Single-center Prospective Observational Study Research Articles

INTEGRATING A VIRTUAL REALITY MASK IN FUNCTIONAL UROLOGICAL SURGERIES UNDER LOCAL ANESTHESIA: A PROSPECTIVE COHORT STUDY ON UTILITY AND SATISFACTION.

To evaluate the safety and efficacy of a virtual reality (VR) mask as a distraction tool during minimally invasive functional urological interventions as part of the local anesthesia protocol. This is a single-centre prospective observational pilot cohort study which included all consecutive patients undergoing intradetrusor botulinum toxin injection, sacral neuromodulation, and urethral bulking agent injection with combined anesthetic protocol composed by local anesthesia and a VR mask (Hypno VRTM virtual reality mask, Strasbourg, France). Preoperative and postoperative evaluation included the State-Trait Anxiety Inventory (STAI) index. Intraoperatively, a 4-point Likert anxiety rating scale and a visual analog scale (VAS) pain score were assessed. Vital signs were measured preoperative and intraoperatively. Postoperatively, two questionnaires exploring patient satisfaction were administered. The evaluated outcomes were the tolerability of the device and patient's reported intraoperative pain and anxiety. Thirty-nine patients were included. Mean age was 64 years. Eleven patients (28%) were affected by neurological conditions. Two patients experienced subjective discomfort. Preoperative and intraoperative mean arterial pressure was 105 and 111 mmHg (p=0.01), respectively. Preoperative and intraoperative mean heart rate was 72 and 75 bpm (p=0.12), respectively. Preoperative and postoperative STAI index were 34.8+-10 and 32.8+-10.3 (p=0.88). Mean Likert anxiety scale value was 2.2+-1.1, mean intraoperative VAS score was 5.3+-2.5. Thirty-four (87%) patients declared themselves satisfied with the surgical procedure and 36 (92.3%) patients would have recommended the same procedure to a relative. Virtual reality mask may play a role in reducing pain and anxiety in minimally-invasive functional urological interventions.

Deceleration of denervated facial muscle atrophy through functional electrical stimulation: a sonographic quantification in patients with facial nerve paralysis.

Functional Electrical Stimulation (FES) is an established intervention for a range of muscular and neurological disorders that has already been studied in numerous publications. However, its application to Peripheral Facial nerve Paralysis (PFP) still needs to be sufficiently investigated. As the first approach known to the authors, this study examines the effect of FES on the facial muscles in complete PFP using ultrasonography as a means of observation. In a prospective single-center observational pilot study, ten patients with complete PFP, confirmed by needle-electromyography (EMG), performed FES of the affected lateral mouth region at home twice daily for 20 minutes. The facial muscles' Cross-Sectional Area (CSA) was regularly assessed using sonographic quantification. While the CSA of most non-stimulated muscles decreased considerably during ongoing paralysis, a significant CSA increase of the Zygomaticus Muscle (ZYG), which was regularly subjected to FES, could be demonstrated. FES can halt the atrophy of denervated ZYG and potentially other facial muscles. Further investigations with a more significant patient collective are recommended. From now on, FES could be established as an additive method in the non-invasive treatment of PFP.

A Prospective Observational Study Analyzing the Diversity and Specific Composition of the Oral and Gut Microbiota in Lung Cancer Patients.

Host microbiota dysbiosis has been recognized as a key factor in lung cancer. However, the specific diversity and composition of microbiota in lung cancer patients remain unknown. This single-center prospective observational study analyzed both saliva and fecal samples from 74 participants [lung cancer (LC) patients: n=53; lung inflammation (LI) patients: n=11; healthy control (HC): n=10]. We performed 16S ribosomal RNA gene sequencing and analyzed the associations between oral and gut microbiota diversity and composition across the three groups. Alpha diversity of the oral microbiota was significantly lower in the LC group than in the HC group (Chao 1, p=0.004; Simpson, p=0.018; Shannon, p=0.009). Beta diversity of both oral and gut microbiota showed significant differences among the three groups (PERMANOVA, oral: p=0.005; gut: p=0.002). Compositional differences in the oral microbiota were observed between the HC and LC or LI groups; in particular, Bacilli class, Streptococcaceae family, Streptococcus genus, Firmicutes phylum, and Lactobacillales order were more abundant in the LC group. Additionally, six oral-related microbiota showed significant abundance in the gut of the LC group (p=0.00182). The oral microbiota in lung cancer patients is significantly different from that in healthy individuals. Specific changes in oral microbiota and oral-related gut microbiota compositions were evident in lung cancer patients. These findings might be useful for identifying novel biomarkers to predict the risk of lung cancer and prevent the disease.

