Publications by authors named "Shang-Hung Chang"

141 Publications

Long-Term Outcomes of Acute Kidney Injury After Different Types of Cardiac Surgeries: A Population-Based Study.

J Am Heart Assoc 2021 May 21;10(9):e019718. Epub 2021 Apr 21.

Division of Thoracic and Cardiovascular Surgery Department of Surgery Chang Gung Memorial Hospital Linkou Medical Center Chang Gung University Taoyuan City Taiwan.

Background Dialysis-requiring acute kidney injury (D-AKI) is a major complication of cardiovascular surgery that results in worse prognosis. However, the incidence and impacts of D-AKI in different types of cardiac surgeries have not been fully investigated. Methods and Results Patients admitted for cardiovascular surgery between July 1, 2004, and December 31, 2013, were identified from the National Health Insurance Research Database of Taiwan. The patients were grouped into D-AKI (n=3089) and non-D-AKI (n=42 151) groups. The outcome was all-cause mortality and major adverse kidney event. The long-term outcomes were worse in the D-AKI group than the non-D-AKI group (hazard ratio [HR], 3.89; 95% CI, 3.79-3.99 for major adverse kidney event; HR, 2.89; 95% CI, 2.81-2.98 for all-cause mortality). Patients who underwent aortic surgery had higher risk for D-AKI than other types of surgeries, but they were also more likely to recover. The long-term dialysis rate for the patients who recovered from D-AKI was also lowest in those who underwent aortic surgery. Among all types of cardiac surgeries with D-AKI, patients who had heart valve surgery exhibited the greatest risks of all-cause mortality (HR, 6.04; 95% CI, 5.78-6.32). Conclusions Compared with other heart surgeries, aortic surgery resulted in a higher incidence of D-AKI but better renal recovery, better short-term outcome, and lower incidences of long-term dialysis.
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http://dx.doi.org/10.1161/JAHA.120.019718DOI Listing
May 2021

Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm.

J Am Coll Cardiol 2021 Apr;77(15):1875-1887

Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan. Electronic address:

Background: Recent population-based studies have revealed that the use of fluoroquinolones (FQs) is associated with an increased risk of aortic dissection (AD) and aneurysm (AA). However, no evidence is available on whether FQs increase adverse events in patients who had been diagnosed with AD or AA.

Objectives: This study investigated whether the use of FQs increases the risk of aortic-related adverse events and death in this high-risk population.

Methods: A retrospective cohort study was conducted by using the Taiwan National Health Insurance Research Database. A total of 31,570 adult patients who survived after admission for AD or AA between 2001 and 2013 were identified. We divided each calendar year into 6 data units (2 months) for each patient and each year during follow-up. Covariates and exposure of interest (FQs) were reassessed every 2 months. We used another common antibiotic, amoxicillin, as a negative control exposure.

Results: Exposure to FQs was associated with a higher risk of all-cause death (adjusted hazard ratio: 1.61; 95% confidence interval: 1.50 to 1.73), aortic death (adjusted hazard ratio: 1.80; 95% confidence interval: 1.50 to 2.15), and later aortic surgery. However, amoxicillin exposure was not significantly associated with risk of any of the outcomes. A subgroup analysis revealed that the effect of FQs was not significantly different between the AD and AA groups.

Conclusions: Relative to amoxicillin use, FQ exposure in patients with AD or AA was associated with a higher risk of adverse outcomes. FQs should not be used by high-risk patients unless no other treatment options are available.
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http://dx.doi.org/10.1016/j.jacc.2021.02.047DOI Listing
April 2021

Bleeding associated with co-administration of clopidogrel and ACEi in patients undergoing PCI and DAPT.

Atherosclerosis 2021 May 25;324:76-83. Epub 2021 Mar 25.

Division of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan; Center for Big Data Analytics and Statistics, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan; Graduate Institute of Nursing, Chang Gung University of Science and Technology, Taoyuan City, Taiwan. Electronic address:

Background And Aims: The coprescription of an angiotensin-converting enzyme inhibitor (ACEi) with clopidogrel reportedly increases bleeding risk. However, studies have not described such an increase in cases of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).

Methods: We analyzed electronic medical records of patients with discharge records of having undergone DAPT after PCI from a national health insurance claims database for January 1, 2006 to December 31, 2014. The date of PCI was the index date, and the primary outcome was major bleeding. The unit of analysis was one person-quarter. We compared patients who were prescribed with those not prescribed an ACEi in the cohort. A Poisson model with inverse probability of treatment weighting was fitted using generalized estimating equations to measure the risk of outcomes.

Results: In total, 193,258 patients underwent DAPT after PCI; 46% had a coprescription of an ACEi. After screening, 170,775 patients (479,263 person-quarters) remained for analysis. The mean patient age was 65 ± 13 years, and 73.43% were men. In total, 79,739 prescriptions of an ACEi were written: 57%, 14.21%, 8.88%, 7.17%, and 4.68% were for captopril, ramipril, enalapril, perindopril, and imidapril, respectively. A concomitant prescription of an ACEi with clopidogrel was not associated with increased bleeding risk (adjusted rate ratio: 1.08, 99% confidence interval: 0.99-1.17).

Conclusions: The coadministration of an ACEi with clopidogrel after PCI is common. In this real-world cohort study, such coadministration was not associated with an increased risk of major bleeding in patients undergoing DAPT after PCI.
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http://dx.doi.org/10.1016/j.atherosclerosis.2021.03.022DOI Listing
May 2021

Effect of Permanent Pacemaker Implantation After Valve Surgery on Long-Term Outcomes.

Circ J 2021 Mar 19. Epub 2021 Mar 19.

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University.

Background: Patients are prone to permanent pacemaker implantation (PPM) after valve surgery, yet current data on the effects of postoperative PPM are scarce and large-scale studies are lacking. The aim of this study was to determine rates and long-term outcomes of PPM after cardiac valve surgery.Methods and Results:A total of 24,014 patients who received valve surgery from 2000 to 2013 were identified from the Taiwan National Health Insurance Research Database. The number of valve surgeries and the proportion of PPM implantations after valve surgery increased (P<0.001). After 1 : 5 propensity score matching, 602 and 3,010 patients were categorized to the PPM and non-PPM groups, respectively. Late outcomes included all-cause mortality, cardiovascular death, sepsis, and readmission due to any cause. The mean follow up was 4.3 years. PPM was associated with a higher all-cause mortality rate (33.6% vs. 29.8%; hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.98-1.32), though not significant at the threshold of P<0.05. PPM was also associated with higher all-cause mortality rates in subgroups that received mitral valve (MV) replacement surgery, combined aortic valve replacement (AVR) with MV surgeries, and combined AVR with tricuspid valve surgeries.

Conclusions: The PPM rate after valve surgery is increasing, and is associated with short-term adverse effects. Patients with PPM may have a higher long-term mortality rate.
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http://dx.doi.org/10.1253/circj.CJ-20-0905DOI Listing
March 2021

Association of Long-term Use of Antihypertensive Medications With Late Outcomes Among Patients With Aortic Dissection.

