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JOURNAL ARTICLE
Rema Shah, Sarah G Wilkins, Neelima Panth, Sidharth Tyagi, Hannah Dunn, Moira D Bell, Sophie Norgaard, Elizabeth Guyer, Nofrat Schwartz
OBJECTIVE: In 2022, the Food and Drug Administration established a new regulatory category for over-the-counter (OTC) hearing aids for mild to moderate hearing loss. Herein, we aim to better compare the safety and efficacy of these devices to that of prescription hearing aids. STUDY DESIGN: Comparative-effectiveness model. SETTING: Academic Audiology Center. METHODS: The safety and efficacy of prescription and OTC hearing aids was compared using the AudioScan Verifit 2 Testbox software...
May 20, 2024: Otolaryngology—Head and Neck Surgery
#22
REVIEW
Kalpesh Hathi, You Sung Jon Nam, James Fowler, Brad Dishan, Edward Madou, Leigh J Sowerby, S Danielle MacNeil, Anthony C Nichols, Julie E Strychowsky
OBJECTIVE: One minute of operating room (OR) time costs $36 to 37. However, ORs are notoriously inefficient. There is growing literature on improving OR efficiency, but no formal review of this topic within otolaryngology has been performed. This study reviews and synthesizes the current literature on improving OR efficiency within otolaryngology. DATA SOURCES: MEDLINE, EMBASE, Web of Science, CINAHL, Cochrane Library, preprints.org, and medRxiv were searched on November 4, 2022...
May 20, 2024: Otolaryngology—Head and Neck Surgery
#23
JOURNAL ARTICLE
A Elbably, J Richardson-May, N Amerasinghe, R Imonikhe, F Stringa, S Sampath, A Jacob
PURPOSE: The Xen gel stent is a surgical glaucoma device which creates a subconjunctival filtering bleb, which has demonstrated good intraocular pressure (IOP) lowering and safety. Nonetheless, bleb-related problems have been reported. We present a case series of ab externo Xen procedures augmented with a deep intra-scleral lake, aiming to improve both IOP-lowering and post-operative management. METHODS: A retrospective review of 20 patients who underwent combined Xen gel stent implantation with modified deep sclerectomy at our institution from June to November 2022, with a 6-month follow-up period...
May 21, 2024: Eye
#24
JOURNAL ARTICLE
Maaz Ahmed, Ashok Gowda, Fatemeh Alavi Naini, Alexander Le, John Treffalls, Robin Torres, Bryan M Burt
BACKGROUND: Soilage of the surgical endoscope occurs frequently during minimally invasive surgery. The resultant impairment of visualization of the surgical field compromises patient safety, prolongs operative times, and frustrates surgeons. The standard practice for cleaning the surgical camera involves a disruption in the conduct of surgery by completely removing the endoscope from the field, manually cleaning its lens, treating it with a surfactant, and reinserting it into the patient; after which the surgeon resumes the procedure...
May 20, 2024: Surgical Endoscopy
#25
JOURNAL ARTICLE
Akash Makkar, Mohamad Alkhouli, Christopher R Ellis, Atman P Shah, Megan Coylewright, James V Freeman, Jordan A Anderson, Ryan Gage, Dhanunjaya Lakkireddy
BACKGROUND: While expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO using the selected device. OBJECTIVE: To characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent subsequent attempt with an Amulet occluder in the EMERGE LAA post-approval study. METHODS: Patients enrolled in the NCDR LAAO Registry and had an Amulet occluder implant attempt between FDA approval (August 14, 2021) and June 30, 2023 were evaluated...
May 6, 2024: Heart Rhythm: the Official Journal of the Heart Rhythm Society
#26
JOURNAL ARTICLE
L E Nina-Dominguez, A Imbernón-Moya, D Saceda-Corralo, S Vano-Galván
Trichotillomania (TTM) is an obsessive-compulsive disorder in which affected individuals recurrently pull-out hair from any region of the body, causing hair loss or alopecia. The management of TTM is a therapeutic challenge for dermatologists and consists of a combination of pharmacological and non-pharmacological alternatives. Cognitive-behavioral therapy has successfully been used to treat TTM. However, not all patients are willing to follow this treatment strategy. Unconventional support tools are proposed, such as electronic devices, internet therapies and microneedling...
May 18, 2024: Actas Dermo-sifiliográficas
#27
JOURNAL ARTICLE
Marco Stehouwer, Kristina Legg, Roel de Vroege
BACKGROUND: During cardiac surgery the use of a minimal extracorporeal circulation (MiECC) system may reduce the adverse effects for the patient. This is probably caused by reduced inflammation and hemodilution. For the use of a MiECC circuit, a venous bubble trap (VBT) is warranted for safety reasons. The aim of this study was to assess if an arterial filter with a small prime volume has the same (or better) air removal capacities as a VBT in a MiECC circuit and subsequentially may be used as an alternative...
