Expert review of medical devices最新文献_第7页

Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials. 使用左心室辅助装置的患者基于运动的心脏康复：随机对照试验的最新系统综述和荟萃分析。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-27 DOI: 10.1080/17434440.2025.2468788

Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaaban Abdelgalil, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla

{"title":"Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials.","authors":"Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaaban Abdelgalil, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla","doi":"10.1080/17434440.2025.2468788","DOIUrl":"10.1080/17434440.2025.2468788","url":null,"abstract":"Background: Data on the efficacy and safety of exercise-based cardiac rehabilitation (EBCR) in patients with left ventricular assist devices (LVAD) remains limited. This study aims to pool evidence on EBCR's efficacy and safety in LVAD patients and compare high-intensity (HIIT) versus moderate-intensity (MIIT) regimens.Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) from PubMed, Embase, Cochrane, Scopus, and Web of Science up to January 2024. A fixed-effects model reported dichotomous outcomes using risk ratio (RR) and continuous outcomes using standardized mean difference (SMD) with a 95% confidence interval (CI). The study was registered in PROSPERO under the identifier 'CRD42024506485.'Results: Six RCTs with 160 patients were included. No significant difference was found between EBCR and usual care for peak VO2 change [p = 0.22] and six-minute walk distance (6-MWD) change [p = 0.16]. Similarly, no significant difference was observed between HIIT and MICT for peak VO2 change [p = 0.52] and 6-MWD change [p = 0.61]. Moreover, there was no significant difference between EBCR and usual care regarding the incidence of adverse events [p = 0.09], and between HIIT and MICT exercise [p = 0.71].Conclusion: The evidence suggests EBCR does not improve functional capacity, measured by peak VO2 or 6-MWD, in LVAD patients. However, EBCR is safe, with similar adverse event rates compared to usual care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"219-232"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143451254","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}

引用次数: 0

Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations. 除了糖尿病之外，持续血糖监测还有什么作用吗？在新人群中的新兴应用。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-05 DOI: 10.1080/17434440.2025.2463339

Kevin Cowart, Kevin Olson, Nicholas W Carris

引用次数: 0

Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications. 血管内碎石术的进展：机制、装置和临床应用。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-28 DOI: 10.1080/17434440.2025.2472886

Maxime Dubosq-Lebaz, Victoire Jacomino, Raphael Coscas

{"title":"Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications.","authors":"Maxime Dubosq-Lebaz, Victoire Jacomino, Raphael Coscas","doi":"10.1080/17434440.2025.2472886","DOIUrl":"10.1080/17434440.2025.2472886","url":null,"abstract":"Introduction: Peripheral arterial disease (PAD) complicates endovascular interventions due to vascular calcifications, which compromise procedural success and long-term outcomes. Intravascular lithotripsy (IVL) represents a promising innovation to modify calcified lesions with shockwaves, addressing unmet clinical needs.Areas covered: This review explores the mechanisms, devices, and clinical applications of IVL in PAD treatment. It highlights the limitations of conventional approaches (high-pressure balloons, specialty balloons, atherectomy), which often result in suboptimal lesion preparation and procedural complications. Particular emphasis is placed on the combination of atherectomy and IVL, as well as the various IVL devices available and in development, beyond those from Shockwave Medical. Additionally, we discuss future perspectives, including drug penetration enhancement and the issue of post-IVL recoil. Additionally, the literature review methodology, encompassing searches in PubMed and Embase, from January 2008 to December 2023, is briefly outlined.Expert opinion: IVL offers a safe, effective, and innovative approach to treating calcified lesions while preserving surrounding tissues. However, the current evidence, mainly derived from industry-funded studies, is limited by heterogeneous calcification classifications and a lack of long-term outcome data. Independent research is essential to define IVL's role in PAD treatment algorithms, especially regarding its cost-effectiveness and long-term primary patency outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"209-218"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143495035","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}

引用次数: 0

The frozen elephant trunk: an overview of hybrid prostheses. 冷冻象鼻：混合假体的概述。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-03-24 DOI: 10.1080/17434440.2025.2471455

Mariam Hussain, Yousif F Jubouri, Aya Hammad, Ihsan Abubacker, Marco Franchin, Francesca Mauri, Gabriele Piffaretti, Idhrees Mohammed, Matti Jubouri, Mohamad Bashir

