reported 
to the IRB. The patient will remain in the MRI suite holding area until medically stable. The need for 
further treatment will be at the discretion of the monitoring physician. 
 
The EP physician/APP will review and compare the pre/post MRI device data prior to the patient’s 
discharge from the MRI suite. Following testing, the pacemaker or ICD will be reprogrammed to the pre-
procedure parameters. The need for device reprogramming related to the MRI scan will be based on the 
clinical judgment of the attending electrophysiologist. 
 
Follow-up 
 
Patients who do not experience a device-related adverse event will continue with their routine 
pacemaker/ICD follow-up. 
 
Patients who experience one or more device-related adverse events during the MRI will return 1-7 days 
post-MRI for follow-up pacemaker/ICD testing to confirm appropriate function.  At a minimum, device 
interrogation/testing will include:  
 
 
Atrial and right/left ventricular pacing thresholds 
 
P-wave and R-wave amplitude 
 
Lead impedance (atrial, ventricular, high voltage) 
 
Battery voltage 
 
The need for further follow-up will be determined by the physician based on testing results and clinical 
need. 
 
The results of the follow-up device interrogation, including whether MRI-related adverse events have 
resolved, will be documented and kept in the device chart and recorded in the Registry database. 
 
If the insurance provider does not cover the MRI and device checks, those costs may be the full 
responsibility of the patient. The patient will be informed of the status of the pre-authorization before 
scheduling the MRI. 
 
Inclusion Criteria 
 
1.  Patient has a non-MRI conditional permanently implanted pacemaker or ICD implanted after 2001 
2.  Patient has a strong clinical indication for MRI where MRI is the diagnostic modality of choice for 
specific disease state without acceptable alternative imaging technologies as determined by the 
ordering physician and a radiologist 
3.  Patient is at least 18 years of age 
4. Patient is willing and able to sign study informed consent and HIPAA authorization  
 
 
 
 

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Exclusion Criteria 
 
1.  Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, 
morbid obesity) 
2. Presence of capped/abandoned/epicardial leads or subcutaneous coil  
3.  Pregnancy  
4. Device generator at elective replacement interval 
5. Abdominal device implant 
 
Adverse Events 
 
For purposes of this registry, the following will be considered adverse events and will be reported to the 
IRB: 
 
 
Burning/pulling sensation in device pocket/chest during MRI 
 
Potentially lethal/previously non-diagnosed arrhythmias during MRI 
 
Spontaneous and unanticipated pacing rate change 
 
Power on reset  
 
Immediately post-MRI device parameter changes 
o Greater than 50 ohm change in atrial or ventricular (RV and/or LV) lead impedance   
o Greater than 5 ohm change in high voltage lead impedance 
o Greater than 50% decrease in atrial or ventricular (RV and/or LV) sensing threshold 
o Greater than or equal to a 1 volt increase in atrial or ventricular (RV and/or LV) pacing 
threshold  
 
MRI related device malfunction/failure 
 
Serious injury/death related to MRI device malfunction/failure 
 
Changes in vital signs or termination of the scan not related to the presence of a pacemaker or ICD (i.e., 
anxiety-related increase in heart rate/blood pressure, tachypnea/SOB, etc) will not be considered 
adverse events and will not be reported. 
 
All adverse events will be reported to the IRB in writing within 10 days of discovery.  Any death of a 
patient will be reported to the IRB within 24 hours of discovery by research staff. 
 
Sample Size 
 
All patients who meet all the inclusion criteria and none of the exclusion criteria and who are willing sign 
the Registry consent/HIPAA Authorization will be enrolled in this registry at Lancaster General Hospital. 
Registry enrollment will continue indefinitely and/or until CMS approval of the procedure.  
 
Any patient who signs the registry informed consent/HIPAA form but does not have an MRI will not be 
considered a registry participant (consented not enrolled). Patients who sign the research consent form 
and enter the MRI environment are considered enrolled, even if they do not successfully complete the 
scan. 
 
