Expert review of medical devices最新文献

Introduction: The Impella 5.5 device is a surgically inserted, trans-valvular, microaxial flow device capable of providing 5.5 L/min of continuous, antegrade flow from the left ventricle (LV) to the aorta. The ability of the Impella 5.5 to fully pressure and volume unload the dysfunctional LV while allowing for mobilization and rehabilitation has rapidly expanded its use. Clinical use scenarios include escalation of support for acute myocardial infarction cardiogenic shock (AMICS), transition from extracorporeal membrane oxygenation to mobile support, bridge to transplantation or durable MCS in acute decompensated heart failure, or perioperative use in post-cardiotomy cardiogenic shock (PCCS).

Areas covered: This review provides a profile of the Impella 5.5 device, summarizes the current literature surrounding clinical applications, reviews active and upcoming clinical trials, and projects future applications for the device through an expert review.

Expert opinion: The development of the Impella 5.5 has allowed for monitoring of left-heart recovery, optimizing right ventricular function, and rehabilitating patients to meet bridging endpoints. The 2018 heart transplant allocation system modifications have expanded the use of temporary mechanical circulatory support (tMCS) on the transplant waitlist, increasing the number of patients transplanted on support. With increased safety and durability, an expanding frontier is used in perioperative support for PCCS in high-risk cardiac surgery.

Introduction: Nerve-sparing (NS) techniques in robot-assisted radical prostatectomy (RARP) are foundational to preserving sexual function and urinary continence in prostate cancer (PCa) patients.

Areas covered: This article aims to classify nerve-sparing (NS) techniques in RARP based on an anatomical approach to the prostate. We have identified three main NS approaches in RARP: anterior, lateral, and posterior. The anterior approach, which involves early retrograde nerve release, improves early potency rates. The lateral approach, using hybrid techniques and extra-fascial dissection, provides clear nerve visualization and reduces nerve injuries, enhancing continence and potency recovery. The posterior approach, particularly the hood technique, effectively preserves periurethral structures, leading to high continence rates within a year post-surgery. The posterior approach effectively balances nerve preservation with cancer control.

Expert opinion: Re-classifying NS techniques in RARP based on an anatomical approach optimizes patient outcomes and the surgeon choice. A personalized approach to those techniques improves functional recovery and maintains oncological safety in PCa surgery. Further studies are needed to confirm those findings and refine the selection criteria.

Introduction: Implant failures resulting from peri-implant infections can have substantial consequences, underscoring the urgent need for effective strategies to prevent biofilm formation on implant surfaces. However, despite advancements in antimicrobial surface technologies, significant challenges persist in translating these innovations into clinically viable solutions.

Areas covered: This article provides an overview of the limitations of current treatment protocols and explores the potential of antimicrobial surface treatments for controlling such infections. Furthermore, we highlight the importance of balancing antimicrobial efficacy with biocompatibility and mechanical stability, key factors for long-term implant performance. Finally, we address the main challenges in translating these technologies into clinical practice, including the unpredictability of long-term antimicrobial effects, regulatory compliance gaps, and methodological weaknesses in current research.

Expert opinion: The development of antimicrobial surfaces holds promise for enhancing the longevity of dental implants; however, current modifications face persistent challenges, hindering their translation into the dental implant market. Future advancements should prioritize 'smart' or stimulus-responsive surfaces that can release antimicrobials on demand. This strategy aims to efficiently combat infections while minimizing the risks of cytotoxicity and antimicrobial resistance, potentially leading to more effective and clinically translatable solutions.

Introduction: Recent advancements in imaging techniques, particularly optical coherence tomography angiography (OCTA), have transformed our understanding of retinal microvascular changes in various ocular diseases, including dry age-related macular degeneration (AMD). Our literature review summarizes key findings on retinal vascular alterations in dry AMD as observed with OCTA, highlighting their implications for disease progression and management.

Areas covered: Studies reveal significant changes in dry AMD patients, affecting the superficial and deep capillary plexuses as well as the choroid. These alterations include decreased vascular and flow density, variations in the foveal avascular zone, reduced choriocapillaris perfusion, and alterations in choroidal vascularity and thickness. Such changes reflect the complex vascular pathology of dry AMD and serve as potential biomarkers for monitoring disease progression. Variability in study results underscores the importance of considering AMD stage, sample size, follow-up duration, imaging protocols, and standardization.

Expert opinion: OCTA in dry AMD is primarily research-focused due to technical and methodological challenges. Its adoption in clinical practice requires standardized protocols and improved software. With future advancements and a better understanding of disease pathology, OCTA could become a routine part of dry AMD management, especially as new therapies emerge that utilize OCTA for assessing dry AMD progression.

Introduction: The Anaconda aortic stent graft is a trimodular endovascular stent graft with an active infrarenal fixation suitable for the treatment of infrarenal abdominal aortic aneurysms with an infrarenal neck angulation ≤90°. A unique magnet-based mechanism facilitates the cannulation of the contralateral leg.

Areas covered: The present article provides a complete description of the third-generation Anaconda endograft, the Anaconda One-Lok^TM, its clinical performance and the related technical and mechanical characteristics as well as a brief comparison between itself and other similar endografts.

Expert opinion: The Anaconda One-Lok stent graft is particularly suitable for abdominal aortic aneurysms with an infrarenal aortic neck angulation up to 90°. Issues that need to be resolved concern the higher incidence of iliac limb occlusion and distal migration compared to other commercially available endografts and possibly the valley central migration with the risk of covering the renal ostia.

Introduction: Peritoneal catheters are a fundamental form of dialysis access. An appreciation of the principles of catheter design is important for practitioners involved in the insertion and maintenance of peritoneal dialysis access. Although silicone dual-cuffed catheters are standard, the optimal catheter design remains uncertain.

Areas covered: This narrative review outlines common peritoneal dialysis catheter characteristics and summarizes their practical relevance. Catheter material, cuffs, tips, and tunneled segment shape are discussed.

Expert opinion: Peritoneal dialysis catheter selection is informed by theoretic design principles and limited clinical evidence, but operator experience and patient and center factors are probably stronger predictors of outcomes.

Introduction: Translational medicine has been facing a persistent crisis for decades, and the field of neurorehabilitation is no exception. The challenges and delays that prevent patients, caregivers, and clinicians from promptly benefiting from advancements in bioengineering and new technological discoveries are well-documented.

Areas-covered: This perspective presents some ideas to underline the consolidated problems and highlight new obstacles to overcome in the context of translational neurorehabilitation, also considering the increasingly stringent laws for medical devices that are emerging throughout the world.

Expert opinion: The objective of the entire medical-scientific community must be to ensure that patients and their loved ones receive the best care available with the most advanced systems. Bioengineers, healthcare policy makers, certifiers and clinicians must always take translational aspects into consideration and find solutions to mitigate possible problems and delays. The goal of the entire medical and scientific community should be to ensure that patients and their families receive the highest quality care through the most advanced systems. To achieve this, bioengineers, healthcare policymakers, certifiers, and clinicians must consistently address translational challenges and work collaboratively to find solutions that minimize potential problems and delays.