Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)

Tan Min Choon,Yeo Yong Hao,Tham Jia Wei,Tan Jian Liang,Fong Hee Kong,Tan Bryan E-Xin,Lee Kwan S,Lee Justin Z 대한심부전학회 2024 International Journal of Heart Failure Vol.6 No.2

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. 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.

Bioprospecting of Endophytic Fungi as Promising Anti-MRSA Agents

Wei, Yee-Min,Tan, Joo-Shun,Tang, Hock-Wei,Tong, Woei-Yenn,Leong, Chean-Ring,Tan, Wen-Nee The Korean Society of Pharmacognosy 2022 Natural Product Sciences Vol.28 No.3

Methicillin-resistant Staphylococcus aureus (MRSA) is a serious threat to the global healthcare system. Ineffective and resistance to antibiotic treatments have increased morbidity and mortality rates worldwide. New and effective antibiotics are needed to combat against bacterial resistance. Endophytic fungi are crucial reservoirs of novel bioactive metabolites. In particular, the secondary metabolites show promising therapeutic potential, notably, antibacterial. This review discussed the emerging potential of endophytic fungi as anti-MRSA agents. The ecological sources of endophytic fungi were discussed with the synthesis of bioactive metabolites. The mode of antibacterial actions was elucidated to give a better understanding of the mechanisms involved. This review may serve as an important reference for future discovery and developments of anti-MRSA agents from endophytic fungi.

Collapse-resistant performance of a single-story frame assembly and multi-story sub-frame under an internal column-removal scenario

Wei-hui Zhong,Zheng Tan,Li-Min Tian,Bao Meng,Yu-hui Zheng,Shi-chao Daun 국제구조공학회 2021 Steel and Composite Structures, An International J Vol.41 No.5

To elucidate the differences in the collapse behavior between a single-story beam-column assembly and multi-story frame, two 1/3-scale two-bay composite frames, including a single-story composite beam–column assembly and a three-story composite sub-frame, were designed and quasi-statically tested. The load–displacement responses, failure modes, and internal force development of the two frames were analyzed and compared in detail. Furthermore, the resistance mechanisms of the two specimens were explored, and the respective contributions of different load-resisting mechanisms to the total resistances were quantitatively separated to gain deeper insights. The experimental tests indicated that Vierendeel action was present in the two-dimensional multi-story frames, which led to an uneven internal force distribution among the three stories. The collapse resistance of TSDWA-3S in the flexural stage was not significantly increased by the structural redundancy provided by the additional story, as compared to that of TSDWA-1S. Although the development of the load response was similar in the two specimens at flexural stage, the collapse mechanisms of the multi-story composite frame were much more complicated than those of the single-story beam–column assembly, and the combined action between stories was critical in determining the internal force redistribution and rebalancing of the remaining structure.

Improvements in Engineering Properties of Soils through Microbial-Induced Calcite Precipitation

Ng Wei Soon,Lee Min Lee,Tan Chew Khun,Hii Siew Ling 대한토목학회 2013 KSCE JOURNAL OF CIVIL ENGINEERING Vol.17 No.4

Microbial-Induced Calcite Precipitation (MICP) has recently emerged as a sustainable technique for soil improvement. This paper aims to study the effectiveness of MICP in improving the shear strength and reducing the hydraulic conductivity of soils. A species of Bacillus group, B. megaterium was used to trigger the calcite precipitation. The experimental variables included soil types (tropical residual soil and sand), soil densities (85%, 90%, and 95% of their respective maximum densities), and treatment conditions (untreated, treated with cementation reagents only, treated with B. megaterium only, and treated with B. megaterium and cementation reagents). The results showed that MICP could effectively improve shear strength and reduce hydraulic conductivity for both residual soil and sand. The improvements, however, varied with soil densities, soil types, and treatment conditions. With MICP treatment, the improvement ratios in shear strength of the residual soil specimens were significantly higher (1.41-2.64) than those of the sand specimens (1.14-1.25). On the contrary, the sand specimens resulted in greater hydraulic conductivity reduction ratios (0.09-0.15)than those of the residual soil specimens (0.26-0.45). These observations can be explained by the particle-particle contacts per unit volume and pore spaces in the soil specimens. Both soil specimens when treated with cementation reagents only exhibited slight alterations in the shear strength (ranging from 1.06-1.33) and hydraulic conductivity (ranging from 0.69-0.95). The results implied that natural calcite forming microorganisms only exist for insignificant amount. The amount of calcite precipitated in the treated residual soil specimens ranged from 1.080% to 1.889%. The increments of calcite content in the treated sand specimens were comparatively higher, ranging from 2.661% to 6.102%. The results from Scanning Electron Microscope (SEM) analysis confirmed the experimental findings.

