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.

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.

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.

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.

Background: Sepsis is a leading cause of intensive care unit (ICU) admission. However, few studies have evaluated how the ICU model affects the outcomes of patients with sepsis. Methods: This post hoc analysis of data from the Management of Severe Sepsis in Asia’s Intensive Care Units II study included 537 patients with sepsis admitted to 27 ICUs in Korea. The outcome measures of interest were compared between the closed ICU group, patients admitted under the full responsibility of an intensivist as the primary attending physician, and the open ICU group. The association between a closed ICU and ICU mortality was evaluated using a logistic regression analysis. Results: Altogether, 363 and 174 enrolled patients were treated in open and closed ICUs, respectively. Compliance with the sepsis bundles did not differ between the two groups; however, the closed ICU group had a higher rate of renal replacement therapy and shorter duration of ventilator support. The closed ICU group also had a lower ICU mortality rate than the open ICU group (24.7% vs. 33.1%). In a logistic regression analysis, management in the closed ICU was significantly associated with a decreased ICU mortality rate even after adjusting for potential confounding factors (adjusted odds ratio, 0.576; 95% CI, 0.342–0.970), and that association was observed for up to 90 days. Conclusions Sepsis management in closed ICUs was significantly associated with improved ICU survival and decreased length of ICU stay, even though the compliance rates for the sepsis bundles did not differ between open and closed ICUs.

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.

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.

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.

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.

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.