Expert Review of Medical Devices最新文献

Objective: To assess the pediatric anterior segment characteristics in ocular pathology using spectral domain optical coherence tomography (SD-OCT).

Methods: This case series follows 115 eyes of 78 children (2-17 years) with anterior segment pathology in an academic facility. The anterior segment OCT (AS-OCT) analysis was done using the Optopol Revo 80 high-resolution SD-OCT using an imaging adapter. All pathological features visible on imaging were observed, studied, tabulated, and analyzed.

Results: The average age was 11.84 years, with 44 males and 34 females. The primary clinical diagnosis was cataract in 40 (34.8%) eyes, followed by corneal disease in 28 (24.3%) eyes, glaucoma in 18 (15.7%) eyes, and trauma in 15 (13%) eyes. Systemic diseases were associated with 20.9% of the cases. The most common imaging pathology observed was lens opacification in 43 (37.4%), increased reflectivity of the cornea in 31 (28.2%), corneal stromal thinning in 34 (29.6%), increased corneal thickness in 28 (24.3%), a shallow anterior chamber in 17 (14.8%), and cells in the anterior chamber in 18 (15.7%) eyes, along with a multitude of other findings.

Conclusion: This study demonstrates that anterior segment OCT is a useful non-contact technique for the detailed anatomic and pathologic assessment of pediatric ocular diseases.

Introduction: More than 4 out of 5 patients in acute care require intravenous catheters. Complications of catheter dislodgement and failure are commonly reported at rates of 15-69% causing interrupted treatment and greater resource consumption when catheter replacement is required.

Areas covered: This manuscript outlines unmet needs in the prevention of catheter dislodgement and how a novel safety release device (Orchid SRV™, Linear Health Sciences) might address these gaps based on available evidence.

Expert opinion: Healthcare initiatives focus on reducing complications and associated costs with the delivery of intravenous treatments. Tension-activated safety release valve devices, attached to intravenous tubing, are a new feature that adds a level of safety to intravenous catheters to reduce mechanical catheter dislodgement when a pull force of greater than 3 pounds is applied. Incorporating a tension-activated accessory into and between existing intravenous tubing and the catheter and extension set protects the catheter from dislodgement. Flow continues until excessive pull force separates and closes the flow pathway in both directions, while the SRV provides a quick replacement to reestablish flow. The safety release valve is used to prevent accidental catheter dislodgement, limit tubing contamination, and avoid more serious complications while maintaining a functional catheter.

Introduction: Advanced cardiac imaging is an important component in pre-procedural planning for ventricular tachycardia (VT) ablations. inHEART's proprietary software, inHEART Models, and its academic version, Multimodality Platform for Specific Imaging in Cardiology (MUSIC), provide detailed characterization of anatomical structures and scars.

Areas covered: This review highlights the current overview of the market and offers insight into inHEART Models and MUSIC and its application during VT ablations with supporting case examples. An overview of the clinical profile and regulatory status of inHEART Models, and other competing technologies, such as Automatic Detection of Arrhythmia Substrate (ADAS) 3D software and Catheter Precision's View into Ventricular Onset (VIVO), are also discussed.

Expert opinion: inHEART and MUSIC utilization has increased over the last few years and continues to establish its presence as an important aspect of VT ablations. Its unique proprietary software sets itself apart from others in the field. The introduction of dual source-photon counting detector computed tomography (PCD-CT) is expected to make significant advancements in the field and take imaging to a new level. inHEART's continued research in cardiac imaging and digital technology is expected to increase as is its global presence in the electrophysiology (EP) community.

Background: ¹²³I-mIBG-scintigraphy could be a useful stratifying tool for patients with heart failure (HF). The purpose of this retrospective study is to evaluate whether there are differences between men and women with HF in terms of the prediction of cardiac arrhythmic events (AE).

Research and methods: A total of 306 patients, before implantable-cardioverter-defibrillator (ICD) implantation, were evaluated. They underwent ¹²³I-mIBG-scintigraphy and an evaluation of the results was performed after 85 months of follow-up. Early and late planar and SPECT cardiac images were acquired. Heart-to-mediastinum ratio (HM) for planar images and the sum of the segmental scores (SS) for SPECT were calculated.

