Medical Devices-Evidence and Research最新文献

{"title":"Outcome of Pleural Empyema Treated With Video-Assisted Thoracoscopic Surgery in Patients With Severe Co-Morbidities: An Observational Study.","authors":"Hai Anh Vu, Nam Van Nguyen, Tuan Dinh Le, Son Tien Nguyen, Anh Viet Le, Anh The Vu, Ba Van Nguyen, Binh Van Nguyen, Nam Thanh Quan, Nguyen Van An, Thuan Duc Nghiem","doi":"10.2147/MDER.S498901","DOIUrl":"10.2147/MDER.S498901","url":null,"abstract":"<p><strong>Background: </strong>Empyema patients with poor physical condition and severe comorbidities face a significant challenge, with difficulties in choosing appropriate treatment methods, limited treatment outcomes, and a high rate of complications and mortality.</p><p><strong>Objective: </strong>To comment on the indications and to evaluate the treatment outcomes of pleural empyema in patients with poor physical condition and severe comorbidities by thoracoscopic surgery.</p><p><strong>Methods: </strong>An observational study on 12 patients treated at the Department of Thoracic Surgery - Military Hospital 103, from January 2017 to December 2022.</p><p><strong>Results: </strong>The mean of age was 63.4 ± 12.4 years old, with a male/female ratio of 5/1. In this study, 83.3% of cases were presented with stage II empyema. The mean Karnofsky score was 50.0 ± 6.1. Some comorbidities contained chronic obstructive pulmonary disease (COPD) (25.0%), spontaneous esophageal perforation (16.7%), liver cancer, cirrhosis, esophageal cancer, end-stage renal failure - chronic dialysis (8.7%). The surgery procedures were efficient with a short duration (65.6 ± 9.4 minutes), low incidence of blood transfusion (8.3%), and lower rate of postoperative complications (surgical wound infection 8.3%). The length of postoperative stay was 16.8 ± 9.9 days. Pleural drainage was removed in 11 out of 12 cases after an average of 60.1 ± 8.5 days, while one patient had their drainage retained due to esophageal cancer. The total recovery rate at the 1-year follow-up was 91.7%.</p><p><strong>Conclusion: </strong>Video-Assisted Thoracoscopic Surgery (VATS) exhibits positive outcomes in treating stage I and II pleural empyema patients who incurred severe comorbidities.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"87-96"},"PeriodicalIF":1.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Bipolar Electrosurgical Vessel Sealing Device Provides Improved Performance and Procedural Efficiency.","authors":"Rheagan Chambers, Danielle Sarno, Susan Roweton","doi":"10.2147/MDER.S498873","DOIUrl":"10.2147/MDER.S498873","url":null,"abstract":"<p><strong>Purpose: </strong>This study compared the performance of the new LigaSure™ XP Maryland Jaw Sealer/Divider (XP Maryland) to that of LigaSure Atlas™ (Atlas) and LigaSure™ Dolphin Tip (Dolphin Tip), two early LigaSure™ (LigaSure) devices characterized by consistent and reliable clinical performance.</p><p><strong>Methods: </strong>Ex vivo bench testing on porcine renal arteries compared burst pressures, seal times, and rates of sticking, incomplete cuts, and charring between XP Maryland and Atlas and between XP Maryland and Dolphin Tip. In vivo acute testing on a porcine model compared thermal spread, seal times, and rates of hemostasis, sticking, and incomplete cuts between XP Maryland and the two early LigaSure devices.</p><p><strong>Results: </strong>Ex vivo, XP Maryland showed a significantly faster mean seal time compared to Dolphin Tip (P < 0.0001) and Atlas (P < 0.0001). XP Maryland had fewer incomplete cuts than Dolphin Tip (P < 0.0001) and fewer sticking incidents than Atlas (P = 0.0019). Atlas had a statistically higher average burst pressure compared to XP Maryland (P < 0.0001). As with ex vivo results, XP Maryland had a significantly faster mean seal time in vivo compared to Dolphin Tip (P = 0.0168) and Atlas (P < 0.0001). Other in vivo results showed XP Maryland had fewer incomplete cuts compared to Dolphin Tip (P < 0.0001) and statistically less lateral thermal spread than Atlas (P = 0.0010). For all other ex vivo and in vivo performance characteristics, no statistically significant differences were found between XP Maryland and the other devices.</p><p><strong>Conclusion: </strong>The study demonstrated the consistent and reliable performance of XP Maryland and the two early LigaSure devices. In addition, the studies showed XP Maryland has some improved performance characteristics when compared to Atlas and Dolphin Tip that may result in improved procedural efficiency and may reduce potential surgical risks.