Expert review of medical devices最新文献

Introduction: Recent advancements in single-port surgery, robotic platforms, 3D models and artificial intelligence have transformed surgical procedures, especially in urology. These innovations enhance precision, safety, and efficacy, reducing invasiveness and recovery times. The review focuses on the latest in robotic-assisted surgery for genitourinary cancers, highlighting the shift toward personalized, minimally invasive treatments.

Areas covered: A bibliographic search across PubMed, Scopus, and EMBASE databases focused on the last four years of innovations in robotic surgery for urologic tumors. The review highlights the use of the Da Vinci Single Port robotic system, available robotic platforms worldwide, advancements in 3D virtual models, artificial intelligence in robotic surgery and the application of molecular imaging for assessing primary lymph nodes and treating lymph node metastases and local recurrences in prostate cancer.

Expert opinion: The integration of single-port surgery, new robotic platforms, 3D models and artificial intelligence in urological oncology promises transformative impacts on diagnosis, treatment and cost-effectiveness. Despite benefits like enhanced precision and expanded surgical access, challenges such as high costs, training needs, and technological integration barriers persist. Collaboration and further research are critical to optimize outcomes, improve safety protocols, and ensure equitable global access to these innovations.

Objectives: This study aimed to assess the anatomical feasibility of a novel modular triple-branched endograft for aortic arch diseases.

Methods: A cross-sectional study was conducted on 314 patients with aortic arch pathologies treated at a single center from January 2018 to December 2023. Preoperative computed tomography angiography images were analyzed with three-dimensional reconstruction to quantify anatomical features. Feasibility was based on endograft anatomical criteria, and logistic regression identified risk factors for unsuitability.

Results: Out of 132 patients included in the study, 67.4% were deemed anatomically suitable for the triple-branched device. A total of 36 (27.3%) patients were deemed inapplicable due to a large diameter of the proximal landing zone, 12 (9%) patients due to a small diameter of the left common carotid artery, and 1 (0.8%) patient due to a small diameter of the left subclavian artery. Logistic regression identified large proximal landing zone diameter and small left common carotid artery diameter were significant factors for unsuitability (p < 0.001 and p = 0.002, respectively).

Conclusions: The novel triple-branched endograft demonstrated promising anatomical feasibility in two-thirds of patients. However, anatomical constraints limited its applicability. Future device iterations should focus on accommodating a broader range of anatomical variations.

Introduction: Endovascular techniques and materials have significantly expanded their application in the treatment of abdominal and thoraco-abdominal aortic lesions, allowing for the management of increasingly complex pathologies that may require cannulation of target vessels. The treatment of such diseases deserves a particular approach and dedicated materials, for which correct procedural planning is mandatory. In the last decades, the use of 3D printing technology as an assisting tool for preoperative rehearsal of complex cases has progressively widespread.

Areas covered: A review was performed about the use of 3D printing technology for the planning of endovascular repair of complex abdominal and thoraco-abdominal aortic lesions. Also, our experience of planning and simulation of an elective challenging endovascular procedure for a Crawford's type II thoraco-abdominal aortic aneurysm using a Cook Zenith® T-Branch^TM endograft, leveraging a 3D-printed model of the patient-specific anatomy from the aortic arch to the common femoral artery, is herein described.

Expert opinion: The benefits of using 3D printing technologies as an assistive tool in planning complex endovascular repairs of abdominal and thoraco-abdominal aortic lesions have been well-documented in the literature, including their application in urgent cases. However, further research and development are necessary to overcome the current limitations of this potentially highly valuable technology.

Introduction: Heart transplantation, the gold standard for end-stage cardiomyopathy, is hindered by donor shortages and clinical deterioration. Left ventricular assist devices (LVADs) have emerged as crucial alternatives, stabilizing hemodynamics, reversing end-organ damage, and enabling patient discharge. Significant engineering advancements and iterative improvements have since produced devices capable of rivaling heart transplantation in early survival potential. This review serves to provide an overview of LVAD technology, an understanding of current device limitations, and preview new technologies being developed to address them.

