Differences In Baseline Characteristics Research Articles

Genetic and clinical characteristics of single and compound types of patients with long QT syndrome type 3

Objective: To explore the genetic background and clinical features of patients with long QT syndrome type 3 (LQT3). Methods: This retrospective cohort included patients diagnosed with LQT3 at the Department of Cardiology, Renmin Hospital of Wuhan University from January 1998 to December 2022. Patients were categorized into compound type group and single type group based on the presence of a single SCN5A mutation. The two groups were followed up and the differences in baseline characteristics, electrocardiograms, and clinical events between the two groups and probands were compared. Kaplan-Meier curves were used for survival analysis, and the log-rank test was employed to compare the event-free survival rates of first cardiac events between the groups and probands. Results: A total of 97 LQT3 patients were enrolled, including 59 probands. The age at diagnosis was (23.45±19.86) years, with 46 patients (47.4%) being male. Among them, 89 patients were classified as single type group, while 8 patients were classified as compound type group. Genetic testing identified 49 SCN5A mutations, with missense mutations being the majority (91.8%), primarily located in transmembrane regions (40.8%, n=20), interdomain linker regions (28.6%, n=14), and C-terminus (22.4%, n=11). The first cardiac event occurred in 44 patients (45.4%), with an onset age of (13.82±12.50) years. The main trigger was identified as rest or sleep (54.5%, n=24). Compared with patients in single type group, patients in compound type group were younger at diagnosis ((10.35±10.28) years vs. (24.63±20.13) years, P=0.040), had a significantly higher proportion of syncope (87.5% (7/8) vs. 33.7% (30/89), P=0.009), aborted cardiac arrest (62.5% (5/8) vs. 11.2% (10/89), P=0.001), and a lower incidence of event-free survival rates of first cardiac events (12.5% (1/8) vs.58.4% (52/89), log-rank P=0.001). The probands in compound type group had a significantly higher proportion of aborted cardiac arrest comparing to probands in single type group (62.5% (5/8) vs. 17.6% (9/51), P=0.020), while the difference in the incidence rate of event-free survival rates of first cardiac events between the probands in two groups was not statistically significant (12.5% (1/8) vs. 39.2% (20/51), log-rank P=0.08). Conclusion: Compound type LQT3 patients are not uncommon. Such patients are diagnosed at a younger age and exhibit more severe phenotypes, requiring close follow-up and proactive intervention strategies.

Impact of COVID-19 Pandemic on Adolescents Undergoing Metabolic Bariatric Surgery

BackgroundWhile the lasting effect of the COVID-19 pandemic continues to unfold, the impact on adolescents undergoing bariatric surgery remains unseen. ObjectiveWe examined the impact of the pandemic on adolescents undergoing metabolic bariatric surgery. SettingAcademic hospital, New York, NY. MethodsA single-institution review of prospectively collected data evaluated adolescents who underwent laparoscopic sleeve gastrectomy between 2010 and 2023, forming two cohorts: pre-COVID (before March 1, 2019) and COVID (after March 1, 2020). Absolute and percent weight loss and body mass index (BMI) change at 6 and 12 months post-surgery were compared between cohorts. Multivariable linear regression models were constructed to estimate the association between weight loss, adjusting for age, gender, ethnicity, and BMI. Results358 patients were included: 245 in the pre-COVID cohort and 113 in the COVID cohort. There were no significant differences in baseline characteristics. There were no significant differences between cohorts at 6 months in weight loss (21.6 kg vs. 22.5 kg, p=0.43), percent weight loss (18% vs. 18%, p=0.63), and BMI change (8.0 vs. 8.4, p=0.39) which was maintained at 12 months. In multivariate models, after adjusting for age, gender, ethnicity, and baseline BMI, undergoing surgery during the pandemic was not associated with a difference in weight loss or BMI change at 6 and 12 months postoperatively. ConclusionDespite the severe societal impact of the COVID-19 pandemic, laparoscopic sleeve gastrectomy remained a durable intervention for adolescent obesity, with no observed differences in weight loss in patients undergoing surgery during the pandemic compared to pre-pandemic.

Comparison of Blalock-Taussig-Thomas Shunts With Patent Ductus Arteriosus Ligated Versus Left Open.

