Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. Methods: A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Results: Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. Conclusions The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. Methods: A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Results: Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. Conclusions The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Background: Evaluation of regional left ventricle function using two-dimensional echocardiography (2DE) in patients with ischemic heart disease has limitations due to its low objectivity and qualitative nature. In addition, 2DE is limited because multiple acoustic windows are used to obtain the image, whereas three-dimensional echocardiography (3DE) uses a single window. This study aims to demonstrate the clinical utility of 3DE segmental volume analysis for evaluating regional wall motion abnormality (RWMA). Methods: This retrospective study included 33 patients with ischemic heart disease and single-vessel territory RWMA confirmed on coronary angiography. RWMA was visually assessed using 2DE, generating 17-segment bull’s-eye polar maps, and 3DE. In the 3DE study, two independent observers analyzed segmental volumes and segmental volume ejection fractions (SVEFs) using QLAB 3D quantification software. The optimal SVEF cutoff value differentiating normal from abnormal was determined using receiver operating curve analysis. The accuracy of 3DE in predicting culprit coronary arteries was compared with that of 2DE using Cohen κ coefficients, which also were used for interobserver and intraobserver variability assessments. Results: Mean 3DE SVEFs were significantly lower in segments showing RWMA on 2DE. The optimal SVEF cutoff value was 44%, with sensitivity of 75.0% and specificity of 73.9% (area under the curve, 0.801; 95% CI, 0.763–0.838; P < 0.001).The reliability of 3DE-derived bull’s-eye predictions of culprit coronary arteries was 81.8% (κ = 0.672; 95% CI, 0.555– 0.789; P < 0.001). Interobserver and intraobserver variabilities were 97.0% (κ = 0.947; 95% CI, 0.894–1.00; P < 0.001) and 93.9% (κ = 0.897; 95% CI, 0.827–0.967; P < 0.001), respectively. Conclusions The 3DE segmental volume analysis effectively quantified regional left ventricle function and aligned well with 2DE and coronary angiography findings in predicting culprit coronary arteries. Thus, 3DE segmental volume analysis can serve as a quantitative and objective tool for RWMA assessment in patients with ischemic heart disease.

Background: Evaluation of regional left ventricle function using two-dimensional echocardiography (2DE) in patients with ischemic heart disease has limitations due to its low objectivity and qualitative nature. In addition, 2DE is limited because multiple acoustic windows are used to obtain the image, whereas three-dimensional echocardiography (3DE) uses a single window. This study aims to demonstrate the clinical utility of 3DE segmental volume analysis for evaluating regional wall motion abnormality (RWMA). Methods: This retrospective study included 33 patients with ischemic heart disease and single-vessel territory RWMA confirmed on coronary angiography. RWMA was visually assessed using 2DE, generating 17-segment bull’s-eye polar maps, and 3DE. In the 3DE study, two independent observers analyzed segmental volumes and segmental volume ejection fractions (SVEFs) using QLAB 3D quantification software. The optimal SVEF cutoff value differentiating normal from abnormal was determined using receiver operating curve analysis. The accuracy of 3DE in predicting culprit coronary arteries was compared with that of 2DE using Cohen κ coefficients, which also were used for interobserver and intraobserver variability assessments. Results: Mean 3DE SVEFs were significantly lower in segments showing RWMA on 2DE. The optimal SVEF cutoff value was 44%, with sensitivity of 75.0% and specificity of 73.9% (area under the curve, 0.801; 95% CI, 0.763–0.838; P < 0.001).The reliability of 3DE-derived bull’s-eye predictions of culprit coronary arteries was 81.8% (κ = 0.672; 95% CI, 0.555– 0.789; P < 0.001). Interobserver and intraobserver variabilities were 97.0% (κ = 0.947; 95% CI, 0.894–1.00; P < 0.001) and 93.9% (κ = 0.897; 95% CI, 0.827–0.967; P < 0.001), respectively. Conclusions The 3DE segmental volume analysis effectively quantified regional left ventricle function and aligned well with 2DE and coronary angiography findings in predicting culprit coronary arteries. Thus, 3DE segmental volume analysis can serve as a quantitative and objective tool for RWMA assessment in patients with ischemic heart disease.

Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. Methods: A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Results: Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. Conclusions The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Background: Evaluation of regional left ventricle function using two-dimensional echocardiography (2DE) in patients with ischemic heart disease has limitations due to its low objectivity and qualitative nature. In addition, 2DE is limited because multiple acoustic windows are used to obtain the image, whereas three-dimensional echocardiography (3DE) uses a single window. This study aims to demonstrate the clinical utility of 3DE segmental volume analysis for evaluating regional wall motion abnormality (RWMA). Methods: This retrospective study included 33 patients with ischemic heart disease and single-vessel territory RWMA confirmed on coronary angiography. RWMA was visually assessed using 2DE, generating 17-segment bull’s-eye polar maps, and 3DE. In the 3DE study, two independent observers analyzed segmental volumes and segmental volume ejection fractions (SVEFs) using QLAB 3D quantification software. The optimal SVEF cutoff value differentiating normal from abnormal was determined using receiver operating curve analysis. The accuracy of 3DE in predicting culprit coronary arteries was compared with that of 2DE using Cohen κ coefficients, which also were used for interobserver and intraobserver variability assessments. Results: Mean 3DE SVEFs were significantly lower in segments showing RWMA on 2DE. The optimal SVEF cutoff value was 44%, with sensitivity of 75.0% and specificity of 73.9% (area under the curve, 0.801; 95% CI, 0.763–0.838; P < 0.001).The reliability of 3DE-derived bull’s-eye predictions of culprit coronary arteries was 81.8% (κ = 0.672; 95% CI, 0.555– 0.789; P < 0.001). Interobserver and intraobserver variabilities were 97.0% (κ = 0.947; 95% CI, 0.894–1.00; P < 0.001) and 93.9% (κ = 0.897; 95% CI, 0.827–0.967; P < 0.001), respectively. Conclusions The 3DE segmental volume analysis effectively quantified regional left ventricle function and aligned well with 2DE and coronary angiography findings in predicting culprit coronary arteries. Thus, 3DE segmental volume analysis can serve as a quantitative and objective tool for RWMA assessment in patients with ischemic heart disease.

Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. Methods: A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Results: Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. Conclusions The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Gigantomastia is a rare condition characterized by excessive hypertrophy of the connective tissue of the breast, which can cause physical and emotional distress. Surgical intervention is crucial for improving patients’ quality of life; however, it is challenging to balance minimizing the risk of recurrence and maximizing favorable aesthetic outcomes. This study documents the successful management of three rare cases of bilateral gigantomastia resulting from benign tumors. These cases included rapidly growing bilateral diffuse tumorous pseudoangiomatous stromal hyperplasia (PASH) and bilateral juvenile giant fibroadenoma, with no long-term recurrence observed. We discuss the diagnostic challenges and management considerations for gigantomastia, with a focus on reviewing PASH and its differential diagnosis. The findings offer valuable insights into the successful management of diverse gigantomastia cases caused by benign tumors, potentially aiding clinicians in making more informed decisions regarding optimal patient care.

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss–threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.