JAMA Netw Open 2021 Mar 1;4(3):e210469. Epub 2021 Mar 1.

Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan.

Importance: The associations between long-term treatment of aortic dissection with various medications and late patient outcomes are poorly understood.

Objective: To compare late outcomes after long-term use of β-blockers, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or other antihypertensive medications (controls) among patients treated for aortic dissection.

Design, Setting, And Participants: This population-based retrospective cohort study using the National Health Insurance Research Database in Taiwan included 6978 adult patients with a first-ever aortic dissection who survived to hospital discharge during the period between January 1, 2001, and December 31, 2013, and who received during the first 90 days after discharge a prescription for an ACEI, ARB, β-blocker, or at least 1 other antihypertensive medication. Data analysis was conducted from July 2019 to June 2020.

Exposure: Long-term use of β-blockers, ACEIs, or ARBs, with use of other antihypertensive medications as a control.

Main Outcomes And Measures: The primary outcomes of interest were all-cause mortality, death due to aortic aneurism or dissection, later aortic operation, major adverse cardiac and cerebrovascular events, hospital readmission, and new-onset dialysis.

Results: Of 6978 total participants, 3492 received a β-blocker, 1729 received an ACEI or ARB, and 1757 received another antihypertension drug. Compared with patients in the other 2 groups, those in the β-blocker group were younger (mean [SD] age, 62.1 [13.9] years vs 68.7 [13.5] years for ACEIs or ARBs and 69.9 [13.8] years for controls) and comprised more male patients (2520 [72.2%] vs 1161 [67.1%] for ACEIs or ARBs and 1224 [69.7%] for controls). The prevalence of medicated hypertension was highest in the ACEI or ARB group (1039 patients [60.1%]), followed by the control group (896 patients [51.0%]), and was lowest in the β-blocker group (1577 patients [45.2%]). Patients who underwent surgery for type A aortic dissection were more likely to be prescribed β-blockers (1134 patients [32.5%]) than an ACEI or ARB (309 patients [17.9%]) or another antihypertension medication (376 patients [21.4%]). After adjusting for multiple propensity scores, there were no significant differences in any of the clinical characteristics among the 3 groups. No differences in the risks for all outcomes were observed between the ACEI or ARB and β-blocker groups. The risk of all-cause hospital readmission was significantly lower in the ACEI or ARB group (subdistribution hazard ratio [HR], 0.92; 95% CI, 0.84-0.997) and β-blocker group (subdistribution HR, 0.87; 95% CI, 0.81-0.94) than in the control group. Moreover, the risk of all-cause mortality was lower in the ACEI or ARB group (HR, 0.79; 95% CI, 0.71-0.89) and the β-blocker group (HR, 0.82; 95% CI, 0.73-0.91) than in the control group. In addition, the risk of all-cause mortality was lower in the ARB group than in the ACEI group (HR, 0.85; 95% CI, 0.76-0.95).

Conclusions And Relevance: The use of β-blockers, ACEIs, or ARBs was associated with benefits in the long-term treatment of aortic dissection.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.0469DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930924PMC
March 2021

Comparison Between Non-vitamin K Antagonist Oral Anticoagulants and Low-Molecular-Weight Heparin in Asian Individuals With Cancer-Associated Venous Thromboembolism.

JAMA Netw Open 2021 02 1;4(2):e2036304. Epub 2021 Feb 1.

Cardio-Oncology Program, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.

Importance: It is unclear whether the clinical benefits associated with non-vitamin K antagonist oral anticoagulants (NOACs) are similar to those associated with low-molecular-weight heparins (LMWHs) in Asian individuals with cancer and acute venous thromboembolism (VTE).

Objective: To compare the risk of recurrent thromboembolic events and bleeding associated with use of a NOAC vs use of the LMWH enoxaparin in Asian individuals with cancer-associated VTE.

Design, Setting, And Participants: This cohort study was conducted using data from the Chang Gung Research Database, a multi-institutional electronic medical records database in Taiwan. A cohort of 1109 patients with cancer-associated VTE were identified between January 1, 2012, and January 31, 2019. Data were analyzed from March 2019 through December 2020.

Exposures: Receiving a NOAC (including rivaroxaban, apixaban, edoxaban, or dabigatran) or the LMWH enoxaparin.

Main Outcomes And Measures: The primary outcomes were composite recurrent VTE or major bleeding. Stabilized inverse probability of treatment weighting was used to balance baseline covariates. We compared risks of recurrent VTE or major bleeding between groups using Cox proportional hazards models. In addition, we conducted an analysis using a Fine and Gray subdistribution hazard model that considered death as a competing risk.

Results: Among 1109 patients with cancer and newly diagnosed VTE, 578 (52.1%) were women and the mean (SD) age at index date was 66.0 (13.0) years; 529 patients (47.7%) received NOACs and 580 patients (52.3%) received the LMWH enoxaparin. Composite recurrent VTE or major bleeding occurred in 75 patients (14.1%) in the NOAC group and 101 patients (17.4%) in the enoxaparin group (weighted hazard ratio [HR], 0.77; 95% CI, 0.56-1.07; P = .11). The groups had similar risk of VTE recurrence (HR, 0.62; 95% CI, 0.39-1.01; P = .05) and major bleeding (HR, 0.80; 95% CI, 0.52-1.24; P = .32) at 12 months of follow-up. However, taking a NOAC was associated with a significantly lower risk of gastrointestinal bleeding compared with receiving enoxaparin (10 patients [1.9%] vs 41 patients [7.1%]; HR, 0.29; 95% CI, 0.15-0.59; P < .001). Findings for both primary outcomes were consistent with competing risk analyses (recurrent VTE: HR, 0.68; 95% CI, 0.45-1.01; P = .05; major bleeding: HR, 0.77; 95% CI, 0.51-1.16; P = .21).

Conclusions And Relevance: This cohort study found that in real-world practice, among Asian patients with cancer-associated VTE, use of a NOAC was associated with a similar risk for recurrent VTE or major bleeding compared with use of the LMWH enoxaparin. Nonetheless, use of a NOAC was associated with a significantly lower rate of gastrointestinal bleeding. Further prospective studies are needed to confirm these findings.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.36304DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859846PMC
February 2021

Efficacy and safety of NOAC versus warfarin in AF patients with left atrial enlargement.

PLoS One 2020 14;15(12):e0243866. Epub 2020 Dec 14.

Division of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan.

Background: Little is known about the effects of anticoagulation in patients with atrial fibrillation (AF) and left atrial enlargement (LAE).

Methods: Data of patients with AF were retrieved from Chang Gung Research Database during 2007-2016. We excluded patients who were not using oral anticoagulants, used anticoagulants for <30 days, used ≥2 agents concomitantly or switched anticoagulants, had left atrial diameter missing from their data, were aged <65, had received valve surgeries, had mitral stenosis, or had a history of cancer. The primary outcomes were ischemic stroke (IS)/systemic embolism (SE), major bleeding, and death from any cause.

