Expert Review of Medical Devices最新文献

Introduction: Mechanical methods aimed at the filtration of the cerebrospinal fluid (CSF) are a group of therapies that have been proposed to treat neurological conditions where pathogens are present in the CSF. Even though the industry of medical devices has not been very active in this field, there is a lack of systematization of the different systems and procedures that can be applied.

Areas covered: First, we systematize the classification and definitions of procedures and systems for mechanical filtration of the CSF. Then, we made a literature review in search of clinical or preclinical studies where any system of mechanical CSF clearance was proposed or applied.

Expert opinion: We found mechanical filtration of the CSF has been explored in subarachnoid hemorrhage, CNS infections (bacterial, viral, and fungal), meningeal carcinomatosis, multiple sclerosis, autoimmune encephalitis, and polyradiculomyelitis. Brain aging and neurodegenerative diseases are additional potential conditions of interest. While there is some preliminary positive evidence for many of these conditions, more advanced systems, detailed descriptions of procedures, and rigorous validations are needed to make these therapies a reality in the next decades.

Introduction: While 3D printing of bone models for preoperative planning or customized surgical templating has been successfully implemented, the use of patient-specific additively manufactured (AM) implants is a newer application not yet well established. To fully evaluate the advantages and shortcomings of such implants, their follow-up results need to be evaluated.

Area covered: This systematic review provides a survey of the reported follow-ups on AM implants used for oncologic reconstruction, total hip arthroplasty both primary and revision, acetabular fracture, and sacrum defects.

Expert opinion: The review shows that Titanium alloy (Ti4AL6V) is the most common type of material system used due to its excellent biomechanical properties. Electron beam melting (EBM) is the predominant AM process for manufacturing implants. In almost all cases, porosity at the contact surface is implemented through the design of lattice or porous structures to enhance osseointegration. The follow-up evaluations show promising results, with only a small number of patients suffering from aseptic loosening, wear, or malalignment. The longest reported follow-up length was 120 months for acetabular cages and 96 months for acetabular cups. The AM implants have proven to serve as an excellent option to restore premorbid skeletal anatomy of the pelvis.

Introduction: Patient-specific instrumentation (PSI) for primary total knee arthroplasty (TKA) surgery has been shown to increase accuracy of component positioning. However, it is unclear whether this also translates to actual benefits for patients in terms of better outcomes (efficacy) or less complications such as revisions (safety). We therefore systematically reviewed the literature to determine the efficacy and safety of PSI in primary TKA.

Methods: Randomized controlled trials comparing PSI to non-PSI in primary TKA were included. A random effects model was used with meta-regression in case of heterogeneity.

Results: Forty-three studies were included with a total of 1816 TKA in the PSI group and 1887 TKA in the control group. There were no clinically relevant differences between the PSI-group and non-PSI group regarding all outcomes. There was considerable heterogeneity: meta-regression analyses showed that the year the study was published was an important effect modifier. Early publications tended to show a positive effect for PSI compared to non-PSI TKA, whereas later studies found the opposite.

Conclusion: Based on evidence of moderate certainty, our study suggested that there were no clinically relevant differences in efficacy and safety between patients treated with PSI TKA and patients treated with non-PSI TKA.

Introduction: VDD pacing system was introduced more than 30 years ago. Its use is considered by the 2021 European Society of Cardiology guidelines on cardiac pacing as a potential alternative to dual chambers system for patients with atrioventricular block and normal sinus node function.

Areas covered: In this article, we performed a narrative review of current literature in order to identify the strengths and weaknesses of this pacing system. VDD system allows the maintenance of AV synchronous pacing and its hemodynamic advantages. Some disadvantages may be related to the non-negligible incidence of atrial undersensing and the possible subsequent need for upgrade to DDD system. On the other hand, shorter implantation time and lower complications rate may be advantages.

Expert opinion: In the modern pacing era, VDD pacing system struggles to find its own space. However, it may still be considered as a valuable alternative to a dual-chamber pacemaker for selected patients, in specific clinical scenarios.

Introduction: Resistant hypertension (HTN), despite the tremendous advances in pharmacotherapy, is a major global problem. Transcatheter renal denervation (RDN) could be a pertinent strategy for resistant HTN and patients with poor pharmacotherapy adherence. Nonetheless, the adoption of energy-based RDN in clinical practice is slow and alternative approaches are needed.

