Clinical Success Rate Research Articles

Meta-analysis of application of minimally-invasive ablation methods and classical surgical approach in osteoid osteoma and osteoblastoma

Abstract Osteoblastoma and osteoid osteoma are rare benign bone tumours, sometimes considered variations of the same pathologic process. However, they differ in location, incidence, age group, and size. The gold standard treatment is surgical excision for osteoblastoma and radiofrequency ablation for both. Minimally invasive techniques, including radiofrequency ablation, microwave ablations, cryoablation, ultrasound ablation, and laser ablation, are increasingly used. This meta-analysis aimed to review current treatments, focusing on minimally invasive methods versus traditional surgical excision. A data comparison of 17 original articles from the PubMed database (2014-2024) was conducted, examining treatment methods, patient numbers, success rates, pre/post-operative pain scores, and complication rates. New ablation methods achieve similar clinical results to traditional surgery for treating osteoid osteoma and osteoblastoma while minimizing invasiveness. Most procedures have technical success rates near 100%. Both invasive and non-invasive methods significantly reduce preoperative pain. Classical surgery has higher minor complication rates compared to minimally invasive treatments. Among ablation techniques, magnetic resonance guided focused ultrasound surgery is the least invasive, avoiding radiation and antibiotic-related complications. However, in ablation methods caution is needed to prevent thermal damage to nearby joints and nerves. Protective methods, such as skin protection, hydrodissection, gas dissection, and intraoperative neurostimulation, are recommended. New ablation methods provide less invasive alternatives to surgery, with high clinical and technical success rates and lower complication rates. Among these, magnetic resonance guided focused ultrasound surgery is the least invasive and most promising, though more clinical data is needed due to its recent development.

Evaluation of clinical and radiographic success rate of a pulpotomy in primary molar teeth treated in pediatric department of the faculty of dentistry

Evaluation of clinical and radiographic success rate of a pulpotomy in primary molar teeth treated in pediatric department of the faculty of dentistry

The Performance of Peroral Endoscopic Myotomy in Sigmoid-Type Achalasia

Objective: Sigmoid-type achalasia represents an advanced stage of achalasia characterized by significant dilation and tortuosity of the esophageal lumen. Considering the demonstrated efficacy of peroral endoscopic myotomy (POEM) in treating early-stage achalasia, this procedure may offer an alternative therapeutic approach for sigmoid-type achalasia. This study aimed to assess POEM’s feasibility and short-term efficacy in patients with sigmoid-type achalasia. Materials and Methods: We enrolled 16 consecutive patients with sigmoid-type achalasia (eight with type 1 and eight with type 2). The anticipated outcomes were symptom relief during the 12-month follow-up period (evaluated through a reduction in Eckardt symptom scores), an acceptable incidence of procedure-related adverse events, and a decrease in esophageal diameter and barium height. Results: POEM was successfully performed in all cases, with a median operative time of 118.50 minutes (range: 52–206 minutes). No serious complications associated with POEM were observed. During the 12-month follow-up period, the median Eckardt symptom score decreased from 6 (2-10) preoperatively to 1 (0-3) (P = 0.008). Complications were mucosal injuries (31.25% of cases), pneumoperitoneum (12.5%), and minor bleeding (6.25%), although no interventions were needed. Conclusion: POEM procedure has exhibited favorable treatment outcomes, showcasing a high clinical success rate in addressing sigmoid-type achalasia. Despite the occurrence of acceptable adverse events, the procedure remains a viable alternative treatment or bridging therapy for sigmoid-type achalasia. Nonetheless, it is crucial to acknowledge that this procedure presents greater challenges in comparison to the treatment of typical achalasia.

Clinical Success Evaluation of Ultrathin Ceramic Veneers Bonded to Nonprepared Teeth: An Observational Prospective Cohort Study.

