Expert review of medical devices最新文献

Introduction: Due to the complex anatomy of the spine and the intricate surgical procedures involved, spinal surgery demands a high level of technical expertise from surgeons. The clinical application of image-guided spinal surgery has significantly enhanced lesion visualization, reduced operation time, and improved surgical outcomes.

Areas covered: This article reviews the latest advancements in deep learning and artificial intelligence in image-guided spinal surgery, aiming to provide references and guidance for surgeons, engineers, and researchers involved in this field.

Expert opinion: Our analysis indicates that image-guided spinal surgery, augmented by artificial intelligence, outperforms traditional spinal surgery techniques. Moving forward, it is imperative to collect a more expansive dataset to further ensure the procedural safety of such surgeries. These insights carry significant implications for the integration of artificial intelligence in the medical field, ultimately poised to enhance the proficiency of surgeons and improve surgical outcomes.

Introduction: The metaverse is a new digital world powered by cutting-edge technologies that offers tremendous potential for healthcare. The metaverse is anticipated to experience enormous growth and adoption with a rising need for digital healthcare over the next decade. This article offers a comprehensive analysis of the integration of metaverse technologies into healthcare.

Areas covered: This article delves into the multifaceted realm of metaverse technologies within healthcare, offering insights into its diverse contexts. Central to its exploration are the significant contributions, such as examining the current landscape of metaverse technologies in healthcare, offering a nuanced understanding of their applications. The article meticulously explores the array of tools and platforms available for surgical procedures, highlighting their efficacy and it also delves into how these technologies illuminate the evolving landscape of healthcare delivery. Through thorough analysis, this article elucidates the transformative potential of metaverse technologies in revolutionizing healthcare practices.

Expert opinion: The integration of metaverse technologies in healthcare signifies a transformative shift in service delivery. The metaverse, driven by advanced technology, promises substantial changes, enhances medical education, patient care, and research through immersive experiences. This article aims to explore its various contexts heralding a new era in healthcare.

Background: Lumbar spine surgery is a crucial intervention for addressing spinal injuries or conditions affecting the spine, often involving lumbar fusion through pedicle screw (PS) insertion. The precision of PS placement is pivotal in orthopedic surgery. This systematic review compares the accuracy of robot-guided (RG) surgery with free-hand fluoroscopy-guided (FFG), free-hand without fluoroscopy-guided (FHG), and computed tomography image-guided (CTG) techniques for PS insertion.

Methods: A systematic search of various databases from 1 January 2013 to 30 December 2023 was conducted following PRISMA guidelines. Primary outcomes, including PS insertion accuracy and breach rate, were analyzed using a random-effects model. Risk of bias was assessed using the Newcastle-Ottawa Scale.

Results: The overall accuracy of PS insertion using RG, based on 37 studies involving 3,837 patients and 22,117 PS, is 97.9%, with a breach rate of 0.021. RG demonstrated superior accuracy compared to FHG and CTG, with breach rates of 3.4 and 0.015 respectively for RG versus FHG, and 3.8 and 0.026 for RG versus CTG. Additionally, RG was associated with reduced mean estimated blood loss compared to CTG, indicating improved safety.

Conclusions: The RG is associated with enhanced accuracy of PS insertion and reduced breach rates over other methods. However, additional randomized controlled trials comparing these modalities are needed for further validation.

Prospero registration: CRD42023483997.

Introduction: Patients in intensive care units (ICUs) frequently lose control over their fecal continence leading to fecal incontinence (FI). We provide an overview of existing medical devices, which are supposed to alleviate FI-related problems.

Areas covered: Fecal management systems (FMS) prevent infections and complications. They reduce the risk of pressure ulcers and fecal incontinence. The systems enhance patient comfort and mitigate emotional distress during illness. Furthermore, FMS facilitate nursing care by reducing the incontinence-related workload. Finally, these systems can help minimize treatment costs by preventing complications, and reduction of extended hospital stays and additional treatments. Several well accepted systems made of silicone are on the market. A polyurethane-based soft balloon FMS (hygh-tec® basic-plus) has also been introduced, offering more comfort to the patient, safer handling for the healthcare professionals, and provides reliable leakproof access to the patient's colon. In addition to contamination-free fecal diversion, the trans-anal sealing mechanism of the device also allows for irrigation and delivery of medication into the colon.

Expert opinion: FMS in ICUs are integral to patient care and dignity. Recognizing and prioritizing the importance of these systems is essential for providing the highest standard of care to critically ill patients in the ICU.

Introduction: Endoscopic submucosal dissection (ESD) is a widely used technique to remove early neoplastic lesions. It was primarily used in the initial days to treat gastric lesions, but recently, the horizon of this endoscopic procedure has expanded, which has allowed us to manage other technically more complex locations, such as the colorectum.

Areas covered: There has been an exponential growth regarding the wide range of devices available in the market for performing colorectal ESD. As a result, the aim of this review is to highlight the indication of this endoscopic technique, which device is best suited for which indication, as well as future trajectories in this field.