Results: We identified 40,777 patients who received a diagnosis of AF. After the exclusion criteria were applied, 6,445 patients remained, 4,922 with LAE, and they were followed up for 2.4 ±1.9 years. The mean age of the patients was 77.32 ± 0.18 in the NOAC group and 76.58 ± 6.91 in the warfarin group (p < 0.0001); 48.24% of patients in the NOAC group and 46.98% of patients in the warfarin group were men (p > 0.05). The mean CHA2DS2-VASc score was 3.26 ± 1.05 in the NOAC group and 3.07 ± 1.12 in the warfarin group (p < 0.0001). The mean HAS-BLED score was 3.87 ± 3.81 in the NOAC group and 3.86 ± 3.80 in the warfarin group (p > 0.05). Furthermore, the mean LA diameter was 4.75 ± 0.63 cm in the warfarin group and 4.79 ± 0.69 cm in the warfarin group (p > 0.05). Among patients with LAE, NOAC was associated with significantly reduced IS/SE events (CRR = 0.63, 95% CI = 0.52-0.77), no difference in major bleeding (CRR = 0.91, 95% CI = 0.78-1.05), and significantly reduced death from any cause (aHR = 0.65, 95% CI = 0.52-0.80) compared with warfarin.

Conclusions: In elderly patients with AF and LAE, NOAC was associated with reduced IS/SE and death from any cause compared with warfarin, whereas no difference in major bleeding was observed between these treatments.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243866PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735599PMC
February 2021

Effectiveness and Safety of Direct Oral Anticoagulants in an Asian Population with Atrial Fibrillation Undergoing Dialysis: A Population-Based Cohort Study and Meta-Analysis.

Cardiovasc Drugs Ther 2020 Nov 19. Epub 2020 Nov 19.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.

Purpose: Whether direct oral anticoagulants (DOACs) are more effective and safer than warfarin among Asian patients with non-valvular atrial fibrillation (NVAF) undergoing dialysis remains unclear.

Methods: We first compared the risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding associated with DOACs compared with warfarin, in NVAF Asians undergoing dialysis using the Taiwan National Health Insurance Research Database (NHIRD) (Aim 1). Next, we searched PubMed and Medline from January 1, 2010 until January 31, 2020, to perform a systematic review and meta-analysis of all observational real-world studies comparing DOACs with warfarin specifically focused on NVAF patients with stage 4 or 5 chronic kidney disease undergoing dialysis (Aim 2). Finally, we tested the hypothesis whether AF patients undergoing dialysis treated with OACs (warfarin and DOACs) would be associated with lower risk of adverse clinical outcomes as compared to those without OACs using the Taiwan NHIRD (Aim 3).

Results: From June 1, 2012, to December 31, 2017, a total of 3237 and 9263 NVAF patients comorbid with ESRD receiving oral anticoagulant (OACs) (490 on DOAC, 2747 on warfarin) or no OACs, respectively, were enrolled. Propensity score matching was used to balance covariates across the study groups. For the comparison of DOAC vs. warfarin (Aim 1), DOACs had comparable risks of IS/SE and major bleeding to warfarin in our present cohort. From the original 85 results retrieved, nine studies (including our study) with a total of 6490 and 22,494 patients treated with DOACs and warfarin were included in the meta-analysis, respectively. There were 5343 (82%) and 20,337 (90%) patients treated with DOACs and warfarin undergoing dialysis, respectively. The pooled meta-analysis also indicated no difference of the effectiveness (HR:0.90; [95%CI:0.74-1.10]; P = 0.32) and safety outcomes (HR:0.75; [95%CI:0.54-1.05]; P = 0.09) between DOACs and warfarin (Aim 2). For the comparison of OAC (+) vs. OAC (-) (Aim 3), OAC-treatment was associated with a higher risk of IS/SE (hazard ratio (HR):1.54; [95% confidential interval (CI):1.29-1.84];P < 0.0001) and comparable risk of major bleeding compared to those without OAC treatment.

Conclusions: DOACs did not provide benefit over warfarin regarding effectiveness and safety in AF patients undergoing dialysis. The use of OAC was not associated with a lower risk of IS/SE in ESRD AF patients when compared to those without OAC use.
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http://dx.doi.org/10.1007/s10557-020-07108-4DOI Listing
November 2020

Fibrosis index predicts variceal bleeding and reduces need for nonselective beta-blocker in compensated cirrhosis with initial small esophageal varices without red-color sign.

Ann Transl Med 2020 Oct;8(19):1223

Division of Hepatology, Department of Gastroenterology and Hepatology, Chang-Gung Memorial Hospital, Linkou Medical Center, Taoyuan.

Background: Various non-invasive markers predicting hepatic fibrosis are poor predictors of esophageal variceal bleeding (EVB). Elastography performs well but resource-limited. Controversy for small EV prevention also exists. We aim to investigate if a non-invasive marker could predict subsequent EVB within 1 and 2 years in patients with compensated liver cirrhosis (CLC), initial small EV without red-color sign (RCS), without use of non-selective beta-blockers (NSBB) and endoscopic variceal ligation (EVL). This marker would also be tested if it could help reduce use of NSBB, thereby avoiding potential side effects and saving medical costs.

Methods: In this retrospective cohort study, 6,803 CLC patients fulfilling the inclusion-exclusion criteria were enrolled between 2001 and 2018, and were followed-up for 1 year, 2 years. The primary outcomes were subsequent EVB within 1 and 2 years of enrollment. Another 281 CLC patients with NSBB use were compared for additional outcome analysis.

Results: In total, 539 patients and 710 patients experienced EVB within 1 year and 2 years, respectively. The fibrosis index (FI) with cut-off value of 3.95 showed a negative predictive value (NPV) of 94.3% and an area under receiver operating characteristic (AUROC) of 62.95% for predicting subsequent EVB within 1 year. The EVB and mortality of patients with FI <3.95 and not taking NSBB were significantly lower than those of the other 3 groups. Similar results were demonstrated within 2 years.

Conclusions: In CLC patients with initial small EV and no RCS, low FI scores showed a high NPV and moderate AUROC in predicting subsequent EVB and mortalities, signifying clinically non-significant portal hypertension. Patients with low FI scores and not taking NSBB had significantly lowest EVB and mortality. The medical cost savings for cutting NSBB in these patients would be estimated at least $3 million per year in the U.S. Further randomized control trial study needed to validate this screening tool.
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http://dx.doi.org/10.21037/atm-20-2444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607085PMC
October 2020

Sport disciplines and cardiac remodeling in elite university athletes competing in 2017 Taipei Summer Universiade.

Medicine (Baltimore) 2020 Nov;99(45):e23144

Division of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan.

