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Pain and Therapy Jul 2024Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each...
INTRODUCTION
Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each stimulation pulse and uses this information to automatically adjust the stimulation strength in real time, known as ECAP-controlled SCS. This innovative system compensates for fluctuations in the distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a predetermined target level. This data collection study was designed to assess the performance of the first CL-SCS system in a real-world setting under normal conditions of use in multiple European centers. The study analyzes and presents clinical outcomes and electrophysiological and device data and compares these findings with those reported in earlier pre-market studies of the same system.
METHODS
This prospective, multicenter, observational study was conducted in 13 European centers and aimed to gather electrophysiological and device data. The study focused on the real-world application of this system in treating chronic pain affecting the trunk and/or limbs, adhering to standard conditions of use. In addition to collecting and analyzing basic demographic information, the study presents data from the inaugural patient cohort permanently implanted at multiple European centers.
RESULTS
A significant decrease in pain intensity was observed for overall back or leg pain scores (verbal numerical rating score [VNRS]) between baseline (mean ± standard error of the mean [SEM]; n = 135; 8.2 ± 0.1), 3 months (n = 93; 2.3 ± 0.2), 6 months (n = 82; 2.5 ± 0.3), and 12 months (n = 76; 2.5 ± 0.3). Comparison of overall pain relief (%) to the AVALON and EVOKE studies showed no significant differences at 3 and 12 months between the real-world data release (RWE; 71.3%; 69.6%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies. Further investigation was undertaken to objectively characterize the physiological parameters of SCS therapy in this cohort using the metrics of percent time above ECAP threshold (%), dose ratio, and dose accuracy (µV), according to previously described methods. Results showed that a median of 90% (40.7-99.2) of stimuli were above the ECAP threshold, with a dose ratio of 1.3 (1.1-1.4) and dose accuracy of 4.4 µV (0.0-7.1), based on data from 236, 230, and 254 patients, respectively. Thus, across all three metrics, the majority of patients had objective therapy metrics corresponding to the highest levels of pain relief in previously reported studies (usage over threshold > 80%, dose ratio > 1.2, and error < 10 µV).
CONCLUSIONS
In conclusion, this study provides valuable insights into the real-world application of the ECAP-controlled CL-SCS system, highlighting its potential for maintaining effective pain relief and objective neurophysiological therapy metrics at levels seen in randomized control trials, and potential for quantifying patient burden associated with SCS system use via patient-device interaction metrics.
CLINICAL TRIAL REGISTRATION
In the Netherlands, the study is duly registered on the International Clinical Trials Registry Platform (Trial NL7889). In Germany, the study is duly registered as NCT05272137 and in the United Kingdom as ISCRTN27710516 and has been reviewed by the ethics committee in both countries.
PubMed: 38954217
DOI: 10.1007/s40122-024-00628-z -
Lasers in Medical Science Jul 2024Several treatment options for acne vulgaris are limited by their associated adverse effects. An innovative approach involves introducing light-absorbing nanoparticles...
Microchanneling and ultrasonic delivery of gold and platinum nanoparticles for selective photothermolysis of sebaceous follicles in the treatment of acne: a pilot study using porcine skin.
PURPOSE
Several treatment options for acne vulgaris are limited by their associated adverse effects. An innovative approach involves introducing light-absorbing nanoparticles into sebaceous follicles before destroying the follicles using selective photothermolysis. We aimed to investigate efficient methods for introducing gold and platinum nanoparticles into sebaceous follicles and to identify suitable laser equipment and parameters for the effective destruction of these follicles.
METHODS
We used porcine skin as the experimental model. We compared the efficacies of a thulium laser, ultrasound, and manual massage and evaluated the optimal method for delivering nanoparticles in close proximity to sebaceous follicles. Subsequently, a 1064-nm-wavelength neodymium-doped yttrium aluminum garnet (Nd: YAG) laser was employed to induce selective photothermolysis. We compared different parameters to identify the optimal pulse duration and fluence of the Nd: YAG laser. The extent of penetration and destruction of sebaceous follicles was assessed using hematoxylin and eosin (H&E) staining, and a numerical evaluation was conducted.
