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.Weight fluctuation and incidence of end-stage renal disease in Korea: a nationwide cohort study
Koh-Eun SHIN ; Byoungduck HAN ; Gyu Bae LEE ; Jihyun YOON ; Kyungdo HAN ; Yang-Hyun KIM
Cardiovascular Prevention and Pharmacotherapy 2025;7(2):28-37
Background:
The impact of weight or weight changes on kidney function remains a matter of debate. This study aimed to investigate the association between weight fluctuation and the incidence of end-stage renal disease (ESRD) using data from the Korean National Health Insurance Corporation health checkups (2009–2015).
Methods:
The study included 2,310,667 participants (1,546,749 men and 763,918 women), aged ≥40 years. Weight fluctuation was assessed using the average real variability (ARV) of weight and categorized into quartiles (Q1–Q4). Hazard ratios (HRs) and 95% confidence intervals for ESRD incidence were calculated using multivariable Cox proportional hazards models.
Results:
After adjustment for comorbidities, increased body mass index was associated with a decreased HR for ESRD. The highest quartile of weight variability (ARV Q4) demonstrated a higher probability and HR for ESRD compared to the lower variability quartiles (Q1–Q3). Among men, individuals with sustained weight, and those with weight gain, the ARV Q4 group showed significantly increased HRs for ESRD (HR of 1.372, 1.222, and 1.49, respectively). Furthermore, irrespective of changes in creatinine levels, all ARV Q4 groups exhibited increased HRs for ESRD (HR of 1.342, 1.472, and 1.299, respectively).
Conclusions
High weight fluctuation (ARV Q4) was associated with an increased incidence of ESRD in the general Korean population, with notable significance in men and in groups with sustained or increased weight. Clinically, individuals in the ARV Q4 category should be considered at risk for ESRD, and early interventions should be pursued for this population.
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.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.
6.The Korean Academy of Asthma Allergy and Clinical Immunology guidelines for sublingual immunotherapy
Gwanghui RYU ; Hye Mi JEE ; Hwa Young LEE ; Sung-Yoon KANG ; Kyunghoon KIM ; Ju Hee KIM ; Kyung Hee PARK ; So-Young PARK ; Myong Soon SUNG ; Youngsoo LEE ; Eun-Ae YANG ; Jin-Young MIN ; Eun Kyo HA ; Sang Min LEE ; Yong Won LEE ; Eun Hee CHUNG ; Sun Hee CHOI ; Young-Il KOH ; Seon Tae KIM ; Dong-Ho NAHM ; Jung Won PARK ; Jung Yeon SHIM ; Young Min AN ; Man Yong HAN ; Jeong-Hee CHOI ; Yoo Seob SHIN ; Doo Hee HAN ;
Allergy, Asthma & Respiratory Disease 2024;12(3):125-133
Allergen immunotherapy (AIT) has been used for over a century and has been demonstrated to be effective in treating patients with various allergic diseases. AIT allergens can be administered through various routes, including subcutaneous, sublingual, intralymphatic, oral, or epicutaneous routes. Sublingual immunotherapy (SLIT) has recently gained clinical interest, and it is considered an alternative treatment for allergic rhinitis (AR) and asthma. This review provides an overview of the current evidence-based studies that address the use of SLIT for treating AR, including (1) mechanisms of action, (2) appropriate patient selection for SLIT, (3) the current available SLIT products in Korea, and (4) updated information on its efficacy and safety. Finally, this guideline aims to provide the clinician with practical considerations for SLIT.
7.The Korean Academy of Asthma Allergy and Clinical Immunology guidelines for allergen immunotherapy
Hwa Young LEE ; Sung-Yoon KANG ; Kyunghoon KIM ; Ju Hee KIM ; Gwanghui RYU ; Jin-Young MIN ; Kyung Hee PARK ; So-Young PARK ; Myongsoon SUNG ; Youngsoo LEE ; Eun-Ae YANG ; Hye Mi JEE ; Eun Kyo HA ; Yoo Seob SHIN ; Sang Min LEE ; Eun Hee CHUNG ; Sun Hee CHOI ; Young-Il KOH ; Seon Tae KIM ; Dong-Ho NAHM ; Jung Won PARK ; Jung Yeon SHIM ; Young Min AN ; Doo Hee HAN ; Man Yong HAN ; Yong Won LEE ; Jeong-Hee CHOI ;
Allergy, Asthma & Respiratory Disease 2024;12(3):102-124
Allergen immunotherapy (AIT) is a causative treatment of allergic diseases in which allergen extracts are regularly administered in a gradually escalated doses, leading to immune tolerance and consequent alleviation of allergic diseases. The need for uniform practice guidelines in AIT is continuously growing as the number of potential candidates for AIT increases and new therapeutic approaches are tried. This updated version of the Korean Academy of Asthma Allergy and Clinical Immunology recommendations for AIT, published in 2010, proposes an expert opinion by specialists in allergy, pediatrics, and otorhinolaryngology. This guideline deals with the basic knowledge of AIT, including mechanisms, clinical efficacy, allergen standardization, important allergens in Korea, and special consideration in pediatrics. The article also covers the methodological aspects of AIT, including patient selection, allergen selection, schedule and doses, follow-up care, efficacy measurements, and management of adverse reactions. Although this guideline suggests the optimal dosing schedule, an individualized approach and modifications are recommended considering the situation for each patient and clinic.
