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.

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.

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.

BACKGROUNDMedical superstitions remain prevalent in today's stressful and technology driven healthcare environment. These irrational beliefs commonly involve night calls, which are periods of volatile workload. In Singapore and Hong Kong, it is commonly held that consumption of steamed buns ("bao") by on-call physicians is associated with increased patient admissions and mortality, due to a homonymous interpretation of the word "bao" in dialect.

MATERIALS AND METHODSA prospective unblinded randomised controlled trial with a permuted block randomisation design was performed on weekdays over 6 weeks. Steamed buns or control food were offered to the internal medicine night-call team of a tertiary-care hospital on a nightly basis. Information on admissions and mortality was collected from the hospital electronic database. Data on sleep patterns and shift duration were obtained by interview.

RESULTSThere were no significant differences in the median number of hours slept on days on "bao" administration versus "control" intervention (2 +/- median absolute variation of 1.5 h vs 2 +/- 1.5 h, P = 0.30) or in the number of hours spent in the hospital (30.8 +/- 1.9 h vs 30.5 +/- 2.2 h, P = 0.09). There were no significant differences in the median number of general ward admissions per night (n = 73 +/- 6 versus 71 +/- 7 admissions, P = 0.35), monitored care unit admissions (4 +/- 1.5 vs 4 +/- 1.5 admissions, P = 0.65) or inpatient mortality (2 +/- 1.5 vs 2 +/- 1.5 deaths per night, P = 0.47).

CONCLUSIONThe consumption of steamed buns ("bao") has no effect on inpatient admissions, mortality, or sleep duration on call. Regardless, our results indicate that the night call in Singapore remains a challenge in terms of workload and shift duration.

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.
Adult ; Compliance ; Humans ; Indonesia ; Korea ; Malaysia ; Observational Study ; Psoriasis* ; Singapore ; Taiwan ; Ustekinumab

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.
Adult ; Compliance ; Humans ; Indonesia ; Korea ; Malaysia ; Observational Study ; Psoriasis* ; Singapore ; Taiwan ; Ustekinumab

Adrenal Glands ; Humans ; Hyperaldosteronism ; Retrospective Studies ; Singapore