Expert Review of Medical Devices最新文献

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: 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.

Introduction: The automobile passive keyless entry (PKE) system is a potential source of electromagnetic interference (EMI). We aim to determine the incidence and significance of EMI from automobile PKE system in cardiovascular implantable electronic device (CIED) patients.

Methods: This was a single-center cross-sectional study conducted at Maharaj Nakorn Chiang Mai hospital, Thailand. Patients with CIED were instructed to lock and unlock two automobiles using the PKE system. Any EMI or arrhythmias were detected by CIED interrogation and single-lead electrocardiogram event recorder. We also used a spectrum analyzer to identify the automobiles working frequency bandwidth.

Results: There was a total of 102 CIED patients. Device types included 48.0% defibrillators, 37.3% permanent pacemakers, and 14.7% cardiac resynchronization therapy device. Both interrogated data from device and event monitor revealed no incidence of EMI during the PKE activation. We failed to identify the working frequency bandwidth of the two studied cars due to very low signal strength, thus blended in with the background noise.

Conclusions: Automobile PKE systems transmitted very low power signals. Therefore, under normal circumstances, CIED patients can use automobile PKE system safely without any EMI regardless of key fob positions in relation to the CIED pulse generator.

Trial registration: The study was registered at ClinicalTrials.gov (https://clinicaltrials.gov), and the identification number is NCT03016390.

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.

Introduction: The study evaluates the technology of fluoroscopy-based hip navigation that has shown to improve implant positioning in total hip arthroplasty (THA).

Methods: Premier Healthcare data for patients undergoing manual THA or fluoroscopy-based hip navigation THA between 1 January 2016-30 September 2021, were analyzed 90- and 365-day post-THA. The primary outcome was inpatient readmission. Secondary outcomes were operating room (OR) time, length of stay, discharge status, and hospital costs. Baseline covariate differences were balanced using fine stratification and analyzed using generalized linear models.

Results: Among 4,080 fluoroscopy-based hip navigation THA and 429,533 manual THA balanced patients, hip-related readmission rates were statistically significantly lower for the fluoroscopy-based hip navigation THA cohort vs. manual THA for both 90-day (odd ratio [95% CI]: 0.69 [0.52 to 0.91] and 365-day (0.63 [0.49 to 0.81] follow-up. OR time was higher with fluoroscopy-based hip navigation THA vs. manual THA (134.65 vs. 132.04 minutes); however, fluoroscopy-based hip navigation THA patients were more likely to be discharged to home (93.73% vs. 90.11%) vs. manual THA. Hospital costs were not different between cohorts at 90- and 365-day post-operative.

Conclusions: Fluoroscopy-based hip navigation THA resulted in fewer readmissions, greater discharge to home, and similar hospital costs compared to manual THA.

Objectives: To evaluate whether a learning curve affects the bilateral sentinel lymph node (SLN) detection in early-stage cervical cancer.

Methods: All patients with FIGO (2018) stage IA1-IB2 or IIA1 cervical cancer who had undergone robot-assisted SLN mapping performed with a combination of preoperative technetium-99m nanocolloids (including preoperative imaging) and intraoperative blue dye were retrospectively included. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to determine if a learning curve based on bilateral SLN detection existed in this cohort.

Results: A total of 227 cervical cancer patients were included. In 98.2% of patients (223/227) at least one SLN was detected. The bilateral SLN detection rate was 87.2% (198/227). Except for age (OR 1.06 per year, 95%CI 1.02-1.09), no significant risk factors for non-bilateral SLN detection were found (e.g., prior conization, BMI or FIGO stage). The RA-CUSUM analysis showed no clear learning phase during the first procedures and cumulative bilateral detection rate remained at least 80% during the entire inclusion period.

Conclusions: In this single-institution experience, we observed no learning curve affecting robot-assisted SLN mapping using a radiotracer and blue dye in early-stage cervical cancer patients, with stable bilateral detection rates of at least 80% when adhering to a standardized methodology.