Expert review of medical devices最新文献_第8页

Right heart failure after durable left ventricular assist device implantation. 耐久性左心室辅助装置植入术后的右心衰竭。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-19 DOI: 10.1080/17434440.2024.2305362

Tamari Miller, Frederick M Lang, Ashkon Rahbari, Kleanthis Theodoropoulos, Veli K Topkara

{"title":"Right heart failure after durable left ventricular assist device implantation.","authors":"Tamari Miller, Frederick M Lang, Ashkon Rahbari, Kleanthis Theodoropoulos, Veli K Topkara","doi":"10.1080/17434440.2024.2305362","DOIUrl":"10.1080/17434440.2024.2305362","url":null,"abstract":"Introduction: Right heart failure (RHF) is a well-known complication after left ventricular assist device (LVAD) implantation and portends increased morbidity and mortality. Understanding the mechanisms and predictors of RHF in this clinical setting may offer ideas for early identification and aggressive management to minimize poor outcomes. A variety of medical therapies and mechanical circulatory support options are currently available for the management of post-LVAD RHF.Areas covered: We reviewed the existing definitions of RHF including its potential mechanisms in the context of durable LVAD implantation and currently available medical and device therapies. We performed a literature search using PubMed (from 2010 to 2023).Expert opinion: RHF remains a common complication after LVAD implantation. However, existing knowledge gaps limit clinicians' ability to adequately address its consequences. Early identification and management are crucial to reducing the risk of poor outcomes, but existing risk stratification tools perform poorly and have limited clinical applicability. This is an area ripe for investigation with the potential for major improvements in identification and targeted therapy in an effort to improve outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139428093","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

Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training. 利用 3D 打印技术制造的生物模型在手术规划和医学培训方面的比较研究。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-25 DOI: 10.1080/17434440.2024.2306884

M V Requena-Pérez, P Andrés-Cano, L Galán-Romero, M Suffo

{"title":"Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training.","authors":"M V Requena-Pérez, P Andrés-Cano, L Galán-Romero, M Suffo","doi":"10.1080/17434440.2024.2306884","DOIUrl":"10.1080/17434440.2024.2306884","url":null,"abstract":"Objectives: To obtain 3D printed bone models with a haptic sensation similar to that of the real bone, which will help the surgeon to learn and improve based on practice.Methods: From computed tomography, 3 digital anatomical models of the human proximal femur were created and, by modifying the printing parameters, both cortical and trabecular tissues were simulated, which were combined in a different cortico-cancellous interface depending on the bone segment. The 3 equivalent models obtained were compared with a commercial Sawbone synthetic model and subjected to a series of blind surgical practice trials performed by 5 TOC specialists from a hospital, each of them with different degrees of expertise. A statistical analysis of the qualitative data collected based on the Wilcoxon test, the Spearman correlation matrix, and the Validity Ratio Coefficient was performed.Results: The deviations observed in the dimensional study are less than 0.2 millimeter, which confirms the validity of the 3DP-FFF technology to geometrically recreate personalized biomodels with high anatomical precision.Conclusions: The reproductions obtained have given rise to a reliable method that professionals can refine to plan operations with the consequent reduction of time and risks for the patient, as well as for medical training.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139546834","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

Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. 单次无创耳廓迷走神经刺激对精英运动员运动表现的影响：开放标签随机对照试验。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2023-12-30 DOI: 10.1080/17434440.2023.2299300

Adem Çalι, Ali Veysel Özden, İsmail Ceylan

{"title":"Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial.","authors":"Adem Çalι, Ali Veysel Özden, İsmail Ceylan","doi":"10.1080/17434440.2023.2299300","DOIUrl":"10.1080/17434440.2023.2299300","url":null,"abstract":"Objectives: The purpose of this study was to investigate the efficacy of noninvasive auricular vagus nerve stimulation (AVNS) on sports performance.Methods: The intervention group (n = 30) received a single session of AVNS, while the control group (n = 30) received a single session of sham AVNS. Pre- and post-treatment isometric quadriceps muscle strength, heart rate, lower extremity balance, and grip strength were measured.Results: It was ascertained that the differences in heart rate (-0.73 pulse/min, p = 0.032) and modified Star Balance Test scores (anterior 2.72 cm, p = 0.000, posterolateral 3.65 cm, p = 0.000 and posteromedial 2.43 cm, p = 0.000) before and after AVNS were significant in subjects in the experimental group. The results of the one-way ANOVA analysis show that the differences obtained in all measurement parameters are not statistically significant (p > 0.05). Considering the partial eta squared (η2) obtained from the measurements, a small descriptive effect in favor of experimental group was obtained for the quadriceps strength (0.016) and anterior balance (0.054) measurements.Conclusion: This study demonstrates that a single AVNS session compared to sham AVNS shows a modest benefit though not statistically significant improvement in athletic performance. Single-use of AVNS seems not effective in improving athletic performance.Clinical trial registration: www.clinicaltrials.gov identifier NCT05436821.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139038283","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

