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https://www.readbyqxmd.com/read/28214795/pre-implantation-balloon-aortic-valvuloplasty-and-clinical-outcomes-following-transcatheter-aortic-valve-implantation-a-propensity-score-analysis-of-the-uk-registry
#1
Glen P Martin, Matthew Sperrin, Rodrigo Bagur, Mark A de Belder, Iain Buchan, Mark Gunning, Peter F Ludman, Mamas A Mamas
BACKGROUND: Aortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short-term outcomes in the UK TAVI registry. METHODS AND RESULTS: Eleven clinical endpoints were investigated, including 30-day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety...
February 18, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28211168/the-medtronic-micro-vascular-plug%C3%A2-for-vascular-embolization-in-children-with-congenital-heart-diseases
#2
Shyam Sathanandam, Henri Justino, B Rush Waller, Srinath T Gowda, Wolfgang Radtke, Athar M Qureshi
OBJECTIVES: To describe the early multi-center, clinical experience with the Medtronic Micro Vascular Plug™ (MVP) in children with congenital heart disease (CHD) undergoing vascular embolization. BACKGROUND: The MVP is a large diameter vascular occlusion device that can be delivered through a microcatheter for embolization of abnormal blood vessels. METHODS: A retrospective review of embolization procedures using the MVP in children with CHD was performed in 3-centers...
February 16, 2017: Journal of Interventional Cardiology
https://www.readbyqxmd.com/read/28207657/3-tesla-kinematic-mri-of-the-cervical-spine-for-evaluation-of-adjacent-level-disease-after-monosegmental-anterior-cervical-discectomy-and-arthroplasty-results-of-2-year-follow-up
#3
Steffen K Fleck, Soenke Langner, Christian Rosenstengel, Rebecca Kessler, Marc Matthes, Jan-Uwe Müller, Inga Langner, Sascha Marx, Henry W S Schroeder
STUDY DESIGN: We prospectively evaluated adjacent disc levels after anterior cervical discectomy and arthroplasty (ACDA) using kinematic magnetic resonance imaging (MRI) and plain functional radiographs. OBJECTIVE: ACDA is an established treatment for degenerative cervical disc disease. The objective of this study was to evaluate the use of kinematic MRI for assessing the range of motion (ROM) before and after ACDA compared with plain functional radiographs and to evaluate adjacent degenerative disc disease (aDDD) at mid-term follow-up...
February 15, 2017: Spine
https://www.readbyqxmd.com/read/28205324/evaluation-of-subcutaneous-glucose-monitoring-systems-under-routine-environmental-conditions-in-patients-with-type-1-diabetes
#4
Felix Aberer, Martin Hajnsek, Markus Rumpler, Sabine Zenz, Petra Baumann, Hesham Elsayed, Adelheid Puffing, Gerlies Treiber, Thomas R Pieber, Harald Sourij, Julia K Mader
: Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared sensor performance of three commercially available GM systems. 12 patients with type 1 diabetes were included in a single-centre, open-label study where sensor performance of Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo- and hyperglycaemia)...
February 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28196521/comparison-of-two-independent-systematic-reviews-of-trials-of-recombinant-human-bone-morphogenetic-protein-2-rhbmp-2-the-yale-open-data-access-medtronic-project
#5
Jeffrey Low, Joseph S Ross, Jessica D Ritchie, Cary P Gross, Richard Lehman, Haiqun Lin, Rongwei Fu, Lesley A Stewart, Harlan M Krumholz
BACKGROUND: It is uncertain whether the replication of systematic reviews, particularly those with the same objectives and resources, would employ similar methods and/or arrive at identical findings. We compared the results and conclusions of two concurrent systematic reviews undertaken by two independent research teams provided with the same objectives, resources, and individual participant-level data. METHODS: Two centers in the USA and UK were each provided with participant-level data on 17 multi-site clinical trials of recombinant human bone morphogenetic protein-2 (rhBMP-2)...
