{"title":"Assessment of the carpal tunnel and associated neural structures with superb microvascular imaging: a scoping review.","authors":"Ting-Yu Lin, Peng-Chieh Shen, Ke-Vin Chang, Wei-Ting Wu, Levent Özçakar","doi":"10.1080/17434440.2023.2285856","DOIUrl":"10.1080/17434440.2023.2285856","url":null,"abstract":"<p><strong>Introduction: </strong>Superb microvascular imaging (SMI) is an advanced ultrasound technique that portrays microcirculation. Its clinical applications have been studied in various diseases, including carpal tunnel syndrome (CTS) i.e. the most common entrapment neuropathy. This scoping review explores the role of SMI in diagnosing CTS or the assessment of relevant neural structures.</p><p><strong>Methods: </strong>We conducted a comprehensive search of electronic databases (PubMed, Embase and Web of Science) up to 26 September 2023. Two independent authors conducted the literature search, quality assessment, and data extraction.</p><p><strong>Results: </strong>This review includes seven studies comprising 385 wrists. SMI consistently revealed increased intraneural vascularity in the median nerves of patients with CTS compared to healthy individuals. While SMI demonstrated higher sensitivity than traditional Doppler methods for detecting CTS, its specificity was somewhat lower. Combining SMI with B-mode ultrasound appears to enhance the diagnostic accuracy for CTS. However, the relationship between SMI findings and CTS severity remains unclear.</p><p><strong>Conclusions: </strong>This review highlighted the ability of SMI to provide detailed vascular structures in both healthy wrists and those with CTS. Additional research is crucial to determine the typical SMI findings of the carpal tunnel and within that context, tailor more precise diagnostic/therapeutic applications for the CTS population.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136400811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Technology assistance in primary total knee replacement: hype or hope?","authors":"Bart G Pijls","doi":"10.1080/17434440.2023.2287576","DOIUrl":"10.1080/17434440.2023.2287576","url":null,"abstract":"<p><strong>Introduction: </strong>Total knee replacement (TKR) reduces pain, it increases quality of life and it generally lasts a long time with revision rates of less than 5% at 10 years. Some authors have suggested that outcomes may be further improved by technology assistance.</p><p><strong>Areas covered: </strong>Technology assistance in primary TKR includes technologies such as navigated TKR, patient specific instrumentation TKR and robotic TKR.</p><p><strong>Expert opinion: </strong>In general, technology assistance results in higher accuracy of component positioning and alignment, but this is likely not clinically relevant as no clinically important difference in clinical outcomes, quality of life and complications such as revisions has been demonstrated in meta-analyses of randomized controlled trials. As technology assistance in primary TKR is increasingly used to capture patient and surgeon data, surgeons have an increasingly important role in protecting their patients' data and their own data. Real world evidence of implant registries has shown that TKR without technologically assistance can achieve perfectly acceptable outcomes. Although there is a genuine hope that technology-assisted TKR may further improve these outcomes, this hope is based on promises rather than solid evidence. At the same time, technology assisted TKR is heavily promoted including direct patient marketing, which are aspects of a hype.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138296840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mariana Mendonça Santos, Anamaria Mendonça Santos, José Adão Carvalho Nascimento, Cláudio Carvalho Santana, Ana Maria Santos Oliveira, Silvia Vitoria Silva Cezar, Alcimary Bispo Santos, Luiza Abrahão Frank, Mairim Russo Serafini
{"title":"Devices for osteoarthritis symptoms treatment: a patent review.","authors":"Mariana Mendonça Santos, Anamaria Mendonça Santos, José Adão Carvalho Nascimento, Cláudio Carvalho Santana, Ana Maria Santos Oliveira, Silvia Vitoria Silva Cezar, Alcimary Bispo Santos, Luiza Abrahão Frank, Mairim Russo Serafini","doi":"10.1080/17434440.2023.2298729","DOIUrl":"10.1080/17434440.2023.2298729","url":null,"abstract":"<p><strong>Introduction: </strong>Osteoarthritis is a musculoskeletal disease that can lead to the loss and inability of those affected to perform normal daily functions, which leads to a decrease in quality of life. The main symptoms of osteoarthritis are tenderness, joint pain, stiffness, crepitus, limited movement, and local inflammation.</p><p><strong>Areas covered: </strong>The selected patents were deposited from 2010 to April 2022 involving 57 documents that were in line with the study objective in the final selection. The patents were classified in years, country, and applicants. Also, the therapeutic fields that presented the most documents were electrical stimulation, phototherapy, and ultrasound, followed by magnetic, electromagnetic, and thermotherapy. Therefore, the most current therapies used in the documents are already on the market.</p><p><strong>Expert opinion: </strong>Although the OA is cureless, non-surgical treatments are classified as the primary management approach for this disease. The pharmacological and non-pharmacological therapies are employed to reduce its prevalence and ensure the effectiveness of treatments. A strategy for relieving OA symptoms is non-pharmacological treatment, which can be based on exercise and patient education, combined with other alternative therapies. These therapies are used as supplements to the main OA treatments, enhancing the effectiveness of treatment outcomes.