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.ACTG2 Variants in Pediatric Chronic Intestinal Pseudo-obstruction With Megacystis
Jong Woo HAHN ; Soo Young MOON ; Min Soo KIM ; Min Hyung WOO ; Min Ji SOHN ; Hyun-Young KIM ; Moon-Woo SEONG ; Sung Sup PARK ; Sung-Hye PARK ; Jin Soo MOON ; Jae Sung KO
Journal of Neurogastroenterology and Motility 2022;28(1):104-110
Background/Aims:
Chronic intestinal pseudo-obstruction (CIPO) is a clinically heterogeneous syndrome characterized by compromised peristalsis and intestinal obstruction. Variants of actin gamma 2 (ACTG2), a protein crucial for correct enteric muscle contraction, have been found in CIPO patients. The aim of this study is to examine the clinical features and ACTG2 variants in Korean patients with CIPO.
Methods:
From January 1995 to August 2020, 12 patients diagnosed with CIPO were included and genetic analysis testing of ACTG2 was performed.
Results:
Heterozygous ACTG2 missense variants were found in 6 patients (50.0%). The p.Arg257Cys variant was found in 3 patients, and p.Arg63Gln and p.Arg178His variants were found in 1 patient each. A novel variant, p.Ile193Phe, was found in 1 patient. Three patients were diagnosed at birth, 2 at the age of 1 year, and 1 at 3 years of age. Abnormal prenatal genitourinary ultrasonographic findings were found in all 6 patients; microcolon was found in 4 patients (66.7%), and megacystis in all 6 patients. The pathology showed abnormal ganglion cells as well as myopathic findings. All patients are dependent on total parenteral nutrition and are to date alive.
Conclusions
ACTG2 variants are commonly found in Korean patients with CIPO. In CIPO patients with megacystis and abnormal prenatal ultrasonography, genetic testing of ACTG2 should be considered. Molecular diagnosis of CIPO is more important than pathologic diagnosis.
6.Clinical use of perioperative magnetic resonance imaging-based breast volumetric analysis in final implant volume prediction for two-stage breast reconstruction
Min Ji KIM ; Tae Wook KIM ; Hyung Min HAHN ; Il Jae LEE
Annals of Surgical Treatment and Research 2022;103(4):195-204
Purpose:
Breast volume is an important factor in breast reconstruction; however, the surgeon is expected to deliver the volume expectation with his aesthetic inspiration. Therefore, objective volumetry must be developed. This study aimed to conduct an MRI-based breast volumetric analysis. With periodic analysis of 2-stage breast reconstruction, we suggest the possibility of clinical use of breast volumetry in implant volume prediction.
Methods:
This retrospective study included 140 patients who underwent unilateral 2-stage breast reconstruction (tissue expander followed by implant insertion) between January 1, 2017 and December 31, 2019. The MRI image was converted into a 3-dimensional image with a reconstruction program (A-VIEW, Coreline Soft). MRI image was obtained before the surgery and then at 1, 3, 6, 12, and 24 months postoperatively. The volume was automatically calculated.
Results:
Compared with the preoperative volume, maximized volume and differences were noted at 1 month and minimized at 1 year. The correlation between MRI-based preoperative breast volumetry and the mastectomy specimen volume was 0.611. Volume difference between the MRI-based preoperative state and the implant volume showed a minimal difference at 1 year. The final implant size prediction formula was calculated using the 1-year postoperative volume (P < 0.001, R 2= 0.594).
Conclusion
To avoid breast reconstruction based solely on the surgeon’s subjective assessment, MRI-based breast volumetry could be a useful method to develop more scientific and objective breast reconstruction planning. We suggest a volume prediction formula that describes the relationship between the postoperative breast volume and the final breast implant size.