May 20, 2024: Perfusion
#28
JOURNAL ARTICLE
Consuelo Grant, Sheila M Gephart, Nicholas Rattray
OBJECTIVE: To examine mothers' internet usage, in conjunction with social, health care, and virtual peer support navigations, when congenital anomalies were diagnosed in utero. DESIGN: Qualitative descriptive, consisting of semistructured interviews. SETTING: Interview data were collected over Zoom; mothers participated from locations of their choosing. PARTICIPANTS: Mothers of neonates discharged postoperatively from NICUs for uterine-diagnosed congenital anomalies...
May 17, 2024: Nursing for Women's Health
#29
JOURNAL ARTICLE
Mark P Sendak, Vincent X Liu, Ashley Beecy, David E Vidal, Keo Shaw, Mark A Lifson, Danny Tobey, Alexandra Valladares, Brenna Loufek, Murtaza Mogri, Suresh Balu
OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software. MATERIALS AND METHODS: We use sepsis as a case study to highlight the patient safety and regulatory compliance tradeoffs that 6129 hospitals in the United States must navigate. RESULTS: Sepsis CDS remains in broad, routine use. There is no commercially available sepsis CDS system that is FDA cleared as a medical device...
May 20, 2024: Journal of the American Medical Informatics Association: JAMIA
#30
REVIEW
Nicolò Ubaldi, Miltiadis Krokidis, Michele Rossi, Gianluigi Orgera
Pulmonary embolism (PE) is a significant contributor to global cardiovascular-related mortality that mainly depends on the severity of the event. The treatment approach for intermediate and high-risk PE remains a topic of debate due to the fine balance between hemodynamic deterioration and bleeding risk. The initial treatment choice for intermediate-risk PE with hemodynamic deterioration and high-risk PE is historically systemic thrombolysis, but this approach is not always effective and carries a notable risk of severe bleeding...
May 20, 2024: Insights Into Imaging
#31
JOURNAL ARTICLE
Y U Wenxi, Tang Lina, L I Hongtao, Wang Yonggang, Shen Zan
OBJECTIVE: To assess the efficacy and safety of Neiguan (PC6) acupoint acustimulation in preventing chemotherapy-induced nausea and vomiting (CINV), especially for patients with guideline-inconsistent CINV prophylaxis (GICP) due to personal reasons METHODS: From January 2021 to December 2021, 373 patients suffered from solid malignancy were recruited according to the inclusion criteria. Complete response (no emesis and no rescue medication use) rate during the overall phase (0-120 h of each chemo-cycle) was the primary assessment of CINV control...
June 2024: Journal of Traditional Chinese Medicine
#32
JOURNAL ARTICLE
Chuqiao Wang, Qi Yu, Qimin Zhou, Fang Li, Jibo Zhou
PURPOSE: To investigate the efficacy and safety of a modified dual-incision ophthalmic viscosurgical device-free (OVD-free) method for implantable collamer lens (ICL) implantation in high myopic eyes. METHODS: A total of 68 participants were enrolled in this prospective randomized clinical trial, including 33 in the OVD-free group and 35 in the standard group. Operation time and intraocular pressure (IOP) at 2 hours postoperatively were recorded. Visual acuity, refractive power, IOP, corneal endothelium parameters, and anterior segment parameters were assessed at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively...
May 20, 2024: Indian Journal of Ophthalmology
#33
JOURNAL ARTICLE
Reinoud E Knops, Michael S Lloyd, Paul R Roberts, David J Wright, Lucas V A Boersma, Rahul Doshi, Paul A Friedman, Petr Neuzil, Carina Blomström-Lundqvist, Maria Grazia Bongiorni, Martin C Burke, Daniel Gras, Steven P Kutalek, Anish K Amin, Eugene Y Fu, Laurence M Epstein, Jose Maria Tolosana, Thomas D Callahan, Johan D Aasbo, Ralph Augostini, Harish Manyam, Devi G Nair, Blandine Mondésert, Wilber W Su, Chris Pepper, Marc A Miller, Jon Grammes, Karim Saleh, Christelle Marquie, Faisal M Merchant, Yong-Mei Cha, Colin Cunnington, David S Frankel, Julie West, Elizabeth Matznick, Bryan Swackhamer, Amy J Brisben, Jonathan Weinstock, Kenneth M Stein, Vivek Y Reddy, Lluis Mont
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system...
May 18, 2024: New England Journal of Medicine
#34
JOURNAL ARTICLE
Radoslaw Parma, Michael Joner, Francesco Saia, Thomas Cuisset, Victoria Delgado, Josep Rodes-Cabau, Thomas Modine, Eric Van Belle, Luca Nai Fovino, Uri Landes, Mohamed Abdel-Wahab, Jose Luis Zamorano, Matthias Eden, Filippo Cademartiri, Joanna Nawara Skipirzepa, Jana Kurucova, Daniel Greinert, Peter Bramlage, Giuseppe Tarantini
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI...
