Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads

doi:10.1016/j.hrthm.2017.10.022

Heart Rhythm

Volume 15, Issue 2, February 2018, Pages 228-233

https://doi.org/10.1016/j.hrthm.2017.10.022 Get rights and content

Background

During magnetic resonance imaging (MRI), abandoned leads may act as antennae that result in tissue heating and arrhythmia induction.

Objective

The purpose of this study was to assess the safety of MRI in patients with abandoned leads, with the addition of cardiac troponin T (cTnT) assessment to screen for myocardial damage.

Methods

We reviewed our prospectively collected database of patients with cardiovascular implantable electronic devices (CIEDs) undergoing MRI between 2008 and 2017 at Mayo Clinic, Rochester, MN, and selected patients who had abandoned leads. We compared the adverse events in this population with an age, sex, and site of MRI–matched cohort of patients selected from this database. We evaluated paired (before/after) cTnT values using MRI in these patients.

Results

Of 952 patients, 80 (8.4%) underwent 97 MRI scans with CIEDs in situ with 90 abandoned leads in place during the scans. The median age was 66 years (interquartile range 22.3 years) 66.1 years (interquartile range, Q1,Q3: 53.6, 75.9) with 66.3% (53 patients) men. There was no clinical or electrical evidence of CIED dysfunction, arrhythmias, or pain. Paired samples for the measurement of cTnT values were available in 40 patients undergoing 44 MRI examinations. The mean difference between the pre- and postimaging values was −0.002 ± 0.006 ng/mL (interquartile range 0). There was no difference after adjustment for total number of leads per patient and total number of implantable cardioverter-defibrillator coils.

Conclusion

There was no evidence of myocardial injury as measured by paired cTnT. The risk of MRI with abandoned leads appears low, suggesting a favorable risk-benefit profile in patients with CIEDs and abandoned leads who are considered for MRI.

Introduction

There has been a steady increase in the use of pacemakers and defibrillators—cardiovascular implantable electronic devices (CIEDs)—in the past decade.1, 2 They have proven efficacy in the prevention of cardiovascular morbidity and mortality.³ The utility of magnetic resonance imaging (MRI) has also grown in tandem owing to its superior soft-tissue imaging capabilities.⁴ It is now predicted that 3 of 4 patients with CIEDs will need MRI once in their lifetime.5, 6

The strong static and gradient magnetic fields in concert with the radiofrequency fields when performing MRI can damage devices. CIED leads can act as antennae to receive MRI field energy and potentially cause myocardial damage. However, integrated teams consisting of specialists in medical imaging, nurses, and electrophysiologists have devised protocols to minimize this risk.⁷

There has been a robust body of literature in the recent past that has demonstrated the relative safety of performing MRI in patients with CIEDs using these principles.7, 8, 9 However, the majority of the existing literature still pertains to the use of MRI in patients with CIEDs without abandoned leads. Because of limitations in evaluating these leads pre- and postimaging, there has been hesitation in performing the MRI scan. Cardiac troponin I and cardiac troponin T (cTnT) are biomarkers of cardiac injury, which can be used to detect damage to the myocardium postscan.¹⁰

We hypothesized that under carefully controlled conditions, that is, in the presence of multidisciplinary teams, MRI using legacy non–MRI-conditional CIED systems with abandoned leads in situ is relatively safe with minimal risk of any adverse clinical events. To prove the same, we retrospectively analyzed a prospectively collected database to evaluate the safety of the scan in this subgroup and compare the adverse event rate with that of a similar cohort without any abandoned leads. We also compared the mean change in cTnT values in both these cohorts.

Section snippets

Study design

We conducted a retrospective study using prospectively collected databases at Mayo Clinic, Rochester, MN. The study design was approved by the institutional review board. This was an investigator-initiated study without any industry support.

Data source

The database collected information on patients who underwent MRI with CIEDs. MRI-conditional CIEDs were defined as CIED systems (pulse generator and leads) with Food and Drug Administration approval for MRI under prespecified conditions. Data were collected

Results

From January 1, 2008, through February 28, 2017, 952 patients with underwent MRI with CIEDs (1292 total MRI scans). A total of 97 scans were performed in 80 patients with abandoned leads.

