Early Safety Research Articles

A sex-specific comparison of valve-in-valve transcatheter aortic valve implantation

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Since patients receiving initially a new bioprosthetic aortic valve are predominantly male, data on a sex-specific comparison of ViV-TAVI is scarce. Thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of female (F) versus male (M) patients with failing bioprosthetic aortic valves undergoing ViV-TAVI. Methods A total of 375 Patients at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 160 (42.6 %) women and 215 (57.4 %) men were included. Women were older (F 81 (77; 84), p < 0.001), had a greater surgical risk (STS PROM F: 9.1 (6.1; 13,9) %, p < 0.001) and a higher rate of previous coronary bypass surgery (F: 25.6 % vs M: 40 %, p = 0.004), while presenting mostly failed valve sizes < 20 mm (F: 59.4 % vs M: 33.4 %, p < 0.001) and therefore higher gradients (F: 40 (31; 50) mmHg vs M: 32 (25; 42) mmHg, p < 0.001). Aortic regurgitation was the mode of failure in 7.5 % of F vs. 14.4 % of M. The number of stentless valves was higher in men (F: 8,1 % vs M: 14 %, p = 0.08). Patients received a self-expanding TAVI prostheses in 79.4 % and 75.8 % respectively in F and M patients. The rates of technical success (F: 75.6 % vs M: 83.3 %, p =0.06), device success (F: 52.5 % vs M: 58.2 %, p = 0.27) and early safety (F: 67.5 % vs M: 67 %, p = 0.91) were comparable between genders. Residual mean gradients were higher in F (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.03), while the rates of residual regurgitations were greater in M patients (F: 1 (0.6 %) vs M: 11 (5.1 %), p = 0.04). The Kaplan-Meier estimated 30-day mortality rate (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality rates (F: 10 % vs M: 92.6 %, p = 0.37) were comparable between genders. Conclusion: F and M patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar mortality rates after 30 days and 1 year. The residual gradients in F and residual regurgitations in M could be explained by structural features of their failed valves. Further large scale studies are needed to determine, if such procedural outcomes are truly sex-specific.

Initial Safety of Total Talus Replacement Used to Treat Talar Avascular Necrosis.

Total talus replacement (TTR) implants are designed to replace the diseased talar anatomy, reduce pain, maintain ankle range of motion, and restore ankle function after conservative treatments have failed. Currently TTR implants are produced by 3D printing a patient-specific implant designed from the patient's preoperative anatomy. TTR surgery using patient-specific implants is a relatively new technique that remains understudied in the literature. Therefore, the purpose of this investigation was to determine the early safety and potential benefit of the TTR implant in patients with talar avascular necrosis. This retrospective, multicenter, cohort study evaluates the safety and potential benefits of TTR using 3D-printed patient-specific implants across 4 US centers. The primary outcome was the occurrence of early adverse events after TTR surgery. Secondary outcomes including, pain, and physical function were assessed using the pain visual analog scale (VAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF), respectively. The study team analyzed 15 patients with more than 1 year of follow-up. The mean duration of follow-up was 25.9 months (range: 18.3-41 months). Although 33.3% (5 of 15) of patients experienced adverse events, primarily occurring within the initial 6 months postoperatively, 93% (14 of 15) of patients reported implant survivorship. Of the 5 cases (33.3%) resulting in an adverse event, 3 (60.0%) were determined to be unrelated to the subject device, 2 (40.0%) were determined to be possibly procedure-related, and none (0%) were determined to be device-related. Although further studies are needed to compare TTR with the standard of care, the results of this study demonstrate the relative early safety of TTR surgery using a 3D-printed implant for the treatment of challenging talar pathologies. A larger and longer clinical study is required to see if the efficacy of this approach will be statistically and clinically meaningful.

