Purpose: This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC). Materials and Methods: Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results: In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib. Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.

Background: Sutureless valves are widely used in aortic valve replacement surgery, with Perceval valves and Intuity valves being particularly prominent. However, concerns have been raised about postoperative thrombocytopenia with Perceval valves (Corcym, UK). We conducted a comparative analysis with the Intuity valve (Edwards Lifesciences, USA), and assessed how thrombocytopenia affected patient and transfusion outcomes. Methods: Among 595 patients who underwent aortic valve replacement from June 2016 to March 2023, sutureless valves were used in 53 (Perceval: n=23; Intuity: n=30). Platelet counts were monitored during hospitalization and outpatient visits. Daily platelet count changes were compared between groups, and the results from patients who underwent procedures using Carpentier Edwards Perimount Magna valves were used as a reference group. Results: Compared to the Intuity group, the Perceval group showed a significantly higher amount of platelet transfusion (5.48±1.64 packs vs. 0.60±0.44 packs, p=0.008). During the postoperative period, severe thrombocytopenia (<50,000/μL) was significantly more prevalent in the Perceval group (56.5%, n=13) than in the Intuity group (6.7%, n=2). After initial postoperative depletion, daily platelet counts increased, with significant differences observed in the extent of improvement between the Perceval and Intuity groups (p<0.001).However, there was no significant difference in early mortality or the incidence of neurological complications between the 2 groups. Conclusion The severity of postoperative thrombocytopenia differed significantly between the Perceval and Intuity valves. The Perceval group showed a significantly higher prevalence of severe thrombocytopenia and higher platelet transfusion volumes. However, thrombocytopenia gradually recovered during the postoperative period in both groups, and the early outcomes were similar in both groups.

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.

Purpose: This study aimed to analyze the immunologic profile of children with postinfectious bronchiolitis obliterans (PIBO) in order to approach pathophysiology affected by host factors. Methods: A total of 10 children with PIBO were prospectively enrolled. We obtained information on demographics from their caregiver and electric medical records. Peripheral blood samples were collected before cyclic systemic methylprednisolone therapy and complete blood count, immunoglobulin level and lymphocyte subset were analyzed. Results: The white blood cell count and immunoglobulin level were within the normal range in children with PIBO. The CD4+/CD8+ ratio was not significantly different from those of the healthy control group. A decreased proportion of both central memory T cells (median [interquartile range]; 13.5% [8.3%–16.3%] vs. 18.5% [15.9%–24.1%], P = 0.01) and effector memory T cells (10.3% [5.0%–18.4%] vs. 20.9% [16.6%–26.3%], P = 0.03) in CD4+T cells was observed in the PIBO group compared with those in the control group. In CD8+T cells, the proportion of effector memory T cells (7.8% [4.2%–13.8%] vs. 24.3% [15.3%–27.9%], P = 0.02) and CD45RA+effector memory T cells (16.2% [11.0%–36.6%] vs. 24.2% [17.1%–39.7%], P = 0.04) was decreased in the patient group compared with the control group. Conclusion It is suggested that T lymphocyte subset abnormalities may be associated with a decrease in the ability to differentiate the T cells immediately upon reinfection and induce an effective response to infection. These results may partially explain the pathophysiological individual vulnerabilities to PIBO after lower respiratory tract infections in children.

Background/Aims: Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. Materials and Methods: We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. Results: The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. Conclusions Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.

Background/Aims: Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. Materials and Methods: We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. Results: The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. Conclusions Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.

Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Background: Iliac artery aneurysm is frequently found in patients undergoing surgical repair of an abdominal aortic aneurysm. The use of commercial bifurcated grafts is insufficient for aorto-biiliac replacement with complete iliac artery aneurysm resection. We evaluated the effectiveness of handmade composite grafts for this purpose. Methods: A total of 233 patients underwent open surgery for abdominal aortic aneurysm between 2003 and 2019, including 155 patients (67%) treated with commercial grafts and 78 patients (33%) treated with handmade composite grafts. Their operative characteristics, postoperative outcomes, and late outcomes were retrospectively reviewed. Results: The early mortality rate did not differ significantly between the groups. On average, the handmade composite graft technique took approximately 15 minutes longer than the commercial graft technique (p=0.037). Among patients who underwent elective surgery, no significant differences between the conventional and composite groups were observed in the major outcomes, including red blood cell transfusion volume (2.8±4.7 units vs. 3.1±4.7 units, respectively; p=0.680), reoperation for bleeding (2.7% vs. 3.1%, respectively; p>0.999), bowel ischemia (0% vs. 1.6%, respectively; p=0.364), and intensive care unit stay duration (1.9±6.6 days vs. 1.6±2.4 days, respectively; p=0.680). The incidence of target vessel occlusion also did not differ significantly between groups. Conclusion The increased technical demand involved with handmade composite grafting did not negatively impact the outcomes. This technique may be a viable option because it overcomes problems associated with commercial grafts.

Background: We aimed to investigate the associations of critical care provided in a cardiac surgical intensive care unit (CSICU) staffed by an attending intensivist with improvements in intensive care unit (ICU) quality and reductions in postoperative complications. Methods: Patients who underwent elective isolated coronary artery bypass grafting (CABG) between January 2007 and December 2012 (the control group) were propensity- matched (1:1) to CABG patients between January 2013 and June 2018 (the intensivist group). Results: Using propensity score matching, 302 patients were extracted from each group. The proportion of patients with at least 1 postoperative complication was significantly lower in the intensivist group than in the control group (17.2% vs. 28.5%, p=0.001). In the intensivist group, the duration of mechanical ventilation (6.4±13.7 hours vs. 13.7±49.3 hours, p=0.013) and length of ICU stay (28.7±33.9 hours vs. 41.7±90.4 hours, p=0.018) were significantly shorter than in the control group. The proportions of patients with prolonged mechanical ventilation (2.3% vs. 7.6%, p=0.006), delirium (1.3% vs. 6.3%, p=0.003) and acute kidney injury (1.3% vs. 5.3%, p=0.012) were significantly lower in the intensivist group than in the control group. Conclusion A transition from an open ICU model with trainee coverage to a closed ICU model with attending intensivist coverage can be expected to yield improvements in CSICU quality and reductions in postoperative complications.