Medical Devices-Evidence and Research最新文献

Purpose: The objective of this observational, real-world study was to describe reoperation, revision, index healthcare utilization and hospital costs among patients treated with PEEK (polyetheretherketone) or 3D-printed-titanium cages during lumbar/lumbosacral posterior fusion procedures, either TLIF (transforaminal lumbar interbody fusion) or PLIF (posterior lumbar interbody fusion). Statistical comparisons were not conducted.

Methods: This was a descriptive, retrospective, observational study. Patients with PEEK (OPAL™, DePuy Synthes, Raynham, MA) or 3D-printed-titanium (CONDUIT™ TLIF (transforaminal lumbar interbody fusion)/PLIF (posterior lumbar interbody fusion) Cage/EIT™ Cellular Titanium TLIF/PLIF Cage (DePuy Synthes, Raynham, MA)) spinal cages were identified in the Premier Healthcare Database between 1/1/2007 and 9/30/2022. Patients were required to have posterior approaches of the lumbar/lumbosacral spine and DDD, stenosis, back pain, instability, spondylolisthesis, or pseudarthrosis/failed prior surgery. Patient and procedure, healthcare utilization and hospital cost data were collected at the index surgery, and patients were followed up to 3 months for reoperation and 12 months for revision. All data were summarized descriptively, and no statistical comparisons were made between cage groups.

Results: A total of 5118 PEEK and 1189 3D-printed-titanium cage patients were included in this study. Among 3D-printed-titanium cages, 804 had PLIF and 345 had Curved TLIF cage types. Most PEEK cage patients were 18-64 years (61.9%), and 3D-printed-titanium was evenly distributed across age categories. The mean index hospital cost was ~$40,000, LOS was ~3 days, and discharge status to home/home health was ~85% for both; surgery time was 267 minutes for PEEK and 280 minutes for 3D-printed-titanium. The 0-3 month reoperation cumulative incidence was 1.0% for PEEK and 1.3% for 3D-printed-titanium. For revision, incidence within 0-3, 4-6, and 7-12 months was 1.2%, 0.6%, and 1.7% for PEEK and 1.6%, 0.5%, and 1.2% for 3D-printed-titanium. The mean costs per patient associated with reoperation and revision for the entire cohort were $220 and $1228 for PEEK and $290 and $1754 for 3D-printed-titanium.

Conclusion: This study provides real-world economic insights into an area where practice data are sparse, within hospital settings for PEEK and 3D-printed-titanium spinal cages. A key study limitation is the descriptive design in which potential confounding factors that may affect the outcome estimates are not addressed.

Purpose: The aim of this study was to use calorimetry to understand the difference in energy transferred by three phacoemulsification surgical platforms to the eye.

Patients and methods: A phacoemulsification tip was lowered into a double-walled calorimeter filled with distilled water. The foot pedal was depressed for 30 seconds and the change in temperature of the water was measured by a temperature probe. Three phacoemulsification systems were compared: the Alcon Centurion, Johnson & Johnson Veritas and Oertli CataRhex 3. The following conditions remained constant across trials and platforms: continuous longitudinal ultrasound, flow rate 12mL/min, vacuum 0mmHg, and clamped inflow and outflow tubing. The different platforms were directly compared at 20%, 40%, 60%, 80% and 100% power.

Results: A two-way ANOVA found a significant difference (P < 0.001) in overall energy output across all trials between the CataRhex 3, Centurion and Veritas with an F value of 63.97 and two degrees of freedom.

Conclusion: Given identical settings, the amount of energy produced was significantly different across phacoemulsification platforms. This data can aid surgeons' understanding of how power level by surgical platform can impact the amount of energy introduced into the anterior segment during cataract surgery.

Background: Biomarkers are essential tools for diagnosing diseases. Saliva, as a human fluid, effectively reflects the body's condition due to its rich composition. Analyzing saliva components allows for noninvasive, cost-effective, and time-efficient screening and diagnosis. Alpha-amylase, a key biomarker present in saliva, has been linked to oral diseases. This study introduces an innovative method for the noninvasive detection of alpha-amylase using screen-printed electrodes (SPEs), enabling easy and efficient screening and diagnosis.

Methods: The proposed method involves measuring varying concentrations of alpha-amylase using Cyclic Voltammetry (CV) and Differential Pulse Voltammetry (DPV). Saliva samples are applied directly onto electrodes pre-coated with biomarkers and a conditioning agent, allowing for precise detection and analysis.

Results: The screen-printed carbon electrode demonstrated excellent performance in detecting alpha-amylase, with clear voltammogram results, achieving a limit of detection (LOD) of 104.252 units and a limit of quantification (LOQ) of 315.915 units.

