Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment
Background Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. Objective The purpose of this prospective, randomized, controlled, worldwide clinical trial was to e...
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| creator | Wilkoff, Bruce L., MD, FHRS, CCDS Bello, David, MD Taborsky, Milos, MD, PhD, FESC Vymazal, Josef, MD, PhD Kanal, Emanuel, MD, FACR, FISMRM Heuer, Hubertus, MD Hecking, Katrin, MD Johnson, W. Ben, MD, CCDS Young, William, MD Ramza, Brian, MD, PhD Akhtar, Naveed, MD Kuepper, Bernhard, MD Hunold, Peter, MD Luechinger, Roger, PhD Puererfellner, Helmut, MD Duru, Firat, MD Gotte, M.J.W., MD Sutton, Richard, MD, PhD Sommer, Torsten, MD |
| description | Background Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. Objective The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient. Methods Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups. Results No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups. Conclusion This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function. |
| doi_str_mv | 10.1016/j.hrthm.2010.10.002 |
| format | Article |
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Ben, MD, CCDS ; Young, William, MD ; Ramza, Brian, MD, PhD ; Akhtar, Naveed, MD ; Kuepper, Bernhard, MD ; Hunold, Peter, MD ; Luechinger, Roger, PhD ; Puererfellner, Helmut, MD ; Duru, Firat, MD ; Gotte, M.J.W., MD ; Sutton, Richard, MD, PhD ; Sommer, Torsten, MD</creator><creatorcontrib>Wilkoff, Bruce L., MD, FHRS, CCDS ; Bello, David, MD ; Taborsky, Milos, MD, PhD, FESC ; Vymazal, Josef, MD, PhD ; Kanal, Emanuel, MD, FACR, FISMRM ; Heuer, Hubertus, MD ; Hecking, Katrin, MD ; Johnson, W. Ben, MD, CCDS ; Young, William, MD ; Ramza, Brian, MD, PhD ; Akhtar, Naveed, MD ; Kuepper, Bernhard, MD ; Hunold, Peter, MD ; Luechinger, Roger, PhD ; Puererfellner, Helmut, MD ; Duru, Firat, MD ; Gotte, M.J.W., MD ; Sutton, Richard, MD, PhD ; Sommer, Torsten, MD ; EnRhythm MRI SureScan Pacing System Study Investigators</creatorcontrib><description>Background Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. Objective The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient. Methods Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups. Results No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups. Conclusion This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.</description><identifier>ISSN: 1547-5271</identifier><identifier>EISSN: 1556-3871</identifier><identifier>DOI: 10.1016/j.hrthm.2010.10.002</identifier><identifier>PMID: 20933098</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Bradycardia - therapy ; Bradycardia pacing ; CapSureFixMRI ; Cardiac Pacing, Artificial ; Cardiovascular ; Contraindications ; EnRhythmMRI ; Equipment Design ; Humans ; Magnetic Resonance Imaging ; MRI ; Pacemaker ; Pacemaker, Artificial ; Prospective Studies ; RevoMRI ; Safety ; SureScan</subject><ispartof>Heart rhythm, 2011, Vol.8 (1), p.65-73</ispartof><rights>Heart Rhythm Society</rights><rights>2011 Heart Rhythm Society</rights><rights>Copyright © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c458t-e4ac000cc9a14e4f061c239efed7cb1e4b48caaa08cf234dd19265edfee871153</citedby><cites>FETCH-LOGICAL-c458t-e4ac000cc9a14e4f061c239efed7cb1e4b48caaa08cf234dd19265edfee871153</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1547527110010799$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20933098$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wilkoff, Bruce