Dataset Information

Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.

ABSTRACT: Magnetic resonance imaging (MRI) has long been contraindicated in patients with implanted pacemakers, defibrillators, and cardiac resynchronisation therapy (CRT) devices due to the risk of adverse effects through electromagnetic interference. Since many recipients of these devices will have a lifetime indication for an MRI scan, the implantable systems should be developed as 'MRI-conditional' (be safe for the MRI environment under predefined conditions). We evaluated the clinical safety of several Biotronik ProMRI ('MRI-conditional') defibrillator and CRT systems during head and lower lumbar MRI scans at 1.5 Tesla. The study enrolled 194 patients at 22 sites in Australia, Canada, and Europe. At ?9 weeks after device implantation, predefined, non-diagnostic, specific absorption rate (SAR)-intensive head and lower lumbar MRI scans (total ?30?minutes per patient) were performed in 146 patients that fulfilled pre-procedure criteria. Three primary endpoints were evaluated: freedom from serious adverse device effects (SADEs) related to MRI and defibrillator/CRT (leading to death, hospitalisation, life-threatening condition, or potentially requiring implanted system revision or replacement), pacing threshold increase, and sensing amplitude decrease, all at the 1-month post-MRI clinical visit. No MRI-related SADE occurred. Lead values remained stable, measured in clinic and monitored daily by the manufacturer home monitoring technology.

SUBMITTER: Bauer WR

PROVIDER: S-EPMC6890633 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.

Bauer Wolfgang Rudolf WR Lau Dennis H DH Wollmann Christian C McGavigan Andrew A Mansourati Jacques J Reiter Theresa T Frömer Simone S Ladd Mark E ME Quick Harald H HH

Scientific reports 20191203 1

Magnetic resonance imaging (MRI) has long been contraindicated in patients with implanted pacemakers, defibrillators, and cardiac resynchronisation therapy (CRT) devices due to the risk of adverse effects through electromagnetic interference. Since many recipients of these devices will have a lifetime indication for an MRI scan, the implantable systems should be developed as 'MRI-conditional' (be safe for the MRI environment under predefined conditions). We evaluated the clinical safety of sever ...[more]

PMID: 31796767

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Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Project description:BACKGROUND:Cardiovascular magnetic resonance (CMR) studies in patients with implanted cardioverter/defibrillators (ICD) are increasingly required in daily clinical practice. However, the clinical experience regarding the feasibility as well as clinical value of CMR studies in patients with subcutaneous ICD (S-ICD) is still limited. Besides safety issues, image quality and analysis can be impaired primarily due the presence of image artefacts associated with the generator. METHODS:Twenty-three patients with an implanted S-ICD (EMBLEM, Boston Scientific, Marlborough, Massachusetts, USA; MR-conditional) with suspected cardiomyopathy and/or myocarditis underwent multi-parametric CMR imaging. Studies were performed on a 1.5 T CMR scanner after device interrogation and comprised standard a) balanced steady state free precession cine, b) T2 weighted-edema, c) velocity-encoded cine flow, d) myocardial perfusion, e) late-gadolinium-enhancement (LGE)-imaging and f) 3D-CMR angiography of the aorta. In case of substantial artefacts, alternative CMR techniques such as spoiled gradient-echo cine-sequences and wide-band inversion-recovery LGE (wb-LGE) sequences were applied. RESULTS:Successful CMR studies could be performed in all patients without any case of unexpected early termination or relevant technical complication other than permanent loss of the S-ICD system beeper volume in 52% of our patients. Assessment of cine-CMR images was predominantly impaired in the left ventricular (LV) anterior, lateral and inferior wall segments and a switch to spoiled gradient echo-based cine-CMR allowed an accurate assessment of cine-images in N?=?17 (74%) patients with only limited artefacts. Hyperintensity artefacts in conventional LGE-images were predominantly observed in the LV anterior, lateral and inferior wall segments and image optimisation by use of the wb-LGE was helpful in 15 (65%) cases. Aortic flow measurements and 3D-CMR angiography were assessable in all patients Perfusion imaging artefacts precluded a meaningful assessment in at least one half of the patients. A benefit in clinical-decision making was documented in 17 (74%) patients in the present study. CONCLUSION:Safe 1.5?T CMR imaging was possible in all patients with an S-ICD, though the majority had permanent loss of the S-ICD beeper volume. Achieving good image quality may be challenging in some patients - particularly for perfusion imaging. Using spoiled gradient echo-based cine-sequences and wb-LGE sequences may help to reduce the extent of artefacts, thereby allowing accurate cardiac assessment. Thus, 1.5?T CMR studies should not be withhold in patients with S-ICD for safety concerns and/or fear of extensive imaging artefacts precluding successful image analysis.

Project description:ImportanceCardiac resynchronization therapy (CRT) reduces the risk for mortality and heart failure-related events in select patients. Little is known about the use of CRT in combination with an implantable cardioverter defibrillator (ICD) in patients who are eligible for this therapy in clinical practice.ObjectiveTo (1) identify patient, clinician, and hospital characteristics associated with CRT defibrillator (CRT-D) use and (2) determine the extent of hospital-level variation in the use of CRT-D among guideline-eligible patients undergoing ICD placement.Design, setting, and participantsMulticenter retrospective cohort from 1428 hospitals participating in the National Cardiovascular Data Registry ICD Registry between April 1, 2010, and June 30, 2014. Adult patients meeting class I or IIa guideline recommendations for CRT at the time of device implantation were included in this study.Main outcomes and measuresImplantation of an ICD with or without CRT.ResultsA total of 63 506 eligible patients (88.6%) received CRT-D at the time of device implantation. The mean (SD) ages of those in the ICD and CRT-D groups were 67.9 (12.2) years and 68.4 (11.5) years, respectively. In hierarchical multivariable models, black race was independently associated with lower use of CRT-D (odds ratio [OR], 0.77; 95% CI, 0.71-0.83) as was nonprivate insurance (OR, 0.90; 95% CI, 0.85-0.95 for Medicare and OR, 0.73; 95% CI, 0.65-0.82 for Medicaid). Clinician factors associated with greater CRT-D use included clinician implantation volume (OR, 1.01 per 10 additional devices implanted; 95% CI, 1.01-1.01) and electrophysiology training (OR, 3.13 as compared with surgery-boarded clinicians; 95% CI, 2.50-3.85). At the hospital level, the overall median risk-standardized rate of CRT-D use was 79.9% (range, 26.7%-100%; median OR, 2.08; 95% CI, 1.99-2.18).Conclusions and relevanceIn a national cohort of patients eligible for CRT-D at the time of device implantation, nearly 90% received a CRT-D device. However, use of CRT-D differed by race and implanting operator characteristics. After accounting for these factors, the use of CRT-D continued to vary widely by hospital. Addressing disparities and variation in CRT-D use among guideline-eligible patients may improve patient outcomes.

Dataset Information

Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.

Publications

Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.

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