Areas covered: The review focuses on the assessment of the Peregrine System Infusion Catheters. The system is designed for chemically mediated transcatheter RDN by the infusion publications on the Peregrine system. The theoretical assumptions for chemically mediated RDN, design of the system, data from preclinical and clinical studies, and further perspectives are discussed.

Expert opinion: Peregrine System Infusion Catheters are the only catheter on the market designed for chemically mediated RDN by the infusion of the neurolytic agent. Chemical neurolysis more efficiently destroys nerves around the renal artery in comparison to energy-based catheters, due to deeper tissue penetration and circumferential distribution resulting in a wider range of effective nerve injury. Chemically mediated RDN by the infusion of the neurolytic agent (alcohol) has an excellent safety profile as confirmed in initial clinical trials which also suggested high efficacy. Currently, there is an ongoing phase III sham-control study. Other possible applications of this technology include clinical settings like heart failure or atrial fibrillation.

Background: Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective alternative to surgery for aortic stenosis (AS). However, there are still differences in the procedural process and outcome of bicuspid aortic valve (BAV) treated with TAVI compared with tricuspid aortic valve.

Areas covered: This review paper aims to summarize the main characteristics and clinical evidence of TAVI in patients with bicuspid and tricuspid aortic valves and compare the outcomes of TAVI procedure.

Expert opinion: The use of TAVI in patients with BAV has shown similar clinical outcomes compared with tricuspid aortic valve. The efficacy of TAVI for challenging BAV anatomies remains a concern due to the lack of randomized trials. Detailed preprocedural planning is of great importance in low-surgical-risk BAV patients. A better understanding of which subtypes of BAV anatomy are at greater risk for adverse outcomes can potentially benefit the selection of TAVI or open-heart surgery in low surgical risk AS patients.

Introduction: Treatment efficacy of reflex syncope is mainly related to the mechanism underlying syncope rather than its etiology or clinical presentation. The predominant mechanism underlying reflex syncope can be assigned to hypotensive or to bradycardic phenotypes.

Areas covered: Methodology and diagnostic criteria of the most useful tests for the identification of hypotensive and bradycardic phenotypes are discussed. Diagnostic tests for the hypotensive phenotype include office blood pressure measurement with active standing test, home, and wearable blood pressure monitoring, 24-h ambulatory blood pressure monitoring and tilt table test. Diagnostic tests for the bradycardic phenotype include carotid sinus massage, tilt table test and prolonged ECG monitoring.

Expert opinion: In reflex syncope, the documentation of bradycardia/asystole during a syncopal episode does not rule out the possibility that a preceding or parallel hypotensive reflex plays an important role. Similarly, even when a hypotensive mechanism is established, the possibility of an associated cardioinhibitory reflex should be investigated. Investigating the mechanism of reflex syncope is mandatory in patients with severe recurrent episodes, with the final aim to develop a personalized treatment strategy. Recent trials have demonstrated the benefits of personalized mechanism-based therapy, thus highlighting the importance of a comprehensive assessment of the mechanisms underlying syncope.

Purpose: A previous study reported a shorter time to tracheal intubation by reducing percentage of glottic opening (POGO) view to <50% when intubating a normal adult airway using the Glidescope^TM blade. We evaluate the efficacy of reducing POGO to <50% when intubating patients with rigid cervical immobilization using CMAC^TM D blade.

Methods: One hundred and four adult patients were randomized to group POGO 100% or POGO <50% . Laryngoscopy was performed by advancing tip of the D blade at vallecula. POGO 100% was achieved by exerting upward force to displace epiglottis until glottic opening from the anterior commissure to inter arytenoid notch. POGO < 50% was acquired by withdrawing the D blade tip dorsally from vallecula. The primary outcome was time to intubation.

Results: The median time (IQR) to successful intubation was 29 (25-35) seconds for group POGO < 50% and 34 (28-40) seconds for group with POGO 100% (difference in medians, 5 seconds; 95% confidence interval, 2 to 8, p = 0.003). Complications were minor.

Conclusion: Using the CMAC^TM D blade with a reduced POGO in patients with cervical spine immobilization resulted in faster tracheal intubation.

Trial registration: The trial is registered at ClinicalTrial.gov (CT.gov identifier: NCT04833166).