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The Journal of Innovations in Cardiac... Jun 2024Atrial fibrillation (AF) is a prevalent cardiac arrhythmia marked by irregular and frequent tachycardic rhythms in the atria, affecting 1%-2% of the general population.... (Review)
Review
Comparative Profiles of the WATCHMAN™ and Amplatzer™ Cardiac Plug/Amplatzer™ Amulet™ Devices for Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation: A Comprehensive Systematic Review and Meta-analysis.
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia marked by irregular and frequent tachycardic rhythms in the atria, affecting 1%-2% of the general population. The WATCHMAN™ device from Boston Scientific (Marlborough, MA, USA) and the Amplatzer™ Amulet™ device from Abbott (Chicago, IL, USA) are two devices used globally for left atrial appendage closure (LAAC) in non-valvular AF. A systematic search was conducted in PubMed, the Cochrane Library, and Elsevier's ScienceDirect literature databases to identify studies comparing the WATCHMAN™ procedure with Amulet™ device implantation for LAAC in patients with AF. The analyses were conducted using the random-effects model. A total of 20 studies were identified, with 18 falling into the category of observational studies and 2 being randomized controlled trials. A total of 6310 participants were included in this meta-analysis, with 3198 individuals (50.68%) assigned to the WATCHMAN™ procedure group and 3112 individuals (49.32%) allocated to the Amplatzer™ Cardiac Plug (ACP) group. The analysis revealed a higher risk of stroke associated with the WATCHMAN™ technique (relative risk [RR], 1.14), albeit without statistical significance. Conversely, the WATCHMAN™ approach led to a significantly lower risk of cardiac death (RR, 0.44; = .04). Notably, the risks of all-cause mortality (RR, 0.89; 95% confidence interval [CI], 0.73-1.08; = 0%; = .25) and major bleeding (RR, 0.93; 95% CI, 0.65-1.33; = 31%; = .70) were clinically reduced with the WATCHMAN™ procedure, although statistical significance was not achieved. Compared to Amulet™ device implantation, WATCHMAN™ device implantation decreased the risk of cardiac mortality, while the risks of stroke, systemic embolism, all-cause mortality, and major bleeding were not statistically significant.
PubMed: 38948665
DOI: 10.19102/icrm.2024.15061 -
Sichuan Da Xue Xue Bao. Yi Xue Ban =... May 2024Ultrasound diagnosis and treatment is easy to perform and takes little time. It is widely used in clinical practice thanks to its non-invasive, real-time, and dynamic...
OBJECTIVE
Ultrasound diagnosis and treatment is easy to perform and takes little time. It is widely used in clinical practice thanks to its non-invasive, real-time, and dynamic characteristics. In the process of ultrasound diagnosis and treatment, the probe may come into contact with the skin, the mucous membranes, and even the sterile parts of the body. However, it is difficult to achieve effective real-time disinfection of the probes after use and the probes are often reused, leading to the possibility of the probes carrying multiple pathogenic bacteria. At present, the processing methods for probes at home and abroad mainly include probe cleaning, probe disinfection, and physical isolation (using probe covers or sheaths). Yet, each approach has its limitations and cannot completely prevent probe contamination and infections caused by ultrasound diagnosis and treatment. For example, when condoms are used as the probe sheath, the rate of condom breakage is relatively high. The cutting and fixing of cling film or freezer bags involves complicated procedures and is difficult to perform. Disposable plastic gloves are prone to falling off and causing contamination and are hence not in compliance with the principles of sterility. Furthermore, the imaging effect of disposable plastic gloves is poor. Therefore, there is an urgent need to explore new materials to make probe covers that can not only wrap tightly around the ultrasound probe, but also help achieve effective protection and rapid reuse. Based on the concept of physical barriers, we developed in this study a heat sealing system for the rapid reuse of ultrasound probes. The system uses a heat sealing device to shrink the protective film so that it wraps tightly against the surface of the ultrasound probe, allowing for the rapid reuse of the probe while reducing the risk of nosocomial infections. The purpose of this study is to design a heat sealing system for the rapid reuse of ultrasound probes and to verify its application effect on the rapid reuse of ultrasound probes.
