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https://www.readbyqxmd.com/read/28437339/a-multicenter-evaluation-of-clinical-and-radiographic-outcomes-following-high-grade-spondylolisthesis-reduction-and-fusion
#1
Gurpreet S Gandhoke, Manish K Kasliwal, Justin S Smith, JoAnne Nieto, David Ibrahimi, Paul Park, Frank Lamarca, Christopher Shaffrey, David O Okonkwo, Adam S Kanter
OBJECTIVE: A retrospective review of the clinical and radiographic outcomes from a multicenter study of surgical treatment for high-grade spondylolisthesis (HGS) in adults. The objective was to assess the safety of surgical reduction, its ability to correct regional deformity, and its clinical effectiveness. METHODS: Retrospective, multicenter review of adults (age above 18 y) with lumbosacral HGS (Meyerding grade 3-5) treated surgically with open decompression, attempted reduction, posterior instrumentation, and interbody fusion...
May 2017: Clinical Spine Surgery
https://www.readbyqxmd.com/read/28437244/second-transcatheter-closure-for-residual-shunt-following-percutaneous-closure-of-patent-foramen-ovale
#2
Njomeza Susuri, Slayman Obeid, Mirjam Ulmi, George Cm Siontis, Andreas Wahl, Stephan Windecker, Fabian Nietlispach, Bernhard Meier, Fabien Praz
AIMS: Residual shunt following percutaneous patent foramen ovale (PFO) closure has been described in up to 49% of the patients and is associated with recurrent cerebrovascular events. Our aim was to evaluate the safety, feasibility, and mid-term outcomes of transcatheter residual shunt closure. METHODS AND RESULTS: From 1994 to July 2016, 2679 patients underwent transcatheter PFO closure for treatment of presumed paradoxical embolism at our institution. Among them, 100 patients (3...
April 25, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28436736/are-you-okay-to-drive-commuting-behavior-and-blood-alcohol-concentrations-amongst-restaurant-diners
#3
B Scott-Parker, L Stokes, S Panaho, M Cawkwell, J Caldwell
Objective Drink driving is widely recognised as a major road safety problem. In Australia, health promotion messages encourage monitoring the number of standard drinks consumed prior to driving. The pilot research aimed to investigate commuting behaviour and blood alcohol concentration (BAC) of diners, including intended-drivers, at Sunshine Coast restaurants. Methods Five hundred and forty-four diners (n = 260 males) consented to participate in a brief interview and to use a breathalyser device to measure their BAC...
February 25, 2017: Traffic Injury Prevention
https://www.readbyqxmd.com/read/28434049/a-prospective-study-of-the-safety-and-efficacy-of-a-combined-bipolar-radiofrequency-intense-pulsed-light-and-infrared-diode-laser-treatment-for-global-facial-photoaging
#4
Min Jiang, Fang Yan, Mathew Avram, Zhong Lu
The clinical features of photoaging include: skin texture changes, laxity, rhytides, pigmentary changes, and vascular changes such as erythema and telangiectasias. In order to meet patients' increasing demands for improving all aspects of photoaging at one office visit, employing a multi-modality treatment for all aspects of photoaging has become increasingly desirable for the physician and patient alike. We examine a novel device that employs bipolar radiofrequency (RF), intense pulsed light (IPL), and infrared diode laser...
April 23, 2017: Lasers in Medical Science
https://www.readbyqxmd.com/read/28433400/an-in-home-advanced-robotic-system-to-manage-elderly-home-care-patients-medications-a-pilot-safety-and-usability-study
#5
Pekka Rantanen, Timo Parkkari, Saija Leikola, Marja Airaksinen, Alan Lyles
PURPOSE: We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. METHODS: There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic malfunctions would hinder the device's safe use. Phase II involved home-care patients from 3 sites (n = 27) who were on long-term medication. On-time dispensing and missed doses were recorded by the robotic system...
April 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28432853/an-evidence-based-approach-to-reducing-cardiac-telemetry-alarm-fatigue
#6
Ekta Srinivasa, Jaspreet Mankoo, Charles Kerr
BACKGROUND: It is estimated that between 80% and 99% of alarms in the clinical areas are in actionable alarms (Gross, Dahl, & Nielson). Alarm management is one of the Joint Commission's National Patient Safety Goals (2014) because sentinel events have directly been linked to the devices generating these alarms. PURPOSE: At an acute care facility in Boston, a multidisciplinary team consisting of Nursing, Biomedical Engineers, Patient Safety and Providers was formed to conduct a pilot study on the state of telemetry alarms on a surgical floor...
