Single-center Prospective Observational Study Research Articles

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.

Age-Related Response to Remimazolam among Older Patients Undergoing Orthopedic Surgery: A Single-Center Prospective Observational Study.

Background and Objectives: Remimazolam, an ultra-short-acting benzodiazepine, is increasingly used in procedural sedation and general anesthesia. It is characterized by rapid onset of action, inactive metabolites, no delay in recovery, and few adverse events. Its hemodynamic and respiratory stability are comparable to other anesthetics, and it is safe in high-risk and geriatric patients. Materials and Methods: This prospective, observational study enrolled 110 geriatric patients (aged 65 to 85 years) scheduled for primary total knee arthroplasty (TKA). The patients were divided into the old (65 to <75 years; n = 52) and the elderly (75 to 85 years; n = 47) geriatric groups. All surgical and anesthetic methods were applied in the same manner, and TKA was performed by one surgeon. Remimazolam was infused at 6 mg/kg/h for 3 min and then at 1 mg/kg/h until the end of surgery The primary study endpoint was the requirement for flumazenil; secondary endpoints were the times to reach a bispectral index (BIS) < 60 and >80, as well as the rate of apnea occurrence. Results: Flumazenil administration was similar in both groups. There were no differences in the time to reach BIS < 60 or the rate of apnea occurrence. Recovery characteristics, including the time to reach BIS > 80 and the achievement of full consciousness, were also comparable between the groups. Conclusions: Remimazolam is well-tolerated in geriatric patients undergoing orthopedic surgery, with minimal age-related differences in response. These results suggest that remimazolam is an appropriate anesthetic for geriatric patients, even with similar dosing strategies. It provides effective anesthetic depth with no significant increases in adverse outcomes during orthopedic surgery.

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

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

HCV-HIV co-infection in people who inject drugs: Barriers to treatment and cure of HCV infection in the era of DAAs, a prospective study in Athens, Greece.

HIV/hepatitis C virus (HCV) co-infection among people who inject drugs (PWID) remains a global health problem. The goal of our study was to evaluate, in a real-world setting, success rates of sustained virological response (SVR) using direct-acting antivirals (DAAs) to treat a population of PWID living with HCV/HIV. This was a prospective single-center observational study. We collected demographic, socioeconomic, and clinical data pertaining to HIV and HCV infection in PWID with several barriers to care. We identified risk factors for SVR failure. Among 130 individuals retained to HIV care, we planned HCV treatment in 119/130 (91.5%); 106/119 (89.1%) started treatment with DAAs and 100/106 (94.3%) completed treatment. People not starting treatment were more often in active opioid drug use (odds ratio [OR] 0.25; 95% confidence interval [CI] 0.07-0.97, p = 0.045) and benzodiazepine abuse (OR 0.25; 95% CI 0.07-0.95, p = 0.042). Only 86/100 (86%) were tested for SVR at 12 weeks (SVR12) and 72/86 (83.7%) achieved SVR. PWID in opioid substitution programmes tended to return for SVR12 testing more often (54.7% vs. 30%, p = 0.081). Individuals in active opioid drug use (OR 0.226; 95% CI 0.064-0.793, p = 0.02) or with poor adherence (OR 0.187; 95% CI 0.043-0.814, p = 0.025) were less likely to achieve SVR. At the end of our study period, 113/119 (95%) treatment-eligible patients remained alive. HCV infection was cured in 68/113 (61.1%) people. Our findings underscore the importance of prioritizing combatting substance use to achieve HCV elimination goals. A systematic approach with effort to overcome barriers to receiving and completing treatment and encourage to enrol in opioid substitution programmes if not possible to completely abstain from use, can help increase chances of HCV cure.

Amyloidosis and carpal tunnel syndrome: can we predict occurrence?