Alteplase vs. Tenecteplase: An In-depth Analysis of Their Relative Effectiveness in Treating Acute Ischemic Stroke

Dear Editor, Stroke stands as the second-leading cause of death worldwide [1, 2]. Each year, over 12 million individuals are impacted by stroke, resulting in approximately 6.5 million fatalities [1]. Stroke globally ranks as the third-leading factor causing a combination of death and disability [2]. Every year, around seven hundred thousand individuals in the United States undergo an Acute Ischemic Stroke (AIS), making up 85% of all stroke cases [2]. New treatments like intravenous thrombolysis and mechanical thrombectomy have cut mortality by 10% compared to older methods, enhancing long-term disability prevention rates following Acute Ischemic Stroke [2]. Alteplase is the sole FDA-approved thrombolytic drug in AIS within the first 4.5 hours. Despite its potential for disability-free recovery, its usage is constrained by a brief time window and adverse effects, notably a 6% risk of symptomatic bleeding. In addition, its fibrinolytic efficacy is limited, achieving vascular reopening in less than half of the patients, and can cause cytotoxicity to the already hypoxic brain with resultant cerebral edema [2]. Tenecteplase (TNK), a modified variant of alteplase, has improved features including greater fibrin selectivity and longer half-life and is given as a single bolus instead of an infusion, thanks to genetic recombinant technology [3]. Numerous studies have supported TNK's efficacy over alteplase in treating AIS. In 2016, Bruce C.V. Campbell and colleagues demonstrated that, according to the analysis of modified Rankin scale scores, tenecteplase exhibited a more favorable overall functional outcome compared to alteplase [4]. A dosage of 0.25 mg/kg of tenecteplase emerges as a promising alternative to replace alteplase as the preferred treatment for patients with AIS occurring within 4.5 hours due to TNK's superior early neurological recovery rates and comparable safety outcomes [3]. Despite gathering evidence from experimental trials indicating TNK's advantages over alteplase for AIS, the use of TNK at a dosage of 0.4 mg/kg appears to pose safety concerns when compared to alteplase [3]. Bruce C.V. Campbell and his fellow researchers revealed in their study that in spite of the beneficial effects of TNK relative to alteplase, there was no significant variation in the speed of recovery to independent function. Notably, they found no discernible distinction in the occurrence of intracranial hemorrhage [4]. ---Continue

TCT-886 Incidence, Predictors, and Clinical Impact of Early Safety After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria

TCT-886 Incidence, Predictors, and Clinical Impact of Early Safety After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria

Vía transapical para reemplazo percutáneo de válvula mitral por valvulopatía: una experiencia ibérica

Introduction and objectives: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure.Methods: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year.Results: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively.Conclusions: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

TCT-154 Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve Replacement Device With Polymer Leaflets in Treating Patients With Severe Calcific Aortic Stenosis: Sekilia Valve

TCT-154 Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve Replacement Device With Polymer Leaflets in Treating Patients With Severe Calcific Aortic Stenosis: Sekilia Valve

Trends and Outcomes of Aortic Root Enlargement During Bioprosthetic Aortic Valve Replacement

BackgroundAortic root enlargement (ARE) during aortic valve replacement (AVR) mitigates prosthesis-patient mismatch, but its use has been low. Transcatheter aortic valve-in-valve (VIV) as a treatment for failing bioprosthetic valves is limited by small surgical valves, renewing interest in ARE during the index AVR. This study demonstrates trends and outcomes of ARE after commercial approval of VIV in 2015. MethodsThis retrospective cohort study analyzed 2182 patients undergoing nonemergent AVR between August 2007 and December 2022. Endocarditis, aortic dissection, and concomitant root replacement or ventricular assist device placement were excluded. Trends in ARE use, valve size, and types were compared. Outcome measures included 30-day mortality and gradients and were compared between patients with and without ARE. ResultsOverall, 74 patients (3.4%) underwent ARE, 14 (1.0%) before 2015 and 60 (7.6%, P < .0001) after 2015. Use of smaller valves (19-21 mm) decreased from 372 (26.8%) before 2015 to 85 (10.7%, P < .0001) after 2015. ARE group was younger than the AVR-alone group (64 vs 68 years, P = .001) but had similar predicted risk of mortality (median, 1.7%). Both groups had comparable postoperative mean gradients (ARE: 11 vs AVR-alone: 10 mm Hg, P = .42). ARE had higher 30-day mortality (5 [7%] vs 48 [2%], P = .014); however, no difference was found in elective patients (2 of 65 [3%] vs 39 of 1898 [2%], P = .57). ConclusionsARE use has increased since commercial approval of VIV. The addition of ARE to AVR did not affect early safety in elective cases, and postoperative gradients were similar to those in patients not requiring ARE. Further studies are required to determine long-term outcomes after ARE, including VIV candidacy.

