Multicenter Investigation Research Articles

Predictors of success in left bundle branch area pacing with stylet-driven pacing leads: a multicenter investigation.

Although left bundle branch area pacing (LBBAP) is an emerging conduction system pacing modality, it is unclear which parameters predict procedural success and how many implant attempts are acceptable. This study aimed to assess predictors of successful LBBAP, left bundle branch (LBB) capture, and factors associated with the number of LBBAP implant attempts. This retrospective observational multicenter study was conducted in Korea. LBBAP was attempted in 119 patients; 89.3% of patients had bradyarrhythmia (atrioventricular block 82.4%), and 10.7% of patients had heart failure (cardiac resynchronization therapy) indication. Procedural success and electrophysiological and echocardiographic parameters were evaluated. The acute success rate of lead implantation in LBBAP was 95.8% (114 of 119 patients) and that of LBB capture was 82.4% (98 of 119 patients). Fewer implant attempts were associated with LBBAP success (three or fewer vs. over three times, p = 0.014) and LBB capture (three or fewer vs. over three times, p = 0.010). In the multivariate linear regression, the patients with intraventricular conduction delay (IVCD) required a greater number of attempts than those without IVCD [estimates = 2.33 (0.35-4.31), p = 0.02], and the larger the right atrial (RA) size, the more the attempts required for LBBAP lead implantation [estimates = 2.08 (1.20-2.97), p < 0.001]. An increase in the number of implant attempts was associated with LBBAP procedural failure and LBB capture failure. The electrocardiographic parameter IVCD and the echocardiographic parameter RA size may predict the procedural complexity and the number of lead implant attempts for LBBAP.

Multicenter exploration of specialist palliative care in patients with left ventricular assist devices – a retrospective study

BackgroundThe number of advanced heart failure patients with left ventricular assist devices (LVAD) is increasing. Despite guideline-recommendations, little is known about specialist palliative care involvement in LVAD-patients, especially in Europe. This study aims to investigate timing and setting of specialist palliative care in LVAD-patients.MethodsWe conducted a retrospective multicenter study in 2022. Specialist palliative care services in German LVAD-centers were identified and invited to participate. Forty adult LVAD-patients (mean age 65 years (SD 7.9), 90% male) from seven centers that received a specialist palliative care consultation during hospitalization were included.ResultsIn 37 (67.3%) of the 55 LVAD-centers, specialist palliative care was available. The median duration between LVAD-implantation and first specialist palliative care contact was 17 months (IQR 6.3–50.3 months). Median duration between consultation and death was seven days (IQR 3–28 days). 65% of consults took place in an intensive/intermediate care unit with half of the patients having a Do-Not-Resuscitate order. Care planning significantly increased during involvement (advance directives before: n = 15, after: n = 19, p < 0.001; DNR before: n = 20, after: n = 28, p < 0.001). Symptom burden as assessed at first specialist palliative care contact was higher compared to the consultation requests (request: median 3 symptoms (IQR 3–6); first contact: median 9 (IQR 6–10); p < 0.001) with a focus on weakness, anxiety, overburdening of next-of-kin and dyspnea. More than 70% of patients died during index hospitalization, one third of these in a palliative care unit.ConclusionsThis largest European multicenter investigation of LVAD-patients receiving specialist palliative care shows a late integration and high physical and psychosocial symptom burden. This study highlights the urgent need for earlier integration to identify and address poorly controlled symptoms. Further studies and educational efforts are needed to close the gap between guideline-recommendations and the current status quo.

Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial

IntroductionThe systemic inflammatory response syndrome during the perioperative period of cardiac surgery can lead to serious postoperative complications and significantly increase the hospital mortality rate. Colchicine, a widely used traditional...

Screening for Fabry disease in patients with left ventricular hypertrophy in China: A multicentre and prospective study.