RESULTS
H&E staining showed that irradiation with a long-pulsed Nd: YAG laser following a combination of thulium laser and sonophoresis effectively destroyed sebaceous follicles, with destruction rates exceeding 50%. These results were valid with a long pulse duration and a high fluence of the Nd: YAG laser.
CONCLUSION
This study demonstrated that sebaceous follicles can be effectively destroyed through a mixture of gold and platinum nanoparticle delivery by a combination of microchanneling and sonophoresis, followed by selective thermal damage induced by a 1064-nm long-pulsed high-fluence Nd: YAG laser.
Topics: Animals; Gold; Swine; Platinum; Pilot Projects; Metal Nanoparticles; Acne Vulgaris; Lasers, Solid-State; Skin; Sebaceous Glands
PubMed: 38954141
DOI: 10.1007/s10103-024-04124-w -
International Ophthalmology Jul 2024To compare early changes in the corneal biomechanical parameters after photorefractive keratectomy (PRK) and small incision lenticule extraction (SMILE) and their...
PURPOSE
To compare early changes in the corneal biomechanical parameters after photorefractive keratectomy (PRK) and small incision lenticule extraction (SMILE) and their correlations with corneal shape parameters.
METHODS
One hundred twenty four eyes received myopic PRK and SMILE for similar amounts of myopia. Corneal tomography with Pentacam HR, biomechanical parameters using Corvis ST, and Ocular Response Analyzer (ORA) were evaluated before and 2 weeks after surgery. The change in each parameter was compared between groups, while the difference in central corneal thickness and cornea-compensated intraocular pressure measured before and after surgery were considered as covariates.
RESULTS
A significant reduction was seen in the corneal stiffness parameter at first applanation, and an increase in deformation amplitude ratio (DAR), and integrated inverse radius (IIR) in both groups after surgery (p < 0.001) Changes in DAR, and IIR were significantly greater in the SMILE than in the PRK group (p < 0.001) Corneal hysteresis (CH) and corneal resistance factor (CRF) decreased in both SMILE and PRK groups after surgery, (p < 0.001) with no statistically significant difference between groups (p > 0.05) Among new Corvis ST parameters, DAR showed a significant correlation with changes in Ambrosio relational thickness in both groups (p < 0.05).
CONCLUSIONS
Both techniques caused significant changes in corneal biomechanics in the early postoperative period, with greater elastic changes in the SMILE group compared to the PRK group, likely due to lower tension in the SMILE cap and thinner residual stromal bed in SMILE. There were no differences in viscoelastic changes between them, so the lower CH may reflect the volume of tissue removed.
Topics: Humans; Photorefractive Keratectomy; Myopia; Cornea; Female; Male; Adult; Elasticity; Biomechanical Phenomena; Young Adult; Lasers, Excimer; Intraocular Pressure; Corneal Surgery, Laser; Refraction, Ocular; Corneal Topography; Corneal Stroma; Postoperative Period; Visual Acuity; Prospective Studies; Follow-Up Studies
PubMed: 38954134
DOI: 10.1007/s10792-024-03169-8 -
Techniques in Coloproctology Jul 2024Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs.... (Observational Study)
Observational Study Comparative Study
BACKGROUND
Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs. Technological improvements in anastomotic devices could reduce the incidence of leakage and its economic impact. The aim of the present study was to assess if the use of a new powered circular stapler is cost-effective.
METHOD
This observational study included patients undergoing left-sided circular stapled colorectal anastomosis between January 2018 and December 2021. Propensity score matching was carried out to create two comparable groups depending on whether the anastomosis was performed using a manual or powered circular device. The rate of anastomotic leakage, its severity, the consumption of hospital resources, and its cost were the main outcome measures. A cost-effectiveness analysis comparing the powered circular stapler versus manual circular staplers was performed.
