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https://www.readbyqxmd.com/read/28727156/safety-and-effectiveness-of-a-6-french-mri-conditional-pacemaker-lead-the-ingevitytm-clinical-investigation-study-results
#1
Jens C Nielsen, Michael Giudici, Jose Maria Tolasana Viu, Engwooi Chew, Elke Sommerijns, Nicholas Wold, Linda Evert, Charles J Love, Kenneth Stein, Hedrich Olaf
BACKGROUND: The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance and MRI conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads...
July 20, 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/28719087/mri-guided-stereotactic-neurosurgical-procedures-in-a-diagnostic-mri-suite-background-and-safe-practice-recommendations
#2
Paul S Larson, Jon T Willie, Sudhakar Vadivelu, Hooman Azmi-Ghadimi, Amy Nichols, Loretta Litz Fauerbach, Helen Boehm Johnson, Denise Graham
The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI...
July 2017: Journal of Healthcare Risk Management: the Journal of the American Society for Healthcare Risk Management
https://www.readbyqxmd.com/read/28715319/cad-based-virtual-humans-design-and-safety-assessment-of-mri-coils
#3
Gregory M Noetscher, Nicholas D Maino, Patrick Lacroix, Marc Horner, Sara Louie
Magnetic resonance imaging (MRI) is a ubiquitous tool used in clinical settings around the world to provide detailed three-dimensional information on the internal anatomy and physiology of human patients without the use of ionizing radiation, which is the primary safety concern associated with computed tomography. This information is obtained noninvasively and can be used in the diagnosis of pathological conditions as well as the monitoring of treatments.
July 2017: IEEE Pulse
https://www.readbyqxmd.com/read/28715316/virtual-humans-for-implantable-device-safety-assessment-in-mri-mitigating-magnetic-resonance-imaging-hazards-for-implanted-medical-devices
#4
James E Brown, Rui Qiang, Paul J Stadnik, Larry J Stotts, Jeffrey A Von Arx
Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation [1]...
July 2017: IEEE Pulse
https://www.readbyqxmd.com/read/28707952/systemic-delivery-of-dysferlin-overlap-vectors-provides-long-term-functional-improvement-for-dysferlinopathy
#5
Rachael A Potter, Danielle A Griffin, Patricia C Sondergaard, Ryan W Johnson, Eric R Pozsgai, Kristin N Heller, Ellyn L Peterson, Kimmo K Lehtimaki, Hillarie P Windish, Plavi J Mittal, Doug E Albrecht, Jerry R Mendell, Louise R Rodino-Klapac
Dysferlinopathies comprise a family of disorders caused by mutations in the dysferlin (DYSF) gene leading to a progressive dystrophy characterized by chronic muscle fiber loss, fat replacement and fibrosis. To correct the underlying histopathology and function, expression of full-length DYSF is required. We have developed dual adeno-associated virus vectors defined by a region of homology to serve as a substrate for reconstitution of the full 6.5 kb dysferlin cDNA. Our previous work studied the efficacy of this treatment through intramuscular and regional delivery routes...
July 14, 2017: Human Gene Therapy
https://www.readbyqxmd.com/read/28707736/genetically-encoded-iron-associated-proteins-as-mri-reporters-for-molecular-and-cellular-imaging
#6
REVIEW
Anna V Naumova, Greetje Vande Velde
All cell imaging applications rely on some form of specific cell labeling to achieve visualization of cells contributing to disease or cell therapy. The purpose of this review article is to summarize the published data on genetically encoded iron-based imaging reporters. The article overviews regulation of iron homeostasis as well as genetically encoded iron-associated molecular probes and their applications for noninvasive magnetic resonance imaging (MRI) of transplanted cells. Longitudinal repetitive MRI of therapeutic cells is extremely important for providing key functional endpoints and insight into mechanisms of action...
