1.Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation:The First-in-Man Experiences
Eun Kyoung KIM ; Min-Ku CHON ; Hyun-Sook KIM ; Yong-Hyun PARK ; Sang-Hyun LEE ; Ki Seok CHOO ; Hyung Gon JE ; Dae-Hee KIM ; Tae Oh KIM ; Yoon Seok KOH ; Jae-Hyeong PARK ; Jae-Hwan LEE ; Young Jin CHOI ; Eun Seok SHIN ; Hyuck-Jun YOON ; Seung-Whan LEE ; Joo-Yong HAHN
Korean Circulation Journal 2025;55(1):20-31
Background and Objectives:
Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
Methods:
All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment.
Results:
A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period.
Conclusions
The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.
2.Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation:The First-in-Man Experiences
Eun Kyoung KIM ; Min-Ku CHON ; Hyun-Sook KIM ; Yong-Hyun PARK ; Sang-Hyun LEE ; Ki Seok CHOO ; Hyung Gon JE ; Dae-Hee KIM ; Tae Oh KIM ; Yoon Seok KOH ; Jae-Hyeong PARK ; Jae-Hwan LEE ; Young Jin CHOI ; Eun Seok SHIN ; Hyuck-Jun YOON ; Seung-Whan LEE ; Joo-Yong HAHN
Korean Circulation Journal 2025;55(1):20-31
Background and Objectives:
Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
Methods:
All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment.
Results:
A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period.
Conclusions
The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.
3.Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation:The First-in-Man Experiences
Eun Kyoung KIM ; Min-Ku CHON ; Hyun-Sook KIM ; Yong-Hyun PARK ; Sang-Hyun LEE ; Ki Seok CHOO ; Hyung Gon JE ; Dae-Hee KIM ; Tae Oh KIM ; Yoon Seok KOH ; Jae-Hyeong PARK ; Jae-Hwan LEE ; Young Jin CHOI ; Eun Seok SHIN ; Hyuck-Jun YOON ; Seung-Whan LEE ; Joo-Yong HAHN
Korean Circulation Journal 2025;55(1):20-31
Background and Objectives:
Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
Methods:
All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment.
Results:
A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period.
Conclusions
The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.
4.Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation:The First-in-Man Experiences
Eun Kyoung KIM ; Min-Ku CHON ; Hyun-Sook KIM ; Yong-Hyun PARK ; Sang-Hyun LEE ; Ki Seok CHOO ; Hyung Gon JE ; Dae-Hee KIM ; Tae Oh KIM ; Yoon Seok KOH ; Jae-Hyeong PARK ; Jae-Hwan LEE ; Young Jin CHOI ; Eun Seok SHIN ; Hyuck-Jun YOON ; Seung-Whan LEE ; Joo-Yong HAHN
Korean Circulation Journal 2025;55(1):20-31
Background and Objectives:
Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
Methods:
All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment.
Results:
A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period.
Conclusions
The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.
5.Conventional machine learning-based prediction models did not outperform the International IgA Nephropathy Prediction Tool
Sehoon PARK ; Yisak KIM ; Chung Hee BAEK ; Hyunjeong CHO ; Ji In PARK ; Eun Sil KOH ; Jung Pyo LEE ; Sun-Hee PARK ; Hyung Woo KIM ; Seung Hyeok HAN ; Ho Jun CHIN ; Dong Ki KIM ; Kyung Chul MOON ; Young-Gon KIM ; Hajeong LEE
Kidney Research and Clinical Practice 2025;44(5):802-813
Immunoglobulin A nephropathy (IgAN) is a major cause of end-stage kidney disease (ESKD). The International IgA Nephropathy Prediction Tool (IIgAN-PT) predicts IgAN prognosis, but improvement in the prediction performance using machine learning (ML)-based methods is needed. Methods: We analyzed 4,425 biopsy-confirmed patients with IgAN and ≥6 months of follow-up from nine tertiary university hospitals in Korea. The study population was divided into development and validation cohorts. Using the collected 87 clinicodemographic and pathological variables, ML-based prediction models for ESKD or estimated glomerular filtration rate decline (50% reduction or <15 mL/min/1.73 m2 ) were constructed: 1) the conventional CatBoost model, 2) the optimized CatBoost model with Cox proportional hazards, 3) the deep Cox proportional hazards model, and 4) the deep Cox mixture model. The area under the curve (AUC) and calibration plots were used to investigate the discriminative and calibration performance of the models, which were then compared with those of the IIgAN-PT full model. Results: The full model showed excellent performance (AUC [95% confidence interval] for 5-year outcome, 0.896 [0.853–0.940]), with acceptable calibration results. The ML-based models showed good performance in predicting adverse kidney outcomes and revealed acceptable discrimination performance in the external validation (AUC [95% confidence interval] for the 5-year outcome: 1) 0.829 [0.791–0.866]; 2) 0.847 [0.804–0.890]; 3) 0.823 [0.784–0.862]; and 4) 0.832 [0.794–0.870]), although the models showed underestimation in calibration analysis of the external validation cohort. With the validation data, the overall performance of the IIgAN-PT was non-inferior to that of the ML-based model. Conclusions: Our ML-based models showed good performance in predicting adverse kidney outcomes in patients with IgAN but they did not outperform the IIgAN-PT.
