Clinical Success Rate Research Articles

Endoscopic Ultrasound Guided Gastro-enterostomy for Malignant Gastric Outlet Obstruction: Impact of Clinical and Demographic Factors on Outcomes

Endoscopic ultrasound guided gastroenterostomy (EUS-GE) has emerged as an alternative to surgical gastrojejunostomy and endoluminal stenting for malignant gastric outlet obstruction (MGOO). Studies regarding factors associated with the EUS-GE outcomes are limited. A retrospective observational study was conducted with consecutive patients who underwent EUS-GE for MGOO at our center from January 2016 to November 2023. Primary outcomes were technical success (Establishing EUS-GE) and clinical success (Low residue diet tolerance without re-intervention at 90-day follow-up). Secondary outcomes were adverse events (AEs), reinterventions and full regular diet tolerance. Technical success and clinical success rates were 92.70% (127/137) and 88.00%, respectively, with 42.86% of the patients tolerating a regular diet. Patients with peritoneal carcinomatosis had lower odds of technical success (OR: 0.19, 95% CI: 0.04-0.93). Obstruction at the level of stomach, compared to duodenum, had lower odds of clinical success (OR: 0.06, 95% CI: 0.006-0.56). AE and reintervention rates were 14.17% and 8.66%, respectively. NGT decompression prior to EUS-GE was associated with lower AE rates in multivariable analysis (OR: 0.32, 95% CI: 0.11-0.95). Prior gastrointestinal surgery was associated with reintervention in multivariable analysis (OR: 4.09; 95% CI: 1.02-16.45, p-value: 0.047). EUS-GE has high technical and clinical success rates, with many patients tolerating regular diet. Routine NGT decompression should be considered to minimize AEs. MGOO at the level of stomach is associated with lower clinical success rates. Extra care should be taken while performing EUS-GE in patients with peritoneal carcinomatosis. Prior gastrointestinal surgery is a likely risk factor for reintervention.

Safety and Efficacy of Lumen-Apposing Metal Stents for Management of Late Refractory Gastro-jejunal Structures in Patients with Roux-en-Y Gastric Bypass (with Video).

Roux-en-Y gastric bypass (RYGB) related late gastro-jejunal (GJ) strictures are often resistant to endoscopic balloon dilations. Lumen-apposing metal stents (LAMSs) have been used to treat benign strictures with favorable results. However, the data remains limited to justify LAMS use for management of post-RYGB late GJ strictures. We aim to evaluate the safety and efficacy of LAMS placement for the management of late GJ strictures that are refractory to balloon dilations in post-RYGB patients. This was a single center retrospective study that included all post-RYGB patients who underwent LAMS placement for management of late GJ strictures that had previously failed balloon dilations. Primary outcomes were technical and clinical success, and secondary outcomes were LAMS-related adverse events. A total of 28 patients underwent LAMS placement for management of GJ strictures. Median age was 60.5 (IQR 50.5, 67.0) years and majority were females (27, 96.4%). Median interval between surgery and first diagnosis of GJ stricture was 13 years (IQR 7, 17.5). 20 × 10 mm LAMS was the most used stent (n = 24, 85.7%). The median procedure time was 23.5 (IQR 14.5, 32.0) minutes. Technical and short-term clinical success of LAMS placement was 100% (95% CI 87.9-100.0). Long-term success was achieved in 19 out of 25 patients (76.0%, 95% CI 56.6-88.5) that had over 3 months follow-up after LAMS removal. Stent migration was noted in 2 (7.1%) patients, and 1 (3.6%) patient each experienced pain and minor bleeding without the need for additional interventions. No patient in our cohort required surgical revision of GJ anastomosis. Placement of LAMS is safe, technically feasible, and associated with a high clinical success rate in patients with late GJ strictures after RYGB who have failed prior balloon dilations. Placement of LAMS can be considered early in patients requiring multiple balloon dilations.