The optimal approach to patent ductus arteriosus management during systemic-to-pulmonary artery shunt placement is currently unknown. The purpose of this study is to examine the outcomes of variable strategies for patent ductus arteriosus management during Blalock-Taussig-Thomas shunt surgery. A retrospective cohort study of infants who underwent shunt placement was performed, comparing those who had the ductus ligated with those who had the ductus left open. Indicators of low cardiac output syndrome, development of necrotizing enterocolitis, and secondary outcomes such as resuscitation events were examined. Thirty-six infants were included all of whom had their shunt placed via median sternotomy. Twenty infants had their ductus ligated at the time of the shunt, and they were compared with 16 infants whose ductus was left open. There was no statistical difference in preoperative baseline characteristics, including corrected gestational age, age in days, weight, mechanical ventilation, vasoactive use, heterotaxy, and gastrointestinal anomalies. There was also no statistical difference in postoperative indicators of low cardiac output, including urine production, total fluids given, renal injury, maximum lactate, and vasoactive-inotropic score. Three patients had postoperative renal injury, and all were in the ligated duct group. There was also no statistical difference in any secondary outcomes, including the development of necrotizing eneterocolitis, resuscitation events, reinterventions, length of intubation, total length of stay, and mortality. This study provides evidence that variable management of the ductus during shunt placement does not significantly impact outcomes. Leaving the ductus open allows for a potential rescue source of pulmonary blood flow and does not appear to increase the risk of postoperative low cardiac output.

Reduction in Unindicated Cervical Cancer Screening in Adolescents in a Large Health Care System.

Evidence-based guidelines recommend against screening for cervical cancer (Pap testing) in average-risk adolescents <21 years old. Despite this, many still undergo unindicated screenings with subsequent detrimental reproductive health and economic consequences. Our aim was to reduce unindicated cervical cancer screening in individuals <21 years old in a large health care system by utilizing an electronic provider notification. Starting in July 2020, a Best Practice Advisory (BPA) appeared in the electronic medical record (EMR) if providers ordered Pap testing on individuals <21 years old. This BPA reiterated that screening was not indicated for average-risk adolescents and prompted users to choose an indication if they wanted to proceed.A retrospective chart review, pre/post intervention study was performed comparing individuals <21 years old with Pap testing performed before and after intervention (January 2019-June 2020 and July 2020-June 2021, respectively). Patient characteristics were extracted from the EMR and analyzed using Fisher exact tests, Kruskal-Wallis tests, and logistic regression. There were 140 subjects included: 106 preintervention and 34 postintervention. There were no differences in baseline characteristics. Neither Pap nor human papillomavirus testing results differed between the groups. Preintervention, 6.6% of cytology tests were indicated compared to 20.6% postintervention (p = .042). The proportion of indicated human papillomavirus testing did not differ preintervention and postintervention at 65% and 45%, respectively (p = .295). The overall reduction in unindicated cervical cancer screening postintervention was 13.9% (95% CI = 4.0-23.7). We demonstrated that incorporating a BPA to the EMR reduces unindicated cervical cancer screening.

Safety and efficacy of motor imagery-based physical activity in high-risk pregnancy: A randomized controlled study.

This study aimed to investigate the acute effects of motor imagery-based physical activity on maternal well-being, maternal blood pressure, heart rate, oxygen saturation, fetal heart rate, and uterine contractions in women with high-risk pregnancies. This randomized controlled trial was conducted in Izmir Tepecik Education and Research Hospital from August 2023 to January 2024. Seventy-six women with high-risk pregnancies were randomized into two groups: a motor imagery group (n = 38, diaphragmatic-breathing exercise and motor imagery-based physical activity) and a control group (n = 38, diaphragmatic-breathing exercise). Maternal well-being was determined using the Numerical Rating Scale-11. Digital sphygmomanometry was used to measure maternal heart rate and blood pressure, pulse oximetry for oxygen saturation, and cardiotocography for fetal heart rate and uterine contractions. Assessments were performed pre-intervention, mid-intervention, and post-intervention. There were no significant differences in baseline characteristics between groups (P > 0.05). There was a significant main effect of time in terms of maternal well-being and maternal heart rate (P = 0.001 and P = 0.015). In addition, there was a significant main effect of the group on oxygen saturation (P = 0.025). The overall group-by-time interaction was significant for maternal well-beingm with an effect size of 0.05 (P = 0.041). The combination of diaphragmatic-breathing exercises and a motor imagery-based physical activity program in women with high-risk pregnancies was determined to have no adverse effects on the fetus, did not induce uterine contractions, and resulted in a significant improvement in maternal well-being and oxygen saturation. Thus, imagery-based physical activity can be used in high-risk pregnancies where physical activity and exercise are not recommended.

