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.

Protective effect of procyanidin B2 on hydrogen peroxide (H2O2)-induced oxidative damage in MCF-7 cells

Tan Jia-qi,Li Peng-cheng,Li Qian,Tang Jin-tian,Xue Hong-kun 한국응용생명화학회 2020 Applied Biological Chemistry (Appl Biol Chem) Vol.63 No.5

The aim of this study is to assess the cytoprotection and potential molecular mechanisms of procyanidin B2 ( PCB2) on hydrogen peroxide ( H2O2)-induced oxidative damage in MCF-7 cells. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay was performed to determine the viability of MCF-7 cell exposure to H2O2 or PCB2. We measured the antioxidant properties of PCB2 by determining the activities of SOD, GSH-Px, LDH and MDA levels, and evaluated apoptosis and intracellular reactive oxygen species (ROS) levels. The related proteins expression levels were monitored by Western blot. MCF-7 cells induced with H2O2 had a remarkable decrease in cell viability that was suppressed when it was interfered with PCB2 (0.1–10.0 μM). PCB2 interference memorably and dose-dependently inhibited H2O2- induced LDH leakage, ROS and MDA overproduction, while PCB2 markedly increased H2O2- induced the activities of SOD and GSH-Px. Eventually, H2O2 prominently down-regulated the ratio of Bcl-2/Bax and the relative proteins expression levels of Nrf2, GCLC, NQO1 and HO-1, and up-regulated the relative proteins expression levels of cytochrome c, caspase-3 and Keap1. However, the relative expression levels of these proteins were reversed in PCB2- interfered MCF-7 cells. This study implied that protective effect of PCB2 on H2O2- induced oxidative damage in MCF-7 cells might be related to inhibition of mitochondria-dependent apoptosis, activation of Keap1/Nrf2/HO-1 signaling pathway and improvement of the antioxidant enzymes activities.

Venous thromboembolism among Asian populations with localized colorectal cancer undergoing curative resection: is pharmacological thromboprophylaxis required? A systematic review and meta-analysis

Tan Shih Jia Janice,Tan Emile Kwong-Wei,Ng Yvonne Ying Ru,Sultana Rehena,Allen John Carson,Seow-En Isaac,Mathew Ronnie,Chok Aik Yong 대한대장항문학회 2024 Annals of Coloproctolgy Vol.40 No.3

Purpose: We compared the incidence of venous thromboembolism (VTE) among Asian populations with localized colorectal cancer undergoing curative resection with and without the use of pharmacological thromboprophylaxis (PTP).Methods: A comprehensive literature search was undertaken to identify relevant studies published from January 1, 1980 to February 28, 2022. The inclusion criteria were patients who underwent primary tumor resection for localized nonmetastatic colorectal cancer; an Asian population or studies conducted in an Asian country; randomized controlled trials, case-control studies, or cohort studies; and the incidence of symptomatic VTE, deep vein thrombosis, and/or pulmonary embolism as the primary study outcomes. Data were pooled using a random-effects model. This study was registered in PROSPERO on October 11, 2020 (No. CRD42020206793).Results: Seven studies (2 randomized controlled trials and 5 observational cohort studies) were included, encompassing 5,302 patients. The overall incidence of VTE was 1.4%. The use of PTP did not significantly reduce overall VTE incidence: 1.1% (95% confidence interval [CI], 0%–3.1%) versus 1.9% (95% CI, 0.3%–4.4%; P = 0.55). Similarly, PTP was not associated with significantly lower rates of symptomatic VTE, proximal deep vein thrombosis, or pulmonary embolism.Conclusion: The benefit of PTP in reducing VTE incidence among Asian patients undergoing curative resection for localized colorectal cancer has not been clearly established. The decision to administer PTP should be evaluated on a case-bycase basis and with consideration of associated bleeding risks.

淺朝鮮半島변文述略

담가건 ( Jia Jian Tan ) 한국중국산문학회 2015 중국산문연구집간 Vol.5 No.-

Korean Peninsula lies to the east of China. In its history, significant anthologies like Parallel Prose of Koreans(Dong Ren Zhi Wen Si Liu), Anthology of Korean Prose(Dong Wen Xuan) and so on to a large extent reflect the achievements of parallel prose. As early as 470s, a few of parallel prose written by Baekje civil officials were still in existence. Since then, eminent figures came forth with large numbers, and over a thousand year, parallel prose can be found in the collected works of literati in large quantities. The achievements of Ancient Korean parallel prose embody the affiliation shared by Chinese and Korean culture traditions. Furthermore, these works enjoy multiple document value out of their extensive concern for politics, diplomacy, learning and aesthetic.