Patients' increasing interest in achieving optimal cosmetic outcomes and the widespread use of ultrathin ceramic veneers offer advantages such as high esthetic results and long-term durability. Several issues related to tooth preparation have been raised, including dental sensitivity, periodontal diseases, and increased treatment phases, in addition to complications associated with previous procedures, the treatment of which remains controversial to date. With the advancement of dental ceramic and its manufacturing techniques, it was widely used to manufacture ultrathin ceramic veneers with minimal preparation. Issues such as fracture and abfraction are the most common in ceramic veneers made of feldspathic ceramic due to their weak mechanical properties against various forces, which led to the emergence of lithium disilicate glass-ceramic manufactured using the heat-press technique. This has resulted in ultrathin ceramic veneers with a thickness of up to 0.1-0.2 mm easily bonded and finished as they have high mechanical properties and esthetic qualities that mimic natural tooth color and shape. The current cohort study aimed to evaluate the success rates of this kind of treatment for patients treated at our department. This observational cohort study's sample comprised 60 ultrathin ceramic veneers manufactured from lithium disilicate glass-ceramic bonded to nonprepared upper teeth. The clinical performance of the studied sample was evaluated and monitored at monthly intervals (one month, three months, six months, and one year) using the clinical success evaluation based on Walton's principles adopted for evaluating the success and failure of fixed restorations. Ultrathin ceramic veneers made from lithium disilicate glass-ceramic, bonded to nonprepared teeth, proved to be a successful clinical and esthetic treatment option, with a clinical success rate of 100% during the entire follow-up period. This study's findings indicate that ultrathin ceramic veneers made from lithium disilicate glass-ceramic, bonded to nonprepared teeth, area successful clinical and esthetic treatment option, with a clinical success rate of 100% during the entire follow-up period.

Assessment of MMP levels in reversible and irreversible pulpitis and a randomized controlled trial comparing clinical success of two different calcium-silicate cements in pulpotomy treatment of primary molars with an 18-month follow-up

BackgroundMatrix metalloproteinases (MMPs) are critical enzymes involved in the remodeling and defense mechanisms of dental pulp tissue. While their role in permanent teeth has been extensively studied, research focusing on MMPs in primary teeth remains limited. This gap highlights the need for further investigations to understand the specific contributions of MMPs to pulpal defense in primary teeth. Moreover, the clinical efficacy of Biodentine as a pulpotomy material in primary teeth warrants further exploration through well-designed studies to establish its success and long-term outcomes in pediatric dentistry.AimThis study aims to compare the expression levels of MMP-2, MMP-8, and MMP-9 in cases of reversible and irreversible pulpitis. Additionally, it seeks to evaluate the clinical success of Mineral Trioxide Aggregate (MTA) and Biodentine when used as pulpotomy agents in primary molars. By analyzing the differential expression of these MMPs, the study will contribute to a better understanding of their role in pulpal inflammation and the potential therapeutic outcomes of MTA and Biodentine in primary molars.DesignIn this parallel randomized controlled trial, 63 mandibular primary second molars were assigned to two main groups: Group 1, consisting of 42 teeth diagnosed with reversible pulpitis, and Group 2, consisting of 21 teeth diagnosed with irreversible pulpitis. Group 1 was further divided into two randomized subgroups, each containing 21 teeth. The expression levels of MMP-2, MMP-8, and MMP-9 were evaluated in all samples. Pulpotomy treatments were performed using MTA and Biodentine in Group 1. Clinical and radiographic evaluations were conducted over an 18-month follow-up period. Statistical analyses were carried out using The Kolmogorov-Smirnov test, t-test and Fisher’s exact test (p < 0.05).ResultsThe study revealed that MMP-2 and MMP-9 expression levels were significantly elevated in specimens with irreversible pulpitis (p = 0.01), indicating a potential correlation between these matrix metalloproteinases and the severity of pulpal inflammation. However, no significant difference was observed in the clinical success rates of pulpotomies performed with MTA and Biodentine, suggesting that both materials are equally effective in the treatment of primary molars with reversible pulpitis.ConclusionsThe expression of MMP-2 and MMP-9 in pulpal blood presents a promising biomarker for assessing the degree of pulpal inflammation in primary teeth, offering a potentially valuable diagnostic tool. Additionally, the clinical success of Biodentine in pulpotomy procedures supports its viability as an effective alternative to MTA, providing a reliable option.Clinical Trial Registration IDThe study protocol has been registered with an ID: NCT05145686. Registration Date: 9th November 2021.