A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections

ObjectiveTo demonstrate the noninferiority of intravenous (IV) sulopenem to IV ertapenem, each followed by an oral regimen, in adults with complicated intraabdominal infections (cIAI). MethodsHospitalized adults with cIAI were randomized to 5 days of IV sulopenem followed by oral sulopenem etzadroxil/probenecid twice daily or 5 days of IV ertapenem followed by oral ciprofloxacin/metronidazole or amoxicillin-clavulanate depending on baseline pathogen susceptibility. The target treatment duration was 7-10 days. The primary (FDA-specified) endpoint was clinical response at Day 28 [Test-of-Cure (TOC)] in the micro-Modified Intent to Treat (micro-MITT) population. Results674 patients were randomized. The two treatment arms were well-balanced. E. coli (395 patients) and B. fragilis (111 patients) were the most frequently isolated pathogens. Clinical success rates in the micro-MITT population were 81.9% (204/249) for sulopenem-treated patients and 87.9% (233/265) for ertapenem-treated patients. The lower bound of the confidence interval (CI) for the treatment difference of the primary endpoint was below the prespecified non-inferiority margin of -10.0 [treatment difference -6.0%, 95% CI [-12.2, 0.2]. In all other analysis populations, the lower limit of the 95% CI was above -10.0. Treatment emergent adverse events (all, 26.0% [87/335] vs 23.4% [78/333]; related, 6.0% [20/335] vs 5.1% [17/333]) were similar for sulopenem and ertapenem, respectively. Most events were mild to moderate in severity. There were more serious adverse events in the sulopenem arm (7.5% [25/335] vs 3.6% [12/333]), only two of which were considered possibly drug-related. ConclusionsSulopenem IV followed by oral sulopenem etzadroxil/probenecid was not noninferior to ertapenem followed by oral step-down in treating cIAI in the micro-MITT population. This finding should be interpreted in the context of country regulations, as endpoint timing, primary analysis population and noninferiority margin may vary regionally. Both IV and oral sulopenem were well-tolerated; the oral formulation allowed patients with resistant pathogens to step down from IV therapy. Clinical Trial RegistrationNCT03358576.

Efficacy of gastric per-oral endoscopic myotomy remains similar after failure of interventional techniques in refractory gastroparesis

Background and aimsGastric per-oral endoscopic myotomy (G-POEM) is a new therapeutic option for the treatment of refractory gastroparesis. However, the outcome of G-POEM after the failure of gastric electrical stimulation (GES) or other pylorus-targeting therapies has been poorly reported. MethodsData were collected from patients referred for G-POEM for refractory gastroparesis. The efficacy in patients with previous interventional techniques was compared to patients naïve to instrumental technique. The primary endpoint was the 6-month clinical success rate, defined as at least a 1-point decrease in the Gastroparesis Cardinal Symptom Index (GCSI). ResultsAmong 48 patients referred for G-POEM, 32 patients had had previous instrumental treatments (66%): 15 (31%) had had GES, and 17 (35%) had had pyloric endoscopic dilation or toxin injection. The technical success rate was 100%. At 6 months, clinical success was achieved in 25/48 patients (52%) and the GCSI decreased from 3.38 (2.94–3.95) to 2.25 (1.11–3.36) (p < 0.001). The 6-month success rate was similar in patients with or without previous instrumental treatment (50.0% vs 56.3%; p = 0.41). The complication rate was also similar in the two groups (6.3% vs 12.5%; p = 0.59), with only one severe adverse event. The only predictive factor for success at 6 months was a higher body mass index (OR = 1.14 [1.01–1.32]; p = 0.05). ConclusionG-POEM is safe and remains effective after GES or previous pyloric treatment failure, with 50% efficacy at 6 months. The therapeutic strategy in refractory gastroparesis remains to be defined.

Percutaneous Sclerotherapy of Cystic Lesions at Kenyatta National Hospital: Indications, Outcomes, Efficacy, and Complications

Background: Percutaneous sclerotherapy is a minimally invasive treatment for cystic lesions and has emerged as a preferred alternative to traditional surgical methods due to its faster recovery times and lower complication rates. A sclerosing agent is instilled into the lesion causing cyst wall inflammation and lesion shrinkage. It has a significant role in managing cystic lesions, with better health outcomes. Objectives: To evaluate the indications, outcomes, efficacy, and complications of percutaneous sclerotherapy in the management of cystic lesions. Methodology: The study was a prospective cross-sectional study involving patients with cystic lesions referred for percutaneous sclerotherapy. Data was collected, analyzed, and presented in percentages, graphs, tables. Technical and clinical success rates were calculated. Efficacy was analyzed using chi-square test. Results: 27 patients with cystic lesions were treated. Most were females (77.8%), and males (22.2%), with a male-to-female ratio of 1:3.5. The commonest indication was pain (26.1%), followed by pressure symptoms (22.7%) and abnormal swelling (20.5%). Most lesions were located in the liver (25.9%), followed by the kidney (18.5%). Majority had significant improvement in clinical symptoms and size reduction with p-values &lt; 0.05. The technical success rate was 100% and the clinical success rate was 96.3%. Minor complications were encountered including mild pain (7.4%), catheter blockage, cyst abscess formation, catheter insertion site infection, and inflammatory cyst septations (each 3.7%). Conclusion: Percutaneous sclerotherapy is a safe, efficacious treatment of cystic lesions with a high technical and clinical success rate. It should be considered as a first line of treatment for cystic lesions.

