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.Comparative Efficacy of Rosuvastatin Monotherapy and Rosuvastatin/Ezetimibe Combination Therapy on Insulin Sensitivity and Vascular Inflammatory Response in Patients with Type 2 Diabetes Mellitus
Ji Hye HAN ; Kyong Hye JOUNG ; Jun Choul LEE ; Ok Soon KIM ; Sorim CHOUNG ; Ji Min KIM ; Yea Eun KANG ; Hyon-Seung YI ; Ju Hee LEE ; Bon Jeong KU ; Hyun Jin KIM
Diabetes & Metabolism Journal 2024;48(1):112-121
Background:
Type 2 diabetes mellitus (T2DM) induces endothelial dysfunction and inflammation, which are the main factors for atherosclerosis and cardiovascular disease. The present study aimed to compare the effects of rosuvastatin monotherapy and rosuvastatin/ezetimibe combination therapy on lipid profile, insulin sensitivity, and vascular inflammatory response in patients with T2DM.
Methods:
A total of 101 patients with T2DM and dyslipidemia were randomized to either rosuvastatin monotherapy (5 mg/day, n=47) or rosuvastatin/ezetimibe combination therapy (5 mg/10 mg/day, n=45) and treated for 12 weeks. Serum lipids, glucose, insulin, soluble intercellular adhesion molecule-1 (sICAM-1), and peroxiredoxin 4 (PRDX4) levels were determined before and after 12 weeks of treatment.
Results:
The reduction in low density lipoprotein cholesterol (LDL-C) by more than 50% from baseline after treatment was more in the combination therapy group. The serum sICAM-1 levels increased significantly in both groups, but there was no difference between the two groups. The significant changes in homeostasis model assessment of insulin resistance (HOMA-IR) and PRDX4 were confirmed only in the subgroup in which LDL-C was reduced by 50% or more in the combination therapy group. However, after adjusting for diabetes mellitus duration and hypertension, the changes in HOMA-IR and PRDX4 were not significant between the two groups.
Conclusion
Although rosuvastatin/ezetimibe combination therapy had a greater LDL-C reduction effect than rosuvastatin monotherapy, it had no additional effects on insulin sensitivity and vascular inflammatory response. Further studies are needed on the effect of long-term treatment with ezetimibe on insulin sensitivity and vascular inflammatory response.
6.Quality Indicators of Endoscopic Retrograde Cholangiopancreatography in Korea
Hyung Ku CHON ; Ki-Hyun KIM ; Tae Jun SONG ; Dong-Won AHN ; Eaum Seok LEE ; Yun Nah LEE ; Yoon Suk LEE ; Tae Joo JEON ; Chang Hwan PARK ; Kwang Bum CHO ; Dong Wook LEE ; Jin-Seok PARK ; Seung Bae YOON ; Kwang Hyun CHUNG ; Jin LEE ; Miyoung CHOI
Gut and Liver 2024;18(4):564-577
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that requires significant experiences and skills and has various procedure-related complications, some of which can be severe and even result in the death of patients. Expanding ERCP availability has the advantage of increasing accessibility for patients. However, ERCP poses a substantial risk if performed without proper quality management. ERCP quality management is essential for both ensuring safe and successful procedures and meeting the social demands for enhanced healthcare competitiveness and quality assurance. To address these concerns, the Korean Pancreatobiliary Association established a task force to develop ERCP quality indicators (QIs) tailored to the Korean medical environment. Key questions for five pre-procedure, three intra-procedure, and four post-procedure measures were formulated based on a literature search related to ERCP QIs and a comprehensive clinical review conducted by experts. The statements and recommendations regarding each QI item were selected through peer review. The developed ERCP QIs were reviewed by external experts based on the latest available evidence at the time of development.These domestically tailored ERCP QIs are expected to contribute considerably to improving ERCP quality in Korea.
7.Quality Indicators of Endoscopic Retrograde Cholangiopancreatography in Korea
Ki-Hyun KIM ; Hyung Ku CHON ; Tae Jun SONG ; Dong Won AHN ; Eaum Seok LEE ; Yun Nah LEE ; Yoon Suk LEE ; Tae Joo JEON ; Chang Hwan PARK ; Kwang Bum CHO ; Dong Wook LEE ; Jin-Seok PARK ; Seung Bae YOON ; Kwang Hyung CHUNG ; Jin JIN ; Miyoung CHOI
Korean Journal of Pancreas and Biliary Tract 2024;29(4):144-156
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that requires abundant clinical experience and endoscopic skills, and can lead to various complications, some of which may progress to life-threatening conditions. With expanding indications and technological advancements, ERCP is widely utilized, enhancing procedural accessibility. However, without proper quality management, the procedure can pose significant risks. Quality management in ERCP is essential to ensure safe and successful procedures and meet societal demands for improved healthcare competitiveness. To address these concerns, the Korean Pancreatobiliary Association has developed a Korean-specific ERCP quality indicator reflecting domestic medical environments and realities. Initially, based on a review of foreign ERCP quality indicators and related literatures, key questions were formulated for five preprocedural items, three intra-procedural items, and four post-procedural items. Descriptions and recommendations for each item were selected through peer evaluation. The developed Korean-specific ERCP quality indicator was reviewed by external experts based on the latest evidence and consensus in this fields. This Korean-specific indicator is expected to significantly contribute to improving ERCP quality in Korea, as it is tailored to local needs.