Comparison Between Static and Dynamic Spica Cast for Closed Reduction Cases of DDH: A Short-Term Follow-Up

Background: developmental dysplasia of the hip (DDH) is a typical childhood disease that, if left untreated, can lead to early-onset osteoarthritis. Closed reduction and spica casting are the first line of treatment for infants aged 6-18 months. Static and dynamic spica casts are the two primary treatment method used in practice, but the evidence is mixed as to which method provides the best outcomes. Methods: This prospective, randomized, controlled trial compared static and dynamic spica casting in 98 DDH patients from Kurdistan, Iraq. Patients were divided into dynamic and static groups. The hip was follow-up ed by using radiographic parameters such as the acetabular index and Tonnis grade. Treatment success was defined as a favorable hip outcome after one year. Results: There was no significant difference in treatment success between the groups, with 68% of patients in both groups achieving normal hip modification. However, the dynamic cast group had significantly better acetabular indices at 3, 6, and 12 months, and all of them were done under general anesthesia (GA), better hygiene, better caring and more comfortable parents with less cost. Conclusions: Static and dynamic spica casting have similar short-term clinical success rates for DDH, but dynamic casting produces better radiographic outcomes, especially in infants younger than 1. Longer-term studies are needed to determine possible radiographic improvement and whether dynamic type translate into better clinical outcomes since its more comfortable for parent, with less cost.

A New Self-Expandable Metallic Stent with Low Axial Force and a High Axial Force Zero-Border Shows a Very Low Perforation Rate in Malignant Colorectal Obstruction: A Japanese Multicenter Prospective Study.

Background: Recently, there has been a significant increase in the utilization of self-expandable metallic stents (SEMSs) for treating malignant colorectal obstructions through colorectal stenting. The mechanical properties of SEMSs are usually considered to affect clinical outcomes of patients with malignant colorectal obstructions. Methods: This single-arm, prospective, multicenter study of SEMS with a lower axial force and high axial force zero-border included 200 patients with malignant colorectal obstruction. Technical and clinical success, stent patency, and adverse events associated with SEMS placement were evaluated. Results: One patient was excluded, and 199 patients were evaluated. The treatment intent was bridge-to-surgery in 129 and palliation in 70 patients. Technical and clinical success rates were 99.5% and 97.0%, respectively. The percentage of the ColoRectal Obstruction Scoring System scores of 3 or higher improved significantly from 19.2% before placement to 93.9% after placement. Clinical success was not achieved in five patients due to insufficient stent expansion in four patients and stent occlusion in one patient. Only one patient underwent emergency surgery for perforation of the proximal colon, far from where the stent was placed; the rescue procedure was not performed, despite no improvement in proximal dilatation due to insufficient stent expansion. Among the palliation cohort, 15 patients received chemotherapy, including molecular-targeted agents such as bevacizumab. There were no fatal cases related to stent placement. Conclusions: For management of malignant colorectal obstruction, this newly developed SEMS with low axial force and a high axial force zero-border showed high technical and clinical success rates, and an extremely low perforation rate (0.5%).

Clinical and radiological features associated with rupture of pulmonary artery pseudoaneurysm: a retrospective study