{"title":"The frozen elephant trunk: an overview of hybrid prostheses.","authors":"Mariam Hussain, Yousif F Jubouri, Aya Hammad, Ihsan Abubacker, Marco Franchin, Francesca Mauri, Gabriele Piffaretti, Idhrees Mohammed, Matti Jubouri, Mohamad Bashir","doi":"10.1080/17434440.2025.2471455","DOIUrl":"10.1080/17434440.2025.2471455","url":null,"abstract":"Introduction: Thoracic aortic pathologies implicating the aortic arch and the descending thoracic aorta (DTA) are primarily managed with total aortic arch replacement (TAR). This can be performed as a single-procedure hybrid fashion using the frozen elephant trunk technique (FET), which utilizes hybrid prosthesis. Nevertheless, FET presents certain challenges such as distal stent graft-induced new entry (dSINE), negative aortic remodeling, and reintervention.Areas covered: The narrative review provides an overview of the four majors FET prosthesis, highlighting their design features, mechanical properties, configurations, and variants, and evaluating their clinical outcomes reported in the literature. The leading prosthesises were compared through their mortality and survival rates, neurological outcomes, dSINE, aortic remodeling, and reintervention rates.Expert opinion: Four FET devices can be considered the main option on the global market; Thoraflex, E-Vita, Cronus, and Frozenix J Graft. Each hybrid prosthesis (HP) features unique design characteristics, resulting in varying clinical outcomes. Thoraflex and E-Vita are the most widely used and investigated HPs, whilst the use of Cronus and Frozenix is geographically confined to mainly manufacturers' countries. The rates of early mortality, stroke, SCI, dSINE, and reintervention rates were found to be comparable among the four devices, yet, Thoraflex seemed to offer the most optimal clinical profile.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"193-208"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694942","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}

引用次数: 0

Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials. 心理健康聊天机器人在青少年和年轻人抑郁和焦虑中的有效性：随机对照试验的荟萃分析

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-16 DOI: 10.1080/17434440.2025.2466742

Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma

{"title":"Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials.","authors":"Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma","doi":"10.1080/17434440.2025.2466742","DOIUrl":"10.1080/17434440.2025.2466742","url":null,"abstract":"Background: The mental health chatbot is dedicated to providing assistance to individuals grappling with the complexities of depression and anxiety.Objective: The study aimed to evaluate the effectiveness of the mental health chatbot in alleviating symptoms of depression and anxiety among adolescents and young adults.Methods: A systematic review framework was employed with a protocol pre-registered on Prospero (CRD42023418877). Databases were systematically searched, including PubMed, ACM Digital Library, Embase, Cochrane and IEEE. Data synthesis was conducted narratively, and meta-analysis was performed by pooling data from the original studies.Results: Ten randomized controlled trials focused on an acute population, mainly females and university students. Chatbots designed for daily conversations and mood monitoring, using cognitive behavioral therapy techniques, showed efficacy in treating depression (95% CI = -1.09 to -0.23; p = .003). However, it is essential to highlight that these interventions utilizing chatbots for mental health were not found to be efficacious in managing symptoms of anxiety (95% CI = -0.56 to 0.4; p = .74).Conclusions: Evidence supports the effectiveness of mental health chatbots in treating depression, but further exploration and refinement are needed to optimize their efficacy in managing anxiety.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"233-241"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400566","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}

引用次数: 0

The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms. e- inside多内支支架用于胸腹主动脉瘤的治疗。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-24 DOI: 10.1080/17434440.2025.2465686

Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber

{"title":"The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms.","authors":"Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber","doi":"10.1080/17434440.2025.2465686","DOIUrl":"10.1080/17434440.2025.2465686","url":null,"abstract":"Introduction: Endovascular repair for thoracoabdominal aortic aneurysms (TAAAs) has changed treatment paradigm over the past decades. However for urgent cases, there are not many options available. The E-nside (Artivion, Georgia, U.S.A.) endograft is one of the three off-the-shelf-aortic endografts available on the market. Its unique design with four inner branches and other special features offer more versatility, so more patients could be minimally invasively treated.Areas covered: We present a descriptive review based on market analysis on the available devices and a PubMed literature research on the E-nside endograft. The aim of this article is to present its unique structure, deployment method, and cannulation methods and discuss its applicability, indications, associated concerns and an overview of the available alternative devices.Expert opinion: The implantation of the E-nside endograft is a promising technique for treating not only TAAAs but also complex abdominal aortic aneurysm. Unlike FEVAR or BEVAR, which require precise planning and have the disadvantage of long manufacturing time. We think that with the off-the-shelf feature from E-nside endograft this can be obviated, and through its flexible planning along with its simple use, more patients could benefit and so favorable results can be achieve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"177-185"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426843","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}

引用次数: 0

Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific chronic neck pain: a randomised controlled trial. 交互式远程康复和经皮神经电刺激对非特异性慢性颈痛患者疼痛、功能、残疾和生活质量的疗效研究：一项随机对照试验。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-26 DOI: 10.1080/17434440.2025.2471444

