Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453).The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Wound healing is a dynamic process that involves a series of molecular and cellular events aimed at replacing devitalized and missing cellular components and/or tissue layers. Recently, extracellular vesicles (EVs), naturally cell-secreted lipid membrane-bound vesicles laden with biological cargos including proteins, lipids, and nucleic acids, have drawn wide attention due to their ability to promote wound healing and tissue regeneration. However, current exploitation of EVs as therapeutic agents is limited by their low isolation yields and tedious isolation processes. To circumvent these challenges, bioinspired cell-derived nanovesicles (CDNs) that mimic EVs were obtained by shearing mesenchymal stem cells (MSCs) through membranes with different pore sizes. Physical characterisations and high-throughput proteomics confirmed that MSC-CDNs mimicked MSC-EVs. Moreover, these MSC-CDNs were efficiently uptaken by human dermal fibroblasts and demonstrated a dose-dependent activation of MAPK signalling pathway, resulting in enhancement of cell proliferation, cell migration, secretion of growth factors and extracellular matrix proteins, which all promoted tissue regeneration. Of note, MSC-CDNs enhanced angiogenesis in human dermal microvascular endothelial cells in a 3D PEG-fibrin scaffold and animal model, accelerating wound healing in vitro and in vivo. These findings suggest that MSC-CDNs could replace both whole cells and EVs in promoting wound healing and tissue regeneration.

Introduction: Untreated iron deficiency (ID) can lead to severe anaemia, requiring blood transfusion, or increased mortality risk. Globally intravenous (IV) iron is increasingly recognised as a recommended option for patients. This study aims to evaluate the budget impact associated with introducing a new intravenous (IV) iron, ferric derisomaltose (Monofer® [IIM]) as one of the treatment options for the management of ID in the Ministry of Health Malaysia (MOHM) setting. Methods: A 5-year budget impact model was developed from 2020 to 2024 for patients with ID that require a high iron dose (≥500 mg), using the perspective of MOHM. The model was built with four external medical specialists, each with experience and deep knowledge of ID management, to support estimations on the future development of iron use in Malaysia. Results: Compared to the current market mix with the existing IV iron products (i.e., iron sucrose and iron dextran), a cost-saving of MYR 53,910 could be achieved with the introduction of IIM in 2020. The uptake of IIM into MOHM over five years is estimated to lead to an overall budget saving of MYR 11,837,524 over a 5-year time horizon. Conclusion: The use of IIM in place of the current IV iron products in MOHM resulted in a significant cost saving by reducing the number of visits required to achieve the targeted iron dose and the shorter IV infusion time with IIM.

Humans ; COVID-19/epidemiology* ; Pandemics ; Orthopedics ; Orthopedic Procedures ; Telemedicine

COVID-19 ; Dermatology ; Humans ; Inpatients ; SARS-CoV-2 ; Singapore

The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn's and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn's disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.
Adalimumab ; Asia ; Asian Continental Ancestry Group ; Biological Factors ; Biosimilar Pharmaceuticals ; Colitis ; Colitis, Ulcerative ; Consensus ; Cooperative Behavior ; Crohn Disease ; Gastroenterology ; Hepatitis B ; Humans ; Immunologic Factors ; Inflammatory Bowel Diseases ; Infliximab ; Pharmacogenetics ; Philippines ; Practice Guidelines as Topic ; Tuberculosis ; Ulcer

Background: Vitamin D deficiency has been shown to be a determinant of disease severity in patients with atopic dermatitis (AD). There is a lack of information on the prevalence of vitamin D deficiency in Malaysian children with AD. The objective of this study was to determine the association of vitamin D deficiency with AD severity, to compare vitamin D deficiency between children with and without AD and to determine prevalence of vitamin D deficiency in children with AD. Methods: A case-control study to examine serum 25- hydroxyvitamin D [25(OH)D] levels in children with and without AD was done. Serum 25-hydroxyvitamin D [25(OH)D] level was measured by immunoassay. AD severity was evaluated using the SCORing Atopic Dermatitis (SCORAD) index. Results: The serum levels of 25(OH)D, measured in 135 children with AD was not statistically different from 65 children without AD [median (IQR): 25.2ng/mL (15.45) vs 25.9ng/mL (15.87), p=0.616]. However, serum vitamin D levels were significantly lower in children with severe AD compared to those with mild-to-moderate AD [median (IQR): 16.0ng/mL (19.32) vs 26.3ng/mL (15.56), p=0.021]. The odds of having vitamin D deficiency in children with severe AD was 3.82 times that of children with non-severe AD (95% confidence level: 1.13, 12.87). Conclusion: This study suggests that there is an inverse association between vitamin D level and the severity of AD in Malaysian children.

Hoarding refers to an excessive acquisition of objects and inability to part with apparently valueless possessions. While it can lead to excessive clutter, distress and disability, it is important to note that not all cases of hoarding are pathological. This article aims to suggest how one can make recommendations to patients and families when they encounter someone exhibiting hoarding behaviour. It also introduces the Hoarding Task Force and relevant legislation in Singapore to address the issue of hoarding in the community.
Government Agencies ; Hoarding Disorder ; diagnosis ; epidemiology ; Humans ; Referral and Consultation ; Residence Characteristics ; Safety ; Singapore