Cardiac remodeling is common in the athletes. Little data is available regarding the cardiac remodeling on the recently proposed 4 sport disciplines among the elite university athletes.A total of 7639 athletes participated in the 2017 Taipei Summer Universiade. Cardiac evaluation via history, ECG, and echocardiography were performed in 826 athletes who signed up for Check Up Your Heart. Athletes were grouped into one of 4 sport disciplines Skill, Power, Mixed, and Endurance.After excluding 66 participants with missing demographic data, 13 missing echocardiographic data, and 24 inadequate echocardiographic images, a total number of 723 university athletes (mean age 23 ± 3 years, 419 males) from 99 countries engaging in 25 different sporting events were analyzed. Electrocardiograms showed that Endurance group had a slower heart rate and higher percentage of left ventricular (LV) hypertrophy (39%). Echocardiograms showed there were significant differences in LV mass index (P < .001), LV geometry (P < .001), left atrial (LA) dilatation (P = .026), right ventricular (RV) dilatation (P < .001), right atrial (RA) dilatation (P < .0001), and tricuspid annular plane systolic excurse (P = .006). LV ejection fraction, LV strain, RV strain, and LV diastolic function showed no difference in 4 sport disciplines.Eccentric LV hypertrophy was the most common type of cardiac remodeling in the university athletes participated in 2017 Taipei Summer Universiade. Adaptive changes in chamber size were more commonly seen in Endurance sport. RA dilatation was the most sensitive to hemodynamic demand, followed by RV dilatation, LA dilatation, and LV dilatation.
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http://dx.doi.org/10.1097/MD.0000000000023144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7647536PMC
November 2020

Nationwide cohort study of tricuspid valve repair versus replacement for infective endocarditis.

Eur J Cardiothorac Surg 2021 Apr;59(4):878-886

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan.

:

Objectives: The aim of this study was to compare the outcomes of tricuspid valve (TV) repair versus replacement for patients with infective endocarditis (IE).

Methods: In this nationwide population-based cohort study, we identified 704 patients from Taiwan National Health Insurance Research Database who underwent TV surgery due to IE between 2000 and 2013. Of them, 412 (58.5%) underwent TV repair and 292 (41.5%) underwent TV replacement, and their perioperative and late outcomes were analysed. Confounding was reduced using the inverse probability of treatment weighting on propensity score.

Results: After inverse probability of treatment weighting, the in-hospital mortality rate between the 2 groups was not significantly different. However, patients who received TV repair had lower rates of perioperative complications, including massive blood transfusion, de novo dialysis and deep wound infection; longer ICU and hospital stays; and higher hospital cost. Regarding late outcomes, TV repair was associated with lower risks of all-cause readmission [subdistribution hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.60-0.78; P < 0.001], readmission for adverse liver outcomes (subdistribution HR 0.75, 95% CI 0.58-0.97; P = 0.025), new permanent pacemaker implantation (subdistribution HR 0.27, 95% CI 0.15-0.48; P < 0.001) and all-cause mortality (HR 0.60, 95% CI 0.51-0.71; P < 0.001) than TV replacement.

Conclusions: For IE, TV repair is associated with better early and late outcomes than TV replacement. A repair-first strategy is recommended for patients with IE for whom TV surgery is indicated.
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http://dx.doi.org/10.1093/ejcts/ezaa390DOI Listing
April 2021

Hepatic Encephalopathy and Spontaneous Bacterial Peritonitis Improve Cirrhosis Outcome Prediction: A Modified Seven-Stage Model as a Clinical Alternative to MELD.

J Pers Med 2020 Oct 22;10(4). Epub 2020 Oct 22.

Division of Hepatology, Department of Gastroenterology and Hepatology, Chang-Gung Memorial Hospital, Linkou Medical Center, Taoyuan City 33305, Taiwan.

Classification of cirrhosis based on clinical stages is rapid and based on five stages at present. Two other relevant events, hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP), can be considered in a clinical perspective but no study has implemented a seven-stage classification and confirmed its value before. In addition, long-term validation of the Model for End-Stage Liver Disease (MELD) in large cohorts of patients with cirrhosis and comparison with clinical findings are insufficient. Therefore, we performed a study to address these items. From the Chang-Gung Research Database (CGRD), 20,782 patients with cirrhosis were enrolled for an historical survival study. The MELD score, the five-stage clinical score (i.e., occurrence of esophageal varices (EV), EV bleeding, ascites, sepsis) and a novel seven-stage clinical score (i.e., occurrence of EV, EV bleeding, ascites, sepsis, HE, SBP) were compared with their Cox models by receiver operating characteristic (ROC) analysis. The addition of HE and SBP to the seven-stage model had a 5% better prediction result than the five-stage model did in the survival ROC analysis. The result showed that the seven clinical stages are associated with an increased risk for mortality. However, the predicted performances of the seven-stage model and MELD system are likely equivalent. In conclusion, the study (i) proved that clinical staging of cirrhosis based on seven items/stages had higher prognostic value than the five-stage model and (ii) confirmed the validity of the MELD criteria vs. clinical assessment.
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http://dx.doi.org/10.3390/jpm10040186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711993PMC
October 2020

Effect of previous coronary stenting on subsequent coronary artery bypass grafting outcomes.

J Thorac Cardiovasc Surg 2020 Sep 22. Epub 2020 Sep 22.

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan; Center for Big Data Analytics and Statistics, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan. Electronic address:

Objectives: The effect of previous coronary stenting on subsequent coronary artery bypass graft is inconclusive.

Methods: We used Taiwan's National Health Insurance Database to retrospectively evaluate patients with multivessel coronary artery bypass graft between January 2000 and December 2013. Overall, 32,335 patients who received coronary artery bypass graft were included, of whom 3028 had previous coronary stenting. Propensity-score matching yielded 2977 cases each for evaluation under the previous stenting and no stenting groups. The 30-day mortality and major adverse cardiac events, including all-cause mortality, acute myocardial infarction, and revascularization, were considered primary outcomes.

Results: The number of coronary artery bypass grafts decreased per year. However, the percentage of patients who had previous coronary stent implantation before coronary artery bypass graft increased steadily (P for trend <.001), and the average number of stents implanted in a patient also increased per year (P for trend <.001). The previous stent group had a significantly greater 30-day mortality rate than did the no-stent group (7.2% vs 5.0%; odds ratio, 1.47; 95% confidence interval, 1.19-1.82). The previous stent group had a greater rate of revascularization (14.4% and 10.0%; subdistribution hazard ratio, 1.50; 95% confidence interval, 1.30-1.74) in the last follow-up at year 13.

Conclusions: Previous coronary stenting before coronary artery bypass graft for multivessel coronary artery disease significantly increased 30-day mortality but did not affect late survival. However, patients who had coronary stenting before coronary artery bypass graft experienced more revascularization events during late follow-up.
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http://dx.doi.org/10.1016/j.jtcvs.2020.09.068DOI Listing
September 2020

Mid-term survival of patients with chronic kidney disease after extracorporeal membrane oxygenation.

Interact Cardiovasc Thorac Surg 2020 11;31(5):595-602

Division of Nephrology, Kidney Research Center, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.

Objectives: Chronic kidney disease (CKD) impairs the elimination of fluids, electrolytes and metabolic wastes, which can affect the outcomes of extracorporeal membrane oxygenation (ECMO) treatment. This study aimed to elucidate the impact of CKD on in-hospital mortality and mid-term survival of adult patients who received ECMO treatment.

