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https://www.readbyqxmd.com/read/28098579/xen-gel-stent-internal-ostium-occlusion-ab-interno-revision
#1
Nuno Pinto Ferreira, Luis Abegão Pinto, Carlos Marques-Neves
Minimally invasive glaucoma surgery aims to provide a safer and less-invasive means of reducing IOP compared with traditional surgery, with the goal of reducing the need for topical medications. The XEN gel stent is an ab-interno minimally invasive glaucoma surgery device that approaches intraocular pressure reduction by creating a subconjunctival drainage pathway. As with any new device there is lack of experience and knowledge about its long-term results in terms of efficacy, technique, and complications...
January 16, 2017: Journal of Glaucoma
https://www.readbyqxmd.com/read/28097669/mathematical-modeling-of-rotary-blood-pumps-in-a-pulsatile-in-vitro-flow-environment
#2
Tohid Pirbodaghi
Nowadays, sacrificing animals to develop medical devices and receive regulatory approval has become more common, which increases ethical concerns. Although in vivo tests are necessary for development and evaluation of new devices, nonetheless, with appropriate in vitro setups and mathematical models, a part of the validation process can be performed using these models to reduce the number of sacrificed animals. The main aim of this study is to present a mathematical model simulating the hydrodynamic function of a rotary blood pump (RBP) in a pulsatile in vitro flow environment...
January 18, 2017: Artificial Organs
https://www.readbyqxmd.com/read/28096455/multicenter-prospective-study-on-device-associated-infection-rates-and-bacterial-resistance-in-intensive-care-units-of-venezuela-international-nosocomial-infection-control-consortium-inicc-findings
#3
Gabriel D Empaire, Maria E Guzman Siritt, Victor D Rosenthal, Fernando Pérez, Yvis Ruiz, Claudia Díaz, Gabriela Di Silvestre, Evelyn Salinas, Nelva Orozco
BACKGROUND: Device-associated healthcare-acquired infections (DA-HAI) pose a threat to patient safety in the intensive care unit (ICU). METHODS: A DA-HAI surveillance study was conducted by the International Nosocomial Infection Control Consortium (INICC) in two adult medical/surgical ICUs at two hospitals in Caracas, Venezuela, in different periods from March 2008 to April 2015, using the US Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definitions and criteria, and INICC methods...
January 2017: International Health
https://www.readbyqxmd.com/read/28094138/new-normoxic-n-hydroxymethyl-acrylamide-based-polymer-gel-for-3d-dosimetry-in-radiation-therapy
#4
Khalid A Rabaeh, Ahmed A Basfar, Akram A Almousa, Slobodan Devic, Belal Moftah
A novel composition of normoxic polymer gel dosimeters based on radiation-induced polymerization of N-(Hydroxymethyl)acrylamide (NHMA) is introduced in this study for 3D dosimetry for Quality Assurance (QA) in radiation therapy. Dosimeters were irradiated by 6, 10 and 18MV photon beams of a medical linear accelerator at various dose rates to doses of up to 20Gy. The dose response of polymer gel dosimeters was studied using nuclear magnetic resonance (NMR) spin-spin relaxation rate (R2) of hydrogen protons within the water molecule...
January 13, 2017: Physica Medica: PM
https://www.readbyqxmd.com/read/28094136/day-and-night-glycaemic-control-with-closed-loop-insulin-delivery-versus-conventional-insulin-pump-therapy-in-free-living-adults-with-well-controlled-type-1-diabetes-an-open-label-randomised-crossover-study
#5
Lia Bally, Hood Thabit, Harald Kojzar, Julia K Mader, Jehona Qerimi-Hyseni, Sara Hartnell, Martin Tauschmann, Janet M Allen, Malgorzata E Wilinska, Thomas R Pieber, Mark L Evans, Roman Hovorka
BACKGROUND: Tight control of blood glucose concentration in people with type 1 diabetes predisposes to hypoglycaemia. We aimed to investigate whether day-and-night hybrid closed-loop insulin delivery can improve glucose control while alleviating the risk of hypoglycaemia in adults with HbA1c below 7·5% (58 mmol/mol). METHODS: In this open-label, randomised, crossover study, we recruited adults (aged ≥18 years) with type 1 diabetes and HbA1c below 7·5% from Addenbrooke's Hospital (Cambridge, UK) and Medical University of Graz (Graz, Austria)...
January 13, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28093943/clinical-evidence-supporting-us-food-and-drug-administration-premarket-approval-of-high-risk-otolaryngologic-devices-2000-2014
#6
Vinay K Rathi, Bo Wang, Joseph S Ross, Nicholas S Downing, Aaron S Kesselheim, Stacey T Gray
The US Food and Drug Administration (FDA) approves high-risk medical devices based on premarket pivotal clinical studies demonstrating reasonable assurance of safety and effectiveness and may require postapproval studies (PAS) to further inform benefit-risk assessment. We conducted a cross-sectional analysis using publicly available FDA documents to characterize industry-sponsored pivotal studies and PAS of high-risk devices used in the treatment of otolaryngologic diseases. Between 2000 and 2014, the FDA approved 23 high-risk otolaryngologic devices based on 28 pivotal studies...
