Expert review of medical devices最新文献

Introduction: Spinal cord injuries (SCI) often result in motor impairment and lifelong disability.

Methods: This systematic review, conducted in agreement with PRISMA guidelines, aimed to evaluate the effects of cortico-spinal paired associative stimulation (PAS) on motor outcomes in individuals with SCI. PubMed, Scopus/EMBASE, Pedro, and Cochrane databases were consulted from inception to 2023/01/12.

Results: In 1021 articles, 10 studies involving 84 patients meet the inclusion criteria, 7 case series/study, and 3 clinical trials. Despite light differences, the included studies performed a cortico-peripheral PAS using a single transcranial magnetic stimulation and high frequency electrical peripheral nerve stimulation for a consistent number of sessions (>20). All included studies reported improvement in motor outcomes recorded via clinical and/or neurophysiological assessment.

Conclusion: Available evidence showed an increase in motor outcomes after PAS stimulation. Indeed, both clinical and neurophysiological outcomes suggest the effectiveness of a high number of PAS sessions in chronic individuals with SCI. Due to a limited number of studies and an unsatisfactory study design, well-designed RCTs are needed to confirm the potentiality of these approaches and clarify the adequate dose-response of PAS in the SCI population.

Registration id: The protocol was registered on the PROSPERO database (CRD42023485703).

Introduction: The management of the false lumen (FL) when dealing with aortic dissection is a crucial aspect since inducing its thrombosis is necessary in order to achieve aortic remodeling. One of the pitfalls of endovascular treatment of aortic dissection (AD) is retrograde distal FL perfusion and pressurization, which prevents FL thrombosis and thus aortic remodeling, while being associated with aneurysmal degeneration of the FL and poor long-term outcomes.

Areas covered: Currently, there is no CE/FDA approved device for FL closure, however different techniques and devices have been proposed to overcome this challenge, the most known of which is the Candy Plug (CP). This review aims to describe the CP device, its implantation technique, and the available data in the literature (PubMed, Cochrane, and EMBASE databases; last queried, December 31, 2023).

Expert opinions: While the treatment of AD remains technically challenging, the use of the CP technique to close any distal FL reperfusion proved to be feasible and safe with excellent rates of both technical and clinical success. Furthermore, recent studies have shown a quick learning curve with this technique.

Background: Out-of-hospital cardiac arrest (OHCA) is a major issue in aging populations. The use of automatic external defibrillators (AEDs) in public places improves cardiac arrest survival rates. The purpose of this study is to review economic evaluation studies of the use of AED technology in public settings for cardiac arrest resuscitation.

Methods: Our search covered 1990-2021 and included PubMed, Cochrane Library, Embase, Scopus, and Web of Science. We included studies that analyzed cost-effectiveness, cost-utility and cost-benefit of the AED technology. Also, we performed the quality assessment of the studies through the checklist of quality assessment standard of health economic studies (QHES).

Results: Our inclusion criteria were met by 25 studies. AEDs are found to be cost-effective in places with a high occurrence of cardiac arrest. In addition, proper integration of drones with AEDs into existing systems has the potential to significantly improve OHCA survival rates.

Conclusion: The present study found that putting AEDs in high-cardiac arrest and crowded areas reduces average costs. Despite this, the costs associated with acquiring and maintaining AEDs prevent their widespread use. Further research is needed to evaluate feasibility and explore innovative strategies for AED maintenance and accessibility.

Introduction: Failure to adequately secure the skin graft to the lower limbs recipient bed can result in loss of the graft. Our objective was to compare the healing of split-thickness skin grafts three weeks postoperatively, using either negative pressure wound therapy (NPWT) or conventional compression bandaging.

Methods: In this multicenter randomized controlled study, patients with tissue loss ranging from 50 cm² to 600 cm² on the lower limbs and treated with split-thickness skin grafts were included in three French hospitals. A digital photographic evaluation was performed at 3 weeks.

Results: During 9 years, 70 patients were included in the study and allocated to a treatment group. The grafted area was similar in both groups. Loss of graft was significantly reduced in the NPWT group with 14.6 cm2 compared to 29 cm2 in the control group (p = 0.0003). The hospital stay was also significantly reduced in the NPWT group, at 4 days versus 6.5 days in the control group (p = 0.0284). In the NPWT group, 60% reported pain compared to 22.9% in the control group (p = 0.0048).

Conclusions: The use of NPWT dressings improves skin graft take by reducing necrosis, improving the graft's adherence to the recipient site, and reducing hospital length-of-stay.

Introduction: Biliary stents are used to optimize ductal patency and enable bile flow in the management of obstruction or injury related to biliary tract tumors, strictures, stones, or leaks. Although direct therapeutic applications of biliary stents are less well developed, stents can be used to deliver drugs, radioisotopes, and photodynamic therapy.