April 22, 2017: Worldviews on Evidence-based Nursing
https://www.readbyqxmd.com/read/28432775/application-for-lower-facial-fat-reduction-and-tightening-by-static-type-monopolar-1-mhz-radio-frequency%C3%A2-for-body-contouring
#7
Jun Sugawara, Seiko Kou, Kenichi Kokubo, Aimi Kuroda, Yoshie Hashizume, Shinji Kobayashi, Jirou Maegawa, Toshihiko Satake
INTRODUCTION: Liposuction and mesotherapy are popular treatments for fat reduction of lower face, but because these treatments are invasive, a novel non-invasive treatment with similar or better efficacy has been sought. There are various devices such as CoolSculpt, laser, RF, and HIFU that are used as non-invasive treatments for fat reduction and body contouring, but these applications have not been applied to facial fat reduction. In this study, we selected Monopolar 1-MHz RF for body contouring to be applied for fat reduction and tightening of the lower face...
April 22, 2017: Lasers in Surgery and Medicine
https://www.readbyqxmd.com/read/28432385/bioresorbable-vascular-scaffolds-in-coronary-chronic-total-occlusions-revascularization-safety-assessment-related-to-struts-coverage-and-apposition-in-6-month-oct-follow-up
#8
Rosa Alba Abellas-Sequeiros, Raymundo Ocaranza-Sanchez, Ramiro Trillo-Nouche, Carlos Gonzalez-Juanatey, Jose Ramon Gonzalez-Juanatey
Beneficial properties of bioresorbable vascular scaffolds (BVS) regarding to vasomotility restoration and no caging of the vessel make them attractive devices in chronic total occlusions (CTO) revascularization. However, more evidence is needed attending to their use in this specific setting. We aim to determine feasibility and safety of BVS use in CTO revascularization attending to struts coverage and apposition, as well as re-stenosis and stent thrombosis (ST) rates. 29 BVS were deployed in 9 CTO lesions revascularization (mean J-CTO score ≥3) with an acute procedural success rate of 100%...
April 21, 2017: Heart and Vessels
https://www.readbyqxmd.com/read/28431023/safety-and-efficacy-of-the-sofia-6f-plus-distal-access-reperfusion-catheter-in-the-endovascular-treatment-of-acute-ischemic-stroke
#9
Hussain Shallwani, Hakeem J Shakir, Leonardo Rangel-Castilla, Jason M Davies, Ashish Sonig, Mithun G Sattur, Bernard R Bendok, Kenneth V Snyder, Adnan H Siddiqui, Elad I Levy
BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions. OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke. METHODS: In this retrospective study, 41 stroke cases were identified in which the catheter was utilized for thrombolysis/thrombectomy...
April 19, 2017: Neurosurgery
https://www.readbyqxmd.com/read/28430909/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#10
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 18, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28430908/late-thrombotic-events-after-bioresorbable-scaffold-implantation-a-systematic-review-and-meta-analysis-of-randomized-clinical-trials
#11
Carlos Collet, Taku Asano, Yosuke Miyazaki, Erhan Tenekecioglu, Yuki Katagiri, Yohei Sotomi, Rafael Cavalcante, Robbert J de Winter, Takeshi Kimura, Runlin Gao, Serban Puricel, Stéphane Cook, Davide Capodanno, Yoshinobu Onuma, Patrick W Serruys
Aims: To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and Results: A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI)...
April 18, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28430558/lower-esophageal-sphincter-augmentation-for-gastroesophageal-reflux-disease-the-safety-of-a-modern-implant
#12
C Daniel Smith, Robert A Ganz, John C Lipham, Reginald C Bell, David W Rattner
INTRODUCTION: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented. METHODS: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions...
April 21, 2017: Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A
https://www.readbyqxmd.com/read/28429681/microwave-diathermy-in-physiotherapy-units-a-survey-on-spatial-and-time-heterogeneity-of-electromagnetic-field
#13
Andreas Andrikopoulos, Adam Adamopoulos, Ioannis Seimenis, Constantinos Miltiadis Koutsojannis
Microwave diathermy (MWD) is a therapeutic system that is in use for some decades now in all physiotherapy settings, according to national facility establishment regulations. Diathermy devices probably lack validity, as working time passes, introducing the need of control/reset of the device by qualified personnel, in order to maintain its effectiveness in sessions and accurately deliver the energy output the physiotherapist asks for. However, while in the field of physical therapy MWD has been a vital part for practicing the profession of physiotherapist, there is not a clear evidence of health burden due to incorrect usability...
April 21, 2017: Journal of Radiological Protection: Official Journal of the Society for Radiological Protection
https://www.readbyqxmd.com/read/28429537/preliminary-findings-on-the-safety-of-1-5-and-3-tesla-magnetic-resonance-imaging-in-cardiac-pacemaker-patients
#14
V F van Dijk, P P H M Delnoy, J J J Smit, R A Ramdat Misier, A Elvan, H W van Es, B J W M Rensing, G Raciti, L V A Boersma
INTRODUCTION: Modern pacemakers are designed to allow patients to undergo Magnetic Resonance Imaging(MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3 Tesla(T) MRI. METHODS AND RESULTS: Two prospective, non-randomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1...
