Patients With Cardiac Rhythm Management Devices

Patients With Cardiac Rhythm Management Devices

JACC: CLINICAL ELECTROPHYSIOLOGY VOL. ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION -, NO. -, 2017 ISSN 2405-500X/$36.00 PUBLISHED BY E...

108KB Sizes 0 Downloads 98 Views

JACC: CLINICAL ELECTROPHYSIOLOGY

VOL.

ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

-, NO. -, 2017

ISSN 2405-500X/$36.00

PUBLISHED BY ELSEVIER

http://dx.doi.org/10.1016/j.jacep.2017.06.013

EDITORIAL COMMENT

Patients With Cardiac Rhythm Management Devices How True Is the Need for Magnetic Resonance Imaging?* Theofanie Mela, MD

I

maging has become the cornerstone of everyday

the Conformité Européenne in Europe and the Food

diagnostics. Magnetic resonance imaging (MRI)

and Drug Administration in the United States,

and its many applications are the preferred test

respectively, approved the first MRI-conditional

modalities because of their diagnostic capabilities

pacemaker system. Since then a plethora of brady-

and their lack of radiation exposure.

cardia and tachycardia devices have been released

For years, the ability to have an MRI scan was at

under the label of MRI-conditional devices. As a

the top of the wish list of patients with cardiac

result of this revolution, whole-body MRI scans can

rhythm management (CRM) devices and their physi-

now be performed in recipients of these newer CRM

cians. Patients with long-standing back pain who

systems without any significant safety concerns for

were unable to have an MRI scan because of their

these patients. As a matter of fact, 20% of patients

CRM devices had to undergo painful myelograms to

who received a Medtronic SureScan system (Med-

obtain a diagnosis and appropriate therapy. The

tronic, Minneapolis, Minnesota) had undergone an

American Heart Association and the American College

MRI scan within the first 2 years of having the system

of Cardiology suggested as recently as 2007 that “MR

(2), and it is estimated that up to 75% of CRM device

examination of non-pacemaker dependent patients is

recipients will require a clinically indicated MRI scan

discouraged and should only be considered in cases

during their lifetime (3).

where there is a strong clinical indication and in which the benefits clearly outweigh the risk” (1). Since the late 1990s, there had been a simultaneous

Even before the evolution to MRI-conditional devices, there was a whole other effort to define the safety

limits

within

which

non–MRI-conditional

research effort by both industry and academia to

devices could be scanned. Some centers in Europe

advance knowledge about the effect of the magnetic

and the United States had started scanning these

field on implantable devices and to design devices

patients years before the first MRI-conditional system

and leads that would withstand the impact of the

was released. The Johns Hopkins database (4) and the

magnetic field and mitigate the potential harmful

more

effect on the patient. During that time, the majority of

confirmed that on exposure to 1.5-T scanners, CRM

radiologists considered the presence of CRM devices

devices made by all the different manufacturers can

to be an absolute contraindication to MRI scanning.

be safely scanned. Absolute prerequisites, however,

Finally, the unmet technological need was reached in

are appropriate evaluation of the device before the

2008 in Europe and in 2011 in the United States when

scan and careful consideration of the programmed

recently

reported

MagnaSafe

registry

(5)

mode for the scan. The exclusion criteria for these studies included the presence of abandoned leads and epicardial leads. Newer data, however, from a *Editorials published in JACC: Clinical Electrophysiology reflect the views of the author and do not necessarily represent the views of JACC: Clinical Electrophysiology or the American College of Cardiology. From the Pacemaker and ICD Clinic, Cardia Arrhythmia Service, Massachusetts General Hospital, Boston, Massachusetts. Dr. Mela has

small but significant registry including 57 patients with 63 abandoned leads from the Mayo Clinic in Rochester, Minnesota (6), were presented at the Heart Rhythm Society Scientific Sessions in 2017 and sug-

reported receiving speaker’s honoraria from Biotronik, Medtronic, and

gested that even in the presence of abandoned leads,

St. Jude Medical.

an MRI scan can be performed safely, with no

2

Mela

JACC: CLINICAL ELECTROPHYSIOLOGY VOL.

