1.Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea
Eui-Soon KIM ; Sun-Kyeong PARK ; Jong-Chan YOUN ; Hye Sun LEE ; Hae-Young LEE ; Hyun-Jai CHO ; Jin-Oh CHOI ; Eun-Seok JEON ; Sang Eun LEE ; Min-Seok KIM ; Jae-Joong KIM ; Kyung-Kuk HWANG ; Myeong-Chan CHO ; Shung Chull CHAE ; Seok-Min KANG ; Jin Joo PARK ; Dong-Ju CHOI ; Byung-Su YOO ; Jae Yeong CHO ; Kye Hun KIM ; Byung-Hee OH ; Barry GREENBERG ; Sang Hong BAEK
Journal of Korean Medical Science 2024;39(1):e8-
Background:
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry.
Methods:
A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY).
Results:
Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY).
Conclusion
There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.
2.Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
Joo Myung LEE ; Hyun Sung JOH ; Ki Hong CHOI ; David HONG ; Taek Kyu PARK ; Jeong Hoon YANG ; Young Bin SONG ; Jin-Ho CHOI ; Seung-Hyuk CHOI ; Jin-Ok JEONG ; Jong-Young LEE ; Young Jin CHOI ; Jei-Keon CHAE ; Seung-Ho HUR ; Jang-Whan BAE ; Ju-Hyeon OH ; Kook-Jin CHUN ; Hyun-Joong KIM ; Byung Ryul CHO ; Doosup SHIN ; Seung Hun LEE ; Doyeon HWANG ; Hyun-Jong LEE ; Ho-Jun JANG ; Hyun Kuk KIM ; Sang Jin HA ; Eun-Seok SHIN ; Joon-Hyung DOH ; Joo-Yong HAHN ; Hyeon-Cheol GWON ; On behalf of the SMART-REWARD Investigators
Journal of Korean Medical Science 2023;38(5):e34-
Background:
The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance.
Methods:
The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patientoriented composite outcome (POCO) at 2 years.
Results:
Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group.Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel.Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012,P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups.
Conclusion
With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES.
3.J-curve relationship between corrected QT interval and mortality in acute heart failure patients
Chan Soon PARK ; Hyun-Jai CHO ; Eue-Keun CHOI ; Sang Eun LEE ; Min-Seok KIM ; Jae-Joong KIM ; Jin-Oh CHOI ; Eun-Seok JEON ; Kyung-Kuk HWANG ; Shung Chull CHAE ; Sang Hong BAEK ; Seok-Min KANG ; Byungsu YOO ; Dong-Ju CHOI ; Youngkeun AHN ; Kye-Hoon KIM ; Myeong-Chan CHO ; Byung-Hee OH ; Hae-Young LEE
The Korean Journal of Internal Medicine 2020;35(6):1371-1384
Background/Aims:
This study investigated the prognostic power of corrected QT (QTc) interval in patients with acute heart failure (AHF) according to sex.
Methods:
We analyzed multicenter Korean Acute Heart Failure registry with patients with AHF admitted from 2011 to 2014. Among them, we analyzed 4,990 patients who were followed up to 5 years. Regarding QTc interval based on 12 lead electrocardiogram, patients were classified into quartiles according to sex.
Results:
During follow-up with median 43.7 months, 2,243 (44.9%) patients died. The relationship between corrected QT interval and all-cause mortality followed a J-curve relationship. In Kaplan-Meier analysis, both sex had lowest mortality in the second QTc quartile. There were significant prognostic differences between the second and the fourth quartiles in male (log-rank p = 0.002), but not in female (log-rank p = 0.338). After adjusting covariates, the third (hazard ratio [HR], 1.185; 95% confidence interval [CI], 1.001 to 1.404; p = 0.049) and the fourth (HR, 1.404; 95% CI, 1.091 to 1.535; p = 0.003) quartiles demonstrated increased risk of mortality compared to the second quartile in male. In female, however, there was no significant difference across quartiles. QTc interval was associated with 5-year all-cause mortality in J-shape with nadir of 440 to 450 ms in male and 470 to 480 ms in female.
Conclusions
QTc interval was an independent predictor of overall death in male, but its significance decreased in female. The relationship between QTc interval and all-cause mortality was J-shaped in both sex.
4.Clinical Characteristics and Outcome of Acute Heart Failure in Korea: Results from the Korean Acute Heart Failure Registry (KorAHF).