Methods: Patients who received first-time ECMO treatment between 1 January 2003 and 31 December 2013 were included. Those with CKD were identified and matched to patients without CKD using a 1:2 ratio and were followed for 3 years. The study outcomes included in-hospital outcomes and the 3-year mortality rate. A subgroup analysis was conducted by comparing the dialytic patients with the non-dialytic CKD patients.

Results: The study comprised 1008 CKD patients and 2016 non-CKD patients after propensity score matching. The CKD patients had higher in-hospital mortality rates [69.5% vs 62.2%; adjusted odds ratio 1.41; 95% confidence interval (CI) 1.15-1.72] than the non-CKD patients. The 3-year mortality rate was 80.4% in the CKD group and 68% in the non-CKD group (adjusted hazard ratio 1.17; 95% CI 1.06-1.28). The subgroup analysis showed that the 3-year mortality rates were 84.5% and 78.4% in the dialytic and non-dialytic patients, respectively. No difference in the 3-year mortality rate was noted between the 2 CKD subgroups (P = 0.111).

Conclusions: CKD was associated with increased risks of in-hospital and mid-term mortalities in patients who received ECMO treatment. Furthermore, no difference in survival was observed between the patients with end-stage renal disease and non-dialytic CKD patients.
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http://dx.doi.org/10.1093/icvts/ivaa168DOI Listing
November 2020

Major adverse cardiovascular and limb events in patients with diabetes and concomitant peripheral artery disease treated with sodium glucose cotransporter 2 inhibitor versus dipeptidyl peptidase-4 inhibitor.

Cardiovasc Diabetol 2020 09 30;19(1):160. Epub 2020 Sep 30.

Department of Public Health, College of Medicine, Chang Gung University, No. 259, Wenhua 1st Rd., Guishan Dist, Taoyuan, 33302, Taiwan.

Background: Whether sodium glucose co-transporter 2 inhibitors (SGLT2i) are associated with a lower risk of cardiovascular as well as adverse lower limb events in patients with type-2 diabetes mellitus (T2DM) and concomitant peripheral artery disease (PAD) is unclear. We aimed to evaluate the risk of cardiovascular and limb events, and death associated with the use of SGLT2i compared with dipeptidyl peptidase-4 inhibitors (DPP4i) among a longitudinal and national cohort of patients with T2DM.

Methods: In this nationwide retrospective cohort study based on the Taiwan National Health Insurance Research Database, we identified a total of 11,431 and 93,972 consecutive T2DM patients with PAD taking SGLT2i and DPP4i, respectively, from May 1, 2016, to December 31, 2017. We used 1:1 propensity score matching (PSM) to balance covariates across study groups. Patients were followed from the drug index date until the occurrence of clinical outcomes, death, discontinuation of the index drug, or the end of the study period, whichever occurred first.

Results: Overall, 56% and 44% of the patients were treated with dapagliflozin and empagliflozin, respectively. The use of SGLT2i had comparable risks of ischemic stroke and acute myocardial infarction, and was associated with lower risks of congestive heart failure (CHF) [hazard ratio (HR): 0.66; 95% confidence interval (CI) 0.49-0.89; p = 0.0062], lower limb ischemia requiring revascularization (HR: 0.73; 95% CI 0.54-0.98; p = 0.0367) or amputation (HR: 0.43; 95% CI 0.30-0.62; p < 0.0001), and cardiovascular death (HR: 0.67; 95% CI 0.49-0.90; p = 0.0089) when compared with the DDP4i group after PSM. The subgroup analysis revealed consistent results for CHF and major adverse limb outcomes for SGLT2i versus DPP4i among patients aged ≥ 75 years, the presence of chronic kidney disease and established cardiovascular disease was consistent with the main analysis.

Conclusions: SGLT2i were associated with lower risks of CHF and adverse lower limb events compared with DPP4i among patients with T2DM and PAD in real-world practice.
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http://dx.doi.org/10.1186/s12933-020-01118-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528264PMC
September 2020

Mitral valve repair versus replacement in patients with rheumatic heart disease.

J Thorac Cardiovasc Surg 2020 Aug 29. Epub 2020 Aug 29.

Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan.

Background: Rheumatic heart disease remains a major cause of cardiovascular death worldwide. Limited real-world nationwide data are available to compare the long-term outcomes between mitral valve repair and replacement in rheumatic heart disease.

Methods: We identified adult patients with rheumatic heart disease who underwent mitral valve repair or replacement surgery between 2000 and 2013 from Taiwan's National Health Insurance Research Database. Outcomes of interest included operation-related complications, all-cause mortality, and mitral valve reoperation rate. Propensity score matching at a 1:1 ratio was conducted to mitigate possible confounding factors.

Results: A total of 5086 patients with rheumatic heart disease who underwent mitral valve surgery were identified. Of those, 489 (9.6%) and 4597 (90.4%) underwent mitral valve repair and mitral valve replacement, respectively. After propensity score matching was applied, each group had 467 patients. No difference in risk of in-hospital mortality was observed between groups. With a mean follow-up of 6 years, the mitral valve repair group had comparable risks of all-cause mortality with the mitral valve replacement group (33.4% vs 32.5%; hazard ratio, 1.01; 95% confidence interval, 0.81-1.25). However, higher risks of mitral valve reoperation were observed in the mitral valve repair group (subdistribution hazard ratio, 4.32; 95% confidence interval, 2.02-9.23). Previous percutaneous transvenous mitral commissurotomy was identified as a risk factor of mitral valve reoperation in the repair group.

Conclusions: Among patients with rheumatic heart disease, mitral valve repair is not associated with superior long-term outcomes. Patients should be carefully selected for mitral valve repair because of its higher reoperation rate, particularly those with previous percutaneous transvenous mitral commissurotomy.
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http://dx.doi.org/10.1016/j.jtcvs.2020.07.117DOI Listing
August 2020

Late outcomes of endovascular aortic stent graft therapy in patients with chronic kidney disease.

Medicine (Baltimore) 2020 Sep;99(37):e22157

Division of Thoracic and Cardiovascular Surgery, Department of Surgery.

Endovascular aneurysm repair (EVAR) and thoracic endovascular aortic repair (TEVAR) are effective and minimally invasive treatment options for high-risk surgical candidates. Nevertheless, knowledge about the management of aortic stent graft therapy in chronic kidney disease (CKD) is scarce. This study aimed to examine outcomes after EVAR and TEVAR in patients with CKD.Utilizing data from the Taiwan National Health Insurance Research Database, we retrospectively assessed patients who underwent EVAR and TEVAR therapy between January 1, 2006, and December 31, 2013. Patients were divided into CKD and non-CKD groups. Outcomes were in-hospital mortality, all-cause mortality, readmission, heart failure, and major adverse cardiac and cerebrovascular events.There were 1019 patients in either group after matching. The CKD group had a higher in-hospital mortality rate than the non-CKD group (15.2% vs 8.3%, respectively; odds ratio, 1.92; 95% confidence interval [CI], 1.46-2.54). Patients with CKD had higher risks of all-cause mortality including in-hospital death (46.1% vs 33.1%; hazard ratio [HR], 1.61; 95% CI, 1.35-1.92), readmission rate (62.6% vs 55.0%; subdistribution HR [SHR], 1.61; 95% CI, 1.32-1.69), redo stent (7.8% vs 6.2%; SHR, 1.50; 95% CI, 1.09-2.07), and major adverse cardiac and cerebrovascular events (13.3% vs 8.8%; SHR, 1.50; 95% CI, 1.15-1.95). The subgroup analysis did not demonstrate a variation in mortality between the TEVAR and EVAR cohorts (P for interaction = .725). The dialysis group had higher risks of all-cause mortality and readmission than the CKD without dialysis and non-CKD groups.Among EVAR/TEVAR recipients, CKD was independently associated with higher in-hospital mortality, postoperative complication, and all-cause mortality rates. Patients with end-stage renal disease on dialysis had worse outcomes than those in the CKD non-dialysis and non-CKD groups.
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http://dx.doi.org/10.1097/MD.0000000000022157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489716PMC
September 2020