Root-filling materials for endodontic surgery: biological and clinical aspects

The placement of root filling materials aims to prevent the occurrence of post-treatment apical periodontitis following completion of endodontic treatment. Materials should possess properties that will not permit bacterial invasion and infection, namely excellent sealing ability and/or antibacterial properties. In root-end filling procedures or repair of root perforations, the root filling materials are placed in a particularly challenging clinical environment, as they interface with a relatively large area with the periradicular tissues. The biological properties of these materials are therefore of significant importance. The current review discusses the most widely used materials for endodontic surgery (i.e., root-end filling and perforation repair), with particular focus on their biological characteristics, namely antibacterial properties and interactions with host tissue cells, together with clinical studies. Properties of amalgam, glass ionomer cements (GICs), resin systems, zinc oxide eugenol-based cements and hydraulic calcium silicate cements (HCSCs), together with representative and well-researched commercial materials in the context of their use in endodontic surgery are presented. While the use of HCSCs seems to offer several biological advantages, together with addressing issues with the initial formulation in the most recent versions, materials with different chemical compositions, such as zinc oxide eugenol-based cements, are still in use and appear to provide similar clinical success rates to HCSCs. Thus, the significance of the currently available materials on clinical outcomes remains unclear.

Empiric embolization by vasospasm therapy for acute lower gastrointestinal bleeding: a preliminary report

To report the preliminary result of empiric embolization for angiographycally-negative lower gastrointestinal bleeding (LGIB) by using the pharmaco-induced vasospasm technique with or without the adjunctive use of intra-arterial multi-detector computed tomography (MDCT). 23 LGIB patients with positive MDCT findings but negative angiographic results underwent empiric pharmaco-induced vasospasm therapy. The presumed bleeding artery was semi-selectively catheterized, and a segment of bowel was temporarily spasmed with bolus injection of epinephrine and immediately followed by 4-h’ vasopressin infusion. The rebleeding, primary and overall clinical success rates were reported. MDCT showed 19 bleeders in the SMA territory and 4 bleeders in the IMA territory. Early rebleeding was found in 6 patients (26.1%): 2 local rebleeding, 3 from new-foci bleeding and 1 uncertain. Of the 10 small bowel bleeding patients, only 1 out of the 7 who underwent intra-arterial MDCT showed rebleeding, whereas 2 out of the 3 without intra-arterial MDCT rebled. No patients exhibited procedure-related major complications, including bowel ischemia and cardiopulmonary distress. The overall clinical success rate was 91.3% (21/23) with a 30-day mortality rate of 26.1% (2 of the 6 patients had early rebleeding). Empiric pharmaco-induced vasospasm therapy, when localized with/without adjunctive intra-arterial MDCT, seems to be a safe and effective method to treat angiographically-negative LGIB patients.

Long-term patient clinical benefits and healthcare utilization after pulsed field ablation in paroxysmal atrial fibrillation: sub-analyses from the multicenter inspIRE trial

Abstract Background/Introduction The treatment of atrial fibrillation (AF) with pulsed field ablation (PFA) aims to prevent AF recurrence while reducing complications from the ablation modality. Similar to thermal ablation, PFA has proven to be safe and effective for treatment of paroxysmal AF (PAF); however, there is scarce evidence on patient-related clinical benefits, including healthcare utilization, using this new energy modality. Purpose The objective of this study is to assess long-term clinical improvements in patient care, symptoms, and quality-of-life (QOL) after PFA ablation in PAF. Methods InspIRE was a multicentre study evaluating the safety and efficacy of variable loop PFA catheters integrated with a 3D mapping system for treatment of symptomatic PAF. Patients were followed for up to 12 months for the following QOL and healthcare utilization endpoints: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, Class I/III AAD utilization, repeat ablation, incidence of direct current cardioversion (DCCV), and cardiovascular (CV) hospitalization. Post-hoc Kaplan-Meier estimates for clinical benefit success at 12 months were provided. Success was defined as composite freedom from occurrence of the following events post-blanking: repeat ablation, CV hospitalization, AAD utilization, and DCCV post-blanking. Predictors of clinical benefit success were explored via multivariate logistic regression analysis. Results A total of 186 enrolled patients (59±10 years; 70.0% male; CHA2DS2-VASC score 1.3±1.2) underwent PVI. Compared to baseline: 1) improvements in the AFEQT composite score were seen at 12 months (P&amp;lt;0.001); 2) Class I/III AAD use was reduced from 81.7% to 20.1% at 6-12 months (P&amp;lt;0.05); and 3) the proportion of subjects with DCCV decreased from 13.7% up to 12 months before the index procedure to 3.3% up to 12 months after the index procedure (P&amp;lt;0.001, Figure 1). Minimal clinically important difference in QoL (≥5 points improvement in AFEQT) was achieved in 85.2% of patients. Patients free from 12-month AF/AT/AFL recurrence (asymptomatic and symptomatic) had significantly greater improvements in AFEQT scores from baseline to 12 months versus those with recurrence (P=0.01). The clinical benefit success rate at 12 months was 87.5% (Figure 2). Patients who failed the clinical benefit endpoint were counted, including those with repeat ablation (7.5%), those on new or higher dose of AAD (6.5%), those hospitalized for CV (4.8%), and those who had DCCV post-blanking (1.6%). Multivariate logistic regression analysis showed that left ventricle ejection fraction &amp;lt;60% (OR: 0.22; 95% CI: 0.08-0.62; P&amp;lt;0.05) and incidence of diabetes (OR: 7.25; 95% CI: 2.00, 26.3; p&amp;lt;0.05) were associated with a higher risk of clinical benefit failure. Conclusions PFA ablation of PAF patients led to a clinical benefit success rate of 87.5%, with clinically meaningful improvement in QOL, as well as a reductions in AAD use, cardioversion, and hospitalization.Figure 1.Improvements in QoL and HealthFigure 2.Kaplan-Meier Analysis of Time