BackgroundHemoptysis resulting from rupture of the pulmonary artery pseudoaneurysm (PAP) is massive and fatal, while factor contributing to the rupture of pseudoaneurysm remains elusive. This study aimed to elucidate the clinical and radiological features of PAP and identify the risk factors associated with rupture.MethodsPatients who developed hemoptysis with PAP were collected from January 2019 to December 2022 retrospectively. Clinical data of the demographic characteristics, radiological findings, treatment strategies, and prognosis were collected. A comparative analysis was performed on the characteristics in the ruptured and non-ruptured cases.ResultsA total of 58 PAPs were identified in the 50 patients. The most common causes were infection (86%) and cancer (8%). The PAPs were located predominantly in the upper lobes of both lungs, and 57 (99.3%) were distributed in the segmental or subsegmental pulmonary arteries. The median diameter was 6.1(4.3–8.7) mm. A total of 29 PAPs were identified adjacent to pulmonary cavitations, with the median diameter of the cavity being 18.9 (12.4–34.8) mm. Rupture of pseudoaneurysm occurred in 21 cases (42%). Compared to unruptured group, the ruptured group had a significantly higher proportion of massive hemoptysis (57.1% vs. 6.9%, p < 0.001), larger pseudoaneurysm diameter (8.1 ± 3.2 mm vs. 6.0 ± 2.3 mm, p = 0.012), higher incidence of pulmonary cavitation (76.2% vs. 44.8%, p = 0.027), and larger cavitation diameters (32.9 ± 18.8 mm vs. 15.7 ± 8.4 mm, p = 0.005). The mean pulmonary artery pressure (mPAP) in the ruptured group was also significantly higher than that in the unruptured group [23.9 ± 7.4 mmHg vs. 19.2 ± 5.0 mmHg, p = 0.011]. Endovascular treatment was successfully performed in all 21 patients with ruptured PAP, of which the clinical success rate was 96.0%. Five patients experienced recurrent hemoptysis within one year.ConclusionsMassive hemoptysis, pseudoaneurysm diameter, pulmonary cavitation, and elevated mPAP were the risk factors for rupture of pseudoaneurysm. Our findings facilitate early identification and timely intervention of PAP at high risk of rupture.

Calcium Silicate-Based Cements in Restorative Dentistry: Vital Pulp Therapy Clinical, Radiographic, and Histological Outcomes on Deciduous and Permanent Dentition-A Systematic Review and Meta-Analysis.

Vital pulp therapy aims to preserve the vitality of dental pulp exposed due to caries, trauma, or restorative procedures. The aim of the present review was to evaluate the clinical, radiographic, and histological outcomes of different calcium silicate-based cements used in vital pulp therapy for both primary and permanent teeth. The review included 40 randomized controlled trials from a search across PubMed, LILACS, and the Cochrane Collaboration, as well as manual searches and author inquiries according to specific inclusion and exclusion criteria. A critical assessment of studies was conducted, and after data extraction the results were submitted to a quantitative statistical analysis using meta-analysis. The studies, involving 1701 patients and 3168 teeth, compared a total of 18 different calcium silicate-based cements in both dentitions. The qualitative synthesis showed no significant differences in short-term outcomes (up to 6 months) between different calcium silicate-based cements in primary teeth. ProRoot MTA and Biodentine showed similar clinical and radiographic success rates at 6 and 12 months. In permanent teeth, although the global results appeared to be well balanced, ProRoot MTA generally seemed to perform better than other calcium silicate-based cements except for Biodentine, which had comparable or superior results at 6 months. Meta-analyses for selected comparisons showed no significant differences in clinical and radiographic outcomes between ProRoot MTA and Biodentine over follow-up periods. The present review highlights the need for standardized definitions of success and follow-up periods in future studies to better guide clinical decisions. Despite the introduction of new calcium silicate-based cements aiming to address limitations of the original MTA. ProRoot MTA and Biodentine remain the most used and reliable materials for vital pulp therapy, although the results did not deviate that much from the other calcium silicate-based cements. Further long-term studies are required to establish the optimal CSC for each clinical scenario in both dentitions.

Safety and efficacy of bilateral superselective adrenal arterial embolization for treatment of idiopathic hyperaldosteronism: a prospective single-center study

ObjectiveThis study aimed to assess the efficacy and safety of bilateral superselective adrenal arterial embolization (SAAE) in patients with bilateral idiopathic hyperaldosteronism (IHA), a subtype of PA.MethodsNinety-eight patients with bilateral IHA underwent bilateral SAAE between August 2022 and August 2023. Sixty-eight patients were followed up for up to 12 months. The study outcomes were evaluated using the criteria provided by the Primary Aldosteronism Surgical Outcome (PASO) guidelines.ResultsThe mean reductions in systolic and diastolic blood pressure were 27.4 ± 21.3 mmHg and 23.1 ± 17.4 mmHg, respectively (p < 0.001). The rates of clinical success and biochemical success after adrenal artery ablation were 63.2% (43/68) and 39.7% (27/68), respectively. Overall, there were significant reductions in daily defined doses (DDD), aldosterone/renin ratio (ARR), and plasma aldosterone levels (p < 0.001). Plasma renin levels increased by a mean value of 10.4 ± 39.0 pg/mL (p = 0.049), and potassium levels increased by 0.40 ± 0.63 mmol/L (p < 0.001). No significant adverse events were reported during SAAE or the follow-up period of up to one year. Additionally, no abnormalities were detected by adrenal 68Ga-Pentixafor PET/CT scans before or after SAAE.ConclusionBilateral SAAE appears to lead to sustained improvements in blood pressure and biochemical parameters in patients with bilateral PA, with minimal adverse effects. This suggests that bilateral SAAE could serve as an effective alternative approach for treating bilateral IHA, potentially curing this condition.