Is Floppy Eyelid Syndrome predictive of Intraoperative Floppy Iris Syndrome? A prospective and translational study

Intraoperative floppy iris syndrome (IFIS) is defined as an excessive billowing of the iris during cataract surgery. Floppy eyelid syndrome is defined as an excessive hyperlaxity of the eyelids. Based in our daily experience, we suspected FES to be associated with IFIS. This association has been investigated. The goal of the study was to explore whether FES was predictive of IFIS. We conducted a prospective observational single-center study at the University Hospital of Nice. IFIS and FES were investigated in patients undergoing cataract surgery from November 2019 to May 2021. In addition, tarsus and iris samples were harvested in 2 fresh cadavers, and Verhoeff staining was used to identify elastin fibers. We included 452 eyes (n=312 patients, 50.9% male) with a mean age of 71.7years (±11.4). IFIS was diagnosed in 88 (19.5%) patients, including 20 (4.4%) grade 1, 34 (7.5%) grade 2, and 33 (7.3%) grade 3. FES was diagnosed in 35 (7.7%) patients. PEX was found in 23 (5.1%) patients. On multivariate analysis, FES (P<0.001), pseudo exfoliation (P=0.017), intracameral dilatation (P<0.004), senior surgeons (P=0.009) and α1-ARA (P<0.001) were associated with IFIS. Elastin fibers were identified in small amounts in the tarsus samples but not in the iris samples. FES is predictive of IFIS. Surgeons should be aware of this association to prevent intraoperative complications.

Predictors of New-Onset Atrial Fibrillation in Patients With Chronic Coronary Artery Disease After Coronary Artery Bypass Grafting: a Prospective, Observational, Single-Centre, Non-Randomized Study

To study the factors that influence the occurrence of postoperative atrial fibrillation (POAF) in patients with chronic ischemic heart disease (IHD) after coronary artery bypass grafting (CABG). This single-center prospective observational non-randomized study included 152 patients with chronic IHD. Mean age of patients was 64.4±5.9 years. All patients after CABG were divided into two groups based on the occurrence of atrial fibrillation (AF) in the early postoperative period: group 1, with POAF (n=43; 28.3%) and group 2, without POAF (n=109; 71.7%). The primary study endpoint was new-onset POAF in the early postoperative (hospital) period after CABG. The secondary study endpoint was in-hospital postoperative complications (non-fatal/fatal acute coronary syndrome (ACS), non-fatal/fatal stroke, major bleeding, death). Patients with POAF had significantly more pronounced structural and functional changes in the heart than patients with preserved sinus rhythm after CABG: larger left ventricular (LV) volume, greater LV myocardial mass, lower LV systolic function parameters and impaired diastolic function, and an enlarged left atrial (LA) cavity. Analysis of in-hospital complications did not show any differences between the groups associated with the development of POAF. The following risk factors for POAF were identified: age older than 65 years (p=0.022), body mass index ≥30.5 kg/m2 (p=0.020), epicardial adipose tissue thickness &gt;10.5 mm (p=0.015), indexed LA volume &gt;33 ml/m2 (p&lt;0.001), LV myocardial mass index &gt;115 g/m2 (p=0.042), left main coronary artery disease &gt;50% (p=0.043), duration of cardiopulmonary bypass during CABG &gt;60 min (p=0.019), blood potassium concentration in the early postoperative period after CABG (on the first day) &lt;3.6 mmol/l (p&lt;0.001), and pericardial effusion volume in the early postoperative period &gt;88 ml (p&lt;0.001). Determining the risk of developing POAF is important and necessary for the closest monitoring of a patient with chronic IHD in the postoperative period.

Efficacy of Nusinersen Treatment in Type 1, 2, and 3 Spinal Muscular Atrophy: Real-World Data from a Single-Center Study

Background: Spinal muscular atrophy (SMA) is an inherited neuromuscular disease characterized by progressive muscle weakness and atrophy due to the absence of the survival motor neuron 1 (SMN1) gene. SMA is classified into types 0 through 4 based on the age of symptom onset and the severity of motor function decline. Recent advances in SMA treatment, including nusinersen, onasemnogene abeparvovec, and risdiplam, have significantly improved the prognosis of SMA patients. This study evaluated the safety and efficacy of nusinersen in pediatric patients with SMA types 1, 2, and 3 in a real-world clinical setting. Methods: This prospective observational single-center study assessed the treatment effects of nusinersen in 23 pediatric patients with genetically confirmed SMA over a 22-month observation period. All the participants received intrathecal loading doses of 12 mg of nusinersen on days 1, 14, 28, and 63, followed by maintenance doses every four months. Functional assessments were conducted using the CHOP-INTEND scale. Data were collected during routine patient visits, including clinical laboratory tests and vital sign parameters, and adverse events were recorded. The inclusion criteria were defined by the national reimbursement program for nusinersen treatment in Poland. Results: Initially, 37 patients ranging from 1 month old to 18 years old were included, but 23 were ultimately observed due to changes in treatment regimens or assessment scales. The patients showed significantly improved CHOP-INTEND scores over the 22-month period. At 6 months, the average increase was 4.2 points, continuing to 17.8 points at 22 months. By the end of the study, 100% of patients showed either stabilization or improvement, with significant clinical improvements observed in several patients. Nusinersen was generally well-tolerated, with post-lumbar puncture headache and lower back pain being the most common adverse events. Conclusions: Nusinersen treatment significantly enhances motor function in pediatric patients with SMA types 1, 2, and 3. This study demonstrates the importance of early and sustained treatment, with most patients showing the continuous improvement or stabilization of motor function. These findings support the use of nusinersen as an effective therapy for SMA; however, further research is needed to understand the long-term outcomes and optimize treatment strategies.

