Expert review of medical devices最新文献

Introduction: There is a worldwide trend toward 'revisiting' cemented total hip arthroplasty (THA). In Japan, however, cemented THAs accounts for 11%, and the percentage of cemented hemiarthroplasty is estimated to be less than 10%. This review was designed to reconsider the option of cemented THA and to encourage policy changes in Japan to support the best possible care for patients.

Area covered: In this article, we reviewed the history of THA and the current situations of the world, based on past reports and nationwide registries. Merits and demerits of cemented THA were evaluated from various perspectives.

Expert opinion: Cemented THA had great advantages, including establishment of the acetabular cup, diversity of the femoral stem, antibiotic-loaded acrylic cement, revision, low incidence of periprosthetic fracture, and hemiarthroplasty. In patients older than 75 years of age, cemented THA resulted in the lowest risk of revision. Guidelines for femoral neck fracture recommended the use of cemented hemiarthroplasty in many countries because of low incidence of periprosthetic fracture. Numerous contradictions regarding implant price and cost of operations have also been noted in Japan. For the patients, we need to rethink what is truth and what is fiction.

Introduction: This comparative study examines the complexities of adverse event reporting forms for medical devices across various nations. Despite rigorous clinical trials and surveillance techniques, variations persist in processes and data elements used to report adverse events. The study highlights the importance of standardizing adverse event reporting for medical devices and suggests a comprehensive 'Generic Adverse Event Reporting Form' to accurately determine causality. The advice encourages widespread use of this generic form to create a standardized and effective system for reporting adverse events related to medical devices.

Areas covered: The present investigation provides comprehensive comparison of medical devices adverse event reporting form for users and industries across various nations, challenges, and rationale for a unified generic form.

Expert opinion: The introduction of a unified generic adverse event reporting form has the potential to enhance the effectiveness and efficiency of medical device vigilance systems worldwide. However, addressing challenges related to regulatory harmonization, data standardization, usability, and data privacy is essential for successful implementation and adoption of the generic form. Collaborative efforts among stakeholders, including regulators, manufacturers, healthcare professionals, and users are necessary to overcome these challenges and establish a robust global framework for medical device adverse event reporting.

Background: Smartphone electrocardiograms (iECGs) are an innovative method of capturing transient arrhythmias that are occasionally experienced by athletes. This study aimed to assess the accuracy of a 6-lead iECG compared with 12-lead ECG in athletes and those with known genetic heart disease (positive controls).

Research design and methods: Each participant had a resting 12-lead ECG (supine) and a 30 s 6-lead iECG (seated) taken within 2 h. Manual measurements of heart rate, QTc, and PR intervals, and QRS duration were completed using digital calipers. Bland-Altman analysis was used to assess the quantitative agreement of measurements.

Results: The 6-lead readings for heart rate were faster than the 12-lead in athletes (n = 233) and positive controls (n = 49). All other measurements were shorter in the 6-lead. QTc mean difference was smaller in the positive controls (4.7 ± 26.0 ms) than in athletes (12.5 ± 25.0 ms). The largest difference was in PR intervals, both in athletes (12.8 ± 17.7 ms) and positive controls (7.6 ± 18.9 ms). QRS duration had the smallest mean difference (0.6 ± 9.0 ms in athletes, 1.0 ± 12.7 ms in positive controls).

Conclusions: The 6-lead readings had reasonable agreement with the 12-lead ECG. A 6-lead iECG is a reasonable option to opportunistically capture arrhythmias that may occur infrequently, but should not replace a 12-lead if available.

Introduction: Digital therapeutics (DTx) are an emerging phenomenon within the scientific landscape which is attracting considerable international interest. This review aimed to provide an overview of the definition and classification of DTx, focusing on the contribution that DTx may provide in the treatment of a lot of diseases, compared with pharmacological treatments and highlighting it strengthens and weaknesses into the European regulatory landscape.

