Affiliation:
Division of Cardiovascular Medicine, Vanderbilt University Medical
Center, Nashville, TN
Word Count: 1238
Number of Tables: 2
Funding: None
Disclosures: (None)
Magnetic resonance imaging (MRI) has become an indispensable diagnostic
tool across many fields of clinical medicine. Although reprogramming of
cardiac implantable electronic devices (CIEDs) for MRI is now routine at
most institutions, early experiences were notable for potential adverse
effects such as device-related heating, device or lead movement, and
device malfunction.1 The American Society for Testing
and Materials defines three categories of MRI safety (safe, conditional,
and unsafe), as shown in Table 1.2 Additionally, the
term ‘nonconditional’ was included in the 2017 Heart Rhythm Society
guidelines, which describes the up-to-date recommendations for CIEDs in
MRI.3 To date, the Food and Drug Administration (FDA)
has yet to declare a CIED as MR safe.2 The 2017 Heart
Rhythm Society Guidelines make a class I recommendation for MRI with MR
conditional systems in the context of a standardized institutional
workflow and a class IIa recommendation for MR nonconditional systems in
the absence of fractured, epicardial, or abandoned
leads.3 Furthermore, the guidelines suggest a
standardized institutional policy which includes a risk/benefit
assessment of MRI compared to alternate imaging modalities, protocols
for pre-scan and post-scan CIED evaluation, appropriate programming
during the scan based on device and patient characteristics, and
procedures in the event of an adverse clinical event.3
At our institution, the standardized protocol for any MRI includes a
“checklist” that includes the presence or absence of a CIED. Once a
CIED is identified, the system is identified as MR conditional or MR
nonconditional with a concurrent effort to identify fractured,
epicardial, or abandoned leads. If a clinical decision is made to
proceed with MRI, pacing dependence is then determined. An asynchronous
pacing mode (VOO/DOO) is chosen if the patient is pacing-dependent and
sensing-only (OVO/ODO) mode is chosen if non-dependent. An inhibiting
(VVI/DDI) mode can also be chosen if the patient is non-dependent.
However, our preference has been to avoid this mode due to the risk of
inappropriate sensing, which has been previously
described.4 Asynchronous pacing rates are programmed
faster than the underlying rate to avoid competitive pacing. Lastly,
tachycardia detections and therapies are programmed off. The programming
changes are prescribed by the Arrhythmia Section and typically performed
by a field services representative from the individual CIED
manufacturer. Qualified personnel trained in ACLS and an external
defibrillator are readily available in the case of an adverse clinical
event. At the completion of the MRI, the patient’s CIED is checked for
stability of device and lead parameters and subsequently reprogrammed to
pre-MRI settings. Most institutions adhere to similar protocols, with a
relatively low adverse event rate.1
In this issue of the Journal of Cardiovascular Electrophysiology ,
Siddamsetti et al.5 present a novel approach to
programming CIEDs for MRI. The paper describes and analyzes a local
protocol for remote reprogramming of MR conditional Medtronic
(Minneapolis, MN, USA) CIEDs for MRI by a Medtronic field services
representative. In this single-center, observational study conducted
over a course of 20 months, 209 consecutive patients requiring an MRI
underwent remote reprogramming of their CIED. Interestingly, the primary
in-person procedural interaction at the time of reprogramming was
performed by the on-site MRI technician with the Medtronic 2090
programmer while the programming was performed by an off-site field
services representative from the device manufacturer. Remote control of
the Medtronic 2090 programmer was established following access code
verification. CIEDs were programmed to a pre-specified MR safe mode
using the Medtronic MRI SureScanTM system. At the end
of the MRI scan, the device was reprogrammed to the patient’s baseline
settings with a final report uploaded to the electronic medical record.
The protocol resulted in no connectivity or programming errors and no
CIED malfunction for the duration of the observation period.
Furthermore, the MRI was completed in a safe and timely manner with no
requirement of in-person reprogramming. On average, the time saved per
scan, which was attributed to the field service representative’s travel
time, was nearly 30 minutes.
MRI is increasingly becoming the standard imaging modality for
diagnostic purposes due to its desirable spatial resolution, tissue
characterization, and absence of ionizing radiation. Given these
factors, it is predicted that 75% of patients with a CIED will need an
MRI during their lifetime.2 With improvement in safety
protocols, MRI in patients with CIEDs with either conditional or
nonconditional systems is considered safe.1-4 However,
with improvements in remote monitoring capabilities for CIEDs, there has
been a recent desire to expand into remote programming (Table 2). The
six primary CIED companies each have a remote monitoring platform.
However, Medtronic is the only manufacturer that can offer remote
programming. With a growing desire for remote programming capabilities,
other CIED manufacturers will likely create similar platforms.
In the background of the COVID-19 era and a desire to reduce provider
risk for exposure, several recent studies described using the Medtronic
RemoteControlTM system to program CIEDs upon
implant6 or during follow-up interactions, such as
pre- and post-MR.5,7 The programming platform is
currently employed only via the Medtronic 2090 programmer with
RemoteControlTM and is an FDA-approved technology that
allows for remote operation of the bedside programmer in
real-time.5-7 The RemoteControlTMsoftware has embedded security features to authenticate and protect the
connection for remote programming and has been successful in delivering
successful programming in an expeditious, safe, and reliable
manner.5-7
Unfortunately, remote programming platforms will present new security
risks. CIED monitoring and programming has been threatened by
cybersecurity breaches and large scale ‘remote hacking’ continues to be
a primary concern for each of the major CIED
manufacturers.8-13 With continued software and
hardware updates, CIED manufacturers have been able to prevent any
significant breaches to remote technologies to date.12,
13 Remote technologies for CIED have proven to be a safe way to monitor
battery status, lead integrity, and device function while allowing for
patient safety, economy, and convenience.14 In
addition, they have provided an alert for patient-specific conditions
allowing for avoidance of adverse patient events.15
At this time, the unidirectional capability of remote home monitoring
prevents any significant changes to programmable features of CIEDs, with
the exception of arrhythmia detection parameters for implantable cardiac
monitors. In contrast, remote programming via the Medtronic
RemoteControlTM system requires both the hardware
(Medtronic 2090 programmer) and software (BomgarTMand/or CareLinkTM) to allow for changes to programming
parameters, and in this manner provides an additional layer of security.
For the foreseeable future, remote programming will continue to require
the patient to be in the presence of a dedicated hardware programmer,
and rightly so. Any effort to decouple the specialty hardware from the
process would carry a risk of malicious hacking that could have
catastrophic consequences for a large, vulnerable population. Even if
the likelihood of such an event were low, the potential impact would be
catastrophic given the number of patients that could be simultaneously
affected.
Siddamsetti et al.5 present a protocol for remote
programming that is likely to be generally adopted with progressive
innovations in remote capabilities for CIEDs. Following the significant
improvements in remote monitoring over the last two
decades15, remote programming offers a new phase for
CIED companies to deliver expeditious and effective care. The recent
COVID-19 pandemic has accelerated a transition toward remote and
telehealth capabilities more broadly, with a high level of safety and
effectiveness. Although concerns continue to remain regarding
cybersecurity features related to the platform, Siddamsetti et
al.5 have demonstrated that remote programming of
CIEDs for MRI can be completed in an expeditious and efficacious manner.