Less is more: Overlapping communication in trauma resuscitation

BackgroundTimely management of trauma patients is crucial. Better team performance means faster care, but roles of specific communication practices remain unclear. We hypothesized that overlapping communication is associated with less efficient resuscitations. MethodsThis single-center prospective observational study included hypotensive trauma patients from June–September 2023. Data were collected using Trauma Video Review. The association between overlapping communication and resuscitation length was assessed using multivariable linear regression adjusting for demographics, injury mechanism, Injury Severity Score (ISS), vitals, and number of procedures performed. ResultsWe included 87 patients with median ISS 26.0 [interquartile range IQR: 14.0–34.0] and median systolic blood pressure 84.0 [70.0–90.5]. Median resuscitation length was 19.1 [15.4–23.1] minutes. Overlapping communication occurred for median 1.22 [0.7–2.1] minutes. Overlapping communication was associated with longer resuscitations (p ​< ​0.0001). ConclusionsOverlapping communication was associated with less efficient resuscitations in hypotensive trauma patients. Training for trauma teams should target “one voice at a time”.

Predicting cardiovascular death 1-year after transcatheter aortic valve implantation: an artificial-intelligence based risk model

Abstract Background Prediction of cardiovascular death after transcatheter aortic valve implantation (TAVI) remains difficult. Currently, more lower risk patients are considered for TAVI and predicting not only immediate survival, but more longer-term outcomes seems important. Most developed risk tools use standard statistical approaches and focus mainly on short-term (30 days post-TAVI) outcomes. Purpose The aim of this project was to identify important predictors for worse outcomes after aortic valve replacement using machine learning features. Furthermore, we want to develop and artificial intelligence (AI) -model to predict cardiovascular death 1 year after TAVI. Methods For our analysis we used 725 patients with severe AS that underwent TAVI between 2008 and 2022 and were included in a prospective single centre observational study. Leveraging an automated machine learning framework, we systematically evaluated various machine learning algorithms including Random Forest, AdaBoost, Neural Networks, Randomized Decision Trees and and Gradient Boosting. Results We constructed prediction models utilizing three feature subsets: the top 10 most important features, the top 15 most important features (Figure 1), and all available features (n=66). Our analyses yielded area under curve (AUC) values of 0.71, 0.83, and 0.92, respectively (Figure 2). The best model was obtained by Randomized Decision Trees. NYHA classification, left ventricular ejection fraction, Charlson comorbidity index, posterior wall thickness and myocardial infarction 90-days before TAVI appeared as the most influential predictors for cardiovascular death within one year after TAVI. Conclusions Our model was able to identify the most important features indicating high risk for patients undergoing TAVI. Using the 15-feature model, we were able to accurately predict cardiovascular death 1 year after TAVI. AI-models to predict risk can be used to better inform/select patients undergoing TAVI.

A study of intracoronary thrombolytic agents in high thrombotic burden lesions during primary PCI

