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.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
6.Celiomesenteric Trunk with Concurrent Common Hepatic Artery Aneurysm: A Case Report.
So Young CHOI ; Hyun Young HAN ; Hyeong Geun IM ; Hyoung Sim CHOE ; Tong Jin CHON ; Kyu Soon KIM ; Byung Sun CHO
Journal of the Korean Society of Medical Ultrasound 2008;27(2):95-98
Celiomesenteric trunk is a rare anomaly, and its co-occurrence with an aneurysm is even more unusual. We present a case of celiomesenteric trunk with a concurrent hepatic arterial aneurysm, both of which were found incidentally on screening abdominal ultrasonography.
Abdomen
;
Aneurysm
;
Hepatic Artery
;
Mass Screening
7.Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients with Coronary Artery Disease and Diabetic Nephropathy: A Single Center Experience.
Ki Sun BAE ; Hyeong Cheon PARK ; Byung Seung KANG ; Jong Won PARK ; Nu Ri CHON ; Kyung Jin OH ; Young Won YOON ; You Sun HONG ; Sung Kyu HA
The Korean Journal of Internal Medicine 2007;22(3):139-146
BACKGROUND: Patients with diabetic nephropathy (DN) and coronary artery disease (CAD) represent a subset of patients with high cardiovascular morbidity and mortality. The optimal revascularization strategy using either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains controversial. The purpose of this study was to compare the clinical outcomes of PCI to CABG in DN patients with CAD. METHODS: The clinical and angiographic records of DN patients with CAD who underwent either CABG (n=52) or PCI (n=48) were retrospectively analyzed. RESULTS: The baseline characteristics were similar in the two groups except for the severity of the CAD. At 30 days, the death rate (PCI: 2.1% vs. CABG: 9.6%, p=0.21) and major adverse cardiac events (MACE) rate (PCI: 2.1 % vs. CABG: 9.6%, p=0.21) were similar in comparisons between the PCI and CABG groups. At three years, the death rate (PCI: 18.8% vs. CABG: 19.2%, p=0.94) was similar between the PCI and CABG groups but the MACE rate (PCI: 47.9% vs. CABG: 21.2%, p=0.006) was higher in the PCI group compared to the CABG group. In addition, the repeat revascularization rate was higher in the PCI group compared to the CABG group (PCI: 12.5% vs. CABG: 1.9%, p=0.046). CONCLUSIONS: The CABG procedure was associated with a lower incidence of MACE and repeat revascularization for up to three years of follow-up in DN patients with CAD. However, the overall survival rate was similar in the CABG and PCI groups. Therefore, CABG may be superior to PCI with regard to MACE and repeat revascularization.
Aged
;
*Angioplasty, Transluminal, Percutaneous Coronary/adverse effects
;
*Coronary Artery Bypass/adverse effects
;
Coronary Artery Disease/complications/surgery/*therapy
;
*Diabetic Nephropathies/complications
;
Female
;
Humans
;
Male
;
Middle Aged
;
Retrospective Studies
;
Severity of Illness Index
;
Survival Analysis
;
Treatment Outcome
8.A Case of Disseminated Pagetoid Reticulosis.
Hyeong Jin CHON ; Ji Soo PARK ; Sook Ja SON ; Dong Jun KIM
Korean Journal of Dermatology 2000;38(6):802-805
Pagetoid reticulosis(PR) is a rare lymphoproliferative disorder that has been divided into the localized and disseminated type. There has been ongoing debate about the nature of PR. Some authors have regarded PR as a variant of mycosis fungoides(MF). However recent reported cases suggest that PR may represent a spectrum of lymphoproliferative disorders that may not be related to MF. We report a case of a 65-year-old woman who had an erythematous plaque on the anterior chest, buttock and lower extremities for 2 years. Histologically there was dense infiltrate of predominantly CD8-/CD30+ atypical mononuclear cells in the epidermis that produce a pagetoid appearance. We believe this is the first reported case of disseminated pagetoid reticulosis in the Korean literature.
Aged
;
Buttocks
;
Epidermis
;
Female
;
Humans
;
Lower Extremity
;
Lymphoproliferative Disorders
;
Pagetoid Reticulosis*
;
Thorax
9.A Case of Lentigo Maligna Melanoma.
Dong Keun LEE ; Hyeong Jin CHON ; Dong Jun KIM ; Sook Ja SON
Korean Journal of Dermatology 2000;38(4):522-525
We report herein a case of lentigo maligna in a 60-year-old female that progressed to lentigo maligna melanoma. She had an uneven dark brownish pigmented and irregular-bordered macule on the right cheek, which gradually extended peripherally over the last 20 years and became 2.5x2.5cm in size. A dark brownish nodule developed in the inferior portion of the macule 7 months ago. The histopathologic findings were consistent with lentigo maligna and lentigo maligna melanoma. The lesion was excised with a surgical margin of 1cm and a full thickness skin graft was performed.
Cheek
;
Female
;
Humans
;
Hutchinson's Melanotic Freckle*
;
Lentigo*
;
Melanoma*
;
Middle Aged
;
Skin
;
Transplants
10.A Case of Purely Epithelioid Peripheral Nerve Sheath Tumor.
Hyeong Jin CHON ; Dong Keun LEE ; Dong Jun KIM ; Sook Ja SON
Korean Journal of Dermatology 2000;38(4):518-521
The purely epithelioid malignant peripheral nerve sheath tumor(MPNST) is a rare form of MPNST, first described by McCormack et al. in 1954. This tumor type differs from ordinary epithelioid MPNST because of absence of spindle cell components. The patient was 25-year-old woman with palpable bean-sized subcutaneous mass on the right upper arm for 8 months which enlarged gradually. On physical examinations, we could not find a evidence of lymphadenopathy or von Reklinghausen's disease. Microscopically the tumor showed well circumscribed encapsulated nodular pattern composed of epithelioid cells. The cells were plump round or polygonal cells which had vesicular nuclei and prominent nucleoli with abundant eosinophilic and some clear cytoplasms. Immunohistochemical study showed the cells being positive for S-100 protein and neuron specific enolase and negative for HMB-45, cytokeratin and vimentin. We report a case of purely epithelioid malignant peripheral nerve sheath tumor which is located superficially without evidence of von Recklinghaunsen's disease or associated peripheral nerve.
Adult
;
Arm
;
Cellular Structures
;
Cytoplasm
;
Eosinophils
;
Epithelioid Cells
;
Female
;
Humans
;
Keratins
;
Lymphatic Diseases
;
Neurilemmoma
;
Peripheral Nerves*
;
Phosphopyruvate Hydratase
;
Physical Examination
;
S100 Proteins
;
Vimentin

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