February 15, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28194664/phrenic-nerve-stimulation-during-neck-dissection-for-advanced-thyroid-cancer-involving-level-iv-is-it-worth-doing-it
#6
Carlos S Duque, Juan P Dueñas, Marcela Marulanda, Diana Pérez, Andres Londoňo, Soham Roy, Mai Al Khadem
During thyroidectomy and neck dissection surgery for advanced or recurrent metastatic thyroid cancer under intraoperative monitoring, we used the available technology to assess the feasibility of such an intervention to monitor those patients with phrenic nerves at risk. A retrospective review of patients operated on from January 2009 to December 2015 by a single surgeon (CSD) was conducted. Patients who had neck and mediastinal dissection, with or without total thyroidectomy, due to advanced or recurrent metastatic disease to the neck were selected...
February 13, 2017: Updates in Surgery
https://www.readbyqxmd.com/read/28190507/best-practices-in-early-phase-medical-device-development-engineering-prototyping-and-the-beginnings-of-a-quality-management-system
#7
Kristy Fearis, Aidan Petrie
Kristy Fearis is the founder and president of KPConsulting. She has held various positions in the medical device and research industry. She has led programs for medical industry leaders Medtronic, Edward Lifesciences, and Kimberly-Clark Healthcare to develop and commercialize Class II and III devices. Although a true quality management systems specialist at heart, Kristy has a passion for effectively and efficiently applying quality systems principles to early stage development to maximize benefit while minimizing impact on resources and time to market...
March 2017: Surgery
https://www.readbyqxmd.com/read/28186475/programmable-shunt-valve-interactions-with-osseointegrated-hearing-devices
#8
Matthew J Pierson, Daniel Wehrmann, J Andrew Albers, Najib E El Tecle, Dary Costa, Samer K Elbabaa
OBJECTIVE Patients with ventriculoperitoneal (VP) shunts with programmable valves who would benefit from osseointegrated hearing devices (OIHDs) represent a unique population. The aim of this study was to evaluate the magnetic field strengths of 4 OIHDs and their interactions with 5 programmable VP shunt valves. METHODS Magnetic field strength was measured as a function of distance for each hearing device (Cochlear Baha 5, Cochlear Baha BP110, Oticon Ponto Plus Power, and Medtronic Sophono) in the following modes: inactive, active in quiet, and active in 60 decibels of background noise in the sound booth...
February 10, 2017: Journal of Neurosurgery. Pediatrics
https://www.readbyqxmd.com/read/28185817/outcomes-following-melody-transcatheter-pulmonary-valve-implantation-for-right-ventricular-outflow-tract-dysfunction-in-repaired-congenital-heart-disease-first-reported-australian-single-centre-experience
#9
Ryan Markham, Abhinay Challa, Stephen Kyranis, Mugur Nicolae, Dale Murdoch, Michael Savage, Theresa Malpas, Dorothy J Radford, Christian Hamilton-Craig, Darren L Walters
BACKGROUND: Transcatheter pulmonary valve implantation (TPVI) with the Melody® transcatheter pulmonary valve (TPV) has demonstrated good haemodynamic and clinical outcomes in the treatment of right ventricular outflow tract (RVOT) conduit dysfunction in patients with repaired congenital heart disease CHD. We present the first Australian single centre experience of patients treated with Melody TPV. METHOD: A prospective, observational registry was developed to monitor clinical and haemodynamic outcomes in patients with RVOT dysfunction treated with the Melody TPV (Medtronic Inc, Minneapolis, United States)...
January 24, 2017: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/28183466/early-clinical-outcomes-after-transcatheter%C3%A2-aortic-valve-replacement-using-a-novel-self-expanding-bioprosthesis%C3%A2-in%C3%A2-patients-with-severe%C3%A2-aortic%C3%A2-stenosis-who-are-suboptimal%C3%A2-for%C3%A2-surgery-results-of-the-evolut-r-u-s-study
#10
Jeffrey J Popma, Michael J Reardon, Kamal Khabbaz, J Kevin Harrison, G Chad Hughes, Susheel Kodali, Isaac George, G Michael Deeb, Stan Chetcuti, Robert Kipperman, John Brown, Hongyan Qiao, James Slater, Mathew R Williams
OBJECTIVES: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement. BACKGROUND: A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment. METHODS: The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States...