7.Erratum: Correction of Affiliations in the Article “Clinical Characteristics and Treatment Outcomes in Children, Adolescents, and Young-adults with Hodgkin's Lymphoma: a KPHOG Lymphoma Working-party, Multicenter, Retrospective Study”
Jae Min LEE ; Jung Yoon CHOI ; Kyung Taek HONG ; Hyoung Jin KANG ; Hee Young SHIN ; Hee Jo BAEK ; Hoon KOOK ; Seongkoo KIM ; Jae Wook LEE ; Nack-Gyun CHUNG ; Bin CHO ; Seok-Goo CHO ; Kyung Mi PARK ; Eu Jeen YANG ; Young Tak LIM ; Jin Kyung SUH ; Sung Han KANG ; Hyery KIM ; Kyung-Nam KOH ; Ho Joon IM ; Jong Jin SEO ; Hee Won CHO ; Hee Young JU ; Ji Won LEE ; Keon Hee YOO ; Ki Woong SUNG ; Hong Hoe KOO ; Kyung Duk PARK ; Jeong Ok HAH ; Min Kyoung KIM ; Jung Woo HAN ; Seung Min HAHN ; Chuhl Joo LYU ; Ye Jee SHIM ; Heung Sik KIM ; Young Rok DO ; Jae Won YOO ; Yeon Jung LIM ; In-Sang JEON ; Hee won CHUEH ; Sung Yong OH ; Hyoung Soo CHOI ; Jun Eun PARK ; Jun Ah LEE ; Hyeon Jin PARK ; Byung-Kiu PARK ; Soon Ki KIM ; Jae Young LIM ; Eun Sil PARK ; Sang Kyu PARK ; Eun Jin CHOI ; Young Bae CHOI ; Jong Hyung YOON ;
Journal of Korean Medical Science 2021;36(4):e37-
8.Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System in Children under the Age of 3 Years
Meerim PARK ; Jung Woo HAN ; Seung Min HAHN ; Jun Ah LEE ; Joo-Young KIM ; Sang Hoon SHIN ; Dong-Seok KIM ; Hong In YOON ; Kyung Taek HONG ; Jung Yoon CHOI ; Hyoung Jin KANG ; Hee Young SHIN ; Ji Hoon PHI ; Seung-Ki KIM ; Ji Won LEE ; Keon Hee YOO ; Ki Woong SUNG ; Hong Hoe KOO ; Do Hoon LIM ; Hyung Jin SHIN ; Hyery KIM ; Kyung-Nam KOH ; Ho Joon IM ; Seung Do AHN ; Young-Shin RA ; Hee-Jo BAEK ; Hoon KOOK ; Tae-Young JUNG ; Hyoung Soo CHOI ; Chae-Yong KIM ; Hyeon Jin PARK ; Chuhl Joo LYU
Cancer Research and Treatment 2021;53(2):378-388
Purpose:
Atypical teratoid/rhabdoid tumor (ATRT) is a highly aggressive malignancy with peak incidence in children aged less than 3 years. Standard treatment for central nervous system ATRT in children under the age of 3 years have not been established yet. The objective of this study was to analyze characteristics and clinical outcomes of ATRT in children aged less than 3 years.
Materials and Methods:
A search of medical records from seven centers was performed between January 2005 and December 2016.
Results:
Forty-three patients were enrolled. With a median follow-up of 90 months, 27 patients (64.3%) showed at least one episode of disease progression (PD). The first date of PD was at 160 days after diagnosis. The 1- and 3-year progression-free survivals (PFS) were 51.2% and 28.5%, respectively. The 1- and 3-year overall survivals were 61.9% and 38.1%, respectively. The 3-year PFS was improved from 0% in pre-2011 to 47.4% in post-2011. Excluding one patient who did not receive any further therapy after surgery, 27 patients died due to PD (n=21), treatment-related toxicity (n=5), or unknown cause (n=1). In univariate analysis, factors associated with higher 3-year PFS were no metastases, diagnosis after 2011, early adjuvant radiotherapy, and high-dose chemotherapy (HDCT). In multivariate analysis, the use of HDCT and adjuvant radiotherapy remained significant prognostic factors for PFS (both p < 0.01).
Conclusion
Aggressive therapy including early adjuvant radiotherapy and HDCT could be considered to improve outcomes of ATRT in children under the age of 3 years.