May 20, 2024: European Journal of Clinical Investigation
#35
JOURNAL ARTICLE
Axel Kramer, Florian H H Brill
In addition to emissions harmful to the environment, a significant amount of waste is generated in hospitals. In recognition of the fact that medical devices (MDs) contain valuable raw materials, such as rare earth elements, other metals, and high-quality plastics, a recycling concept has been developed. The project was examined for safety and feasibility from a hygiene point of view with sustainability in mind in order to create a reference solution for other areas as applicable. The recycling process begins when the MDs accumulate in the surgical facility and are separated into recyclable and disposable parts...
2024: GMS Hygiene and Infection Control
#36
JOURNAL ARTICLE
Ardit Dvorani, Constantin Wiesener, Christina Salchow-Hommen, Magdalena Jochner, Lotta Spieker, Matej Skrobot, Hanno Voigt, Andrea Kuhn, Nikolaus Wenger, Thomas Schauer
Goal: Parkinson's disease (PD) can lead to gait impairment and Freezing of Gait (FoG). Recent advances in cueing technologies have enhanced mobility in PD patients. While sensor technology and machine learning offer real-time detection for on-demand cueing, existing systems are limited by the usage of smartphones between the sensor(s) and cueing device(s) for data processing. By avoiding this we aim at improving usability, robustness, and detection delay. Methods: We present a new technical solution, that runs detection and cueing algorithms directly on the sensing and cueing devices, bypassing the smartphone...
2024: IEEE open journal of engineering in medicine and biology
#37
Pablo Cruces, Diego Moreno, Sonia Reveco, Yenny Ramírez, Franco Díaz
We report the feasibility of a combined approach of very low low tidal volume (VT) and mild therapeutic hypothermia (MTH) to decrease the ventilatory load in a severe COVID-19-related acute respiratory distress syndrome (ARDS) cohort. Inclusion criteria was patients ≥18-years-old, severe COVID-19-related ARDS, driving pressure ∆P >15 cmH2 O despite low-VT strategy, and extracorporeal therapies not available. MTH was induced with a surface cooling device aiming at 34°C. MTH was maintained for 72 h, followed by rewarming of 1°C per day...
2024: Turkish Journal of Emergency Medicine
#38
JOURNAL ARTICLE
Veronica Bolzon, Michela Bulfoni, Massimo Pesando, Alessandro Nencioni, Emanuele Nencioni
The use of dead probiotics and their cellular metabolites seems to exhibit immunomodulatory and anti-inflammatory properties, providing protection against pathogens. These inanimate microorganisms, often referred to as tyndallized or heat-killed bacteria, are a new class of probiotics employed in clinical practice. Safety concerns regarding the extensive use of live microbial cells have increased interest in inactivated bacteria, as they could eliminate shelf-life problems and reduce the risks of microbial translocation and infection...
2024: Frontiers in Microbiology
#39
JOURNAL ARTICLE
Nicola Cosentino, Xuan Zhang, Emily J Farrar, Halit O Yapici, René Coffeng, Heikki Vaananen, John W Beard
BACKGROUND: Patient monitoring devices are critical for alerting of potential cardiac arrhythmias during hospitalization; however, there are concerns of alarm fatigue due to high false alarm rates. OBJECTIVE: The purpose of this study was to evaluate the sensitivity and false alarm rate of hospital-based continuous electrocardiographic (ECG) monitoring technologies. METHODS: Six commonly used multiparameter bedside monitoring systems available in the United States were evaluated: B125M (GE HealthCare), ePM10 and iPM12 (Mindray), Efficia and IntelliVue (Philips), and Life Scope (Nihon Kohden)...
April 2024: Cardiovascular digital health journal
#40
JOURNAL ARTICLE
Çetin Kürşad Akpınar, Erdem Gurkas, Atilla Ozcan Ozdemir, Hasan Doğan, Ayşenur Önalan, Serhan Yıldırım, Zülfikar Memiş, Emrah Aytaç, Bilgehan Atılgan Acar, Muhammed Nur Öğün, Özlem Aykaç, Zehra Uysal Kocabaş, Türkan Acar, Halil Alper Eryılmaz, Berkhan Topaktaş
INTRODUCTION: While the Thrombite device differs from the Solitare stent with its Helical open-side structure feature, it shows great similarity with its other features. We assessed the Thrombite device's effectiveness and safety in this study. MATERIALS AND METHODS: The study was a retrospective analysis of patients who were included in the Turkish Interventional Neurology database and who had mechanical thrombectomy with the Thrombite device as the first choice between January 2020 and January 2023...
2024: Frontiers in Neurology
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