July 14, 2017: Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
https://www.readbyqxmd.com/read/28707043/leadless-pacing-current-state-and-future-direction
#7
REVIEW
Matthias Merkel, Philipp Grotherr, Andrea Radzewitz, Claus Schmitt
Leadless pacing is now an established alternative to conventional pacing with subcutaneous pocket and transvenous lead for patients with class I or II single-chamber pacing indication. Available 12-month follow-up data shows a 48% fewer major complication rate in patients with Micra™ compared to a historical control group in a nonrandomized study [1]. There is one system with Food and Drug Administration (FDA) approval and two with the Communauté Européenne (CE) mark. The OPS code for the implantation is 8-83d...
July 13, 2017: Cardiology and Therapy
https://www.readbyqxmd.com/read/28702969/bi-layered-collagen-nano-structured-membrane-prototype-collagen-matrix-10826%C3%A2-for-soft-tissue-regeneration-in-rabbits-an-in-vivo-ultra-structural-study-of-the-early-healing-phase
#8
D De Santis, G B Menchini Fabris, J Lotti, C Palumbo, M Ferretti, R Castellani, T Lotti, G Zanotti, F Gelpi, C Covani, P F Nocini
Collagen Matrix (CM) 10826 is a nanostructured bi-layered collagen membrane obtained from type I and III porcine collagen, which in vitro has shown to have the potential to be a substitute and/or stimulant for soft oral tissue regeneration. The objective of this study was to evaluate the in vivo potential and safety of this membrane for soft tissue regeneration in the early stage of wound healing. Two soft tissue wounds (test and control) were created on the back skin of 5 rabbits (female New Zealand White Rabbits specific pathogen free)...
July 13, 2017: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28687923/lapatinib-with-whole-brain-radiotherapy-in-patients-with-brain-metastases-from-breast-and-non-small-cell-lung-cancer-a-phase-ii-study-of-the-hellenic-cooperative-oncology-group-hecog
#9
Christos Christodoulou, Anna Kalogera-Fountzila, Vasilios Karavasilis, George Kouvatseas, Christos N Papandreou, Epaminontas Samantas, Kalliopi Varaki, Georgios Papadopoulos, Mattheos Bobos, Grigorios Rallis, Evangelia Razis, Athina Goudopoulou, Konstantine T Kalogeras, Konstantinos N Syrigos, George Fountzilas
Small molecules, mainly tyrosine kinase inhibitors, are currently used in various malignancies. Lapatinib, a dual inhibitor of EGFR/HER2 tyrosine kinases, has demonstrated effectiveness in brain metastases from HER2-overexpressing breast cancer. It also appears to sensitize EGFR-expressing cell lines to radiation. To evaluate the efficacy of lapatinib in combination with whole brain radiotherapy (WBRT) in patients with brain metastases from non-small cell lung cancer (NSCLC) and breast cancer, as assessed by volumetric analysis by MRI...
July 7, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28685382/safety-and-efficacy-of-transarterial-radioembolisation-in-patients-with-intermediate-or-advanced-stage-hepatocellular-carcinoma-refractory-to-chemoembolisation
#10
Elisabeth G Klompenhouwer, Raphaëla C Dresen, Chris Verslype, Annouschka Laenen, Gert De Hertogh, Christophe M Deroose, Lawrence Bonne, Vincent Vandevaveye, Geert Maleux
INTRODUCTION: Transarterial chemoembolisation (TACE) is the most widely used locoregional treatment for patients with an unresectable hepatocellular carcinoma (HCC). Transarterial radioembolisation (TARE) with yttrium-90 containing microspheres is an emerging interventional treatment that could be complementary or an alternative to TACE. AIM: To evaluate the safety and efficacy of TARE in patients with HCC who are refractory to TACE with drug-eluting beads (DEB-TACE)...