Patient-reported outcomes in total hip arthroplasty for patients with anatomically contoured femoral heads

Introduction: Iliopsoas tendinitis after total hip arthroplasty (THA) has become more prevalent with the increased use of large-diameter femoral heads impinging on native surrounding tissues. Anatomically contoured heads (ACH) are soft-tissue-friendly femoral heads created to minimise this issue. This retrospective study assesses iliopsoas tendinitis prevalence and re-operations in primary THAs with ACH, while determining the minimal clinically important difference (MCID) achievement and improvement with 5 patient-reported outcome measures (PROMs). Methods: We conducted a retrospective analysis of 53 ACHs from January 2020 to July 2023. Patients who completed Hip Injury and Osteoarthritis Outcome Score–Physical Function Short Form (HOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF SF-10a), PROMIS Global Health (GH)-Mental, or PROMIS GH-Physical, and pain score questionnaires were identified. PROM scores were collected preoperatively and at 3-month and 1-year postoperative intervals. Comparisons using chi-square and ANOVA tests were applied. Results: The rates of achieving MCID and improvement within the first year were (69.2 vs. 76.9%) for PROMIS GH-Physical, (38.5 vs. 46.2%) for PROMIS GH-Mental, (71.4 vs. 92.9%) for HOOS-PS, (80.0 vs. 80.0%) for PROMIS PF SF-10a, and (74.0 vs. 91.7%) for pain scores. PROM scores at 3 months and 1 year significantly varied across all categories, except for PROMIS GH-Mental. No patients had iliopsoas tendinitis, dislocations, or re-operations. Discussion: ACH implants may alleviate anterior hip pain, while maintaining comparable strength and bio-compatibility to conventional femoral heads. This study underscores the early safety and potential of ACH implants in reducing iliopsoas tendinitis and impingement.

CharActeristics, sizing anD outcomes of stenotic, tapered, rapHe-type bicuspid aOrtic valves treated with trans-catheter device implantation: Insights the AD HOC registry

BackgroundRaphe-type bicuspid aortic valve (BAV) is a potential hostile scenario in trans-catheter aortic valve replacement (TAVR) due to pronounced calcium burden, possibly associated with tapered valve configuration. Trans-Catheter heart valve (THV) sizing strategy (annular vs. supra-annular) is controversial in this valve subtype. ObjectivesTo describe the phenotypical characteristics of severe, tapered, raphe-type, BAV stenosis undergoing TAVR and to explore safety and efficacy of modern-generation THVs, analysing the impact of annular and supra-annular sizing strategies on short- and mid-terms outcomes. MethodsThis is a retrospective, multicenter registry enrolling consecutive stenotic Sievers type 1 BAV treated with TAVR. Study population was divided into tapered and non-tapered configuration according to MSCT analysis. Matched comparison between annular and supra-annular sizing groups was performed in tapered population. ResultsFrom January 2016 to June 2023, 897 patients were enrolled. Of them, 696 patients displayed a tapered configuration. Of those, 510 received a THV according to annular sizing. After propensity score matching 186 matched pairs were selected. Technical success (96.2 % vs 94.1 %, OR 1.61 [0.61–4.24], p = 0.34), 30-day device success (83.6 % in both groups, OR 1.42 [0.78–2.57], p = 0.25) and 30-day early safety (71.8 % vs 70.5 %, OR 1.07 [0.68–1.68], p = 0.78) were similar between the annular and supra-annular sizing groups; a higher post-TAVR gradient was observed in supra-annular group, although it was only 2 mmHg mean. At mid-term follow-up, the rate of clinical efficacy was 84.7 %. ConclusionsTAVR with modern-generation devices is safe and effective for tapered raphe-type BAV, showing comparable results for annular and supra-annular sizing strategies.

Efficacy and Safety of Durvalumab/Tremelimumab in Unresectable Hepatocellular Carcinoma as Immune Checkpoint Inhibitor Rechallenge Following Atezolizumab/Bevacizumab Treatment.