Abstract Objectives High thrombus burden during Primary PCI begets worst possible outcomes, studies on adjunctive intracoronary thrombolytic agents show heterogeneous1,2 results &amp; have limited long term follow-up. Although early studies support mechanical thrombectomy devices, larger randomized trial show that they are not able to reduce the MACE3, 4. There is no randomised clinical data for sustained mechanical thrombectomy devices till now. Purpose of the study The main purpose of this study is to analyse long term outcomes of low bleeding risk group patients undergoing Primary PCI with high thrombus burden, receiving intracoronary thrombolytic agents as an adjunctive therapy. Methods In this prospective observational single centre study, we analysed one year follow-up data of 108 consecutive primary PCI patients with high thrombus burden (G4, G5) and low bleeding risk, who were stratified into two groups basing on whether they receive intracoronary thrombolytic agent as an adjunctive agent before stent implantation. The primary outcome was NACE (Net Adverse Clinical Events, which include MACE, Death, ST/MI, major bleeding events), secondary outcomes include the individual components of the primary outcomes when analysed separately. Results The primary outcome events occurred in 21 patients (26%) in Primary stent group(PS, n=80), whereas it occurred in 2 patients(6%) in primary intra coronary thrombolysis group(PIT, n=28). Log-Rank (Mantel Cox) NACE curves show that PS group has high events when compared to PIT group(26% Vs 7%, p value – 0.042, Hazard ratio - 2.56; 95% CI - 0.76 – 8.57), there is no statistically significant difference in all other key secondary outcome event curves. Conclusion In patients presenting with STEMI, undergoing primary PCI, with high thrombus burden &amp; low bleeding risk group, those receiving intracoronary thrombolytic agent as the adjunctive therapy before stent implantation, are able to reduce the NACE event rates during the one year of follow-up.Fig1:Log Rank (Mantel Cox) NACE curve

Safety and feasibility of drug eluting and perfusion therapy for left main disease: JDEPTH-LM pilot study

Abstract Background Reducing cardiovascular events arising from ostial lesions of the left circumflex artery (LCx) remains an issue following percutaneous coronary intervention (PCI) for left main disease (LMD). Despite expert consensus recommendation for the drug coated balloon (DCB) use to address it, there are concerns in using DCB following the standard practice of crossover-stenting from the left main trunk (LMT) to left anterior descending artery (LAD). Specifically, utilizing a DCB in isolation for the ostial LCx after stenting may result in additional carina shift. The combination of a conventional balloon for LMT-LAD and a DCB for LMT-LCx in KBT could potentially cause hemodynamical instability due to prolonged occlusion time for the entire left coronary artery system. Accordingly, we hypothesized the combined usage of DCB and perfusion balloon (PB) could provide a safe and effective approach for drug-eluting therapy in ostial LCx lesion. This approach aims to facilitate prolonged inflation while maintaining coronary blood flow during KBT for LMD. Purpose The aim of this study was to assess the safety and feasibility of prolonged KBT with DCB and PB for LMD. Methods In this single-center prospective observational study, we enrolled patients of de-novo LMD with ostial LCx lesion, requiring crossover stenting for the LMT-LAD followed by conventional KBT (C-KBT). IVUS-guided procedure was mandated as per the study protocol. Following confirming the achievement of optimal left main PCI by IVUS, a double-effect KBT (W-KBT) was employed. This technique involved the use of a PB for the LMT-LAD and a DCB for the LMT-LCx, sized in a 1:1 ratio to the balloons used in C-KBT. Patients in cardiogenic shock, those requiring a two-stent technique for LMD, and individuals without achievement of TIMI3 flow in the LCx after C-KBT were excluded. The primary endpoint was procedural success, defined as device delivery and balloon inflation time ≥30 sec. Secondary endpoints included the total balloon inflation time (W-KBT time), the incidence of ST-change cases, time to ST-change (ST-change time), changes in blood pressure and heart rate (delta BP and delta HR, respectively), and the frequency of inotrope usage following W-KBT. Results Between January 2023 and December 2023, 12 patients were included among 73 patients with LMD who underwent PCI during this study period. Mean age was 73.8±7.2 years (91.7% men) and median SYNTAX score was 29 (IQR: 26.3 to 34.5). The incidence of ACS was 8.3%. Procedural success was achieved in 100% of cases. The results of secondary endpoints were as follows: median W-KBT time: 60 sec (IQR: 60 to 60); the incidence of ST-change: 50% (no cases with ST-elevation); mean ST-change time: 41.2±7.1 sec; mean delta BP: -13.7±11.4 mmHg; mean delta HR: -3.4±5.9 bpm; and the use of inotrope: 0%. Conclusion Within the limited sample size of this pilot study, the safety and feasibility of the "first-in-man" technique of W-KBT were confirmed.Procedure of W-KBTStrength of W-KBT

Tongue Pressure and Grip Strength as Indicators of Persistent Dysphagia After Acute Stroke.