A Multicenter Retrospective Study Evaluating Distal Radial Access vs. Conventional Transradial or Transvenous Access for Endovascular Treatment of Malfunctioning Dialysis Fistulas

Background: This study aims to evaluate the feasibility, efficacy, and safety of distal transradial access (dRA) for the endovascular management of malfunctioning dialysis fistulas. This study also compares dRA with conventional access techniques, such as proximal radial and transvenous access, focusing on technical success, clinical outcomes, and vascular access site complications (VASCs). Methods: A retrospective multicenter study was conducted across four hospitals, including 292 patients treated between January 2019 and June 2024. Of these, 57 patients underwent dRA, and 235 received proximal radial or transvenous access. Key outcomes included technical success (successful completion of the procedure), clinical success (restoration of functional dialysis access), and complication rates. Data were collected on procedure times and complication profiles. Results: Technical success was achieved in 96.5% of patients undergoing dRA, compared to 98.3% in those receiving conventional access (p = 0.388). Clinical success was similar between groups (96.5% vs. 97%, p = 0.835). The overall complication rate was 10.5% for dRA and 8.5% for conventional access (p = 0.632). Cannulation time was longer for dRA (109.1 vs. 91.9 s, p &lt; 0.001), but total procedure duration was comparable between the groups. No major complications were observed in either cohort, and improved post-procedure access flow rates were recorded in all patients. Conclusions: Distal transradial access is a feasible and effective approach for the endovascular management of malfunctioning dialysis fistulas, with outcomes comparable to conventional access techniques. It provides a safe alternative, particularly for patients with complex fistulas, while maintaining a low complication profile.

Ultrasound-Guided Intranodal Lipiodol Lymphangiography for the Assessment and Treatment of Chylous Leaks: A Retrospective Case Series from a Single Center in Switzerland and a Systematic Review of the Literature

Background: Lymphatic leaks are well-known complications of major thoracic or abdominal surgeries, which significantly heighten morbidity and mortality rates. While the existing literature provides insights into managing these post-operative leaks, with a step-up approach from conservative measures (CMs) to surgical intervention, there are no standardized treatment guidelines. The purpose of this paper is to offer a management algorithm of post-operative lymphatic leaks based on a systematic literature review (SLR) of the therapeutic effect of Lipiodol lymphangiography (LL), completed by a case series of five patients who underwent LL in our department. Methods: In this IRB-approved study, we conducted an SLR following the PRISMA guidelines, using a PICOS. A quality assessment was performed for each study. The case series consisted of consecutive patients who underwent LL for diagnostic and therapeutic purposes at our institution between September 2018 and December 2020. Results: A total of 39 observational studies were included in the SLR comprising 11 retrospective case reviews (Group 1), and 3 case series as well as 25 case reports (Group 2). In total, these studies report cases of 557 patients (51.52% presenting oncological diagnoses; 43.98% having benefited from lymphadenectomy). Lymphatic or chylous fistulas were the most encountered complication, followed by chylothorax. The median volume of Lipiodol injected during lymphography was 11.7 mL (range: 9.8–75 mL). Overall, LL was technically successful in 77.7% (366/471) of patients. The clinical success of all technically successful LLs was 80.6% (295/366). Time-to-leak resolution after lymphography varied between 1 and 31 days. The factors associated with treatment failure were a high leak output (&gt;500 mL/day) and Lipiodol extravasation on post-LL imaging. Our case series consisted of five patients (mean age: 62 ± 9.24 years; 20% female; 100% oncological diagnoses; 60% having beneficiated from lymphadenectomy). Technical and clinical successes were 80% (4/5) and 75% (3/4), respectively. Time-to-leak resolution varied between 1 and 4 days. The volume and technique of LL was not different from that identified in the SLR. Conclusions: LL is a safe procedure with high technical and clinical success rates that could be proposed as both a diagnostic and therapeutic solution for patients with post-operative central lymphatic lesions.