While guidelines recommend immune checkpoint inhibitor (ICI) rechallenge as second-line therapy for unresectable hepatocellular carcinoma (HCC), data supporting this remain limited, particularly regarding a standard regimen for first- and second-line treatments. Tremelimumab/durvalumab was recently approved but data on ICI rechallenge are lacking. The purpose of this study was to evaluate the early efficacy and safety of tremelimumab/durvalumab for HCC as an ICI rechallenge following initial ICI therapy with atezolizumab/bevacizumab. This multicenter retrospective study included patients with HCC who underwent treatment with tremelimumab/durvalumab, with relevant available clinical information. We evaluated the safety and efficacy of tremelimumab/durvalumab as ICI rechallenge following initial treatment with atezolizumab/bevacizumab. We analyzed the outcomes in patients who underwent tremelimumab/durvalumab as an ICI rechallenge and those who received tremelimumab/durvalumab as their initial ICI therapy RESULT: A total of 45 patients treated with tremelimumab/durvalumab were included, with 55.6% (25/45) undergoing ICI rechallenge. The objective-response and disease-control rates in patients who underwent ICI rechallenge were 14.3% (3/21) and 47.6% (10/21), respectively, similar to those in patients initially treated with tremelimumab/durvalumab. All patients (n = 3) who experienced the best response to progressive disease (PD) with initial atezolizumab/bevacizumab experienced PD during ICI rechallenge. The incidence rates of adverse events were similar between patient groups treated with tremelimumab/durvalumab as ICI rechallenge and initial ICI. Among patients experiencing immune-related adverse events (irAEs) with atezolizumab/bevacizumab, 75% (3/4) encountered similar irAEs during ICI rechallenge. Early safety and efficacy profiles of durvalumab/tremelimumab as ICI rechallenge are satisfactory.

A Coronary-Friendly Device Mitigating Risk of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) induced coronary artery obstruction (CAO) is a rare but devastating complication. Current preventive strategies need additional procedures and may be associated with adverse events. This study aimed to evaluate the early safety and efficacy of stand-alone TAVR using the J-Valve (Jianshi JieCheng Medical Technology Co. Ltd, Shanghai, China) in patients at potential high risk for CAO. CAO was defined as coronary ostia obstruction requiring intervention. Patients at potential high risk for CAO were identified retrospectively from 673 consecutive patients who underwent TAVR from January 2015 to July 2021 at Zhongshan Hospital, Fudan University. Procedural results and early outcomes were evaluated according to Valve Academic Research Consortium-3 definitions. A total of 20 consecutive patients (age 72 ± 9 years; 85% female;) were included. The Society of Thoracic Surgeons-Predicted Risk of Mortality was 5% (interquartile range, 4 to 10%). All patients (100%) had at least 2 classical risk factors for CAO by pre-procedural computed tomography analysis, and 90% patients had native aortic valve diseases. TAVR was successful in 95% of cases, with only 1 patient requiring second device implantation. Early safety at 30 days was achieved in all cases without death. All patients were free from CAO, stroke or emergency reintervention. Post-procedural mean aortic valve gradient was 7 (interquartile range, 4, 12) mmHg, and none/trace or mild aortic regurgitation was present in all patients. Stand-alone TAVR using the J-Valve may mitigate the risk of TAVR-induced CAO.

Retrospective observation of the early efficacy and safety of temperature-sensitive liquid embolic agent combined with polyvinyl alcohol microspheres for prostatic artery embolization in the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia.

In recent years, prostatic artery embolization (PAE) has gradually become a hot topic in the treatment of symptomatic benign prostatic hyperplasia (BPH). However, there is an ongoing debate regarding the best embolization material for PAE. This study aimed to compare the safety and efficacy of the temperature-sensitive liquid embolic agent (TempSLE) combined with polyvinyl alcohol (PVA) microspheres and simple PVA microspheres for PAE in treating lower urinary tract symptoms (LUTS) caused by BPH. The clinical data of 39 patients with LUTS caused by BPH were included in this study, including 21 cases of PVA microspheres group and 18 cases of PVA microspheres + TempSLE group. The changes in various subjective and objective indexes were compared between the two groups before PAE, 1 and 3 months after operation. Three months after operation, the improvement in prostate volume (PV), post-void residual volume (PVR), peak urinary flow rate (Qmax), international prostate symptom score (IPSS), quality of life (QoL) and total prostate-specific antigen (T-PSA) in both groups were significantly improved compared with those before operation (P<0.05). And the above clinical improvement indicators at the 3-month mark demonstrated a statistically significant difference between the two groups (P<0.05). Compared with the PVA microspheres group, the prostate necrosis rate of the PVA microspheres + TempSLE was higher at 1 and 3 months after operation (P<0.05). Moreover, the PVA microspheres + TempSLE group had no significant complications, with the exception of a single case of transient gross hematuria during the perioperative period. The combination of PVA microspheres and TempSLE for PAE appears to be safe and effective in the treatment of symptomatic BPH patients, with a higher degree of damage to hyperplastic prostate tissue compared to simple PVA microspheres embolization.