Coexistence of osteoporosis, sarcopenia and obesity in community-dwelling adults – The Yishun Study

Benedict Wei Jun Pang,Shiou-Liang Wee,Kenneth Kexun Chen,Lay Khoon Lau,Khalid Abdul Jabbar,Wei Ting Seah,Daniella Hui Min Ng,Queenie Lin Ling Tan,Mallya Ullal Jagadish,Tze Pin Ng 대한골다공증학회 2021 Osteoporosis and Sarcopenia Vol.7 No.1

Objectives: To 1) report prevalence of ‘osteosarcopenia’ (OS) and osteosarcopenic obesity (OSO) entities using evidence-based diagnostic techniques and definitions, 2) examine if OSO offers additional predictive value of functional decline over its components, and 3) identify associated factors in a multi-racial Southeast Asian population. Methods: We performed a cross-sectional study of a representative sample of 542 community-dwelling adults (21e90 years old), and assessed anthropometry, cognition, functional performance, and selfreport sociodemographic, health and lifestyle questionnaires. Low muscle mass, and the Asian Working Group for Sarcopenia (AWGS) 2019 criteria, were used to assess sarcopenia. Obesity was defined using percentage body fat and fat mass index. Osteopenia/osteoporosis was determined using lumbar spinal bone mineral density. Associated factors were examined using logistic regression, and OSO’s value investigated using linear regressions with functional performance. Results: OS and OSO prevalence were 1.8% and 0% (21e59 years), 12.9% and 2.8% ( 60 years), 17.3% and 4.1% ( 65 years), and 25.5% and 7.0% (75 years), respectively. OSO entity as defined was not a significant predictor (P > 0.05) and did not improve explanations for functional decline over sarcopenia or sarcopenic obesity. Age, sex, race and body mass index (BMI) were associated with OS, while age, sex, race and alcoholism were associated with OSO. Conclusions: Our results do not support OSO as a distinct entity in relation to functional decline. Aside from biological age, sex, and race, amenable lifestyle factors such as BMI and alcohol intake are important variables that can influence the co-existence of osteopenia/osteoporosis, sarcopenia and obesity.

Dynamic Reconstruction of Anal Sphincter with Camera Shutter Style Double-Opposing Gracilis Flaps

Wong Allen Wei-Jiat,Tan Grace Hui-Min,Koh Frederick Hong-Xiang,Chew Min Hoe 대한성형외과학회 2023 Archives of Plastic Surgery Vol.50 No.5

Fournier's gangrene is a life-threatening infection which requires prompt recognition, early surgical debridement of unhealthy tissue, and initiation of broad-spectrum antibiotics. Relook debridement are usually performed until all the devitalized tissue has been removed. Involvement of the anal sphincter may result in significant morbidity such as permanent incontinence. Dynamic reconstruction of the anal sphincter has always been one of the holy grails in the field of pelvic reconstruction.We demonstrate a new method of camera shutter style double-opposing gracilis muscle flaps that allows dynamic sphincteric function without the need for electrostimulation. The bilateral gracilis muscles are inset in a fashion that allows orthograde contraction of the muscle to narrow and collapse the neoanal opening. With biofeedback training, the patient is able to regain dynamic continence and return to function without a stoma. There was also no need for neurotization or microsurgery techniques to restore sphincteric function to the anus. The patient was able to reverse his stoma 14 months after the initial insult and reconstruction with biofeedback training without the use of electrostimulation.