The median age of the study group was 66 years (interquartile range 22.3 years) with a male to female ratio of 1.5 (66.3% men). The types of CIEDs and the location of the abandoned leads are listed in Table 1. Devices were checked pre- and postimaging. No change in device lead functioning or battery life was

Discussion

The present study is the largest to date that describes the safety of MRI in patients with abandoned CIED leads, namely, leads not connected to a pulse generator. These leads have been historically felt to introduce significant risk on the basis of modeling studies that found abandoned leads resonate heat energy in magnetic fields.¹⁶ Recently a large series reported the safety of nonthoracic MRI at 1.5 T in patients with implanted non–MRI-conditional cardiac devices.⁸ However, all patients with

Conclusion

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Cited by (65)

Multicenter retrospective evaluation of magnetic resonance imaging in pediatric and congenital heart disease patients with cardiac implantable electronic devices
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Guidelines addressing magnetic resonance imaging (MRI) in patients with cardiac implantable electronic devices (CIEDs) provide algorithms for imaging pediatric and congenital heart disease (CHD) patients. Guideline acceptance varies by institution. Guidelines also do not support routine MRI scans in patients with epicardial or abandoned leads, common in pediatric and CHD patients.
The purpose of this study was to determine the incidence of MRI-related complications in pediatric and CHD patients with CIEDs, including epicardial and/or abandoned leads.
A multicenter retrospective review included patients with CIEDs who underwent any MRI between 2007 and 2022 at congenital cardiac centers. The primary outcome was any patient adverse event or clinically significant CIED change after MRI, defined as pacing lead capture threshold increase >0.5 V with output change, P- or R- wave amplitude decrease >50% with sensitivity change, or impedance change >50%.
Across 14 institutions, 314 patients (median age 18.8 [1.3; 31.4] years) underwent 389 MRIs. There were 288 pacemakers (74%) and 87 implantable cardioverter-defibrillators (22%); 52% contained epicardial leads, and 14 (4%) were abandoned leads only. Symptoms or CIED changes occurred in 4.9% of MRI scans (6.1% of patients). On 9 occasions (2%), warmth or pain occurred. Pacing capture threshold or lead impedance changes occurred in 1.4% and 2.0% of CIEDs post-MRI and at follow-up.
Our data provide evidence that MRIs can be performed in pediatric and CHD patients with CIEDs, including non–MRI-conditional CIEDs and epicardial and/or abandoned leads, with rare minor symptoms or CIED changes but no other complications.
Long-term outcomes of abandoned leads of cardiac implantable electronic devices
2023, Heart Rhythm
Evidence of the long-term outcomes of abandoned leads (ALs) in patients with cardiac implantable electronic devices (CIEDs) is scarce.
This study aimed to investigate the long-term outcomes of ALs.
This retrospective cohort study reviewed a single-center CIED registry of 2962 procedures performed from 1984–2018 and identified 130 patients with AL (AL group). We matched 2 controls without AL (by age, sex, device type, and device revision/removal date) to each patient with AL (n = 260) and compared CIED-related infection, venous thrombosis/stenosis, and all-cause mortality between groups using a Cox proportional hazard model analysis.
For a mean follow-up period of 11.2 ± 8.2 years, 14 (3.6%), 7 (1.8%), and 143 (36.7%) patients had a CIED-related infection, venous thrombosis/stenosis, or experienced all-cause mortality, respectively. The AL group had more comorbidities than the control group. Lead malfunction was the most common cause of abandonment (64.6%). After adjustment for covariates, no significant intergroup differences were noted in the risks of infection, venous thrombosis/stenosis, or all-cause mortality (adjusted hazard ratio [aHR] 2.52; 95% confidence interval [CI] 0.77–8.25; aHR 1.18; 95% CI 0.25–5.64; aHR 1.26; 95% CI 0.89–1.80, respectively). Patients with multiple ALs had increased risks of infection and all-cause mortality vs controls (aHR 8.61; 95% CI 2.13–34.84; aHR 2.42; 95% CI 1.17–5.00, respectively).
Patients with a single AL showed similar risks of CIED-related infections, venous thrombosis/stenosis, and all-cause mortality as those without ALs, whereas those with multiple ALs showed increased risks of infection and all-cause mortality.
Evaluation of a compact 3 T MRI scanner for patients with implanted devices
2023, Magnetic Resonance Imaging
