Evaluation of Cumulative Effects of MR Imaging on Pacemaker Systems at 1.5 Tesla

Naehle, Claas P.; Zeijlemaker, Volkert A.; Thomas, Daniel; Meyer, Carsten H.; Strach, Katharina; Fimmers, Rolf; Schild, Hans H.; Sommer, Torsten

doi:10.1111/j.1540-8159.2009.02570.x

Cited by 55 publications

(35 citation statements)

References 25 publications

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“…Several relatively small studies have also reported overall safety (7, 10, 30, 33, 34). Several investigators have reported a lack of change in troponin-I levels as a surrogate of myocardial damage after MRI (11, 12, 35), and recent reports have demonstrated the overall safety of repeated MRI (36) and MRI without SAR restrictions in device recipients (26). Our study adds to the existing literature by providing substantial safety data on the largest number of patients and the most representative sampling of devices implanted to date.…”

Section: Discussionmentioning

confidence: 99%

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients With Implanted Cardiac Devices

Nazarian¹,

Hansford²,

Roguin³

et al. 2011

Ann Intern Med

286

221

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Background Magnetic resonance imaging (MRI) is avoided in most patients with implanted cardiac devices because of safety concerns. Objective To define the safety of a protocol for MRI at the commonly used magnetic strength of 1.5 T in patients with implanted cardiac devices. Design Prospective nonrandomized trial. (ClinicalTrials.gov registration number: NCT01130896) Setting One center in the United States (94% of examinations) and one in Israel. Patients 438 patients with devices (54% with pacemakers and 46% with defibrillators) who underwent 555 MRI studies. Intervention Pacing mode was changed to asynchronous for pacemaker-dependent patients and to demand for others. Tachy-arrhythmia functions were disabled. Blood pressure, electrocardiography, oximetry, and symptoms were monitored by a nurse with experience in cardiac life support and device programming who had immediate backup from an electrophysiologist. Measurements Activation or inhibition of pacing, symptoms, and device variables. Results In 3 patients (0.7% [95% CI, 0% to 1.5%]), the device reverted to a transient back-up programming mode without long-term effects. Right ventricular (RV) sensing (median change, 0 mV [interquartile range {IQR}, −0.7 to 0 V]) and atrial and right and left ventricular lead impedances (median change, −2 Ω[IQR, −13 to 0 Ω], −4 Ω [IQR, −16 to 0 Ω], and −11 Ω [IQR, −40 to 0 Ω], respectively) were reduced immediately after MRI. At long-term follow-up (61% of patients), decreased RV sensing (median, 0 mV, [IQR, −1.1 to 0.3 mV]), decreased RV lead impedance (median, −3 Ω, [IQR, −29 to 15 Ω]), increased RV capture threshold (median, 0 V, IQR, [0 to 0.2 Ω]), and decreased battery voltage (median, −0.01 V, IQR, −0.04 to 0 V) were noted. The observed changes did not require device revision or reprogramming. Limitations Not all available cardiac devices have been tested. Long-term in-person or telephone follow-up was unavailable in 43 patients (10%), and some data were missing. Those with missing long-term capture threshold data had higher baseline right atrial and right ventricular capture thresholds and were more likely to have undergone thoracic imaging. Defibrillation threshold testing and random assignment to a control group were not performed. Conclusion With appropriate precautions, MRI can be done safely in patients with selected cardiac devices. Because changes in device variables and programming may occur, electrophysiologic monitoring during MRI is essential. Primary Funding Source National Institutes of Health.

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Section: Discussionmentioning

confidence: 99%

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients With Implanted Cardiac Devices

Nazarian¹,

Hansford²,

Roguin³

et al. 2011

Ann Intern Med

286

221

View full text Add to dashboard Cite

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“…The transfer of electromagnetic energy can lead to myocardial electrical stimulation, tissue destruction at the lead tip/endocardial interface, pain, and damage to the pulse generator circuitry/battery. This may produce adverse effects on sensing, pacing thresholds, and lead impedances, and can cause inappropriate pacing acceleration or inhibition, and battery depletion [4,6,7,9,20,29,31,33,36,41,43,50,52,61,62,98-100] In a recent investigation by Wilkoff et al [81] on an MR conditional pacing system, these adverse effects were not observed. Pacing thresholds did not change significantly between patients with the device who were scanned and those who served as control patients.…”