This study aimed to identify the independent predictors of postacute stroke dysphagia at discharge using sarcopenia-related parameters. This single-center prospective observational study assessed consecutive inpatients diagnosed with cerebral infarction or cerebral hemorrhage upon admission to the stroke unit. Tongue pressure, grip strength, and body composition were evaluated within 48h. Dysphagia was defined by a functional oral intake scale of ≤ 5. Patient characteristics were compared between non-dysphagia and dysphagia groups using Mann-Whitney or chi-squared tests. Logistic regression analysis was performed using age, sex, tongue pressure, grip strength, skeletal muscle mass index (SMI), and National Institutes of Health Stroke Scale (NIHSS) scores as explanatory variables, with dysphagia at discharge as the objective variable. A total of 302 patients (mean age: 69.4 ± 13.8 years, 67.5% male) were analyzed, with 64 having dysphagia at discharge (21.2%). The dysphagia group was significantly older (p<0.001), had higher NIHSS scores on admission (p<0.001), lower SMI (p = 0.002), lower grip strength (p<0.001), and lower tongue pressure (p<0.001) than the non-dysphagia group. Logistic regression revealed that age (OR: 1.042, p = 0.018), tongue pressure (OR: 0.954, p = 0.010), and grip strength (OR: 0.943, p = 0.048) on admission were independent predictors of dysphagia at discharge, while NIHSS scores (OR: 1.403, p = 0.106), sex, and SMI (OR: 1.403, p = 0.150) were not. Older age, reduced tongue pressure, and reduced grip strength are strong predictors of persistent poststroke dysphagia at discharge. Thus, muscle strength is a more valuable parameter than muscle mass in predicting persistent poststroke dysphagia.

Evaluation of non-target lesions in femoropopliteal disease using near-infrared spectroscopy intravascular ultrasound imaging

Abstract Aim This study aims to assess the plaque morphology of non-target lesions, especially lipid-core-containing plaque (LCP), and compare it to target lesions using near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) in patients with femoropopliteal disease. Methods We conducted a single-center prospective observational study on 14 patients who underwent endovascular therapy for femoropopliteal disease between July 2022 and November 2023. NIRS-IVUS assessment was performed on the whole femoropopliteal arterial segment. Forty-one LCP lesions &amp;gt; maximum lipid-core burden index in any 4-mm region (max LCBI4mm) 100 were detected by NIRS-IVUS. We evaluated patient and lesion characteristics. In addition, the LCP lesions were divided into two groups, the target lesion group (n=18) and the non-target lesion group (n=23), and compared. Results Patient characteristics were notable for advanced age (76.8±6.6 years), high incidence of male (78.7%), hypertension (100%), dyslipidemia (78.6%), diabetes (64.3%), statin use (71.4%). Lipid profiles were as follows: LDL-cholesterol 85.9±26.7 mg/dl, HDL-cholesterol 48.9±12.7 mg/dl, triglyceride 138.9±80.3 mg/dl, lipoprotein(a) 19.6±16.3 mg/dl. Ten participants had LCPs in the non-target lesion (71.4%). For IVUS findings, the target lesion group had significantly longer lesion length (34.6±11.9 mm vs. 22.6±8.7 mm, p=0.001), smaller minimum lumen area (7.0±2.8 mm2 vs. 14.8±5.4 mm2, p&amp;lt;0.001), and larger plaque burden (78.0±5.0 % vs. 53.0±12.0 %, p&amp;lt;0.001) than those in the non-target lesion group. No significant differences were observed in the prevalence of calcification (target lesion group vs. non-target lesion group: 83.3 % vs. 91.3 %, p=0.64) and the extent of calcification (p=0.76). For NIRS findings, the target lesion group contained a significantly smaller proportion of LCP in the lesion length (25.9±15.7 % vs. 50.6±29.2 %, p=0.002) than the non-target lesion group. On the other hand, there were no significant differences in the value of max LCBI4mm (284.4±153.4 vs. 289.5±113.1, p=0.90) and the length of LCP lesion (9.8±9.7 mm vs. 10.7±6.9 mm, p=0.74) and distribution of LCP (p=0.08) between both groups. In addition, the number of LCPs in the target femoropopliteal artery was positively correlated with max LCBI4mm in the target femoropopliteal artery (r=0.671, p=0.008) Conclusion NIRS-IVUS findings in this study demonstrated that the non-target lesions contained LCPs to the same degree as the target lesions.

Necrotizing fasciitis: treatment concepts & clinical outcomes – an institutional experience