Mechanical thrombectomy with the InThrill device for thrombosed hemodialysis access: A single center experience.

To assess the effectiveness and safety of the InThrill Thrombectomy System in treating thrombosed arteriovenous fistulas (AVFs) and grafts (AVGs) via mechanical thrombectomy. Institutional database was retrospectively searched to identify all thrombectomy procedures performed using the study device at our hospital for thrombosis of AVFs or AVGs. Inclusion criteria encompassed patients aged 18 and above who underwent AV access thrombectomy using the study device. Intraprocedural metrics, including procedure time, device time, blood loss, and adjunctive procedures were collected. Technical success was defined as restoration of flow combined with <30% residual diameter stenosis of the treated vascular segment. Clinical success was defined as the resumption of normal hemodialysis for a minimum of at least one session following intervention. Through 3-month follow-up, patency, and adverse events were evaluated. A total of 20 thrombectomies were performed on 2 AVFs and 18 AVGs in 13 patients. Median procedure and device times were 45 and 10 min, respectively. Balloon angioplasty was performed in all cases with additional stenting in 40% (8/20) of cases to address stenosis following thrombus removal. No other mechanical thrombectomy devices were utilized. Intraprocedural thrombolytics were not administered in any case. Average blood loss was 10 mL. The technical success and clinical success rates were 100% (20/20) and 95% (19/20), respectively. There were no intraoperative adverse events. One patient developed a post-operative minor hematoma, and one patient developed a post-operative pseudoaneurysm at the access site. The primary patency rate was 77% (10/13) at 1 month. Both assisted primary and secondary patency rates were 100% at 1 and 3 months. These preliminary results suggest that the InThrill Thrombectomy System is rapid, safe, and effective for thrombolytic-free treatment of AV access thrombosis in hemodialysis patients.

Endoscopic ultrasound-guided hepaticogastrostomy and endoscopic retrograde cholangiopancreatography-guided biliary drainage for distal malignant biliary obstruction due to pancreatic cancer with asymptomatic duodenal invasion: a retrospective, single-center study in Japan.

Duodenal invasion (DI) is a risk factor for early recurrent biliary obstruction (RBO) in endoscopic retrograde cholangiopancreatography-guided biliary drainage (ERCP-BD). Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) may reduce early RBO in cases of asymptomatic DI, even when ERCP is possible. We enrolled 56 patients with pancreatic cancer and asymptomatic DI who underwent EUS-HGS (n=25) or ERCP-BD (n=31). Technical and clinical success, early (<3 months) and overall RBO rates, time to RBO (TRBO), and adverse events (AEs) were compared between the EUS-HGS and ERCP-BD groups. Risk factors for early RBO were also evaluated. Baseline characteristics were similar between the groups. Both procedures demonstrated 100% technical and clinical success rates, with a similar incidence of AE (48% vs. 39%, p=0.59). While the median TRBO was comparable (5.7 vs. 8.8 months, p=0.60), EUS-HGS was associated with a lower incidence of early RBO compared to ERCP-BD (8% vs. 29%, p=0.09). The major causes of early RBO in ERCP-BD were sludge and food impaction, rarely occurring in EUS-HGS. EUS-HGS was potentially reduced early RBO (odds ratio, 0.32; p=0.07). EUS-HGS can be a viable option for treating pancreatic cancer with asymptomatic DI.