Areas covered: They are software-generated therapeutic interventions directly to patients useful to prevent, manage or treat diseases. Digital therapeutics can come in many forms, including mobile apps, online programs, wearables, and virtual reality. The use of digital therapeutics has gained increasing attention in recent years as a potential alternative to traditional pharmacological treatments. According to the European legislation, DTx are not classified as medicinal products but as medical devices, and not always in a homogeneous way between different countries.

Expert opinion: This regulatory lack could impact on the effectiveness of DTx in the European Union, which have the requirements to real impact on patients' health, like pharmacological treatments. It is therefore necessary to implement a stable regulatory system that can support conventional medicines prescriptions.

Introduction: In patients with symptomatic, refractory atrial fibrillation the ablate and pace (A&P) strategy (pacemaker implantation followed by atrio-ventricular junction ablation (AVJA)) is superior to medical therapy in improving quality of life and prognosis. Despite its well-proven benefits, this invasive therapeutic option is still underutilized in clinical practice. The choice of pacing modality (right ventricular pacing, biventricular pacing, BVP, or conduction system pacing, CSP) is crucial and can have significant clinical implications. In particular, in recent years CSP is emerging as an alternative to BVP, showing a good effectiveness and safety profile. Other important aspects are the timing of ablation, the approach used for AVJA, and the correct device programming after AVJA.

Areas covered: This article reviews the currently available evidence on this therapeutic strategy with a particular focus on its impact on patient outcome, recognized indications, technical considerations, and future perspectives.

Expert opinion: With the availability of more robust evidence confirming the better effectiveness and safety profile of CSP compared to conventional pacing modalities, in the next few years CSP will become the standard pacing modality in candidates for A&P. The routine adoption of this pacing modality could lead to a wider use of A&P in clinical practice.

Introduction: Proactive esophageal cooling reduces injury during radiofrequency (RF) ablation of the left atrium (LA) for the treatment of atrial fibrillation (AF). New catheters are capable of higher wattage settings up to 90 W (very high-power short duration, vHPSD) for 4 s. Varying power and duration, however, does not eliminate the risk of thermal injury. Furthermore, alternative energy sources such as pulsed field ablation (PFA) also exhibit thermal effects, with clinical data showing esophageal temperatures up to 40.3°C. The ensoETM esophageal cooling device (Attune Medical, now a part of Haemonetics, Boston, MA, U.S.A.) is commercially available and FDA-cleared to reduce thermal injury to the esophagus during RF ablation for AF and is recommended in the 2024 expert consensus statement on catheter and surgical ablation of AF.

Areas covered: This review summarizes growing evidence of esophageal cooling during high power RF ablation for AF treatment, including data relating to procedural efficacy, safety, and efficiency, and techniques to enhance operator success while providing directions for further research.

Expert opinion: Proactive esophageal cooling reduces injury to the esophagus during high power RF ablation, and utilizing this approach may result in increased success in first-pass isolation, procedural efficiency, and long-term efficacy.

Introduction: Out-of-hospital cardiac arrest (OHCA) is characterized by the cessation of mechanical cardiac activity and voluntary circulation occurring outside of a hospital setting, making it the leading cause of death worldwide. Recently, the optimal approach to airway management has been a subject of controversy.

Methods: Follow PRISMA guidelines for systematic evaluation and meta-analysis. The primary outcome was survival assessed by 4 measures: Restoration of spontaneous circulation, survival to hospital or emergency department, evaluation of functional recovery after PCR (measured at both discharge and 3 months after PCR), and neurological function score at discharge.

Results: A total of 6 RCTs (14,205 patients) were included in the systematic review and 4 RCTs (13,053 patients) were included in the meta-analysis. 5 studies (83.3%)of RCTs with ETI controls were notable for their high quality, with low risk of bias judged in all 7 domains of the risk assessment scale. Showed an advantage of SGA (compared to ETI) with potential for ROSC (95% CI [1.02 to 1.18], I² = 48%, p = 0.01) and survival to hospital or emergency department(95% CI [1.01 to 1.17], I² = 12%, p = 0.02).

Conclusions: This systematic review and meta-analysis found a significant association between SGA and the possibility of obtaining ROSC and reaching the hospital or emergency department after CPR in OHCA.

Background/purpose: Flow diverter porosity directly influences the blood flow reduction at the aneurysm neck level and the anatomical result of the treatment. In this research, we present and compare three methodologies to determine the local porosity of deployed flow diverters.

Method: Three-dimensional rotational angiography was used to obtain computational vessel models of three patients. Different flow diverters were virtually deployed in the computational models and implanted in 3D-printed models of the vasculatures by interventional neuroradiologists. Experimental porosity determinations were conducted using 2D microscope photographs and 3D Dyna-CT images (i.e. cone-beam Computed Tomography angiographic images), while simulated porosity was computed using ANKYRAS software.

Results: No statistically significant differences were observed between the porosity distributions from the three methods (p > 0.01). When computing the differences point-by-point, narrow distributions centered on zero were obtained, revealing a good agreement in the determinations. Orthogonal regression analysis affirmed this equivalence. The lowest agreement between porosity measurement methods was observed to occur at curve segments with relatively low porosity.

Conclusions: The local porosity of deployed flow diverters can be accurately determined by the three methods presented in this work. Assessing FD porosity with 3D Dyna-CT images would allow the evaluation of real patient data, whereas simulations could determine local porosity before the treatment.

Introduction: Traditional monitoring of athletes with cardiac symptoms is limited due to sport-specific considerations and the intermittent nature of symptoms. Some portable electrocardiogram (ECG) devices may have more diagnostic utility than traditional monitoring. Their accuracy, advantages, and limitations should be considered when a clinician is considering the most appropriate device for investigation of an athlete's symptoms.

Areas covered: There are six main categories of portable ECG devices: smartwatches, handheld devices, mobile cardiac telemetry (MCT), patches, rings, and chest sensors. The aim of this review is to highlight to a clinician the potential benefits of some devices over others to assist the physician in identifying the most appropriate device. We present peer-reviewed literature on the accuracy of each type of device along with advantages and limitations.

Expert opinion: For a user-initiated capture of an ECG, smartwatches and handheld devices are easy to use and supported by peer-reviewed literature. Rings can also provide a user-initiated ECG, though there is limited evidence to support their usage. For continuous monitoring, patches and MCT are both useful, though there is limited access to these devices. Chest sensors show some promise, although access is currently limited in some countries.

Introduction: Diagnosing oral cancer is crucial in healthcare, with technological advancements enhancing early detection and outcomes. This review examines the impact of handheld AI-based tools, focusing on Convolutional Neural Networks (CNNs) and their advanced architectures in oral cancer diagnosis.

Methods: A comprehensive search across PubMed, Scopus, Google Scholar, and Web of Science identified papers on deep learning (DL) in oral cancer diagnosis using digital images. The review, registered with PROSPERO, employed PRISMA and QUADAS-2 for search and risk assessment, with data analyzed through bubble and bar charts.

Results: Twenty-five papers were reviewed, highlighting classification, segmentation, and object detection as key areas. Despite challenges like limited annotated datasets and data imbalance, models such as DenseNet121, VGG19, and EfficientNet-B0 excelled in binary classification, while EfficientNet-B4, Inception-V4, and Faster R-CNN were effective for multiclass classification and object detection. Models achieved up to 100% precision, 99% specificity, and 97.5% accuracy, showcasing AI's potential to improve diagnostic accuracy. Combining datasets and leveraging transfer learning enhances detection, particularly in resource-limited settings.

Conclusion: Handheld AI tools are transforming oral cancer diagnosis, with ethical considerations guiding their integration into healthcare systems. DL offers explainability, builds trust in AI-driven diagnoses, and facilitates telemedicine integration.