6.Cranial Tibial Wedge Osteotomy for Treatment of Concomitant Cranial Cruciate Ligament Rupture and Medial Patellar Luxation Using Patient-Specific Surgical Guide in an Immature Cat
Ho-Hyun KWAK ; Su-Hwan KOH ; Jun-Hyung KIM ; Heung-Myong WOO
Journal of Veterinary Clinics 2024;41(4):228-233
A 7-month-old, 5.2 kg spayed female Norwegian Forest cat was referred for chronic, non-weight-bearing lameness in the left pelvic limb that has been present since 3 months old and has not responded to medical conservative therapy. Based on orthopedic and radiographic examination, concomitant cranial cruciate ligament rupture (CCLR) and medial patellar luxation (MPL) of the left hind limb were diagnosed. In this case, cranial tibial wedge osteotomy (CTWO) was adopted to overcome side effect of performing other osteotomy techniques such as impairing the growth plates in the proximal tibia. Additionally, patient-specific surgical guides were applied to improve surgical accuracy. The patient showed an improvement in weight-bearing scores and gait condition during follow-up periods without complications. In our case, CTWO combined with corrective surgery for MPL can be used to treat concomitant CCLR and MPL without damaged on the growth plates and shows good clinical outcomes in an immature cat. Furthermore, the use of a surgical guide facilitates surgical procedures that minimize surgical error and increase surgical precision. This case study suggests that CTWO assisted by patient-specific surgical guides may be a viable surgical option for treating an immature cat with concomitant CCLR and MPL.
7.Impacts of Subtype on Clinical Feature and Outcome of Male Breast Cancer: Multicenter Study in Korea (KCSG BR16-09)
Jieun LEE ; Keun Seok LEE ; Sung Hoon SIM ; Heejung CHAE ; Joohyuk SOHN ; Gun Min KIM ; Kyung-Hee LEE ; Su Hwan KANG ; Kyung Hae JUNG ; Jae-ho JEONG ; Jae Ho BYUN ; Su-Jin KOH ; Kyoung Eun LEE ; Seungtaek LIM ; Hee Jun KIM ; Hye Sung WON ; Hyung Soon PARK ; Guk Jin LEE ; Soojung HONG ; Sun Kyung BAEK ; Soon Il LEE ; Moon Young CHOI ; In Sook WOO
Cancer Research and Treatment 2023;55(1):123-135
Purpose:
The treatment of male breast cancer (MBC) has been extrapolated from female breast cancer (FBC) because of its rarity despite their different clinicopathologic characteristics. We aimed to investigate the distribution of intrinsic subtypes based on immunohistochemistry, their clinical impact, and treatment pattern in clinical practice through a multicenter study in Korea.
Materials and Methods:
We retrospectively analyzed clinical data of 248 MBC patients from 18 institutions across the country from January 1995 to July 2016.