Prevalence and intervention effect of arteriovenous graft stenosis

Objective: To evaluate the prevalence, intervention methods and effect of arteriovenous graft (AVG) stenosis. Methods: The clinical data of patients who received AVG in the Blood Purification Center, the First Affiliated Hospital of Zhengzhou University from January 2018 to December 2022 were retrospectively analyzed. The patency rate, prevalence and intervention effect of AVG stenosis were analyzed. Results: A total of 475 patients aged (55.5±11.8) years were included, and there were 193 male cases (40.6%) and 282 female cases (59.4%). The patients were followed up for [M (Q1, Q3)] 19 (12, 30) months, and the primary, assisted primary and secondary patency were 14 (5, 27), 27 (13, 55), and 59 (33, 65) months, respectively. There were 799 access events which needed intervention, with a total standardized intervention rate of 0.90 per patient-year. Totally, 431(53.9%, 431/799) stenosis events occurred in 207 AVG. Among 422 AVG stenosis events with complete clinical data, 57.8% (244/422) were multi-site stenosis and 42.2% (178/422) were single-site stenosis. The most common sites of stenosis were graft-vein anastomosis (47.6%, 340/715), venous outflows (22.7%, 162/715), and puncture zone (20.0%, 143/715). In the 414 stenosis with intact follow-up data, 90.8% (376/414) were treated by balloon angioplasty, 8.5% (35/414) received covered stent insertion, and 0.7% (3/414) were intervened by open surgery. Clinical success rate was 98.1% (406/414). The primary patency time after endovascular treatment was 6 (4, 12) months. Covered stent significantly increased post-intervention primary patency time compared withballoon angioplasty [6 (3, 7) months vs 3 (1, 4) months, P=0.020]. Conclusions: Stenosis is the most common complication of AVG, and the most common sites are graft-vein anastomosis, venous outflows, and puncture zone. Intervention of AVG stenosis has a high clinical success rate, and a relatively low post-intervention patency. Covered stent insertion improves the post-intervention patency of AVG, which has a poor effect using balloon expansion.

Holistic in silico developability assessment of novel classes of small proteins using publicly available sequence-based predictors.

The development of novel therapeutic proteins is a lengthy and costly process, with an average attrition rate of 91% (Thomas et al. Clinical Development Success Rates and Contributing Factors 2011-2020, 2021). To increase the probability of success and ensure robust drug supply beyond approval, it is essential to assess the developability profile of new potential drug candidates as early and broadly as possible in development (Jain et al. MAbs, 2023. https://doi.org/10.1016/j.copbio.2011.06.002 ). Predicting these properties in silico is expected to be the next leap in innovation as it would enable significantly reduced development timelines combined with broader screens at lower costs. However, developing predictive algorithms typically requires substantial datasets generated under very defined conditions, a limiting factor especially for new classes of therapeutic proteins that hold immense clinical promise. Here we describe a strategy for assessing the developability of a novel class of small therapeutic Anticalin® proteins using machine learning in conjunction with a knowledge-driven approach. The knowledge-driven approach considers developability attributes such as aggregation propensity, charge variants, immunogenicity, specificity, thermal stability, hydrophobicity, and potential post-translational modifications, to calculate a holistic developability score. Based on sequence-derived descriptors as input parameters we established novel statistical models designed to predict the developability scores for Anticalin proteins. The best models yielded low root mean square errors across the entire dataset and were further validated by removing input data from individual screening campaigns and predicting developability scores for those drug candidates. The adoption of the described workflow will enable significantly streamlined preclinical development of Anticalin drug candidates and could potentially be applied to other therapeutic protein scaffolds.

Lipiodol Versus Imipenem/Cilastatin in Genicular Artery Embolization: A Retrospective Study on Safety and Clinical Success.

