Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 9 - 100 |
| Updated: | 2/8/2019 |
| Start Date: | December 2015 |
| End Date: | February 2021 |
An Expanded Evaluation of the Safety of Clinically Indicated Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter
Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic
Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has
been established in patients with pacemakers or ICD's but only in patients in whom strict
vetting procedures were implemented. These vetting procedures were initially developed to
eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over
recent years however, objective scientific evidence has failed to support this concern
raising the question as to whether or not these vetting procedures are necessary.
Investigators hypothesize that in view of the existing objective scientific data, evolution
of device technology and the fact that the investigators have scanned more than 2,000 devices
safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously
excluded from MRI protocols can be safely scanned without prior vetting.
This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an
implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike
previous studies where strict vetting procedures were implemented pre-procedure, All patients
with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the
study provided participants meet standard MRI inclusion/exclusion safety criteria.
Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic
Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has
been established in patients with pacemakers or ICD's but only in patients in whom strict
vetting procedures were implemented. These vetting procedures were initially developed to
eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over
recent years however, objective scientific evidence has failed to support this concern
raising the question as to whether or not these vetting procedures are necessary.
Investigators hypothesize that in view of the existing objective scientific data, evolution
of device technology and the fact that the investigators have scanned more than 2,000 devices
safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously
excluded from MRI protocols can be safely scanned without prior vetting.
This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an
implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike
previous studies where strict vetting procedures were implemented pre-procedure, All patients
with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the
study provided participants meet standard MRI inclusion/exclusion safety criteria.
Pilot studies of approximately 1500 patients, RPN #03-08-12-11 and 00051707 (manuscript
submitted) demonstrated the safety of most contemporary implanted rhythm management devices
in the MRI environment given appropriate precautions.
When pilot studies were developed, there was a theoretical concern that there may be an
increased risk associated with some device and device circumstances including: 1) PPM's or
leads implanted prior to 1996; 2) ICD's implanted prior to 2000; 3) abandoned or endocardial
leads; 4) leads implanted <6 weeks; 5) ICD's where patient is pacemaker dependent.
While it was reasonable to be hyper vigilant when initiating pilot studies by including
restrictive inclusion criteria, the natural evolution of the devices and device related
technologies coupled with a lack of objective scientific data to support investigator's early
safety concerns has caused investigators to reevaluate their necessity. For example, older
pacemakers and ICD's that previously excluded potential participants are now obsolete; all
have expired batteries and have been explanted. Similarly, the technological evolution of
ICD's includes ICD's that are now capable of providing ongoing asynchronous pacing including
in the MRI environment. Despite some concern that abandoned, epicardial and newly implanted
leads may be at increased risk of heating or subject to torque, when investigators evaluated
15 participants with these lead issues and exposed them to MRI (off protocol in life
threatening situations) there were no adverse problems seen.
The vetting procedures investigators implemented in pilot studies required that a registered
nurse obtain all patient device information and chest xrays (when indicated) from referring
physicians, review them in advance of allowing participants to schedule an MRI, and exclude
any patient who did not meet inclusion criteria. Investigators found that these procedures
were time consuming and expensive (as they required a part time Registered Nurse (RN)
salary). In addition, in some cases, patients who might have derived considerable benefit
from an MRI were excluded from obtaining one and the time it took to adhere to the vetting
procedures needlessly delayed the MRI in some participants, causing them unnecessary stress
and frustration and even adversely affecting their clinical care.
MRI's will be done in participants who require a clinically indicated MRI without
implementing the vetting procedures investigators included in pilot studies. Participants
with implanted pacemakers and ICD's will only be eligible for MRI at Johns Hopkins Hospital
(JHH) if they agree to participate in this study. All studies will be done in the 1.5 Tesla
MRI unit. Since the first 100 participants were scanned in investigator's initial protocol
03-08-11-12, MRI scan sequences, field intensity and fields of exposure have been given no
special consideration given the presence of the pacemaker or ICD and there have been no
adverse or unanticipated problems. For this reason, investigators do not feel it is necessary
to impose any special restrictions (related to field intensity or scan sequences/exposure) in
this protocol. In the event that any device manufacturer indicates the need for including
additional safety precautions investigators will amend the protocol immediately to include
them.
Electrocardiogram (ECG) monitoring pads will be placed on the patient for the duration of the
study. Heart rate, blood pressure, O2 saturation will be monitored non-invasively throughout
the study by a registered electrophysiology nurse who is Advanced Cardiac Life Support (ACLS
)certified, fully trained in cardiac device management and familiar with the research
protocol as well as the implications of scanning patients with cardiac devices. In addition
to the electrophysiology nurse, two fully certified MRI technologists familiar with scanning
participants with implanted devices will be present in the control room the entire time the
participant is scanned. The scanner is located in close proximity to the electrophysiology
laboratory where Electrophysiology physicians perform procedures, hence at all times at least
one, but typically more than one Electrophysiology physician who knows both the participant
and the MRI device procedure will be available. A Zoll external defibrillator with
transthoracic pacing capabilities, ACLS drugs and a fully equipped crash cart will be readily
available at all times in an area that is adjacent to the MRI control room.
Prior to the MRI, participants will be handed an alarm button and instructed to notify the
MRI technologist if for any reason he/she feels it is necessary and particularly in the event
that any unusual pains or sensations are experienced. Participants can be seen by the
technologist and the nurse who is monitoring the scan through a large window that separates
the scanner from the control room. In addition, the MRI technologist frequently initiates
conversation between sequences by asking the patient; "how are you".
