Determining the Risks of Magnetic Resonance Imaging at 1.5 Tesla for Patients With Pacemakers and Implantable Cardioverter Defibrillators
Conventional pacemaker and implantable cardioverter-defibrillator product labeling currently cautions against exposure to magnetic resonance imaging (MRI). However, there is a growing clinical need for MRI, without an acceptable alternative imaging modality in many patients with cardiac devices. The...
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| Veröffentlicht in: | The American journal of cardiology 2012-12, Vol.110 (11), p.1631-1636 |
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| creator | Cohen, Jennifer D., MD Costa, Heather S., PhD Russo, Robert J., MD, PhD |
| description | Conventional pacemaker and implantable cardioverter-defibrillator product labeling currently cautions against exposure to magnetic resonance imaging (MRI). However, there is a growing clinical need for MRI, without an acceptable alternative imaging modality in many patients with cardiac devices. The purpose of this study was to determine the risk of MRI at 1.5 T for patients with cardiac devices by measuring the frequency of device failures and clinically relevant device parameter changes. Data from a single-center retrospective review of 109 patients with pacemakers and implantable cardioverter-defibrillators (the MRI group) who underwent 125 clinically indicated MRI studies were compared to data from a prospective cohort of 50 patients with cardiac devices who did not undergo MRI (the control group). In the MRI group, there were no deaths, device failures requiring generator or lead replacement, induced arrhythmias, losses of capture, or electrical reset episodes. Decreases in battery voltage of ≥0.04 V occurred in 4%, pacing threshold increases of ≥0.5 V in 3%, and pacing lead impedance changes of ≥50 Ω in 6%. Although there were statistically significant differences between the MRI and control groups for the mean change in pacing lead impedance (−6.2 ± 23.9 vs 3.0 ± 22.1 Ω) and left ventricular pacing threshold (−0.1 ± 0.3 vs 0.1 ± 0.2 V), these differences were not clinically important. In conclusion, MRI in patients with cardiac devices resulted in no device or lead failures. A small number of clinically relevant changes in device parameter measurements were noted. However, these changes were similar to those in a control group of patients who did not undergo MRI. |
| doi_str_mv | 10.1016/j.amjcard.2012.07.030 |
| format | Article |
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However, there is a growing clinical need for MRI, without an acceptable alternative imaging modality in many patients with cardiac devices. The purpose of this study was to determine the risk of MRI at 1.5 T for patients with cardiac devices by measuring the frequency of device failures and clinically relevant device parameter changes. Data from a single-center retrospective review of 109 patients with pacemakers and implantable cardioverter-defibrillators (the MRI group) who underwent 125 clinically indicated MRI studies were compared to data from a prospective cohort of 50 patients with cardiac devices who did not undergo MRI (the control group). In the MRI group, there were no deaths, device failures requiring generator or lead replacement, induced arrhythmias, losses of capture, or electrical reset episodes. Decreases in battery voltage of ≥0.04 V occurred in 4%, pacing threshold increases of ≥0.5 V in 3%, and pacing lead impedance changes of ≥50 Ω in 6%. Although there were statistically significant differences between the MRI and control groups for the mean change in pacing lead impedance (−6.2 ± 23.9 vs 3.0 ± 22.1 Ω) and left ventricular pacing threshold (−0.1 ± 0.3 vs 0.1 ± 0.2 V), these differences were not clinically important. In conclusion, MRI in patients with cardiac devices resulted in no device or lead failures. A small number of clinically relevant changes in device parameter measurements were noted. However, these changes were similar to those in a control group of patients who did not undergo MRI.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2012.07.030</identifier><identifier>PMID: 22921995</identifier><identifier>CODEN: AJCDAG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Aged ; Arrhythmias, Cardiac - diagnosis ; Arrhythmias, Cardiac - therapy ; Biological and medical sciences ; Cardiology. 