Conclusion: A gold nanoparticle-modified screen-printed electrode (SPE) was developed to measure alpha-amylase quantitatively. Despite sensitivity to external interference, notably temperature, pH, and the duration of incubation, While the sensor showed sensitivity to external factors such as pH and temperature variations, it maintained a strong linear response, reinforcing its potential for reliable diagnostics with linear regression score (R² = 0.9513) across alpha-amylase concentrations of 100-500 units. This study underscores the sensor's effectiveness as a non-invasive tool for early detection using saliva as a biomarker, enhancing patient comfort and compliance. However, further research is needed for medical applications.

Despite the widespread use of ultrasonography (US) in medical diagnostics, there is no similar US device available for visualizing jawbone density. This study is a narrative review of the possible applications of US in dentistry. This review is divided as follows: (a) Pulse-echo ultrasonography: the applications offer new perspectives for periodontal and peri-implant assessment. (b) Through-transmission alveolar US (TTAU): this technique was a novel imaging modality until 2004, when TTAU devices were last available. Quantitative US scaling made the device useful for diagnosing chronic inflammatory conditions in the jaw. (c) Ultrasound transmission velocity (UTV): in 2008, this technique was introduced in German university dental clinics to analyze the mechanical properties of the jawbone without translating the scientific findings into a practical device. (d) Trans-alveolar US device (TAU): the growing importance of "osteoimmune focal bone marrow defects" has led practitioners to develop a new TAU device. The attenuation of US was used for imaging of jawbone density. (e) Patients who benefit from TAU-guided jawbone surgery: research has shown remarkable results in specific disease cases. This review concludes that US has been undervalued as a diagnostic tool in dentistry. The new TAU-n unit offers the opportunity to change this in the future.

Purpose: The study aimed to assess the safety, tolerability, and acceptability of the IntegriMedical® Needle Free Injection System (IM-NFIS) compared to conventional hypodermic needle injections (CHN) in healthy adult subjects across multiple injection sites.

Patients and methods: Thirty healthy male subjects aged 18-45 years were enrolled in this open-label study. Each subject received both NF and CHN injections at five different sites (forearm, abdomen, thigh, buttocks, and arm). In the study, participants in the forearm cohort received 0.1 mL of saline, whereas, for all other injection sites, 0.5 mL of saline was administered. Both needle-free and hypodermic needle injections were used at the designated sites, with a 5- to 10-minute interval between each injection. Since no active drug was used, saline served as a placebo in both methods. Safety assessments included local and systemic reactions, pain scores using the Visual Analog Scale (VAS), and acceptability questionnaires. The study adhered to ethical guidelines and was approved by the Institutional Ethics Committee.

Results: NF injections demonstrated significantly lower pain scores compared to CHN injections (mean VAS score 0.23 vs 1.07, p < 0.01). Local site reactions were minimal and similar between NF and CHN injections, with no significant differences observed at 20-30 minutes post-injection. Systemic reactions were absent in both groups throughout the study period. The NF injection system was highly acceptable, with a majority of subjects reporting reduced anxiety and pain compared to CHN injections (p < 0.01).

Conclusion: IM-NFIS proved to be safe, well tolerated, and highly acceptable for delivering pharmaceuticals compared to conventional needle and syringe injections. This needle-free technology offers potential advantages in improving patient compliance and reducing injection-related anxieties, suggesting its promising role in future medical practices, including pediatric vaccinations and frequent medication administration.

Background: The number of cardiac implantable electronic devices (CIEDs) implanted has been growing and the population who receive the device is older and has more comorbidities. Long bed rest and immobilisation have always been common after the implant, but a consensus does not exist on the argument.

Purpose: To map and synthesise available literature on the mobilisation approach after the implant of a CIED and which correlated outcomes exist.

Methods: A literature search was conducted in December 2023 on six databases. Screening of articles, data extraction and quality appraisal were performed by more than one author. Articles included were primary articles exploring bed rest or mobilisation after a CIED procedure. Descriptive analysis was conducted to present and synthesise the results.

Results: Of the 113 records identified, eight matched the inclusion criteria. The majority of the articles were randomised controlled trials (n = 6). Other studies were quasi-experimental (n = 1), retrospective (n = 1) and cross-sectional (n = 1). Data descriptive analysis led to the development of three main topics: (1) mobilisation modalities, (2) potential complications and (3) type of device.

Conclusions: Early mobilisation after a CIED procedure appears to be safe and not associated with other complications. A predominant barrier to early mobilisation is the lack of a consensus on the time and type of mobilisation. Early mobilisation could be applied more safely with the use of an arm support. To strengthen the evidence there is a need for more rigorous research analysing the type of device and the leads utilised.