Qualifications of Site Investigator: 
 
Site investigators must be a board certified cardiac electrophysiologist or radiologist. The supervising 
physician/APP must be able to place and use a temporary external cardiac pacemaker. The facility must 
have the appropriate physicians and staff available for the insertion of an emergency temporary 
transvenous cardiac pacemaker if needed. 
 
 

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Data Collection 
 
Each patient’s pre procedure and post procedure device data, vital signs, and adverse events as 
described in the protocol will be reviewed by one of the study investigator cardiac electrophysiologists. 
Registry data will be entered into a secure research database (RedCap). Access to the registry data and 
patient information will be restricted to Lancaster Heart & Vascular Institute (LHVI) cardiology research 
staff and physicians. Hard copy data and source documents (data collection forms, informed consent and 
HIPAA authorization, device interrogation data) will be stored in secure files at the LHVI research office. 
 
Registry data will be reviewed and analyzed at least quarterly and after the first 25 patients have been 
scanned. Our data may ultimately expand the routine use of MRI to include this patient population. We 
will track the incidence of adverse events (as defined in this protocol), look for data trends (patient types 
that experience AEs, devices that are adversely affected and how, etc.) using the appropriate statistical 
testing and tools.  
 
We will also collect data on what alternative testing the ordering physician would have used, if any, 
instead of MRI, and how the use or non-use of MRI affected patient management. 
 
Data Monitoring Safety Plan 
 
The Internal Safety Committee 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. Neither Paul Leslie, M.D. 
or Sandeep Bansal, M.D. will be a member of the Safety Committee. 
 
The Safety Committee will meet every 6 months to review study data and all adverse events as 
described in the Registry protocol. If the committee identifies a safety issue, enrollment may be 
suspended until the issue has been satisfactorily resolved. 
 
Consent Process 
 
Potential registry participants will be identified as described in the protocol. All registry participants must 
meet all of the inclusion criteria and none of the exclusion criteria. Informed consent will be obtained by 
one of the investigators or his/her designee from the study team. A copy of the signed informed consent 
and HIPAA Authorization will be scanned into the patient’s permanent medical record in EPIC. 
 
Risks of Study Participation    
 
There are no known significant risks associated the exposure to electromagnetic fields from MRI scans. 
However, patients may be unable to tolerate the confined space of the MRI unit. This can lead to: 
 
Claustrophobia (fear of enclosed spaces) 
 
Mild diaphoresis (sweating) 
 
Hearing impairment (difficulty hearing) 
 
Sensation of bodily warmth 
 
Body stiffness related to immobility 
 
Pacemakers and ICDs have historically been a contraindication for MRI, due to the potential for tissue 
heating where the lead is in contact with the heart tissue, the effect of electromagnetic fields on device 

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function (change of pacing mode or not sensing or treating abnormal rhythms), and the potential for 
mechanical malfunction. However, several recent large clinical trials have demonstrated that MRI can be 
safe for patients with non-MRI conditional pacemakers or ICDs when protocols are in place and adhered 
to.  
 
The potential risks associated with the use of MRI with a non-MRI conditional pacemaker or ICD include, 
but may not be limited to, the following: 
 
 
Movement and or vibration of the device generator and/or leads 
 
Lead electrode (the metal end of the lead) heating with heart muscle damage resulting in loss of 
sensing or capture or both 
 
Device heating resulting in discomfort and/or tissue damage  
 
Life-threatening arrhythmias (ventricular tachycardia, ventricular fibrillation) T 
 
Other arrhythmias (atrial fibrillation, atrial flutter, bradycardia, SVT) 
 
Failure of the device to pace the heart  
 
Change in pacemaker or ICD function, including changes in mode, rate or output 
 
Inability to detect or treat abnormal heart rhythms  
 
Delivery of ICD therapy when it is not needed 
 
Need for device reprogramming ) 
 
Need for a new device 
 
There may be additional risks associated with study participation that are unknown at this time. 
 