8.The Modified S-GRAS Scoring System for Prognosis in Korean with Adrenocortical Carcinoma
Sun Kyung BAEK ; Seung Hun LEE ; Seung Shin PARK ; Chang Ho AHN ; Sung Hye KONG ; Won Woong KIM ; Yu-Mi LEE ; Su Jin KIM ; Dong Eun SONG ; Tae-Yon SUNG ; Kyu Eun LEE ; Jung Hee KIM ; Kyeong Cheon JUNG ; Jung-Min KOH
Endocrinology and Metabolism 2024;39(5):803-812
Background:
Adrenocortical carcinomas (ACCs) are rare tumors with aggressive but varied prognosis. Stage, Grade, Resection status, Age, Symptoms (S-GRAS) score, based on clinical and pathological factors, was found to best stratify the prognosis of European ACC patients. This study assessed the prognostic performance of modified S-GRAS (mS-GRAS) scores including modified grade (mG) by integrating mitotic counts into the Ki67 index (original grade), in Korean ACC patients.
Methods:
Patients who underwent surgery for ACC between January 1996 and December 2022 at three medical centers in Korea were retrospectively analyzed. mS-GRAS scores were calculated based on tumor stage, mG (Ki67 index or mitotic counts), resection status, age, and symptoms. Patients were divided into four groups (0–1, 2–3, 4–5, and 6–9 points) based on total mS-GRAS score. The associations of each variable and mS-GRAS score with recurrence and survival were evaluated using Cox regression analysis, Harrell’s concordance index (C-index), and the Kaplan–Meier method.
Results:
Data on mS-GRAS components were available for 114 of the 153 patients who underwent surgery for ACC. These 114 patients had recurrence and death rates of 61.4% and 48.2%, respectively. mS-GRAS score was a significantly better predictor of recurrence (C-index=0.829) and death (C-index=0.747) than each component (P<0.05), except for resection status. mS-GRAS scores correlated with shorter progression-free survival (P=8.34E-24) and overall survival (P=2.72E-13).
Conclusion
mS-GRAS scores showed better prognostic performance than tumor stage and grade in Asian patients who underwent surgery for ACC.
9.Perfusion Hyperintensities in Patients With Seizures: Evaluation With Arterial Spin Labeling Magnetic Resonance Imaging Within 24 Hours After Onset
Dong Hyun KOH ; Hyeong Gi CHOI ; Dae Seob CHOI ; Hwa Seon SHIN ; Hye Jin BAEK ; Young Soo KIM ; Eun Ha KOH
Investigative Magnetic Resonance Imaging 2024;28(1):18-26
Purpose:
We used arterial spin labeling (ASL) perfusion magnetic resonance (MR) imaging to evaluate cerebral perfusion abnormalities in patients with seizures within 24 hours of symptom onset.
Materials and Methods:
A retrospective search of our institutional database identified 27 patients who had undergone ASL perfusion studies for seizures or seizure-like symptoms.The inclusion criteria were as follows: 1) history of seizure, 2) MR examination performed within 24 hour of seizure onset, and 3) localized perfusion abnormality on ASL. We evaluated the presence, location, and extent of perfusion abnormalities on ASL and signal abnormalities on fluid-attenuated inversion recovery (FLAIR), diffusion-weighted image (DWI), and susceptibility-weighted image (SWI), respectively. All pathological MR findings, accompanying focal neurological symptoms, and electroencephalogram (EEG) findings were compared.
Results:
The mean time from symptom onset to MR examination was 5 h 54 min. All patients (n = 27) showed localized increased perfusion on ASL perfusion imaging. On FLAIR imaging, 20 patients (74.1%) showed hyperintensity in the area of perfusion abnormality.In 19 patients (70.4%), DWI showed hyperintensity of the lesion with decreased apparent diffusion coefficient value (ADC). Seven patients (25.9%) showed a focal parenchymal area of pseudo-narrowed cortical veins on SWI, associated with focal hyperperfusion. In 20 patients (74.1%), the extent of perfusion abnormalities on ASL was greater than that of signal abnormalities on FLAIR or DWI. In 14/16 patients (87.5%) with abnormal EEG findings, the area with EEG findings and the location of the hyperperfusion abnormality on ASL corresponded.
Conclusion
In patients with seizures within 24 hours of symptom onset, ASL perfusion imaging revealed localized hyperperfusion, which was more frequent than signal intensity abnormalities on FLAIR or DWI. The locations of hyperperfusion areas correlated with EEG abnormalities. Thus, the ASL sequence may be a useful clinical assessment protocol for evaluating patients with seizures.
10.Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial
Ji-Jung JUNG ; Jong-Ho CHEUN ; Soo-Yeon KIM ; Jiwon KOH ; Jai Min RYU ; Tae-Kyung YOO ; Hee-Chul SHIN ; Sung Gwe AHN ; Seho PARK ; Woosung LIM ; Sang-Eun NAM ; Min Ho PARK ; Ku Sang KIM ; Taewoo KANG ; Jeeyeon LEE ; Hyun Jo YOUN ; Yoo Seok KIM ; Chang Ik YOON ; Hong-Kyu KIM ; Hyeong-Gon MOON ; Wonshik HAN ; Nariya CHO ; Min Kyoon KIM ; Han-Byoel LEE
Journal of Breast Cancer 2024;27(1):61-71
Purpose:
Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.
Methods
The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.

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