Expert review of medical devices最新文献

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.

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.

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.

Introduction: Previous studies have demonstrated the use of technology in total hip arthroplasty (THA) provided favorable outcomes. This study sought to describe the effect preoperative two-dimensional low-dose (2DLD) full-body radiographs had on the prevention of adverse outcomes following THA.

Methods: We reviewed 11,814 cases of patients who underwent primary, elective THA from 2016 to 2021. Patient demographics and clinical data were compared between patients who did or did not have preoperative standing and sitting 2DLD images (29.5% vs. 70.5%, respectively) using Chi-squared test and multivariate logistic regressions.

Results: The rate of patients with preexisting spinal fusion was higher in the 2DLD cohort (2.2 vs. 0.6%, respectively, p < 0.001). Preoperative 2DLD images were favored in outcomes including length of stay (40.15 vs. 67.16 hours; p < 0.001), rate of discharge to home (94.1 vs. 80.0%; p < 0.001), and 90-day readmission rate (3.5 vs. 6.0%; p < 0.001). Multivariate analysis demonstrated preoperative 2DLD images to be significantly associated with lower odds of dislocation, independent from surgical approach, coexisting spinal fusion, and utilization of dual-mobility implants.

Conclusion: Preoperative 2DLD images were independently associated with decreased risk for dislocations. Even in a higher risk cohort with spinal fusion, the rate of dislocation in the 2DLD cohort was significantly lower.

Introduction: Full-endoscopic spine surgery (FESS) has emerged as an effective and minimally invasive option for the surgical treatment of degenerative lumbar spine disease. FESS can be characterized as endoscopic spine surgery conducted via the percutaneous uniportal approach using working-channel endoscopes under continuous saline irrigation. Despite available evidence, the clinical application of this endoscopic procedure may require more work for standard spine surgeons. Therefore, this review aims to provide comprehensive technical tips to ensure the practical effectiveness of FESS.

Area covered: FESS of the thoracolumbar spine can be performed through the transforaminal and interlaminar approaches according to direction and passing window. Published literature on technical tips and learning were reviewed narratively, after which practical technical pearls were demonstrated specific to the properties of working-channel endoscopes.

Expert opinion: Currently, FESS remains a reliable option for achieving successful surgical outcomes in cases of lumbar disk herniation and spinal stenosis, with few complications and rapid recovery. A comprehensive understanding of the core features of working-channel endoscopes is crucial for expediting the learning process. Importantly, the development of specific instruments, surgical approaches, and optics is a continuous process that is necessary for establishing FESS as the standard technique for degenerative lumbar spine disease.