9.Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System in Children under the Age of 3 Years
Meerim PARK ; Jung Woo HAN ; Seung Min HAHN ; Jun Ah LEE ; Joo-Young KIM ; Sang Hoon SHIN ; Dong-Seok KIM ; Hong In YOON ; Kyung Taek HONG ; Jung Yoon CHOI ; Hyoung Jin KANG ; Hee Young SHIN ; Ji Hoon PHI ; Seung-Ki KIM ; Ji Won LEE ; Keon Hee YOO ; Ki Woong SUNG ; Hong Hoe KOO ; Do Hoon LIM ; Hyung Jin SHIN ; Hyery KIM ; Kyung-Nam KOH ; Ho Joon IM ; Seung Do AHN ; Young-Shin RA ; Hee-Jo BAEK ; Hoon KOOK ; Tae-Young JUNG ; Hyoung Soo CHOI ; Chae-Yong KIM ; Hyeon Jin PARK ; Chuhl Joo LYU
Cancer Research and Treatment 2021;53(2):378-388
Purpose:
Atypical teratoid/rhabdoid tumor (ATRT) is a highly aggressive malignancy with peak incidence in children aged less than 3 years. Standard treatment for central nervous system ATRT in children under the age of 3 years have not been established yet. The objective of this study was to analyze characteristics and clinical outcomes of ATRT in children aged less than 3 years.
Materials and Methods:
A search of medical records from seven centers was performed between January 2005 and December 2016.
Results:
Forty-three patients were enrolled. With a median follow-up of 90 months, 27 patients (64.3%) showed at least one episode of disease progression (PD). The first date of PD was at 160 days after diagnosis. The 1- and 3-year progression-free survivals (PFS) were 51.2% and 28.5%, respectively. The 1- and 3-year overall survivals were 61.9% and 38.1%, respectively. The 3-year PFS was improved from 0% in pre-2011 to 47.4% in post-2011. Excluding one patient who did not receive any further therapy after surgery, 27 patients died due to PD (n=21), treatment-related toxicity (n=5), or unknown cause (n=1). In univariate analysis, factors associated with higher 3-year PFS were no metastases, diagnosis after 2011, early adjuvant radiotherapy, and high-dose chemotherapy (HDCT). In multivariate analysis, the use of HDCT and adjuvant radiotherapy remained significant prognostic factors for PFS (both p < 0.01).
Conclusion
Aggressive therapy including early adjuvant radiotherapy and HDCT could be considered to improve outcomes of ATRT in children under the age of 3 years.
10.In Vitro Analysis of Histology, Mechanics, and Safety of Radiationfree Pre-hydrated Human Acellular Dermal Matrix
Ji Young KIM ; Kyung Min YANG ; Ji Hyun YOUN ; Heejun PARK ; Hyung Min HAHN ; Il Jae LEE
Journal of Breast Cancer 2020;23(6):635-646
Purpose:
Acellular dermal matrix (ADM) supports tissue expanders or implants in implant-based breast reconstruction. The characteristics of ADM tissue are defined by the manufacturing procedure, such as decellularization, preservation, and sterilization, and are directly related to clinical outcomes. This study aimed to compare the properties of a new pre-hydrated-ADM (H-ADM-low) obtained using a decellularization reagent reduction process with a low concentration of detergent with those of radiation-sterilized H-ADM and freeze-dried ADM (FD-ADM).
Methods:
ADMs were evaluated in terms of structure, mechanical quality, and cytotoxicity using histochemical staining, tensile strength testing, and in vitro cell viability analysis.
Results:
The tissue structure of H-ADM-low (CGDERM ONE-STEP) was similar to that of native skin despite complete decellularization. By contrast, in FD-ADM, the tissue structure was damaged by the freeze-drying process, and radiation-sterilized H-ADM showed a compact fibrillar arrangement. Furthermore, matrix components such as collagen and elastin were preserved in H-ADM-low, whereas a loss of elastin fibers with fragmented distribution was observed in radiation-sterilized H-ADMs. H-ADM-low's tensile strength (58.84 MPa) was significantly greater than that of FD-ADM (38.60 MPa) and comparable with that of radiationsterilized H-ADMs. The residual detergent content in H-ADM-low (47.45 mg/L) was 2.67-fold lower than that of H-ADM decellularized with a conventional detergent concentration (126.99 mg/mL), and this finding was consistent with the cell viability results (90.7% and 70.7%, respectively), indicating that H-ADM-low has very low cytotoxicity.
Conclusions
H-ADM-low produced through aseptic processes retains the original tissue structure, demonstrates excellent mechanical properties, and does not affect cell viability.Therefore, this newer H-ADM is suitable for use in implant-based breast reconstruction.

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