Sang Eun LEE ; Hae Young LEE ; Hyun Jai CHO ; Won Seok CHOE ; Hokon KIM ; Jin Oh CHOI ; Eun Seok JEON ; Min Seok KIM ; Jae Joong KIM ; Kyung Kuk HWANG ; Shung Chull CHAE ; Sang Hong BAEK ; Seok Min KANG ; Dong Ju CHOI ; Byung Su YOO ; Kye Hun KIM ; Hyun Young PARK ; Myeong Chan CHO ; Byung Hee OH
Korean Circulation Journal 2017;47(3):341-353
BACKGROUND AND OBJECTIVES: The burden of heart failure has increased in Korea. This registry aims to evaluate demographics, clinical characteristics, management, and long-term outcomes in patients hospitalized for acute heart failure (AHF). SUBJECTS AND METHODS: We prospectively enrolled a total of 5625 consecutive subjects hospitalized for AHF in one of 10 tertiary university hospitals from March 2011 to February 2014. Descriptive statistics were used to determine the baseline characteristics of the study population and to compare them with those from other registries. RESULTS: The mean age was 68.5±14.5 years, 53.2% were male, and 52.2% had de novo heart failure. The mean systolic and diastolic blood pressures were 131.2±30.3 mmHg and 78.6±18.8 mmHg at admission, respectively. The left ventricular ejection fraction was ≤40% in 60.5% of patients. Ischemia was the most frequent etiology (37.6%) and aggravating factor (26.3%). Angiotensin converting enzyme inhibitors/angiotensin receptor blockers, beta-blockers, and aldosterone antagonists were prescribed in 68.8%, 52.2%, and 46.6% of the patients at discharge, respectively. Compared with the previous registry performed in Korea a decade ago, extracorporeal membrane oxygenation (ECMO) and heart transplantation have been performed more frequently (ECMO 0.8% vs. 2.8%, heart transplantation 0.3% vs. 1.2%), and in-hospital mortality decreased from 7.6% to 4.8%. However, the total cost of hospital care increased by 40%, and one-year follow-up mortality remained high. CONCLUSION: While the quality of acute clinical care and AHF-related outcomes have improved over the last decade, the long-term prognosis of heart failure is still poor in Korea. Therefore, additional research is needed to improve long-term outcomes and implement cost-effective care.
Demography
;
Extracorporeal Membrane Oxygenation
;
Follow-Up Studies
;
Guideline Adherence
;
Heart Failure*
;
Heart Transplantation
;
Heart*
;
Hospital Mortality
;
Hospitals, University
;
Humans
;
Ischemia
;
Korea*
;
Male
;
Mineralocorticoid Receptor Antagonists
;
Mortality
;
Peptidyl-Dipeptidase A
;
Prognosis
;
Prospective Studies
;
Quality of Health Care
;
Registries
;
Stroke Volume
;
Treatment Outcome
5.Korean Guidelines for Diagnosis and Management of Chronic Heart Failure.
Min Seok KIM ; Ju Hee LEE ; Eung Ju KIM ; Dae Gyun PARK ; Sung Ji PARK ; Jin Joo PARK ; Mi Seung SHIN ; Byung Su YOO ; Jong Chan YOUN ; Sang Eun LEE ; Sang Hyun IHM ; Se Yong JANG ; Sang Ho JO ; Jae Yeong CHO ; Hyun Jai CHO ; Seonghoon CHOI ; Jin Oh CHOI ; Seong Woo HAN ; Kyung Kuk HWANG ; Eun Seok JEON ; Myeong Chan CHO ; Shung Chull CHAE ; Dong Ju CHOI
Korean Circulation Journal 2017;47(5):555-643
The prevalence of heart failure (HF) is skyrocketing worldwide, and is closely associated with serious morbidity and mortality. In particular, HF is one of the main causes for the hospitalization and mortality in elderly individuals. Korea also has these epidemiological problems, and HF is responsible for huge socioeconomic burden. However, there has been no clinical guideline for HF management in Korea.
The present guideline provides the first set of practical guidelines for the management of HF in Korea and was developed using the guideline adaptation process while including as many data from Korean studies as possible. The scope of the present guideline includes the definition, diagnosis, and treatment of chronic HF with reduced/preserved ejection fraction of various etiologies.