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139379033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Transcatheter aortic valve durability, predictors of bioprosthetic valve dysfunction, longer-term outcomes - a review.","authors":"Abigail Johanna Šolc, Hana Línková, Petr Toušek","doi":"10.1080/17434440.2023.2288275","DOIUrl":"10.1080/17434440.2023.2288275","url":null,"abstract":"<p><strong>Introduction: </strong>Transcatheter aortic valve implantation (TAVI) is one of the most significant inventions in cardiology, as it provides a viable minimally invasive treatment option for patients with aortic stenosis, the most common valvular disease in the developed world and one with a poor prognosis when left untreated. Using data available to date, this review aims to discuss and identify possible predictors of TAVI valve durability - an essential requirement for the device's wide-spread use, especially in younger patients.</p><p><strong>Areas covered: </strong>This article explores the main causes of bioprosthetic valve dysfunction (BVD) based on pathophysiology and available data, and reviews possible predictors of BVD including prosthesis-related, procedure-related, and patient-related factors. An emphasis is made on affectable predictors, which could potentially be targeted with prevention management and improve valve durability. A literature search of online medical databases was conducted using relevant key words and dates; significant clinical trials were identified. A brief overview of important randomized controlled trials with mid to long-term follow-up is included in this article.</p><p><strong>Expert opinion: </strong>Identifying modifiable predictors of valve dysfunction presents an opportunity to enhance and predict valve durability - a necessity as patients with longer life-expectancies are being considered for the procedure.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs.","authors":"Sara Ameen, Hamid A Merchant","doi":"10.1080/17434440.2023.2289691","DOIUrl":"10.1080/17434440.2023.2289691","url":null,"abstract":"<p><strong>Introduction: </strong>Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs).</p><p><strong>Areas covered: </strong>This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues.</p><p><strong>Expert opinion: </strong>Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Assessing the Sentimag system for guiding sentinel node biopsies in patients with breast cancer.","authors":"Hira Abidi, Richard J Bold","doi":"10.1080/17434440.2023.2284790","DOIUrl":"10.1080/17434440.2023.2284790","url":null,"abstract":"<p><strong>Introduction: </strong>Sentinel lymph node biopsy for breast cancer is a method to localize and excise the first draining lymph node from an invasive cancer of the breast. The histopathologic evaluation of the sentinel lymph node is used for predicting recurrence and survival and thus, guiding oncologists for treatment-decision making to administer adjuvant therapies. The ability to identify the sentinel node depends on methods to map lymphatic drainage from the breast to the sentinel node and accurately discriminate that node from other non-sentinel lymph nodes of the axilla.</p><p><strong>Areas covered: </strong>This review covers the clinical demand for technologies to assist the surgeon in intraoperative lymphatic mapping to specifically identify the sentinel lymph node in patients with breast cancer. Performance characteristics are reviewed for superparamagnetic iron oxide tracers used in lymphatic mapping compared to other current available technologies for lymphatic mapping.</p><p><strong>Expert opinion: </strong>The Magtrace (superparamagnetic iron oxide tracer) Sentimag (handheld magnetic probe) system is an FDA-approved technology for intraoperative lymphatic mapping to facilitate sentinel lymph node biopsy in breast cancer with technologic performance characteristics that are equivalent to <sup>99</sup>Technetium-sulfur colloid. Barriers to broader utilization primarily center around the need for nonmetallic devices to be used for the conduct of surgery, which would interfere with the paramagnetic method for tracer localization.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138296839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study.","authors":"Olivia McDermott, Breda Kearney","doi":"10.1080/17434440.2023.2291454","DOIUrl":"10.1080/17434440.2023.2291454","url":null,"abstract":"<p><strong>Objectives: </strong>This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the European Medical Device Regulations.</p><p><strong>Methodology: </strong>A mixed methods study was utilized with qualitative interviews and a quantitative survey.</p><p><strong>Results: </strong>The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence. The primary value of Real World Evidence lies in its ability to provide an accurate and, therefore, more reliable measure of device safety and performance. As a measure of safety and performance, it supplements clinical evidence generated from pre and post-market clinical investigations, reducing the costs associated with these studies and supporting the manufacturer's benefit: risk conclusion.</p><p><strong>Conclusion: </strong>This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hesham Elzomor, Ahmed Elkoumy, Sandeep S Hothi, Osama Soliman