Hierarchical ultra-thin porous Co3O4 nanosheets derived from mixed phase α- and β-Co(OH)2 for high sensitivity and ppb-level acetone sensing

Addressing the energy loss of carriers during transmission and achieving high sensitivity detection of target gases facilitates the synthesis of trace-level acetone sensors, which is of great significance in the fields of air quality early warning, health monitoring, and industrial safety monitoring. Here, we propose a strategy where, under hydrothermal conditions, the content of mixed-phase α- and β-Co(OH)2 is regulated by varying the protonation level of 2-methylimidazole in different solutions, leading to the formation of porous monocrystalline Co3O4 microflower structure. The microflower is assembled from ultrathin nanosheets, and the 3D-interconnected macroporous and mesoporous structure provides high surface area and gas diffusion channels. The monocrystalline and two-dimensional structures favor high carrier mobility, enhancing the signal-to-noise ratio. Furthermore, the thickness of the Co3O4 nanosheets is less than twice the Debye length, making their electrical properties completely dependent on surface. DFT calculations also indicate that the few layers Co3O4 model is conducive to acetone adsorption. The Co3O4 sensor exhibits exceptional gas sensing performance towards acetone, with favourable sensitivity (16.83 to 10 ppm), selectivity, and stability, as well as an ultra-low practical detection limit of 10 ppb. Rich point defects and line defects play a significant role in improving the surface activity of the sensitive material as well. This research offers a pathway for designing sensors with exceptional gas sensitivity by employing a straightforward method to control the morphology of sensitive materials, combined with defect engineering to enhance sensing activity.

Pilot study to assess the early cardiac safety of carbon ion radiotherapy for intra- and para-cardiac tumours.

Modern photon radiotherapy effectively spares cardiac structures more than previous volumetric approaches. Still, it is related to non-negligible cardiac toxicity due to the low-dose bath of surrounding normal tissues. However, the dosimetric advantages of particle radiotherapy make it apromising treatment for para- and intra-cardiac tumours. In the current short report, we evaluate the cardiac safety profile of carbon ion radiotherapy (CIRT) for radioresistant intra- and para-cardiac malignancies in areal-world setting. We retrospectively analysed serum biomarkers (TnI, CRP and NT-proBNP), echocardiographic, and both 12-lead and 24-hour Holter electrocardiogram (ECG) data of consecutive patients with radioresistant intra- and para-cardiac tumours irradiated with CIRT between June 2019 and September 2022. In the CIRT planning optimization process, to minimize the delivered doses, we contoured and gave ahigh priority to the cardiac substructures. Weekly re-evaluative 4D computed tomography scans were carried out throughout the treatment. Atotal of 16patients with intra- and para-cardiac localizations of radioresistant tumours were treated up to atotal dose of 70.4 Gy relative biological effectiveness (RBE) and amean heart dose of 2.41 Gy(RBE). We did not record any significant variation of the analysed serum biomarkers after CIRT nor significant changes of echocardiographic features, biventricular strain, or 12-lead and 24-hour Holter ECG parameters during 6months of follow-up. Our pilot study suggests that carbon ion radiotherapy is apromising radiation technique capable of sparing off-target side effects at the cardiac level. Alarger cohort, long-term follow-up and further prospective studies are needed to confirm these findings.

340: Early safety analysis of hypofractionated proton beam therapy for rectal cancer

340: Early safety analysis of hypofractionated proton beam therapy for rectal cancer

A Versatile Visual Molecular Imprinting-Driven Switchable Nanozyme Activity-Based Trimodal Assay and Logic Gate Circuits of Ethyl Carbamate.

