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.Recommendations for Adult Immunization by the Korean Society of Infectious Diseases, 2023: Minor Revisions to the 3rd Edition
Won Suk CHOI ; Joon Young SONG ; Ki Tae KWON ; Hyo-Jin LEE ; Eun Ju CHOO ; Jihyeon BAEK ; BumSik CHIN ; Woo Joo KIM ; Mi Suk LEE ; Wan Beom PARK ; Sang Hoon HAN ; Jun Yong CHOI ; Joon Sup YEOM ; Jin-Soo LEE ; Hee-Jung CHOI ; Young Hwa CHOI ; Dong-Gun LEE ; Jung-Hyun CHOI ; Hee Jin CHEONG ;
Infection and Chemotherapy 2024;56(2):188-203
The Korean Society of Infectious Diseases has been regularly developing guidelines for adult immunization since 2007. In 2023, the guidelines for the following seven vaccines were revised: influenza, herpes zoster, pneumococcal, tetanus-diphtheria-pertussis (Tdap), human papillomavirus (HPV), meningococcal, and rabies vaccines. For the influenza vaccine, a recommendation for enhanced vaccines for the elderly was added. For the herpes zoster vaccine, a recommendation for the recombinant zoster vaccine was added. For the pneumococcal vaccine, the current status of the 15-valent pneumococcal conjugate vaccine and 20-valent PCV was described. For the Tdap vaccine, the possibility of using Tdap instead of tetanus-diphtheria vaccine was described. For the HPV vaccine, the expansion of the eligible age for vaccination was described. For the meningococcal vaccine, a recommendation for the meningococcal B vaccine was added. For the rabies vaccine, the number of pre-exposure prophylaxis doses was changed. This manuscript documents the summary and rationale of the revisions for the seven vaccines. For the vaccines not mentioned in this manuscript, the recommendations in the 3rd edition of the Vaccinations for Adults textbook shall remain in effect.
7.The Korean Medication Algorithm Project for Depressive Disorder 2021: Comparisons with Other Treatment Guidelines
Young Sup WOO ; Won-Myong BAHK ; Jeong Seok SEO ; Young-Min PARK ; Won KIM ; Jong-Hyun JEONG ; Se-Hoon SHIM ; Jung Goo LEE ; Seung-Ho JANG ; Chan-Mo YANG ; Sheng-Min WANG ; Myung Hun JUNG ; Hyung Mo SUNG ; Il Han CHOO ; Bo-Hyun YOON ; Sang-Yeol LEE ; Duk-In JON ; Kyung Joon MIN
Clinical Psychopharmacology and Neuroscience 2022;20(1):37-50
The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) first was published in 2002, and has been revised four times, in 2006, 2012, 2017, and 2021. In this review, we compared recommendations from the recently revised KMAP-DD 2021 to four global clinical practice guidelines (CPGs) for depression published after 2010. The recommendations from the KMAP-DD 2021 were similar to those from other CPGs, although there were some differences. The KMAP-DD 2021 reflected social culture and the healthcare system in Korea and recent evidence about pharmacotherapy for depression, as did other recently published evidence-based guidelines. Despite some intrinsic limitations as an expert consensus-based guideline, the KMAP-DD 2021 can be helpful for Korean psychiatrists making decisions in clinical settings by complementing previously published evidence-based guidelines, especially for some clinical situations lacking evidence from rigorously designed clinical trials.
8.Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study
Hee Seo SON ; Cheol Young OH ; Myung-Soo CHOO ; Hyeong Gon KIM ; Joon Chul KIM ; Kyu-Sung LEE ; Dong Gil SHIN ; Sung Yong CHO ; Seong Jin JEONG ; Ju Tae SEO ; Hana YOON ; Hong Sang MOON ; Jang Hwan KIM
International Neurourology Journal 2022;26(2):119-128
Purpose:
DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients.
Methods:
This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged ≥19 years with OAB symptoms for ≥3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=∆) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients’ subjective responses were analyzed.
Results:
In the full analysis set, the mean (standard deviation) [median] values for ∆ 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in ∆ 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ∆ number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient.
