MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: Randomized trial results

Shenthar, Jayaprakash; Milašinović, Goran; Fagih, Ahmed Al; Götte, Marco J.W.; Engel, Gregory; Wolff, Steven; Tse, Hung‐Fat; Herr, Julie; Carrithers, John A.; Cerkvenik, Jeffrey; Nähle, C.

doi:10.1016/j.hrthm.2014.12.035

Cited by 34 publications

(14 citation statements)

References 18 publications

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“…5 The MR-ICD had specific design and material modifications to reduce interaction with the MRI environment as described elsewhere. 6 Briefly, ferromagnetic material was reduced, a hall sensor replaced the mechanical reed switch, filters to prevent gradient and radiofrequency energy coupling were added, and battery circuitry protection was built in.…”

Section: Study Devicementioning

confidence: 99%

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Schwitter

Gold

Fagih

et al. 2016

Circ: Cardiovascular Imaging

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C ardiac magnetic resonance imaging (MRI) is generally accepted as a valuable diagnostic tool to detect and monitor a large variety of cardiac diseases; it has both excellent tissue characterization capabilities and high image quality in most cases. In a large population of >9900 patients cardiac image quality was shown to be diagnostic in 98.2%. 1 Even in the presence of a pacemaker system, the diagnostic quality of cardiac MRI (CMR) of the left (LV) and right (RV) ventricles is preserved. 2 Thus, the high reliability and robustness of CMR is known for patients implanted with a pacemaker system. It is estimated that >60% of patients implanted with an ICD will require an MRI within 10 years post implant, 3 and recently an MR-conditional ICD system was shown to be safe and effective when scanned at 1.5 Tesla (T). 4 In comparison with pacemakers, the larger size of the ICD pulse generator Background-Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system. Methods and Results-The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single-or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD-and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001). Conclusions-FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02117414.(Circ Cardiovasc Imaging. 2016;9:e004025.

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Section: Study Devicementioning

confidence: 99%

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Schwitter

Gold

Fagih

et al. 2016

Circ: Cardiovascular Imaging

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“…published data from a randomized, multicenter trial of 266 patients implanted with a dual‐chamber MRI conditional pacemaker. Investigators reported no MRI scan‐related complications in 156 patients who underwent 1.5‐T MRI scanning using a series of chest and head sequences at 9–12 weeks after implant . In a single‐center pilot study by Wollmann et al., there were no MRI scan‐related adverse events reported in 36 patients who underwent cMRI scan.…”

Section: Discussionmentioning

confidence: 98%

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI

Ching

Chakraborty

Kler

et al. 2017

Pacing Clinical Electrophis

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“…17 Many patients with suspected CS, however, have received a pacemaker, ICD or CRTD, which are contraindicated for CMR, except for the recently introduced MR-conditional pacemaker. 28 Twenty-five patients (48%) could not undergo CMR for the diagnosis of CS, and 34 patients (65%) required cardiac-assist devices. SPECT is an essential tool to assess myocardial injury for such patients.…”

Section: Discussionmentioning

confidence: 99%

Diagnosis and Detection of Myocardial Injury in Active Cardiac Sarcoidosis　– Significance of Myocardial Fatty Acid Metabolism and Myocardial Perfusion Mismatch –

Momose

Fukui

Kondo

et al. 2015

Circ J

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Background: Myocardial injury can be detected more sensitively using 123 I-radioiodinated 15-(p-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP) than thallium-201 (TL). The present study investigated whether 18 F-fluorodeoxyglucose-positron emission tomography (FDG-PET) uptake as an index of active inflammation in patients with cardiac sarcoidosis (CS) is associated with BMIPP and TL findings, and whether dual single-photon emission computed tomography (SPECT) can facilitate diagnosis of CS. Methods and Results:We retrospectively enrolled 52 consecutive patients with suspected CS who were assessed on FDG-PET/computed tomography (CT) and BMIPP/TL dual SPECT. The SPECT images were divided into 17 segments and then BMIPP and TL total defect scores (BMDS, TLDS) as well as mismatch scores (BMDS-TLDS: sumMS) were calculated. Maximum standardized uptake value (SUVmax) in the entire myocardium was obtained from FDG-PET/CT. SUVmax was much higher in patients with, than without CS (P<0.0001). BMDS was higher and sumMS much higher in CS (P<0.05 and P<0.0001, respectively). The sensitivity and specificity of sumMS to detect CS were 74% and 80%, respectively. SUVmax was not associated with either BMDS or sumMS in the patients with CS. On multivariate analysis, the combination of sumMS and SUVmax had greater prognostic significance compared with each parameter on its own. equipped with low-energy general-purpose collimators. Data were acquired over 180° in 32 steps of 50 s each in a 64×64 matrix with electrocardiographic gating of 8 frames per cardiac cycle. The TL and BMIPP data were obtained using symmetrical 72±10-and 159±10-keV windows, respectively, to separate the distribution of the isotopes. 18 Conclusions CMRPatients without the relevant contraindication underwent CMR. Cardiac MR images were acquired on either Intera Achieva 1.5T (Phillips) or Ingenia 3.0T (Phillips) with a cardiac-dedicated phased-array coil. Cine images were acquired in multiple short-axis, vertical long-axis and 4-chamber view for assessment of LV function. Ten minutes after the additional administration of 0.1 mmol/kg gadolinium-DTPA, short-axis and 4-chamber images were obtained with spin echo to assess for the presence of late gadolinium-enhancing (LGE) lesions.

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MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: Randomized trial results

Abstract: MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.

Cited by 34 publications

References 18 publications

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI

Diagnosis and Detection of Myocardial Injury in Active Cardiac Sarcoidosis　– Significance of Myocardial Fatty Acid Metabolism and Myocardial Perfusion Mismatch –

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MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: Randomized trial results

Abstract: MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.

Cited by 34 publications

References 18 publications

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI

Diagnosis and Detection of Myocardial Injury in Active Cardiac Sarcoidosis – Significance of Myocardial Fatty Acid Metabolism and Myocardial Perfusion Mismatch –

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Diagnosis and Detection of Myocardial Injury in Active Cardiac Sarcoidosis　– Significance of Myocardial Fatty Acid Metabolism and Myocardial Perfusion Mismatch –