Concerns regarding the hazard of the carcinogenic ethyl carbamate (EC) have driven attempts to exploit efficient, timely, straightforward, and economic assays for warning early food safety. Here, we proposed a novel molecularly imprinted polymer Co@MOF-MIP, with a high peroxidase (POD)-like activity and a bright blue fluorescence emission, to develop a versatile visual assay for colorimetric, fluorescent, and photothermal trimodal detection and logic gate outputting of EC. Briefly, the POD-like activity of Co@MOF-MIP made it to decompose H2O2 into ·OH for oxidizing colorless 3,3',5,5'-tetramethylbenzidine (TMB) into a blue oxTMB, resulting in a 660 nm irradiated photothermal effect and bursting the blue fluorescence of Co@MOF-MIP via inner filter effect, observing a decreased fluorescence signal together with an increased colorimetric and 660 nm irradiated photothermal signals. However, EC could specifically fill the imprinted cavities of Co@MOF-MIP to block the catalytic substrates TMB and H2O2 out of Co@MOF-MIP for further reacting with the inside catalytic center of Co2+, resulting in the transformation suppressing of TMB into oxTMB, yielding an EC concentration-dependent trimodal responses in fluorescence signal enhancement, colorimetric, and 660 nm irradiated photothermal signal decreases. Assisted by the portable devices such as smartphones and hand-held thermal imagers, a visual onsite portable trimodal analytical platform was proposed for EC fast and accurate detection with the low detection limits of 1.64, 1.24, and 1.78 μg/L in colorimetric, fluorescent, and photothermal modes, respectively. Interestingly, these reactive events could be programmed by the classical Boolean logic gate analysis to offer a novel promising avenue for the big data Internet of Things monitoring and warning early residual EC in a more intelligent, dynamical, fast, and accurate manner, safeguarding food safety.

Maternal knowledge on nutritional-focused nurturing care and associated factors among women with stunted children aged 6-23 months in Yogyakarta, Indonesia: A cross-sectional study.

Childhood stunting poses serious long-term risks to cognitive development, education, and adult productivity. While research has explored stunting's causes and effects, there is a lack of focus on maternal knowledge of nutrition-focused nurturing care for stunted children. This gap limits the ability to design effective interventions that target improved caregiving practices. This study aimed to assess maternal knowledge of nutrition-focused nurturing care and explore associated factors, including child gender, maternal age, education, income, and prior exposure to nurturing care information, among mothers of stunted children aged 6-23 months in Indonesia. A cross-sectional study was conducted with 73 mothers in Kulon Progo, Yogyakarta. Data were collected from February to March 2024 using a validated self-assessment questionnaire covering four domains: responsive caregiving, early learning opportunities, safety and security, and supportive caregiver well-being. Statistical analyses, including t-tests and one-way ANOVA, were performed. Overall maternal knowledge of nurturing care was high, with a mean score of 25.15 (SD = 4.72). Factors significantly associated with higher knowledge included having male children (p = 0.017), being aged 30-34 years (p = 0.035), possessing higher education levels (p = 0.002), and prior exposure to nurturing care information (p <0.001). Family income significantly influenced knowledge in the domain of early learning opportunities (p = 0.006), though not in other areas. Maternal knowledge of nutrition-focused nurturing care was influenced by child gender, maternal age, education, income, and prior exposure to nurturing care information. These findings emphasize the importance of focused educational interventions in nursing practice to enhance maternal knowledge. Addressing these factors can help align nursing strategies better to support the healthy growth and development of children.

Performance of a NLP Tool for Text Classification from Orthopaedic Operative Reports, Using Data from the Large Network of Clinical Data Warehouses of the West of France: The HACRO-HUGORTHO Project.

Electronic health data concerning implantable medical devices (IMD) opens opportunities for dynamic real-world monitoring to assess associated risks related to implanted materials. Due to population ageing and expanding demands, total hip, knee, and shoulder arthroplasties are increasing. Automating the collection and analysis of orthopedic device features could benefit physicians and public health policies enabling early issue detection, IMD monitoring and patient safety assessment. A machine learning tool using natural language processing (NLP) was developed for the automated extraction of operation information from medical reports in orthopedics. A corpus of 959 orthopaedic operative reports from 5 centres was manually annotated using the Prodigy software® with a strong inter-annotator agreement of 0.80. Data to extract concerned key clinical and procedure information (n= 9) selected by a multidisciplinary group based on the French health authority checklist. Performances parameters of the NLP model estimated an overall strong precision and recall of respectively 97.0 and 96.0 with a F1-score 96.3. Systematic monitoring of orthopedic devices could be ensured by an automated tool, leveraging clinical data warehouses. Traceability of medical devices with implantation modalities will allow detection of implant factors leading to complications. The evidence from real-world data could provide concrete and dynamic insights to surgeons and infectious disease specialists concerning implant follow-up, guiding therapeutic decision-making, and informing public health policymakers. The tool will be applied on clinical data warehouses to automate information extraction and presentation, providing feedback on mandatory information completion and contents of operative reports to support improvements, and thereafter implant research projects.