Results: In the general population, age, early SS (ESS), late SS (LSS), and ejection fraction (EF) were statistically significant for the prediction of AE at Cox regression, while early and late HM (eHM,lHM) were not significative for the prediction of AE. Population was divided into females and males and univariate analysis was conducted separately for the two cohorts: no significant variables for prediction of AE were found in females. For males, ESS, LSS, EF, and late HM were statistically significant predictors of AE. The overall survival was similar in males and females, but the risk of AE is lower in males than in females.

Conclusions: ¹²³I-mIBG represents a more effective tool for the prediction of AE in male patients than in women.

Background: This review aims to summarize the findings from recent literature (2010-2022) reporting on complications that resulted from the surgical use of SURGICEL for intraoperative hemostasis.

Methods: A literature search was conducted using the MEDLINE (OVID), Embase, and Cochrane Central Register of Controlled Trials - CENTRAL (OVID) databases. The studies were sorted into case reports and other study types for data extraction. Covidence was used for data extraction and statistics were descriptive.

Results: Of the total 560 articles screened, 73 papers were selected for a full-text review and 70 studies were included in this review. A total of 7,242 participants were included in the studies (case studies n = 93, others n = 7149). 67/70 of the included studies reported complications when SURGICEL was used intraoperatively. Reported complications included: SURGICEL induced masses (granulomas, abscesses, hematomas, cysts) (n = 25), hemorrhagic complications (n = 12), masses misdiagnosed as tumors, cardiovascular, nervous system, and hepatobiliary complications, pain, and infections. Other complications included: fistulas, erectile dysfunction, chorioamnionitis, swelling, urinary leak, renal failure, and anaphylaxis.

Conclusions: Publications reporting on complications associated with the use of SURGICEL intraoperatively have continued to emerge. Future studies should compare how the types and rates of complications compare between SURGICEL and alternative hemostatic agents.

Introduction: Obsessive-compulsive disorder (OCD) is clinically and pathologically heterogenous, with symptoms often refractory to first-line treatments. Deep brain stimulation (DBS) for the treatment of refractory OCD provides an opportunity to adjust and individualize neuromodulation targeting aberrant circuitry underlying OCD. The tailoring of DBS therapy may allow precision in symptom control based on patient-specific pathology. Progress has been made in understanding the potential targets for DBS intervention; however, a consensus on an optimal target has not been agreed upon.

Areas covered: A literature review of DBS for OCD was performed by querying the PubMed database. The following topics were covered: the evolution of DBS targeting in OCD, the concept of an underlying unified connectomic network, current DBS targets, challenges facing the field, and future directions which could advance personalized DBS in this challenging population.

Expert opinion: To continue the increasing efficacy of DBS for OCD, we must further explore the optimal DBS response across clinical profiles and neuropsychiatric domains of OCD as well as how interventions targeting multiple points in an aberrant circuit, multiple aberrant circuits, or a connectivity hub impact clinical response. Additionally, biomarkers would be invaluable in programming adjustments and creating a closed-loop paradigm to address symptom fluctuation in daily life.

Aim: The aim of the present study was to investigate the histological differences between samples processed by different devices and to confirm safe clinical application of different dentin matrix obtained from three devices: BonMaker, Tooth Transformer, and Smart Dentin Grinder in regeneration of maxillary defects.

Research design: The study involved 39 patients with two-wall or three-wall defects who underwent bone augmentation procedures in the maxilla using dentin matrix grafts from the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices. Histological examination was conducted on samples obtained from patients who received each device. In this article, histological samples have been selected and are presented.

Results: In all patients, bone defects were successfully augmented with ground dentin matrix. The histological examination revealed no inflammation and a good connection between the bone and dentin matrix and clinically all patients were qualified for implant placement.

Conclusions: After comparing the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices in our practice, we concluded that all these systems have the potential for obtaining regenerative material from the patient's teeth.