April 21, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28427972/endovascular-treatment-of-complex-distal-posterior-cerebral-artery-aneurysms-with-the-pipeline-embolization-device
#15
Paul Mazaris, Tapan Mehta, Mohammed Hussain, Violiza Inoa, Justin Singer, Gary Spiegel, Inam Kureshi, Martin Ollenschleger
INTRODUCTION: The purpose of our study is to assess the safety and efficacy of the Pipeline Embolization Device (PED) for endovascular treatment of complex, distal posterior cerebral artery (PCA) aneurysms. METHODS: We conducted a retrospective review of patients who underwent endovascular treatment of complex PCA aneurysms with PED from November 2012 to December 2015. A total of 4 patients were identified and treated. 12 month angiographic and clinical follow-up was available for all patients...
April 17, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/28427582/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#16
REVIEW
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 25, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28427054/preceding-intravenous-thrombolysis-in-patients-receiving-endovascular-therapy
#17
Hong-Kyun Park, Jong-Won Chung, Jeong-Ho Hong, Min Uk Jang, Hyun-Du Noh, Jong-Moo Park, Kyusik Kang, Soo Joo Lee, Youngchai Ko, Jae Guk Kim, Jae-Kwan Cha, Dae-Hyun Kim, Hyun-Wook Nah, Moon-Ku Han, Beom Joon Kim, Tai Hwan Park, Sang-Soon Park, Kyung Bok Lee, Jun Lee, Keun-Sik Hong, Yong-Jin Cho, Byung-Chul Lee, Kyung-Ho Yu, Mi-Sun Oh, Ki-Hyun Cho, Joon-Tae Kim, Dong-Eog Kim, Wi-Sun Ryu, Jay Chol Choi, Wook-Joo Kim, Dong-Ick Shin, Min-Ju Yeo, Sung Il Sohn, Ji Sung Lee, Juneyoung Lee, Byung-Woo Yoon, Hee-Joon Bae
BACKGROUND: The beneficial effects of endovascular therapy (EVT) in acute ischemic stroke have been demonstrated in recent clinical trials using new-generation thrombectomy devices. However, the comparative effectiveness and safety of preceding intravenous thrombolysis (IVT) in this population has rarely been evaluated. METHODS: From a prospective multicenter stroke registry database in Korea, we identified patients with acute ischemic stroke who were treated with EVT within 8 h of onset and admitted to 14 participating centers during 2008-2013...
April 21, 2017: Cerebrovascular Diseases
https://www.readbyqxmd.com/read/28426239/performance-of-an-artificial-pancreas-system-for-young-children-with-type-1-diabetes
#18
Mark D DeBoer, Marc D Breton, Christian Wakeman, Elaine M Schertz, Emma G Emory, Jessica L Robic, Laura L Kollar, Boris P Kovatchev, Daniel R Cherñavvsky
BACKGROUND: Young children 5-8 years old with type 1 diabetes (T1D) exhibit clear needs for improved glycemic control but may be limited in their ability to safely interact with an artificial pancreas system. Our goal was to evaluate the safety and performance of an artificial pancreas (AP) system among young children with T1D. RESEARCH DESIGN AND METHODS: In a randomized, crossover trial, children with T1D age 5-8 years were enrolled to receive on separate study periods (in random order) either the UVa AP using the DiAs Control Platform software with child-resistant lock-out screens (followed as an out-patient admission) or their usual insulin pump+continuous glucose monitor (CGM) care at home...
April 20, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28424922/assistive-technology-for-ultrasound-guided-central-venous-catheter-placement
#19
REVIEW
Mohammad Ikhsan, Kok Kiong Tan, Andi Sudjana Putra
This study evaluated the existing technology used to improve the safety and ease of ultrasound-guided central venous catheterization. Electronic database searches were conducted in Scopus, IEEE, Google Patents, and relevant conference databases (SPIE, MICCAI, and IEEE conferences) for related articles on assistive technology for ultrasound-guided central venous catheterization. A total of 89 articles were examined and pointed to several fields that are currently the focus of improvements to ultrasound-guided procedures...
April 19, 2017: Journal of Medical Ultrasonics
https://www.readbyqxmd.com/read/28424223/low-dose-paclitaxel-coated-versus-uncoated-percutaneous-transluminal-balloon-angioplasty-for-femoropopliteal-peripheral-artery-disease-1-year-results-of-the-illumenate-european-randomized-clinical-trial
#20
Henrik Schroeder, Martin Werner, Dirk-Roelfs Meyer, Peter Reimer, Karsten Krüger, Michael R Jaff, Marianne Brodmann
Background -Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease (PAD) of the superficial femoral and popliteal arteries. However, the treatment effect compared to an uncoated balloon has differed greatly amongst the randomized trials with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low dose (2 µg/mm(2) surface dose of paclitaxel) DCB...
April 19, 2017: Circulation
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