Left ventricular hypertrophy (LVH) is frequently detected via echocardiography in individuals with Fabry disease (FD), sometimes leading to confusion with hypertrophic cardiomyopathy (HCM) of other aetiologies. Considering this diagnosis challenge, FD should be included in the list of differential diagnosis for patients presenting with LVH. To address this concern, we conducted a prospective screening study in China, using dried blood spot (DBS) testing, to evaluate patients with unexplained LVH. Our study was designed as a nationwide, multicentre prospective investigation. A total of 1015 patients from 55 different centres who were diagnosed with LVH by echocardiography were screened in the study from September 2022 to December 2023. Demographic information, biochemistry data, echocardiography parameters and clinical observations were meticulously collected from all participants. The DBS method was used to assess α-galactosidase A (α-Gal A) activity in males and both α-Gal A and globotriaosylsphingosine (lyso-Gb3) levels in females. The final screening population included 906 patients (589 males, 65%) with LVH, characterized by a mean maximal myocardial thickness of 14.8±4.6mm and an average age of 56.9±17.2years. In total, 43 patients (38 males, 5 females) exhibited low α-Gal A activity measurement (<2.2μmol/L), while 21 patients (10 males, 11 females) presented low α-Gal A activity or elevated lyso-Gb3 levels (>1.1ng/mL). Among these patients, eight individuals (7 males and 1 female) were genetically confirmed to harbour pathogenic GLA mutations, resulting in a total prevalence of 0.88%. Compared with patients without FD, patients with FD tended to have proteinuria (75% vs. 21.2%, P=0.001), family history of HCM (37.5% vs. 2.3%, P<0.01) and neuropathic pain (37.5% vs. 4.4%, P<0.01) but lower systolic blood pressure (118.5±12.5 vs. 143.3±29.3mmHg, P=0.017). Five mutations were previously recognized as associated with FD while the remaining two, p.Asp313Val (c.938A>T) and c.547+3A>G, were deemed potentially pathogenic. Subsequent familial validation post-diagnosis identified an additional 14 confirmed cases. This pioneering screening study for FD among Chinese patients with unexplained LVH using DBS measurement, revealed an FD detection rate of 0.88%. Our findings confirmed that the combined measurement of lyso-Gb3 and α-Gal A activity is beneficial for primary screening of FD in patients with LVH. Given the availability of efficacious therapies and the value of cascade screening in extended families, early detection of FD in LVH patients is clinically important.

Multicenter investigation of preoperative distinction between primary central nervous system lymphomas and glioblastomas through interpretable artificial intelligence models.

Research into the effectiveness and applicability of deep learning, radiomics, and their integrated models based on Magnetic Resonance Imaging (MRI) for preoperative differentiation between Primary Central Nervous System Lymphoma (PCNSL) and Glioblastoma (GBM), along with an exploration of the interpretability of these models. A retrospective analysis was performed on MRI images and clinical data from 261 patients across two medical centers. The data were split into a training set (n = 153, medical center 1) and an external test set (n = 108, medical center 2). Radiomic features were extracted using Pyradiomics to build the Radiomics Model. Deep learning networks, including the transformer-based MobileVIT Model and Convolutional Neural Networks (CNN) based ConvNeXt Model, were trained separately. By applying the "late fusion" theory, the radiomics model and deep learning model were fused to produce the optimal Max-Fusion Model. Additionally, Shapley Additive exPlanations (SHAP) and Grad-CAM were employed for interpretability analysis. In the external test set, the Radiomics Model achieved an Area under the receiver operating characteristic curve (AUC) of 0.86, the MobileVIT Model had an AUC of 0.91, the ConvNeXt Model demonstrated an AUC of 0.89, and the Max-Fusion Model showed an AUC of 0.92. The Delong test revealed a significant difference in AUC between the Max-Fusion Model and the Radiomics Model (P = 0.02). The Max-Fusion Model, combining different models, presents superior performance in distinguishing PCNSL and GBM, highlighting the effectiveness of model fusion for enhanced decision-making in medical applications. The preoperative non-invasive differentiation between PCNSL and GBM assists clinicians in selecting appropriate treatment regimens and clinical management strategies.

Multicentre investigation on the effect of decompressive surgery on Balance and physical ActiviTy Levels amongst patients with lumbar Spinal stenosis (B-ATLAS): protocol for a prospective cohort study

IntroductionPatients with lumbar spinal stenosis may have poor balance, decreased physical function and problems maintaining physical activity levels due to radiculopathy. Decompressive surgery is often indicated if conservative management fails...

Laparoscopic Sacrohysteropexy for the Management of Uterovaginal Prolapse: a Pilot, Single-Center Experience from Saudi Arabia.