Areas covered: This manuscript reviews the evolution of LVAD technology, discussing its benefits, drawbacks, and contemporary outcomes. It will detail the progression, current state, and future directions of LVAD technology, emphasizing its pivotal role in managing advanced heart failure.

Expert opinion: The modern day LVAD has significantly extended the lifespan of patients with end-stage heart failure. However, adverse events remain abound and will be the focus of the next generation of devices. A burgeoning pipline of new technologies abound and preview the possibilities of a sustainable solution to a devastating disease.

Introduction: Recently, there has been growing experience with utilizing a veno-arterial extracorporeal membrane oxygenator (VA ECMO) routinely during lung transplantation procedures. Yet, there is a lack of consensus on the protocols, benefits, and outcomes of routine VA ECMO use in lung transplantation.

Areas covered: This article presents an overview of the current status of routine use of VA ECMO during lung transplantation, including rationale, protocols, applications, and outcomes.

Expert opinion: Utilization of VA ECMO during lung transplantation has emerged as an alternative mechanical circulatory support modality to cardiopulmonary bypass, with growing evidence showing lower rates of peri-operative complications. Some groups took that further into routine application of VA ECMO during lung transplantation. The current available evidence suggests that routine utilization of VA ECMO during lung transplantation is associated with lower rates of primary graft dysfunction and improved early outcomes. Use of VA ECMO allows controlled reperfusion of the allograft and avoids an unplanned "crash" on pump in case of hemodynamic instability, which carries worse outcomes after lung transplantation. As a relatively new approach, further follow-up of growing experience, as well as prospective clinical trials, is necessary to develop a consensus about routine utilization of VA ECMO during lung transplantation.

Introduction: A closed-loop or feedback-control system is a process which considers the system's output in order to automatically adjust the input. Compared to a traditional open-loop system, a closed-loop system allows for a higher degree of accuracy with minimal human intervention. Novel methods of closed loop 'adaptive' deep brain stimulation DBS (aDBS) are being developed.

Areas covered: This review focuses on the current state of aDBS for various neuropsychiatric conditions: common movement disorders such as Parkinson's disease, dystonia, essential tremor, and Tourette syndrome, as well as psychiatric disorders of depression and obsessive-compulsive disorder. Finally, the future directions of closed-loop neuromodulation treatments are also discussed.

Expert opinion: Recently, aDBS has been shown to offer benefits compared to open-loop DBS. Understanding the biomarkers of pathological states across various disorders is, however, crucial to implementation of aDBS, and improved sensing-capable hardware and advances in machine learning are poised to allow its effective implementation.

Background: The advent of ultrasonic scalpels has remarkably advanced minimally invasive surgery; however, the Chinese market's reliance on imports highlights the urgent need for a cost-effective, efficient, and domestically produced surgical scalpel. This study aimed to compare SanAgile^TMSA01 with the Johnson & Johnson GEN11, and HAR36 surgical devices.

Research design and methods: In total, 152 participants requiring urological or general laparoscopic surgery were randomly and equally divided between the two hospitals and randomized to the test and control groups. Clinical outcomes, adverse event rates, intraoperative bleeding, and surgery duration were compared between the two devices.

Results: The clinical application rate of both devices was 100%. There were no significant differences between the two groups in intraoperative bleeding, surgery duration, and incidence of adverse events. In the test group, five device-related adverse events occurred (6.58%), compared to two (2.63%) in the control group (no significant difference). The device-related adverse events did not result in any sequelae.

Conclusions: The clinical performance of the SanAgile^TMSA01 was comparable to that of the Johnson & Johnson GEN11 and HAR36. The SanAgile^TMSA01 device may serve as a viable alternative ultrasonic surgical tool, thereby providing clinicians with additional options.

Trial registration: Registration number of Shanghai Medical Equipment Preparation 20,190,114.