Single-center Prospective Observational Study Research Articles

MicroRNAs in Plasma-Derived Extracellular Vesicles as Non-Invasive Biomarkers for Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is a chronic inflammatory esophageal disorder. The lack of non-invasive biomarkers currently results in dependency on endoscopy with biopsies for its diagnosis and monitoring. We aimed to identify potential non-invasive biomarkers using microRNAs (miRNAs) in plasma-derived extracellular vesicles (pEVs). This was a prospective single-center observational study of a discovery cohort of EoE patients (n = 26) with active disease (EoE.Basal) and after anti-inflammatory treatment (EoE.Post.tx) and control subjects (n = 16). Small-RNA-seq was performed to identify differentially regulated small RNAs (sRNAs). Candidate miRNAs were validated in an independent cohort (EoE patients, n = 33; controls, n = 14). The pEVs-sRNA cargo differed among conditions. Compared with controls, Ser_Comb_22, Leu_Comb_5, miR-10b-5p, and miR-125a-5p were upregulated in EoE.Basal, and miR-224-5p, miR-221-3p, let-7d-5p, and miR-191-5p were downregulated. The combination of miR-221-3p and miR-10b-5p showed the best diagnostic performance. Comparing paired EoE samples, miR-374a-5p and miR-30a-3p were upregulated in EoE.Basal, while miR-15a-5p and let-7d-5p were downregulated. Combined miR-30a-3p and miR-15a-5p showed the best AUC values, and miR-30a-3p alone was best as a monitoring biomarker (p = 0.001). In conclusion, pEVs-sRNA changed upon inflammation in EoE patients, and miR-30a-3p was proposed as a potential biomarker for monitoring the treatment. This study was the first to explore the use of pEVs as a non-invasive biomarker for EoE.

Effect of intermittent infusion hemodiafiltration on cerebral and hepatic oxygenation

BackgroundHepatosplanchnic circulation plays a crucial role in maintaining hemodynamic stability during hemodialysis (HD). In patients undergoing HD, hepatic oxygenation decreases before the onset of intradialytic hypotension. However, clinical studies comparing systemic tissue oxygenation, particularly in the brain and liver, between HD and intermittent infusion hemodiafiltration (I-HDF) are limited. We aimed to compare changes in the cerebral and hepatic oxygenation during I-HDF and HD.MethodsThis single-center prospective observational study included 25 patients undergoing dialysis therapy. I-HDF involved a dialysate infusion volume of 200 mL, administered at a rate of 150 mL/min via back-filtration every 30 min. Cerebral and hepatic regional oxygenation saturation (rSO2) levels were monitored during HD and I-HDF using the INVOS 5100C oxygen saturation monitor. Changes in these parameters were compared between the two modalities.ResultsThe relative blood volume change (%ΔBV) at the end of therapy was significantly smaller with I-HDF compared with HD (−8.0 ± 4.4% versus −10.0 ± 5.0%, p = 0.019). No significant differences in cerebral and hepatic rSO2 were observed at the initiation of HD and I-HDF (cerebral rSO2: 54.5 ± 6.3% versus 54.0 ± 6.0%, p = 0.444; hepatic rSO2: 63.4 ± 11.8% versus 63.4 ± 12.3%, p = 0.977). During I-HDF, cerebral and hepatic rSO2 levels significantly increased in response to dialysate infusion, compared with corresponding time points during HD. The percentage (%) change in hepatic rSO2 after the seventh dialysate infusion was significantly greater than those after the first, third, and fifth infusions. Additionally, percentage changes in hepatic rSO2 were negatively correlated with %ΔBV (ρ = −0.394, p < 0.001) and positively correlated with the ratio of the dialysate infusion volume to circulating BV just before infusion (ρ = 0.387, p < 0.001).ConclusionsThis study demonstrated that BV reduction at the end of I-HDF was significantly smaller than that of HD, and that hepatic oxygenation increased rapidly after dialysate infusion during I-HDF. Further studies are required to elucidate the impact of increased hepatic oxygenation during I-HDF on intradialytic hemodynamic stability.