Laparoscopic sacrohysteropexy is an emerging uterine-preserving strategy for management of uterovaginal prolapse (UVP). The literature on laparoscopic sacrohysteropexy for management of UVP is very scarce from Saudi Arabia. This research examined the feasibility, clinical utility, and safety of laparoscopic sacrohysteropexy in a Saudi setting. A retrospective study was conducted, including all patients who met the inclusion criteria. The laparoscopic sacrohysteropexy technique was adapted with modifications from the "Oxford hysteropexy". The primary endpoint was overall success, defined as anatomical success in all vaginal compartments (UVP grade 0 or 1 postoperatively). The secondary endpoint was the mean change in point C. Descriptive data were summarized with numbers and percentages, while numerical data used means ± standard deviations. Fisher's exact and Student's t tests were used for univariate analyses. Significant surgical outcome predictors were identified via logistic regression, with p <0.05 considered statistically significant. Overall, 21 patients met the inclusion criteria. The most frequent indication for laparoscopic sacrohysteropexy was UVP without anterior or posterior wall prolapse (n = 15, 71.4%), whereas the most frequent grade of UVP was grade III (n = 13, 61.9%). One patient (4.8%) required switch to laparotomy due to severe adhesions. No perioperative complications were recorded. The mean change in point C and hospital stay were 5.8 ± 2.1 (range: 0-8) and 1.4 ± 0.6 days (range: 1-3), respectively. Surgical success was achieved in 18 patients (85.7%). Only three patients experienced recurrences (one, two, and six months postoperatively). The mean change in point C was significantly higher in successful cases contrasted with the failed cases (6.5 versus 1.3). Laparoscopic sacrohysteropexy for management of uterovaginal prolapse revealed technical feasibility, safety, and beneficial utility of the procedure. Further large-sized and multicentric investigations are important to gather additional pertinent information on laparoscopic sacrohysteropexy.

Commentator Discussion: A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of AMDS in the Treatment of acute DeBakey Type I Dissection trial

Commentator Discussion: A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of AMDS in the Treatment of acute DeBakey Type I Dissection trial

Mortality and Health Outcomes Among Patients With Sarcoidosis Treated With Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers

Sarcoidosis is a multisystem inflammatory disease where management and outcomes can vary widely. The renin-angiotensin-aldosterone system (RAAS) has been implicated in its pathogenesis, yet the impact of RAAS modulators on health outcomes in sarcoidosis remains poorly understood. How do pharmacological modulators of RAAS affect health outcomes in patients diagnosed with sarcoidosis? We conducted a large multicenter investigation using the TriNetX Research Network database. Patients included in our study were individuals diagnosed with sarcoidosis and prescribed either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). All cohorts were matched for important covariates, and outcomes measured included mortality, cardiac and respiratory outcomes, and sepsis rates following sarcoidosis diagnosis. We observed an increased mortality risk among sarcoidosis patients prescribed ACE inhibitors compared to patients prescribed ARB therapies. Furthermore, sarcoidosis patients prescribed ACE inhibitors had worse cardiac and respiratory outcomes, and increased sepsis rates compared to the ARB cohort. Our findings suggest that ACE inhibitors and ARB's have divergent effects on outcomes in sarcoidosis patients. These findings highlight the potential pathogenic role of RAAS signaling in this disease and underscore the importance of carefully selecting RAAS modulators for individuals with sarcoidosis.

291P Multi-center investigation of a detection model utilizing cfDNA for early-stage breast cancer screening

291P Multi-center investigation of a detection model utilizing cfDNA for early-stage breast cancer screening

Diagnostic laparoscopy for pre-operative selection of patients with known peritoneal carcinomatosis for CRS-HIPEC: A systematic review and meta-analysis

BackgroundPreoperative selection of patients with Peritoneal Carcinomatosis (PC) for Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is challenging due to associated risks. Diagnostic laparoscopy (DL), an emerging alternative to conventional radiological imaging, has uncertain efficacy. This study aims to evaluate DL's diagnostic performance through a systematic review of available literature. MethodsA comprehensive search of MEDLINE and SCOPUS databases from January 1987 to September 2023 identified studies investigating DL's diagnostic accuracy in selecting PC patients for CRS-HIPEC. Methodological bias assessment and analysis of performance metrics such as positive predictive value (PPV), sensitivity, specificity, and diagnostic odds ratio (DOR) were conducted. Subgroup analyses were performed for primary ovarian cancer studies, and false positive sites were identified. The summary receiver operating characteristic curve (sROC) was plotted to assess overall diagnostic efficacy, with meta-regression conducted to identify sources of heterogeneity across studies. ResultsThis study included 25 studies comprising 3820 patients. Pooled PPV was 93.04 %, with a complication rate of 1.61 %. Pooled sensitivity was 98.26 % and pooled specificity was 83.67 %. The pooled DOR was 139.18, and sROC plot yielded an area under the curve of 0.96. Meta-regression found the ovarian subgroup as a strong source of heterogeneity. Subgroup analysis indicated similar findings in primary ovarian cancer studies, while false positives were commonly observed in the celiac axis, mesentery, ureters and para-aortic lymph nodes. ConclusionDL demonstrates robust diagnostic accuracy in selecting PC patients for CRS-HIPEC, with potential benefits in patient outcomes and resource optimization. Further multicenter investigations are warranted to validate DL's efficacy across diverse primary cancer types.