IntroductionCarpal tunnel syndrome, especially when bilateral, may be associated with amyloid deposits, a precursor of systemic amyloidosis. Systemic amyloidosis affects various organs, cardiac involvement having the poorest prognosis. Diagnosis is often delayed. Current treatments are only effective in the early stages of the disease. The primary objective of our study was to evaluate the incidence of amyloidosis in patients with bilateral carpal tunnel syndrome; the secondary aim was to screen for cardiac forms. Material and methodsBetween 2019 and 2023, we conducted a single-center prospective observational and diagnostic study to investigate the anatomical pathology of amyloid deposits in tenosynovial samples taken during open nerve release surgery on the median nerve. The tenosynovial biopsy was sent to a specific laboratory for analysis, and typing if positive. If amyloidosis was detected, the patient was referred to a specialist for a specific work-up. ResultsWe included 54 patients, with a mean age of 67 years (range, 51–89 years): 16 men and 38 women. Sixteen analyses were positive, 12 of which were transthyretin and 4 non-typed. Discussion/conclusionBilateral carpal tunnel syndrome was predictive of amyloidosis. As synovial biopsy during surgery is simple and rapid, it should be implemented to identify amyloidosis at an early stage. This could change prognosis, by improving survival through screening and initiation of early specific treatment. Level of evidenceIV.

Adnexal Masses in Pregnancy: A Single-Centre Prospective Observational Cohort Study

Objective: To prospectively determine the nature of adnexal masses diagnosed during pregnancy and investigate whether ultrasound was a reliable means of assessing these. Methods: A single-centre prospective observational cohort study was conducted in a large tertiary referral hospital in London. Pregnant women with an adnexal mass detected at or prior to the 12-week routine ultrasound received a detailed ultrasound by a level II ultrasound practitioner at the time of detection; at 12 weeks; 20 weeks; and 6 weeks postpartum. The following outcomes were recorded: subjective impression of the mass; International Ovarian Tumor Analysis simple rules classification; resolution and intervention rate; and the incidence of complications related to the mass. Results: A total of 28,683 pregnant patients were scanned and an adnexal masses was detected in 277 patients, yielding an incidence of 1%. 274 participants were included in the analysis. Subjective impression was as follows: simple 75.9%; dermoid 29.1%; endometrioma 6.6%; haemorrhagic 3.3%; para-ovarian 2.6%; torted simple 0.7%; decidualized endometrioma 0.4%; fibroma 0.4%; theca luteal 0.4%; and borderline ovarian tumour: 0.7%. There was a significant reduction in the volume at each scan (p &lt; 0.0001). Approximately 74.2% of the masses resolved spontaneously. Surgery was performed in 14/274: 2 antenatally, 6 at caesarean section, and 6 postpartum. In 5/247 (2%), there were complications due to the mass. Using IOTA simple rules, 272/274 (99.3%) (p &lt; 0.0001) were classifiable. Only 1/274 (0.4%) had malignant features as per IOTA (p = 0.05). As there were no confirmed malignancies, the accuracy of IOTA simple rules could not be calculated. Conclusions: Adnexal masses in pregnancy are uncommon and the majority spontaneously resolve. Malignancy is rare, as are complications. In the absence of concerns regarding malignancy or cyst accident, there is no need for additional monitoring of these masses during pregnancy.

Association of corticosteroid therapy with reduced acute kidney injury and lower NET markers in severe COVID-19: an observational study

BackgroundAcute kidney injury (AKI) is common in critical cases of coronavirus disease 2019 (COVID-19) and associated with worse outcome. Dysregulated neutrophil extracellular trap (NET) formation is one of several suggested pathophysiological mechanisms involved in the development of COVID-19 associated AKI. The corticosteroid dexamethasone was implemented as a standard treatment for severe COVID-19 as of June 2020. A sub-analysis of a prospective observational single center study was performed to evaluate the effect of corticosteroid treatment on AKI development and NET markers in critical cases of COVID-19.ResultsTwo hundred and ten adult patients admitted to intensive care at a tertiary level hospital due to respiratory failure or shock secondary to SARS-CoV-2-infection between March 13th 2020 and January 14th 2021 were included in the study. Ninety-seven of those did not receive corticosteroids. One hundred and thirteen patients were treated with corticosteroids [dexamethasone (n = 98) or equivalent treatment (n = 15)], but the incidence of AKI was assessed only in patients that received corticosteroids before any registered renal dysfunction (n = 63). Corticosteroids were associated with a lower incidence of AKI (19% vs 55.8%, p < 0.001). Fewer patients demonstrated detectable concentrations of extracellular histones in plasma when treated with corticosteroids (8.7% vs 43.1%; p < 0.001). Extracellular histones and in particular non-proteolyzed histones were observed more frequently with increasing AKI severity (p < 0.001). MPO-DNA was found in lower concentrations in patients that received corticosteroids before established renal dysfunction (p = 0.03) and was found in higher concentrations in patients with AKI stage 3 (p = 0.03). Corticosteroids did not ameliorate established AKI during the first week of treatment.ConclusionCorticosteroid treatment in severe COVID-19 is associated with a lower incidence of AKI and reduced concentrations of NET markers in plasma.

Efficacy and safety of pulmonary artery catheterization with combined transesophageal echocardiography and pressure waveform: A prospective observational study

ObjectiveThis study investigated whether pulmonary artery catheter placement method with combined transesophageal echocardiography and pressure waveform measurement improve the placement success rate within 5 min and reduce the incidence of arrhythmia during pulmonary artery catheter placement compared to conventional pulmonary artery catheter placement with pressure waveform measurement only. MethodsThis single center prospective observational study included 129 patients scheduled for cardiac surgery. Patients were divided into two groups. In the conventional group, the pulmonary artery catheter was placed by monitoring the pressure waveform and the length of placement; in the combination group, not only were the pressure waveform and the length monitored but also the following transesophageal echocardiography images: “mid esophageal bicaval view,” " mid esophageal modified bicaval view,” a mirror image of “mid esophageal 4 chamber view,” “mid esophageal right ventricular inflow-outflow view,” and “mid esophageal ascending aortic short axis view." ResultsA 1:1 propensity score matching was used to adjust for confounding factors. The success rates of pulmonary artery catheter placement within 5 min in the conventional and combination groups were 85.5 % vs. 97.8 % (p = 0.032) before matching, and 73.7 % vs. 100 % (p = 0.001) after matching. The incidences of arrhythmias in the conventional and combination groups were 28.9 % vs. 17.4 % (p = 0.20) before matching, and 28.9 % vs. 18.4 % (p = 0.42) after matching. ConclusionPulmonary artery catheter placement with transesophageal echocardiography had a significantly higher rate of successful placement within 5 min, but no significant differences were observed in the incidences of arrhythmias.

T cell responses and clinical symptoms among infants with congenital cytomegalovirus infection.

BACKGROUNDCongenital cytomegalovirus (cCMV) infection can cause developmental impairment and sensorineural hearing loss (SNHL). To determine the relationship between immune responses to cCMV infection and neurologic sequelae, T cell responses were compared for their connection to clinical symptoms at birth and neurodevelopmental outcomes.METHODSThirty cCMV-infected and 15 uninfected infants were enrolled in a single-center prospective observational case-control study. T cell pp65-specific cytokine responses; CD57, CD28, and PD-1 expression; and memory subsets were compared.RESULTSInfected neonates (73% symptomatic at birth) lacked pp65-specific cytokine-secreting T cells, with elevated frequencies of CD57+, CD28-, and PD-1+CD8+ T cells and effector memory subsets. Though frequencies overlapped between cCMV symptom groups, asymptomatic infants had higher frequencies of CD57+PD-1+CD8+ T cells. Neonates with subsequent developmental delay lacked detectable CMV-specific T cell responses, with patterns resembling those of uninfected infants. Two children with progressive SNHL had high frequencies of PD-1+CD8+ T cells over the first year compared with children without progressive SNHL.CONCLUSIONSimilar to published reports, neonatal viral antigen-specific cytokine-secreting T cell responses were not detected, but overall patterns indicate that globally differentiated memory CD8+ T cell populations were induced by cCMV infection, with higher frequencies of terminally differentiated PD-1+CD8+ T cells potentially associated with asymptomatic infection. In this cohort, a lack of in utero T cell differentiation was associated with developmental delay, and high frequencies of PD-1+CD8+ T cells persisted only in children with progressive SNHL. Further work is needed to define the specificity of these T cells and their mechanistic connection to these outcomes.FUNDINGThis study was funded through an intramural research award at Nationwide Children's Hospital, the Pediatric Infectious Disease Society Fellowship Award funded by Stanley and Susan Plotkin and Sanofi Pasteur, the Abigail Wexner Research Institute at Nationwide Children's Hospital, and the Pichichero Family Foundation Vaccines for Children Initiative Research Award from the Pediatric Infectious Diseases Society Foundation.