L., MD, FHRS, CCDS</creatorcontrib><creatorcontrib>Bello, David, MD</creatorcontrib><creatorcontrib>Taborsky, Milos, MD, PhD, FESC</creatorcontrib><creatorcontrib>Vymazal, Josef, MD, PhD</creatorcontrib><creatorcontrib>Kanal, Emanuel, MD, FACR, FISMRM</creatorcontrib><creatorcontrib>Heuer, Hubertus, MD</creatorcontrib><creatorcontrib>Hecking, Katrin, MD</creatorcontrib><creatorcontrib>Johnson, W. Ben, MD, CCDS</creatorcontrib><creatorcontrib>Young, William, MD</creatorcontrib><creatorcontrib>Ramza, Brian, MD, PhD</creatorcontrib><creatorcontrib>Akhtar, Naveed, MD</creatorcontrib><creatorcontrib>Kuepper, Bernhard, MD</creatorcontrib><creatorcontrib>Hunold, Peter, MD</creatorcontrib><creatorcontrib>Luechinger, Roger, PhD</creatorcontrib><creatorcontrib>Puererfellner, Helmut, MD</creatorcontrib><creatorcontrib>Duru, Firat, MD</creatorcontrib><creatorcontrib>Gotte, M.J.W., MD</creatorcontrib><creatorcontrib>Sutton, Richard, MD, PhD</creatorcontrib><creatorcontrib>Sommer, Torsten, MD</creatorcontrib><creatorcontrib>EnRhythm MRI SureScan Pacing System Study Investigators</creatorcontrib><title>Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment</title><title>Heart rhythm</title><addtitle>Heart Rhythm</addtitle><description>Background Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. Objective The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient. Methods Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups. Results No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups. Conclusion This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.</description><subject>Bradycardia - therapy</subject><subject>Bradycardia pacing</subject><subject>CapSureFixMRI</subject><subject>Cardiac Pacing, Artificial</subject><subject>Cardiovascular</subject><subject>Contraindications</subject><subject>EnRhythmMRI</subject><subject>Equipment Design</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging</subject><subject>MRI</subject><subject>Pacemaker</subject><subject>Pacemaker, Artificial</subject><subject>Prospective Studies</subject><subject>RevoMRI</subject><subject>Safety</subject><subject>SureScan</subject><issn>1547-5271</issn><issn>1556-3871</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1PGzEQhq0KVD7aX1Cp8o3Tpv7ar0ORUERLJRAH2rPljGcTh11vajug_Hu8hPYAB062R-881jxDyBfOZpzx6tt6tgppNcwEe67MGBMfyDEvy6qQTc0Ppruqi1LU_IicxLjOgbZi8iM5EqyVkrXNMfE3ZukxOaAB4-iNB6RuMEvnl9R5ujHJoU-RPrq0oia_AQdzj4HGXUw4UIvRZYCl3RhoWiEd3vLQP7gw-iGDPpHDzvQRP7-cp-TPj8vf86vi-vbnr_nFdQGqbFKBygBjDKA1XKHqWMVByBY7tDUsOKqFasAYwxrohFTW8lZUJdoOMU_OS3lKzvbcTRj_bjEmPbgI2PfG47iNuhFcNXXViJyU-ySEMcaAnd6ELCDsNGd68qzX-tmznjxPxawxd3194W8XA9r_Pf_E5sD3fQDzlA8Og46QTQJaFxCStqN754PzV_3QO-_A9Pe4w7get8FngZrrKDTTd9Oqp01zliF128onzcWnYA</recordid><startdate>2011</startdate><enddate>2011</enddate><creator>Wilkoff, Bruce L., MD, FHRS, CCDS</creator><creator>Bello, David, MD</creator><creator>Taborsky, Milos, MD, PhD, FESC</creator><creator>Vymazal, Josef, MD, PhD</creator><creator>Kanal, Emanuel, MD, FACR, FISMRM</creator><creator>Heuer, Hubertus, MD</creator><creator>Hecking, Katrin, MD</creator><creator>Johnson, W. Ben, MD, CCDS</creator><creator>Young, William, MD</creator><creator>Ramza, Brian, MD, PhD</creator><creator>Akhtar, Naveed, MD</creator><creator>Kuepper, Bernhard, MD</creator><creator>Hunold, Peter, MD</creator><creator>Luechinger, Roger, PhD</creator><creator>Puererfellner, Helmut, MD</creator><creator>Duru, Firat, MD</creator><creator>Gotte, M.J.W., MD</creator><creator>Sutton, Richard, MD, PhD</creator><creator>Sommer, Torsten, MD</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>2011</creationdate><title>Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment</title><author>Wilkoff, Bruce L., MD, FHRS, CCDS ; Bello, David, MD ; Taborsky, Milos, MD, PhD, FESC ; Vymazal, Josef, MD, PhD ; Kanal, Emanuel, MD, FACR, FISMRM ; Heuer, Hubertus, MD ; Hecking, Katrin, MD ; Johnson, W. Ben, MD, CCDS ; Young, William, MD ; Ramza, Brian, MD, PhD ; Akhtar, Naveed, MD ; Kuepper, Bernhard, MD ; Hunold, Peter, MD ; Luechinger, Roger, PhD ; Puererfellner, Helmut, MD ; Duru, Firat, MD ; Gotte, M.J.W., MD ; Sutton, Richard, MD, PhD ; Sommer, Torsten, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c458t-e4ac000cc9a14e4f061c239efed7cb1e4b48caaa08cf234dd19265edfee871153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Bradycardia - therapy</topic><topic>Bradycardia pacing</topic><topic>CapSureFixMRI</topic><topic>Cardiac Pacing, Artificial</topic><topic>Cardiovascular</topic><topic>Contraindications</topic><topic>EnRhythmMRI</topic><topic>Equipment Design</topic><topic>Humans</topic><topic>Magnetic Resonance Imaging</topic><topic>MRI</topic><topic>Pacemaker</topic><topic>Pacemaker, Artificial</topic><topic>Prospective Studies</topic><topic>RevoMRI</topic><topic>Safety</topic><topic>SureScan</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wilkoff, Bruce L., MD, FHRS, CCDS</creatorcontrib><creatorcontrib>Bello, David, MD</creatorcontrib><creatorcontrib>Taborsky, Milos, MD, PhD, FESC</creatorcontrib><creatorcontrib>Vymazal, Josef, MD, PhD</creatorcontrib><creatorcontrib>Kanal, Emanuel, MD, FACR, FISMRM</creatorcontrib><creatorcontrib>Heuer, Hubertus, MD</creatorcontrib><creatorcontrib>Hecking, Katrin, MD</creatorcontrib><creatorcontrib>Johnson, W. Ben, MD, CCDS</creatorcontrib><creatorcontrib>Young, William, MD</creatorcontrib><creatorcontrib>Ramza, Brian, MD, PhD</creatorcontrib><creatorcontrib>Akhtar, Naveed, MD</creatorcontrib><creatorcontrib>Kuepper, Bernhard, MD</creatorcontrib><creatorcontrib>Hunold, Peter, MD</creatorcontrib><creatorcontrib>Luechinger, Roger, PhD</creatorcontrib><creatorcontrib>Puererfellner, Helmut, MD</creatorcontrib><creatorcontrib>Duru, Firat, MD</creatorcontrib><creatorcontrib>Gotte, M.J.W., MD</creatorcontrib><creatorcontrib>Sutton, Richard, MD, PhD</creatorcontrib><creatorcontrib>Sommer, Torsten, MD</creatorcontrib><creatorcontrib>EnRhythm MRI SureScan Pacing System Study Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Heart rhythm</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wilkoff, Bruce L., MD, FHRS, CCDS</au><au>Bello, David, MD</au><au>Taborsky, Milos, MD, PhD, FESC</au><au>Vymazal, Josef, MD, PhD</au><au>Kanal, Emanuel, MD, FACR, FISMRM</au><au>Heuer, Hubertus, MD</au><au>Hecking, Katrin, MD</au><au>Johnson, W. Ben, MD, CCDS</au><au>Young, William, MD</au><au>Ramza, Brian, MD, PhD</au><au>Akhtar, Naveed, MD</au><au>Kuepper, Bernhard, MD</au><au>Hunold, Peter, MD</au><au>Luechinger, Roger, PhD</au><au>Puererfellner, Helmut, MD</au><au>Duru, Firat, MD</au><au>Gotte, M.J.W., MD</au><au>Sutton, Richard, MD, PhD</au><au>Sommer, Torsten, MD</au><aucorp>EnRhythm MRI SureScan Pacing System Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment</atitle><jtitle>Heart rhythm</jtitle><addtitle>Heart Rhythm</addtitle><date>2011</date><risdate>2011</risdate><volume>8</volume><issue>1</issue><spage>65</spage><epage>73</epage><pages>65-73</pages><issn>1547-5271</issn><eissn>1556-3871</eissn><abstract>Background Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. Objective The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient. Methods Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups. Results No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups. Conclusion This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>20933098</pmid><doi>10.1016/j.hrthm.2010.10.002</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Bradycardia - therapy Bradycardia pacing CapSureFixMRI Cardiac Pacing, Artificial Cardiovascular Contraindications EnRhythmMRI Equipment Design Humans Magnetic Resonance Imaging MRI Pacemaker Pacemaker, Artificial Prospective Studies RevoMRI Safety SureScan |
| title | Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment |
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