-, NO. -, 2017 - 2017:-–-

Patients With Cardiac Rhythm Management Devices

evidence of device malfunction, arrhythmias, or

in each case. In 75% of the neurological patients and in

myocardial injury.

90% of the cardiovascular patients, the MRI scan

An integral part of the safety of the procedure is

added substantial value to the management of the

that, both for MRI-conditional and non–MRI-condi-

patient. The patient population was representative of

tional devices, significant preparation involving both

a “real-life” practice and included patients with

the radiology team and the cardiology team is

complete heart block, which had been excluded by

required before the scan. The radiology team needs to

other registries, and patients with abandoned leads or

confirm the eligibility of the device-bearing patient

recently implanted leads (less than 6 weeks from

for an MRI scan by searching the device data and

implant) when the indication for the study was very

obtaining a chest radiograph to confirm the lack of

strong. There were no negative sequelae of these MRI

abandoned or epicardial leads. Subsequently, the

scans; however, Samar et al. (7) emphasize the sig-

device needs to be interrogated, the implantable

nificance of having these studies performed by expert

cardioverter-defibrillator needs to have the therapies

personnel and under the supervision of an expert

turned off, and the pacing must be programmed

member of the cardiology team.

according to the patient’s underlying conduction

The finding that these studies occurred at a time

disease. Therefore, a technician needs to be readily

when scant data on the safety of performing MRI

available for the device to be programmed and

scans in patients with non–MRI-conditional devices

reprogrammed before and after the MRI scan. For

existed suggests that these patients had very strong

non–MRI-conditional devices, a cardiologist or a

indications for MRI and a high pre-test probability of

cardiology nurse must be present to supervise the

benefiting from the scan. Therefore, the majority

patient during the scan. After the scan, the device

of the tests had a high diagnostic yield. As the use of

needs to be interrogated again and programmed back

MRI in such patients is constantly expanding, this

to its original mode.

strategy should continue to be applicable because the

All this effort raises a number of questions: Is it

risk for a serious complication from an MRI scan of a

really necessary for the patient to have an MRI scan?

non–MRI-conditional device is not negligible (8). This

Are we exaggerating in our quest for MRI-safe device

is especially true given that groups of patients who

technology or safe MRI protocols so that we can scan

have not been studied extensively before (pace-

patients with non–MRI-conditional devices? Is the

maker-dependent patients were mostly excluded

extra effort rewarded? Are these studies even covered

from previous registries, and patients with aban-

by the patient’s insurance? Should these patients

doned or epicardial leads have been studied in only

have alternative tests, as in previous decades?

very small numbers) are involved.

The paper by Samar et al. (7) in this issue of JACC:

Although the ability to perform MRI has benefited

Clinical Electrophysiology answers some of these

patients with challenging neurological and cardio-

questions as it examines the clinical significance of

vascular conditions who have non–MRI-conditional

MRI for patients with non–MRI-conditional CRM

devices, limitations still exist. Published studies have

devices when there is either no alternative test or

used only 1.5-T MRI. The risk of 3-T MRI, which offers

there is clinical uncertainty after other diagnostic

much a better quality of imaging, for these devices is

tests have been performed.

likely higher, and this technique is therefore avoided.

The 136 patients in this study had already under-

Image quality may also be a limitation. The study by

gone other diagnostic studies (computed tomography

Samar et al. (7) reported that in 2 patients whose

imaging or myelography for neurological or orthope-

implantable cardioverter-defibrillator was inside the

dic cases, transthoracic echocardiography, trans-

thoracic field of view, the device caused severe image

esophageal echocardiography, nuclear examination,

distortion and field degradation. In addition, the

or computed tomography angiography for cardiac

quality of the image may be distorted by the presence

cases), and either the diagnosis had remained unre-

of the leads in the heart and the proximity of the

solved or the patients could not tolerate studies such

device. In 1 patient only partial data were obtained,

as myelography. The scans took place between 2005

and in another patient the data were uninterpretable

and 2015, but mostly after 2009. The MRI protocol

for viability. There is increasing expertise, however,

was similar to that followed by the MagnaSafe regis-

in improving image quality, and this limitation is

try and involved only 1.5-T scans.

becoming much less relevant (9). Finally, at this time,

MRI of the brain or the spinal cord was performed in

the Centers for Medicare and Medicaid Services are

73% of patients, and a cardiovascular examination was

not reimbursing providers for MRI studies performed

performed in 22% of these patients, thus suggesting

in patients with non–MRI-conditional devices, except

that a serious indication for the MRI study was present

under a research protocol (10).