Early detection of neurological deterioration in serious acute brain injury is seen as an important goal to reduce death and disability, but monitoring for neurological deterioration remains challenging. Routine methods, such as neurological examination and brain imaging, often identify brain injuries only after they have progressed to an irreversible stage. Alternate approaches such as invasive brain monitoring, are complex, costly and carry inherent risks. The optical brain pulse monitor (OBPM) is a novel, non-invasive, safe, and continuous monitoring device designed to provide earlier detection of neurological deterioration and address the limitations of traditional approaches. This review presents the development, technical aspects, and clinical results from past and ongoing trials over the last five years.

Background: Patients who have experienced a cryptogenic stroke (CS) may benefit from extended monitoring and possible earlier detection of atrial fibrillation (AF), allowing for the timely initiation of appropriate pharmacotherapy.

Objective: This economic study aimed to evaluate the clinical and cost outcomes of using mid-term cardiac monitors (referred to as "ePatch") versus ILR-only in post-CS patients in the UK, Netherlands (NL) and Sweden.

Methods: An existing cost-minimization model was modified to fit healthcare settings in the UK, Netherlands and Sweden. The model's target population was composed of adult patients who had previously experienced a CS, but had no documented history of AF. The model compares the one-year direct medical costs between two groups: one group receiving wearable ePatch, the other group proceeding directly to ILR.

Results: When applied to a group of 1,000 patients, the ePatch versus ILR approach resulted in cost savings, due to combination of reduced expenses and decreased modelled occurrence of recurrent strokes in all three countries studied. In the base case analysis, the cost savings per patient with detected AF for ePatch ranged from 3.4-6.0 times, depending on the country.

Conclusion: Utilizing ePatch extended wear Holter for mid-term ECG monitoring in CS patients represents a cost-saving alternative to monitoring with ILR. The cost savings were achieved by reducing device expenses and by prevention of recurrent strokes via earlier anticoagulation initiation. Preventing recurrent strokes in this population is highly significant, as it can lead to improved long-term health outcomes and reduced overall healthcare costs.

The NOL-Nociception Level Index^® is a multiparameter index, based on artificial intelligence for the monitoring of nociception (physiological pain response) during anesthesia that has recently been authorized by the FDA. The monitor utilizes continuous streams of information from a finger probe comprising four sensors, including photoplethysmography, to provide a personalized nociception score on a scale of 0-100. Recent studies have suggested racial bias in pulse oximeter measurements due to the effect of melanin levels on photoplethysmography measurements. Therefore, there is a need to clinically validate new monitoring technologies in patients of all skin tones. The performance of the NOL scale in 8 patients that self-identified as Black or multiracial was compared to a database of 447 consented patients, assessing the response to surgical events at different levels of intensity. The descriptive, pilot data suggest that NOL performance in Black and multiracial patients is not different from the performance shown for the large database. Larger studies utilizing recognized skin tone scales to ensure accurate assessment of skin pigmentation are planned for the future.

Purpose: Press-through packages (PTPs) are frequently used for the packaging of prescription drugs in Japan. However, tablets or capsules packaged in PTPs may become unstable and difficult to store. Therefore, aluminum pouches (pillow packages) are applied as an additional packaging option. Especially for 10-sheet tablet (capsule) PTPs, there are many opportunities for health-care professionals (mainly pharmacists) to open pillow packages during the dispensing process. However, aluminum pouches (pillow packages) that are easy to open and store appropriately by not only pharmacists, but also patients, are needed.

Methods: A 100-unit PTP (pillow package) with conventional specifications ① and two other products (②: open vertically by a wavy processed half-cut and ③: pinch the backlining open) were developed with the aim of improving the ease of opening. The study participants, consisting of pharmacists and patients, performed tasks such as opening and taking drugs out of the PTP for each sample, and evaluated the differences in usability.

Results: The results of a sensory test revealed that pharmacists rated products ② and ③ higher than product ①. On the other hand, patients, including those with weak grip and pinching strengths, rated ③ highly, confirming the superiority of usability in the order of ③, ②, and ①. In addition, item ③ was successfully opened by all patients.

Conclusion: The present results indicated the superiority of the developed pillow packaging, which enables pharmacists to save time in the dispensing process. In addition, product ③ was evaluated highly by patients, especially those with disabilities, for its ease of use not only in terms of opening, but also storage. Sensory testing by actual users applying ergonomic methods enabled a multifaceted evaluation of the products and provided insights into the actual status of pharmacists' dispensing work (product issues) and patients' daily medication use.