BackgroundA severe infection of the skin and soft tissues, Necrotizing Fasciitis (NF), spreads quickly along the deep fascia. This study aimed to characterize the clinicopathological features, analyze the implicated bacteria’s antibiotic sensitivity, evaluate surgical management, and assess the diagnostic accuracy of the Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) score in Necrotizing Soft Tissue Infection (NST).MethodsThis single-center prospective observational study was conducted in the Department of General Surgery, Kasturba Medical College, Manipal, with 171 proven cases of NSTI between 2019 and 2021. Clinico-demographic data and laboratory investigation values were collected at two-time points (at admission and 72 h after admission). Imaging data, LRINEC score, culture results, and antibiotic sensitivity were recorded. Appropriate descriptive and analytical statistics were used for the statistical analysis.ResultsOf the 171 patients, 150 were male (87.7%). The mean age was 57.6 ± 13.1 years. The presenting features in all the cases were pain, swelling, and fever. Diabetes mellitus (DM) is the most common comorbidity. The lower extremities were the most commonly affected sites. Streptococcus pyogenes showed significant growth in 25.41% of the samples. Ceftriaxone sensitivity was seen in 41/141. A score of ≥ 8 was obtained in 118/171 (69%) patients, suggesting a higher severity and significant risk for NSTI. The Area Under the Curve of Receiver Operating characteristic Curve (ROC) for establishing diagnostic accuracy for LRINEC was 0.694. Mortality was significantly higher in the patients with higher LRINEC scores and elevated procalcitonin. The mortality rate was higher in patients who underwent surgery within 12 h.ConclusionNecrotizing fasciitis is a soft tissue infection with a high mortality rate. The clinical features and determinants of mortality in patients with NF are highlighted in this study. At the outset, a high index of suspicion was critical. Using prognostic evaluation techniques in daily clinical practice will assist medical professionals in providing adequate on-time care and significantly lowering mortality. The AUC for LRINEC score, although significant, is low. LRINEC score is not to be used to determine whether surgical intervention should be expedited or anticipated. Its role is to aid in prognosticating the outcome of the individual patient. Our study concludes that early extensive surgical debridement remains the single most crucial intervention in patients diagnosed with necrotizing fasciitis (NF), regardless of disease severity and the LRINEC score.

Risk Factors for Increased Opioid Use During Postoperative Intensive Care.

In the ICU, opioids treat pain and improve ventilator tolerance as part of an analgosedation approach. Identifying predictors of opioid consumption during the ICU course might highlight actionable items to reduce opioid consumption. To identify risk factors for opioid use during a postoperative ICU course. Patients enrolled in the Michigan Genomics Initiative single-center prospective observational cohort study completed baseline preoperative sociodemographic and mental/physical health questionnaires and provided blood samples for genetic analysis. Included patients were 18 years old and older, admitted to ICU postoperatively, and received opioids postoperatively. The primary outcome was ICU mean daily oral morphine equivalent (OME) use. The association between OME and phenotypic risk factors and genetic variants previously associated with pain were analyzed through univariable and multivariable linear regression models. The cohort consisted of 1865 mixed-surgical patients with mean age of 56 years (sd, 15 yr). Preoperative opioid users were more likely to continue to receive opioids throughout their ICU stay than opioid-naive patients. OME (log10 scale) was most strongly associated with ICU mechanical ventilation (β = 0.27; 95% CI, 0.15-0.38; p < 0.0001; effect size 1.85 for receiving > 24 hours of mechanical ventilation), preoperative opioid use (β = 0.22; 95% CI, 0.16-0.29; p < 0.0001; effect size 1.67 for receiving preoperative opioids), major surgery (β = 0.21; 95% CI, 0.12-0.30; p < 0.0001; effect size 1.62 compared with minor surgery), and current/former illicit drug use (β = 0.12; 95% CI, 0.01-0.23; p = 0.04; effect size 1.30 for drug use). Younger age, centralized pain, and longer anesthetic duration were also significantly associated with OME but with smaller effect sizes. Selected genetic variants (FKBP5, COMT, and OPRM1) were not associated with OME use. Mechanical ventilation and preoperative opioids were the strongest risk factors for postoperative ICU opioid consumption, whereas psychologic factors and genetic variants were not associated.

Access to Hysterectomy-What Is the Realistic Rate for Pure Vaginal Hysterectomy? A Single-Center Prospective Observational Study.

Background/Objectives: Hysterectomy (HE) is the most common surgical procedure in gynecology worldwide. The guidelines of most countries unanimously recommend vaginal hysterectomy (VH) as the access of first choice. However, there are significant international differences in the implementation of this recommendation. Methods: In the consistent implementation of the national guidelines, the aim of this prospective observational cohort study was to evaluate how many hysterectomies can be performed vaginally under real-world conditions for benign indications excluding genital prolapse and extensive endometriosis. For this purpose, the requirements of the guidelines were implemented for all HE cases. All HEs were performed by a single, experienced surgeon. The aim was not to go to the limits of the method, but to develop a reproducible benchmark with the lowest possible complication rate. Results: From 2011 to 2020, 230 hysterectomies were performed for benign indications. A VH was performed in 146 cases (63.5%), and a laparoscopic hysterectomy (LH) in 75 cases (32.6%). An abdominal hysterectomy (AH) was only required in nine cases (3.9%). The decision for LH was made in half of the cases due to the assumed presence of endometriosis or a significantly enlarged uterus. The median duration of VH was 32 min (range 16-118 min), and the uterine weights were 15-540 g. The rate of postoperative complications of VH was 3.4%. Conclusions: In line with international guidelines, VH is possible in over 60% of cases with a short surgical time and a low complication rate. LH procedures are useful in the presence of assumed additional pathology in 35%. AH is reserved for huge uteri. A reduction in AH below 10% is possible. The global target could be a rate of 60-30-10% for VH, LH, and AH.

Surveillance of fever and neutropenia episodes at Yeolyan Hematology and Oncology Center in Armenia

Abstract Background Fever and neutropenia frequently occur as complications in pediatric patients with malignancies, significantly escalating morbidity and mortality if not appropriately addressed. We implemented a fever registry to identify patient factors and outcomes associated with fever in patients undergoing treatment at our facility. Methods We conducted a single-center prospective observational study at the Pediatric Cancer and Blood Disorders Center of Armenia. All patients aged 0-21 years with a malignancy diagnosis and developing fever and neutropenia between June 25 and November 20, 2023, were included. Variables collected included age, gender, date and time of fever onset, patient symptoms, time to antibiotic administration, identified microbiologic and clinical infections, and subsequent outcomes, including mortality and requirement for critical care level interventions. Data were entered in Microsoft Excel 2016 and analyzed using descriptive statistical methods. Results Sixty-one patient episodes in 36 patients met the inclusion criteria. Of these, 22% of episodes had fever at home. The most common malignancy was acute leukemia, specifically B-ALL (21/61), followed by T-ALL (9/61), AML (7/61), and mixed T- and B-type (1/61). Eight out of 61 fever episodes occurred in patients with relapsed disease. The median time-to-antibiotics was 100 minutes (max: 24 hours 40 minutes) in patients developing fever outside the hospital; for inpatient cases, the median time-to-antibiotics was 30 minutes (max: 6 hours 45 minutes). The time-to-antibiotics was longer for patients experiencing fever at home compared to those in inpatient settings (p=0.043). 21% of patient episodes were pretreated, however 11 out of 61 patient episodes (18%) had a positive blood culture. Of 13 total positive cultures, ten were obtained at the time of the patient’s presentation. The most common pathogens identified were Staphylococcus spp. (8/13) including coagulase-negative (3/8), and Klebsiella spp. (3/13). Polymicrobial-positive cultures were observed during two fever and neutropenia episodes. During 35 episodes, patients presented with no complaints except for general weakness. Among the identified sources of infection (20/61), central-line-related bloodstream infections (n=6), bacteremia (n=5), and Clostridiodes difficile colitis (n=5) were the most common. One febrile neutropenia episode resulted in death (1.6%). Conclusion In summary, over 75% of episodes were observed among patients with hematologic malignancies, and localizing symptoms were absent in half of episodes at presentation. We have identified opportunities for quality improvement in time to administration of antibiotics in outpatient fever episodes. The adaptation of an electronic-based medical record system will simplify the tracking process for a febrile episode.

COVID-19 is associated with cardiac structural and functional remodelling in healthy middle-aged and older individuals.

Coronavirus disease 2019 (COVID-19) was declared a global pandemic in 2019. It remains uncertain to what extent COVID-19 effects the heart in heathy individuals. To evaluate the effect of the COVID-19 on cardiac structure and function in middle-aged and older individuals. A single-centre prospective observational study enroled a total of 124 participants (84 with history of COVID-19 [COVID-19 group] and 40 without a history of COVID-19 [non-COVID group]). All participants underwent echocardiography with speckle tracking to assess cardiac structure and function at rest and during peak exercise. There were no differences in left and right ventricular diastolic function (p ≥ 0.05) between the COVID-19 and non-COVID-19 groups. Participants in COVID-19 group demonstrated higher left ventricular mass (130 ± 39.8 vs. 113 ± 27.2 g, p = 0.008) and relative wall thickness (0.38 ± 0.07 vs. 0.36 ± 0.13, p = 0.049). Left ventricular global longitudinal strain was reduced in the COVID-19 group at rest and at peak-exercise (rest: 18.3 ± 2.01 vs. 19.3 ± 1.53%, p = 0.004; peak exercise: 19.1 ± 2.20 vs. 21.0 ± 1.58%, p ≤ 0.001). However, no difference was seen in resting left ventricular ejection fraction (58 ± 2.89 vs. 59 ± 2.51%, p = 0.565) between groups. Right ventricular fractional area change was reduced in the COVID-19 group (p = 0.012). Cardiac structural and functional remodelling was observed in middle-aged and older otherwise healthy individuals with a history of COVID-19.

Why do patients stay in hospital after enhanced recovery thoracoscopic wedge resection? A prospective observational study.

