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.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
6.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
7.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
8.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
9.The Profile of Early Sedation Depth and Clinical Outcomes of Mechanically Ventilated Patients in Korea
Dong-gon HYUN ; Jee Hwan AHN ; Ha-Yeong GIL ; Chung Mo NAM ; Choa YUN ; Jae-Myeong LEE ; Jae Hun KIM ; Dong-Hyun LEE ; Ki Hoon KIM ; Dong Jung KIM ; Sang-Min LEE ; Ho-Geol RYU ; Suk-Kyung HONG ; Jae-Bum KIM ; Eun Young CHOI ; JongHyun BAEK ; Jeoungmin KIM ; Eun Jin KIM ; Tae Yun PARK ; Je Hyeong KIM ; Sunghoon PARK ; Chi-Min PARK ; Won Jai JUNG ; Nak-Jun CHOI ; Hang-Jea JANG ; Su Hwan LEE ; Young Seok LEE ; Gee Young SUH ; Woo-Sung CHOI ; Keu Sung LEE ; Hyung Won KIM ; Young-Gi MIN ; Seok Jeong LEE ; Chae-Man LIM
Journal of Korean Medical Science 2023;38(19):e141-
Background:
Current international guidelines recommend against deep sedation as it is associated with worse outcomes in the intensive care unit (ICU). However, in Korea the prevalence of deep sedation and its impact on patients in the ICU are not well known.
Methods:
From April 2020 to July 2021, a multicenter, prospective, longitudinal, noninterventional cohort study was performed in 20 Korean ICUs. Sedation depth extent was divided into light and deep using a mean Richmond Agitation–Sedation Scale value within the first 48 hours. Propensity score matching was used to balance covariables; the outcomes were compared between the two groups.
Results:
Overall, 631 patients (418 [66.2%] and 213 [33.8%] in the deep and light sedation groups, respectively) were included. Mortality rates were 14.1% and 8.4% in the deep and light sedation groups (P = 0.039), respectively. Kaplan-Meier estimates showed that time to extubation (P < 0.001), ICU length of stay (P = 0.005), and death P = 0.041) differed between the groups. After adjusting for confounders, early deep sedation was only associated with delayed time to extubation (hazard ratio [HR], 0.66; 95% confidence inter val [CI], 0.55– 0.80; P < 0.001). In the matched cohort, deep sedation remained significantly associated with delayed time to extubation (HR, 0.68; 95% 0.56–0.83; P < 0.001) but was not associated with ICU length of stay (HR, 0.94; 95% CI, 0.79–1.13; P = 0.500) and in-hospital mortality (HR, 1.19; 95% CI, 0.65–2.17; P = 0.582).
Conclusion
In many Korean ICUs, early deep sedation was highly prevalent in mechanically ventilated patients and was associated with delayed extubation, but not prolonged ICU stay or in-hospital death.
10.Pilot Study About the Effects of the Soma Experiencing Motion (Soma e-Motion) Program on Interoceptive Awareness and Self-Compassion
Mi-Sun LEE ; Sun Je KIM ; Jeong-Ho CHAE ; Soo-Young BHANG ; Mimi LEE ; Hyeong Beom KIM ; Hyu Jung HUH
Psychiatry Investigation 2023;20(3):284-292
Objective:
The purpose of this study was to examine the effects of the Soma experiencing motion (Soma e-motion) program on interoceptive awareness and self-compassion among novices.
Methods:
A total of 19 adults (clinical group=9, non-clinical group=10) participated in the intervention. Psychological and physical changes after program were qualitatively analyzed using in-depth interviews. The Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA) and the Korean version of the Self-Compassion Scale (K-SCS) were used as quantitative measures.
Results:
The non-clinical group showed statistically significant differences in the K-MAIA scores (z=-2.805, p<0.01) and K-SCS scores (z=-2.191, p<0.05); however, the clinical group showed no significant differences (K-MAIA: z=-0.652, p>0.05; K-SCS: z=-0.178, p>0.05). According to the in-depth interviews, the results of the qualitative analysis were categorized into five dimensions (psychological and emotional, physical, cognitive, behavioral, and aspects participants found challenging and needs improvement).
Conclusion
The Soma e-motion program was feasible for improving interoceptive awareness and self-compassion in the non-clinical group. However, further research is needed to investigate the clinical efficacy of the Soma e-motion program for clinical group.

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