Prognostic value of the stress-hyperglycaemia ratio in patients with moderate-to-severe coronary artery calcification: Insights from a large cohort study.

To evaluate the relationship between the stress-hyperglycaemia ratio (SHR) and the clinical prognosis of patients with moderate-to-severe coronary artery calcification (MSCAC). We consecutively enrolled 3841 patients with angiography-detected MSCAC. The individuals were categorized into three groups based on SHR tertiles: T1 (SHR ≤ 0.77), T2 (0.77 < SHR ≤ 0.89) and T3 (SHR > 0.89). The SHR value was calculated using the formula SHR = [admission glucose (mmol/L)]/[1.59 × HbA1c (%) - 2.59]. The primary outcomes were major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause death, non-fatal myocardial infarction and non-fatal stroke. During a median follow-up of 3.11 years, 241 MACCEs were recorded. Kaplan-Meier survival analysis showed that the SHR T3 group had the highest incidence of MACCEs (P < .001). Moreover, findings from the restricted cubic spline analysis showed a significant and positive association between the SHR and MACCEs. This correlation remained consistent even after considering other variables that could potentially impact the results (Pnon-linear = .794). When comparing SHR T1 with SHR T3, it was found that SHR T3 was significantly associated with an increased risk of the primary outcome (adjusted hazard ratio = 1.50; 95% confidence interval: 1.10-2.03). Patients with MSCAC showed a positive correlation between the SHR and MACCE rate over a 3-year follow-up period. The study showed that an SHR value of 0.83 is the key threshold, indicating a poor prognosis. Future large-scale multicentre investigations should be conducted to determine the predictive value of the SHR in patients with MSCAC.

Impact of longitudinal tumor location on postoperative outcomes in gallbladder cancer: Fundus and body vs. neck and cystic duct, a retrospective multicenter study.

Systematic investigations into the prognostic impact of the longitudinal tumor location in gallbladder cancer (GBC) remain insufficient. To address the limitations of our pilot study, we conducted a multicenter investigation to clarify the impact of the longitudinal tumor location on the oncological outcomes of GBC. A retrospective multicenter study was conducted on 372 patients undergoing radical resections for GBC from January 2010 to December 2019 across seven hospitals that belong to the Daejeon-Chungcheong branch of the Korean Association of Hepato-Biliary-Pancreatic Surgery. Patients were divided into GBC in the fundus/body (FB-GBC) and GBC in the neck/cystic duct (NC-GBC) groups, based on the longitudinal tumor location. Of 372 patients, 282 had FB-GBC, while 90 had NC-GBC. NC-GBC was associated with more frequent elevation of preoperative carbohydrate antigen (CA) 19-9 levels, requirement for more extensive surgery, more advanced histologic grade and tumor stages, more frequent lymphovascular and perineural invasion, lower R0 resection rates, higher recurrence rates, and worse 5-year overall and disease-free survival rates. Propensity score matching analysis confirmed these findings, showing lower R0 resection rates, higher recurrence rates, and worse survival rates in the NC-GBC group. Multivariate analysis identified elevated preoperative CA 19-9 levels, lymph node metastasis, and non-R0 resection as independent prognostic factors, but not longitudinal tumor location. NC-GBC exhibits more frequent elevation of preoperative CA 19-9 levels, more advanced histologic grade and tumor stages, lower R0 resection rates, and poorer overall and disease-free survival rates, compared to FB-GBC. However, the longitudinal tumor location was not analyzed as an independent prognostic factor.

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study

IntroductionRefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device.MethodsA prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD.ResultsAvailable data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux.ConclusionThese results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop’s dynamic physiologic interaction and non-encircling nature.

The Multicenter STudy On a Precise algorithm for diagnosis of heart failure with preserved ejection fraction, STOP-HFPEF study: study protocol and design.

