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.Detection of Clarithromycin Resistance in Helicobacter pylori Using the AllplexTM H. pylori & ClariR Assay and the Ezplex® HP-CLA Real-Time PCR Kit
Tae-Woo KIM ; Won Seok LEE ; Dong Jin YOON ; Ilsoo KIM ; Joon Sung KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2025;25(1):42-47
Objectives:
The success of Helicobacter pylori eradication using clarithromycin-based triple therapy relies on the bacteria being sensitive to clarithromycin. This study evaluated the diagnostic performance of two frequently used polymerase chain reaction (PCR) methods (AllplexTM H. pylori & ClariR Assay [Seegene] and Ezplex® HP-CLA Real-time PCR [SML Genetree]) to detect H. pylori infection and identify point mutations associated with clarithromycin resistance.
Methods:
Patients who underwent esophagogastroduodenoscopy between August 2023 and April 2024 at Incheon St. Mary’s Hospital were enrolled in this study. The diagnostic performance of the Allplex method was evaluated against the rapid urease test (RUT), culture, and Ezplex HP-CLA methods. Point mutation detection using the Allplex and Ezplex methods was compared with the results of gene sequencing. The rates of H. pylori eradication following Ezplex-based tailored therapy were also analyzed.
Results:
Eighty-seven gastric biopsy specimens were analyzed. For diagnosing H. pylori infections, Allplex demonstrated kappa values of 0.670 compared with RUT, 0.468 compared with culture, and 0.880 compared with Ezplex. Among the 87 bacterial isolates subjected to gene sequencing to detect clarithromycin resistance-associated point mutations, the Allplex and Ezplex methods demonstrated 74 and 76 concordant results, respectively. The H. pylori eradication rate using Ezplex-based tailored therapy was 90.7%.
Conclusions
This study demonstrated that both the Allplex and Ezplex methods are helpful for diagnosing H. pylori infections and detecting clarithromycin resistance. Furthermore, the Ezplex method was clinically effective for guiding tailored therapy to yield successful H. pylori eradication.
4.Better Chemotherapeutic Response of Small Cell Lung Cancer in Never Smokers than in Smokers
Ha-Young PARK ; Hyung-Joo OH ; Hwa Kyung PARK ; Joon-Young YOON ; Chang-Seok YOON ; Bo Gun KHO ; Tae-Ok KIM ; Hong-Joon SHIN ; Chul-Kyu PARK ; Yong-Soo KWON ; Yu-Il KIM ; Sung-Chul LIM ; Young-Chul KIM ; In-Jae OH
Tuberculosis and Respiratory Diseases 2025;88(2):334-341
Background:
Small cell lung cancer (SCLC) is called ‘smoker’s disease’ because it is strongly associated with smoking and most cases occur in smokers. However, it can also occur in never smokers. We investigated the clinical features of never smokers with SCLC and compared their treatment outcomes with those of smokers with SCLC.
Methods:
We retrospectively reviewed the clinical data of patients who had proven SCLC and had received chemotherapy at a single cancer center between July 2002 and April 2021.
Results:
Of 1,643 patients, 1,416 (86.2%) were enrolled in this study. A total of 162 (11.4%) and 1,254 (88.6%) patients were never smokers and smokers, respectively. There were more female never smokers than smokers (n=130; 80.2% vs. 79, 6.3%, p=0.000), and the incidence of ischemic heart disease was lower among never smokers than among smokers (4/1,416, [2.5%] vs. 83/1,416 [6.6%], p=0.036). Never smokers showed less symptoms at diagnosis than smokers (80.9% vs. 87.2%, p=0.037); however, they showed more toxicity after first-line treatment (61.7% vs. 47.8%, p=0.001). The objective response rate (ORR) was significantly higher in never smokers (74.1% vs. 59.6%, p=0.000). In the multivariate analysis, never smoking and second-line treatment were associated with a better ORR. However, progression-free survival and overall survival were not significantly different between never smokers and smokers.
Conclusion
In conclusion, never smokers accounted for 11.4% of patients with SCLC. They had distinguishing clinical characteristics and showed better chemotherapeutic responses than smokers.
5.Detection of Clarithromycin Resistance in Helicobacter pylori Using the AllplexTM H. pylori & ClariR Assay and the Ezplex® HP-CLA Real-Time PCR Kit
Tae-Woo KIM ; Won Seok LEE ; Dong Jin YOON ; Ilsoo KIM ; Joon Sung KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2025;25(1):42-47
Objectives:
The success of Helicobacter pylori eradication using clarithromycin-based triple therapy relies on the bacteria being sensitive to clarithromycin. This study evaluated the diagnostic performance of two frequently used polymerase chain reaction (PCR) methods (AllplexTM H. pylori & ClariR Assay [Seegene] and Ezplex® HP-CLA Real-time PCR [SML Genetree]) to detect H. pylori infection and identify point mutations associated with clarithromycin resistance.
Methods:
Patients who underwent esophagogastroduodenoscopy between August 2023 and April 2024 at Incheon St. Mary’s Hospital were enrolled in this study. The diagnostic performance of the Allplex method was evaluated against the rapid urease test (RUT), culture, and Ezplex HP-CLA methods. Point mutation detection using the Allplex and Ezplex methods was compared with the results of gene sequencing. The rates of H. pylori eradication following Ezplex-based tailored therapy were also analyzed.
Results:
Eighty-seven gastric biopsy specimens were analyzed. For diagnosing H. pylori infections, Allplex demonstrated kappa values of 0.670 compared with RUT, 0.468 compared with culture, and 0.880 compared with Ezplex. Among the 87 bacterial isolates subjected to gene sequencing to detect clarithromycin resistance-associated point mutations, the Allplex and Ezplex methods demonstrated 74 and 76 concordant results, respectively. The H. pylori eradication rate using Ezplex-based tailored therapy was 90.7%.
Conclusions
This study demonstrated that both the Allplex and Ezplex methods are helpful for diagnosing H. pylori infections and detecting clarithromycin resistance. Furthermore, the Ezplex method was clinically effective for guiding tailored therapy to yield successful H. pylori eradication.
6.Better Chemotherapeutic Response of Small Cell Lung Cancer in Never Smokers than in Smokers
Ha-Young PARK ; Hyung-Joo OH ; Hwa Kyung PARK ; Joon-Young YOON ; Chang-Seok YOON ; Bo Gun KHO ; Tae-Ok KIM ; Hong-Joon SHIN ; Chul-Kyu PARK ; Yong-Soo KWON ; Yu-Il KIM ; Sung-Chul LIM ; Young-Chul KIM ; In-Jae OH
Tuberculosis and Respiratory Diseases 2025;88(2):334-341
Background:
Small cell lung cancer (SCLC) is called ‘smoker’s disease’ because it is strongly associated with smoking and most cases occur in smokers. However, it can also occur in never smokers. We investigated the clinical features of never smokers with SCLC and compared their treatment outcomes with those of smokers with SCLC.
Methods:
We retrospectively reviewed the clinical data of patients who had proven SCLC and had received chemotherapy at a single cancer center between July 2002 and April 2021.
Results:
Of 1,643 patients, 1,416 (86.2%) were enrolled in this study. A total of 162 (11.4%) and 1,254 (88.6%) patients were never smokers and smokers, respectively. There were more female never smokers than smokers (n=130; 80.2% vs. 79, 6.3%, p=0.000), and the incidence of ischemic heart disease was lower among never smokers than among smokers (4/1,416, [2.5%] vs. 83/1,416 [6.6%], p=0.036). Never smokers showed less symptoms at diagnosis than smokers (80.9% vs. 87.2%, p=0.037); however, they showed more toxicity after first-line treatment (61.7% vs. 47.8%, p=0.001). The objective response rate (ORR) was significantly higher in never smokers (74.1% vs. 59.6%, p=0.000). In the multivariate analysis, never smoking and second-line treatment were associated with a better ORR. However, progression-free survival and overall survival were not significantly different between never smokers and smokers.
Conclusion
In conclusion, never smokers accounted for 11.4% of patients with SCLC. They had distinguishing clinical characteristics and showed better chemotherapeutic responses than smokers.
7.Detection of Clarithromycin Resistance in Helicobacter pylori Using the AllplexTM H. pylori & ClariR Assay and the Ezplex® HP-CLA Real-Time PCR Kit
Tae-Woo KIM ; Won Seok LEE ; Dong Jin YOON ; Ilsoo KIM ; Joon Sung KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2025;25(1):42-47
Objectives:
The success of Helicobacter pylori eradication using clarithromycin-based triple therapy relies on the bacteria being sensitive to clarithromycin. This study evaluated the diagnostic performance of two frequently used polymerase chain reaction (PCR) methods (AllplexTM H. pylori & ClariR Assay [Seegene] and Ezplex® HP-CLA Real-time PCR [SML Genetree]) to detect H. pylori infection and identify point mutations associated with clarithromycin resistance.
Methods:
Patients who underwent esophagogastroduodenoscopy between August 2023 and April 2024 at Incheon St. Mary’s Hospital were enrolled in this study. The diagnostic performance of the Allplex method was evaluated against the rapid urease test (RUT), culture, and Ezplex HP-CLA methods. Point mutation detection using the Allplex and Ezplex methods was compared with the results of gene sequencing. The rates of H. pylori eradication following Ezplex-based tailored therapy were also analyzed.