JACC: CLINICAL ELECTROPHYSIOLOGY VOL.

-, NO. -, 2017

Mela

- 2017:-–-

Today,

Patients With Cardiac Rhythm Management Devices

MRI-

The CRM device wish list has become shorter over

conditional CRM devices. The use of these devices is

the past 10 years, but the future seems to be even

financial

more exciting. The newly released leadless pace-

gradually

all

the

manufacturers

expanding,

despite

produce

certain

considerations. It is evident that the financial burden

maker

of performing multiple diagnostic tests that are infe-

subcutaneous implantable cardioverter-defibrillator.

rior to MRI and the effort and expertise necessary to

Future expectations include that MRI-conditional

perform MRI examinations in non–MRI-conditional

technology should have no price difference and

devices exceed the financial concerns about the use

that complete automatization of the MRI process will

of MRI-conditional technology.

exist so that the intervention by the cardiologist is

is

already

MRI

conditional,

as

is

the

The future therefore appears to trend toward the

not required. The cardiologist will continue to

increased use of MRI-conditional technology. The next

supervise non–MRI-conditional devices closely to

step will include automatization of these devices so

offer patients the safest way to undergo valuable

that when they are exposed to a magnetic field, they

MRI scans.

will be reprogrammed automatically to an MRI mode. A newly released feature by Biotronik (Lake Oswego,

ADDRESS FOR CORRESPONDENCE: Dr. Theofanie

Oregon) enables the device to be programmed to

Mela, Pacemaker and ICD Clinic, Cardiac Arrhythmia

an MRI mode 2 weeks before a scheduled MRI scan so

Service, Massachusetts General Hospital, 75 Fruit

that the device will automatically convert to the pre-

Street, Boston, Massachusetts 02114. E-mail: tmela@

selected mode once it enters the magnetic field.

mgh.harvard.edu.

REFERENCES 1. Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878–91. 2. Ramza B, Zhong Y, Pouliot E, Compton SJ. Are there cumulative effects of multiple MRI on MRIconditional pacemakers? Poster PO06-24. Presented at: Heart Rhythm Society Scientific

4. Nazarian S, Hansford R, Roguin A, et al. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med 2011;155: 415–24. 5. Russo RJ, Costa HS, Silva PD, et al. Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. N Engl J Med 2017;376: 755–64. 6. Padmanabhan D, Kella DK, Mehta R, et al. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and

Sessions; May 7–10 2014; San Francisco, California.

abandoned leads. Abstract C-PO01-27. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 10–13, 2017; Chicago.

3. Taruya A, Tanaka A, Nishiguchi T, et al. Necessity of magnetic resonance imaging examinations after permanent pacemaker implantation. Int J Cardiol 2015;184:497–8.

7. Samar H, Yamrozik JA, Williams RB, et al. Diagnostic value of MRI in patients with implanted pacemakers and ICDs across a cross population. J Am Coll Cardiol EP 2017;3:xxx–x.

8. Higgins JV, Sheldon SH, Watson RE, et al. “Power-on resets” in cardiac implantable electronic devices during magnetic resonance imaging. Heart Rhythm 2015;12:540–4. 9. Stevens SM, Tung R, Rashid S, et al. Device artifact reduction for magnetic resonance imaging of patients with implantable cardioverterdefibrillators and ventricular tachycardia: late gadolinium enhancement correlation with electroanatomic mapping. Heart Rhythm 2014;11:289–98. 10. Bailey WM, Rosenthal L, Fananapazir L, et al. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm 2015;12:1183–91.

KEY WORDS implantable cardioverterdefibrillator, magnetic resonance imaging, pacemakers

3