Access to high-quality MR exams is severely limited for patients with some implanted devices due to labeled MR safety conditions, but small-bore systems can overcome this limitation. For example, a compact 3 T MR scanner (C3T) with high-performance gradients can acquire exams of the head, extremities, and infants. Because of its reduced bore size and the patient being advanced only partially into the bore, the associated electromagnetic (EM) fields drop off rapidly caudal to the head, compared to whole-body systems. Therefore, some patients with MR conditional implanted devices can safely receive 3 T brain exams on the C3T using its strong gradients and a multiple-channel receive coil, while a corresponding exam on whole-body MR is precluded. The purpose of this study is to evaluate the performance of a small-bore scanner for subjects with MR conditional spinal or sacral nerve stimulators, or abandoned cardiac implantable electronic device (CIED) leads. The spatial dependence of specific absorption rate (SAR) on the C3T was compared to whole-body scanners. A device assessment tool was developed and applied to evaluate MR safety individually on the C3T for 12 subjects with implanted devices or abandoned CIED leads. Once MR safety was established, the subjects received a C3T brain exam along with their clinical, 1.5 T exam. The resulting images were graded by three board-certified neuroradiologists. The C3T exams were well-tolerated with no adverse events, and significantly outperformed the whole-body 1.5 T exams in terms of overall image quality.
Safety of magnetic resonance imaging in patients with surgically implanted permanent epicardial leads
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Magnetic resonance imaging (MRI) safety in patients with an epicardial cardiac implantable electronic device (CIED) is uncertain.
The purpose of this study was to assess the safety and adverse effects of MRI in patients who had surgically implanted epicardial CIED.
Patients with surgically implanted CIEDs who underwent MRI with an appropriate cardiology–radiology collaborative protocol between January 2008 and January 2021 were prospectively studied in 2 clinical centers. All patients underwent close cardiac monitoring through MRI procedures. Outcomes were compared between the epicardial CIED group and the matched non–MRI-conditional transvenous CIED group.
Twenty-nine consecutive patients with epicardial CIED (41.4% male; mean age 43 years) underwent 52 MRIs in 57 anatomic regions. Sixteen patients had a pacemaker, 9 had a cardiac defibrillator or cardiac resynchronization therapy–defibrillator, and 4 had no device generator. No significant adverse events occurred in the epicardial or transvenous CIED groups. Battery life, pacing, sensing thresholds, lead impedance, and cardiac biomarkers were not significantly changed, except 1 patient had a transient decrease in atrial lead sensing function.
MRI of CIEDs with epicardially implanted leads does not represent a greater risk than transvenous CIEDs when performed with a multidisciplinary collaborative protocol centered on patient safety.
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In the COVID-19 pandemic, to minimize aerosol-generating procedures, cardiac magnetic resonance imaging (CMR) was utilized at our institution as an alternative to transesophageal echocardiography (TEE) for diagnosing infective endocarditis (IE). This retrospective study evaluated the clinical utility of CMR for detecting IE among 14 patients growing typical microorganisms on blood cultures or meeting modified Duke Criteria. Seven cases were treated for IE. In 2 cases, CMR results were notable for possible leaflet vegetations and were clinically meaningful in guiding antibiotic therapy, obtaining further imaging, and/or pursuing surgical intervention. In 2 cases, vegetations were missed on CMR but detected on TEE. In 3 cases, CMR was non-diagnostic, but patients were treated empirically. There was no difference in antibiotic duration or outcomes over 1 year. CMR demonstrated mixed results in diagnosing valvular vegetations and guiding clinical decision-making. Further prospective controlled trials of CMR Vs TEE are warranted.

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ClinicalDevicesSafety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Study design

Data source

Results

Discussion

Conclusion

Heart Rhythm

Heart Rhythm

Heart Rhythm

Am Heart J

J Am Coll Cardiol

European utilization of the implantable defibrillator: has 10 years changed the ‘enigma’?

Europace

Circulation

Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010

JAMA

Current clinical issues for MRI scanning of pacemaker and defibrillator patients

Pacing Clin Electrophysiol

Utilization and likelihood of radiologic diagnostic imaging in patients with implantable cardiac defibrillators

J Magn Reson Imaging

A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices

Ann Intern Med

Clinical
Devices
Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads