Expert review of medical devices最新文献

Background: Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field.

Research design and methods: A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform.

Results: Results were derived from 94 participants (27% clinicians, 62% researchers, 11% companies) and evidenced mostly a fair knowledge of MDR (despite self-judged as poor by 51%). Safety (83%), validation (56%), risk management (50%) were considered relevant and associated with the regulatory process. Structured support and regulatory procedures connected with medical devices in daily practice at the institutional level are lacking (only 33% report availability of a regulatory department).

Conclusions: Regulation was recognized relevant by the VascAgeNet community and specific support and training in medical device regulatory science was considered important. A direct link with the regulatory sector is not yet easily available.

Introduction: Repair of aortic arch pathologies such as degenerative aneurysms and dissections still represents a significant challenge for vascular and cardiac surgeons. We focused on the design, evolution, implementation, and prospects of endovascular dual branch technology for treatment of pathologies in the aortic arch.

Areas covered: The literature search was conducted in a non-systematic fashion through the PubMed and Scopus databases; articles deemed relevant to the scope of the work and fully published in English language from January 12,000 until December 2023 were considered for inclusion. Two companies so far have developed and launched in market a dedicated arch dual branch platform: Terumo Aortic and Cook Medical.

Expert opinion: A common limitation to the available technology is represented by the fact that urgent cases (i.e. large or rapidly growing aneurysms, symptomatic patients) cannot be treated because the customization process generally takes between 6 and 8 weeks, and there is an inherent risk for aorta-related adverse events to happen during the waiting time. While the future holds much promise, several technical hurdles still exist and further developments (in device design, operators' skills, patients' selection, and outcomes assessment) are needed to establish the safety and effectiveness of treatment particularly over the long-run.

Objectives: To assess the accuracy and precision of acetabular component placement in robot-assisted surgery total hip arthroplasty (RAS-THA) using three different approaches.

Methods: This study is a secondary analysis from a multicenter, randomized controlled trial comparing the Trex RS Hip 1.0 robot navigation system across different surgical approaches. It involved 145 patients treated at three Chinese medical centers from June 2021 to July 2022. Patients with end-stage joint disease were randomly assigned to either the RAS or control group. Acetabular component positioning was evaluated radiographically, and registration accuracy was measured using Root Mean Square Error (RMSE).

Results: The overall RMSE was 0.72 mm (SD = 0.24 mm), indicating consistent accuracy regardless of surgical approach. Significant variations in anteversion were noted across groups (p = 0.001). Lateral RAS-THA showed enhanced precision. The RAS Direct Anterior Approach (DAA) group had the least deviation in the rotation center's horizontal distance (0.89 ± 1.14 mm, p = 0.0014) and minimal leg length discrepancy (2.41 ± 1.17 mm). The RAS DAA approach also produced more consistent results.

Conclusion: Robotic assistance in THA, especially via the DAA approach, enhances the accuracy and precision of acetabular component positioning. Consistent registration accuracy across various surgical approaches confirms the reliability of these methods for THA.

Clinical trial registration: www.clinicaltrials.gov identifier is ChiCTR2100044124.

Objectives: To investigate the clinical value of rigid bronchoscopy combined with fiberoptic bronchoscopy in patients with early bronchogenic lung cancer who underwent sleeve lobectomy.

Methods: A retrospective study was performed on 76 patients with early bronchogenic lung cancer admitted to our center from March 2016 to March 2017. Patients in the control group received conventional sleeve lobectomy (n = 38), while patients in the observation group underwent sleeve lobectomy by using rigid bronchoscopy combining fiberoptic bronchoscopy (n = 38). We compared perioperative period indicators and the recovery of pulmonary function indexes one month after the operation were compared in two groups. The prognosis of the patients were also analyzed.

Results: Compared with the control group, the intraoperative blood loss, operation duration and airway reconstruction duration in the observation group were significantly reduced. The total incidence of perioperative complications was markedly lower in the observation group than in the control group. The percentage of DLCO% was significantly improved in the observation group. The relapse-free survival (RFS) in the observation group was remarkably longer than in the control group.

Conclusion: Rigid bronchoscopy combined with fiberoptic bronchoscopy is beneficial to improve the clinical outcome and prognosis of patients with early bronchogenic lung cancer more effectively.

Introduction: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority.

Areas covered: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.

Expert opinion: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.

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.

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.

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.

Introduction: Over the last two decades, mitral transcatheter edge-to-edge repair (M-TEER) has become a safe and effective therapy for severe mitral regurgitation in patients deemed at high surgical risk.

Areas covered: This review aims to encompass the most relevant and updated evidence in the field of M-TEER from its inception, focusing on clinical and anatomical features for proper patient and device selection.

Expert opinion: Growing operator experience and device iterations have resulted in improved clinical outcomes and an expansion of the therapy to patients with complex anatomies and clinical scenarios. Future investigations are warranted to determine the best management options and the most suitable device for every patient with MR.

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.