Results:
The median age of MBC patients was 63 years (range, 25 to 102 years). Among 148 intrinsic subtype classified patients, 61 (41.2%), 44 (29.7%), 29 (19.5%), and 14 (9.5%) were luminal A, luminal B, human epidermal growth factor receptor 2, and triple-negative breast cancer, respectively. Luminal A subtype showed trends for superior survival compared to other subtypes. Most hormone receptor-positive patients (166 patients, 82.6%) received adjuvant endocrine treatment. Five-year completion of adjuvant endocrine treatment was associated with superior disease-free survival (DFS) in patients classified with an intrinsic subtype (hazard ratio [HR], 0.15; 95% confidence interval [CI], 0.04 to 0.49; p=0.002) and in all patients (HR, 0.16; 95% CI, 0.05 to 0.54; p=0.003).
Conclusion
Distribution of subtypes of MBC was similar to FBC and luminal type A was most common. Overall survival tended to be improved for luminal A subtype, although there was no statistical significance. Completion of adjuvant endocrine treatment was associated with prolonged DFS in intrinsic subtype classified patients. MBC patients tended to receive less treatment. MBC patients should receive standard treatment according to guidelines as FBC patients.
8.Pegfilgrastim Prophylaxis Is Effective in the Prevention of Febrile Neutropenia and Reduces Mortality in Patients Aged ≥ 75 Years with Diffuse Large B-Cell Lymphoma Treated with R-CHOP: A Prospective Cohort Study
Seong Hyun JEONG ; Seok Jin KIM ; Dok Hyun YOON ; Yong PARK ; Hye Jin KANG ; Youngil KOH ; Gyeong-Won LEE ; Won-Sik LEE ; Deok-Hwan YANG ; Young Rok DO ; Min Kyoung KIM ; Kwai Han YOO ; Yoon Seok CHOI ; Hwan Jung YUN ; Jun Ho YI ; Jae-Cheol JO ; Hyeon-Seok EOM ; Jae-Yong KWAK ; Ho-Jin SHIN ; Byeong Bae PARK ; Shin Young HYUN ; Seong Yoon YI ; Ji-Hyun KWON ; Sung Yong OH ; Hyo Jung KIM ; Byeong Seok SOHN ; Jong Ho WON ; Se-Hyung KIM ; Ho-Sup LEE ; Cheolwon SUH ; Won Seog KIM
Cancer Research and Treatment 2022;54(4):1268-1277
Purpose:
Febrile neutropenia (FN) can cause suboptimal treatment and treatment-related mortality (TRM) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP).
Materials and methods:
We conducted a prospective cohort study to evaluate the effectiveness of pegfilgrastim prophylaxis in DLBCL patients receiving R-CHOP, and we compared them with the PROCESS cohort (n=485).
Results:
Since January 2015, 986 patients with DLBCL were enrolled. Pegfilgrastim was administered at least once in 930 patients (94.3%), covering 90.3% of all cycles. FN developed in 137 patients (13.9%) in this cohort (23.7% in the PROCESS cohort, p<0.001), and 4.2% of all cycles (10.2% in the PROCESS cohort, p<0.001). Dose delay was less common (≥3 days: 18.1% vs. 23.7%, p=0.015; ≥5 days: 12.0% vs. 18.3%, p=0.023) in this cohort than in the PROCESS cohort. The incidence of TRM (3.2% vs. 5.6%, p=0.047) and infection-related death (1.8% vs. 4.5%, p=0.004) was lower in this cohort than in the PROCESS cohort. The 4-year overall survival (OS) and progression-free survival (PFS) rates of the two cohorts were not different (OS: 73.0% vs. 71.9%, p=0.545; PFS: 69.5% vs. 68.8%, p=0.616). However, in patients aged ≥75 years, the 4-year OS and PFS rates were higher in this cohort than in the PROCESS cohort (OS: 49.6% vs. 33.7%, p=0.032; PFS: 44.2% vs. 30.3% p=0.047).
Conclusion
Pegfilgrastim prophylaxis is effective in the prevention of FN and infection-related death in DLBCL patients receiving R-CHOP, and it also improves OS in patients aged ≥75 years.