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"75-86"},"PeriodicalIF":1.3,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a Cost and Variation Reduction Program for Hemostasis Products at a Large Academic Medical Center: A Multi-Stakeholder Perspective.","authors":"Tejen Shah, Stacy Brethauer, Walter A Danker, Ishita Doshi, Matthew O'Hara, Abigail Silber, William K Vasileff","doi":"10.2147/MDER.S488279","DOIUrl":"10.2147/MDER.S488279","url":null,"abstract":"<p><strong>Goal: </strong>Cost-saving initiatives targeting surgical supplies management have become increasingly common to address rising healthcare costs. However, few studies provide details on hospital stakeholder experiences or learnings from implementing such initiatives. Thus, we sought to evaluate hospital stakeholder satisfaction with conversion to a sole supplier for hemostasis products, in addition to economic and clinical impacts, to help develop best practices for implementation.</p><p><strong>Methods: </strong>This cross-sectional study assessed satisfaction with converting to a sole supplier for hemostasis products at a large US academic medical center using qualitative interviews and quantitative surveys with clinical and non-clinical stakeholders, on the decision-making process, conversion, and vendor-supported hemostasis optimization program (HOP) post-implementation (February 2022-May 2022). Perioperative hemorrhage events, adjunctive hemostat utilization, and total annual hospital expenditure on hemostatic products were also evaluated pre- and post-conversion (2020-2022) to identify impacts on clinical and economic outcomes.</p><p><strong>Findings: </strong>Ten hospital stakeholders completed qualitative interviews (n = 7 surgeons, n = 2 surgical technicians, n = 1 administrator) and 22 completed quantitative surveys (n = 6 surgeons, n = 5 surgical technicians, n = 11 nurses). Survey respondents noted overall satisfaction with conversion, including the level of input they provided in the decision-making process (75% were somewhat to extremely satisfied), availability of hemostatic agents during the conversion process (87%), and the vendor-supported HOP (100%). The outcomes analyses revealed a nearly 25% decrease in supply expenditure without changes to the number of postoperative hemorrhage events following implementation.</p><p><strong>Practical applications: </strong>Converting to a sole vendor for hemostasis products was achieved with high satisfaction among hospital stakeholders and cost savings to the institution without impacting the quality of patient care. This study provides a roadmap of best practices for other institutions interested in implementing similar initiatives and presents an example of a successful transition to a sole vendor for hemostasis products driven by effective supplier, institution, and hospital stakeholder coordination.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"63-73"},"PeriodicalIF":1.3,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11774113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mapping Trends and Hotspots Regarding the Use of Lung Ultrasound in the Field of Anesthesiology: A Bibliometric Analysis of Global Research.","authors":"Wencai Jiang, Kang Kang, Xinyu Zhou, Xuemeng Chen, Hai Yu, Xianjie Zhang","doi":"10.2147/MDER.S492488","DOIUrl":"10.2147/MDER.S492488","url":null,"abstract":"<p><strong>Purpose: </strong>Lung ultrasound (LUS) is increasingly utilized in the field of anesthesiology due to its focused, quick application and the advantage of not exposing patients to ionizing radiation. This study aims to analyze the status and trends in this area from a macroscopic perspective.</p><p><strong>Methods: </strong>A bibliometric analysis was conducted using the Web of Science (WoS) Core Collection. The analysis and visualization were performed using WoS, Excel, VOSviewer, and CiteSpace. Parameters such as publications, countries, institutions, journals, and keywords were analyzed.</p><p><strong>Results: </strong>A total of 133 articles published over the last 10 years were analyzed to clarify the current status and future trends on the use of LUS in anesthesiology. The number of publications increased markedly from May 1, 2014, to April 30, 2024. China is the highest productive country, while the USA had the highest number of citations. In the institution, Seoul National University in South Korea published the most articles and had the highest number of citations. Kim Jin-Tae emerged as the most prolific and influential author. BMC Anesthesiology and the Journal of Cardiothoracic and Vascular Anesthesia were identified as the most popular journals in the field. Keywords such as \"atelectasis\", \"mechanical ventilation\", and \"pulmonary complications\" were closely related to the use of LUS in anesthesiology.</p><p><strong>Conclusion: </strong>This study provides a comprehensive analysis of research on the use of LUS in anesthesiology, highlighting the growing interest in LUS and its relevance to pulmonary complications.