Early outcomes of 5-0 Prolene gonioscopy-assisted transluminal trabeculotomy combined with phacoemulsification in eyes of Indian glaucoma patients.

To study the early postoperative efficacy and safety of 5-0 Prolene gonioscopy-assisted transluminal trabeculotomy (GATT) combined with phacoemulsification in Indian eyes. This was a prospective, interventional study. Patients with primary and secondary glaucoma who underwent GATT combined with phacoemulsification (Phaco-GATT) or standalone GATT were included. All patients were evaluated on postoperative days 1, 15, and 30, as well as 3 months and 6 months postoperatively. Baseline and follow-up visits were compared to determine the significant difference in the number of intraocular pressure (IOP), antiglaucoma medications (AGM), and best corrected visual acuity (BCVA). Other outcome measures included surgical success, complications, and interventions. A P value of < 0.05 was considered statistically significant. One hundred and five eyes (95 patients) were included. Seventy-five eyes underwent GATT along with phacoemulsification and 30 eyes underwent GATT. In the Phaco-GATT group, the mean IOP reduced significantly from 17.71 ± 6.85 to 12.29 ± 4.44, 12.33 ± 4.44, and 12.18 ± 3.49 mmHg and in the GATT group, it reduced from 21.67 ± 11.42 mmHg to 16.38 ± 8.42, 16.47 ± 10.26, and 13.10 ± 3.25 mmHg at 1, 3, and 6 months, respectively (P < 0.001). The number of AGM also significantly reduced from 1.67 ± 1.22 to 0.41 ± 0.87 and 0.34 ± 0.82 in the phaco-GATT group and from 2.63 ± 1.19 to 0.67 ± 1.09 and 0.60 ± 1.25 in the GATT group at 3 and 6 months, respectively (P < 0.001). Complete success (IOP > 6-≤21 mmHg/20% reduction without AGM) was 96.7% in the Phaco-GATT group and 91.2% in the GATT group. BCVA improved from log of minimum angle of resolution 0.30 to 0.00 (P < 0.001) in phaco-GATT group. Hyphema was the most common complication. Macrohyphema (>1 mm) was seen in six patients, out of which two patients required anterior chamber wash. IOP spikes (>30 mmHg) were seen in three patients. In Indian eyes, GATT combined with phacoemulsification and standalone GATT are efficacious and safe with good surgical outcomes.

Neutrophil-to-lymphocyte ratio and prognostic nutritional index in predicting composite endpoint of early safety following transcatheter aortic valve replacement.

The incidence of composite endpoint of early safety (CEES) after transcatheter aortic valve replacement (TAVR) has been a topic of focus within the cardiovascular field due to its impact on long-term patient outcomes. Timely prophylactic interventions are crucial for patients identified as high risk for CEES through preoperative risk stratification. This study aimed to explore the connection between inflammatory and nutritional markers, specifically the neutrophil-to-lymphocyte ratio (NLR) and prognostic nutritional index (PNI), and CEES occurrence. A cohort of 134 patients undergoing TAVR in a single center was studied. The study endpoint was the occurrence of CEES, which was defined according to the Valve Academic Research Consortium 3. The CEES was reached in 25.4% of patients at 30 days. A high NLR was associated with a 5.55-fold increased risk of CEES (95% confidence interval (95% CI): 1.52-20.29; p < 0.05), while a low PNI was linked to a 4.43-fold increased risk (95% CI: 1.55-12.65; p < 0.01). Combining NLR and PNI provided additional risk stratification for high-risk patients (hazard ratio (HR), 95% CI: 2.24-43.37; p < 0.005). A high NLR and low PNI were shown to be significant predictors of CEES following TAVR. These findings underscore the significance of NLR and PNI in the risk assessment of TAVR patients, offering valuable insights for preventive measures.