July 6, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28685353/peginterferon-beta-1a-reduces-the-evolution-of-mri-lesions-to-black-holes-in-patients-with-rrms-a-post-hoc-analysis-from-the-advance-study
#11
Douglas L Arnold, Xiaojun You, Carmen Castrillo-Viguera
The presence of chronic black holes, i.e., chronic lesions that are hypointense on T1-weighted images and are indicative of more severe tissue injury, has been increasingly utilized as a surrogate marker of therapeutic outcome in multiple sclerosis. The ADVANCE study was a 2-year, double-blind, pivotal trial evaluating the safety and efficacy of subcutaneous peginterferon beta-1a 125 mcg in 1512 patients with relapsing-remitting multiple sclerosis (RRMS). This report describes the correlation of clinical outcomes with the evolution of acute lesions into chronic black holes in ADVANCE, and the efficacy of peginterferon beta-1a in reducing this evolution...
July 7, 2017: Journal of Neurology
https://www.readbyqxmd.com/read/28684845/multiple-fresh-fecal-microbiota-transplants-induces-and-maintains-clinical-remission-in-crohn-s-disease-complicated-with-inflammatory-mass
#12
Zhi He, Pan Li, Jianguo Zhu, Bota Cui, Lijuan Xu, Jie Xiang, Ting Zhang, Chuyan Long, Guangming Huang, Guozhong Ji, Yongzhan Nie, Kaichun Wu, Daiming Fan, Faming Zhang
The ancient Chinese medical literature, as well as our prior clinical experience, suggests that fecal microbiota transplantation (FMT) could treat the inflammatory mass. We aimed to evaluate the efficacy and safety of multiple fresh FMTs for Crohn's disease (CD) complicated with intraabdominal inflammatory mass. The "one-hour FMT protocol" was followed in all patients. Twenty-five patients were diagnosed with CD and related inflammatory mass by CT or MRI. All patients received the initial FMT followed by repeated FMTs every 3 months...
July 6, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28682265/virtual-humans-models-for-electromagnetic-studies-and-their-applications
#13
Sergey Makarov, Gregory Noetscher, Ara Nazarian, Alexander Prokop, Aapo Nummenma
Numerical simulation of the electromagnetic, thermal and mechanical responses of the human body to different stimuli in MRI safety, antenna research, electromagnetic tomography, and electromagnetic stimulation is currently limited by the availability of anatomically adequate and numerically efficient cross-platform computational models or "virtual humans". The objective of this study is to provide a comprehensive review of modern human models and body region models available in the field and their important features...
June 30, 2017: IEEE Reviews in Biomedical Engineering
https://www.readbyqxmd.com/read/28676464/endonasal-endoscopic-odontoidectomy-in-ventral-pathologies-of-the-cranio-cervical-junction-results-of-a-multicenter-experience
#14
Salvatore Chibbaro, Helene Cebula, Sorin Aldea, Bertrand Baussart, Leonardo Tigan, Julien Todeschi, Antonio Romano, Mario Ganau, Christian Debry, Franco Servadei, Francois Proust, Stephane Gaillard
BACKGROUND: Over the past decades, supported by preliminary anatomical and clinical studies exploring its feasibility and safety, an ever growing experience was built on the use of the endoscopic endonasal approach (EEA) to ventral pathologies at the cranio-cervical junction (CCJ). PATIENTS AND METHODS: Multicenter study over a 4 years period on 14 patients managed by EEA odontoidectomy for CCJ pathologies causing irreducible atlanto-axial dislocation. The surgical set up included an IGS system based on CT and MRI images fusion, and 0° and 30° angled endoscopes with dedicated endoscopic tools...
July 1, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/28676065/prior-balloon-valvuloplasty-versus-direct-transcatheter-aortic-valve-implantation-directavi-study-protocol-for-a-randomized-controlled-trial
#15
Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla
BACKGROUND: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation...
July 4, 2017: Trials
https://www.readbyqxmd.com/read/28670405/intradiscal-injection-of-autologous-platelet-rich-plasma-releasate-to-treat-discogenic-low-back-pain-a-preliminary-clinical-trial
#16
Koji Akeda, Kohshi Ohishi, Koichi Masuda, Won C Bae, Norihiko Takegami, Junichi Yamada, Tomoki Nakamura, Toshihiko Sakakibara, Yuichi Kasai, Akihiro Sudo
STUDY DESIGN: Preliminary clinical trial. PURPOSE: To determine the safety and initial efficacy of intradiscal injection of autologous platelet-rich plasma (PRP) releasate in patients with discogenic low back pain. OVERVIEW OF LITERATURE: PRP, which is comprised of autologous growth factors and cytokines, has been widely used in the clinical setting for tissue regeneration and repair. PRP has been shown in vitro and in vivo to potentially stimulate intervertebral disc matrix metabolism...
