scholarly journals The Cumulative Effects and Clinical Safety of Repeat Magnetic Resonance Imaging on an MRI-conditional Pacemaker System at 1.5-Tesla

2020 ◽  
Author(s):  
Thuy D. Nguyen ◽  
Sarah A. Sandberg ◽  
Amir K. Durrani ◽  
Kevin W. Mitchell ◽  
Matthew D. Keith ◽  
...  
2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Wolfgang Rudolf Bauer ◽  
Dennis H. Lau ◽  
Christian Wollmann ◽  
Andrew McGavigan ◽  
Jacques Mansourati ◽  
...  

AbstractMagnetic 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.


2018 ◽  
Vol 20 (2) ◽  
pp. 68-71
Author(s):  
Naoko Kamiya ◽  
Shuji Hatakeyama ◽  
Naoki Kanda ◽  
Sho Yonaha ◽  
Dai Akine ◽  
...  

2017 ◽  
Vol 12 (8) ◽  
pp. 910-914 ◽  
Author(s):  
Kuan H Ng ◽  
Mukul Sharma ◽  
Oscar Benavente ◽  
Laura Gioia ◽  
Thalia S Field ◽  
...  

Rationale Patients with transient ischemic attack or minor stroke are at high risk of early recurrent cerebrovascular events. Anticoagulation with heparin or warfarin acutely after ischemic stroke is at least as efficacious as aspirin for preventing recurrent events but is associated with an increased risk of clinical worsening due to hemorrhagic transformation. Aim and hypothesis We aim to demonstrate the safety of early anticoagulation with dabigatran, an oral direct thrombin inhibitor, in acute cerebrovascular syndrome patients. The primary hypothesis is that symptomatic hemorrhagic transformation rates in dabigatran and aspirin-treated patients will be similar. Sample size estimates At least 136 participants in two groups required to demonstrate an absolute between-group difference in the rate of hemorrhagic transformation of 5.6% with 80% power, assuming alpha = 5%. Methods and design A randomized, multicenter open-label clinical trial (NCT02295826). Three-hundred participants with a transient ischemic attack/ischemic stroke (National Institutes of Health Stroke Scale ≤ 9) will undergo magnetic resonance imaging within 72 h of symptom onset and will be randomized to aspirin 81 mg daily or dabigatran 150 mg twice daily for 30 days. Participants undergo repeat magnetic resonance imaging at 30 days and clinical assessment to 90 days. Study outcomes The primary outcome is the symptomatic hemorrhagic transformation rate. Secondary outcomes include recurrent stroke and new ischemic lesions on repeat magnetic resonance imaging. Discussion This study will determine the safety of early anticoagulation with dabigatran in patients with acute transient ischemic attack/ischemic stroke and will inform the design of a phase III randomized trial aimed at demonstrating reduced recurrent early ischemic events after acute transient ischemic attack/stroke.


Heart Rhythm ◽  
2015 ◽  
Vol 12 (6) ◽  
pp. 1183-1191 ◽  
Author(s):  
William M. Bailey ◽  
Lawrence Rosenthal ◽  
Lameh Fananapazir ◽  
Marye Gleva ◽  
Alexander Mazur ◽  
...  

2016 ◽  
Vol 10 (3) ◽  
pp. 661-667 ◽  
Author(s):  
Salvatore Vadala di Prampero ◽  
Marco Marino ◽  
Francesco Toso ◽  
Claudio Avellini ◽  
Vu Nguyen ◽  
...  

Extraintestinal manifestations are common in inflammatory bowel disease; however, muscular involvement in Crohn disease is rarely reported. We present a case of a 26-year-old male with ileocolonic Crohn disease who developed sudden tenderness in both calves. Doppler ultrasound was negative for deep vein thrombosis. Magnetic resonance imaging of the gastrocnemius muscle showed high intensity signal in the muscle fibers, and muscle biopsy demonstrated nonspecific lymphocytic myositis. Other relevant laboratory results included normal antineutrophil cytoplasmic antibodies and creatine kinase as well as elevated C-reactive protein, erythrocyte sedimentation rate, and anti-Saccharomyces cerevisiae IgG titer. The patient was in clinical remission, being treated with azathioprine 2.5 mg/kg. Prednisone 60 mg/day was initiated with rapid resolution of calf tenderness; however, tenderness soon returned when the dose was tapered to 10 mg/day. Subsequently, prednisone and azathioprine were discontinued, and adalimumab was started at standard induction and maintenance doses. The patient’s symptoms resolved shortly after the first induction dose. A repeat magnetic resonance imaging of the calves – 3 months after starting adalimumab – showed complete resolution of muscle inflammation. To our knowledge, this is the first case of gastrocnemius myositis – a rare extraintestinal manifestation of Crohn disease – successfully treated with anti-tumor necrosis factor agents.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R Murphy ◽  
R K Kerley ◽  
P K Kearney

Abstract Background Cardiac implantable electronic devices (CIEDs) were long considered a contraindication for magnetic resonance imaging (MRI). Modern devices are now MRI conditional, but still the majority of CIEDs in the population are legacy devices and are classified as unsafe for MRI. There is growing consensus that MRI is also safe in these patients. Purpose The purpose of this study was to perform an up to date systematic review of the evidence evaluating the use of MRI in patients with non-conditional CIEDs. Methods Searches of the PubMed, CINAHL and Embase databases were performed. Studies that assessed the rate of adverse outcomes after MRI in patients with non-conditional CIEDs were included. Studies were excluded if they did not disclose the conditionality of patients CIEDs. Case reports or case series were not included. Results 36 cohort studies were identified. No patient in these studies died during or immediately after MRI. Symptom associated with either torque or heating occurred in <1% of patients. Electrical resets occurred 1–2% of patients. There were no cases of non-conditional lead or generator failure. Inappropriate pacing occurred in <1% of patients. No ICD shocks occurred during MRI. Changes in CIED parameters occurred in 1–4% of patients. Conclusions This systematic review highlights the relative safety of the use of MRI in patients with non-conditional CIEDs. Demonstrated be the fact that no deaths or device shocks have been suffered as a consequence of MRI in any of these studies, and the extremely low incidence of device or lead related complications. Still strict selection and monitoring protocol should be used when imaging these patients. FUNDunding Acknowledgement Type of funding sources: None.


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