A modified technique for radial artery access: how interventional radiologists can optimise the cardiologists’ technique to suite their procedures

BackgroundThis is a single-centre prospective observational study examining radial access in 62 Prostatic Artery Embolisation (PAE) procedures. Evaluation of left radial artery diameter using high frequency ultrasound before and after administration of sublingual glycerl trinitrate (GTN). Pre-procedure questionnaires calculating symptom severity score compared with post-procedure.ResultsSublingual GTN resulted in a statistically significant increase in radial artery diameter (p < .00001). There was a statistically significant reduction in both average International Prostate Symptom Score (IPSS) and Quality of Life (QoL) from pre-procedure to post-PAE. The radial sheath was successfully inserted in 100% of cases. Crossover rate to femoral access was low (4%). Radial artery access had a low complication rate (2%). Radial artery variant anatomy was reasonably common (7%).ConclusionsSublingual GTN significantly increase radial artery diameter. PAE from radial access is associated with a symptomatic improvement at 2-month follow-up.

The change of detrusor contractility at 5 years after transurethral resection of the prostate: a single center prospective observational study.

To prospectively assess the impact of transurethral resection of the prostate (TURP) on detrusor function using pressure flow study (PFS) at 5 years after surgery in a single center prospective non-randomized observational study. Sixty consecutive male patients were prospectively enrolled and underwent TURP from November 2014 to November 2018. A questionnaire survey, free uroflowmetry and PFS were performed at baseline, and 6, 24 and 60 months after surgery. We divided the age groups at 70 years and defined the younger group as those younger than 70 years old, and the elderly group as those aged 70 years or older. The primary endpoint was the change of the bladder contractility index (BCI). Of the 60 patients, 39 completed the protocol. Regardless of age, the bladder outlet obstruction indices at 6, 24, and 60 months after surgery were significantly lower than before surgery (all, p<0.01). Although the BCI did not significantly change during 60 months for the entire group of 39 patients, it was significantly decreased at 60 months (85.6) after surgery compared to before surgery (102) in the elderly group (p=0.02). We prospectively evaluated detrusor contractility up to 5 years after TURP. It was significantly reduced in the elderly, in spite of which the relief of bladder outlet obstruction was maintained for 5 years after surgery.

Current status of postoperative morbidity following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for colorectal cancer with peritoneal metastasis: a prospective single-center observational study.

This study aimed to evaluate current morbidity rates following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colorectal cancer and peritoneal metastasis. A total of 42 patients who underwent CRS and HIPEC for colorectal cancer with peritoneal metastasis at a single tertiary referral center between January 2022 and December 2022 were included. Perioperative outcomes and postoperative complications were prospectively assessed. The mean peritoneal cancer index (PCI) was 16.0. The distribution of PCI scores was as follows: <10, 33.3%; 10-19, 26.2%; and ≥ 20, 40.5%. Completeness of the cytoreduction (CCR) scores were as follows: 57.1% of patients achieved CCR-0, 16.7% achieved CCR-1, 7.1% achieved CCR-2, and 19.0% achieved CCR-3. The mean operation time was 9.1 hours, and the median hospital stay was 17.0 days. Postoperative complications occurred within 30 days in 47.6% of cases and between 30 and 60 days in 11.9% of cases. Reoperation within 30 days was required in 5 cases, and 1 patient died within 30 days. The most common complications were pleural effusion (5 patients), anastomosis site leakage (3 patients), and pneumonia (3 patients). Patients with higher PCI scores were more likely to experience complications (P = 0.038). Although CRS and HIPEC are still associated with high morbidity and mortality compared to other colorectal surgeries, outcomes have improved with increased experience. These results suggest that the procedure is becoming a more acceptable treatment option over time.

Postoperative corneal remodeling after corneal allograft intrastromal ring segment (CAIRS) implantation for keratoconus: An OCT study.