Alternating Hemiplegia of Childhood in a Person of Malay Ethnicity with Diffusion Tensor Imaging Abnormalities

Ai Huey Tan,Tien Lee Ong,Norlisah Ramli,Li Kuo Tan,Jia Lun Lim,Mohamad Addin Azhan,Azlina Ahmad Annuar,Khairul Azmi Ibrahim,Zariah Abdul-Aziz,Laurie J. Ozelius,Allison Brashear,Shen-Yang LIM 대한파킨슨병및이상운동질환학회 2019 Journal Of Movement Disorders Vol.12 No.2

Alternating hemiplegia of childhood (AHC) is a rare neurodevelopmentaldisorder with an incidence of one per million,characterized by paroxysmal alternating hemiplegia, eye movementabnormalities, dystonia, and epilepsy.1 In 2012, mutationsin the ATP1A3 gene encoding the Na+-K+-ATPase α3 subunit(originally discovered in rapid-onset dystonia-parkinsonism)were identified as the cause for AHC.1,2 However, the diagnosisof AHC is still often delayed or missed. We report a case of AHCdiagnosed in adulthood; to our knowledge, this is the first reportin a person of Malay ethnicity.

Systematic review: total knee arthroplasty (TKA) in patients with pigmented villonodular synovitis (PVNS)

( Yi Chuen Tan ),( Jia Yin Tan ),( Konstantinos Tsitskaris ) 대한슬관절학회 2021 대한슬관절학회지 Vol.33 No.-

Background: To determine the functional outcomes, complications and revision rates following total knee arthroplasty (TKA) in patients with pigmented villonodular synovitis (PVNS). Materials and methods: We conducted a systematic review of the literature. Five studies with a total of 552 TKAs were included for analysis. The methodological quality of the articles was evaluated using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) scale. Functional outcomes, complications and revision rates were assessed. The mean age was 61 years (range 33-94 years) and the mean follow-up period was 61.1 months (range 0.2-35 years). Results: All the studies reported improvement in knee function following TKA. Post-operative stiffness was the most frequently reported complication, affecting 32.7% (n = 32) of patients in our review. Symptomatic recurrence of PVNS, component loosening, tibial-component fracture, instability and periprosthetic infection were the main factors leading to the need for revision TKA. Conclusion: The findings of this review support the use of TKA to alleviate the functional limitations and pain due to knee degeneration in patients with PVNS. The operating surgeon should be aware of the increased risk of postoperative stiffness, as well as a potentially higher risk of infection. Implant survival should also be considered inferior to the one expected for the general population undergoing TKA.

Laboratory Measurement of Stress-dependent Fluid Flow Capability of Intact Slates, Foliations and Artificially Generated Fractures

( Jia-jyun Dong ),( Xuan-xinh Nguyen ),( Tan-minh Le ),( Che-wei Yeh ) 대한지질공학회 2024 대한지질공학회 학술발표회논문집 Vol.2024 No.1

Sound absorption coefficient measurement and analysis of bio-composite micro perforated panel (BC-MPP)

Tan Wei Hong,Faridah Wahab,Lee Jia Jian,Siti Hajar Ishak 대한기계학회 2023 JOURNAL OF MECHANICAL SCIENCE AND TECHNOLOGY Vol.37 No.7

The sound absorption performance of bio-composite micro-perforated panel (BC-MPP) made from composite polypropylene (PP) filled rice husk (PP/RH), and coconut coir (PP/CC) is presented. The sound absorption coefficient (SAC) of BC-MPP was obtained via the impedance tube two-microphone method, and the investigation was according to types of fillers, filler compositions, perforation ratio, and the air gap size. It was found that the SAC of BCMPP PP/RH provides a higher SAC value than BC-MPP PP/CC. Furthermore, the SAC peak was observed to shift to the lower frequency spectrum when there was an increment in filler content, the distance between the perforation, and the air gap size. The SAC value from the simulation also shows a good agreement with the experimental result.

Effect of 3.7 at% F doping on the atomic structure and reducibility of CeO2(111) surface: A first principles calculation

Jia Huiling,Hu Jinbao,Chen Hao,Wu Jinxiu,Tan Xin,Sun Shiyang 한국물리학회 2022 Current Applied Physics Vol.43 No.-

Density functional theory calculations was conducted to clarify effect of fluorination on the reducibility of CeO2 polishing powder. The atomic structure and O vacancy formation energy of F-doped CeO2(111) surface were systematically calculated, and electronic structure was also analyzed to understand the calculation results. It showed that the CeO1.963(111) surface needs absorb 7.853 eV to be reduced further, so it is difficult to generate the second O vacancy (V2). After fluorination, the first O vacancy (V1) in CeO1.926F0.037(111) surface caused adjacent atoms to move significantly, and O vacancy formation energy decreased to 2.913 eV, which promoted the formation of V2. Moreover, electronic structure calculation also showed that the interaction between O2p and Ce4f5d orbits was enhanced in reduced CeO1.963(111) surface, which hindered the formation of V2. The F2p orbit in CeO1.926F0.037(111) surface moved towards the low energy level, V1 made the reduced surface stable and promoted the formation of V2.

Fecal Calprotectin in Parkinson’s Disease and Multiple System Atrophy

Jia Wei Hor,Ai Huey Tan 대한파킨슨병및이상운동질환학회 2022 Journal Of Movement Disorders Vol.15 No.2

Converging evidence suggests that intestinal inflammation is involved in the pathogenesis of neurodegenerative diseases. Previous studies on fecal calprotectin in Parkinson’s disease (PD) were limited by small sample sizes, and literature regarding intestinal inflammation in multiple system atrophy (MSA) is very scarce. We investigated the levels of fecal calprotectin, a marker of intestinal inflammation, in PD and MSA.