Short-Term Clinical and Technical Outcomes of a Modified Zenker's Peroral Endoscopic Myotomy (Z-POEM) With Mucosal Flap Incision.

Zenker's diverticulum (ZD) per-oral endoscopic myotomy (Z-POEM) is an effective treatment for symptomatic (ZD). A modification to Z-POEM is the mucosal flap incision (MFI). We describe the technical and clinical success of patients who underwent Z-POEM with MFI. We included patients who underwent Z-POEM with MFI for ZD at 8 international centers. The primary outcome was the rate of clinical success, assessed by post-procedure Kothari-Haber symptom score (KHSS) without retreatment. Secondary outcomes included technical success, serious adverse events, and clinical recurrence with need for retreatment. 36 patients (69% male, age 69 + 9 years) underwent Z-POEM with MFI for symptomatic ZD. Mean ZD size was 32 mm (+ 14). Clinical success was achieved in 35 (97%) cases. Median pre-procedure KHSS was 6 and median post-procedure KHSS was 1 (P <0.0001). Technical success was achieved in all cases. Mean procedure time was 57 minutes (+ 32), median follow up time was 196 days (IQR 39-499). There was one adverse event (3%) which was treated endoscopically. Z-POEM with MFI has a high rate of technical and clinical success. Prospective evaluation is needed to further validate this technique in patients with large ZD.

Transcatheter Valve Repair for TricuspidRegurgitation: 1-Year Results from a Large European Real-World Registry.

Tricuspid valve transcatheter edge-to-edge repair has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR). This study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in a real-world patient population. The PASTE (PASCAL for Tricuspid Regurgitation-a European registry) study is an investigator-initiated, multicenter, retrospective, and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from February 2019 to November 2023. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were subjected to centralized analysis. The study included 1,059 high-risk patients (mean age 79 ± 9 years; 53% female; TRI-SCORE risk 23% ± 18%; 87% NYHA functional class III/IV) with multiple comorbidities. Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to Tricuspid Valve Academic Research Consortium criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. Independent predictors for a postprocedure residual TR of >moderate were coaptation gaps≥8mm (OR: 1.67; 95%CI: 1.03-2.72; P=0.038), tenting height≥10mm (OR: 2.18; CI: 1.30-3.65; P=0.003), the presence of a transvalvular lead (OR: 1.91; 95% CI: 1.19-3.05; P=0.007), right ventricular dilatation >42mm (OR: 3.35; 95% CI: 1.37-9.1; P=0.009) and massive/torrential TR at baseline (OR: 4.59; 95% CI:2.35-8.96; P< 0.001). At 1 year, 83% of patients showed ≤moderate TR. Significant clinical improvements included enhanced NYHA functional class (66% class I/II vs 17% at baseline; P< 0.001). Patients treated with the first-generation PASCAL system (n = 570) and with the new PASCAL Precision system (n = 489) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63% vs 49%; P< 0.001), shorter procedure times (median 93minutes [Q1-Q3: 69-130 minutes] vs 120minutes [Q1-Q3: 82-165 minutes]; P< 0.001), and higher clinical success rates according to the Tricuspid Valve Academic Research Consortium at 30days and 1 year (87% vs 81% [P=0.021] and 56% vs 50% [P=0.044], respectively). Higher center experience (≥21 patients/year) resulted in higher intraprocedural and clinical success. The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up. (PASCAL for Tricuspid Regurgitation-a European registry [PASTE]; NCT05328284).

Outcomes of Catheter Directed Thrombolysis for Early and Late Re-occlusions in Acute Lower Limb Ischemia.