9.Osteoporosis Is Associated with an Increased Risk of Colorectal Adenoma and High-Risk Adenoma: A Retrospective, Multicenter, Cross-Sectional, Case-Control Study
Ji Hyung NAM ; Myung KOH ; Hyoun Woo KANG ; Kum Hei RYU ; Dong Seok LEE ; Su Hwan KIM ; Dong Kee JANG ; Ji Bong JEONG ; Ji Won KIM ; Kook Lae LEE ; Dong Jun OH ; Yun Jeong LIM ; Seong-Joon KOH ; Jong Pil IM ; Joo Sung KIM
Gut and Liver 2022;16(2):269-276
Background/Aims:
The protective effects of vitamin D and calcium on colorectal neoplasms are known. Bone mineral density (BMD) may be a reliable biomarker that reflects the long-term anticancer effect of vitamin D and calcium. This study aimed to evaluate the association between BMD and colorectal adenomas including high-risk adenoma.
Methods:
A multicenter, cross-sectional, case-control study was conducted among participants with average risk of colorectal cancer who underwent BMD and screening colonoscopy between 2015 and 2019. The main outcome was the detection of colorectal neoplasms. The variable under consideration was low BMD (osteopenia/osteoporosis). The logistic regression model included baseline demographics, components of metabolic syndrome, fatty liver disease status, and aspirin and multivitamin use.
Results:
A total of 2,109 subjects were enrolled. The mean age was 52.1±10.8 years and 42.6% were male. The adenoma detection rate was 43%. Colorectal adenoma and high-risk adenoma were both more prevalent in subjects with low BMD than those with normal BMD (48.2% vs 38.8% and 12.1% vs 9.1%). In the univariate analysis, old age, male sex, smoking, metabolic components, fatty liver, and osteoporosis were significantly associated with the risk of adenoma and high-risk adenoma. In the multivariate analysis, osteoporosis was independently associated with risk of colorectal adenoma (odds ratio [OR], 1.65; 95% confidence interval [CI], 1.11 to 2.46; p=0.014) and high-risk adenoma (OR, 1.94; 95% CI, 1.14 to 3.29; p=0.014).
Conclusions
Osteoporosis is an independent risk factor of colorectal adenoma and high-risk adenoma
10.Association between History of Pregnancy and Liver Fibrosis Using Fibrosis-4 Index in Korean Postmenopausal Women: A Nationwide Population-Based Study
Jae-Joon AHN ; Joo-Hyun PARK ; Do-Hoon KIM ; Hyun-Jin KIM ; Hyung-Seok KO ; Jun-Yeon KWON ; Young-Sang KOH ; Jin-Hyung JUNG ; Gyu-Na LEE ; Kyungdo HAN
Korean Journal of Family Medicine 2022;43(6):388-395
Background:
The association between a history of pregnancy and liver fibrosis remains unclear. Herein, we investigated the association between reproductive factors, including a history of pregnancy and liver fibrosis, in postmenopausal Korean women.
Methods:
This study used nationally representative, population-based data collected from the Korea National Health and Nutrition Examination Survey 2008–2017. Of 14,624 women with natural menopause, 11,085 with no previous history of any type of cancer, hepatitis, or chronic heavy alcohol consumption were enrolled. We investigated the reproductive factors, including a history of pregnancy, total reproductive years, age at menarche and menopause, and oral contraceptive use. Liver fibrosis was defined as a Fibrosis-4 index score ≥2.67 kg/m2.
Results:
Of the study participants, 372 (3.3%) had advanced liver fibrosis. Multivariable logistic regression analysis showed that women with a history of more than one pregnancy were associated with a lower risk of liver fibrosis compared to women who had never been pregnant, after adjusting for potential confounders (adjusted odds ratio, 0.30; 95% confidence interval, 0.15–0.59). The risk of liver fibrosis did not increase significantly with an increasing number of pregnancies (P for trend=0.135). Other reproductive factors, including total reproductive years, age at menopause and menarche, and oral contraceptive use, were not significantly associated with liver fibrosis.
Conclusion
Postmenopausal women who had experienced one or more pregnancies had a reduced risk of liver fibrosis. Our findings reveal a potential protective role of pregnancy against liver fibrosis.

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