All devices will undergo a complete interrogation and testing prior to imaging and following
imaging. PPMs will be programmed to an asynchronous mode if dependent and to an inhibited
mode in patients without pacemaker dependence.
The pacemaker function of ICD's in pacemaker independent patients will be programmed to
ventricular inhibited (VVI) mode at 50 bpm. Pacemaker dependent participants with ICD's who
were previously excluded from prior studies will no longer be excluded as ICD's are now
reliably capable of maintaining adequate pacing when programmed to an asynchronous pacing
mode..
After the appropriate MRI protocol for each MRI patient 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 a 1-6 week follow-up device
evaluation that will also be done as standard of care.
submitted) demonstrated the safety of most contemporary implanted rhythm management devices
in the MRI environment given appropriate precautions.
When pilot studies were developed, there was a theoretical concern that there may be an
increased risk associated with some device and device circumstances including: 1) PPM's or
leads implanted prior to 1996; 2) ICD's implanted prior to 2000; 3) abandoned or endocardial
leads; 4) leads implanted <6 weeks; 5) ICD's where patient is pacemaker dependent.
While it was reasonable to be hyper vigilant when initiating pilot studies by including
restrictive inclusion criteria, the natural evolution of the devices and device related
technologies coupled with a lack of objective scientific data to support investigator's early
safety concerns has caused investigators to reevaluate their necessity. For example, older
pacemakers and ICD's that previously excluded potential participants are now obsolete; all
have expired batteries and have been explanted. Similarly, the technological evolution of
ICD's includes ICD's that are now capable of providing ongoing asynchronous pacing including
in the MRI environment. Despite some concern that abandoned, epicardial and newly implanted
leads may be at increased risk of heating or subject to torque, when investigators evaluated
15 participants with these lead issues and exposed them to MRI (off protocol in life
threatening situations) there were no adverse problems seen.
The vetting procedures investigators implemented in pilot studies required that a registered
nurse obtain all patient device information and chest xrays (when indicated) from referring
physicians, review them in advance of allowing participants to schedule an MRI, and exclude
any patient who did not meet inclusion criteria. Investigators found that these procedures
were time consuming and expensive (as they required a part time Registered Nurse (RN)
salary). In addition, in some cases, patients who might have derived considerable benefit
from an MRI were excluded from obtaining one and the time it took to adhere to the vetting
procedures needlessly delayed the MRI in some participants, causing them unnecessary stress
and frustration and even adversely affecting their clinical care.
MRI's will be done in participants who require a clinically indicated MRI without
implementing the vetting procedures investigators included in pilot studies. Participants
with implanted pacemakers and ICD's will only be eligible for MRI at Johns Hopkins Hospital
(JHH) if they agree to participate in this study. All studies will be done in the 1.5 Tesla
MRI unit. Since the first 100 participants were scanned in investigator's initial protocol
03-08-11-12, MRI scan sequences, field intensity and fields of exposure have been given no
special consideration given the presence of the pacemaker or ICD and there have been no
adverse or unanticipated problems. For this reason, investigators do not feel it is necessary
to impose any special restrictions (related to field intensity or scan sequences/exposure) in
this protocol. In the event that any device manufacturer indicates the need for including
additional safety precautions investigators will amend the protocol immediately to include
them.
Electrocardiogram (ECG) monitoring pads will be placed on the patient for the duration of the
study. Heart rate, blood pressure, O2 saturation will be monitored non-invasively throughout
the study by a registered electrophysiology nurse who is Advanced Cardiac Life Support (ACLS
)certified, fully trained in cardiac device management and familiar with the research
protocol as well as the implications of scanning patients with cardiac devices. In addition
to the electrophysiology nurse, two fully certified MRI technologists familiar with scanning
participants with implanted devices will be present in the control room the entire time the
participant is scanned. The scanner is located in close proximity to the electrophysiology
laboratory where Electrophysiology physicians perform procedures, hence at all times at least
one, but typically more than one Electrophysiology physician who knows both the participant
and the MRI device procedure will be available. A Zoll external defibrillator with
transthoracic pacing capabilities, ACLS drugs and a fully equipped crash cart will be readily
available at all times in an area that is adjacent to the MRI control room.
Prior to the MRI, participants will be handed an alarm button and instructed to notify the
MRI technologist if for any reason he/she feels it is necessary and particularly in the event
that any unusual pains or sensations are experienced. Participants can be seen by the
technologist and the nurse who is monitoring the scan through a large window that separates
the scanner from the control room. In addition, the MRI technologist frequently initiates
conversation between sequences by asking the patient; "how are you".
All devices will undergo a complete interrogation and testing prior to imaging and following
imaging. PPMs will be programmed to an asynchronous mode if dependent and to an inhibited
mode in patients without pacemaker dependence.
The pacemaker function of ICD's in pacemaker independent patients will be programmed to
ventricular inhibited (VVI) mode at 50 bpm. Pacemaker dependent participants with ICD's who
were previously excluded from prior studies will no longer be excluded as ICD's are now
reliably capable of maintaining adequate pacing when programmed to an asynchronous pacing
mode..
After the appropriate MRI protocol for each MRI patient 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 a 1-6 week follow-up device
evaluation that will also be done as standard of care.
Inclusion Criteria:
- Patients implanted an ICD or pacemaker who have a clinical need for MR imaging
Exclusion Criteria:
- Patients who complete the MRI standard screening form and are deemed inappropriate for
MRI for any reason
We found this trial at
1
site
Click here to add this to my saved trials