Plasma treatment of multi-walled carbon nanotubes for lipase immobilization

Xun Cao,Rui Zhang,Wei-min Tan,Ce Wei,Jing Wang,Ze-meng Liu,Ke-quan Chen,Ping-Kai Ouyang 한국화학공학회 2016 Korean Journal of Chemical Engineering Vol.33 No.5

Plasma-modified multiwalled carbon nanotubes (MWNTs) were used as a support to immobilize lipase. The effects of vacuum plasma treatment power, vacuum plasma treatment time, immobilization temperature, immobilization time, and initial protein concentration of the lipase on the amount of lipase immobilized and on the subsequent activity of the immobilized lipase were investigated. The results showed that the adsorption capacity of the plasma-modified MWNTs could reach 0.15 g/g and that the maximal enzyme activity of the immobilized lipase was 520U/g under optimized conditions. Fourier transform infrared (FTIR) analysis and transmission electron microscopy (TEM) were used to characterize the properties of the plasma-modified MWNTs and plasma-modified MWNTslipase, and the results showed that the lipase was successfully immobilized on the plasma-modified MWNTs. Also, the MWNTs-lipase produced an esterification rate of approximately 47% in the synthesis of polyethylene glycol (PEG)-aliphatic esters.

Parametric Research on Underactuated Tendon-Driven Grasping Mechanism for Space Capture Operation

Jian Tian,Cheng Wei,Min Luo,Ning Wang,Chunlin Tan,Yang Zhao 한국정밀공학회 2020 International Journal of Precision Engineering and Vol.21 No.2

Space objects always stay in rotation mode with various nutation according to their different inertia parameters during free flying. It is hard for designing a grasping mechanism to capture a rotating target with unknown velocity and unknown size. An under-actuated tendon-driven grasping mechanism is designed and researched in this paper, and which could handle the uncertainties during the capturing using its structural flexibility and strong adaption to space unknown rotating objects for taking the advantage of under-actuation. The under-actuated grasping mechanism consists of four fingers, and each finger has four joints, but driven by only one tendon and four pre-designed springs, which make it a typical under-actuated mechanism. The partial feedback linearization method is modified for the control with time varying constraints and the parametric design method is proposed to complete the tracking control of multiple joint angle using a single driven tendon, and which is validated by the simulation of the whole capturing procedure.

High-Conductivity SiO2-Matrix B-Doped Si-NC Thin Films by Following Ion-Beam Treatment

Junjun Huang,Weiyan Wang,Jie Yang,Yongzhen Tan,Wei Chen,Tianyu Ge,Yajun Zhang,Min Gao,Zhenming Chen 대한금속·재료학회 2016 ELECTRONIC MATERIALS LETTERS Vol.12 No.6

In this work, further ion-beam was performed on SiO2-matrix B-doped Si-NC (SBC) thin films in order to enhance conductivity. The effect of ionbeamtype on the electrical properties of SBC thin films was investigatedsystematically. The results indicated that the conductivities of SBC thinfilms were significantly improved by both argon and hydrogen ion-beamtreatments, and the higher the hydrogen ion ratio, the higher theconductivity of SBC thin films. The conductivity of SBC thin films wasincreased from 1.82 × 10−6 S/cm to 3.2 × 10−3 S/cm with followinghydrogen-ion-beam treatment. The change in conductivity of SBC thinfilms was most possibly resultant from the ion-beam treatment facilitatingthe formation of higher superficial order and lower defects. An alternativemethod was proposed to prepare high-conductivity SBC thin films, whichmay be applied to other heterogeneous thin films.

The MARCOPOLO Study of Ustekinumab Utilization and Efficacy in a Real-World Setting: Treatment of Patients with Plaque Psoriasis in Asia-Pacific Countries

( Sang Woong Youn ),( Tsen Fang Tsai ),( Colin Theng ),( Siew Eng Choon ),( Benny E. Wiryadi ),( Antonio Pires ),( Wei Hao Tan ),( Min Geol Lee ) 대한피부과학회 2016 Annals of Dermatology Vol.28 No.2

Background: Ustekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response. Objective: To evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries. Methods: In this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events. Results: Overall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies. Conclusion: More than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results.(Ann Dermatol 28(2) 222∼231, 2016)