Conclusions
Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.
9.Korean Medication Algorithm Project for Depressive Disorder 2021 (III): Child and Adolescent
Chan-Mo YANG ; Se-Hoon SHIM ; Won-Myong BAHK ; Young Sup WOO ; Jong-Hyun JEONG ; Sheng-Min WANG ; Won KIM ; Jeong Seok SEO ; Jung Goo LEE ; Young-Min PARK ; Seung-Ho JANG ; Myung Hun JUNG ; Hyung Mo SUNG ; IL Han CHOO ; Bo-Hyun YOON ; Sang-Yeol LEE ; Duk-In JON ; Kyung Joon MIN
Journal of Korean Neuropsychiatric Association 2021;60(3):193-203
Objectives:
The Korean Medication Algorithm Project for Depressive Disorder 2021 (KMAP-DD 2021) was a revision of previous works. The main purpose of the current study was to amend guidelines for the treatment of a major depressive disorder (MDD) for children and adolescents.
Methods:
The survey consisted of 21 questionnaires for children and adolescents. A total of 33 of the 46 experts in child and adolescent psychiatry answered the survey.
Results:
Antidepressant (AD) monotherapy was selected as the 1st line option for MDD with mild to moderate severity. As the 1st line of treatment for MDD severe without psychotic features in children and adolescents, AD monotherapy and AD augmented with atypical antipsychotics (AAP) were recommended. For MDD with psychotic features, AD augmented with AAP was preferred as the 1st line of treatment.
Conclusion
We developed an algorithm for child and adolescent populations with depressive disorders, more specifically than the KMAP-DD 2017. We expect this algorithm will provide clinicians useful information and help in the treatment of children and adolescents with depressive disorders.
10.Korean Medication Algorithm Project for Depressive Disorder 2021 (II): The Subtypes of Depression
Young-Min PARK ; Jeong Seok SEO ; Young Sup WOO ; Won-Myong BAHK ; Won KIM ; Jong-Hyun JEONG ; Se-Hoon SHIM ; Jung Goo LEE ; Seung-Ho JANG ; Sheng-Min WANG ; Myung Hun JUNG ; Hyung Mo SUNG ; L Han CHOO ; Bo-Hyun YOON ; Sang-Yeol LEE ; Duk-In JON ; Kyung Joon MIN
Journal of Korean Neuropsychiatric Association 2021;60(3):186-192
Objectives:
The Korean Medication Algorithm Project for Depressive Disorder (KMAP-DD) was developed in 2002 and revised in 2006, 2012, 2017. In 2021, the fifth edition was published.This edition reflected new findings and the latest trends in the areas of pharmacological treatment. The aim of this study is to present strategies and treatment options according to the subtype of depression using data from the KMAP-DD-2021.
Methods:
Ninety-seven psychiatrists with clinical experience in depressive disorder were selected. The questionnaires for KMAP-DD 2021 were sent to participants via mail. KMAP-DD 2021 consists of overall treatment strategies and treatment options under specific circumstances.Each treatment strategy or treatment option was evaluated with an overall score of nine and was divided into the three phases of recommendation that include primary, secondary, and tertiary.
Results:
For persisting depressive disorder, antidepressant monotherapy including selective serotonin reuptake inhibitor (SSRI) (escitalopram, fluoxetine, sertraline, paroxetine), serotoninnorepinephrine reuptake inhibitor (SNRI) (desvenlafaxine, venlafaxine, duloxetine, milnacipran), vortioxetine, and mirtazapine, was recommended as first-line medications. For melancholia of major depressive disorder, SSRI, SNRI, vortioxetine, and mirtazapine also were recommended as first-line medications. For mixed features, SSRI, bupropion, mirtazapine, SNRI, except for duloxetine, and milnacipran were recommended as first-line medications. For anxious distress, SSRI, mirtazapine, and SNRI, except milnacipran, were recommended as first-line medications.
Conclusion
The preferences of antidepressants by experts differed according to the subtype of depression. These findings suggest that experts treat patients with a major depressive disorder after considering the subtype of depression involved.

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