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"53-62"},"PeriodicalIF":1.3,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Healthcare Outcomes of Patients Treated with 3D-Printed-Titanium and PEEK Cages During Fusion Procedures in the Lumbar Spine.","authors":"Katherine A Corso, Andreas A Teferra, Annalisa Michielli, Kristin Corrado, Amy Marcini, Mark Lotito, Caroline Smith, Michelle Costa, Jill Ruppenkamp, Anna Wallace","doi":"10.2147/MDER.S493988","DOIUrl":"10.2147/MDER.S493988","url":null,"abstract":"<p><strong>Purpose: </strong>The objective of this observational, real-world study was to describe reoperation, revision, index healthcare utilization and hospital costs among patients treated with PEEK (polyetheretherketone) or 3D-printed-titanium cages during lumbar/lumbosacral posterior fusion procedures, either TLIF (transforaminal lumbar interbody fusion) or PLIF (posterior lumbar interbody fusion). Statistical comparisons were not conducted.</p><p><strong>Methods: </strong>This was a descriptive, retrospective, observational study. Patients with PEEK (OPAL™, DePuy Synthes, Raynham, MA) or 3D-printed-titanium (CONDUIT™ TLIF (transforaminal lumbar interbody fusion)/PLIF (posterior lumbar interbody fusion) Cage/EIT™ Cellular Titanium TLIF/PLIF Cage (DePuy Synthes, Raynham, MA)) spinal cages were identified in the Premier Healthcare Database between 1/1/2007 and 9/30/2022. Patients were required to have posterior approaches of the lumbar/lumbosacral spine and DDD, stenosis, back pain, instability, spondylolisthesis, or pseudarthrosis/failed prior surgery. Patient and procedure, healthcare utilization and hospital cost data were collected at the index surgery, and patients were followed up to 3 months for reoperation and 12 months for revision. All data were summarized descriptively, and no statistical comparisons were made between cage groups.</p><p><strong>Results: </strong>A total of 5118 PEEK and 1189 3D-printed-titanium cage patients were included in this study. Among 3D-printed-titanium cages, 804 had PLIF and 345 had Curved TLIF cage types. Most PEEK cage patients were 18-64 years (61.9%), and 3D-printed-titanium was evenly distributed across age categories. The mean index hospital cost was ~$40,000, LOS was ~3 days, and discharge status to home/home health was ~85% for both; surgery time was 267 minutes for PEEK and 280 minutes for 3D-printed-titanium. The 0-3 month reoperation cumulative incidence was 1.0% for PEEK and 1.3% for 3D-printed-titanium. For revision, incidence within 0-3, 4-6, and 7-12 months was 1.2%, 0.6%, and 1.7% for PEEK and 1.6%, 0.5%, and 1.2% for 3D-printed-titanium. The mean costs per patient associated with reoperation and revision for the entire cohort were $220 and $1228 for PEEK and $290 and $1754 for 3D-printed-titanium.</p><p><strong>Conclusion: </strong>This study provides real-world economic insights into an area where practice data are sparse, within hospital settings for PEEK and 3D-printed-titanium spinal cages. A key study limitation is the descriptive design in which potential confounding factors that may affect the outcome estimates are not addressed.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"37-51"},"PeriodicalIF":1.3,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11745063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Ultrasound Energy Delivered to the Anterior Segment Across Different Phacoemulsification Surgical Platforms.","authors":"Tanner K Nelson, Reiker G Ricks, Ivan A Cardenas, Tyler Whitaker, Jenna L Jensen, Randall J Olson, Jeff H Pettey","doi":"10.2147/MDER.S493847","DOIUrl":"https://doi.org/10.2147/MDER.S493847","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to use calorimetry to understand the difference in energy transferred by three phacoemulsification surgical platforms to the eye.</p><p><strong>Patients and methods: </strong>A phacoemulsification tip was lowered into a double-walled calorimeter filled with distilled water. The foot pedal was depressed for 30 seconds and the change in temperature of the water was measured by a temperature probe. Three phacoemulsification systems were compared: the Alcon Centurion, Johnson & Johnson Veritas and Oertli CataRhex 3. The following conditions remained constant across trials and platforms: continuous longitudinal ultrasound, flow rate 12mL/min, vacuum 0mmHg, and clamped inflow and outflow tubing. The different platforms were directly compared at 20%, 40%, 60%, 80% and 100% power.</p><p><strong>Results: </strong>A two-way ANOVA found a significant difference (P < 0.001) in overall energy output across all trials between the CataRhex 3, Centurion and Veritas with an F value of 63.97 and two degrees of freedom.