Codelivery of Sustainable Antimicrobial Agents and Platelet-Derived Growth Factor via Biodegradable Nanofibers for Repair of Diabetic Infectious Wounds.

ACS Infect Dis 2020 10 28;6(10):2688-2697. Epub 2020 Sep 28.

Department of Mechanical Engineering, Chang Gung University, Tao-Yuan 33302, Taiwan.

More than half of diabetic wounds demonstrate clinical signs of infection at presentation and lead to poor outcomes. This work develops coaxial sheath-core nanofibrous poly(lactide--glycolide) (PLGA) scaffolds that are loaded with bioactive antibiotics and platelet-derived growth factor (PDGF) for the repair of diabetic infectious wounds. PDGF and PLGA/antibiotic solutions were pumped, respectively, into two independent capillary tubings for coaxial electrospinning to prepare biodegradable sheath-core nanofibers. Spun nanofibrous scaffolds sustainably released PDGF, vancomycin, and gentamicin for 3 weeks. The scaffolds also reduced the phosphatase and tensin homologue content, enhanced the amount of angiogenesis marker (CD31) around the wound area, and accelerated healing in the early stage of infected diabetic wound repair. Antibiotic/biomolecule-loaded PLGA nanofibers may provide a very effective way to aid tissue regeneration at the sites of infected diabetic wounds.
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http://dx.doi.org/10.1021/acsinfecdis.0c00321DOI Listing
October 2020

Association of pregnancy outcomes in women with type 2 diabetes treated with metformin versus insulin when becoming pregnant.

BMC Pregnancy Childbirth 2020 Sep 4;20(1):512. Epub 2020 Sep 4.

Center for Big Data Analytics and Statistics, Chang Gung Memorial Hospital, Linkou, No.15, Wunhua 1st Rd., Gueishan Dist, Taoyuan City, 333, Taiwan.

Background: Metformin use in pregnancy is controversial because metformin crosses the placenta and the safety on the fetus has not been well-established. This retrospective study aimed to compare pregnancy outcomes in women with preexisting type 2 diabetes receiving metformin or standard insulin treatment.

Methods: The cohort of this population-based study includes women of age 20-44 years with preexisting type 2 diabetes and singleton pregnancies in Taiwan between 2003 and 2014. Subjects were classified into three mutually exclusive groups according to glucose-lowering treatments received before and after becoming pregnant: insulin group, switching group (metformin to insulin), and metformin group. A generalized estimating equation model adjusted for patient age, duration of type 2 diabetes, hypertension, hyperlipidemia, retinopathy, and aspirin use was used to estimate the adjusted odds ratio (aOR) and 95% confidence interval (CI) of adverse pregnancy outcomes.

Results: A total of 1166 pregnancies were identified in the insulin group (n = 222), the switching group (n = 318) and the metformin group (n = 626). The insulin group and the switching group had similar pregnancy outcomes for both the mother and fetus, including risk of primary cesarean section, pregnancy-related hypertension, preeclampsia, preterm birth (< 37 weeks), very preterm birth (< 32 weeks), low birth weight (< 2500 g), high birth weight (> 4000 g), large for gestational age, and congenital malformations. The metformin group had a lower risk of primary cesarean section (aOR = 0.57; 95% CI, 0.40-0.82) and congenital malformations (aOR, 0.51; 95% CI; 0.27-0.94) and similar risk for the other outcomes as compared with the insulin group.

Conclusions: Metformin therapy was not associated with increased adverse pregnancy outcomes in women with type 2 diabetes as compared with standard insulin therapy.
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http://dx.doi.org/10.1186/s12884-020-03207-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487639PMC
September 2020

Association of Family History With Incidence and Outcomes of Aortic Dissection.

J Am Coll Cardiol 2020 09;76(10):1181-1192

Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City, Taiwan. Electronic address:

Background: Aortic dissection (AD) is a life-threatening emergency. However, the heritability and association of family history with late outcomes are unclear.

Objectives: The purpose of this study was to evaluate the effect of family history of AD on the incidence and prognosis of AD and estimate the heritability and environmental contribution in AD in Taiwan.

Methods: Both cross-sectional and cohort studies were conducted using Taiwan National Health Insurance database. A registry parent-offspring relationship algorithm was used to reconstruct the genealogy of this population for heritability estimation. The cross-sectional study included 23,868 patients with a diagnosis of AD in 2015. The prevalence and adjusted relative risks (RRs) were evaluated, and the liability threshold model was used to examine the effects of heritability and environmental factors. Furthermore, a 1:10 propensity score-matched cohort comprising AD patients with or without a family history of AD was included to compare late outcomes in the cohort study.

Results: A family history of AD in first-degree relatives was associated with an RR of 6.82 (95% confidence interval [CI]: 5.12 to 9.07). The heritability of AD was estimated to be 57.0% for genetic factors, and 3.1% and 40.0% for shared and nonshared environmental factors, respectively. After excluding individuals with Marfan syndrome or bicuspid aortic valve, a family history of AD was associated with an RR of 6.56 (95% CI: 4.92 to 8.77) for AD. Furthermore, patients with AD and a family history of AD had a higher risk of later aortic surgery than those with AD without a family history (subdistribution hazard ratio: 1.40; 95% CI: 1.12 to 1.76).

Conclusions: A family history of AD was a strong risk factor for AD. Furthermore, patients with AD with a family history of AD had a higher risk of later aortic surgery than those with no family history of AD.
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http://dx.doi.org/10.1016/j.jacc.2020.07.028DOI Listing
September 2020

Corrigendum to 'Outcome of extracorporeal membrane oxygenation support in patients with liver cirrhosis: a nationwide population-based cohort study'.

Eur J Cardiothorac Surg 2020 09;58(3):665

Department of Surgery, Division of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan.

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http://dx.doi.org/10.1093/ejcts/ezaa217DOI Listing
September 2020

Angiographic Complete versus Clinical Selective Incomplete Percutaneous Revascularization in Heart Failure Patients with Multivessel Coronary Disease.

J Interv Cardiol 2020 27;2020:9506124. Epub 2020 Jul 27.

Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Address: No. 5, Fu-Hsing Street, Kwei-Shan, Taoyuan, Taiwan.