Aged
;
Diagnosis*
;
Heart Failure*
;
Heart*
;
Hospitalization
;
Humans
;
Korea
;
Mortality
;
Prevalence
6.The Re-infection of Helicobacter pylori and the Presence of Metachronous Lesions after Endoscopic Mucosal Resection of Gastric Neoplasias.
Min HUH ; Byung Wook KIM ; Bo In LEE ; Hwang CHOI ; Se Hyun CHO ; Jeong Seon JI ; Kyu Yong CHOI ; Min Kuk KIM ; Hyun Jung JUNG ; Jeong Won JANG ; Hiun Suk CHAE ; In Sik CHUNG
Korean Journal of Gastrointestinal Endoscopy 2008;36(5):257-261
BACKGROUND/AIMS: The aims of this study were to determine the H. pylori re-infection rate in patients that underwent endoscopic mucosal resection (EMR) due to a gastric adenoma and gastric adenocarcinoma, and to define the correlation between H. pylori re-infection and the presence of metachronous lesions. METHODS: An endoscopic examination with a biopsy was performed at six months, 12 months, and every year thereafter to determine if H. pylori re-infection occurred and if metachronous lesions were present in patients that had undergone EMR (EMR group). At least a three-year follow-up examination was performed, and patients with an on-site recurrent lesion were excluded. The re-infection rate was compared to the rate in patients with peptic ulcers (control group). RESULTS: Six patients (24%) among the 25 patients included in this study had H. pylori re-infection, an indication of a high re-infection rate as compared to the rate in patients with peptic ulcers (p=0.03). Two patients (33.3%) who were re-infected with H. pylori had metachronous lesions (p=0.009). CONCLUSIONS: Determination of the H. pylori status during a follow-up study after EMR is essential and re-eradication therapy is recommended in patients with H. pylori re-infection to prevent metachronous lesions.
Adenocarcinoma
;
Adenoma
;
Biopsy
;
Follow-Up Studies
;
Helicobacter
;
Helicobacter pylori
;
Humans
;
Peptic Ulcer
7.A Case of Choroid Plexus Papilloma of a Child with Anorexia and Failure to Thrive.
Soon Cheul HONG ; Soo Ahn CHAE ; Dong Keun LEE ; Byung Kuk MIN
Journal of the Korean Child Neurology Society 2003;11(1):168-172
Choroid plexus papilloma is a very rare disease in children. The manifestations of the disease differ according to the tumor size and the location. Increased CSF production by the tumor, hydrocephalus and symptoms of increased ICP are the main symptoms. The first line of treatment is surgical excision, but sometimes excision itself is very difficult due to the site and the size of the mass. Adjunctive radiation therapy or chemotherapy is not recommended. Since gross total resection without adjunctive therapy offers highest likelihood of success. Significant prognostic factors are sex, age, time of diagnosis, the duration between the appearance of symptoms and diagnosis, tumor volume, tumor site and the extent of surgery. We report a case of choroid plexus papilloma, in a child with anorexia and failure to thrive.
Anorexia*
;
Child*
;
Choroid Plexus*
;
Choroid*
;
Diagnosis
;
Drug Therapy
;
Failure to Thrive*
;
Humans
;
Hydrocephalus
;
Papilloma, Choroid Plexus*
;
Rare Diseases
;
Tumor Burden
8.Apoptosis in the Human Neonatal Vascular Remodeling.