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.

The influence of sex, age, and body height on the pulmonary vascular permeability index – a prospective observational study

The pulmonary vascular permeability index (PVPI) is a quotient of the extravascular lung water (EVLW) and the pulmonary blood volume (PBV). In acute respiratory distress syndrome (ARDS), the alveolar-capillary membrane integrity is disrupted. The result is a disproportionate increase of EVLW compared to the PBV and, hence, an increase in PVPI. Thus, PVPI has repetitively been discussed to extend the definition of ARDS. Besides sex, the influence of other anthropometric variables on PVPI has not been studied so far. However, since it is known that EVLW depends on body height and sex, we hypothesize that PVPI depends on anthropometric variables as well. This prospective single-center observational study included 1533 TPTD measurements of 251 non-critically ill patients (50.6% men) undergoing elective neuro-, thoracic, or abdominal surgery at the Munich Clinic Bogenhausen of the Technical University of Munich. Multivariate regressions were used to measure the influence of sex, age, and body height on PVPI. In all patients, PVPI was significantly higher in women (P < 0.001), with 34.4% having a PVPI > 2 compared to 15.9% of men. Mean PVPI significantly decreased with height (P < 0.001) and age (P < 0.001). Multivariate regressions allowed the calculation of mean reference surfaces. The 95th percentile surface for PVPI was > 3 for small and young women and well above 2 for all but tall and elderly men. In patients who underwent (lung reduction) thoracic surgery, the PVPI before and after surgery did not differ significantly (P = 0.531), and post-surgical PVPI did not correlate with the amount of lung resected (P = 0.536). Hence, we conclude that PVPI may be independent of the extent of lung volume reduction. However, PVPI is heavily dependent on sex, age, and body height. Anthropometric variables thus have a significant impact on the likelihood of misclassified abnormal PVPI. This warrants further studies since an increased PVPI, e.g. in the context of an ARDS, may be overlooked if anthropometric variables are not considered. We suggest reference surfaces based on the 95th-percentile corrected for sex, age, and height as a novel approach to normalize PVPI.

Genetic susceptibility and clinical features of CYP2D6 associated with systemic lupus erythematosus in a Chinese population.

This study aims to explore possible susceptibility genes and clinical features for systemic lupus erythematosus (SLE) patients in a Chinese population. Expanding on the results of a prior single-center observational study involving 60 systemic lupus erythematosus patients, a subsequent single-center prospective observational study was conducted on SLE patients undergoing treatment at Nanfang Hospital Affiliated to Southern Medical University from 2021 to 2023. The identification process for drug-related target genes entailed an extensive search across PharmGKB (https://www.pharmgkb.org/), the Clinical Pharmacogenetics Implementation Consortium (CPIC),and PubMed literature databases, to pinpoint common drugs and target single nucleotide polymorphisms(SNPs)for SLE. Blood samples were individually collected and genotyped using MassARRAY® high-throughput nucleic acid mass spectrometry. Genotype frequency differences were assessed through Chi-square tests against both the larger East Asian population as well as kidney transplant recipients. Data collection relied on electronic medical records, encompassing demographic details(age, gender),medication regimens(hormones, NSAIDs, hydroxychloroquine, DMARDs, biologic agents, stomach medications, calcitriol, etc.),laboratory indicators(RF, Anti-CCP antibody, ESR, CRP, anti-ANA antibodies, dsDNA antibodies, anti-SM antibodies, S m. RNP antibodies, A LT, ALB, CR, UA, WBC, PLT, HGB, Ca, K, Glu, CHOL, TG, LDL-C, HDL-C) and lupus activity scores(SLEDAI-2K). Possible disease susceptibility genes were categorized, and SPSS26 software facilitated statistical analyses. The research encompassed a total of 137 SLE patients along with 50 SNPs. After conducting statistical analyses, it emerged that there existed significant disparities in CYP2D6 gene (rs1065852) distribution when compared against allele mutation rates within both East Asian populations (p < .05) and kidney transplant patients(p < .05). Wild-type gene (GG) constituted 14% of cases while mutant gene (GA + AA) constituted 86%. Allele mutation rate (A63.6%) was significantly higher among SLE patients (RR = 0.802; p = .0355). Furthermore, the variant rs1065852 genotype (GA + AA) demonstrated significant associations with lower CRP levels, higher HGB levels, and higher HDL-C levels (p < 0 0.05). The metabolic enzyme CYP2D6 may be used as susceptibility gene for predicting systemic lupus erythematosus and are correlated with CRP and other indicators.