METHODS
1) The heat sealing system for the rapid reuse of ultrasound probes was designed and tested by integrating medical and engineering methods. The system included a protective film (a multilayer co-extruded polyolefin thermal shrinkable film) and a heat sealing device, which included heating wire components, a blower, a photoelectric switch, temperature sensors, a control and drive circuit board, etc. According to the principle of thermal shrinkage, the ultrasound probe equipped with thermal shrinkable film was rapidly heated and the film would wrap closely around the ultrasound probe placed on the top of the heat sealing machine. The ultrasound probe was ready for use after the thermal shrinkage process finished. Temperature sensors were installed on the surface of the probe to test the thermal insulation performance of the system. The operation procedures of the system are as follows: placing the ultrasound probe covered with the protective film in a certain space above the protective air vent, which is detected by the photoelectric switch; the heating device heats the thermal shrinkable film with a constant flow of hot air at a set temperature value. Then, the probe is rotated so that the thermal shrinkable film will quickly wrap around the ultrasound probe. After the heat shrinking is completed, the probe can be used directly. 2) Using the convenience sampling method, 90 patients from the Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Xi'an Jiaotong University were included as the research subjects. All patients were going to undergo arterial puncture under ultrasound guidance. The subjects were divided into 3 groups, with 30 patients in each group. Three measures commonly applied in clinical practice were used to process the probes in the three groups and water-soluble fluorescent labeling was applied around the puncture site before use. In the experimental group, the probes were processed with the heat sealing system. The standard operating procedures of the heat sealing system for rapid reuse of ultrasonic probes were performed to cover the ultrasonic probe and form a physical barrier to prevent probe contamination. There were two control groups. In control group 1, disinfection wipes containing double-chain quaternary ammonium salt were used to repeatedly wipe the surface of the probe for 10-15 times, and then the probe was ready for use once it dried up. In the control group 2, a disposable protective sheath was used to cover the front end of the probe and the handle end of the sheath was tied up with threads. Comparison of the water-soluble fluorescent labeling on the surface of the probe (which reflected the colony residues on the surface of the probe) before and after use and the reuse time (i.e., the lapse of time from the end of the first use to the beginning of the second use) were made between the experimental group and the two control groups.
RESULTS
1) The temperature inside the ultrasound probe was below 40 ℃ and the heat sealing system for rapid reuse did not affect the performance of the ultrasound probe. 2) The reuse time in the heat sealing system group, as represented by (median [P, P]), was (8.00 [7.00, 10.00]) s, which was significantly lower than those of the disinfection wipe group at (95.50 [8.00, 214.00]) s and the protective sleeve group at (25.00 [8.00, 51.00]) s, with the differences being statistically significant (<0.05). No fluorescence residue was found on the probe in either the heat sealing system group or the protective sheath group after use. The fluorescence residue in the heat sealing system group was significantly lower than that in the disinfection wipes group, showing statistically significant differences ( =45.882, <0.05).
CONCLUSION
The thermal shrinkable film designed and developed in this study can be cut and trimmed according to the size of the equipment. When the film is heated, it shrinks and wraps tightly around the equipment, forming a sturdy protective layer. With the heat sealing system for rapid reuse of ultrasonic probes, we have realized the semi-automatic connection between the thermal shrinkable film and the heating device, reducing the amount of time-consuming and complicated manual operation. Furthermore, the average reuse time is shortened and the system is easy to use, which contributes to improvements in the reuse and operation efficiency of ultrasound probes. The heat sealing system reduces colony residues on the surface of the probe and forms an effective physical barrier on the probe. No probes were damaged in the study. The heat sealing system for rapid reuse of ultrasonic probes can be used as a new method to process the ultrasonic probes.
PubMed: 38948302
DOI: 10.12182/20240560202 -
Regenerative Therapy Jun 2024Skeletal muscle injury (SMI) is often treated conservatively, although it can lead to scar tissue formation, which impedes muscle function and increases muscle re-injury...
BACKGROUND
Skeletal muscle injury (SMI) is often treated conservatively, although it can lead to scar tissue formation, which impedes muscle function and increases muscle re-injury risk. However, effective interventions for SMIs are yet to be established.
HYPOTHESIS
The administration of Silk Elastin® (SE), a novel artificial protein, to the SMI site can suppress scar formation and promote tissue repair.
STUDY DESIGN
A controlled laboratory study.
METHODS
: Fibroblast migration ability was assessed using a scratch assay. SE solution was added to the culture medium, and the fibroblast migration ability was compared across different concentrations. : An SMI model was established with Sprague-Dawley rats, which were assigned to three groups based on the material injected to the SMI site: SE gel (SE group; n = 8), atelocollagen gel (Atelo group; n = 8), and phosphate buffer saline (PBS group; n = 8). Histological evaluations were performed at weeks 1 and 4 following the SMI induction. In the 1-week model, we detected the expression of transforming growth factor (TGF)-β1 in the stroma using immunohistological evaluation and real-time polymerase chain reaction analysis. In the 4-week model, we measured tibialis anterior muscle strength upon peroneal nerve stimulation as a functional assessment.