RESULTS
A total of 330 patients were included in the study, 165 in each group. Anastomotic leakage rates were significantly different (p = 0.012): 22 patients (13.3%) in the manual group versus 8 patients (4.8%) in the powered group. The effectiveness of the powered stapler and manual stapler was 98.27% and 93.69%, respectively. The average cost per patient in the powered group was €6238.38, compared with €9700.12 in the manual group. The incremental cost-effectiveness ratio was - €74,915.28 per patient without anastomotic complications.
CONCLUSION
The incremental cost of powered circular stapler compared with manual devices was offset by the savings from lowered incidence and cost of management of anastomotic leaks.
Topics: Humans; Anastomotic Leak; Cost-Benefit Analysis; Female; Surgical Staplers; Male; Anastomosis, Surgical; Middle Aged; Aged; Incidence; Surgical Stapling; Colon; Rectum; Propensity Score; Adult; Cost-Effectiveness Analysis
PubMed: 38954099
DOI: 10.1007/s10151-024-02936-0 -
Mikrochimica Acta Jul 2024A fluorescence probe based on molecularly imprinted polymers on red emissive biomass-derived carbon dots (r-BCDs@MIPs) was developed to detect tyramine in fermented meat...
Fabrication of fluorescence probe based on molecularly imprinted polymers on red emissive biomass-derived carbon dots coupled with smartphone readout for tyramine determination in fermented meat products.
A fluorescence probe based on molecularly imprinted polymers on red emissive biomass-derived carbon dots (r-BCDs@MIPs) was developed to detect tyramine in fermented meat products. The red emissive biomass-derived carbon dots (r-BCDs) were synthesized by the one-step solvothermal method using discarded passion fruit shells as raw materials. The fluorescence emission peak of r-BCDs was at 670 nm, and the relative quantum yield (QY) was about 2.44%. Molecularly imprinted sensing materials were prepared with r-BCDs as fluorescent centers for the detection of trace tyramine, which showed a good linear response in the concentration range of tyramine from 1 to 40 µg L. The linear correlation coefficient was 0.9837, and the limit of detection was 0.77 µg L. The method was successfully applied to the determination of tyramine in fermented meat products, and the recovery was 87.17-106.02%. The reliability of the results was verified through high-performance liquid chromatography (HPLC). Furthermore, we combined the r-BCDs@MIPs with smartphone-assisted signal readout to achieve real-time detection of tyramine in real samples. Considering its simplicity and convenience, the method could be used as a rapid and low-cost promising platform with broad application prospects for on-site detection of trace tyramine with smartphone-assisted signal readout.
Topics: Tyramine; Smartphone; Carbon; Quantum Dots; Meat Products; Fluorescent Dyes; Molecularly Imprinted Polymers; Limit of Detection; Spectrometry, Fluorescence; Biomass; Fermentation
PubMed: 38954059
DOI: 10.1007/s00604-024-06499-7 -
Lasers in Medical Science Jul 2024Nowadays, lasers are used in various medical fields. Ophthalmology was the first medical specialty to utilize lasers in patient treatment and still remains the leading... (Review)
Review
Nowadays, lasers are used in various medical fields. Ophthalmology was the first medical specialty to utilize lasers in patient treatment and still remains the leading medical field that uses laser energy for both therapeutic and diagnostic purposes. The neodymium: yttrium-aluminum-garnet (Nd: YAG) laser is one of the most common lasers used in ophthalmology. It is a solid-state laser with a wavelength of 1064 nm that works on the principle of photodisruption. Since its introduction in ophthalmology over 40 years ago, it has found various applications, mainly for procedures where cutting or disruption of ocular tissue is required. Compared to surgical alternatives, the use of Nd: YAG lasers on ocular tissue is minimally invasive. In this review, we focus on the two most common ophthalmic applications of Nd: YAG laser - laser peripheral iridotomy and posterior capsulotomy. The history of the techniques, current trends, potential complications, and the prognosis for future use is discussed.
Topics: Humans; Lasers, Solid-State; Laser Therapy; Posterior Capsulotomy; Iridectomy; Ophthalmology; Iris
PubMed: 38954050
DOI: 10.1007/s10103-024-04118-8 -
Indian Journal of Public Health Apr 2024The medical devices industry plays a critical role in public health and requires attention in research and policy. The COVID-19 pandemic exposed a lack of resilience in...
BACKGROUND
The medical devices industry plays a critical role in public health and requires attention in research and policy. The COVID-19 pandemic exposed a lack of resilience in areas of drugs and vaccines but also in medical products.
OBJECTIVES
The study analyzes India's strengths and weaknesses in the trade of medical devices and identifies specific devices where India can attain self-sufficiency and areas where trade is still beneficial.
MATERIALS AND METHODS
A set of critical products traded during the COVID-19 pandemic were identified from the World Integrated Trade Solution website at the 6-digit Harmonized System code level. A detailed analysis of exports and imports of medical products at disaggregated 8-digit codes was carried out.
RESULTS
During the pandemic, India had a trade surplus in some low-technology-based products such as suture needles, catheters, and cannulae along with X-ray apparatus and electrocardiographs among the medium-tech products. The imports of high-tech devices like in vitro diagnostics almost doubled to meet the surge in demand. The requirement of pulse oximeters, ventilators, and other monitoring devices jumped, and their imports reported an 800% increase from $134 million in 2019-2020 to $1162 million in 2021-2022. Most of India's imports of medical devices come from the top five exporting countries, with the share of the USA and China at 39%-40%.
CONCLUSION
There is a need to expand the manufacturing capacity of surgical instruments, consumables and disposables, apart from some high-tech products. The public health care facilities should procure domestically manufactured medical devices and trade with neighbouring countries to reduce import concentration must be prioritised.
Topics: COVID-19; India; Humans; Equipment and Supplies; Commerce; SARS-CoV-2; Pandemics
PubMed: 38953811
DOI: 10.4103/ijph.ijph_1403_23 -
European Heart Journal Jul 2024Physical activity has proven effective in preventing atherosclerotic cardiovascular disease, but its role in preventing degenerative valvular heart disease (VHD) remains...
BACKGROUND AND AIMS
Physical activity has proven effective in preventing atherosclerotic cardiovascular disease, but its role in preventing degenerative valvular heart disease (VHD) remains uncertain. This study aimed to explore the dose-response association between moderate to vigorous physical activity (MVPA) volume and the risk of degenerative VHD among middle-aged adults.
METHODS
A full week of accelerometer-derived MVPA data from 87 248 UK Biobank participants (median age 63.3, female: 56.9%) between 2013 and 2015 were used for primary analysis. Questionnaire-derived MVPA data from 361 681 UK Biobank participants (median age 57.7, female: 52.7%) between 2006 and 2010 were used for secondary analysis. The primary outcome was the diagnosis of incident degenerative VHD, including aortic valve stenosis (AS), aortic valve regurgitation (AR), and mitral valve regurgitation (MR). The secondary outcome was VHD-related intervention or mortality.
RESULTS
In the accelerometer-derived MVPA cohort, 555 incident AS, 201 incident AR, and 655 incident MR occurred during a median follow-up of 8.11 years. Increased MVPA volume showed a steady decline in AS risk and subsequent AS-related intervention or mortality risk, levelling off beyond approximately 300 min/week. In contrast, its association with AR or MR incidence was less apparent. The adjusted rates of AS incidence (95% confidence interval) across MVPA quartiles (Q1-Q4) were 11.60 (10.20, 13.20), 7.82 (6.63, 9.23), 5.74 (4.67, 7.08), and 5.91 (4.73, 7.39) per 10 000 person-years. The corresponding adjusted rates of AS-related intervention or mortality were 4.37 (3.52, 5.43), 2.81 (2.13, 3.71), 1.93 (1.36, 2.75), and 2.14 (1.50, 3.06) per 10 000 person-years, respectively. Aortic valve stenosis risk reduction was also observed with questionnaire-based MVPA data [adjusted absolute difference Q4 vs. Q1: AS incidence, -1.41 (-.67, -2.14) per 10 000 person-years; AS-related intervention or mortality, -.38 (-.04, -.88) per 10 000 person-years]. The beneficial association remained consistent in high-risk populations for AS, including patients with hypertension, obesity, dyslipidaemia, and chronic kidney disease.