January 1, 2017: Otolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/28093867/paramedic-resuscitation-competency-a-survey-of-australian-and-new-zealand-emergency-medical-services
#7
Kylie Dyson, Janet E Bray, Karen Smith, Stephen Bernard, Lahn Straney, Judith Finn
OBJECTIVE: We have previously established that paramedic exposure to out-of-hospital cardiac arrest (OHCA) is relatively rare, therefore clinical exposure cannot be relied on to maintain resuscitation competency. We aimed to identify the current practices within emergency medical services (EMS) for developing and maintaining paramedic resuscitation competency. METHODS: We developed and conducted an online cross-sectional survey of Australian and New Zealand EMS in 2015...
January 16, 2017: Emergency Medicine Australasia: EMA
https://www.readbyqxmd.com/read/28093312/palliative-medicine-and-preparedness-planning-for-patients-receiving-left-ventricular-assist-device-as-destination-therapy-challenges-to-measuring-impact-and-change-in-institutional-culture
#8
Brandon P Verdoorn, Angela J Luckhardt, Sara E Wordingham, Shannon M Dunlay, Keith M Swetz
CONTEXT: While left ventricular assist devices as destination therapy (DT-LVAD) can improve survival, quality of life, and functional capacity in well-selected patients with advanced heart failure, there remain unique challenges to providing quality end-of-life care in this population. Palliative care involvement is universally recommended, but how to best operationalize this care and measure success is unknown. OBJECTIVES: To characterize the process of preparedness planning (PP) for patients receiving DT-LVAD at our institution and better understand opportunities for quality improvement or procedural transferability...
January 13, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28093118/surgical-fires-and-operative-burns-lessons-learned-from-a-33-year-review-of-medical-litigation
#9
Asad J Choudhry, Nadeem N Haddad, Mohammad A Khasawneh, Daniel C Cullinane, Martin D Zielinski
OBJECTIVE: We aimed to understand the setting and litigation outcomes of surgical fires and operative burns. METHODS: Westlaw, an online legal research data-set, was utilized. Data were collected on patient, procedure, and case characteristics. RESULTS: One hundred thirty-nine cases were identified; 114 (82%) operative burns and 25 (18%) surgical fires. Median plaintiff (patient) age was 46 (IQR:28-59). Most common site of operative burn was the face (26% [n = 36])...
December 12, 2016: American Journal of Surgery
https://www.readbyqxmd.com/read/28092978/variability-in-foot-and-ankle-case-volume-in-orthopaedic-residency-training
#10
Steven F DeFroda, Joseph A Gil, Brad D Blankenhorn, Alan H Daniels
: Surgical case volume during orthopaedic surgical residency is a concern among trainees and program directors alike. With an ongoing trend toward further subspecialization and the rapid development of new techniques and devices, the breadth of procedures that residents are exposed to continues to increase. Accreditation Council for Graduate Medical Education surgical case logs from 2009 to 2013 for graduating orthopaedic surgery residents were examined to assess the national averages of orthopaedic procedures logged by graduating orthopaedic surgery residents in the leg/ankle and foot/toes categories...
January 1, 2017: Foot & Ankle Specialist
https://www.readbyqxmd.com/read/28092783/pulmonary-emboli-cardiac-arrest-with-cpr-complication-liver-laceration-and-massive-abdominal-bleed-a-case-report
#11
John Lundqvist, Jan G Jakobsson
INTRODUCTION: Massive pulmonary emboli may cause right ventricular failure and backward stasis with parenchymal organ swelling thus increasing the risk for laceration, e.g. if CPR is needed. PRESENTATION OF CASE: A 28-year-old Colombian female with no medical history but taking contraceptive pills and having had a recent longer flight was admitted to Danderyds hospital Emergency Department because of respiratory failure. She developed cardiac arrest in the emergence department following the emergent diagnosis of pulmonary emboli...
January 3, 2017: International Journal of Surgery Case Reports
https://www.readbyqxmd.com/read/28092219/the-21st-century-cures-act-pharmacoeconomic-boon-or-bane
#12
Roger Lee Mendoza
Barriers to entry in healthcare markets constitute one of the overriding concerns of health economists. The recent enactment of the 21st Century Cures Act in the United States is one landmark legislation that reduces statutory entry barriers to the discovery, development, testing and licensing of drugs and medical devices. However, it brings with it many critical challenges concerning the safety, efficacy and value of drugs and devices, along with novel opportunities for medical innovation and faster treatment of diseases...
January 16, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28090771/differential-adhesive-bioactive-properties-of-polymeric-surface-coated-with-graphene-oxide-thin-film
#13
Sudhin Thampi, A Maya Nandkumar, Vignesh Muthuvijayan, Ramesh Parameswaran
Surface engineering of implantable devices involving polymeric biomaterials has become an essential aspect for medical implants. Surface enhancement technique can provide an array of unique surface properties that improves its biocompatibility and functionality as an implant. Polyurethane based implants that have found extensively acclaimed usage as an implant in biomedical applications, especially in the area of cardiovascular devices still lacks any mechanism to ward off bacterial or platelet adhesion. To bring out such a defense mechanism we are proposing a surface modification technique...
January 16, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28089592/stapleless-laparoscopic-sleeve-gastrectomy-preliminary-report
#14
Jose Luis Leyba, Salvador Navarrete Llopis, Salvador Navarrete Aulestia, Ricardo Ochoa, Eliana Azuaje
BACKGROUND: Laparoscopic sleeve gastrectomy (SG) as a single-stage procedure for the treatment of morbid obesity is becoming increasingly popular. In undeveloped countries, the linear staples required to create the sleeve are not always available because of their high cost. As an alternative to the staples, the bipolar vessel sealer device could be used in bariatric surgery to divide and temporarily seal the stomach. SETTINGS: Universidad Central de Venezuela, Caracas, Venezuela...
December 7, 2016: Surgery for Obesity and related Diseases: Official Journal of the American Society for Bariatric Surgery
https://www.readbyqxmd.com/read/28089562/sequential-multiple-assignment-randomized-trials-an-opportunity-for-improved-design-of-stroke-reperfusion-trials
#15
William J Meurer, Nicholas J Seewald, Kelley Kidwell
BACKGROUND: Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice...
January 12, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28089455/comparison-of-transcatheter-aortic-valve-implantation-with-the-newest-generation-sapien-3-vs-direct-flow-medical-valve-in-a-single-center-cohort
#16
Eberhard Schulz, Alexander Jabs, Alexander Tamm, Patrick Herz, Andreas Schulz, Tommaso Gori, Stephan von Bardeleben, Walter Kasper-König, Ulrich Hink, Christian-Friedrich Vahl, Thomas Münzel
BACKGROUND: The latest generation transcatheter heart valves including Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM) were designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of these 2 transcatheter aortic valve systems. METHODS: Of 174 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) at our institution between August 2013 and June 2015, 113 were treated with ES3 and 61 with DFM...
January 7, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28089444/health-care-associated-infections-in-neonates-children-and-adolescents-an-analysis-of-paediatric-data-from-the-european-centre-for-disease-prevention-and-control-point-prevalence-survey
#17
Walter Zingg, Susan Hopkins, Angèle Gayet-Ageron, Alison Holmes, Mike Sharland, Carl Suetens
BACKGROUND: In 2011-12, the European Centre for Disease Prevention and Control (ECDC) held the first Europe-wide point-prevalence survey of health-care-associated infections in acute care hospitals. We analysed paediatric data from this survey, aiming to calculate the prevalence and type of health-care-associated infections in children and adolescents in Europe and to determine risk factors for infection in this population. METHODS: Point-prevalence surveys took place from May, 2011, to November, 2012, in 1149 hospitals in EU Member States, Iceland, Norway, and Croatia...
January 12, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28089143/long-term-mortality-following-pseudomonas-aeruginosa-bloodstream-infection
#18
K L McCarthy, D L Paterson
BACKGROUND: Pseudomonas aeruginosa bloodstream infections (BSI) are associated with substantial short-term mortality. There is little data on long-term mortality associated with this BSI. AIM: To describe mortality rates up to one year post infection and the significant factors associated with death. METHODS: Positive blood cultures for P. aeruginosa were identified retrospectively from January 2008 to January 2011 at seven tertiary care hospitals...
November 30, 2016: Journal of Hospital Infection
https://www.readbyqxmd.com/read/28088344/design-control-considerations-for-biologic-device-combination-products
#19
Dave Anderson, Roger Liu, J Anand Subramony, Jon Cammack
Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products...
January 11, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28087484/inhibition-of-bacterial-adhesion-and-biofilm-formation-by-dual-functional-textured-and-nitric-oxide-releasing-surfaces
#20
Li-Chong Xu, Yaqi Wo, Mark E Meyerhoff, Christopher A Siedlecki
: In separate prior studies, physical topographic surface modification or nitric oxide (NO) release has been demonstrated to each be an effective approach to inhibit and control bacterial adhesion and biofilm formation on polymeric surfaces. Such approaches can prevent biomaterial-associated infection without causing the antibiotic resistance of the strain. In this work, both techniques were successfully integrated and applied to a polyurethane (PU) biomaterial surface that bears ordered pillar topographies (400/400 nm and 500/500 nm patterns) at the top surface and a S-nitroso-N-acetylpenicillamine (SNAP, NO donor) doped sub-layer in the middle, via a soft lithography two-stage replication process...
January 10, 2017: Acta Biomaterialia
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