RESULTS
: The fibroblast migration ability was suppressed by SE added at a concentration of 10⁴ μg/mL in the culture medium. : In the 1-week model, the SE group exhibited significantly lower TGFβ -1 expression than the PBS group. In the 4-week model, the SE group had a significantly larger regenerated muscle fiber diameter and smaller scar formation area ratio than the other two groups. Moreover, the SE group was superior to the other two groups in terms of regenerative muscle strength.
CONCLUSION
Injection of SE gel to the SMI site may inhibit tissue scarring by reducing excessive fibroblast migration, thereby enhancing tissue repair.
CLINICAL RELEVANCE
The findings of this study may contribute to the development of an early intervention method for SMIs.
PubMed: 38948131
DOI: 10.1016/j.reth.2024.05.012 -
Cureus May 2024Left atrial appendage occlusion (LAAO) devices have emerged as a promising alternative for stroke prevention in non-valvular atrial fibrillation...
Left atrial appendage occlusion (LAAO) devices have emerged as a promising alternative for stroke prevention in non-valvular atrial fibrillation (NVAF) patients with contraindications to chronic anticoagulation therapy. The most common life-threatening procedural complications described in the literature include pericardial effusion, air embolism, and stroke. We here present a case report of two patients who experienced identical but rare post-procedural complications of pulmonary venous bleed, presenting as hemoptysis.
PubMed: 38947731
DOI: 10.7759/cureus.61451 -
Cureus May 2024Proximal femur fractures are common in older patients and typically require surgical treatment, with cephalomedullary nails being the gold standard device for this...
INTRODUCTION
Proximal femur fractures are common in older patients and typically require surgical treatment, with cephalomedullary nails being the gold standard device for this approach. This study aimed to identify the factors associated with the failure of cephalomedullary nailing.
MATERIALS AND METHODS
We retrospectively evaluated 380 patients treated with a cephalomedullary nail between August 2021 and August 2022 in a trauma referral center in Brazil. A total of 221 (58.1%) patients were included in the study after applying specific eligibility criteria. Data were collected and rates were determined by reviewing patients' medical records and radiographs.
RESULTS
Of 221 patients, 14 (6.3%) had nail failures A significant association was found between post-fixation cervico-diaphyseal angle and the occurrence of nail failure (p<0.001). Furthermore, calcar-referenced tip-apex distance (CalTAD) and tip-apex distance (TAD) values were higher in cases with nail failure than in those without nail failure. Cutoff points were established for TAD and CalTAD to measure the correspondence with nail failures.
CONCLUSION
The present study supports previous evidence that varus reduction potentially causes collapse and nail failure in pertrochanteric fractures treated with cephalomedullary nailing and that high TAD and CalTAD values contribute to the incidence of cut-out.
PubMed: 38947728
DOI: 10.7759/cureus.61363 -
Cureus May 2024Rhinomanometry is a pivotal diagnostic technique in rhinology, providing a quantitative assessment of nasal airflow and resistance. This review comprehensively examines... (Review)
Review
Rhinomanometry is a pivotal diagnostic technique in rhinology, providing a quantitative assessment of nasal airflow and resistance. This review comprehensively examines the historical development, principles and clinical applications of rhinomanometry, emphasising its role in diagnosing nasal obstructions, preoperative evaluations and monitoring therapeutic outcomes. Recent advancements, including the integration with imaging technologies and the application of artificial intelligence (AI), have significantly enhanced the accuracy and utility of rhinomanometry. Despite facing challenges such as technical limitations and the need for standardisation, rhinomanometry remains an invaluable tool in both clinical and research settings. The review also explores future directions, highlighting the potential for device miniaturisation, telemedicine integration, personalised protocols and collaborative research efforts. These advancements will likely expand the accessibility, accuracy and clinical relevance of rhinomanometry, solidifying its importance in the ongoing evolution of rhinology practice.
PubMed: 38947630
DOI: 10.7759/cureus.61370 -
Cureus May 2024Both public and academic scrutiny of the financial relationships between the medical device industry and the healthcare society occur less frequently than those...
Both public and academic scrutiny of the financial relationships between the medical device industry and the healthcare society occur less frequently than those involving the pharmaceutical industry, and Japan is no exception to these shortcomings. This paper examines the ethical and legal challenges inherent in Japan's medical device industry through the lens of bribery scandals, placing these issues within the broader context of global healthcare corruption. It aims to derive lessons and suggest universal strategies for ethical and legal enhancements. The discussion includes two notable cases: one involving inappropriate transactions between a cancer center and a biliary stent manufacturer, and another concerning a corrupt donation scheme between a medical device company and a university's anesthesiology department, which was found guilty. In our analysis, we also acknowledge the industry's efforts toward compliance and reform to maintain a balanced perspective. The analysis not only highlights the unique culture and structure of the Japanese medical device industry, such as the exploitation of flexible pricing and opaque financial practices but also contrasts these issues with the tightly regulated pharmaceutical industry. This approach reveals both sector-specific challenges and common corruption drivers, enhancing our understanding of why such scandals occur and persist. We propose ethical and compliance-focused business measures such as centralizing donation decisions, limiting the financial independence of marketing divisions, and increasing transparency, alongside adopting mandatory disclosure practices based on successful models from the United States and Europe. By emphasizing integrity and presenting diverse perspectives, this study aims to elevate ethical and legal standards in the medical device industry and improve patient health outcomes worldwide.