This single-centre prospective observational study aimed to investigate reasons for prolonged hospitalization [over the median length of stay (LOS)] after enhanced recovery thoracoscopic [ERAS 3-port video-assisted thoracoscopic surgery (VATS)] wedge resection. All patients were evaluated twice-daily by an investigator for reasons of hospitalization. Each reason was analysed individually. Predictors for prolonged hospitalization were identified using a multivariable backward stepwise logistic regression model. A total of 150 consecutive patients (lymphadenectomy 8.7%) were included from November 2022 to December 2023, with a median LOS of 1 (interquartile range 1-2) day. Of these, 55 patients (36.7%) experienced prolonged hospitalization. The main reasons included postoperative pain (16.0%), air leak (14.7%) and social factors (14.7%), followed by oxygen dependency (7.3%), gastrointestinal factors (5.3%), urinary factors (4.7%), pneumonia (1.3%), pleural effusion (1.3%), chylothorax (0.7%), atrial fibrillation (0.7%), confusion (0.7%) and fatigue (0.7%). Multivariable analysis revealed that an increase in the percentage of predicted forced expiratory volume in 1 s (FEV1%pre) by 1% [odds ratio (OR) 0.41, P = 0.023) and percentage of predicted diffusing capacity for carbon monoxide (DLCO%pre) by 1% (OR 0.95, P = 0.002) decreased likelihood of prolonged hospitalization. Conversely, each additional pack-year (OR 1.01, P = 0.028) and living alone (OR 3.55, P = 0.005) increased the risk of prolonged hospitalization. Prolonged hospitalization (LOS > 1 day) after ERAS 3-port VATS wedge resection, with 8.7% lymphadenectomy, was mainly due to pain, air leak and social factors. Smokers with decreased FEV1%pre or DLCO%pre and patient living alone were at increased risk. ClinicalTrials.gov: NCT06118593 (https://clinicaltrials.gov/study/NCT06118593?cond=why%20in%20hospital&rank=2).

The reflux symptom score has good screening value for laryngopharyngeal reflux

ObjectiveTo investigate the consistency between the reflux symptom score (RSS) and the multitemporal salivary pepsin test in screening for laryngopharyngeal reflux (LPR) and the screening value of the RSS for LPR by simultaneously administering daytime multitemporal salivary pepsin test and RSS to patients.MethodsThis was a single-center prospective observational study. All included patients underwent simultaneous daytime multitemporal salivary pepsin testing and RSS. A participant was considered to have LPR when one or more positive salivary pepsin test results or RSS score > 13 were obtained. The consistency between the multitemporal salivary pepsin test and the RSS was compared by the weighted Cohen’s kappa statistic. The screening value of the RSS for LPR was investigated by receiver operating characteristic (ROC) analysis.ResultsA total of 67 patients were included. The positivity rate of LPR was 71.64% according to the results of the multitemporal salivary pepsin test. According to RSS, the positive rate of LPR was 70.15%. The weighted Kappa value between the multitemporal salivary pepsin test and the RSS was 0.675 (p < 0.001). The area under curve of RSS screening for LPR was 0.843 (p < 0.01), and the sensitivity, specificity, positive predictive value, and negative predictive value of RSS screening for LPR were 89.58%, 78.95%, 91.49%, and 75%, respectively.ConclusionThere is a good consistency between the RSS and the multitemporal salivary pepsin test, and the RSS has a good screening value for LPR, which can be applied to screen for LPR in otolaryngologic patients.

The Impact of a Digital Referral Platform to Improve Access to Child and Adolescent Mental Health Services: A Prospective Observational Study with Real-World Data.

(1) Background: In the UK, mental health needs for children and young people (CYP) are rising, whilst access to care is declining, particularly in the North of England and post-COVID-19. However, Health Information Technologies (HITs) can simplify access to Child and Adolescent Mental Health Services (CAMHS), reduce waiting times, and provide anonymous support and reliable information. (2) Methods: A single-centre prospective observational study examined the impact of "CYP as One"-a digital referral point to CAMHS-on waiting times and referral rejection rates. (3) Results: Waiting times during the first 12 months of "CYP as One" implementation were compared to the 12 months prior using non-parametric tests. "CYP as One" demonstrated an increase of 1314 referrals, with self-referrals rising by 71%. Initial implementation showed an increase in waiting times by 16.13 days (53.89 days) compared to pre-implementation (37.76 days) (p < 0.001). However, months 10 (M = 16.18, p < 0.001), 11 (M = 17.45, p < 0.001), and 12 (M = 31.45, p < 0.001) implementation showed reduced waiting times. Rejection rates rose due to a 108% increase in referral volume. "CYP as One" improved access and reduced waiting times after the initial phase. (4) Conclusions: Further research is needed to assess its long-term impact and cost-effectiveness, particularly regarding specific mental health conditions and staff time.