To demonstrate corneal remodeling after corneal allograft intrastromal ring segment (CAIRS) with an anterior-segment optical coherence tomography (AS-OCT). A prospective observational single-center study. This observational study included keratoconus patients who underwent CAIRS implantation into a stromal tunnel. Topographical, refractive, and visual changes were obtained from the patient records. Epithelial thickness (ET), anterior stromal thickness (AST), allograft corneal ring thickness (ACRT), and posterior stromal thickness (PST) were measured on the first day and 1, 3, 6, and 12 months postoperatively using AS-OCT. The study included 35 eyes of 27 patients with advanced keratoconus. The mean keratometry decreased from 48.26 ± 4.78 D to 44.50 ± 4.42 D at 1-year postoperatively (P = 0.004), mean corrected distance visual acuity increased from 0.29 ± 0.18 to 0.70 ± 0.24 (P < 0.001), and spherical equivalent (SE) decreased from -6.94 ± 4.32 D to -1.44 ± 4.44 D (P < 0.001). The mean AST decreased by 17.39 ± 5.78 μm in the postoperative 1st month compared to 1st day after surgery (P = 0.040). No statistically significant variations were observed in AST after the first month. There was no statistically significant difference in the mean ET, ACRT, and PST measurements between follow-up times. Significant negative correlations were found between SE change and ET (r = -0.543, P = 0.023) and between K1 change and ACRT (r = -0.548, P = 0.008). CAIRS is an effective treatment method to improve visual acuity and keratometry measurements and does not cause significant changes in graft thickness or recipient corneal epithelial and stromal thicknesses during the 1-year follow-up period. The observed correlations between SE, keratometry, and corneal thickness suggest that epithelial and stromal remodeling play crucial roles in postoperative outcomes of CAIRS.

Protocol for evaluating physiological and psychological acclimatization mechanisms in Tibetan plateau environment: a clinical study of doctors from Peking Union Medical College Hospital.

The transition from low to high altitude environments is associated with a multifaceted series of physiological and psychological alterations that manifest over time. These changes are intricately intertwined, with physiological acclimatization primarily mediated through the regulation of hypoxia-inducible factor (HIF), which orchestrates the expression of critical molecules and hormones. This process extends to encompass the epigenome, metabolism, and other regulatory mechanisms. In the realm of psychological acclimatization, chronic hypoxia and changes in atmospheric pressure at high altitudes may contribute to decreased levels of neurotransmitters, with potential implications for mental health, particularly in relation to sleep quality. Despite significant advancements in our understanding of plateau acclimatization mechanisms in recent years, there remain many uncertain factors that necessitate further research. This study is a single-center prospective observational study. It aims to utilize a series of physiological and medical instruments in conjunction with internationally recognized physiological and psychological questionnaires to monitor the dynamic shifts in the acclimatization ability of doctors from Peking Union Medical College Hospital. The monitoring will occur at seven distinct time points: pre-departure from Beijing, 1-7 days post-arrival at the Tibetan plateau during the acute phase of plateau hypoxic stress, and during the chronic phase of plateau hypoxic stress at 2 weeks, 3 months, 6 months, 12 months of residency in Tibet, and post-return to Beijing. Concurrently, a spectrum of omics analyses will be conducted, including comprehensive genomic, proteomic, and metabolomic assessments of blood leukocytes, fecal, and oral samples.

Influence of baseline characteristics and stratification level of patients living with HIV on pharmaceutical interventions developed according to the Capacity-Motivation-Opportunity methodology

ObjectiveIn recent years the therapeutic approach to patients with HIV has gone from being multidisciplinary to multidimensional, being vital to know the different aspects that define patients in order to...

Risk factors and prediction model of breast cancer-related lymphoedema in a Chinese cancer centre: a prospective cohort study protocol

IntroductionLymphoedema is a distressing and long-term complication for breast cancer survivors. However, the reported incidence of lymphoedema varies, and its risk factors remain underexplored. Currently, a well-established risk prediction model...