Areas covered: This report provides an in-depth overview of the clinical indications, and therapeutic utility of biliary stents. Unique considerations for the design of biliary stents are described. The properties and functionalities of materials used for stents such as metal alloys, plastic polymers, or biodegradable materials are described, and opportunities for design of future stents are outlined. Current and potential applications of stents for therapeutic applications for biliary tract diseases are described.

Expert opinion: Therapeutic biliary stents could be used to minimize inflammation, prevent stricture formation, reduce infections, or provide localized anti-cancer therapy for biliary tract cancers. Stents could be transformed into therapeutic platforms using advanced materials, 3D printing, nanotechnology, and artificial intelligence. Whilst clinical study and validation will be required for adoption, future advances in stent design and materials are expected to expand the use of therapeutic biliary stents for the treatment of biliary tract disorders.

Introduction: Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality.

Areas covered: We performed a review of expandable spinal implants and devices by querying the National Library of Medicine MEDLINE database and Google Patents database from 1933 to 2024. Five major types of mechanical jacks that drive expansion were identified: scissor, pneumatic, screw, ratchet, and insertion-expansion.

Expert opinion: We identified a trend of screw jack mechanism being the predominant machinery in vertebral body reconstruction cages and scissor jack mechanism predominating in interbody cages. Pneumatic jacks were most commonly found in kyphoplasty devices. Critically reviewing the mechanisms of expansion and identifying trends among effective and successful cages allows both surgeons and medical device companies to properly identify future areas of development.

Introduction: Surgery and biomedical imaging encompass a big share of the medical-device market. The ever-mounting demand for precision surgery has driven the integration of these two into the field of image-guided surgery. A key-question herein is how imaging modalities can guide the surgical decision-making process. Through performance-based design, chemists, engineers, and doctors need to build a bridge between imaging technologies and surgical challenges.

Areas-covered: This perspective article highlights the complementary nature between the technological design of an image-guidance modality and the type of procedure performed. The specific roles of the involved professionals, imaging technologies, and surgical indications are addressed.

Expert-opinion: Molecular-image-guided surgery has the potential to advance pre-, intra- and post-operative tissue characterization. To achieve this, surgeons need the access to well-designed indication-specific chemical-agents and detection modalities. Hereby, some technologies stimulate exploration ('go'), while others stimulate caution ('stop'). However, failing to adequately address the indication-specific needs rises the risk of incorrect tool employment and sub-optimal surgical performance. Therefore, besides the availability of new technologies, market growth is highly dependent on the practical nature and impact on real-life clinical care. While urology currently takes the lead in the widespread implementation of image-guidance technologies, the topic is generic and its popularity spreads rapidly within surgical oncology.

Objectives: Differentiation of iris and ciliary body lesions as benign or malignant and cystic or solid is important. The aim of this study was to compare anterior segment swept-source optical coherence tomography (AS SS-OCT) and ultrasound biomicroscopy (UBM) findings in iris and ciliary body tumors.

Research design and methods: Forty-two eyes of 38 cases with iris and ciliary body tumors imaged with UBM and AS SS-OCT between September 2018 and September 2023 were evaluated retrospectively.

Results: Of 42 eyes, 14 had melanoma, 14 iris pigment epithelial (IPE) cysts, 7 nevi, 3 Lisch nodules, 2 iris stromal cysts, 1 pars plana cysts, and 1 iris mammillations. An equivalent (100%) visualization of the anterior tumor margin was obtained with both techniques. Compared to AS SS-OCT, UBM was superior for posterior margin visualization in melanocytic tumors and IPE cysts. Bland-Altman plots demonstrated good agreement between UBM and AS SS-OCT for melanocytic tumors < 2.5 mm in base diameter and < 2 mm in thickness.

Conclusions: Although, UBM is the gold standard for ciliary body and iridociliary tumors. AS SS-OCT should be considered as an excellent alternative to UBM, especially in minimally elevated iris lesions.

Introduction: Traditionally echocardiography was used by pediatric cardiologists to diagnose congenital heart defects in neonates. Formalized neonatal hemodynamic fellowships have been established where neonatologists acquire advanced echocardiographic skills to gain anatomical, physiological, and hemodynamic information in real time and utilize this information in making a timely and accurate physiology-based clinical decision.

Area covered: Differences between a comprehensive formal structural echocardiography, neonatologist performed targeted echocardiography and limited assessment on point-of-care-ultrasonography for specific indications have been covered. This article is focused at providing a comprehensive review of the status of echocardiography in the neonatal units, recent advancements and its future prospects in the neonatal intensive care units.

Expert opinion: Comprehensive guidelines providing the scope of practice, a framework for training, and robust clinical governance process for the neonatologist performed targeted echocardiography have been established. In the last decade, echocardiography has emerged as essential vital bedside diagnostic tool in providing high-quality care to the sick infants in the neonatal units, and it has proved to improve the outcomes in neonates. It is now being considered as a modern hemodynamic monitoring tool. Advances in technology, machine learning, and application of artificial intelligence in applications of echocardiography seem promising adjunct tools for rapid assessment in emergency situations.