Expert Review of Medical Devices最新文献

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.

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.

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.

Background: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques.

Research design and methods: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months.

Results: Among 149 randomized patients, 122 received CTR-US (n = 94) or mOCTR (n = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) (p < 0.001). Median time to return to daily activities (2 vs. 2 days; p = 0.81) and work (3 vs. 4 days; p = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p = 0.55).

Conclusions: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05405218.

Objectives: This study aimed to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonular length measurements using very high-frequency digital ultrasound (Insight 100).

Methods: Two examiners performed ultrasound imaging independently in each subject. The length of temporal and nasal zonules were then measured with a built-in software. Coefficient of variations (CVs) of the three repeated measurements were used to determine intra-examiner variances. Inter-examiner reproducibility was evaluated using intraclass correlation coefficients (ICCs) and the Bland-Altman method.

Results: 40 eyes of 40 subjects (14male and 26female; mean age 23.9 ± 2.4 years) were included in the study. The CVs for intra-examiner measurement were 2.74% temporally and 4.32% nasally for Examiner 1, and were 1.96% temporally and 1.75% nasally for Examiner 2. For inter-examiner reproducibility, all ICCs were above 0.9. However, there were significant differences between the two examiners in temporal zonular length measurements (p = 0.001), and the differences mainly came from measuring the zonular length manually (p = 0.001) rather than recording images (p = 0.480). No significant differences were found between two measurements by the same examiner after one month (all p > 0.05, all ICCs > 0.8).

Conclusion: The Insight 100 device can be used to measure the length of anterior lens zonule with relatively good repeatability and reproducibility.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05657951.

Introduction: Peri-implantitis is the leading cause of dental implant loss and is initiated by a polymicrobial dysbiotic biofilm formation on the implant surface. The destruction of peri-implant tissue by the host immune response and the low effectiveness of surgical or non-surgical treatments highlight the need for new strategies to prevent, modulate and/or eliminate biofilm formation on the implant surface. Currently, several surface modifications have been proposed using biomolecules, ions, antimicrobial agents, and topography alterations.

Areas covered: Initially, this review provides an overview of the etiopathogenesis and host- and material-dependent modulating factors of peri-implant disease. In addition, a critical discussion about the antimicrobial surface modification mechanisms and techniques employed to modify the titanium implant material is provided. Finally, we also considered the future perspectives on the development of antimicrobial surfaces to narrow the bridge between idea and product and favor the clinical application possibility.

Expert opinion: Antimicrobial surface modifications have demonstrated effective results; however, there is no consensus about the best modification strategy and in-depth information on the safety and longevity of the antimicrobial effect. Modified surfaces display recurring challenges such as short-term effectiveness, the burst release of drugs, cytotoxicity, and lack of reusability. Stimulus-responsive surfaces seem to be a promising strategy for a controlled and precise antimicrobial effect, and future research should focus on this technology and study it from models that better mimic clinical conditions.

Background: Needlestick injuries (NSIs) may potentially expose healthcare professionals (HCPs) to bloodborne pathogens. Safety needles are designed to protect against NSIs. We evaluated whether a new fully passive safety needle could be used safely by HCPs.

Research design and methods: The passive safety needle was tested by physicians, nurses, and pharmacists in subcutaneous or intramuscular injection scenarios in simulation studies (1-3). Data collected included successes, close calls, difficulties, use errors, and failures. In study 4, HCPs rated the device safety (21-item questionnaire).

Results: Overall, 104 participants completed 4772 simulated tasks, including 932 injections. 915 injections (98.18%) were performed successfully and no NSIs (0%) were observed in any of the studies. Studies 1 & 2: 84.15% tasks and 96.06% injections were completed successfully, but use errors occurred, mostly arising from the participants' mental model. There were no failures in Study 3. In Study 4, >98% of participants responded positively to every question, while all felt that the passive safety feature could eliminate NSIs and would better protect against bloodborne pathogens than other existing devices with active or semi-passive safety mechanisms.

Conclusions: The passive safety needle was used successfully by HCPs, did not lead to any NSIs, and was rated as the safest compared to similar devices.

Introduction: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease.

Areas covered: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status.

Expert opinion: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Introduction: This review summarizes the available recent literature on different mechanisms and parameters of pulsed ultrasound (US) that have been used during orthodontic treatments to prevent and repair root resorption.

Areas covered: A literature search was conducted between January (2002) and September (2022) in the following databases: PubMed, Google-Scholar, Embase, and The-Cochrane-Library. After exclusions, a total of 19 papers were included in the present review. The most used US parameters with positive outcomes were frequency of 1.5 MHz, pulse repetition frequency of 1000 Hz, output intensity of 30 mW/cm2, duration of application of 20 min and total number sessions were 14 with a repetition interval of 1 day. The suggested mechanisms induced by US were alteration of cementoblasts, osteoblasts, osteoclasts, alkaline-phosphatase (ALP), runt-related-gene-2 (Runx2), osteoprotegerin (OPG), type-I-collagen (Col-I), C-telopeptide-type-I-collagen (CTX-I), hepatocyte-growth-factor (HGF), bone morphogenetic protein-2 (BMP-2), cyclooxygenase-2 (Cox-2), calcium (Ca2+), receptor activator of nuclear factor-kappa-B ligand (RANKL), and receptor activator of nuclear factor-kappa-B (RANK).

Expert opinion: Understanding mechanisms and deciding which parameters of US that can be used during orthodontic treatment to prevent and repair root resorption is a great challenge. This work summarizes all the available data that can aid this process and suggest that US is an effective noninvasive method not only in prevention and repairing of orthodontic induced root resorption but also in accelerating teeth movement.

Introduction: Intimal hyperplasia (IH) is a significant factor limiting the success of revascularization surgery for blood flow restoration. IH results from a foreign body response and mechanical disparity that involves complex biochemical reactions resulting in graft failure. The available treatment option utilizes either different pharmacological interventions or mechanical support to the vascular grafts with limited success.

Areas covered: This review explains the pathophysiology of IH, responsible mechanical and biological factors, and treatment options, emphasizing perivascular devices. They are designed to provide mechanical support and pharmacology actions. The perivascular drug delivery concept has successfully demonstrated efficacy in various animal studies. Accurate projections of drug release mechanisms using mathematical modeling could be used to formulate prolonged drug elution devices. Numerical modeling aspects for the prediction of design outcomes have been given due importance that fulfills the unmet clinical need for better patient care.

Expert opinion: IH could be effectively prevented by simultaneous mechanical scaffolding and sustained local drug delivery. Future perivascular medical devices could be designed to integrate these essential features. Numerical modeling for device performance prediction should be utilized in the development of next-generation perivascular devices.