Results:
Eighty-seven gastric biopsy specimens were analyzed. For diagnosing H. pylori infections, Allplex demonstrated kappa values of 0.670 compared with RUT, 0.468 compared with culture, and 0.880 compared with Ezplex. Among the 87 bacterial isolates subjected to gene sequencing to detect clarithromycin resistance-associated point mutations, the Allplex and Ezplex methods demonstrated 74 and 76 concordant results, respectively. The H. pylori eradication rate using Ezplex-based tailored therapy was 90.7%.
Conclusions
This study demonstrated that both the Allplex and Ezplex methods are helpful for diagnosing H. pylori infections and detecting clarithromycin resistance. Furthermore, the Ezplex method was clinically effective for guiding tailored therapy to yield successful H. pylori eradication.
8.Better Chemotherapeutic Response of Small Cell Lung Cancer in Never Smokers than in Smokers
Ha-Young PARK ; Hyung-Joo OH ; Hwa Kyung PARK ; Joon-Young YOON ; Chang-Seok YOON ; Bo Gun KHO ; Tae-Ok KIM ; Hong-Joon SHIN ; Chul-Kyu PARK ; Yong-Soo KWON ; Yu-Il KIM ; Sung-Chul LIM ; Young-Chul KIM ; In-Jae OH
Tuberculosis and Respiratory Diseases 2025;88(2):334-341
Background:
Small cell lung cancer (SCLC) is called ‘smoker’s disease’ because it is strongly associated with smoking and most cases occur in smokers. However, it can also occur in never smokers. We investigated the clinical features of never smokers with SCLC and compared their treatment outcomes with those of smokers with SCLC.
Methods:
We retrospectively reviewed the clinical data of patients who had proven SCLC and had received chemotherapy at a single cancer center between July 2002 and April 2021.
Results:
Of 1,643 patients, 1,416 (86.2%) were enrolled in this study. A total of 162 (11.4%) and 1,254 (88.6%) patients were never smokers and smokers, respectively. There were more female never smokers than smokers (n=130; 80.2% vs. 79, 6.3%, p=0.000), and the incidence of ischemic heart disease was lower among never smokers than among smokers (4/1,416, [2.5%] vs. 83/1,416 [6.6%], p=0.036). Never smokers showed less symptoms at diagnosis than smokers (80.9% vs. 87.2%, p=0.037); however, they showed more toxicity after first-line treatment (61.7% vs. 47.8%, p=0.001). The objective response rate (ORR) was significantly higher in never smokers (74.1% vs. 59.6%, p=0.000). In the multivariate analysis, never smoking and second-line treatment were associated with a better ORR. However, progression-free survival and overall survival were not significantly different between never smokers and smokers.
Conclusion
In conclusion, never smokers accounted for 11.4% of patients with SCLC. They had distinguishing clinical characteristics and showed better chemotherapeutic responses than smokers.
9.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.
10.Detection of Clarithromycin Resistance in Helicobacter pylori Using the AllplexTM H. pylori & ClariR Assay and the Ezplex® HP-CLA Real-Time PCR Kit
Tae-Woo KIM ; Won Seok LEE ; Dong Jin YOON ; Ilsoo KIM ; Joon Sung KIM
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2025;25(1):42-47
Objectives:
The success of Helicobacter pylori eradication using clarithromycin-based triple therapy relies on the bacteria being sensitive to clarithromycin. This study evaluated the diagnostic performance of two frequently used polymerase chain reaction (PCR) methods (AllplexTM H. pylori & ClariR Assay [Seegene] and Ezplex® HP-CLA Real-time PCR [SML Genetree]) to detect H. pylori infection and identify point mutations associated with clarithromycin resistance.
Methods:
Patients who underwent esophagogastroduodenoscopy between August 2023 and April 2024 at Incheon St. Mary’s Hospital were enrolled in this study. The diagnostic performance of the Allplex method was evaluated against the rapid urease test (RUT), culture, and Ezplex HP-CLA methods. Point mutation detection using the Allplex and Ezplex methods was compared with the results of gene sequencing. The rates of H. pylori eradication following Ezplex-based tailored therapy were also analyzed.
Results:
Eighty-seven gastric biopsy specimens were analyzed. For diagnosing H. pylori infections, Allplex demonstrated kappa values of 0.670 compared with RUT, 0.468 compared with culture, and 0.880 compared with Ezplex. Among the 87 bacterial isolates subjected to gene sequencing to detect clarithromycin resistance-associated point mutations, the Allplex and Ezplex methods demonstrated 74 and 76 concordant results, respectively. The H. pylori eradication rate using Ezplex-based tailored therapy was 90.7%.
Conclusions
This study demonstrated that both the Allplex and Ezplex methods are helpful for diagnosing H. pylori infections and detecting clarithromycin resistance. Furthermore, the Ezplex method was clinically effective for guiding tailored therapy to yield successful H. pylori eradication.

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