February 13, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28160364/peripheral-nerve-stimulation-of-brachial-plexus-nerve-roots-and-supra-scapular-nerve-for-chronic-refractory-neuropathic-pain-of-the-upper-limb
#11
Bénédicte Bouche, Marie Manfiotto, Philippe Rigoard, Jean Lemarie, Véronique Dix-Neuf, Michel Lanteri-Minet, Denys Fontaine
OBJECTIVES: We report the outcome of a consecutive series of 26 patients suffering from chronic medically-refractory neuropathic pain of the upper limb (including 16 patients with complex regional pain syndrome), topographically limited, treated by brachial plexus (BP) nerve roots or supra-scapular nerve (SSN) peripheral nerve stimulation (PNS). MATERIALS AND METHODS: The technique consisted in ultrasound-guided percutaneous implantation of a cylindrical lead (Pisces-Quad, Medtronic) close to the SSN or the cervical nerve roots within the BP, depending on the pain topography...
February 3, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28151413/use-of-the-0-027-inch-via-microcatheter-for-delivery-of-pipeline-flex-a-technical-note
#12
REVIEW
Li-Mei Lin, Geoffrey P Colby, Matthew Bender, Risheng Xu, Judy Huang, Rafael J Tamargo, Alexander L Coon
BACKGROUND: The Pipeline Embolization Device (PED; Medtronic Neurovascular, Irvine, California, USA) is designed for delivery through a 0.027″ microcatheter. Challenges with the second-generation PED Flex include limited support from the Marksman microcatheter for consistent resheathing and transmission of push forces for device delivery. The VIA27 (Sequent Medical/MicroVention Terumo, Tustin, California, USA) is an alternative 0.027″ microcatheter originally designed for intrasaccular flow diverter delivery...
February 1, 2017: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/28150422/successful-restoration-of-fecal-continence-using-sacral-nerve-stimulation-following-chemoradiation-and-transanal-excision-of-an-anal-melanoma-with-partial-internal-anal-sphincter-resection-a-case-report
#13
Tyler Cameron Tolopka, Craig A Messick
OBJECTIVE: This case report provides evidence for our hypothesis that use of a sacral nerve stimulator may be considered in patients with fecal incontinence (FI) following chemoradiation and transanal operations in the setting of cancer including partial internal sphincter resections. MATERIALS AND METHODS: A 57-year-old female with a history of anal melanoma was treated with neoadjuvant chemoradiation followed by wide local, transanal tumor excision with partial internal anal sphincter resection that resulted in ≥2 full fecal incontinent episodes/week with gas, liquid, and solid stool leakage ≥10/day requiring pad changes...
February 1, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28145874/comparative-matched-outcome-of-evolut-r-vs-corevalve-transcatheter-aortic-valve-implantation
#14
Uri Landes, Tamir Bental, Alon Barsheshet, Abid Assali, Hana Vaknin Assa, Amos Levi, Katia Orvin, Ran Kornowski
OBJECTIVES: The Evolut-R (Medtronic, Inc) is a transcatheter aortic valve implantation (TAVI) system that was built on the well-established foundation of Medtronic's CoreValve device platform. Although already in extensive clinical utilization, it is unknown if the Evolut-R improves TAVI outcomes. Herein, we compared TAVI outcomes of the Evolut-R and CoreValve devices. METHODS: A propensity score 1:1 matching was conducted on 358 Evolut-R patients (n = 75) and CoreValve patients (n = 283)...
February 2017: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/28139202/postoperative-analysis-of-the-mechanical-interaction-between-stent-and-host-tissue-in-patients-after-transcatheter-aortic-valve-implantation
#15
Raoul Hopf, Simon H Sündermann, Silvia Born, Carlos E Ruiz, Nicolas M Van Mieghem, Peter P de Jaegere, Francesco Maisano, Volkmar Falk, Edoardo Mazza
The analysis is based on a finite element procedure to extract the contact forces between an implanted Nitinol stent and the surrounding host tissue using postoperative CT images. The methodology was applied for patients (N=46) which have undergone a TAVI procedure with the Medtronic CoreValve Revalving System (MCRS) to obtain corresponding deformation and force maps. The postoperative CT data were recorded for each patient in both systolic and diastolic phase of the heart cycle. Scalar parameters were defined, which map deformed geometry and contact force field to mechanically relevant quantities: radial dilatation, radial shape distortion, non-convex points, mean force, a force deviation measure and a pressure equivalent...