Intraoperative Electroencephalogram Frontal Low Alpha Power for Predicting Postoperative Delirium in Elderly Patients after Orthopedic Surgery: A Prospective Cohort Study.

Postoperative delirium (POD) is a common complication with significant adverse effects in elderly patients. Electroencephalography (EEG) provides a promising approach for predicting the risk of POD. This study aims to elucidate the correlation between intraoperative EEG spectrum and the incidence of POD in elderly patients undergoing orthopedic surgery. A single-center prospective observational cohort study was conducted at Zhongda Hospital, Southeast University, from September 2022 to March 2023, registered on Chinese Clinical Trail Registry (ChiCTR2300069548). Among the 172 patients who underwent orthopedic surgery, 125 completed the study with available data. Preoperative baseline cognitive function was assessed using the mini-mental state examination (MMSE). An intraoperative 4-channel EEG was recorded. Total power spectra and power spectral density for beta, alpha, theta, and delta bands were calculated. Spectral edge frequency, burst suppression ratio, and patient state index were directly extracted from the EEG monitor. The primary outcome was POD, assessed using a 3-minute Diagnostic Interview for Confusion Assessment Method (CAM)-Defined Delirium scale or the CAM for the Intensive Care Unit. Patients were divided into POD and non-postoperative delirium (non-POD) groups. Logistic regression analysis was conducted to evaluate the independent predictive effect of intraoperative spectral distribution and other quantitative EEG data for POD. The incidence of delirium within 72 hours after surgery was 8.8%. Compared to the non-POD group, the POD group showed significantly lower absolute power in the beta [0.06 (0.03, 0.09) dB vs 0.14 (0.08, 0.26) dB, p < 0.001], alpha [0.41 (0.25, 0.71) dB vs 1.24 (0.55, 2.57) dB, p = 0.008], and theta [0.77 (0.44, 1.01) dB vs 1.19 (0.72, 2.02) dB, p = 0.035] bands. Logistic regression analysis identified several independent risk factors for POD, including lower intraoperative alpha power [odds ratio (OR) 10.210, 95% confidence interval (CI) 1.233-84.568, p = 0.031], advanced age (OR 7.713, 95% CI 1.022-58.204, p = 0.048), preoperative anemia (OR 6.636, 95% CI 1.091-40.358, p = 0.040), and preoperative depression (OR 10.089, 95% CI 1.029-98.909, p = 0.047). In contrast, higher preoperative MMSE scores appeared to be a protective factor for POD (OR 0.130, 95% CI 0.021-0.820, p = 0.030). Intraoperative EEG frontal low alpha power demonstrated a significant independent association with POD in elderly patients after orthopedic surgery. This parameter may serve as an intraoperative neurophysiological marker of cerebral vulnerability to POD. Additionally, advanced age, lower preoperative MMSE scores, preoperative anemia, and preoperative depression were independent risk factors for POD. Chinese Clinical Trial Registry (ChiCTR2300069548).

The Efficacy and Safety of a Microwave Ablation System with a Dipole Antenna Design Featuring Floating Sleeves and Anti-Phase Technology in Stereotactic Percutaneous Liver Tumor Ablation: Results from a Prospective Study.

Purpose: To evaluate the efficacy and safety of the Surgnova Dophi™ M150E microwave ablation system in a prospective single-center observational study. Methods: A cohort of 50 patients with 77 primary or secondary liver tumors underwent CT-navigated stereotactic percutaneous microwave ablation with curative intention using the Surgnova Dophi™ M150E system. The endpoints were primary technique efficacy (PTE), number of complications, ablation defect dimensions, and sphericity index compared to previously reported findings. Results: The PTE was 97.4%, with complete ablation in 75 out of 77 tumors. Complications occurred in 10% of patients, with 4% classified as major. A comparison with previous in vivo data confirmed the reliability of the system in achieving reproducible and predictable ablation results. Conclusions: Stereotactic percutaneous microwave ablation with the Surgnova Dophi™ M150E system is safe and effective for liver tumor treatment.

Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study.

The broad consent (BC) developed by the German Medical Informatics Initiative is a pivotal national strategy for obtaining patient consent to use routinely collected data from electronic health records, insurance companies, contact information, and biomaterials for research. Emergency departments (EDs) are ideal for enrolling diverse patient populations in research activities. Despite regulatory and ethical challenges, obtaining BC from patients in ED with varying demographic, socioeconomic, and disease characteristics presents a promising opportunity to expand the availability of ED data. This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED and to explore factors influencing consent and dropout rates. A single-center prospective observational study was conducted in a German tertiary ED from September to December 2022. Every 30th patient was screened for eligibility. Eligible patients were informed via one of three modalities: (1) directly in the ED, (2) during their inpatient stay on the ward, or (3) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analyzing potential influences on the success and dropout rates based on patient characteristics, information mode, and the interaction time required for patients to make an informed decision. Of 11,842 ED visits, 419 patients were screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 (45%) consented to at least 1 BC module, while 24 (15.9%) refused participation. The dropout rate was 39.1% (n=59) and was highest in the telephone-based group (57/109, 52.3%) and lowest in the ED group (1/14, 7.1%). Patients informed face-to-face during their inpatient stay following the ED treatment had the highest consent rate (23/27, 85.2%), while those approached in the ED or by telephone had consent rates of 69.2% (9/13 and 36/52). Logistic regression analysis indicated that longer interaction time significantly improved consent rates (P=.03), while female sex was associated with higher dropout rates (P=.02). Age, triage category, billing details (inpatient treatment), or diagnosis did not significantly influence the primary outcome (all P>.05). Obtaining BC in an ED environment is feasible, enabling representative inclusion of ED populations. However, discharge from the ED and female sex negatively affected consent rates to the BC. Face-to-face interaction proved most effective, particularly for inpatients, while telephone-based approaches resulted in higher dropout rates despite comparable consent rates to direct consenting in the ED. The findings underscore the importance of tailored consent strategies and maintaining consenting staff in EDs and on the wards to enhance BC information delivery and consent processes for eligible patients. German Clinical Trials Register DRKS00028753; https://drks.de/search/de/trial/DRKS00028753.

Impact of Drug Eluting Stents’ Length and Diameter on Short Term Outcome in Patients Undergoing Primary Percutaneous Coronary Intervention

Abstract Introduction Little information is available on the impact of drug eluting stents (DES) on Major adverse cardiac events (MACEs). Aim was to assess the impact of stent length and diameter on angiographic and MACE outcomes during in-hospital &amp; short term follow up in patients undergoing primary percutaneous coronary intervention (PPCI). Methods This is a single-center prospective observational study that included 404 patients who underwent primary PCI. Exclusion criteria were previous PCI, ectatic lesions, multi-vessel disease, and complex lesions. Stent length was divided into &lt;20 mm, 20 - 40 mm and &gt; 40 mm. Stent diameter was divided into &lt; 3.0 mm, 3.0 – 3.5 mm and &gt; 3.5 mm. Outcomes include angiographic data, e.g slow flow/no-reflow (SF-NR), and in-hospital and 3 months’ follow up MACE assessment. Results 404 patients (79% males, mean age 56 ± 11.35 years) were included. There was higher incidence of SF-NR (P=0.016), pre-dilatation (P= 0.01), median door to device time (P=0.011), median of onset of chest pain to wire time (P=&lt;0.001), mean procedure time (P=&lt;0.001) and mean contrast amount (P=0.013) for longer stents vs. medium and shorter stents. Patients having longer stents had significantly higher incidence of recurrent attacks of acute coronary syndrome (ACS) during the follow up period (P=0.003), and no significant difference was detected regarding other MACEs. Side branch compromise was more prevalent in larger diameter stents (P=0.042). In-hospital and 3 months’ follow up MACE incidence was similar. Conclusion Long DESs during PPCI are associated with higher incidence of SF-NR, however stent diameter has no impact on outcomes. Trial registration number in Clinical trials.gov.: NCT04110691

Prosthetic Valve Thrombosis: Clinical Profile, Assessment of Safety and Efficacy of Low Dose Slow Flow Thrombolysis with Alteplase – A Non Randomised, Prospective Single Center Observational Study.