Background: Patients with multivessel disease (MVD) often pursue complete revascularization (CR) during percutaneous coronary intervention (PCI) to improve prognosis. However, angiographic CR is not always feasible and is associated with some procedure-related complications in heart failure (HF) patients with MVD. Clinical selective incomplete revascularization (IR) may be reasonable for these high-risk patients, but its role in long-term outcomes remains uncertain.

Methods: Six hundred patients with HF and MVD submitted to PCI were enrolled. Major adverse cardiac events (MACEs) were defined as a composite of recurrent myocardial infarction, any revascularization, and all-cause mortality at 5 years.

Results: During a mean follow-up period of 3.7 ± 1.9 years, there was no significant difference in 5-year MACEs between selective IR and successful angiographic CR in HF patients with MVD. However, patients who failed CR had a significantly greater incidence of 5-year MACEs than those in the other two groups (failed CR: 46.4% vs. selective IR: 27.7% vs. successful CR: 27.8%, < 0.001).

Conclusions: Long-term outcomes of selective IR were comparable with those of successful angiographic CR in HF patients with MVD. However, patients that failed CR showed 2.53-fold increased risk of MACEs compared to patients undergoing either selective IR or successful angiographic CR. A more comprehensive planning strategy should be devised before PCI in HF patients with MVD.
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http://dx.doi.org/10.1155/2020/9506124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403924PMC
January 2021

Ubiquitin Pathway Is Associated with Worsening Left Ventricle Function after Mitral Valve Repair: A Global Gene Expression Study.

Int J Mol Sci 2020 Jul 18;21(14). Epub 2020 Jul 18.

College of Medicine, Chang-Gung University, Taoyuan 333, Taiwan.

The molecular mechanism for worsening left ventricular (LV) function after mitral valve (MV) repair for chronic mitral regurgitation remains unknown. We wished to assess the LV transcriptome and identify determinants associated with worsening LV function post-MV repair. A total of 13 patients who underwent MV repair for chronic primary mitral regurgitation were divided into two groups, preserved LV function (N = 8) and worsening LV function (N = 5), for the study. Specimens of LV from the patients taken during surgery were used for the gene microarray study. Cardiomyocyte cell line HL-1 cells were transfected with gene-containing plasmids and further evaluated for mRNA and protein expression, apoptosis, and contractile protein degradation. Of 67,258 expressed sequence tags, microarrays identified 718 genes to be differentially expressed between preserved-LVF and worsening-LVF, including genes related to the protein ubiquitination pathway, bone morphogenetic protein (BMP) receptors, and regulation of eIF4 and p70S6K signaling. In addition, worsening-LVF was associated with altered expressions of genes pathologically relevant to heart failure, such asdownregulated apelin receptors and upregulated peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PPARGC1A). HL-1 cardiomyocyte cells transfected with ubiquitination-related genes demonstrated activation of the protein ubiquitination pathwaywith an increase in the ubiquitin activating enzyme E1 (UAE-E1). It also led to increased apoptosis, downregulated and ubiquitinated X-linked inhibitor of apoptosis protein (XIAP), and reduced cell viability. Overexpression of ubiquitination-related genes also resulted in degradation and increased ubiquitination of α-smooth muscle actin (SMA). In conclusion, worsening-LVF presented differential gene expression profiles from preserved-LVF after MV repair. Upregulation of protein ubiquitination-related genes associated with worsening-LVF after MV repair may exert adverse effects on LV through increased apoptosis and contractile protein degradation.
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http://dx.doi.org/10.3390/ijms21145073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404186PMC
July 2020

Off-label dosing of non-vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation.

Heart Rhythm 2020 12 20;17(12):2102-2110. Epub 2020 Jul 20.

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Clinical Medicine and Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan.

Background: Off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed for Asian patients with atrial fibrillation (AF).

Objective: The purpose of this study was to investigate the associations between inappropriate dosing of NOACs and clinical outcomes.

Methods: We used medical data from a multicenter health care system in Taiwan, which included 2068, 5135, 2589, 1483, and 2342 AF patients taking dabigatran, rivaroxaban, apixaban, edoxaban, and warfarin, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding in patients treated with underdosing or overdosing NOACs were compared to those of on-label dosing NOACs and warfarin.

Results: About 27% and 5% of AF patients were treated with underdosing and overdosing NOACs, respectively. Compared to on-label dosing, underdosing NOACs were associated with a significantly higher risk of IS/SE (adjusted hazard ratio [aHR] 1.59; 95% confidence interval [CI] 1.25-2.02; P <.001), whereas overdosing NOACs were associated with a significantly higher risk of major bleeding (aHR 2.01; 95% CI 1.13-3.56; P = .017). Compared to warfarin, the 4 on-label dosing NOACs were associated with a comparable risk of IS/SE and a significantly lower risk of major bleeding, whereas underdosing NOACs were associated with a higher risk of IS/SE (aHR 1.46; P = .012).

Conclusion: About 3 in 10 Asian AF patients were treated with off-label dosing NOACs in daily practice. Compared to on-label dosing, underdosing was associated with a higher risk of IS/SE, whereas overdosing was associated with a higher risk of major bleeding. Thus, even for Asian AF patients at higher risk for bleeding, NOACs still should be prescribed at the dosing based on clinical trial criteria and guideline recommendations.
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http://dx.doi.org/10.1016/j.hrthm.2020.07.022DOI Listing
December 2020

Novel oral anticoagulant vs. warfarin in elderly atrial fibrillation patients with normal, mid-range, and reduced left ventricular ejection fraction.

ESC Heart Fail 2020 10 16;7(5):2862-2870. Epub 2020 Jul 16.

Division of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, No. 5, Fuxing Street, Guishan District, Taoyuan City, 33305, Taiwan.

Aims: Patients with concomitant atrial fibrillation (AF) and reduced left ventricular ejection fraction (LVEF) have poor prognosis. Outcomes of novel oral anticoagulant (NOAC) in elderly AF patients with normal, mid-range, and reduced LVEF were investigated.

Methods And Results: Data were retrieved from Chang Gung Research Database during 2010-2017 for patients with AF. We excluded patients with venous thromboembolism within 6 months, total knee/hip replacement and heart valve replacement within 6 months, end-stage renal disease, stroke/systemic embolism (SE)/death within 7 days, age <65 years old, or no records of LVEF. Primary outcomes were ischaemic stroke (IS)/SE, major bleeding, and death from any cause. There was a total of 50 035 elderly AF patients retrieved. After exclusion criteria, 9615 patients with normal LVEF ≥ 50%, 737 with mid-range LVEF 41-49%, and 908 with reduced LVEF ≤ 40% were studied. At end of follow-up, patients on NOAC had significantly reduced IS/SE compared with warfarin in LVEF ≥ 50% [adjusted hazard ration (aHR) 0.80, 95% confidence interval (CI) 0.71-0.89] and LVEF 41-49% (aHR 0.57, 95% CI 0.36-0.88) after adjusting for covariates, while there was no difference in LVEF ≤ 40%. Patients on NOAC had significantly reduced major bleeding in all LVEF groups. In addition, patients on NOAC had significantly reduced death compared with warfarin in LVEF ≥ 50% (aHR 0.81, 95% CI 0.67-0.98).