{"title":"Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis.","authors":"Hesham Elzomor, Ahmed Elkoumy, Sandeep S Hothi, Osama Soliman","doi":"10.1080/17434440.2023.2298716","DOIUrl":"10.1080/17434440.2023.2298716","url":null,"abstract":"<p><strong>Introduction: </strong>Transcatheter aortic valve implantation (TAVI) is becoming the standard of care for severe symptomatic aortic stenosis (AS). Yet, some patients with AS are not indicated/eligible for TAVI. Several noninvasive, catheter-based or surgical alternatives exist, and other therapeutic options are emerging.</p><p><strong>Areas covered: </strong>This review provides an overview of non-TAVI options for severe AS. Non-invasive, transcatheter, and alternative surgical strategies are discussed, emphasizing their backgrounds, techniques, and outcomes.</p><p><strong>Expert opinion: </strong>Alternative therapies to TAVI, whether device-based or non-device-based, continue to evolve or emerge and provide either alternative treatments or a bridge to TAVI, for patients not meeting indications for, or having contraindications to TAVI.Although TAVI and SAVR are the current dominant therapies, there are still some patients that could benefit in the future from other alternatives.Data on alternative options for such patients are scarce. Many advantages and disadvantages arise when selecting a specific treatment strategy for individual patients.Head-to-head comparison studies could guide physicians toward better patient selection and procedural planning. Awareness of therapeutic options, indications, techniques, and outcomes should enable heart teams to achieve optimized patient selection. Furthermore, it can increase the use of these alternatives to optimize the management of AS among different patient populations.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139081177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bimodular femoral stems in primary total hip arthroplasty.","authors":"Jan Zajc, Samo K Fokter","doi":"10.1080/17434440.2023.2264177","DOIUrl":"10.1080/17434440.2023.2264177","url":null,"abstract":"<p><strong>Introduction: </strong>This review critically examines the efficacy of dual-modular stems in primary total hip arthroplasty. Given the variability and non-comparability of certain femoral stem designs and stem-neck couplings, with some even being withdrawn from the market, this review offers an in-depth analysis of predominant implant performances.</p><p><strong>Areas covered: </strong>The paper explores a brief historical summary related to dual-modular stems, including the complications associated with their use, diagnostic tools for evaluation, analysis of both recalled and currently available models, as well as alternative therapeutic options. This information is pertinent for both clinical and research domains.</p><p><strong>Expert opinion: </strong>While dual-modular systems were initially touted to offer several advantages, the evidence substantiating these benefits has been ambiguous. Further, these systems introduce the risk of alternative complications. In specific cases involving patients with developmental hip dysplasia and certain proximal femoral deformities requiring complex reconstructions, dual-modular systems might be relevant. Nonetheless, the use of long interchangeable necks in patients with a body mass index above 30 kg/m<sup>2</sup> is discouraged, and pairing a long varus-oriented neck with an extra-long femoral head should be avoided in all patients.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41174832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alberto Nieri, Luigi Manco, Matteo Bauckneht, Luca Urso, Matteo Caracciolo, Maria Isabella Donegani, Francesca Borgia, Kevin Vega, Alessandro Colella, Carmelo Ippolito, Corrado Cittanti, Silvia Morbelli, Gianmario Sambuceti, Alessandro Turra, Stefano Panareo, Mirco Bartolomei
{"title":"[18F]FDG PET-TC radiomics and machine learning in the evaluation of prostate incidental uptake.","authors":"Alberto Nieri, Luigi Manco, Matteo Bauckneht, Luca Urso, Matteo Caracciolo, Maria Isabella Donegani, Francesca Borgia, Kevin Vega, Alessandro Colella, Carmelo Ippolito, Corrado Cittanti, Silvia Morbelli, Gianmario Sambuceti, Alessandro Turra, Stefano Panareo, Mirco Bartolomei","doi":"10.1080/17434440.2023.2280685","DOIUrl":"10.1080/17434440.2023.2280685","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the relevance of incidental prostate [<sup>18</sup>F]FDG uptake (IPU) and to explore the potential of radiomics and machine learning (ML) to predict prostate cancer (PCa).</p><p><strong>Methods: </strong>We retrieved [<sup>18</sup>F]FDG PET/CT scans with evidence of IPU performed in two institutions between 2015 and 2021. Patients were divided into PCa and non-PCa, according to the biopsy. Clinical and PET/CT-derived information (comprehensive of radiomic analysis) were acquired. Five ML models were developed and their performance in discriminating PCa vs non-PCa IPU was evaluated. Radiomic analysis was investigated to predict ISUP Grade.</p><p><strong>Results: </strong>Overall, 56 IPU were identified and 31 patients performed prostate biopsy. Eighteen of those were diagnosed as PCa. Only PSA and radiomic features (eight from CT and nine from PET images, respectively) showed statistically significant difference between PCa and non-PCa patients. Eight features were found to be robust between the two institutions. CT-based ML models showed good performance, especially in terms of negative predictive value (NPV 0.733-0.867). PET-derived ML models results were less accurate except the Random Forest model (NPV = 0.933). Radiomics could not accurately predict ISUP grade.</p><p><strong>Conclusions: </strong>Paired with PSA, radiomic analysis seems to be promising to discriminate PCa/non-PCa IPU. ML could be a useful tool to identify non-PCa IPU, avoiding further investigations.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71523946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}