Prosthetic Valve Thrombosis: Clinical Profile, Assessment of Safety and Efficacy of Low Dose Slow Flow Thrombolysis with Alteplase – A Non Randomised, Prospective Single Center Observational Study.

Effects of Biologics on Temporomandibular Joint Inflammation in Juvenile Idiopathic Arthritis.

This prospective study investigates the efficacy of biologics in combination with methotrexate or leflunomide on juvenile idiopathic arthritis (JIA)- related temporomandibular joint (TMJ) arthritis measured by magnetic resonance imaging (MRI)-based inflammation score and deformity score. A prospective single center observational cohort study of 18 consecutive patients were performed between September 2018- April 2023. Inclusion criteria were: 1) Diagnosis of JIA, 2) MRI-verified TMJ arthritis leading to treatment with tumor necrosis factor inhibitor (TNFi), 3) MRI at 6 and 24 months after treatment initiation, 4) clinical follow-up contemporary with the MRI by a pediatric rheumatologist and an orthodontist. We included 18 patients (89% females). At time of first MRI median age was 13.2 years (IQR 11.3-16.9), median disease duration was 7.8 years (IQR 3.4-11.1) and 4 received MTX/leflunomide. During the observation period, significant improvements were observed in TMJ movement pain (p=0.01), morning stiffness (p=0.004), opening capacity (p=0.03) and maximal incisal opening (p=0.006). The inflammation score decreased significantly from median 2 (IQR 1-3) at baseline to median 1(IQR 0-2) at 24 months, p=0.009. In 17 out of 36 TMJs (48%), the deformity score improved or remained stable and no significant increase in the median score was observed. This is the first prospective observational study with evidence to support that the orofacial signs, symptoms and MRI-derived inflammation score in TMJ arthritis can be reduced by treatment with TNFi.

Comparison of ROTEM® Delta and ROTEM® Sigma transfusion algorithm performance in thoracic aortic surgery: a single-centre prospective observational cohort study

BackgroundThromboelastometry plays a key role in many transfusion algorithms. ROTEM® Sigma is the fully automated successor of ROTEM® Delta. Compatibility with current ROTEM® Delta-based algorithms remains uncertain. This study compares ROTEM® Delta with ROTEM® Sigma in patients undergoing thoracic aortic surgery. MethodsThree ROTEM® measurements in duplicate (one Delta and one Sigma) per patient were performed during aortic surgery. The primary outcome was the percentage of patients who would have received a different haemostatic intervention after protamine reversal based on the institutional ROTEM®-guided transfusion algorithm (‘deviation’). A 10% deviation was deemed acceptable. Secondary outcomes were differences in numerical values assessed by Passing–Bablok regressions, Bland–Altman plots, and correlations with conventional coagulation tests. ResultsOf 111 patients, 102 had matched post-protamine ROTEM® measurements. There were 43 algorithm deviations. Most deviations (29) were attributable to conflicting advice on CT EXTEM-based plasma or prothrombin complex concentrate (PCC) administration; in 25 patients, Delta results advised the administration of plasma or PCC, whereas Sigma did not, and vice versa in four patients. Deviations on additional protamine, fibrinogen concentrate, or platelet administration were acceptable. All numerical ROTEM® variables examined passed the criteria for equivalence, except for A10 FIBTEM at baseline and A10 EXTEM in heparinised and post-protamine samples, which would not have led to clinical consequences. Correlations with conventional coagulation tests were similar or better for Sigma compared with Delta. ConclusionsROTEM® Sigma can be used with existing ROTEM-guided transfusion algorithms in cardiothoracic surgery except for the advice for administration of plasma or PCC. Clinical Trial RegistrationNetherlands trial register NL8273.