June 2017: Asian Spine Journal
https://www.readbyqxmd.com/read/28669654/hydrogen-gas-inhalation-treatment-in-acute-cerebral-infarction-a-randomized-controlled-clinical-study-on-safety-and-neuroprotection
#17
Hirohisa Ono, Yoji Nishijima, Shigeo Ohta, Masaki Sakamoto, Kazunori Kinone, Tohru Horikosi, Mituyuki Tamaki, Hirosi Takeshita, Tomoko Futatuki, Wataru Ohishi, Taichi Ishiguro, Saori Okamoto, Shou Ishii, Hiroko Takanami
BACKGROUND: Molecular hydrogen (H2) acts as a therapeutic antioxidant. Inhalation of H2 gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H2 gas. Here, we evaluate the H2 treatment on acute cerebral infarction. METHODS: Through this randomized controlled clinical study, we assessed the safety and effectiveness of H2 treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6)...
June 29, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28668426/fetal-mri-of-the-central-nervous-system-state-of-the-art
#18
REVIEW
Lucia Manganaro, Silvia Bernardo, Amanda Antonelli, Valeria Vinci, Matteo Saldari, Carlo Catalano
Prenatal ultrasonographic (US) examination is considered as the first tool in the assessment of fetal abnormalities. However, several large-scale studies point out that some malformations, in particular central nervous system (CNS) anomalies, are not well characterized through US. Therefore, the actual malformation severity is not always related to prenatal ultrasound (US) findings. Over the past 20 years, ultrafast Magnetic Resonance Imaging (MRI) has progressively increased as a prenatal 3rd level diagnostic technique with a good sensitivity, particularly for the study of fetal CNS malformations...
August 2017: European Journal of Radiology
https://www.readbyqxmd.com/read/28663267/comparison-of-gadoterate-meglumine-and-gadobutrol-in-the-mri-diagnosis-of-primary-brain-tumors-a-double-blind-randomized-controlled-intraindividual-crossover-study-the-remind-study
#19
K R Maravilla, D San-Juan, S J Kim, G Elizondo-Riojas, J R Fink, W Escobar, A Bag, D R Roberts, J Hao, C Pitrou, A J Tsiouris, E Herskovits, J B Fiebach
BACKGROUND AND PURPOSE: Effective management of patients with brain tumors depends on accurate detection and characterization of lesions. This study aimed to demonstrate the noninferiority of gadoterate meglumine versus gadobutrol for overall visualization and characterization of primary brain tumors. MATERIALS AND METHODS: This multicenter, double-blind, randomized, controlled intraindividual, crossover, noninferiority study included 279 patients. Both contrast agents (dose = 0...
June 29, 2017: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/28659052/magnetic-resonance-guided-focused-ultrasound-for-treatment-of-bone-tumors
#20
Vivek Ajit Singh, Syed Usman Shah, Nor Faissal Yasin, Basri Johan Jeet Abdullah
AIMS: Magnetic resonance guided focused ultrasound (MRgFUS) is a new modality in the management of primary and secondary bone tumors. We aimed to investigate the safety, efficacy, and feasibility of using MRgFUS for the treatment of (1) benign bone tumors with the intent of complete tumor ablation, (2) primary malignant bone tumors with the intent to assess its effectiveness in causing tumor necrosis, and (3) metastatic bone disease with the intent of pain relief. METHOD: Twenty-four patients with benign bone tumors, primary malignant bone tumors, and metastatic bone disease were treated with one session of MRgFUS...
May 2017: Journal of Orthopaedic Surgery
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