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However, there is a growing clinical need for MRI, without an acceptable alternative imaging modality in many patients with cardiac devices. The purpose of this study was to determine the risk of MRI at 1.5 T for patients with cardiac devices by measuring the frequency of device failures and clinically relevant device parameter changes. Data from a single-center retrospective review of 109 patients with pacemakers and implantable cardioverter-defibrillators (the MRI group) who underwent 125 clinically indicated MRI studies were compared to data from a prospective cohort of 50 patients with cardiac devices who did not undergo MRI (the control group). In the MRI group, there were no deaths, device failures requiring generator or lead replacement, induced arrhythmias, losses of capture, or electrical reset episodes. Decreases in battery voltage of ≥0.04 V occurred in 4%, pacing threshold increases of ≥0.5 V in 3%, and pacing lead impedance changes of ≥50 Ω in 6%. Although there were statistically significant differences between the MRI and control groups for the mean change in pacing lead impedance (−6.2 ± 23.9 vs 3.0 ± 22.1 Ω) and left ventricular pacing threshold (−0.1 ± 0.3 vs 0.1 ± 0.2 V), these differences were not clinically important. In conclusion, MRI in patients with cardiac devices resulted in no device or lead failures. A small number of clinically relevant changes in device parameter measurements were noted. However, these changes were similar to those in a control group of patients who did not undergo MRI.</description><subject>Aged</subject><subject>Arrhythmias, Cardiac - diagnosis</subject><subject>Arrhythmias, Cardiac - therapy</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular</subject><subject>Confidence intervals</subject><subject>Contraindications</subject><subject>Defibrillators, Implantable</subject><subject>Equipment Design</subject><subject>Equipment Failure - statistics & numerical data</subject><subject>Equipment Safety</subject><subject>FDA approval</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Magnetic fields</subject><subject>Magnetic Resonance Imaging, Cine - adverse effects</subject><subject>Magnetic Resonance Imaging, Cine - instrumentation</subject><subject>Male</subject><subject>Medical sciences</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Pacemaker, Artificial</subject><subject>Questioning</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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Vascular system</topic><topic>Cardiovascular</topic><topic>Confidence intervals</topic><topic>Contraindications</topic><topic>Defibrillators, Implantable</topic><topic>Equipment Design</topic><topic>Equipment Failure - statistics & numerical data</topic><topic>Equipment Safety</topic><topic>FDA approval</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Magnetic fields</topic><topic>Magnetic Resonance Imaging, Cine - adverse effects</topic><topic>Magnetic Resonance Imaging, Cine - instrumentation</topic><topic>Male</topic><topic>Medical sciences</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Pacemaker, Artificial</topic><topic>Questioning</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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However, there is a growing clinical need for MRI, without an acceptable alternative imaging modality in many patients with cardiac devices. The purpose of this study was to determine the risk of MRI at 1.5 T for patients with cardiac devices by measuring the frequency of device failures and clinically relevant device parameter changes. Data from a single-center retrospective review of 109 patients with pacemakers and implantable cardioverter-defibrillators (the MRI group) who underwent 125 clinically indicated MRI studies were compared to data from a prospective cohort of 50 patients with cardiac devices who did not undergo MRI (the control group). In the MRI group, there were no deaths, device failures requiring generator or lead replacement, induced arrhythmias, losses of capture, or electrical reset episodes. Decreases in battery voltage of ≥0.04 V occurred in 4%, pacing threshold increases of ≥0.5 V in 3%, and pacing lead impedance changes of ≥50 Ω in 6%. Although there were statistically significant differences between the MRI and control groups for the mean change in pacing lead impedance (−6.2 ± 23.9 vs 3.0 ± 22.1 Ω) and left ventricular pacing threshold (−0.1 ± 0.3 vs 0.1 ± 0.2 V), these differences were not clinically important. In conclusion, MRI in patients with cardiac devices resulted in no device or lead failures. A small number of clinically relevant changes in device parameter measurements were noted. However, these changes were similar to those in a control group of patients who did not undergo MRI.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>22921995</pmid><doi>10.1016/j.amjcard.2012.07.030</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Arrhythmias, Cardiac - diagnosis Arrhythmias, Cardiac - therapy Biological and medical sciences Cardiology. Vascular system Cardiovascular Confidence intervals Contraindications Defibrillators, Implantable Equipment Design Equipment Failure - statistics & numerical data Equipment Safety FDA approval Female Follow-Up Studies Humans Magnetic fields Magnetic Resonance Imaging, Cine - adverse effects Magnetic Resonance Imaging, Cine - instrumentation Male Medical sciences NMR Nuclear magnetic resonance Pacemaker, Artificial Questioning Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Retrospective Studies Risk Assessment - methods Risk Factors Studies |
| title | Determining the Risks of Magnetic Resonance Imaging at 1.5 Tesla for Patients With Pacemakers and Implantable Cardioverter Defibrillators |
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