PubMed: 38947609
DOI: 10.7759/cureus.61285 -
IDCases 2024Infections associated with healthcare manipulations, particularly bloodstream infections stemming from catheters and medical devices, significantly heighten the...
Infections associated with healthcare manipulations, particularly bloodstream infections stemming from catheters and medical devices, significantly heighten the probability of vertebral osteomyelitis. The diagnosis of infective endocarditis (IE) frequently overlaps with vertebral osteomyelitis (VO). In cases where individuals are suspected of having hematogenous vertebral osteomyelitis and have an intravascular catheter or device, it is recommended to undertake blood culture collection. We present a case of a 39-year-old male with a history of interventional AVM embolization and cerebral angiography, experiencing recurrent vertebral osteomyelitis. No definitive source of infection had been found, and transthoracic echocardiography (TTE) yielded negative results for IE. In Trans Esophageal Echocardiography (TEE), a retained micro-catheter extending from the aortic arch to the inguinal artery was discovered. Although we cannot definitively attribute the source of the osteomyelitis to the retained micro-catheter, no episodes of infection have been reported ever since. This case underscores the need to enhance our approaches and guidelines related to operating protocols in the surgical setting. Improving these guidelines can prevent similar occurrences in the future, emphasizing the importance of continuous improvement in healthcare practices.
PubMed: 38947558
DOI: 10.1016/j.idcr.2024.e02005 -
Infection and Drug Resistance 2024Contact lenses (CL) have become an immensely popular means of vision correction, offering comfort to millions worldwide. However, the persistent issue of biofilm... (Review)
Review
Contact lenses (CL) have become an immensely popular means of vision correction, offering comfort to millions worldwide. However, the persistent issue of biofilm formation on lenses raises significant problems, leading to various ocular complications and discomfort. The aim of this review is to develop safer and more effective strategies for preventing and managing microbial biofilms on CL, improving the eye health and comfort of wearers. Taking these into consideration, the present study investigates the intricate mechanisms of biofilm formation, by exploring the interplay between microbial adhesion, the production of extracellular polymeric substances, and the properties of the lens material itself. Moreover, it emphasizes the diverse range of microorganisms involved, encompassing bacteria, fungi, and other opportunistic pathogens, elucidating their implications within lenses and other medical device-related infections and inflammatory responses. Going beyond the challenges posed by biofilms on CL, this work explores the advancements in biofilm detection techniques and their clinical relevance. It discusses diagnostic tools like confocal microscopy, genetic assays, and emerging technologies, assessing their capacity to identify and quantify biofilm-related infections. Finally, the paper delves into contemporary strategies and innovative approaches for managing and preventing biofilms development on CL. In Conclusion, this review provides insights for eye care practitioners, lens manufacturers, and microbiology researchers. It highlights the intricate interactions between biofilms and CL, serving as a foundation for the development of effective preventive measures and innovative solutions to enhance CL safety, comfort, and overall ocular health. Research into microbial biofilms on CL is continuously evolving, with several future directions being explored to address challenges and improve eye health outcomes as far as CL wearers are concerned.
PubMed: 38947374
DOI: 10.2147/IDR.S463779 -
Health Care Science Jun 2024The medical device and pharmaceutical industries include a range of drugs, machines, instruments, and apparatuses used to prevent, diagnose, treat disease and illness,... (Review)
Review
The medical device and pharmaceutical industries include a range of drugs, machines, instruments, and apparatuses used to prevent, diagnose, treat disease and illness, or aid in rehabilitation for patients, and are expected to grow substantially in the coming years. However, they are often targets of criminal organizations who manufacture and profit from fraudulent products, infiltrating the market with counterfeit medical supply chains. In this paper, we discuss and analyze the extent and nature of this problem and make suggestions for mitigation and prevention of this worldwide challenge. Ultimately, we argue that a holistic approach is essential to addressing this problem, including the creation and dissemination of reliable and good quality data, developing healthcare systems to be more robust, establishing/enhancing intra- and international cooperation around this issue, and employing effective technological solutions, such as digital tracing.
PubMed: 38947363
DOI: 10.1002/hcs2.97