BACKGROUND: The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. OBJECTIVES: This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. METHODS: Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included. The retrieval success rate was evaluated for all attempted retrievals. Site-reported complications associated with LP retrievals were quantified, with the severity and relationship adjudicated by an independent clinical events committee. RESULTS: There were 1,423 successful LP implants and 234 chronic LP retrieval attempts in 233 subjects. The overall retrieval success rate was 87.6% (205 of 234 attempts). The most common reason for failed retrieval (86.2%, 25 of 29 attempts) was inability to access the LP docking button. The mean time from implantation to attempted retrieval was 3.2 years (range 0.2-9.0 years) and did not significantly influence the retrieval success (P = 0.71). The clinical events committee adjudicated 11 complications in 9 subjects as being retrieval related (3.9%, 9 of 233 subjects). CONCLUSIONS: The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
- MeSH
- Equipment Design MeSH
- Adult MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Device Removal * methods MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
... Arthroplasty 385 -- 15c Disk Arthroplasty Using the ProDisc-L® -- Total Disk Replacement 279 -- 21 Retrieval ... ... Analysis of Arthroplasty -- Devices 401 -- 15d The Maverick™ Artificial Disc 295 -- Index 411 -- Total ...
... FISHER -- 8.2 Retrieval Analysis of Mobile Bearing Prosthetic Knees Devices 74 -- J.P. ...
Cerebral air embolism after removal of central venous catheter (CVC) is a rare complication but can lead to fatal outcomes. We report a rare case of both cerebral venous and arterial embolism occurring in a patient with underlying scleroderma-related interstitial lung disease (SSc-ILD) and pulmonary hypertension following removal of percutaneous introducer sheath for pulmonary artery catheterization. We discuss the mechanisms, pathophysiology, management and prevention of cerebral air embolism.
- MeSH
- Lung Diseases, Interstitial etiology diagnosis therapy MeSH
- Intracranial Embolism * etiology diagnosis MeSH
- Middle Aged MeSH
- Humans MeSH
- Device Removal methods adverse effects MeSH
- Catheterization, Swan-Ganz adverse effects instrumentation MeSH
- Embolism, Air * etiology diagnosis MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
AIMS: We report our single-centre experience of mid-term to long-term retrieval and reimplantation of a tine-based leadless pacemaker [Micra transcatheter pacing system (TPS)]. The TPS is a clinically effective alternative to transvenous single-chamber ventricular pacemakers. Whereas it is currently recommended to abandon the TPS at the end of device life, catheter-based retrieval may be favourable in specific scenarios. METHODS AND RESULTS: We report on nine consecutive patients with the implanted TPS who subsequently underwent transcatheter retrieval attempts. The retrieval system consists of the original TPS delivery catheter and an off-the-shelf single-loop 7 mm snare. The procedure was guided by fluoroscopy and intracardiac echocardiography. After an implantation duration of 3.1 ± 2.8 years (range 0.4-9.0), the overall retrieval success rate was 88.9% (8 of 9 patients). The mean procedure time was 89 ± 16 min, and the fluoroscopy time was 18.0 ± 6.6 min. No procedure-related adverse device events occurred. In the one unsuccessful retrieval, intracardiac echocardiography revealed that the TPS was partially embedded in the ventricular tissue surrounding the leadless pacemaker body in the right ventricle. After retrieval, three patients were reimplanted with a new TPS device. All implantations were successful without complications. CONCLUSION: A series of transvenous late retrievals of implanted TPS devices demonstrated safety and feasibility, followed by elective replacement with a new leadless pacing device or conventional transvenous pacing system. This provides a viable end-of-life management alternative to simple abandonment of this leadless pacemaker.
- MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Echocardiography MeSH
- Radiography, Interventional MeSH
- Cardiac Pacing, Artificial methods MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Device Removal * methods MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Cardiac Catheterization * methods instrumentation MeSH
- Cardiac Catheters MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: In recent years, there has been an increasing effort to take advantage of the potential use of low magnetic induction devices with less than 1 T, referred to as Low-Field MRI (LF MRI). LF MRI systems were used, especially in the early days of magnetic resonance technology. Over time, magnetic induction values of 1.5 and 3 T have become the standard for clinical devices, mainly because LF MRI systems were suffering from significantly lower quality of the images, e.g., signal-noise ratio. In recent years, due to advances in image processing with artificial intelligence, there has been an increasing effort to take advantage of the potential use of LF MRI with induction of less than 1 T. This overview article focuses on the analysis of the evidence concerning the diagnostic efficacy of modern LF MRI systems and the clinical comparison of LF MRI with 1.5 T systems in imaging the nervous system, musculoskeletal system, and organs of the chest, abdomen, and pelvis. METHODOLOGY: A systematic literature review of MEDLINE, PubMed, Scopus, Web of Science, and CENTRAL databases for the period 2018-2023 was performed according to the recommended PRISMA protocol. Data were analysed to identify studies comparing the accuracy, reliability and diagnostic performance of LF MRI technology compared to available 1.5 T MRI. RESULTS: A total of 1275 publications were retrieved from the selected databases. Only two articles meeting all predefined inclusion criteria were selected for detailed assessment. CONCLUSIONS: A limited number of robust studies on the accuracy and diagnostic performance of LF MRI compared with 1.5 T MRI was available. The current evidence is not sufficient to draw any definitive insights. More scientific research is needed to make informed conclusions regarding the effectiveness of LF MRI technology.
- Publication type
- Journal Article MeSH
- Review MeSH
INTRODUCTION: Hip and knee osteoarthritis (OA) are increasingly common with a significant impact on individuals and society. Non-pharmacological treatments are considered essential to reduce pain and improve function and quality of life. EULAR recommendations for the non-pharmacological core management of hip and knee OA were published in 2013. Given the large number of subsequent studies, an update is needed. METHODS: The Standardised Operating Procedures for EULAR recommendations were followed. A multidisciplinary Task Force with 25 members representing 14 European countries was established. The Task Force agreed on an updated search strategy of 11 research questions. The systematic literature review encompassed dates from 1 January 2012 to 27 May 2022. Retrieved evidence was discussed, updated recommendations were formulated, and research and educational agendas were developed. RESULTS: The revised recommendations include two overarching principles and eight evidence-based recommendations including (1) an individualised, multicomponent management plan; (2) information, education and self-management; (3) exercise with adequate tailoring of dosage and progression; (4) mode of exercise delivery; (5) maintenance of healthy weight and weight loss; (6) footwear, walking aids and assistive devices; (7) work-related advice and (8) behaviour change techniques to improve lifestyle. The mean level of agreement on the recommendations ranged between 9.2 and 9.8 (0-10 scale, 10=total agreement). The research agenda highlighted areas related to these interventions including adherence, uptake and impact on work. CONCLUSIONS: The 2023 updated recommendations were formulated based on research evidence and expert opinion to guide the optimal management of hip and knee OA.
- MeSH
- Osteoarthritis, Knee * therapy rehabilitation MeSH
- Osteoarthritis, Hip * therapy rehabilitation MeSH
- Weight Loss MeSH
- Humans MeSH
- Evidence-Based Medicine MeSH
- Self-Help Devices MeSH
- Self-Management methods MeSH
- Exercise Therapy * methods MeSH
- Patient Education as Topic methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Practice Guideline MeSH
- Geographicals
- Europe MeSH
INTRODUCTION: This systematic review aims to identify previously used techniques in biomechanics to assess pelvic instability following pelvic injury, focusing on external fixation constructs. METHODS: A systematic literature search was conducted to include biomechanical studies and to exclude clinical trials. RESULTS: Of an initial 4666 studies found, 38 met the inclusion criteria. 84% of the included studies were retrieved from PubMed, Scopus, and Web of Science. The studies analysed 106 postmortem specimens, 154 synthetic bones, and 103 computational models. Most specimens were male (97% synthetic, 70% postmortem specimens). Both the type of injury and the classification system employed varied across studies. About 82% of the injuries assessed were of type C. Two different fixators were tested for FFPII and type A injury, five for type B injury, and fifteen for type C injury. Large variability was observed for external fixation constructs concerning device type and configuration, pin size, and geometry. Biomechanical studies deployed various methods to assess injury displacement, deformation, stiffness, and motion. Thereby, loading protocols differed and inconsistent definitions of failure were determined. Measurement techniques applied in biomechanical test setups included strain gauges, force transducers, and motion tracking techniques. DISCUSSION AND CONCLUSION: An ideal fixation method should be safe, stable, non-obstructive, and have low complication rates. Although biomechanical testing should ensure that the load applied during testing is representative of a physiological load, a high degree of variability was found in the current literature in both the loading and measurement equipment. The lack of a standardised test design for fixation constructs in pelvic injuries across the studies challenges comparisons between them. When interpreting the results of biomechanical studies, it seems crucial to consider the limitations in cross-study comparability, with implications on their applicability to the clinical setting.