8.Quality Indicators of Endoscopic Retrograde Cholangiopancreatography in Korea
Ki-Hyun KIM ; Hyung Ku CHON ; Tae Jun SONG ; Dong Won AHN ; Eaum Seok LEE ; Yun Nah LEE ; Yoon Suk LEE ; Tae Joo JEON ; Chang Hwan PARK ; Kwang Bum CHO ; Dong Wook LEE ; Jin-Seok PARK ; Seung Bae YOON ; Kwang Hyung CHUNG ; Jin LEE ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(3):111-122
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that requires abundant clinical experience and endoscopic skills, and can lead to various complications, some of which may progress to life-threatening conditions. With expanding indications and technological advancements, ERCP is widely utilized, enhancing procedural accessibility. However, without proper quality management, the procedure can pose significant risks. Quality management in ERCP is essential to ensure safe and successful procedures and meet societal demands for improved healthcare competitiveness. To address these concerns, the Korean Society of Pancreatobiliary Endoscopy has developed a Korean-specific ERCP quality indicator reflecting domestic medical environments and realities. Initially, based on a review of foreign ERCP quality indicators and related literatures, key questions were formulated for five pre-procedural items, three intra-procedural items, and four post-procedural items. Descriptions and recommendations for each item were selected through peer evaluation. The developed Korean-specific ERCP quality indicator was reviewed by external experts based on the latest evidence and consensus in this fields. This Korean-specific indicator is expected to significantly contribute to improving ERCP quality in Korea, as it is tailored to local needs.
9.Hematological differentiation of bladder rupture and complete/partial urethral obstruction in castrated Hanwoo (Korean indigenous cattle) with urolithiasis
Young-Jun KIM ; Seung-Min HA ; Ji-Yeong KU ; Ji-Seon YOON ; Jinho PARK
Journal of Veterinary Science 2023;24(5):e62-
This case report describes the hematological and radiological examination of urinary bladder rupture and complete urethral obstruction. associated with urolithiasis in Hanwoo.Hyponatremia, hypochloremia, azotemia, and hyperglycemia were observed in both urethral obstruction and urinary bladder rupture. However, cattle with urethral obstruction showed hyperkalemia and mild hyperglycemia, whereas cattle with bladder rupture showed marked hyperglycemia and normal potassium levels. In ultrasonography, the urethral obstruction showed a dilated bladder with a thick bladder wall. In contrast to previous literature, in this study, severe electrolyte changes such as severe hyponatremia, hypochloremia, and hyperkalemia occurred in a case of complete urethral obstruction.
10.Immunogenicity and Safety of Vaccines against Coronavirus Disease in Actively Treated Patients with Solid Tumors: A Prospective Cohort Study
Yae Jee BAEK ; Youn-Jung LEE ; So Ra PARK ; Kyoo Hyun KIM ; Seung-Hoon BEOM ; Choong-kun LEE ; Sang Joon SHIN ; Sun Young RHA ; Sinyoung KIM ; Kyoung Hwa LEE ; Jung Ho KIM ; Su Jin JEONG ; Nam Su KU ; Jun Yong CHOI ; Joon-Sup YEOM ; Minkyu JUNG ; Jin Young AHN
Cancer Research and Treatment 2023;55(3):746-757
Purpose:
We aimed to assess the humoral response to and reactogenicity of coronavirus disease 2019 (COVID-19) vaccination according to the vaccine type and to analyze factors associated with immunogenicity in actively treated solid cancer patients (CPs).
Materials and Methods:
Prospective cohorts of CPs, undergoing anticancer treatment, and healthcare workers (HCWs) were established. The participants had no history of previous COVID-19 and received either mRNA-based or adenovirus vector–based (AdV) vaccines as the primary series. Blood samples were collected before the first vaccination and after 2 weeks for each dose vaccination. Spike-specific binding antibodies (bAbs) in all participants and neutralizing antibodies (nAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) wild-type, Delta, and Omicron variants in CPs were analyzed and presented as the geometric mean titer.
Results:
Age-matched 20 HCWs and 118 CPs were included in the analysis. The bAb seroconversion rate and antibody concentrations after the first vaccination were significantly lower in CPs than in HCWs. After the third vaccination, antibody levels in CPs with a primary series of AdV were comparable to those in HCWs, but nAb titers against the Omicron variant did not quantitatively increase in CPs with AdV vaccine as the primary series. The incidence and severity of adverse reactions post-vaccination were similar between CPs and HCWs.
Conclusion
CPs displayed delayed humoral immune response after SARS-CoV-2 vaccination. The booster dose elicited comparable bAb concentrations between CPs and HCWs, regardless of the primary vaccine type. Neutralization against the Omicron variant was not robustly elicited following the booster dose in some CPs, implying the need for additional interventions to protect them from COVID-19.

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