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This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.
This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abandoned or broken endocardial leads and surgically placed permanent epicardial leads | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI (CMR) | Device | Conducting cardiac MRI in a high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present) to determine the diagnostic value of Cardiac MRI in these patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the safety of CMR | To systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present). This is done by evaluating and reviewing the CMR images. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Value of CMR | To determine the diagnostic value of cardiac MRI in these patients, including the quality of imaging and the ability to address clinical questions. This is done by evaluating and reviewing the CMR images. | 6 months |
| Protocol Development. |
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Inclusion Criteria:
Exclusion Criteria:
Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Vascular Hospital | Dallas | Texas | 75226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21797902 | Background | Langman DA, Finn JP, Ennis DB. Abandoned pacemaker leads are a potential risk for patients undergoing MRI. Pacing Clin Electrophysiol. 2011 Sep;34(9):1051-3. doi: 10.1111/j.1540-8159.2011.03176.x. Epub 2011 Jul 28. No abstract available. | |
| 28225684 | Background | Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265. |
| Label | URL |
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| Related Info | View source |
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To develop and refine cardiac MRI protocols that effectively minimize risks while maintaining diagnostic quality in this patient group. This is done by taking the results of the CMR imaging and data collected and implementing changes to future protocol to minimize risks. |
| 2 years. |
| 28502708 | Background | Indik JH, Gimbel JR, Abe H, Alkmim-Teixeira R, Birgersdotter-Green U, Clarke GD, Dickfeld TL, Froelich JW, Grant J, Hayes DL, Heidbuchel H, Idriss SF, Kanal E, Lampert R, Machado CE, Mandrola JM, Nazarian S, Patton KK, Rozner MA, Russo RJ, Shen WK, Shinbane JS, Teo WS, Uribe W, Verma A, Wilkoff BL, Woodard PK. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Heart Rhythm. 2017 Jul;14(7):e97-e153. doi: 10.1016/j.hrthm.2017.04.025. Epub 2017 May 11. No abstract available. |
| 31713219 | Background | Balmer C, Gass M, Dave H, Duru F, Luechinger R. Magnetic resonance imaging of patients with epicardial leads: in vitro evaluation of temperature changes at the lead tip. J Interv Card Electrophysiol. 2019 Dec;56(3):321-326. doi: 10.1007/s10840-019-00627-7. Epub 2019 Nov 12. |
| 30781967 | Background | Vuorinen AM, Pakarinen S, Jaakkola I, Holmstrom M, Kivisto S, Kaasalainen T. Clinical experience of magnetic resonance imaging in patients with cardiac pacing devices: unrestricted patient population. Acta Radiol. 2019 Nov;60(11):1414-1421. doi: 10.1177/0284185119830288. Epub 2019 Feb 19. |
| 29045806 | Background | Padmanabhan D, Kella DK, Mehta R, Kapa S, Deshmukh A, Mulpuru S, Jaffe AS, Felmlee JP, Jondal ML, Dalzell CM, Asirvatham SJ, Cha YM, Watson RE Jr, Friedman PA. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads. Heart Rhythm. 2018 Feb;15(2):228-233. doi: 10.1016/j.hrthm.2017.10.022. Epub 2017 Oct 16. |
| 32533566 | Background | Gakenheimer-Smith L, Etheridge SP, Niu MC, Ou Z, Presson AP, Whitaker P, Su J, Puchalski MD, Asaki SY, Pilcher T. MRI in pediatric and congenital heart disease patients with CIEDs and epicardial or abandoned leads. Pacing Clin Electrophysiol. 2020 Aug;43(8):797-804. doi: 10.1111/pace.13984. Epub 2020 Jul 6. |
| 33595595 | Background | Schaller RD, Brunker T, Riley MP, Marchlinski FE, Nazarian S, Litt H. Magnetic Resonance Imaging in Patients With Cardiac Implantable Electronic Devices With Abandoned Leads. JAMA Cardiol. 2021 May 1;6(5):549-556. doi: 10.1001/jamacardio.2020.7572. |
| 38219955 | Background | Kim D, Collins JD, White JA, Hanneman K, Lee DC, Patel AR, Hu P, Litt H, Weinsaft JW, Davids R, Mukai K, Ng MY, Luetkens JA, Roguin A, Rochitte CE, Woodard PK, Manisty C, Zareba KM, Mont L, Bogun F, Ennis DB, Nazarian S, Webster G, Stojanovska J. SCMR expert consensus statement for cardiovascular magnetic resonance of patients with a cardiac implantable electronic device. J Cardiovasc Magn Reson. 2024 Summer;26(1):100995. doi: 10.1016/j.jocmr.2024.100995. Epub 2024 Jan 12. |
| Background | Habash F, Wang H, Assar M. Assessment of Safety and Time Utilization of Remote Device Interrogation in Patients with Conditional and Non-conditional Cardiac Implantable Electronic Devices Undergoing MRI. Heart Rhythm, Vol 20, No 5S, May Supplement 2023 |
| Background | Sovic W, Habash F, Doss R, Shaar M, Wang H, Assar M. Safety of MRI in Patients with Non-Conditional Cardiovascular Implantable Electronic Devices Due to Legacy Components or Generator and Lead Manufacturer Mismatch. Selected to be orally presented at HRS 2024 meeting. |