CONCLUSIONS
Higher MVPA volume was associated with a lower risk of developing AS and subsequent AS-related intervention or mortality. Future research needs to validate these findings in diverse populations with longer durations and repeated periods of activity monitoring.
PubMed: 38953786
DOI: 10.1093/eurheartj/ehae406 -
European Heart Journal Jul 2024Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is not a dichotomous disease trait. Technological innovations enable long-term rhythm monitoring...
Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is not a dichotomous disease trait. Technological innovations enable long-term rhythm monitoring in many patients and can estimate AF burden. These technologies are already used to detect and monitor AF. This review describes the relation between AF burden and outcomes and potential effects of AF burden reduction. A lower AF burden is associated with a lower risk of stroke and heart failure in patients with AF: stroke risk without anticoagulation is lower in patients with device-detected AF and a low AF burden (stroke rate 1%/year) than in patients with persistent and permanent AF (stroke rate 3%/year). Paroxysmal AF shows intermediate stroke rates (2%/year). Atrial fibrillation burden-reducing interventions can reduce cardiovascular outcomes in patients with AF: early rhythm control reduces cardiovascular events including stroke and heart failure in patients with recently diagnosed AF and cardiovascular conditions. In patients with heart failure and AF, early rhythm control and AF ablation, interventions that reduce AF burden, reduce mortality and heart failure events. Recent technological innovations allow to estimate AF burden in clinical care, creating opportunities and challenges. While evidence remains limited, the existing data already suggest that AF burden reduction could be a therapeutic goal. In addition to anticoagulation and treatment of cardiovascular conditions, AF burden reduction emerges as a therapeutic goal. Future research will define the AF burden that constitutes a relevant risk of stroke and heart failure. Technologies quantifying AF burden need careful validation to advance the field.
PubMed: 38953776
DOI: 10.1093/eurheartj/ehae373 -
Operative Neurosurgery (Hagerstown, Md.) Jul 2024In cases where dumbbell-shaped cervical schwannoma encases the vertebral artery (VA), there is a risk of VA injury during surgery. The objective of this study is to...
BACKGROUND AND OBJECTIVES
In cases where dumbbell-shaped cervical schwannoma encases the vertebral artery (VA), there is a risk of VA injury during surgery. The objective of this study is to propose a strategy for preserving the VA during the surgical excision of tumors adjacent to the VA through the utilization of anatomic layers.
METHODS
A retrospective analysis was conducted on 37 patients who underwent surgery for dumbbell-shaped cervical schwannoma with contacting VA from January 2004 to July 2023. The VA encasement group consisted of 12 patients, and the VA nonencasement group included 25 patients.
RESULTS
The perineurium acted as a protective barrier from direct VA exposure or injury during surgery. However, in the VA encasement group, 1 patient was unable to preserve the perineurium while removing a tumor adjacent to the VA, resulting in VA injury. The patient had the intact dominant VA on the opposite side, and there were no new neurological deficits or infarctions after the surgery. Gross total resection was achieved in 25 patients (67.6%), while residual tumor was confirmed in 12 patients (32.4%). Four patients (33.3% of 12 patients) underwent reoperation because of the regrowth of the residual tumor within the neural foramen. In the case of the 8 patients (66.7% of 12 patients) whose residual tumor was located outside the neural foramen, no regrowth was observed, and there was no recurrence of the tumor within the remaining perineurium after total resection.
CONCLUSION
In conclusion, when resecting a dumbbell-shaped cervical schwannoma contacting VA, subperineurium dissection prevents VA injury because the perineurium acts as a protective barrier.
PubMed: 38953646
DOI: 10.1227/ons.0000000000001245