Correlations between intraoperative and postoperative echocardiographic measurements in patients undergoing aortic bioprosthetic valve replacement: a prospective observational study.

Patient-prosthesis mismatch (PPM) should be avoided during surgical aortic valve replacement because PPM would worsen the mortality and morbidity. Diagnosis of PPM could be made using various parameters measured by intraoperative transesophageal echocardiography. However, few studies have examined which parameters correlate most accurately between intraoperative and postoperative values. This single-center prospective observational study analyzed 46 patients who underwent surgical aortic valve replacement (SAVR). Echocardiography was performed at the following 3-time points: preoperatively, intraoperatively, and 1month postoperatively. The correlation between intraoperative and postoperative measurement values, including peak velocity (PV), mean pressure gradient (MPG), effective orifice area (EOA), and effective orifice area index (EOAI), were assessed using Pearson's correlation coefficient. Moreover, to evaluate whether a multivariable linear regression model with intraoperative and postoperative stroke volume added as an explanatory variable improves the correlation, the multiple correlation coefficients were calculated. PV, MPG, EOA, and EOAI measured intraoperatively and 1month postoperatively were significantly correlated. The r values of each measurement were 0.35, 0.344, 0.411 and 0.323, respectively. The multivariable linear regression model showed that the multiple correlation coefficients for MG and EOA were 0.491 and 0.663, respectively. Intraoperative and postoperative PV, MPG, EOA, and EOAI were significantly correlated in patients undergoing SAVR with a bioprosthetic valve. The r value for EOA was 0.441, the largest among the measured values. Adjustment for stroke volume improved the strength of the correlation. Intraoperative evaluation of prosthetic valve function was considered most appropriate using EOA. University Hospital Medical Information Network Clinical Trials Registry, registration number UMIN000046164, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052695 .

Gait, Quality of Life, and Knee Function in Advanced Knee Osteoarthritis: A Single-Center, Prospective, Observational Study.

Background/Objectives: Treatment of advanced knee osteoarthritis with total knee arthroplasty typically results in an improvement in function, gait, and quality of life, which tend to be affected by the condition. It is, however, necessary to determine the baseline factors that could influence the patients' postoperative outcome. Methods: This is a single-center prospective observational study of patients with advanced knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) treated with total knee arthroplasty. Gait parameters were recorded at baseline and at various postoperative time points using a wireless device. Progression of function was assessed using the Knee Society Score questionnaire and quality of life by means of the EQ-5D and Knee Injury and Osteoarthritis Outcome Score questionnaires. Progression of gait and quality of life was analyzed in all patients, distinguishing between those where baseline velocity was < 1 m/s and those where it was ≥1 m/s. The potential correlation between baseline and postoperative parameters was also evaluated. Results: All 119 patients showed a significant improvement in their gait, function, and quality of life parameters at one year from the procedure (p < 0.05). No statistically significant differences were found in any of the postoperative subscales, regardless of baseline velocity (< o ≥ 1 m/s) or between any of the baseline or postoperative parameters (r < 0.29). Conclusions: Baseline gait parameters in patients with advanced knee osteoarthritis do not appear to bear a statistically significant relationship with function or quality of life outcomes following total knee arthroplasty. Such parameters exhibit a significant improvement one year after surgery.