Mitral transcatheter edge-to-edge repair: patient selection, current devices, and clinical outcomes. 二尖瓣经导管边缘对边缘修补术：患者选择、现有设备和临床结果。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2023-12-28 DOI: 10.1080/17434440.2023.2298713

Albert Massó van-Roessel, Lluis Asmarats, Chi Hion Pedro Li, Xavier Millán, Estefanía Fernández-Peregrina, Irene Menduiña, Juan Sanchez-Ceña, Dabit Arzamendi

引用次数: 0

Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury. 单脉冲经颅磁刺激用于评估早期脑损伤婴儿的运动发育。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-03 DOI: 10.1080/17434440.2023.2299310

Ellen N Sutter, Cameron P Casey, Bernadette T Gillick

{"title":"Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury.","authors":"Ellen N Sutter, Cameron P Casey, Bernadette T Gillick","doi":"10.1080/17434440.2023.2299310","DOIUrl":"10.1080/17434440.2023.2299310","url":null,"abstract":"Introduction: Single-pulse transcranial magnetic stimulation (TMS) has many applications for pediatric clinical populations, including infants with perinatal brain injury. As a noninvasive neuromodulation tool, single-pulse TMS has been used safely in infants and children to assess corticospinal integrity and circuitry patterns. TMS may have important applications in early detection of atypical motor development or cerebral palsy.Areas covered: The authors identified and summarized relevant studies incorporating TMS in infants, including findings related to corticospinal development and circuitry, motor cortex localization and mapping, and safety. This special report also describes methodologies and safety considerations related to TMS assessment in infants, and discusses potential applications related to diagnosis of cerebral palsy and early intervention.Expert opinion: Single-pulse TMS has demonstrated safety and feasibility in infants with perinatal brain injury and may provide insight into neuromotor development and potential cerebral palsy diagnosis. Additional research in larger sample sizes will more fully evaluate the utility of TMS biomarkers in early diagnosis and intervention. Methodological challenges to performing TMS in infants and technical/equipment limitations require additional consideration and innovation toward clinical implementation. Future research may explore use of noninvasive neuromodulation techniques as an intervention in younger children with perinatal brain injury to improve motor outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10947901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139081178","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}

引用次数: 0

Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters. 用于减少 PICC 和中线导管并发症的亲水性生物材料静脉注射水凝胶导管。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-03-06 DOI: 10.1080/17434440.2024.2324885

Nancy Moureau

{"title":"Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters.","authors":"Nancy Moureau","doi":"10.1080/17434440.2024.2324885","DOIUrl":"10.1080/17434440.2024.2324885","url":null,"abstract":"Introduction: More than 30% of peripherally inserted central catheters (PICCs) and midline catheters experience complications. Most complications are related to thrombotic cellular adherence to catheter materials.Areas covered: This manuscript outlines PICC and midline catheter complications, the need to reduce complications and how hydrogel catheters may provide a solution to address these unmet needs based on available evidence.Expert opinion: Patients commonly require PICC or midline catheters for treatment to establish a reliable form of intravenous access. Catheters, while reliable in most cases, are not without complications, including occlusion, thrombosis and infection, each related to cellular adherence to the catheter material. Hydrophilic catheter coatings and composites have been developed to mitigate these thrombotic complications, reduce adherence of blood and bacterial cells to catheters and provide greater patient safety with these devices. Hydrogel materials are highly biocompatible and have been effective in reducing cellular adherence and the formation of biofilms on surfaces. Smooth hydrophilic catheter surfaces are potentially more comfortable for the patient, with reduced friction during insertion and removal. A catheter constructed of hydrophilic biomaterial, a hydrogel composite material, may minimize thrombotic complications in PICC and midline catheters, improving catheter performance and outcomes for patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140041185","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