Pregnancy & cardiovascular disease: the PREG-CVD-HH registry.

Cardiovascular disease (CVD) remains the leading cause of death in pregnant and peripartal women in western countries. Physiological changes during pregnancy can lead to cardiovascular complications in the mother; women with pre-existing heart disease may not tolerate these changes well, increasing their susceptibility to adverse cardiovascular outcomes during pregnancy. The aim of this study is to characterize pregnancy-induced changes in cardiac function, biomarker concentrations and cardiovascular outcomes in women with CVD during pregnancy at a tertiary care hospital in Germany. The PREG-CVD-HH study is a prospective single-center observational study of pregnant women with prevalent CVD treated at the University Medical Center Hamburg, Germany and currently includes 63 women with congenital or acquired heart disease and ten women from the general population included as controls. Participants underwent baseline assessment and dedicated comprehensive echocardiography. Biomarkers N-terminal pro B-type natriuretic peptide (NT-proBNP), MR-proadrenomedullin (MRproADM) and high-sensitivity cardiac troponin I (hs-cTnI) were measured serially throughout pregnancy and until 6 and 12 months postpartum. A maternal cardiac event was defined as death due to cardiovascular cause, arrhythmia, heart failure or hospitalization for other cardiac intervention. Mean maternal age was 34 years. A majority had a congenital heart disease (N=41), 10 patients developed pregnancy-associated CVD (e.g., preeclampsia, peripartum cardiomyopathy) and 12 women had known acquired heart disease (e.g., valvular disease, arrhythmia, cardiomyopathy). New-onset heart failure was observed in 14.1% of patients (N=9). Five patients developed arrhythmia and three patients developed preeclampsia. About 21.2% of patients were hospitalized due to cardiovascular events. Death from any or cardiovascular cause did not occur over the study period. Left and right ventricular global longitudinal strain (LV GLS, RV GLS) showed a transient worsening in the third trimester and peripartum period. NT-proBNP ranges broadened during the pregnancy and tended to progressively decrease postpartum in women with CVD. Hs-cTnI levels tended to trend upwards during pregnancy in patients with CVD, however, the hs-cTnI levels remained consistently low throughout pregnancy. In our cohort, pregnancy was associated with a transient increase in cardiac biomarkers and worsening of cardiac function during the third trimester and peripartum. These temporal changes reversed at 6-12 months postpartum, potentially due to decreased cardiac load, fluid shifts and hormonal changes. Overall, data on reference ranges in echocardiographic and biomarker measurements in the pregnant cardiac population are limited and require further investigation. Albeit one third of our cohort was deemed at high and highest maternal risk during pregnancy, there was no maternal death. We recommend that women with CVD receive preconceptional counselling and ongoing management by a specialized "Pregnancy Heart Team" to optimize care and, potentially, maternal outcomes.

Assessing the potential of artificial intelligence to enhance colonoscopy adenoma detection in clinical practice: a prospective observational trial.

This study aimed to evaluate the effectiveness of the GI Genius (Medtronic) module in clinical practice, focusing on the adenoma detection rate (ADR) during colonoscopy. Computer-aided polyp detection (CADe) systems using artificial intelligence have been shown to improve adenoma detection in controlled trials. However, the effectiveness of these systems in clinical practice has recently been questioned. This single-center prospective observational study was conducted at the University Hospital of Southern Denmark and included all individuals referred for colonoscopy between November 2020 and January 2021. The primary outcome was ADR, comparing patients examined with CADe to those examined without it. The selection of patients to be examined with the CADe module was completely random. A total of 502 patients were analyzed (318 in the control group and 184 in the CADe group). The overall ADR was 32.1% with a slight increase in the CADe group (34.7% vs. 30.5%). Multivariable analysis showed a very modest and statistically insignificant increase in ADR (risk ratio, 1.12; 95% confidence interval, 0.88-1.43). The use of CADe in clinical practice did not increase ADR with statistical significance when compared to colonoscopy without CADe. These findings suggest that the impact of CADe systems in everyday clinical practice are modest.