This study aims to develop a new heart failure with preserved ejection fraction (HFpEF) diagnostic algorithm tailored to Asian populations, addressing limitations of current diagnostic models. Existing HFpEF diagnostic algorithms primarily target patients with dyspnea and metabolic comorbidities, such as obesity, which are more prevalent in Western populations. However, in Asian countries, HFpEF cases are less frequently associated with obesity, leading to less prominent dyspnea and more noticeable symptoms such as fatigue. By incorporating exercise stress echocardiography and focusing on early-stage HFpEF, particularly in patients with symptoms beyond dyspnea, we seek to enable early diagnosis and intervention, ultimately extending healthy life expectancy and improving quality of life. The STOP-HFPEF (The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction) study is a multicenter prospective observational investigation in Japan. Certified by the Japanese Society of Echocardiography, the study includes participants aged 20 and older who undergo exercise stress echocardiography. The primary goal is to develop a scoring model for diagnosing HFpEF in heart-failure stages A, B, and C. Secondary outcomes will assess the clinical utility of the new diagnostic score by comparing heart-failure incidence, cardiovascular events, and mortality rates.Study registration: Registered at the UMIN registry (UMIN000054565) on 1 July 2024.

Influence of Hospital Transfer Status on Surgical Outcomes for Traumatic Thoracolumbar Spine Fractures: Insights from a Multicenter Investigation

Surgical intervention for unstable thoracolumbar spine fractures is common, but delayed management and complications can impact outcomes. This study compares perioperative outcomes between patients directly admitted and those transferred from another facility for thoracolumbar spine surgery, aiming to identify predictors of complications and mortality. A multicenter retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program database from 2011 to 2021 identified 61,626 patients undergoing fusion surgeries for thoracolumbar spine fractures, excluding spinal cord injury or pathological fractures. Patients were categorized as Direct (admitted from the emergency department) and Transfer (transferred from another facility). Perioperative outcomes, including operative time, length of stay (LOS), 30-day mortality, and complications, were compared. Our patient population (54.3% female, mean age 62.4±12.9years) comprised 12.2% Transfer and 87.8% Direct patients. Following propensity score matching, Transfer patients had a longer hospital LOS (5.1 ± 5.7days vs. 4.5 ± 4.6days, P < 0.001). Transfer exhibited higher rates of superficial incisional surgical site infection (1.7% vs. 1.1%, P= 0.003), sepsis (1.7% vs. 1.3%, P= 0.038), pneumonia (1.7% vs. 1.2%, P= 0.019), postoperative reintubation (0.9% vs. 0.6%, P= 0.036), and failure to wean off ventilator >48hours postsurgery (0.7% vs. 0.3%, P= 0.005) compared to Direct admissions. Direct group had a higher rate of perioperative transfusion (16.5% vs. 13.4%, P < 0.001). Transfer patients also had a higher 30-day mortality rate compared to Direct admissions (1.1% vs. 0.6%, P= 0.002). Interhospital transfers significantly affect hospital LOS, postoperative morbidity, and mortality in thoracolumbar spine surgery. Enhancing postoperative monitoring for transfer patients is crucial.

A randomised study comparing performance and safety of Eyestil Plus® vs Vismed Multi® in moderate-to-severe dry eye syndrome patients.

This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients. This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety. 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events. This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.

Prospective study of epilepsy with generalized tonic-clonic seizures alone: Clinical features, response to treatment, and likelihood of medication withdrawal.