</p><p><strong>Conclusion: </strong>Given identical settings, the amount of energy produced was significantly different across phacoemulsification platforms. This data can aid surgeons' understanding of how power level by surgical platform can impact the amount of energy introduced into the anterior segment during cataract surgery.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"29-35"},"PeriodicalIF":1.3,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11742454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Noninvasive Detection of Alpha-Amylase in Saliva Using Screen-Printed Carbon Electrodes: A Promising Biomarker for Clinical Oral Diagnostics.","authors":"Faris Hernando Reviansyah, Azzahra Delvyra Ristin, Adil Abdul Rauf, Prisilia Dita Sepirasari, Fahmi Nur Alim, Yuspian Nur, Veni Takarini, Muhammad Yusuf, Dudi Aripin, Sri Susilawati, Maria Komariah, Boy Yoseph Cahya Sunan Sakti Syah Alam","doi":"10.2147/MDER.S493383","DOIUrl":"10.2147/MDER.S493383","url":null,"abstract":"<p><strong>Background: </strong>Biomarkers are essential tools for diagnosing diseases. Saliva, as a human fluid, effectively reflects the body's condition due to its rich composition. Analyzing saliva components allows for noninvasive, cost-effective, and time-efficient screening and diagnosis. Alpha-amylase, a key biomarker present in saliva, has been linked to oral diseases. This study introduces an innovative method for the noninvasive detection of alpha-amylase using screen-printed electrodes (SPEs), enabling easy and efficient screening and diagnosis.</p><p><strong>Methods: </strong>The proposed method involves measuring varying concentrations of alpha-amylase using Cyclic Voltammetry (CV) and Differential Pulse Voltammetry (DPV). Saliva samples are applied directly onto electrodes pre-coated with biomarkers and a conditioning agent, allowing for precise detection and analysis.</p><p><strong>Results: </strong>The screen-printed carbon electrode demonstrated excellent performance in detecting alpha-amylase, with clear voltammogram results, achieving a limit of detection (LOD) of 104.252 units and a limit of quantification (LOQ) of 315.915 units.</p><p><strong>Conclusion: </strong>A gold nanoparticle-modified screen-printed electrode (SPE) was developed to measure alpha-amylase quantitatively. Despite sensitivity to external interference, notably temperature, pH, and the duration of incubation, While the sensor showed sensitivity to external factors such as pH and temperature variations, it maintained a strong linear response, reinforcing its potential for reliable diagnostics with linear regression score <i>(R²</i> = 0.9513) across alpha-amylase concentrations of 100-500 units. This study underscores the sensor's effectiveness as a non-invasive tool for early detection using saliva as a biomarker, enhancing patient comfort and compliance. However, further research is needed for medical applications.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"15-27"},"PeriodicalIF":1.3,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dental Ultrasonography for Visualizing Osteoimmune Conditions and Assessing Jaw Bone Density: A Narrative Review.","authors":"Robert Huber, Elisa Choukroun, Harald Fahrenholz, Florian Notter","doi":"10.2147/MDER.S491331","DOIUrl":"10.2147/MDER.S491331","url":null,"abstract":"<p><p>Despite the widespread use of ultrasonography (US) in medical diagnostics, there is no similar US device available for visualizing jawbone density. This study is a narrative review of the possible applications of US in dentistry. This review is divided as follows: (a) Pulse-echo ultrasonography: the applications offer new perspectives for periodontal and peri-implant assessment. (b) Through-transmission alveolar US (TTAU): this technique was a novel imaging modality until 2004, when TTAU devices were last available. Quantitative US scaling made the device useful for diagnosing chronic inflammatory conditions in the jaw. (c) Ultrasound transmission velocity (UTV): in 2008, this technique was introduced in German university dental clinics to analyze the mechanical properties of the jawbone without translating the scientific findings into a practical device. (d) Trans-alveolar US device (TAU): the growing importance of \"osteoimmune focal bone marrow defects\" has led practitioners to develop a new TAU device. The attenuation of US was used for imaging of jawbone density. (e) Patients who benefit from TAU-guided jawbone surgery: research has shown remarkable results in specific disease cases. This review concludes that US has been undervalued as a diagnostic tool in dentistry. The new TAU-n unit offers the opportunity to change this in the future.