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      • 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.

      • Relation between Ki-67, ER, PR, Her2/neu, p21, EGFR, and TOP II-α Expression in Invasive Ductal Breast Cancer Patients and Correlations with Prognosis

        Yan, Jian,Liu, Xiao-Long,Han, Lu-Zhe,Xiao, Gang,Li, Ning-Lei,Deng, Yi-Nan,Yin, Liang-Chun,Ling, Li-Juan,Yu, Xiao-Yuan,Tan, Can-Liang,Huang, Xiao-Ping,Liu, Li-Xin Asian Pacific Journal of Cancer Prevention 2015 Asian Pacific journal of cancer prevention Vol.16 No.2

        The aim of the present study was to investigate the expression of the transcription factor Ki-67, ER, PR, Her2/neu, p21, EGFR, and TOP II-${\alpha}$ in the tumor tissue of patients with invasive ductal carcinoma(IDC); in addition, we examined correlations between these markers. Two hundred and sixteen IDC patients, who were not previously been treated with chemo- or radiotherapy, were included in the study. All tumors were grade I-III. Expression of molecular markers was determined by immunohistochemical analysis on paraffin-embedded tissue sections. Follow-up data were collected for 3 months to 10 years and analyzed for tumor recurrence, survival time, and prognostic risk factors. We determined Ki-67 expression correlates with the expression of ER, PR, HER-2, EGFR, and TOP-${\alpha}$, as well as lymph node involvement, high tumor grade, lymphovascular invasion, high tumor stage, and high TNM stage in IDC. Positive Ki-67 expression was a risk factor for rapid tumor recurrence and may help tumor progression, leading to poor prognosis in IDC. Ki-67 was directly correlated with EGFR, TOP II-${\alpha}$, lymph node involvement, high tumor grade, lymphovascular invasion, high tumor stage, and high TNM stage in the hormone receptor subtypes of breast cancer. In triple negative breast cancer, Ki-67 correlated with TOP II-${\alpha}$. Expression of Ki-67 correlated with that of ER, PR, HER-2, EGFR, TOP II-${\alpha}$, and p21. In addition, the biomarker Ki-67 has a role as a prognostic factor and indicates a poor prognosis in IDC.

      • KCI등재

        THE LINEAR 2-ARBORICITY OF PLANAR GRAPHS WITHOUT ADJACENT SHORT CYCLES

        Hong-Yu Chen,Xiang Tan,Jian-Liang Wu 대한수학회 2012 대한수학회보 Vol.49 No.1

        Let G be a planar graph with maximum degree Δ. The linear 2-arboricity $la_2$(G) of G is the least integer k such that G can be partitioned into k edge-disjoint forests, whose component trees are paths of length at most 2. In this paper, we prove that (1) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+8$ if G has no adjacent 3-cycles; (2) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+10$ if G has no adjacent 4-cycles; (3) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+6$ if any 3-cycle is not adjacent to a 4-cycle of G.

      • SCIESCOPUSKCI등재

        THE LINEAR 2-ARBORICITY OF PLANAR GRAPHS WITHOUT ADJACENT SHORT CYCLES

        Chen, Hong-Yu,Tan, Xiang,Wu, Jian-Liang Korean Mathematical Society 2012 대한수학회보 Vol.49 No.1

        Let G be a planar graph with maximum degree $\Delta$. The linear 2-arboricity $la_2$(G) of G is the least integer k such that G can be partitioned into k edge-disjoint forests, whose component trees are paths of length at most 2. In this paper, we prove that (1) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+8$ if G has no adjacent 3-cycles; (2) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+10$ if G has no adjacent 4-cycles; (3) $la_2(G){\leq}{\lceil}\frac{\Delta}{2}\rceil+6$ if any 3-cycle is not adjacent to a 4-cycle of G.

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