1.Trends in cardiovascular death related to mechanical complications of cardiac electronic devices in the United States from 1999 to 2020
Min Choon TAN ; Yong Hao YEO ; Boon Jian SAN ; Jian Liang TAN
International Journal of Arrhythmia 2023;24(3):19-
Background:
While cardiac implantable electronic devices (CIED) are increasingly used, real-world data on the mortality rate due to mechanical complications of CIED is scarce.
Objective:
This study aimed to determine longitudinal trends in mortality attributed to mechanical complications of CIED.
Methods:
We queried the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research and performed serial cross-sectional analyses of national death certificate data for mechanical complications of CIED-related mortality among the United States population aged ≥ 35 years from 1999 to 2020. Cardiovascular disease (ICD-10: I00–I99) was listed as the underlying cause of death, and mechanical complication of the cardiac electronic device (ICD-10: T82.1) was stated as the contributing cause of death. We calculated age-adjusted mortality rates (AAMRs) per 1,000,000 individuals. Linear regression was used to calculate for the significance of the annual percent of changes in AAMRs.
Results:
1237 cardiovascular deaths related to mechanical complications of CIED were identified between 1999 and 2020. The AAMR dropped significantly from 0.45 per 1,000,000 individuals in 1999 to 0.21 per 1,000,000 individuals in 2020 (p < 0.01). Cumulative AAMRs were higher in males than females (0.39 per 1,000,000 individuals vs. 0.26 per 1,000,000 individuals, p < 0.01), higher in White populations than African American populations (0.32 per 1,000,000 individuals vs. 0.30 per 1,000,000 individuals, p < 0.01), and higher in the rural areas than in the urban areas (0.50 per 1,000,000 individuals vs. 0.27 per 1,000,000 individuals, p < 0.01).
Conclusion
While the cardiovascular deaths related to mechanical complications of CIED were decreasing over the past decades, disparities in the AAMRs across sex, races and geographical region still present.
4.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)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
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.
5.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)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
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.
6.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)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
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.
7.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)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
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.
8.Mask lift and facial aesthetic sculpturing.
Xiao-ping CHEN ; Jian-liang SONG ; Song-min SHI ; Xiao-yan TAN ; Hao SUN ; Jin-de LIN ; Zhen-kun SONG ; Jian SHEN
Chinese Journal of Plastic Surgery 2004;20(6):405-407
OBJECTIVETo improve the outcome of the face-lift with a craniofacial contouring procedure.
METHODSThirty-seven patients aged 29-53 years (31 in female, 6 in male) were treated through a bicoronal incision. The facial tissue was lifted through a subperiosteal procedure and the facial skeleton was remodeled in three dimensions by osteotomies.
RESULTSThe results were satisfactory after the 3-12 months of the follow-ups.
CONCLUSIONSThe Face-lift combined with the facial aesthetic sculpturing may be more effective for the aging-face rejuvenating.
Adult ; Esthetics ; Female ; Humans ; Male ; Middle Aged ; Rhytidoplasty ; methods
9.Chemical constituents of Ligularia dictyoneura.
Ai-min TAN ; Hong-ping HE ; Hong YANG ; Mian ZHANG ; Zheng-tao WANG ; Xiao-jiang HAO
Acta Pharmaceutica Sinica 2003;38(12):924-926
AIMTo study the chemical constituents of Ligularia dictyoneura.
METHODSVarious chromatographic techniques were used to separate and purify the compounds. Their spectral data (MS, IR, NMR) were measured for structure elucidation.
RESULTSFour sesquiterpenes were isolated from Ligularia dictyoneura and their structures were identified as ligudicin A (1), ligudicin C (2), ligudicin D (3) and isopetasin (4).
CONCLUSIONCompound 1 is a new compound, compound 2 is a new natural product, and compounds 3 and 4 are obtained from Ligularia dictyoneura for the first time.
Asteraceae ; chemistry ; Molecular Conformation ; Molecular Structure ; Plants, Medicinal ; chemistry ; Sesquiterpenes ; chemistry ; isolation & purification
10.Effect of kistrin on expression of collagen type IV in lens posterior capsule
Feng-ting, HU ; Shao-jian, TAN ; Hao, LIANG ; Jian-feng, HE ; Xia, LI ; Min-li, HUANG ; Jin-mao, CHEN ; Ying-ying, CHEN
Chinese Journal of Experimental Ophthalmology 2012;30(1):37-40
BackgroundThe proliferation of lens epithelial cellsLECs) following extracapsular cataract extraction is the biological basis of posterior capsular collagen and cataract formation.Disintegrin is certified to competitively bind the integrin with extracellular matrix and therefore prevent the posterior capsular opacification (PCO).But,its molecular mechanism is below understand.ObjectiveThe present study was to investigative the effects of disintegrin (kistrin) on the expression of collagen in lens posterior capsular.MethodsThe right eyes of 24 New Zealand white rabbits received transparent lens extracapsular enudeation and were randomly divided into two groups using random number table,0.2 ml of kistrin ( 80 mg/L) was intracapsularly injected at end of the operation in 12 eyes ( kistrin group) and the same volume of normal saline solution was used at the same way in other 12 operative eyes ( normal saline group).The PCO was graded in postoperative 1,3,5,7,14 days on Odrich' s criteria under the slit lamp.The lens section was prepared at 14 days and 3 months after operation.Haematoxylin and eosin stain was used to examine the proliferation of LECs in posterior capsule; Masson stain was used to observe the collagenous fiber formation in capsule bag,and the expression of collagen type Ⅳ was detected by immunochemistry.Results No significant difference in the number PCO eye was found in postoperative 14 days between normal saline group and kistrin group ( P =0.093 ).However,the eye numbers of 2-3 grades of PCO were significant increased in normal saline group compared with kistrin group in 1,2,3 months after operation( P=0.041,0.014,0.022).In the operative 14 days,staining and adhesion of LECs in posterior capsule were more in normal saline group than kistrin group,and the fibrocytes in capsule were evidently increased in normal saline group in 3 months.Masson stain certified that the blue stain was seen to be stronger and more in posterior capsule in normal saline group in comparison with kistrin group in 3 months after operation,and the immunochemistry showed that the gray values of collagen type Ⅳ in posterior capsule were significant lower in normal saline group compared with kistrin group in both 14 days and 3 months after operation (P=0.000,0.001 ).ConclusionsKistrin can suppresses the proliferation of LECs and collagen type Ⅳ on rabbit lens posterior capsular after transparent lens extracapsular enudeation.