Towards an evaluation framework for medical device-integrated electronic medical record. 医疗设备集成电子病历的评估框架。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-02-13 DOI: 10.1080/17434440.2024.2315024

Aeshah Alhammad, Maryati Mohd Yusof, Dian Indrayani Jambari

{"title":"Towards an evaluation framework for medical device-integrated electronic medical record.","authors":"Aeshah Alhammad, Maryati Mohd Yusof, Dian Indrayani Jambari","doi":"10.1080/17434440.2024.2315024","DOIUrl":"10.1080/17434440.2024.2315024","url":null,"abstract":"Introduction: Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures.Areas covered: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.Expert opinion: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139693719","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

Correction. 更正。

Expert review of medical devices Pub Date : 2024-01-10 DOI: 10.1080/17434440.2023.2300226

引用次数: 0

Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review. 通过远程医疗监测运动障碍和多发性硬化症患者步态和姿势的可穿戴设备：系统综述。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2298342

Francesca Salaorni, Giulia Bonardi, Federico Schena, Michele Tinazzi, Marialuisa Gandolfi

{"title":"Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review.","authors":"Francesca Salaorni, Giulia Bonardi, Federico Schena, Michele Tinazzi, Marialuisa Gandolfi","doi":"10.1080/17434440.2023.2298342","DOIUrl":"10.1080/17434440.2023.2298342","url":null,"abstract":"Introduction: Wearable devices and telemedicine are increasingly used to track health-related parameters across patient populations. Since gait and postural control deficits contribute to mobility deficits in persons with movement disorders and multiple sclerosis, we thought it interesting to evaluate devices in telemedicine for gait and posture monitoring in such patients.Methods: For this systematic review, we searched the electronic databases MEDLINE (PubMed), SCOPUS, Cochrane Library, and SPORTDiscus. Of the 452 records retrieved, 12 met the inclusion/exclusion criteria. Data about (1) study characteristics and clinical aspects, (2) technical, and (3) telemonitoring and teleconsulting were retrieved, The studies were quality assessed.Results: All studies involved patients with Parkinson's disease; most used triaxial accelerometers for general assessment (n = 4), assessment of motor fluctuation (n = 3), falls (n = 2), and turning (n = 3). Sensor placement and count varied widely across studies. Nine used lab-validated algorithms for data analysis. Only one discussed synchronous patient feedback and asynchronous teleconsultation.Conclusions: Wearable devices enable real-world patient monitoring and suggest biomarkers for symptoms and behaviors related to underlying gait disorders. thus enriching clinical assessment and personalized treatment plans. As digital healthcare evolves, further research is needed to enhance device accuracy, assess user acceptability, and integrate these tools into telemedicine infrastructure.Prospero registration: CRD42022355460.","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":"138833699","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 current use of tissue expanders in breast reconstruction: device design, features, and technical considerations. 组织扩张器在乳房重建中的当前应用:设备设计、特点和技术考虑。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2288911

Min-Jeong Cho, Rana V Farhadi, David W Nash, Joseph Kaleeny, Stephen P Povoski, Albert H Chao

{"title":"The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations.","authors":"Min-Jeong Cho, Rana V Farhadi, David W Nash, Joseph Kaleeny, Stephen P Povoski, Albert H Chao","doi":"10.1080/17434440.2023.2288911","DOIUrl":"10.1080/17434440.2023.2288911","url":null,"abstract":"Introduction: The use of tissue expanders (TE) in post-mastectomy breast reconstruction is a widely accepted practice, especially in patients desiring implant-based breast reconstruction. It has become the standard of care to perform a two-staged breast reconstruction using tissue expanders for the past 50 years due to its reliability, safety, cost-effectiveness, and versatility. Due to its popularity, there are numerous types and features of breast tissue expanders and various surgical approaches available for plastic surgeons.Areas covered: In this article, we will review the role of tissue expanders in breast reconstruction, the types and features of breast tissue expanders, and technical considerations.Expert opinion: The use of tissue expanders in breast reconstruction offers significant advantages of preserving the breast skin envelope and reestablishing the breast mound. With evolving approaches to breast reconstruction, tissue expander design, and application underwent several refinements and modifications. Due to these advances, studies on its long-term efficacy and safety profile typically fall behind and more studies with higher levels of evidence are needed to better evaluate the efficacy and safety profile of tissue expanders. With increased understanding, reconstructive surgeons can minimize complications and maximize reconstructive, aesthetic outcomes with high patient satisfaction.","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":"138465157","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