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.

Circulating tumor DNA (ctDNA) has emerged as a promising tool for various clinical applications, including early diagnosis, therapeutic target identification, treatment response monitoring, prognosis evaluation, and minimal residual disease detection. Consequently, ctDNA assays have been incorporated into clinical practice. In this review, we offer an indepth exploration of the clinical implementation of ctDNA assays. Notably, we examined existing evidence related to pre-analytical procedures, analytical components in current technologies, and result interpretation and reporting processes. The primary objective of this guidelines is to provide recommendations for the clinical utilization of ctDNA assays.

Purpose: Semantic segmentation is a fundamental part of the surgical application of deep learning. Traditionally, segmentation in vision tasks has been performed using convolutional neural networks (CNNs), but the transformer architecture has recently been introduced and widely investigated. We aimed to investigate the performance of deep learning models in segmentation in robot-assisted radical prostatectomy (RARP) and identify which of the architectures is superior for segmentation in robotic surgery. Materials and Methods: Intraoperative images during RARP were obtained. The dataset was randomly split into training and validation data. Segmentation of the surgical instruments, bladder, prostate, vas and seminal vesicle was performed using three CNN models (DeepLabv3, MANet, and U-Net++) and three transformers (SegFormer, BEiT, and DPT), and their performances were analyzed. Results: The overall segmentation performance during RARP varied across different model architectures. For the CNN models, DeepLabV3 achieved a mean Dice score of 0.938, MANet scored 0.944, and U-Net++ reached 0.930. For the transformer architectures, SegFormer attained a mean Dice score of 0.919, BEiT scored 0.916, and DPT achieved 0.940. The performance of CNN models was superior to that of transformer models in segmenting the prostate, vas, and seminal vesicle. Conclusions Deep learning models provided accurate segmentation of the surgical instruments and anatomical structures observed during RARP. Both CNN and transformer models showed reliable predictions in the segmentation task; however, CNN models may be more suitable than transformer models for organ segmentation and may be more applicable in unusual cases. Further research with large datasets is needed.

Purpose: With the recent rising interest in artificial intelligence (AI) in medicine, many studies have explored the potential and usefulness of AI in urological diseases. This study aimed to comprehensively review recent applications of AI in urologic oncology. Materials and Methods: We searched the PubMed-MEDLINE databases for articles in English on machine learning (ML) and deep learning (DL) models related to general surgery and prostate, bladder, and kidney cancer. The search terms were a combination of keywords, including both “urology” and “artificial intelligence” with one of the following: “machine learning,” “deep learning,” “neural network,” “renal cell carcinoma,” “kidney cancer,” “urothelial carcinoma,” “bladder cancer,” “prostate cancer,” and “robotic surgery.” Results: A total of 58 articles were included. The studies on prostate cancer were related to grade prediction, improved diagnosis, and predicting outcomes and recurrence. The studies on bladder cancer mainly used radiomics to identify aggressive tumors and predict treatment outcomes, recurrence, and survival rates. Most studies on the application of ML and DL in kidney cancer were focused on the differentiation of benign and malignant tumors as well as prediction of their grade and subtype. Most studies suggested that methods using AI may be better than or similar to existing traditional methods. Conclusions AI technology is actively being investigated in the field of urological cancers as a tool for diagnosis, prediction of prognosis, and decision-making and is expected to be applied in additional clinical areas soon. Despite technological, legal, and ethical concerns, AI will change the landscape of urological cancer management.

Background: Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined. Methods: This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months. Conclusion This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.

Purpose: The purpose of this study was to explore the association between benign prostatic hyperplasia (BPH) and the incidence of falls from the perspective of geriatric morbid conditions. Methods: Data were sourced from the triennial National Survey of Older Koreans conducted by the Ministry of Health and Welfare (2017–2020). In total, 8,135 male participants aged 65 and older were included, and information was gathered through questionnaires and physical measurements. Logistic regression analysis was utilized to determine the impact of BPH on the risk of falls, and subgroup analyses were conducted to examine the influence of BPH on specific types of falls. Results: Of the participants, 15.2% (1,238 of 8,135) reported that their BPH treatment exceeded 3 months, and 8.0% (648 of 8,135) reported experiencing falls, with 61.4% (398/648) of these falls resulting in injuries. A significant association was identified between BPH and both falls (odds ratio [OR], 1.798; 95% confidence interval [CI], 1.479–2.185) and falls with injuries (OR, 2.133; 95% CI, 1.689–2.694). A subgroup analysis indicated a correlation between BPH and falls in groups having one (OR, 1.912; 95% CI, 1.356–2.694) and 2 or more conditions (OR, 1.856; 95% CI, 1.455–2.367) involving visual and auditory impairments, cognitive decline, depression, lower motor weakness, and limitations in daily activities. Conclusions The findings indicate that BPH contributes to the incidence of falls among older men, particularly those with comorbid conditions. Considering the heightened fall risk among elderly individuals suffering from multiple morbidities, particularly those with BPH, targeted interventions are essential for mitigating the risk of falls in this vulnerable group.

Purpose: Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies. Methods The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.