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"1-13"},"PeriodicalIF":1.3,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Pilot Open-Label Randomized Study to Evaluate the Safety, Tolerability, and Acceptability of the IntegriMedical® Needle Free Injection System versus a Conventional Needle-Based System in Healthy Volunteers, Using Normal Saline as a Placebo.","authors":"Almas Pathan, Kavitha Shetty Narasimha, Ankur Naik, Arati Ranade","doi":"10.2147/MDER.S491883","DOIUrl":"10.2147/MDER.S491883","url":null,"abstract":"<p><strong>Purpose: </strong>The study aimed to assess the safety, tolerability, and acceptability of the IntegriMedical® Needle Free Injection System (IM-NFIS) compared to conventional hypodermic needle injections (CHN) in healthy adult subjects across multiple injection sites.</p><p><strong>Patients and methods: </strong>Thirty healthy male subjects aged 18-45 years were enrolled in this open-label study. Each subject received both NF and CHN injections at five different sites (forearm, abdomen, thigh, buttocks, and arm). In the study, participants in the forearm cohort received 0.1 mL of saline, whereas, for all other injection sites, 0.5 mL of saline was administered. Both needle-free and hypodermic needle injections were used at the designated sites, with a 5- to 10-minute interval between each injection. Since no active drug was used, saline served as a placebo in both methods. Safety assessments included local and systemic reactions, pain scores using the Visual Analog Scale (VAS), and acceptability questionnaires. The study adhered to ethical guidelines and was approved by the Institutional Ethics Committee.</p><p><strong>Results: </strong>NF injections demonstrated significantly lower pain scores compared to CHN injections (mean VAS score 0.23 vs 1.07, p < 0.01). Local site reactions were minimal and similar between NF and CHN injections, with no significant differences observed at 20-30 minutes post-injection. Systemic reactions were absent in both groups throughout the study period. The NF injection system was highly acceptable, with a majority of subjects reporting reduced anxiety and pain compared to CHN injections (p < 0.01).</p><p><strong>Conclusion: </strong>IM-NFIS proved to be safe, well tolerated, and highly acceptable for delivering pharmaceuticals compared to conventional needle and syringe injections. This needle-free technology offers potential advantages in improving patient compliance and reducing injection-related anxieties, suggesting its promising role in future medical practices, including pediatric vaccinations and frequent medication administration.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"525-536"},"PeriodicalIF":1.3,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is Known About Early Mobilisation After Cardiac Electronic Device Implant? A Scoping Review.","authors":"Dalia Caleffi, Paola Ferri, Mauro Bellifemine, Sergio Rovesti, Miriam Valenti","doi":"10.2147/MDER.S493641","DOIUrl":"10.2147/MDER.S493641","url":null,"abstract":"<p><strong>Background: </strong>The number of cardiac implantable electronic devices (CIEDs) implanted has been growing and the population who receive the device is older and has more comorbidities. Long bed rest and immobilisation have always been common after the implant, but a consensus does not exist on the argument.</p><p><strong>Purpose: </strong>To map and synthesise available literature on the mobilisation approach after the implant of a CIED and which correlated outcomes exist.</p><p><strong>Methods: </strong>A literature search was conducted in December 2023 on six databases. Screening of articles, data extraction and quality appraisal were performed by more than one author. Articles included were primary articles exploring bed rest or mobilisation after a CIED procedure. Descriptive analysis was conducted to present and synthesise the results.</p><p><strong>Results: </strong>Of the 113 records identified, eight matched the inclusion criteria. The majority of the articles were randomised controlled trials (n = 6). Other studies were quasi-experimental (n = 1), retrospective (n = 1) and cross-sectional (n = 1). Data descriptive analysis led to the development of three main topics: (1) mobilisation modalities, (2) potential complications and (3) type of device.</p><p><strong>Conclusions: </strong>Early mobilisation after a CIED procedure appears to be safe and not associated with other complications. A predominant barrier to early mobilisation is the lack of a consensus on the time and type of mobilisation. Early mobilisation could be applied more safely with the use of an arm support. To strengthen the evidence there is a need for more rigorous research analysing the type of device and the leads utilised.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"513-524"},"PeriodicalIF":1.3,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11660658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}