This prospective study aimed to delineate the demographics, natural progression, and treatment response of patients newly diagnosed with epilepsy with generalized tonic-clonic seizures alone (EGTCA). Furthermore, our objective includes assessing the seizure recurrence rate post antiseizure medication (ASM) discontinuation within this cohort, alongside exploring predictive factors for seizure relapse. The study cohort, derived from an ongoing, prospective, multicenter investigation on children and adults with new-onset unprovoked seizures, included consecutive patients enrolled between March 2010 and March 2020, and meeting mandatory ILAE criteria for EGTCA diagnosis. Participants underwent a 3-h sleep-deprived video-EEG recording along with an epilepsy protocol brain magnetic resonance imaging (MRI) with repeat EEG at each follow-up. Cumulative time-dependent probabilities of seizure recurrence were calculated using Kaplan-Meier survival analysis. Logistic regression identified variables associated with seizure recurrence following ASM taper. Eighty-nine patients with a median age of 16 years were included, constituting 31% of those diagnosed with an idiopathic generalized epilepsy. Regarding the circadian distribution of seizures, 59.6% of patients exclusively experienced diurnal seizures, 12.4% exclusively nocturnal, and 28.1% experienced both diurnal and nocturnal seizures. Generalized spike-wave discharges (GSWD) were present in the initial EEG of 88% of patients. A GTC recurred in 14% of patients treated with ASM compared with 73% of untreated patients (p < 0.00001). ASM discontinuation was attempted in 50 patients after a median treatment duration of 3 years, with 44% experiencing a recurrence. Patient-initiated taper and a mixed circadian seizure pattern independently predicted a higher likelihood of recurrence post-ASM discontinuation. Our findings underscore the importance of prompt treatment upon the diagnosis of EGTCA. Notably, lifelong treatment may not be imperative; patients seizure-free for at least 2 years, with the absence of GSWD on EEG, often maintained seizure freedom after ASM withdrawal, especially with physician-initiated tapering. Seizures in individuals diagnosed with "epilepsy with generalized tonic-clonic seizures alone" (EGTCA) typically start during adolescence and often respond well to antiseizure medications. An electroencephalogram, which measure brain waves, will show abnormal discharges in most patients with EGTCA. Lifelong treatment with antiseizure medication is not necessary for everyone with EGTCA; approximately, 40% can successfully stop treatment without facing seizure recurrence. Patients who stop medication on their own have a higher risk of seizures returning compared with those who undergo cessation under a doctor's supervision.

Gender Differences in Gambling Disorder: Results from an Italian Multicentric Study.

Although gender-specific evidence on Gambling Disorder (GD) is still limited, some studies reported specific differences, mainly in psychopathological profiles, gambling behavior patterns, and pathogenesis. In order to further examine the role of gender in GD, we conducted a multicenter investigation in a sample of Italian outpatients. One hundred-four outpatients with a diagnosis of GD based on DSM-5 criteria were consecutively recruited at two clinics based in Milan. Socio-demographic and clinical variables were collected for the whole sample and analyzed for the effect of gender. The severity of illness was assessed using the Canadian Problem Gambling Index and the Gambling Attitudes and Beliefs (GABS). Among females, a significantly higher mean age (52.23 ± 10.95 vs. 40.96 ± 15.76; p=0.005) and older age at illness onset emerged (43.5 ± 11.92 vs. 29.22 ± 14.26; p<0.001). Females showed a significantly higher rate of psychiatric comorbidities, lifetime suicide ideation, stressful events at GD onset, and positive family history for GD compared to males. A predictive effect of male gender was found for the GABS questionnaires by performing a linear regression model, with males showing a higher risk to reach higher scores compared to females (B= 11.833; t=2.177; p=0.034). Our study seems to confirm the hypotheses that gender in GD may influence psychopathological profiles, course, and comorbidity. GD in female gender is frequently a comorbid condition with other specific clinical characteristics compared to males. Identifying specific clinical factors by gender may prompt more focus on the public health of women in relation to gambling, while still recognizing that males are at-risk of earlier gambling problems. These findings should be considered in therapeutic perspectives.

Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration Desonide Phosphate in Dry Eye Disease Treatment.

Patients with dry eye disease (DED) complain of a multitude of symptoms that affect their visual function and quality of life (QoL). This clinical investigation assessed the performance, tolerance, and safety of a novel preservative-free ophthalmic solution containing xanthan gum 0.2% and desonide sodium phosphate 0.025%. This was an observational, prospective, multicentric, and post-market clinical investigation to assess the effect of three times a day instillation of the study formulation in patients suffering from DED. The primary objective was to achieve a 50% reduction in conjunctival hyperemia index as assessed with the OCULUS Keratograph after 1 month of treatment compared to baseline values. The secondary objectives included patient-reported outcomes, clinical performance, and safety. Thirty patients were enrolled (21 women, 9 men) with a mean age of 61.10 ± 14.53years. The instillation of the study formulation was associated with a significant reduction in redness scores after 1 month of treatment compared to baseline (mean - 0.51 ± 0.51; p ≤ 0.0001). Although the primary endpoint was not completely met, a 50% reduction in the conjunctival hyperemia index was achieved in 23% of the participants, and 77% showed a reduction of 26% of the same index. In addition, the ophthalmic solution significantly increased tear film break-up time, and a significant reduction of corneal and conjunctival staining with fluorescein was achieved. It also reduced DED symptoms and had a very good safety profile. the study formulation produced a significant improvement in the signs, symptoms, and QoL of patients with mild to moderate DED with a good safety profile after 1 month of treatment.