Acute lower limb ischemia (ALI) is a sudden decrease in arterial limb perfusion due to an arterial blockage, threatening limb and life. Catheter-directed thrombolysis (CDT) is a minimally invasive procedure to remove such obstructions. However, approximately one-third of patients endure a re-occlusion after successful CDT. This study aimed to investigate the short- and long-term outcomes of CDT for early (<1 year) and late (>1 year) re-occlusions. This retrospective multicenter study reviewed patients from 2 medical centers with an acute arterial re-occlusion of the lower limb after successful CDT between December 1996 and April 2021. The primary endpoints were angiographic success, defined as thrombus dissolution over 95% with outflow to at least 1 crural artery, and clinical success, defined as a score of ≥1 on the Rutherford scale for assessing changes in clinical status. Secondary endpoints included bleeding complications, patency, amputation, and mortality. Kaplan-Meier analyses were used to estimate patency, survival, and freedom from amputation. Seventy-seven cases were included, with 52 early re-occlusions (<1 year) and 25 late re-occlusions (>1 year). The median time to re-occlusion since the last CDT treatment was 4 months in the early re-occlusion group and 24 months in the late re-occlusion group. Angiographic success was achieved in 73% of early and 64% of late re-occlusions. Clinical success rates were 80.8% for the early and 80.0% of the late re-occlusion cases. Major bleeding occurred in 2% of the early and 8% of the late re-occlusion group. Patients were followed up until symptoms or signs of limb ischemia were resolved, with a median follow-up time of 15 months for the early and 22 months for the late re-occlusion group. During follow-up, secondary re-occlusions were observed in 59.6% of the early and 44% in the late group. Cumulative amputation rates at 1, 5, and 8 years were 36%, 36%, and 52% for early and 18%, 30%, and 30% for the late re-occlusions, respectively. In our experience, CDT is an effective short-term revascularization strategy for the majority of patients with both early and late re-occlusions. Long-term results are limited by secondary re-occlusions and limb loss. Catheter-directed thrombolysis (CDT) is a well-established treatment for acute lower limb ischemia (ALI). Re-occlusions after successful treatment are, however, observed in almost a third of the patients. Yet, the outcomes of CDT for re-occlusions for patients who were previously treated with CDT are not well known. This study showed that CDT is effective in achieving revascularization in cases of early and late re-occlusion after treatment for ALI, but the risk for further re-occlusions is high. Future studies should focus on maintaining patency after successful CDT for ALI.

Photoredox-catalysed amidyl radical insertion to bicyclo[1.1.0]butanes

AbstractReplacing planar aromatic rings in drug molecules with C(sp3)-rich isosteric mimetics, such as bicyclo[n.1.1]alkanes, can significantly alter their physicochemical and pharmacokinetic properties, often leading to higher clinical success rates. However, unlike a benzene ring, the structurally rigid C(sp3)-rich isosteric mimetics of heteroaromatic rings are rare. Heterobicyclo[n.1.1]alkanes are promising in this regard, but the lack of modular synthetic methods has currently hindered their exploration. We envisioned that the strategic and selective insertion of different heteroatomic units to bicyclo[1.1.0]butanes could offer a highly modular platform to access diverse heterobicyclo[n.1.1]alkanes. Herein we report a photoredox-catalysed highly regioselective and chemoselective insertion of amidyl radicals to bicyclo[1.1.0]butanes, providing direct access to 2-oxa-4-azabicyclo[3.1.1]hept-3-enes. The exit vector analysis shows a geometric resemblance of these C(sp3)-rich heterobicyclic motifs with pyridine and pyrimidine derivatives, suggesting their potential as isosteric mimetics of such medicinally important heterocycles. Additionally, various downstream transformations demonstrate their utility as versatile building blocks in synthetic chemistry.

Trans-arterial embolization for treatment of acute lower gastrointestinal bleeding-a multicenter analysis.

To assess the technical feasibility, safety, and clinical success rate of trans-arterial embolization (TAE) as an emergency treatment for acute lower gastrointestinal bleeding (LGIB). Consecutive patients who received urgent TAE due to active LGIB at five academic centers in Germany were retrospectively analyzed. LGIB was confirmed and localized using contrast-enhanced computed tomography (CT) or endoscopy. Outcome parameters including technical and clinical success rates as well as ischemia-related adverse events were analyzed. Furthermore, treatment-related variables that may affect technical and clinical success were analyzed using a regression model. One hundred and forty-one patients were included. TAE was performed in 91% (128/141) of patients. In 81% (114/141) of patients, TAE was performed due to active bleeding visible at angiography, the remaining 10% (14/141) underwent empiric embolization based on pre-interventional imaging. In 9% (13/141) of patients, no TAE was performed. Microcoils were the most used embolic 48.5% (62/128), followed by glue 23.5% (30/128) and Microparticles (8%; 10/128). In the case of bleeding visible in angiography, the technical success rate was 100% (114/114); the clinical success rate was 93.6% (120/128). Severe ischemia-related adverse events necessitating bowel surgery occurred in 14% (18/128) of all patients after embolization. Thirty-day mortality was 14% (21/141). Regression analysis revealed no significant correlations but a statistical trend toward a higher incidence of bowel resection when glue was used (p = 0.090) and toward a higher 30-day mortality when an unselective embolization was performed (p = 0.057). TAE for LGIB has a high technical and clinical success rate. Severe ischemia-related adverse events necessitating bowel surgery occurred in 14% of patients without identifying a significant correlation to the embolization technique or an embolic. Question Is trans-arterial embolization (TAE) viable as an emergency treatment for acute lower gastrointestinal bleeding (LGIB)? Findings TAE demonstrated a 100% technical and 93.6% clinical success rate in treating acute LGIB, with severe ischemia-related adverse events occurring in 14% of patients. Clinical relevance TAE is highly effective and has an acceptable complication rate in treating lower gastrointestinal bleeding, emphasizing the need for a direct head-to-head comparison between endovascular and endoscopic therapy.