December 30, 2016: Journal of Biomechanics
https://www.readbyqxmd.com/read/28134564/glucose-outcomes-with-the-in-home-use-of-a-hybrid-closed-loop-insulin-delivery-system-in-adolescents-and-adults-with-type-1-diabetes
#16
Satish K Garg, Stuart A Weinzimer, William V Tamborlane, Bruce A Buckingham, Bruce W Bode, Timothy S Bailey, Ronald L Brazg, Jacob Ilany, Robert H Slover, Stacey M Anderson, Richard M Bergenstal, Benyamin Grosman, Anirban Roy, Toni L Cordero, John Shin, Scott W Lee, Francine R Kaufman
BACKGROUND: The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated. METHODS: Adolescents (n = 30, ages 14-21 years) and adults (n = 94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMed(®) 670G system was used during a 2-week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, with Auto Mode enabled during a 3-month study phase...
January 30, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28134226/-the-evaluation-of-the-ventricular-arrhythmias-and-interventions-of-cardiac-implantable-electronic-devices-in-patients-with-dilated-cardiomyopathy-for-primary-prevention-of-sudden-cardiac-death-in-ambulatory-and-telemetric-follow-up
#17
Jacek Lelakowski, Anna Rydlewska, Maria Lelakowska, Joanna Pudło, Justyna Piekarz
: Telemetric follow-up (RM) after cardiac devices implantation is not inferior to classic follow-up and enables earlier clinical complications detection. AIM: The aim of the study was to evaluation of the ventricular arrhythmias and interventions of ICD/CRTD in ambulatory and telemetric follow-up in patients with dilated cardiomyopathy. MATERIALS AND METHODS: Group A (CRT-D+ICD) - retrospective, patients followed-up in outpatient clinic - was consisted with 273 patients (mean age 65±11 years, 230M)...
January 23, 2017: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/28131864/comparison-of-fine-needle-aspiration-and-fine-needle-biopsy-for-eus-guided-sampling-of-suspected-gi-stromal-tumors
#18
Abdul Hamid El Chafic, David Loren, Ali Siddiqui, Rawad Mounzer, Natalie Cosgrove, Thomas Kowalski
BACKGROUND AND AIM: Subepithelial lesions (SEL) are found in about 1% of all esophagogastroduodenoscopy (EGD) procedures, and GI stromal tumors (GISTs) are a type of SEL commonly encountered. Although the majority of SELs are benign, GISTs have malignant potential, making a definitive diagnosis important. Currently, the criterion standard for the diagnosis of GISTs is EUS-directed fine-needle aspiration (EUS-FNA). The definitive diagnosis of GISTs relies upon immunohistochemical (IHC) staining, which depends on enough tissue being submitted to the pathologist...
January 25, 2017: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/28131425/evaluation-of-hemodynamic-performance-of%C3%A2-aortic-valve-bioprostheses-in-a-model-of%C3%A2-oversizing
#19
John D Cleveland, Michael E Bowdish, Carol E Eberhardt, Wendy J Mack, James A Crabtree, Thomas A Vassiliades, Alan M Speir, Yogesh A Darekar, Amy E Hackmann, Vaughn A Starnes, Robbin G Cohen
BACKGROUND: The risk of patient-prosthesis mismatch drives most surgeons to select the largest bioprosthesis possible during aortic valve replacement, but interactions between the native aortic annulus and valve prosthesis remain poorly defined. We examined the hemodynamic and functional consequences of oversizing contemporary bioprostheses in an in vitro model. METHODS: Three sizes each (21, 23, and 25 mm) of 5 aortic bioprostheses (Magna, Edwards Lifesciences, Irvine, CA; Trifecta and Epic, St...
January 25, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/28128540/determinants-of-aortic-regurgitation-after-transcatheter-aortic-valve-implantation-an-observational-study-using-multi-slice-computed-tomography-msct-guided-sizing
#20
Zouhair Rahhab, Nahid El Faquir, Ramón Rodríguez-Olivares, Claire Ren, Nicolas VAN Mieghem, Marcel L Geleijnse, Carl Schultz, Ron VAN Domburg, Peter P DE Jaegere
BACKGROUND: To explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using Multi Slice Computed Tomography (MSCT) instead of echocardiography-guided sizing. METHODS: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic(MCS, n=259) or Edwards Sapien or XT(ESV, n=54) using MSCT- guided sizing. AR was assessed by angiography immediately after TAVI (n=313, Sellers) and by echocardiography at discharge (n=285, VARC-2)...
January 27, 2017: Journal of Cardiovascular Surgery
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