Section: Introductionmentioning

confidence: 99%

Magnetic resonance imaging in patients with cardiac pacemakers: era of “MR Conditional” designs

Shinbane

Colletti

Shellock

2011

Journal of Cardiovascular Magnetic Resonance

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Advances in cardiac device technology have led to the first generation of magnetic resonance imaging (MRI) conditional devices, providing more diagnostic imaging options for patients with these devices, but also new controversies. Prior studies of pacemakers in patients undergoing MRI procedures have provided groundwork for design improvements. Factors related to magnetic field interactions and transfer of electromagnetic energy led to specific design changes. Ferromagnetic content was minimized. Reed switches were modified. Leads were redesigned to reduce induced currents/heating. Circuitry filters and shielding were implemented to impede or limit the transfer of certain unwanted electromagnetic effects. Prospective multicenter clinical trials to assess the safety and efficacy of the first generation of MR conditional cardiac pacemakers demonstrated no significant alterations in pacing parameters compared to controls. There were no reported complications through the one month visit including no arrhythmias, electrical reset, inhibition of generator output, or adverse sensations. The safe implementation of these new technologies requires an understanding of the well-defined patient and MR system conditions. Although scanning a patient with an MR conditional device following the strictly defined patient and MR system conditions appears straightforward, issues related to patients with pre-existing devices remain complex. Until MR conditional devices are the routine platform for all of these devices, there will still be challenging decisions regarding imaging patients with pre-existing devices where MRI is required to diagnose and manage a potentially life threatening or serious scenario. A range of other devices including ICDs, biventricular devices, and implantable physiologic monitors as well as guidance of medical procedures using MRI technology will require further biomedical device design changes and testing. The development and implementation of cardiac MR conditional devices will continue to require the expertise and collaboration of multiple disciplines and will need to prove safety, effectiveness, and cost effectiveness in patient care.

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“…Both, patients with pacemakers [5][6][7][8][9][10][11][12][13] and implantable cardioverter-defibrillators [14][15][16][17][18][19] underwent MRI examinations. This phenomenon is inevitable.…”

Section: Discussionmentioning

confidence: 99%

The use of 1.5T magnetic resonance imaging for therapeutic decisions in patients with cardiac implantable electronic devices and significant neurological, neurosurgical and neuro-oncology diagnostic indications

Hawryluk

Sterliński

Marczak

et al. 2015

Neurologia i Neurochirurgia Polska

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Cardiac implantable electronic device Magnetic resonance imaging Therapeutic decision a b s t r a c t Between September 2009 and May 2014 the classification of 36 patients with cardiac implantable electronic devices (CIEDs) in terms of the feasibility of MRI scanning due to strong clinical indications was carried out. Finally MRI examinations were performed in 20 patients, of whom 27 studies were conducted and a total number of 35 anatomical regions were scanned. Neurological, neurosurgical and neuro-oncology indications for MRI were reported in 19 patients (95%) in whom 26 MRI studies (96.3%) were performed, and 34 anatomical regions (97.1%) were scanned. One patient had indications for MRI in the field of cardiology. Medical information obtained from 27 MRI studies allowed decisions to be made regarding the treatment in all patients. After 8 studies (29.6%), patients were classified into 9 different neurosurgical procedures. In the case of the remaining 19 studies (70.4%), there were no indications for surgical treatment and the decisions to implement conservative treatment were made.There were no complications related to the implanted CIEDs observed: neither immediate nor in the follow-up.

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Evaluation of Cumulative Effects of MR Imaging on Pacemaker Systems at 1.5 Tesla

Cited by 55 publications

References 25 publications

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients With Implanted Cardiac Devices

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients With Implanted Cardiac Devices

Magnetic resonance imaging in patients with cardiac pacemakers: era of “MR Conditional” designs

The use of 1.5T magnetic resonance imaging for therapeutic decisions in patients with cardiac implantable electronic devices and significant neurological, neurosurgical and neuro-oncology diagnostic indications

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