Conclusions: In elderly AF patients ≥65 years, using NOAC was associated with lower IS/SE compared with warfarin in normal and mid-range LVEF but not in reduced LVEF. Using NOACs was associated with lower death compared with warfarin in normal LVEF.
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http://dx.doi.org/10.1002/ehf2.12890DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524083PMC
October 2020

Biologic Agents Reduce Cardiovascular Events in Rheumatoid Arthritis Not Responsive to Tumour Necrosis Factor Inhibitors: A National Cohort Study.

Can J Cardiol 2020 Nov 15;36(11):1739-1746. Epub 2020 Jan 15.

Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Center for Big Data Analytics and Statistics, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Graduate Institute of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan. Electronic address:

Background: Tumour necrosis factor inhibitors (TNFis) improve joints outcomes and reduce cardiovascular (CV) risk in patients with rheumatoid arthritis (RA). However, 20%-45% of RA patients are TNFi poor responders and have a significantly higher risk of CV events. In these TNFi nonresponders, the use of second-line biologic agents to improve synovial outcomes is supported by clinical trials and real-world experience. However, it remains unknown what kind of immune-mediated agent has the best CV prevention effect in this high-risk population.

Methods: A nationwide RA cohort obtained from Taiwan's National Health Insurance claims database was constructed. RA patients first treated with TNFis who then received either rituximab, tocilizumab, or abatacept were enrolled and followed for 2 years.

Results: A total of 89,973 RA patients were screened and 1,584 patients ultimately included. The incidences of major adverse cardiac events (MACE) at 2 years in the rituximab, tocilizumab, and abatacept groups were 7.17%, 2.75% and 2.38%, respectively. Multivariate adjusted Cox analysis showed that tocilizumab had significantly lower risk than rituximab in myocardial infarction (hazard ratio [HR] 0.12, 95% confidence interval [CI] 0.02-0.56; P = 0.008), and MACE (HR 0.41, 95% CI 0.23-0.72; P = 0.002). In addition, abatacept also had significant lower adjusted risk than rituximab in stroke (HR 0.18, 95% CI 0.05-0.64; P = 0.008), heart failure (HR 0.20, 95% CI 0.05-0.83; P = 0.027), and MACE (HR 0.25, 95% CI 0.11-0.55; P < 0.001) in multivariate analysis.

Conclusions: TNFi-nonresponder patients with RA who received second-line tocilizumab or abatacept had more benefit on CV events prevention compared with those who received rituximab.
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http://dx.doi.org/10.1016/j.cjca.2020.01.003DOI Listing
November 2020

The Reply.

Am J Med 2020 07;133(7):e388

Center for Big Data Analytics and Statistics, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan. Electronic address:

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http://dx.doi.org/10.1016/j.amjmed.2020.01.014DOI Listing
July 2020

Impact of massive blood transfusion during adult extracorporeal membrane oxygenation support on long-term outcomes: a nationwide cohort study in Taiwan.

BMJ Open 2020 06 23;10(6):e035486. Epub 2020 Jun 23.

Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan

Objectives: Bleeding is a common problem during adult extracorporeal membranes oxygenation (ECMO) support, requiring blood transfusion for correction of volume depletion and coagulopathy. The goal of this study is to investigate the long-term outcomes for adults under support of ECMO with massive blood transfusion (MBT).

Design: Retrospective nationwide cohort study.

Setting: Data were provided from Taiwan National Health Insurance Research Database (NHIRD).

Participants And Interventions: Totally 2757 adult patients were identified to receive MBT (red blood cell ≥10 units) during ECMO support from 2000 to 2013 via Taiwan NHIRD.

Main Outcome Measures: The outcomes included in-hospital major complications/mortality, all-cause mortality, cardiovascular death, newly onset end-stage renal disease and respiratory failure during the follow-up period.

Results: Patients with MBT had higher in-hospital mortality (65.6% vs 52.1%; OR 1.74; 95% CI 1.53 to 1.98) and all-cause mortality during the follow-up (47.0% vs 35.8%; HR 1.46; 95% CI 1.25 to 1.71) than those without MBT. Not only higher incidences of post ECMO sepsis, respiratory failure and acute kidney injury, but also longer duration of ECMO support, ventilator use and intensive care unit stay were demonstrated in the MBT group. Moreover, a subdistribution hazard model presented higher cumulative of respiratory failure (19.8% vs 16.2%; subdistribution HR 1.36; 95% CI 1.07 to 1.73) for the MBT cohort. Positive dose-dependent relationship was found between the amount of transfused red blood cell product and in-hospital mortality. In the MBT subgroup analysis for the impact of transfused ratio (fresh frozen plasma/packed red blood cell) on in-hospital mortality, ratio ≥1.0 had higher mortality.

Conclusions: Patients with MBT during ECMO support had worse long-term outcomes than non-MBT population. The transfused amount of red blood cell had positive dose-dependent effect on in-hospital mortality.
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http://dx.doi.org/10.1136/bmjopen-2019-035486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7312286PMC
June 2020

Oral Anticoagulants and Antiplatelet Agents in Patients With Atrial Fibrillation and Concomitant Critical Limb Ischemia: A Nationwide Cohort Study.

Can J Cardiol 2021 Jan 19;37(1):113-121. Epub 2020 Feb 19.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.

Background: Evidence of clinical outcomes for oral anticoagulants and antiplatelet treatment (APT) in patients with atrial fibrillation (AF) and critical limb ischemia (CLI) is very limited.

Methods: In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, 1223 patients with AF and CLI taking direct-acting oral coagulants (DOACs), warfarin, or APT were identified from June 1, 2012, to December 31, 2017. We used propensity score stabilized weighting (PSSW) to balance covariates across study groups.

Results: After PSSW, DOAC (n = 446) was associated with lower risks of ischemic stroke/systemic embolism (IS/SE), all major adverse limb events, and all major bleeding events compared with warfarin (n = 237). DOAC was associated with lower risks of IS/SE, acute myocardial infarction (AMI), and all major adverse limb events and a comparable risk of major bleeding events compared with APT (n = 540). DOAC has a lower risk of composite net-clinical-benefit outcome (IS/SE, AMI, all major adverse limb events, plus all major bleeding events) compared with warfarin (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.35-0.65; P < 0.0001) or APT (HR: 0.44; 95% CI: 0.34-0.56; P < 0.0001). The composite net-clinical-benefit outcome was comparable for warfarin vs APT. The reduced risk of net-clinical-benefit outcome for DOAC vs warfarin or APT persisted in high subgroups including age > 75 years, presence of diabetes mellitus, or chronic kidney disease.

Conclusions: DOAC was associated with a significantly lower risk of composite net-clinical-benefit outcome than either warfarin or APT in patients with AF and concomitant CLI. Further prospective study is necessary to validate the findings in the future.
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http://dx.doi.org/10.1016/j.cjca.2020.02.071DOI Listing
January 2021