Musa Çankaya, Pariya PourİYamanesh, Sami Küçükşen

{"title":"Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific chronic neck pain: a randomised controlled trial.","authors":"Musa Çankaya, Pariya PourİYamanesh, Sami Küçükşen","doi":"10.1080/17434440.2025.2471444","DOIUrl":"10.1080/17434440.2025.2471444","url":null,"abstract":"Objectives: Despite the widespread use of TENS in the treatment of chronic nonspecific neck pain (CNNP), there are few studies on Telerehabilitation (TR), and no studies comparing their effectiveness compared to each other in this field. It was planned to investigate and compare the effectiveness of TENS and TR, which is an online rehabilitation tool.Methods: Forty-eight (female 45, male 3) patients with CNNP, aged 36.31 + 12.54 years, were randomized into TENS, TR or control groups. Pain severity was determined by Visual Analog Scale (VAS), Bournemouth Neck Questionnaire (NBQ), Neck Disability Index (NDI), Copenhagen Neck Functional Disability Scale (CNFDS), and World Health Organization Quality of Life Module (WHOQOL-BREF).Results: VAS, NBQ, NBI, CNFDS Time*Group interaction showed a significant positive change after treatment (p = 0.013, p = 0.007, p = 0.022, p = 0.005, respectively). The effect size of this difference over time was large (pη2 = 0.177, pη2 = 0.198, pη2 = 0.156, pη2 = 0.208, respectively). Post-treatment, the highest mean difference was found in VAS and NDI values in the TENS (MD:2.656, MD:7.000, p < 0.001), NBQ, CNFDS, WHOQOL-Bref in the TR (MD:13.187, MD:5.312, MD:-9.660, p < 0.001, respectively).Conclusion: VAS and NBQ in the TENS and NDI, CNFS, WHOQOL-Bref in the TR group were more effective after treatment than before treatment in patients with CNNP.Trial registration: The clinical trial registration number for this study was: NCT06206343 (ClinicalTrials.gov).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"243-252"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143485190","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}

引用次数: 0

Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety. 符合ISO 15197:2013精度标准的新型arkray glucocard S onyx血糖仪的红细胞压积和药物干扰研究-对患者安全的贡献

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-03-07 DOI: 10.1080/17434440.2025.2470295

Claudio Burrini, Beatrice Morrocchi, Nicola Giorgetti, Beate Saeger

{"title":"Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety.","authors":"Claudio Burrini, Beatrice Morrocchi, Nicola Giorgetti, Beate Saeger","doi":"10.1080/17434440.2025.2470295","DOIUrl":"10.1080/17434440.2025.2470295","url":null,"abstract":"Introduction: Abnormal HCT levels and medications can cause inaccurate readings with blood glucose meters (BGM) in routine practice. The GLUCOCARD S onyx (ARKRAY Inc.) BGM was evaluated over a wide HCT range (20-70%) and its interaction with 27 common drug interferences, as per ISO15197:2013/EN ISO15197:2015, compared to clinical laboratory reference methods.Methods: Pooled venous blood samples from >200 participants were prepared with four HCT concentrations (20-70%) and three glucose concentrations (60-360 mg/dL). These were spiked with 27 potential interfering substances and tested using GLUCOCARD S onyx, Atellica CH (D-Glucose), and Sysmex XN-10 (HCT).Results: Stable performance meeting ISO15197:2013 criteria were observed at HCT concentrations of 20-25%, 42±2%, 55±2%, and 66-69% (Levene, one-way ANOVA, p>0.05). No significant differences in averages were found for most substances, except for Ascorbic acid (>6 mg/dL), Sodium (>180 mmol/L), and Xylose (>600 mg/dL). Ascorbic acid at 3 mg/dL and Sodium at 90 mmol/L showed no interference for normal to low glucose readings. .Conclusion: The GLUCOCARD S onyx BGM provided accurate glucose readings across a wide HCT range (20-70%) and under various medication conditions, enabling reliable diabetes management by patients and effective treatment by healthcare providers in complex clinical scenarios.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"253-260"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143545343","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}

引用次数: 0

Vigilance and medical devices: from theory to the field, the example of electroporation in atrial fibrillation. 警惕性与医疗器械：从理论到实际，心房颤动电穿孔的例子。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-11 DOI: 10.1080/17434440.2025.2463340

Cordélia Salomez-Ihl, Marvin Jacquet, Laura Quarteroni, Pascal Defaye, Delphine Schmitt, Philippe Py, Pierrick Bedouch

引用次数: 0

The use of predetermined change control plans to enable the release of new versions of software as a medical device. 使用预先确定的变更控制计划，以便作为医疗设备发布新版本的软件。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-28 DOI: 10.1080/17434440.2025.2468787

Jacques Andre DuPreez, Olivia McDermott

{"title":"The use of predetermined change control plans to enable the release of new versions of software as a medical device.","authors":"Jacques Andre DuPreez, Olivia McDermott","doi":"10.1080/17434440.2025.2468787","DOIUrl":"10.1080/17434440.2025.2468787","url":null,"abstract":"Objectives: This study investigates how Predetermined Change Control Plans (PCCPs) can support the Software Development Life Cycle (SDLC) of certain Software as a Medical Device (SaMD).Methods: Targeted surveys collected qualitative and quantitative data on the current regulatory change process for SaMD; the use of PCCPs; the potential parameters of PCCPs in terms of technical, clinical, usability, and administrative changes to SaMD; and whether PCCPs could be used more broadly for all SaMDs.Results: Results indicate that the current regulatory approach is not fit for purpose, specifically regarding fast-moving SaMD or continuous-learning AI SaMD. There was strong support for PCCPs to cover device technology, usability, and administrative changes, while clinical changes had limited support and required further investigation. The EU lags behind the US and now the UK in addressing these challenges and should look to legislate and implement PCCPs to ensure ongoing innovation and investment in digital health technologies.Conclusion: This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK, and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"261-275"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442967","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}

引用次数: 0