- MeSH
- Biomechanical Phenomena MeSH
- External Fixators MeSH
- Fracture Fixation methods MeSH
- Fractures, Bone * MeSH
- Humans MeSH
- Pelvic Bones * surgery MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Systematic Review MeSH
BACKGROUND: National surveillance of physical activity (PA) is essential to establish public health policy actions for PA promotion and evaluation, thereby promoting accountability. The main goal of this study is to comprehensively analyse surveillance data on PA behaviours, outcomes, and influencing factors among Slovakian children and adolescents by using the methodology of the Active Healthy Kids Global Alliance Global Matrix (AHKGA-GM) project. Secondary goals are to provide comparisons with international data and the identification of surveillance gaps. METHODS: A comprehensive multilevel search strategy for data about 10 core indicators and 1 additional indicator published between 2015 and 2020 (solely pre-COVID-19-pandemic data) was used. The data were then synthesised, and a set of standardised benchmarks was used to assign grades according to The Global Matrix 4.0 Grading Rubric. RESULTS: A total of 552 potentially relevant data resources were retrieved, of which 34 were identified as eligible for data extraction. Grade B was assigned to four core indicators, grade C to five core indicators, and grade D to one core indicator. The additional Sleep indicator was graded a C-. Compared with the average grades from countries with high Human Development Index scores, Slovakia received higher grades in five core indicators (Overall Physical Activity, Active Transportation, Sedentary Behaviours, School, Government), and in the aggregate Behavioural average and Overall average. Compared with global averages, Slovakia had higher grades in the aforementioned core and aggregate indicators, and in the Community and Environment core indicator and aggregate Sources of Influence average indicator. Numerous surveillance gaps were identified. CONCLUSIONS: The overall grading of the available surveillance data suggests the need for improvement in all 10 surveilled core indicators, and in additional Sleep indicator. Despite the fact that numerous identified surveillance gaps limit the overall informative value of the current grade, they provide the important information needed to enhance surveillance of PA-related indicators in Slovakia. For instance, the focus should be put on younger children and parents, on obtaining the device-measured data on various movement behaviours, on the topic of outdoor physical activities, and policy evaluation.
- Publication type
- Journal Article MeSH
Internet of Medical Things (IoMT) is an emerging subset of Internet of Things (IoT), often called as IoT in healthcare, refers to medical devices and applications with internet connectivity, is exponentially gaining researchers' attention due to its wide-ranging applicability in biomedical systems for Smart Healthcare systems. IoMT facilitates remote health biomedical system and plays a crucial role within the healthcare industry to enhance precision, reliability, consistency and productivity of electronic devices used for various healthcare purposes. It comprises a conceptualized architecture for providing information retrieval strategies to extract the data from patient records using sensors for biomedical analysis and diagnostics against manifold diseases to provide cost-effective medical solutions, quick hospital treatments, and personalized healthcare. This article provides a comprehensive overview of IoMT with special emphasis on its current and future trends used in biomedical systems, such as deep learning, machine learning, blockchains, artificial intelligence, radio frequency identification, and industry 5.0.
- MeSH
- Internet * MeSH
- Humans MeSH
- Reproducibility of Results MeSH
- Machine Learning MeSH
- Artificial Intelligence * MeSH
- Health Facilities MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH