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.Subacromial Steroid Injection Is Safe and Effective in Patients with Persistent Painful Stiffness after Arthroscopic Rotator Cuff Repair: a Level III Retrospective Cohort Study in Korea
Ajay WANKHADE ; Hyeon Jang JEONG ; Young Ki MIN ; Ji Hyun YEO ; Je Kyun KIM ; Joo Han OH
The Korean Journal of Sports Medicine 2025;43(1):30-36
Purpose:
Persistent postoperative stiffness is a common complication after arthroscopic rotator cuff repair (ARCR).We hypothesized that a subacromial steroid injection (SAI) may improve the early outcomes in patients with persistent stiffness without increasing steroid-associated complications. Therefore, we evaluated the effectiveness and safety of SAI in patients with persistent stiffness 3 months after ARCR.
Methods:
We retrospectively analyzed 300 ARCR cases performed between January 2012 and May 2014, in which repair integrity was confirmed at postoperative 3 months. Patients were divided into SAI and control groups. The SAI group received a single SAI (triamcinolone 40 mg and ropivacaine 52.5 mg) to address postoperative stiffness, with no additional SAI thereafter. The control group did not receive any injections until the final follow-up. Functional and radiological outcomes were compared between the two groups.
Results:
The mean follow-up period was 18.1±4.7 months (range, 12.1–37.2 months), with no difference between groups (p=0.731). At the time of injection, the range of motion was significantly lower in the SAI (all p<0.001). However, functional outcomes were comparable between the two groups at 3 months after injection and the final follow-up (all p> 0.05). The healing failure rate at the final follow-up also did not differ between the SAI and control groups (14.9% vs. 13.2%, p=0.671).
Conclusion
This short-term follow-up study suggests that the administration of a single SAI to treat persistent stiffness at 3 months after ARCR may improve functional recovery without increasing the risk of healing failure.
4.The Application of L-Serine-Incorporated Gelatin Sponge into the Calvarial Defect of the Ovariectomized Rats
Yoon-Jo LEE ; Ji-Hyeon OH ; Suyeon PARK ; Jongho CHOI ; Min-Ho HONG ; HaeYong KWEON ; Weon-Sik CHAE ; Xiangguo CHE ; Je-Yong CHOI ; Seong-Gon KIM
Tissue Engineering and Regenerative Medicine 2025;22(1):91-104
BACKGROUND:
Osteoporosis, characterized by decreased bone mineral density due to an imbalance between osteoblast and osteoclast activity, poses significant challenges in bone healing, particularly in postmenopausal women. Current treatments, such as bisphosphonates, are effective but associated with adverse effects like medication-related osteonecrosis of the jaw, necessitating safer alternatives.
METHODS:
This study investigated the use of L-serine-incorporated gelatin sponges for bone regeneration in calvarial defects in an ovariectomized rat model of osteoporosis. Thirty rats were divided into three groups: a control group, a group treated with a gelatin sponge containing an amino acid mixture, and a group treated with a gelatin sponge containing L-serine. Bone regeneration was assessed using micro-computed tomography (micro-CT) and histological analyses.
RESULTS:
The L-serine group showed a significant increase in bone volume (BV) and bone area compared to the control and amino acid groups. The bone volume to total volume (BV/TV) ratio was also significantly higher in the L-serine group.Immunohistochemical analysis demonstrated that L-serine treatment suppressed the expression of cathepsin K, a marker of osteoclast activity, while increasing serine racemase activity.
CONCLUSION
These findings suggest that L-serine-incorporated gelatin sponges not only enhance bone formation but also inhibit osteoclast-mediated bone resorption, providing a promising and safer alternative to current therapies for osteoporosis-related bone defects. Further research is needed to explore its clinical applications in human patients.
5.Subacromial Steroid Injection Is Safe and Effective in Patients with Persistent Painful Stiffness after Arthroscopic Rotator Cuff Repair: a Level III Retrospective Cohort Study in Korea
Ajay WANKHADE ; Hyeon Jang JEONG ; Young Ki MIN ; Ji Hyun YEO ; Je Kyun KIM ; Joo Han OH
The Korean Journal of Sports Medicine 2025;43(1):30-36
Purpose:
Persistent postoperative stiffness is a common complication after arthroscopic rotator cuff repair (ARCR).We hypothesized that a subacromial steroid injection (SAI) may improve the early outcomes in patients with persistent stiffness without increasing steroid-associated complications. Therefore, we evaluated the effectiveness and safety of SAI in patients with persistent stiffness 3 months after ARCR.
Methods:
We retrospectively analyzed 300 ARCR cases performed between January 2012 and May 2014, in which repair integrity was confirmed at postoperative 3 months. Patients were divided into SAI and control groups. The SAI group received a single SAI (triamcinolone 40 mg and ropivacaine 52.5 mg) to address postoperative stiffness, with no additional SAI thereafter. The control group did not receive any injections until the final follow-up. Functional and radiological outcomes were compared between the two groups.
Results:
The mean follow-up period was 18.1±4.7 months (range, 12.1–37.2 months), with no difference between groups (p=0.731). At the time of injection, the range of motion was significantly lower in the SAI (all p<0.001). However, functional outcomes were comparable between the two groups at 3 months after injection and the final follow-up (all p> 0.05). The healing failure rate at the final follow-up also did not differ between the SAI and control groups (14.9% vs. 13.2%, p=0.671).
Conclusion
This short-term follow-up study suggests that the administration of a single SAI to treat persistent stiffness at 3 months after ARCR may improve functional recovery without increasing the risk of healing failure.
6.The Application of L-Serine-Incorporated Gelatin Sponge into the Calvarial Defect of the Ovariectomized Rats
Yoon-Jo LEE ; Ji-Hyeon OH ; Suyeon PARK ; Jongho CHOI ; Min-Ho HONG ; HaeYong KWEON ; Weon-Sik CHAE ; Xiangguo CHE ; Je-Yong CHOI ; Seong-Gon KIM
Tissue Engineering and Regenerative Medicine 2025;22(1):91-104
BACKGROUND:
Osteoporosis, characterized by decreased bone mineral density due to an imbalance between osteoblast and osteoclast activity, poses significant challenges in bone healing, particularly in postmenopausal women. Current treatments, such as bisphosphonates, are effective but associated with adverse effects like medication-related osteonecrosis of the jaw, necessitating safer alternatives.
METHODS:
This study investigated the use of L-serine-incorporated gelatin sponges for bone regeneration in calvarial defects in an ovariectomized rat model of osteoporosis. Thirty rats were divided into three groups: a control group, a group treated with a gelatin sponge containing an amino acid mixture, and a group treated with a gelatin sponge containing L-serine. Bone regeneration was assessed using micro-computed tomography (micro-CT) and histological analyses.
RESULTS:
The L-serine group showed a significant increase in bone volume (BV) and bone area compared to the control and amino acid groups. The bone volume to total volume (BV/TV) ratio was also significantly higher in the L-serine group.Immunohistochemical analysis demonstrated that L-serine treatment suppressed the expression of cathepsin K, a marker of osteoclast activity, while increasing serine racemase activity.
CONCLUSION
These findings suggest that L-serine-incorporated gelatin sponges not only enhance bone formation but also inhibit osteoclast-mediated bone resorption, providing a promising and safer alternative to current therapies for osteoporosis-related bone defects. Further research is needed to explore its clinical applications in human patients.
7.Subacromial Steroid Injection Is Safe and Effective in Patients with Persistent Painful Stiffness after Arthroscopic Rotator Cuff Repair: a Level III Retrospective Cohort Study in Korea
Ajay WANKHADE ; Hyeon Jang JEONG ; Young Ki MIN ; Ji Hyun YEO ; Je Kyun KIM ; Joo Han OH
The Korean Journal of Sports Medicine 2025;43(1):30-36
Purpose:
Persistent postoperative stiffness is a common complication after arthroscopic rotator cuff repair (ARCR).We hypothesized that a subacromial steroid injection (SAI) may improve the early outcomes in patients with persistent stiffness without increasing steroid-associated complications. Therefore, we evaluated the effectiveness and safety of SAI in patients with persistent stiffness 3 months after ARCR.
Methods:
We retrospectively analyzed 300 ARCR cases performed between January 2012 and May 2014, in which repair integrity was confirmed at postoperative 3 months. Patients were divided into SAI and control groups. The SAI group received a single SAI (triamcinolone 40 mg and ropivacaine 52.5 mg) to address postoperative stiffness, with no additional SAI thereafter. The control group did not receive any injections until the final follow-up. Functional and radiological outcomes were compared between the two groups.
Results:
The mean follow-up period was 18.1±4.7 months (range, 12.1–37.2 months), with no difference between groups (p=0.731). At the time of injection, the range of motion was significantly lower in the SAI (all p<0.001). However, functional outcomes were comparable between the two groups at 3 months after injection and the final follow-up (all p> 0.05). The healing failure rate at the final follow-up also did not differ between the SAI and control groups (14.9% vs. 13.2%, p=0.671).
Conclusion
This short-term follow-up study suggests that the administration of a single SAI to treat persistent stiffness at 3 months after ARCR may improve functional recovery without increasing the risk of healing failure.
8.The Application of L-Serine-Incorporated Gelatin Sponge into the Calvarial Defect of the Ovariectomized Rats
Yoon-Jo LEE ; Ji-Hyeon OH ; Suyeon PARK ; Jongho CHOI ; Min-Ho HONG ; HaeYong KWEON ; Weon-Sik CHAE ; Xiangguo CHE ; Je-Yong CHOI ; Seong-Gon KIM
Tissue Engineering and Regenerative Medicine 2025;22(1):91-104
BACKGROUND:
Osteoporosis, characterized by decreased bone mineral density due to an imbalance between osteoblast and osteoclast activity, poses significant challenges in bone healing, particularly in postmenopausal women. Current treatments, such as bisphosphonates, are effective but associated with adverse effects like medication-related osteonecrosis of the jaw, necessitating safer alternatives.
METHODS:
This study investigated the use of L-serine-incorporated gelatin sponges for bone regeneration in calvarial defects in an ovariectomized rat model of osteoporosis. Thirty rats were divided into three groups: a control group, a group treated with a gelatin sponge containing an amino acid mixture, and a group treated with a gelatin sponge containing L-serine. Bone regeneration was assessed using micro-computed tomography (micro-CT) and histological analyses.
RESULTS:
The L-serine group showed a significant increase in bone volume (BV) and bone area compared to the control and amino acid groups. The bone volume to total volume (BV/TV) ratio was also significantly higher in the L-serine group.Immunohistochemical analysis demonstrated that L-serine treatment suppressed the expression of cathepsin K, a marker of osteoclast activity, while increasing serine racemase activity.
CONCLUSION
These findings suggest that L-serine-incorporated gelatin sponges not only enhance bone formation but also inhibit osteoclast-mediated bone resorption, providing a promising and safer alternative to current therapies for osteoporosis-related bone defects. Further research is needed to explore its clinical applications in human patients.
9.Profiling of Anti-Signal-Recognition Particle Antibodies and Clinical Characteristics in South Korean Patients With Immune-Mediated Necrotizing Myopathy
Soo-Hyun KIM ; Yunjung CHOI ; Eun Kyoung OH ; Ichizo NISHINO ; Shigeaki SUZUKI ; Bum Chun SUH ; Ha Young SHIN ; Seung Woo KIM ; Byeol-A YOON ; Seong-il OH ; Yoo Hwan KIM ; Hyunjin KIM ; Young-Min LIM ; Seol-Hee BAEK ; Je-Young SHIN ; Hung Youl SEOK ; Seung-Ah LEE ; Young-Chul CHOI ; Hyung Jun PARK
Journal of Clinical Neurology 2025;21(1):31-39
Background:
and Purpose This study evaluated the diagnostic utility of an anti-signal-recognition particle 54 (anti-SRP54) antibody-based enzyme-linked immunosorbent assay (ELISA) as well as the clinical, serological, and pathological characteristics of patients with SRP immune-mediated necrotizing myopathy (IMNM).