Benefits of Study Participation 
 
There may be benefit from study participation due to the use of a standardized MRI protocol designed to 
minimize the risks associated with MRI use in the presence of a non-MRI conditional pacemaker or ICD. 
This may include the diagnostic benefit of the MRI itself, which is the diagnostic exam of choice for 
several disease entities. Study participation may also lead to a generally accepted protocol for MRI for 
patients with a non-MRI conditional pacemaker or ICD. Alternatively, there may be no benefit of study 
participation. 
  
Study Results 
 
The study investigators and research staff will analyze data at least quarterly. Results will be reported to 
the IRB at least every six months and to CMS quarterly. At a minimum, the reports will include: 
 
 
The number of patients screened 
 
The number of patients scanned 
 
The device models scanned 
 
Incidence and description of adverse events (as described above). Adverse events will also be 
reported to the IRB as they occur (see above)  
 
Patient outcomes 
Registry results will be submitted for publication to one or more peer reviewed journals and may also be 
presented internally to physicians and other stakeholders who care for the defined study population. 
Results will also be reported on the ClinicalTrials.gov website on at least an annual basis. 
 
 
 
 
 

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Appendix A: Study Algorithm 
 
 
 
                                                                                                                                                                                        
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
PPG/ICD implanted after 2001? 
YES 
NO 
YES 
 
 
 
Proceed with alternate 
testing 
 
Abandoned/capped transvenous passive fixation or epicardial 
leads and/or subcutaneous coil in place? 
NO 
1)  PPG/ICD Programming during MRI  
Non-pacemaker dependent AAI/VVI/DDI @ 40 bpm  
Pacemaker dependent AOO/VOO/DOO at programmed 
lower rate  
2)  Deactivate: 
Magnet response (ICD)  
PVC option 
Noise reversion algorithm  
Ventricular sense response 
Mode switching 
Tachycardia detection/therapies (ICD) 
Call 45151 to schedule MRI 
Lime Street facility 
0800-1400 
Prior to MRI interrogate PPG/ICD and record: 
Underlying rhythm 
Atrial (A) and ventricular (V) pacing threshold 
P/R wave amplitude 
A, V, High Voltage (HV) lead impedances 
Battery voltage 
Adverse Event? 
Potentially lethal and/or previously undiagnosed arrhythmia 
Sensation of heat/pulling in chest or device pocket 
Spontaneous device programming changes during MRI 
o Power on reset   
o Pacing rate change 
Immediately post-MRI device parameter changes 
o Greater than 50 ohm change in atrial or ventricular (RV and/or LV) lead 
impedance   
o Greater than 5 ohm change in high voltage lead impedance 
o Greater than 50% decrease in atrial or ventricular (RV and/or LV) sensing 
threshold 
o Greater than or equal to a 1 volt increase in atrial or ventricular (RV 
and/or LV) pacing threshold 
MRI related device malfunction/failure 
Serious injury/death related to MRI device malfunction/failure 
Monitor VS at least Q 5 minutes throughout MRI  
HR 
ECG 
NIBP 
O2 sat 
Signs/symptoms  
1)  STOP MRI immediately 
2)  Remove patient from scanner 
3)  Provide emergency treatment as needed 
4)  Interrogate PPG/ICD and record  
Underlying rhythm 
A & V pacing threshold 
P/R wave amplitude 
A, V, HV lead impedance 
Battery voltage 
5)  Compare data with pre-MRI values. 
6)  Reprogram to original PPG/ICD parameters or as 
indicated by testing 
7)  Re-interrogate & test PPG/ICD in 1-7 days 
8)  Schedule additional follow-up as clinically indicated   
      and physician discretion. 
1) Interrogate PPG/ICD and record  
Underlying rhythm 
A & V pacing threshold 
P/R wave amplitude 
A, V, HV lead impedance 
Battery voltage.  
2)  Compare with pre-MRI values. 
3)  Re-program original PPG/ICD parameters 
4)  Patient resumes normal follow-up schedule 
NO 
YES 

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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. 
 
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Ferriera, A., Costa, F., et al. (2014). MRI-conditional pacemakers: current perspectives. Medical  
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Indik, JH, et. al. 2017 HRS expert consensus statement on magnetic resonance imaging and  
 
 
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Published May 11, 2017. 
 
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