Galectin-3 as an independent predictor of postoperative atrial fibrillation

Objective: to evaluate the significance of preoperative plasma galectin-3 levels for predicting postoperative atrial fibrillation (AFP) in a cohort of patients who underwent elective heart surgery.Materials and methods: this prospective observational single-center cohort study was conducted at the Research Institute – Regional Clinical Hospital No. 1 n. a. prof. S.V. Ochapovsky, Krasnodar. In the period from September 1, 2023 to February 1, 2024, all patients admitted for elective coronary artery bypass grafting and/or valve surgery (valve replacement or reconstruction) were included in this study. In the early postoperative period, POAF developed in 158 patients, who formed the main group A, and from 436 patients with sinus rhythm, a control group B was generated using a random number generator, comparable with the main group in the number of observed patients and amounted to 160 patients.Results: the onset of POAF from the beginning of the operation is 66.2±41.7 hours (on average, on the 3rd day, minimum 1 hour, maximum 166.5 hours, i.e. on the 7th day). When comparing laboratory data in patients before the operation (blood sampling was performed 12–24 hours before cardiac surgery), a statistically significant factor associated with the development of POAF was the level of galectin-3 in the blood (2.1±1.99 ng/ml in patients from group A, 1.87±1.64 ng/ml in patients from group B, p 0.01). Moreover, the blood galectin-3 level in patients with POAF significantly increased in the early postoperative period (up to 2.75±2.1 ng/ml, p &lt;0.001), which was confirmed by the ROC curve (the area under the AUC curve was 0.522 (AUC: 0.522, 95% CI: 0.457–0.588; P =0.033)).Conclusions: preoperative plasma galectin-3 levels have an independent value for predicting POAF and can serve as a useful prognostic parameter in a multimodal approach to risk assessment in the era of personalized treatment.

An observational study of ultrasound semiquantitative scoring for predicting the risk of gout flare.

An observational study was conducted to determine whether semiquantitative scoring of ultrasound signs of gout predicted flare over 12months. Gout patients were enrolled consecutively in this 12-month prospective observational single-center study. Ultrasound evaluation and clinical assessment were performed at baseline. All patients were examined bilaterally evaluating 14joints (knee, ankle, metatarsophalangeal joints 1-5) and 10tendons (posterior tibial, quadriceps, peroneus longus and brevis scored as one, patellar, and Achilles tendons). The following ultrasound features were examined and semiquantitative scoring was performed: DC sign, aggregates, tophi, bone erosion, synovial hypertrophy, PD activity, and tenosynovitis. Patients were divided into two groups, one with flares during the follow-up period and the other without flares. Atotal of 119 participants completed the study; 61(51.3%) participants experienced at least one flare over 12months, with amedian of 2.0flares. The ultrasound findings indicative of DC sign, aggregate, tophi, bone erosion, and PD activity at baseline were significantly correlated with the development of gout flares over 12months. Logistic regression analysis suggested that DC sign score (OR:2.41, 95% CI: 0.92-4.37; P = 0.02), tophi score (OR:1.87, 95% CI: 0.65-2.28; P = 0.04), and PD activity score (OR:1.93, 95% CI: 0.58-3.26; P = 0.03) were independent predictors of flare. ROC curve analysis to assess ultrasound semiquantitative scoring has good sensitivity and specificity for the prediction of gout flares. Ultrasound semiquantitative scoring can predict the risk of flare, and ultrasound findings indicative of DC sign, tophi, and PD activity are independent predictors of gout flares over 12months.