This study aims to evaluate the safety and effectiveness of genicular artery embolization (GAE) using lipiodol in comparison to imipenem/cilastatin (IPM-CS). This retrospective study screened patients who underwent GAE between January 2022 and February 2023 for inclusion. Clinical outcomes were assessed at 1, 3, and 6months post-procedure using the Visual Analog Scale (VAS) for pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness, functional capacity, and total scores. Technical and clinical success rates, complications, and patient-reported outcomes were assessed. A total of 42 patients were included in the study, with 13 patients treated with lipiodol and 29 with IPM-CS for GAE. Transient skin discoloration was noted in 23.1% of lipiodol patients and 31% of the IPM-CS group (p = 0.722). One patient (7.6%) in the lipiodol group developed knee edema and erythema due to drug-induced vasculitis (p = 0.309). Clinical success rates in the lipiodol group were 76.9% at 1month, consistent at 3months, and 69.2% at 6months. For the IPM-CS group, success rates were 89.7, 86.2, and 75.9%, respectively, with no significant differences (p = 0.353, p = 0.657, p = 0.713). The median percentage change in WOMAC stiffness scores for the lipiodol group at 1, 3, and 6months post-GAE were - 25%, - 16.7%, and - 16.7%, respectively, while the IPM-CS group showed decreases of - 40%, - 50%, and - 50%. Significant differences were found between the groups at all time points (p = 0.017, p = 0.009, and p = 0.002, respectively). Lipiodol shows comparable clinical success to IPM-CS in GAE.

Short-term outcomes of the iCover balloon-expandable covered stent for iliac artery lesions.

To describe the short-term follow-up results of the recently introduced iCover balloon-expandable covered stents for iliac artery lesions. All consecutive patients treated with iCover balloon-expandable covered stents between March 2022 and August 2023 were retrospectively reviewed. The primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints included major adverse events, freedom from TLR throughout the follow-up period, primary and secondary patency, and clinical and technical success. In the study population of 40 adult patients (87.5% men, mean age: 63.5 ± 11 years), the mean follow-up period was 6.2 ± 2.8 months. A total of 98 stents of various sizes were implanted. The technical success rate was 100%. Freedom from TLR was 95.8% [95%, confidence interval (CI): 95%- 96.6%], the primary patency rate was 91.7% (95%, CI: 89.8%-93.6%), and the secondary patency rate was 95.8% (95%, CI: 95%-96.6%) at 6 months. The all-cause mortality rate was 5%. These real-world data demonstrate a high technical and clinical success rate, a high 6-month primary patency rate, and a low requirement for TLR. These are promising indicators for the safety and efficacy of iCover stents. Balloon-expandable covered stents are frequently used in iliac artery atherosclerotic disease. This study shows that the short-term follow-up results of the new iCover stent are satisfactory, indicating its safety and efficacy.

The Dawn of a New Pharmaceutical Epoch: Can AI and Robotics Reshape Drug Formulation?

Over the last four decades, pharmaceutical companies' expenditures on research and development have increased 51-fold. During this same time, clinical success rates for new drugs have remained unchanged at about 10 percent, predominantly due to lack of efficacy and/or safety concerns. This persistent problem underscores the need to innovate across the entire drug development process, particularly in drug formulation, which is often deprioritized and under-resourced.

A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair.

The present standard of care to treat aortic arch pathologies is open surgical repair with cardiopulmonary bypass and deep hypothermic arrest. With approaches for total endovascular and extra-anatomic cervical debranching hybrid arch repair becoming more diverse, understanding what is considered a successful operation is prerequisite for a rigorous comparison of techniques. This review describes the specific outcomes reported, the rates of success, and the definitions of technical and clinical success in total endovascular and extra-anatomic cervical debranching hybrid aortic arch repair. A comprehensive search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed. Studies with patients undergoing total endovascular or hybrid extra-anatomic cervical debranching repair of the aortic arch were included. Any publications including only patients with Ishimaru zone 2 or distal repairs were excluded from this review. Studies with less than 5 patients were excluded. Data extraction was performed by one author. Data items included were study design, procedure type, procedural details, underlying pathology, type of cervical debranching, type of endograft repair, surgical outcomes, definition of cerebrovascular events, technical success, and the definition of technical success. Of 1754 studies screened for review, 85 studies with 5521 patients were included. By frequency, the included studies examined the following interventions: fenestrated devices, branched devices, parallel grafting. Most studies were retrospective single-institution studies. There were no randomized controlled trials. Short-term mortality and cerebrovascular events were nearly universally reported, present in 99% and 95% of studies reviewed, respectively. Only 27% of studies provided an explicit definition for cerebrovascular events. While 75% of studies reported a technical success rate, only 45% of those studies provided explicit criteria. Clinical success rates were infrequently reported, present in only 5.9% of studies reviewed. The definitions of technical success that were provided fell short of analogous defined reporting standards in nearly all studies, inflating technical success rates. Definitions of cerebrovascular events and technical success require stringent criteria to uniformly compare various methods of endovascular aortic arch repair. A societal consensus document for reporting standards of endovascular aortic arch repair would allow for higher-quality outcomes research. Total endovascular and extra-anatomic cervical debranching hybrid operations are being increasingly utilized for complex aortic arch repair. These techniques, however, can be associated with serious complications. Currently, there is no accepted metric to define technical or report clinical outcomes. Due to the paucity of high-quality data, use of these approaches may be limited in clinical practice. This study emphasizes the need for the development of standards for reporting outcomes in endovascular aortic arch repair. Future studies can then utilize these benchmarks, whcih will allow for improved efficacy and safety in these techniques.