Safety and efficacy of peroral endoscopic myotomy for treating achalasia in pediatric and geriatric patients: A meta-analysis.

As a less invasive technique, peroral endoscopic myotomy (POEM) has recently been widely accepted for treating achalasia with an excellent safety profile, durability, and efficacy in adults. In pediatric and geriatric patients, the treatment is more difficult. To discuss the clinical outcomes of POEM in pediatric and geriatric patients with achalasia. We conducted a comprehensive search of PubMed, Embase and Cochrane Library databases from inception to July 2024. The primary outcomes were technical and clinical success. Secondary outcomes of interest included adverse events and gastroesophageal reflux disease (GERD). The pooled event rates were calculated by comprehensive meta-analysis software. A total of 32 studies with 547 pediatric patients and 810 geriatric patients were included in this study. The pooled event rates of technical success, clinical success, GERD and adverse events of POEM for treating achalasia in pediatric patients were 97.1% [95% confidence interval (CI): 95.0%-98.3%; I² = 0%; P < 0.000], 93.2% (95%CI: 90.5%-95.2%; I² = 0%; P < 0.000), 22.3% (95%CI: 18.4%-26.7%; I² = 43.874%; P < 0.000) and 20.4% (95%CI: 16.6%-24.8%; I² = 67.217%; P < 0.000), respectively. Furthermore, in geriatric patients, the pooled event rates were 97.7% (95%CI: 95.8%-98.7%; I² = 15.200%; P < 0.000), 93.2% (95%CI: 90.3%-95.2%; I² = 0%; P < 0.000), 23.9% (95%CI: 19.4%-29.1%; I² = 75.697%; P < 0.000) and 10.8% (95%CI: 8.3%-14.0%; I² = 62.938%; P < 0.000], respectively. Our findings demonstrated that POEM was an effective and safe technique for pediatric and geriatric patients with achalasia.

Ensemble machine learning models for sperm quality evaluation concerning success rate of clinical pregnancy in assisted reproductive techniques

This study aimed to investigate the influence of various sperm quality characteristics, including morphology, motility, and count, on the success rates of clinical pregnancy achieved through assisted reproductive technologies (ART) such as in-vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and intrauterine insemination (IUI). The secondary objective was to assess the impact of these sperm parameters on the clinical pregnancy rate that resulted in the detection of a fetal heartbeat during the 11th week of gestation, a crucial milestone in successful ART-derived pregnancies. The researchers employed a retrospective analysis, evaluating data from 734 couples undergoing IVF/ICSI and 1197 couples undergoing IUI across two infertility centers. Exclusion criteria included cases involving donated eggs or sperm, surrogate uteri, and infertile couples with combined male and female factors. Five ensemble machine-learning models were utilized to predict the clinical pregnancy success rates. The Random Forest (RF) model achieved the highest mean accuracy (0.72) and area under the curve (AUC) (0.80), outperforming the other models for both IVF/ICSI and IUI procedures. The Shapley Additive Explanations (SHAP) value analysis revealed that for IUI cycles, all three sperm parameters (morphology, motility, and count) had significant negative impacts on the prediction of clinical pregnancy success. In contrast, for IVF/ICSI cycles, sperm motility had a positive effect, while sperm morphology and count were negative factors. In cycles with 1 to 5 retrieved eggs, sperm motility, and count, they positively affected the clinical pregnancy rate. The study also identified cut-off values for sperm count, with 54 and 35 being the respective thresholds for IVF/ICSI and IUI. Additionally, a significant cut-off point 30 was found for the sperm morphology parameter across all procedures. This study underscores the immense potential of leveraging ensemble machine learning models with traditional sperm quality assessments. This integrated approach can elevate the precision and personalization of clinical decision-making in the field of assisted reproductive technologies, ultimately offering more hope and better outcomes for couples struggling with infertility.