Kyung Kuk HWANG ; Hyo Soo KIM ; Jung Uk SEO ; In Ho CHAE ; Chul Ho KIM ; Dae Won SOHN ; Byung Hee OH ; Myoung Mook LEE ; Young Bae PARK ; Yun Shik CHOI ; Young Woo LEE
Korean Circulation Journal 2001;31(7):681-700
BACKGROUND AND OBJECTIVES: In order to verify that apoptosis is one of the possible mechanisms of human neonatal vascular remodeling during transition from fetal to neonatal circulation, we identified apoptosis and analyzed its mechanism by evaluating apoptosis-related genes in umbilical vessel versus ascending aorta, ductus arteriosus (DA) versus adjacent pulmonary artery and aorta, and aorta versus its branching arteries. MATERIALS AND METHODS: Twenty-two umbilical cords, six ductus arteriosus with adjacent aortae and pulmonary arteries, and four aortic arches with their branching great arteries, were obtained from neonates. The presence of apoptotic cells was demonstrated by electron microscopy (EM) and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL). Immunohistochemical staining and Western blotting were used for the analysis of the proteins of apoptosis-related gene. RESULTS: Apoptosis of the smooth muscle cells of the umbilical vessels were identified in all UC, which were examined by electron microscopy and TUNEL. The expressions of Bax and Bcl-X were shown by immunohistochemistry to be stronger in umbilical artery than in the neonatal aorta, but Bcl-2 was weak in both arteries. In the immunoblot analysis of UC, the expression of the proapoptotic short isoform of Bcl-X was stronger than in other tissue, and caspase-3 was selectively activated whereas it was not in the other components of the cardiovascular system. However, the expression patterns of the Fas Ag and Fas ligand (i.e. positive Fas Ag and negative Fas ligand), were similar in umbilical artery and aorta. This Bax-associated apoptosis was also observed in other vascular sites which undergo dramatic hemodynamic changes during birth, such as, the ductus arteriosus and the branching points of the great arteries from the aortic arch. CONCLUSIONS: Apoptosis is involved in the closure and regression of human umbilical vessels and the ductus arteriosus and in the remodeling of the branching great arteries during the neonatal period, where the Bax/Bcl-2/Bcl-X system, not Fas Ag/Fas ligand system, is likely to play a key role.
Aorta
;
Aorta, Thoracic
;
Apoptosis*
;
Arteries
;
Blotting, Western
;
Cardiovascular System
;
Caspase 3
;
Ductus Arteriosus
;
Fas Ligand Protein
;
Hemodynamics
;
Humans*
;
Immunohistochemistry
;
In Situ Nick-End Labeling
;
Infant, Newborn
;
Microscopy, Electron
;
Myocytes, Smooth Muscle
;
Parturition
;
Pulmonary Artery
;
Umbilical Arteries
;
Umbilical Cord
10.The Role of Apoptosis in the Closure of Human Umbilical Vessels at Birth and Its Mechanism.
Kyung Kuk HWANG ; Hyo Soo KIM ; Jung Uk SEO ; In Ho CHAE ; Dae Won SOHN ; Byung Hee OH ; Myoung Mook LEE ; Young Bae PARK ; Yun Shik CHOI ; Jung Don SEO ; Young Woo LEE
Korean Journal of Medicine 1998;55(6):991-1004
BACKGROUND: The mechanism of the closure of umbilical vessels is known to be multifactorial. In order to verify that apoptosis is one of the possible closure mechanisms, we studied to identify apoptosis in umbilical vessels and evaluate its mechanism by studying apoptosis-related gene and the relationship between the pattern of apoptosis and gestational age (GA). METHODS: Twelve umbilical cords of GA of 37-42 weeks were obtained immediatly (less than 10 min. for minimal ongoing external influences) after birth. The presence of apoptotic cells was demonstrated by electron microscopy (EM) and terminal deoxynucleotidyl transferase- mediated dUTP nick end labeling (TUNEL). Immunohistochemical staining and Western blotting were used for the analysis of the proteins of apoptosis-related gene. RESULTS: Apoptosis of the smooth muscle cells of media and intima of umbilical vessels was identified at EM, regardless of GA from 37 to 42 weeks. The proportion of TUNEL (+) cells was 80% in intima, 40% in media, 80% in connective tissue of umbilical cord. The expressions of bax-alpha, bcl-Xs/L were strong in intima, in media and connective tissue, but those of bcl-2 were detected in only in connective tissue, regardless of GA in immunohistochemistry. The ratios of expressions of bax-alpha to bcl-2, bcl-Xs to bcl-XL, did not change with increasing GA from 37 to 42 weeks in Western blotting. CONCLUSION: Apoptosis was identified in umbilical vessels. The closure of umbilical vessels can be explained by apoptosis where the ratios of bax-alpha/bcl-2, bcl-Xs/ bcl-XL play an important role. The fact that there were no differences in the extent of apoptosis and the expressions of bax-alpha/bcl-2, bcl-Xs/bcl-XL according to GA, suggests that apoptosis of umbilical vessels is more dependent on the external stimuli during delivery than GA.
Apoptosis*
;
Blotting, Western
;
Connective Tissue
;
Gestational Age
;
Humans*
;
Immunohistochemistry
;
In Situ Nick-End Labeling
;
Microscopy, Electron
;
Myocytes, Smooth Muscle
;
Parturition*
;
Umbilical Cord

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