Methods:
We evaluated 87 patients with idiopathic inflammatory myopathy and 107 healthy participants between January 2002 and December 2023. The sensitivity and specificity of the ELISA for anti-SRP54 antibodies were assessed, and the clinical profiles of patients with antiSRP54 antibodies were determined.
Results:
The ELISA for anti-SRP54 antibodies had a sensitivity and specificity of 88% and 99%, respectively, along with a test–retest reliability of 0.92 (p<0.001). The 32 patients diagnosed with anti-SRP IMNM using a line-blot immunoassay included 28 (88%) who tested positive for anti-SRP54 antibodies using the ELISA, comprising 12 (43%) males and 16 (57%) females whose median ages at symptom onset and diagnosis were 43.0 years and 43.5 years, respectively. Symptoms included proximal muscle weakness in all 28 (100%) patients, neck weakness in 9 (32%), myalgia in 15 (54%), dysphagia in 5 (18%), dyspnea in 4 (14%), dysarthria in 2 (7%), interstitial lung disease in 2 (7%), and myocarditis in 2 (7%). The median serum creatine kinase (CK) level was 7,261 U/L (interquartile range: 5,086–10,007 U/L), and the median anti-SRP54 antibody level was 2.0 U/mL (interquartile range: 1.0–5.6 U/mL). The serum CK level was significantly higher in patients with coexisting anti-Ro-52 antibodies.
Conclusions
This study has confirmed the reliability of the ELISA for anti-SRP54 antibodies and provided insights into the clinical, serological, and pathological characteristics of South Korean patients with anti-SRP IMNM.
10.Profiling of Anti-Signal-Recognition Particle Antibodies and Clinical Characteristics in South Korean Patients With Immune-Mediated Necrotizing Myopathy
Soo-Hyun KIM ; Yunjung CHOI ; Eun Kyoung OH ; Ichizo NISHINO ; Shigeaki SUZUKI ; Bum Chun SUH ; Ha Young SHIN ; Seung Woo KIM ; Byeol-A YOON ; Seong-il OH ; Yoo Hwan KIM ; Hyunjin KIM ; Young-Min LIM ; Seol-Hee BAEK ; Je-Young SHIN ; Hung Youl SEOK ; Seung-Ah LEE ; Young-Chul CHOI ; Hyung Jun PARK
Journal of Clinical Neurology 2025;21(1):31-39
Background:
and Purpose This study evaluated the diagnostic utility of an anti-signal-recognition particle 54 (anti-SRP54) antibody-based enzyme-linked immunosorbent assay (ELISA) as well as the clinical, serological, and pathological characteristics of patients with SRP immune-mediated necrotizing myopathy (IMNM).
Methods:
We evaluated 87 patients with idiopathic inflammatory myopathy and 107 healthy participants between January 2002 and December 2023. The sensitivity and specificity of the ELISA for anti-SRP54 antibodies were assessed, and the clinical profiles of patients with antiSRP54 antibodies were determined.
Results:
The ELISA for anti-SRP54 antibodies had a sensitivity and specificity of 88% and 99%, respectively, along with a test–retest reliability of 0.92 (p<0.001). The 32 patients diagnosed with anti-SRP IMNM using a line-blot immunoassay included 28 (88%) who tested positive for anti-SRP54 antibodies using the ELISA, comprising 12 (43%) males and 16 (57%) females whose median ages at symptom onset and diagnosis were 43.0 years and 43.5 years, respectively. Symptoms included proximal muscle weakness in all 28 (100%) patients, neck weakness in 9 (32%), myalgia in 15 (54%), dysphagia in 5 (18%), dyspnea in 4 (14%), dysarthria in 2 (7%), interstitial lung disease in 2 (7%), and myocarditis in 2 (7%). The median serum creatine kinase (CK) level was 7,261 U/L (interquartile range: 5,086–10,007 U/L), and the median anti-SRP54 antibody level was 2.0 U/mL (interquartile range: 1.0–5.6 U/mL). The serum CK level was significantly higher in patients with coexisting anti-Ro-52 antibodies.
Conclusions
This study has confirmed the reliability of the ELISA for anti-SRP54 antibodies and provided insights into the clinical, serological, and pathological characteristics of South Korean patients with anti-SRP IMNM.

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