Efficacy and safety of per-oral endoscopic myotomy in non-achalasia esophageal motility disorders: a systematic review and meta-analysis.

Per‑oral endoscopic myotomy (POEM) is the preferred endoscopic modality for managing achalasia cardia. However, there are no recommendations on the role of POEM in non‑achalasia esophageal dysmotility disorders (NAEMD), including esophagogastric junction outflow obstruction (EGJOO), distal esophageal spasm (DES), and hypercontractile esophagus (HE). The present systematic review and meta-analysis aimed to assess the safety and efficacy of POEM in the treatment of NAEMD. MEDLINE, Embase, and Scopus were searched from inception to August 2023 for studies analyzing the outcome of POEM in NAEMD. Clinical success and adverse events were the main outcomes assessed. The event rates and their 95% confidence interval were calculated using a random effects model. A total of 11 studies with 271 patients were included in the final analysis. The pooled clinical success rate with POEM in NAEMD was 86.9% (82.9-90.9). On subgroup analysis, the pooled clinical success rates of POEM in DES and EGJOO were 97.8% (90.9-100.0) and 92.7% (86.3-95.1), which were significantly higher thanin HE 81.2% (73.5-88.8). Data from limited studies showed that the pooled rate of improvement in dysphagia and chest pain was 88.5% (83.0-93.9) and 87.4% (80.5-94.4). The pooled incidence of overall AEs and serious AEs was 12.6% (5.7-19.5) and 0.3% (0.0-1.9), respectively. On follow-up, the pooled incidence of new-onset heartburn was 18.7% (11.1-26.2). POEM is a safe and efficacious treatment modality for the management of NAEMD with a lower clinical success in patients with HE. Further large-scale studies are required to validate the findings of the present analysis.

Safety and Efficacy of Primary EUS-Guided Choledochoduodenostomy for Malignant Distal Biliary Obstruction: A Systematic Review and Meta-Analysis

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is preferred for biliary drainage in malignant distal biliary obstruction (MDBO). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is considered a rescue therapy for failed ERCP. This study aims to evaluate the safety and efficacy of this technique as the primary modality for MDBO biliary drainage. Methods: An electronic database search was conducted following PRISMA guidelines to identify studies on EUS-CDS for primary biliary drainage in MDBO. A meta-analysis was performed using random and fixed effects models. Results: We extracted data from 10 eligible studies comprising 519 patients. The mean age for the study was 70 years ± SD 2.66. The pooled technical success rate was 92.36% (95% CI = 88.39–95.56), and the clinical success rate was 88.91% (95% CI = 85.22–92.13). The pooled stent dysfunction rate was 13.66% (95% CI = 7.47–21.35), and the reintervention rate was 15.91% (95% CI = 11.00–21.54) of patients. The mean stent patency duration was 229.20 days ± SD 113.9. The total pooled adverse events rate was 17.50% (95% CI = 12.90–22.64), and 9.03% (95% CI = 4.43–15.05) was considered moderate to severe. Procedure-related pancreatitis had a pooled rate of 0%. The pooled adverse event rate of acute cholangitis was 6.84% (95% CI = 3.69–10.88), and for acute cholecystitis it was 2.61% (95% CI = 1.06–4.83). Conclusions: EUS-CDS demonstrates favorable outcomes when used as a primary approach in MDBO. With a long stent patency duration and no procedure-related acute pancreatitis, it may be considered the primary technique when expertise is available.