Expert opinion: Although some devices have proven to be more advantageous than others in this area, very often the choice is still subjective, which is commonly attributed to individual preferences and experience. However, an accurate knowledge of the available tools and their functioning, with their pros and cons, is fundamental for any endoscopist venturing into the field of third space endoscopy. In this way, one can choose which device best suits a particular situation, along with simultaneously having the wealth of knowledge related to therapeutic armamentarium at our disposal in the endoscopy suite.

Introduction: Type A acute aortic dissection (TA-AAD) is a great challenge for aortic surgeons. The establishment of a standardized surgical approach, particularly the determination of whether and when to address the aortic arch and the distal aorta in the same operation as the proximal aorta, is still unclear.

Areas covered: Frozen elephant trunk (FET) has emerged as a valuable treatment for TA-AAD over the last decade. Here, we discuss the fundamentals and pitfalls of frozen elephant trunk procedures and present the latest innovations.

Expert opinion: FET has the potential to simplify arch reconstruction in patients with complex arch tears and rupture, optimize perfusion in the distal true lumen for those with a compressed true lumen and malperfusion, address distal reentry tears, and promote false lumen thrombosis and late aortic remodeling. Nevertheless, FET is still associated with non-negligible mortality and morbidity rates. Patient selection, surgical expertise, and postoperative care remain crucial determinants in ensuring successful outcomes. Recent innovations in FET surgery involve the development of techniques to minimize or avoid hypothermic circulatory arrest and new FET devices with different arch branch configurations aiming to facilitate subsequent aortic reinterventions. We believe that both these advancements have the potential to improve patient outcomes.

Introduction: Interest in unicompartmental knee arthroplasty (UKA) has recently grown. Mobile bearing UKA, in which the bearing is not fixed but rather perfectly conforms with femoral and tibial components and moves completely passively between the femoral and tibial implant, has now been used for approximately half a century.

Areas covered: Alongside the recognized advantages of UKA, the mobile-bearing variant benefits from an extremely low rate of polyethylene wear and tolerable minor malalignment. Revision rates for UKA have been reported to exceed those of total knee arthroplasty, but long-term survival rates and outcomes from mobile-bearing UKA have been found to be satisfactory. In addition to the lateral osteoarthritis and loosening, which are main complications of UKA, bearing dislocation is a specific complication of mobile bearing UKA. Fractures and valgus subsidence are more prevalent than in the cementless UKA. While these continue to be features to be addressed, they have been partially solved.

Expert opinion: Given the manifold benefits of UKA, its application could be extended to a larger patient population. Successful outcomes rely on careful patient selection and the surgeon's extensive familiarity with the procedure. Looking ahead, the incorporation of robotic surgery, already a feature of some fixed-bearing UKAs, might shape the future trajectory of mobile-bearing UKA.

Background: Autologous bone dust can be filled in bone defects to promote effective bone healing but typically it is lost when using suction during surgery. The aim of this study was to develop a novel bone collector that can be used to collect bone chips/dust of varying sizes without changing current surgical procedures.

Research design and methods: This collector was designed to connect to a surgical continuous suction system and comprised a plate filter with a 3 mm hole and featured a taper filter with a mesh size of 0.27 mm for the separation and collection of both coarse and fine bone chips/dust. The bone collector was manufactured using nylon 3D printing and plastic injection with biocompatible materials.

Results: The bone collector functional test revealed high bone chip collection efficiency (93%) with automatic size separation function. Low (3.42%) filtration errors showed that most of the water can be drained smoothly from the bone collector. In clinical usability testing, bone collectors can provide functions demonstrated in in vivo spinal fusion and femoral fracture surgeries with different bone grafting size requirements.

Conclusions: The novel bone collector has been validated as a viable and effective surgical device, offering surgeons an additional option to enhance patient outcomes.

Introduction: The introduction of drug-eluting coronary stents (DES) into clinical practice in 2002 represented a major milestone in the treatment of obstructive coronary artery disease. Over the years, significant advances in polymer coating and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation DES.

Areas covered: Development of platinum chromium (PtCr) alloys with high radial strength and high radiopacity have enabled the design of new, thin-strut, flexible, and highly trackable stent platforms, while simultaneously improving stent visibility. These advances have facilitated complex percutaneous treatment of a diverse population of patients in clinical practice. This review will provide an overview of the evolution in PtCr everolimus-eluting stents from PROMUS Element™ to SYNERGY™ to the recently introduced SYNERGY MEGATRON™. The clinical data will be summarized and put into perspective, especially focusing on the role of the SYNERGY™ and MEGATRON™ platforms in the treatment of complex coronary artery disease and high-risk patients.

Expert opinion: The SYNERGY™ stent demonstrates favorable clinical efficacy and safety outcome data, and whilst the clinical data on MEGATRON™ are sparse, early experience is promising. The specific overexpansion capabilities, visibility, and radial strength of the MEGATRON™ are attractive features for complex coronary interventions.