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.

Purpose: This study elucidates the mechanism of the physiological effect of cannabidiol (CBD) by assessing its impact on lipopolysaccharide (LPS)-induced inflammation in RWPE-1 cells and prostatitis-induced by 17β-estradiol and dihydrotestosterone in a rat model, focusing on its therapeutic potential for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Materials and Methods: RWPE-1 cells were stratified in vitro into three groups: (1) controls, (2) cells with LPS-induced inflammation, and (3) cells with LPS-induced inflammation and treated with CBD. Enzyme-linked immunosorbent assays and western blots were performed on cellular components and supernatants after administration of CBD. Five groups of six Sprague–Dawley male rats were assigned: (1) control, (2) CP/CPPS, (3) CP/CPPS and treated with 50 mg/kg CBD, (4) CP/CPPS and treated with 100 mg/kg CBD, and (5) CP/CPPS and treated with 150 mg/kg CBD. Prostatitis was induced through administration of 17β-estradiol and dihydrotestosterone. After four weeks of CBD treatment, a pain index was evaluated, and prostate tissue was collected for subsequent histologic examination and western blot analysis. Results: CBD demonstrated efficacy in vivo for CP/CPPS and in vitro for inflammation. It inhibited the toll-like receptor 4 (TLR4)uclear factor-kappa B (NF-κB) pathway by activating the CB2 receptor, reducing expression of interleukin-6, tumor necrosis factor-alpha, and cyclooxygenase-2 (COX2) (p<0.01). CBD exhibited analgesic effects by activating and desensitizing the TRPV1 receptor. Conclusions CBD inhibits the TLR4/NF-κB pathway by activating the CB2 receptor, desensitizes the TRPV1 receptor, and decreases the release of COX2. This results in relief of inflammation and pain in patients with CP/CPPS, indicating CBD as a potential treatment for CP/CPPS.

Purpose: The purpose of this study was to compare the effectiveness of pericapsular nerve group (PENG) block with periarticular multimodal drug injection (PMDI) on postoperative pain management and surgical outcomes in patients who underwent total hip arthroplasty (THA). We hypothesized that PENG block with PMDI would exhibit superior effects on postoperative pain control after THA compared to PMDI alone. Materials and Methods: From April 2022 to February 2023, 58 patients who underwent THA were randomly assigned into two groups: PENG block with PMDI group (n=29) and PMDI-only group (n=29). Primary outcomes were postoperative numeric rating scale (NRS) at rest and during activity at 6, 24, and 48 hours postoperatively. Secondary outcomes were postoperative complications (nausea and vomiting), Richards-Campbell Sleep Questionnaire (RCSQ) score, length of hospital stay, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Harris Hip Score (HHS), and total morphine usage after surgery. Results: There was no significant difference in postoperative pain for either resting NRS or active NRS. Postoperative nausea and vomiting, RCSQ score, length of hospital stay, WOMAC index, HHS, and total morphine usage exhibited no significant differences between the two groups. Conclusion Both groups showed no significant differences in postoperative pain and clinical outcomes, indicating that the addition of PENG block to PMDI does not improve pain management after applying the posterolateral approach of THA. PMDI alone during THA would be an efficient, fast, and safe method for managing postoperative pain. This article was registered with ClinicalTrials.gov (Gov ID: NCT05320913).

Purpose: This study focused on analyzing the contact pressure and area on different patellar component designs in total knee arthroplasty (TKA) to evaluate biomechanics related to the patellofemoral (PF) joint. Materials and Methods: The patellar components studied included the dome design, modified dome design, and anatomical design implants. Using finite element analysis and mechanical testing, the pressure and area were evaluated. The first loading condition was simulated at flexion angles of 0°, 15°, 45°, 90°, 120°, and 150°. The second loading condition was simulated for a clinically relevant scenario, involving a 2-mm medial shift at a flexion angle of 45°. Results: For both the modified dome and anatomical designs, the contact area and pressure increased with the flexion angle. The dome design reached its maximum contact area at a flexion angle of 120°. Among the designs, the anatomical design had the largest contact area and a lower contact pressure compared to the dome and modified dome designs. However, when a medial shift of 2 mm was simulated at a 45° flexion angle, which can occur clinically, the anatomical design showed edge contact, leading to higher contact pressure and reduced contact area. In contrast, the modified dome design demonstrated the lowest contact pressure and the greatest contact area under the same shifted conditions. Conclusion These findings suggest that the design of the patellar component significantly affects patellar biomechanics and stability. Specifically, the modified dome design showed improved biomechanical effects in clinically relevant scenarios. Therefore, patellar components with a modified dome design are expected to better manage PF joint pain and reduce complications in TKA.

Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients. Materials and Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided. Results: From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient. Conclusion Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

Remimazolam is a novel benzodiazepine with unique pharmacokinetic and pharmacodynamic properties, making it an ideal candidate for sedation during endoscopic procedures. Distinguished by its rapid onset and short duration of action, remimazolam offers a safer and more efficient alternative to traditional sedatives, such as midazolam and propofol, with fewer side effects, such as hypotension, bradycardia, and respiratory depression. This article reviews the characteristics of remimazolam and its practical advantages, including ease of use, quick recovery time, and minimal residual sedation, emphasizing its potential to improve patient safety and procedural efficiency in clinical endoscopy settings.

Purpose: This study elucidates the mechanism of the physiological effect of cannabidiol (CBD) by assessing its impact on lipopolysaccharide (LPS)-induced inflammation in RWPE-1 cells and prostatitis-induced by 17β-estradiol and dihydrotestosterone in a rat model, focusing on its therapeutic potential for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Materials and Methods: RWPE-1 cells were stratified in vitro into three groups: (1) controls, (2) cells with LPS-induced inflammation, and (3) cells with LPS-induced inflammation and treated with CBD. Enzyme-linked immunosorbent assays and western blots were performed on cellular components and supernatants after administration of CBD. Five groups of six Sprague–Dawley male rats were assigned: (1) control, (2) CP/CPPS, (3) CP/CPPS and treated with 50 mg/kg CBD, (4) CP/CPPS and treated with 100 mg/kg CBD, and (5) CP/CPPS and treated with 150 mg/kg CBD. Prostatitis was induced through administration of 17β-estradiol and dihydrotestosterone. After four weeks of CBD treatment, a pain index was evaluated, and prostate tissue was collected for subsequent histologic examination and western blot analysis. Results: CBD demonstrated efficacy in vivo for CP/CPPS and in vitro for inflammation. It inhibited the toll-like receptor 4 (TLR4)uclear factor-kappa B (NF-κB) pathway by activating the CB2 receptor, reducing expression of interleukin-6, tumor necrosis factor-alpha, and cyclooxygenase-2 (COX2) (p<0.01). CBD exhibited analgesic effects by activating and desensitizing the TRPV1 receptor. Conclusions CBD inhibits the TLR4/NF-κB pathway by activating the CB2 receptor, desensitizes the TRPV1 receptor, and decreases the release of COX2. This results in relief of inflammation and pain in patients with CP/CPPS, indicating CBD as a potential treatment for CP/CPPS.

Purpose: The purpose of this study was to compare the effectiveness of pericapsular nerve group (PENG) block with periarticular multimodal drug injection (PMDI) on postoperative pain management and surgical outcomes in patients who underwent total hip arthroplasty (THA). We hypothesized that PENG block with PMDI would exhibit superior effects on postoperative pain control after THA compared to PMDI alone. Materials and Methods: From April 2022 to February 2023, 58 patients who underwent THA were randomly assigned into two groups: PENG block with PMDI group (n=29) and PMDI-only group (n=29). Primary outcomes were postoperative numeric rating scale (NRS) at rest and during activity at 6, 24, and 48 hours postoperatively. Secondary outcomes were postoperative complications (nausea and vomiting), Richards-Campbell Sleep Questionnaire (RCSQ) score, length of hospital stay, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Harris Hip Score (HHS), and total morphine usage after surgery. Results: There was no significant difference in postoperative pain for either resting NRS or active NRS. Postoperative nausea and vomiting, RCSQ score, length of hospital stay, WOMAC index, HHS, and total morphine usage exhibited no significant differences between the two groups. Conclusion Both groups showed no significant differences in postoperative pain and clinical outcomes, indicating that the addition of PENG block to PMDI does not improve pain management after applying the posterolateral approach of THA. PMDI alone during THA would be an efficient, fast, and safe method for managing postoperative pain. This article was registered with ClinicalTrials.gov (Gov ID: NCT05320913).

Purpose: This study focused on analyzing the contact pressure and area on different patellar component designs in total knee arthroplasty (TKA) to evaluate biomechanics related to the patellofemoral (PF) joint. Materials and Methods: The patellar components studied included the dome design, modified dome design, and anatomical design implants. Using finite element analysis and mechanical testing, the pressure and area were evaluated. The first loading condition was simulated at flexion angles of 0°, 15°, 45°, 90°, 120°, and 150°. The second loading condition was simulated for a clinically relevant scenario, involving a 2-mm medial shift at a flexion angle of 45°. Results: For both the modified dome and anatomical designs, the contact area and pressure increased with the flexion angle. The dome design reached its maximum contact area at a flexion angle of 120°. Among the designs, the anatomical design had the largest contact area and a lower contact pressure compared to the dome and modified dome designs. However, when a medial shift of 2 mm was simulated at a 45° flexion angle, which can occur clinically, the anatomical design showed edge contact, leading to higher contact pressure and reduced contact area. In contrast, the modified dome design demonstrated the lowest contact pressure and the greatest contact area under the same shifted conditions. Conclusion These findings suggest that the design of the patellar component significantly affects patellar biomechanics and stability. Specifically, the modified dome design showed improved biomechanical effects in clinically relevant scenarios. Therefore, patellar components with a modified dome design are expected to better manage PF joint pain and reduce complications in TKA.