Effectiveness of intraosseous access during resuscitation: a retrospective cohort study

PurposeDuring resuscitation in emergency situations, establishing intravascular access is crucial for promptly initiating delivery of fluids, blood, blood products, and medications. In cases of emergency, when intravenous (IV) access proves unsuccessful, intraosseous (IO) access serves as a viable alternative. However, there is a notable lack of information concerning the frequency and efficacy of IO access in acute care settings. This study aims to assess the efficacy of intraosseous (IO) access in acute care settings, especially focusing on children in a level 1 trauma center.MethodsThis retrospective study included patients with IO access presented in a level 1 trauma center emergency department (ED) between January 2015 and April 2020. Data regarding medication and fluid infusion was documented, and the clinical success rate was calculated.ResultsOf the 109,548 patients that were admitted to the ED, 25,686 IV lines were inserted. Documentation of 188 patients of which 73 (38.8%) children was complete and used for analysis. In these 188 patients, a total of 232 IO accesses were placed. Overall, 182 patients had a functional IO access (204 needles) (88%). In children (age < 18 years) success rate was lower as compared to adults, 71–84% as compared to 94%. However, univariate regression showed no association between the percentage of functional IO access and gender, age, weight, health care location (prehospital and in hospital), anatomical position (tibia as compared to humerus) or type of injury.ConclusionIntraosseous access demonstrates a high success rate for infusion, independent of gender, age, weight, anatomical positioning, or healthcare setting, with minimal complication rates. Caution is especially warranted for children under the age of six months, since success rate was lower.

Impact of a novel-covered colonic stent in obstructive colon cancer.

Although the short-term outcomes of bridge-to-surgery (BTS) procedures using self-expandable metal stents are favorable, concerns remain regarding worsened prognosis due to tissue injury in the tumor area. Herein, we describe a newly developed covered stent, the Kawasumi Jabara colonic stent™, designed to reduce tissue damage/injury associated with stent-related complications in BTS procedures. This study aimed to evaluate the efficacy and safety of the Kawasumi Jabara colonic stent as a BTS for obstructive colorectal cancer (OCC). This multicenter retrospective observational study included 44 OCC patients who underwent BTS with stents at four facilities between September 2020 and November 2022. The groups of patients receiving the Kawasumi Jabara and non-covered colonic stents were designated Groups C and NC, respectively. Treatment outcomes related to stent placement and surgery were compared using propensity score matching (PSM) analysis. Groups NC and C (n = 34 and 10, respectively) showed no significant differences in sex, age, tumor location, histological type, Colorectal Obstruction Scoring System (CROSS) score, or cStage; however, the stent placement duration was shorter in Group C. No significant differences were found in terms of the technical and clinical success rates for stent placement. Stent dislocation was observed in 0 and 2 cases in Groups C and NC, respectively. PSM analysis between eight cases, each from Groups C and NC, revealed no significant differences in stent-related or surgical outcomes between the groups. However, regarding the gross injury score in the resected specimens, Group C had a lower score than Group NC (1.8 vs. 5.5), and the proportion of pathological tissue injury involving deeper layers was also lower in Group C (37.5% vs. 100%). Compared to conventional non-covered stents, the Kawasumi Jabara colonic stent™ demonstrated favorable safety during stent insertion, retention, and surgery, with only mild tissue injury.

A retrospective comparative study of biliary drainage using balloon endoscopy and endoscopic ultrasound for malignant obstruction in patients with surgically altered anatomy.

Endoscopic biliary drainage for malignant biliary obstruction (MBO) in patients with surgically altered anatomy is challenging, and technical difficulty could differ by the anatomy. Balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) are both emerging procedures, and we conducted the single-center, retrospective study to compare clinical outcomes of BE-ERCP and EUS-BD for MBO. Consecutive patients with surgically altered anatomy who underwent BE-ERCP or EUS-BD for MBO were retrospectively studies. Technical and clinical success rates, adverse events (AEs), and time to recurrent biliary obstruction (TRBO) were compared. Patient characteristics were comparable between BE-ERCP (n = 118) and EUS-BD (n = 32), other than more patients with hepaticojejunostomy in the BE-ERCP group (66% vs. 44%, P = 0.03). Technical success rate was significantly higher in the EUS-BD group (70% vs. 94%, P = 0.005), but clinical success rates (84% vs. 90%, P = 0.55), early AE (14% vs. 22%, P = 0.29) and late AE rates (42% vs. 38%, P = 0.84), and RBO rates (31% vs. 34%, P = 0.67) were comparable between the groups. TRBO was 170 and 206days in the BE-ERCP and EUS-BD group (P = 0.37). In the subgroup analysis of patients with the intact papilla, the technical success rate of BE-ERCP was as low as 55%, compared to 94% in EUS-BD (P = 0.003). EUS-BD was associated with higher technical success rate than BE-ERCP for MBO in patients with surgically altered anatomy.