Clinical comparison of total gastrectomy with single-vessel transection Roux-en-Y(SR-Y) reconstruction versus total gastrectomy with conventional Roux-en-Y reconstruction for proximal gastric cancer

PurposeThe aim of this study was to investigate the clinical benefits of single-vessel transection Roux-en-Y reconstruction following total gastrectomy. MethodsA total of 194 patients with proximal gastric cancer were prospectively collected at Fudan University Shanghai Cancer Center between January 2021 and September 2022. This included 97 patients who underwent conventional Roux-en-Y reconstruction and 97 patients who underwent single-vessel transection Roux-en-Y reconstruction. Clinicopathological characteristics, surgical outcomes, and postoperative complications were compared between the conventional and single-vessel transection groups. ResultsThere were no significant differences in baseline characteristics between the two groups in terms of age(p=0.882), sex (p=0.595), BMI(p=0.683), tumor location (p=0.568), TNM stage(p=0.122), tumor size(p=0.927), anemia (p=0.756), neoadjuvant chemotherapy(p=0.730) and surgical approach (p=0.592). However, in comparion with the conventional group, the single-vessel transection group had a shorter operation time (162.5±37.6min vs 178.5±48.3min; p=0.011) and less intraoperative bleeding (167.2±91.8ml vs 207.8±167.5ml; p=0.037) after complete reservation of the terminal jejunal vascular archs. Nevertheless, there were no significant differences in tensions of jejunal mesentery, durations of peritoneal drainage, postoperative hospital stay durations or the number of lymph node dissections and early complications between the two groups. ConclusionsThe single-vessel transection Roux-en-Y reconstruction could simplify surgical procedures, reduce operating time, and minimize intraoperative bleeding without increasing tensions of jejunal mesentery or short-term complications. It is feasible and safe and worth further promotion in clinical practice.

Clinical observation of the subthreshold micropulse laser combined with ranibizumab for treatment of diabetic macular edema

Objective: To evaluate the efficacy and safety of the subthreshold micropulse laser (SMPL) combined with ranibizumab in treating diabetic macular edema (DME). Methods: This was a prospective randomized controlled study. Patients diagnosed with DME in the Ophthalmology Department of Beijing Hospital were enrolled from January 2020 to December 2022. Patients were randomized in a ratio of 1∶1 using a table of random numbers into the ranibizumab monotherapy group and the SMPL combined with ranibizumab therapy group. We compared the changes of best-corrected visual acuity, central macular thickness measured by optical coherence tomography and optical coherence tomography angiography parameters, including the vessel density of the superficial and deep capillary plexus (DCP), foveal avascular zone size and peripapillary vessel density, at baseline, 6 and 12 months after the treatment. After 12 months of follow-up, fundus fluorescein angiography results, adverse events, and the number of injections or laser therapies were recorded. The Fisher's exact test and group t-test were used for statistical analysis. Results: Seventy-two patients (72 eyes) were enrolled, with a mean age of (61.1±8.2) years. Patients in the combination therapy group included 19 males and 17 females, while patients in the ranibizumab monotherapy group were 17 males and 19 females. There was no statistically significant difference in baseline characteristics between the two groups (P>0.05). A significant improvement in best-corrected visual acuity was shown in both groups at 6 and 12 months [(58.5±12.9) and (58.2±12.2) ETDRS letters in the combination therapy group, and (63.3±13.1) and (63.8±12.5) ETDRS letters in the ranibizumab monotherapy group]. A significant reduction in central macular thickness was shown in both groups at 6 and 12 months [(451.0±185.5) and (380.4±159.3)μm in the combination therapy group, and (387.5±135.5) and (372.8±146.1)μm in the ranibizumab monotherapy group]. However, there was no significant difference between groups at each timepoint (all P>0.05). At 12 months, the vessel density of the superficial capillary plexus showed no statistical difference compared to the baseline value in each group or between groups (42.6%±5.9% in the ranibizumab monotherapy group and 42.2%±5.5% in the combination therapy group, P>0.05). The vessel density of the DCP in the combination therapy group significantly increased to 47.5%±5.6% at 12 months, significantly different from that in the ranibizumab group (43.4%±5.1%; P<0.05). The foveal avascular zone size in the ranibizumab monotherapy group reduced to (0.32±0.13) mm2, significantly different from that in the combination therapy group [(0.34±0.16) mm2] at 12 months (P<0.05). Patients in the ranibizumab monotherapy group received (7.3±2.5) intravitreal injections, while patients in the combination therapy group received 3 injections. No unfavorable outcomes on fundus fluorescein angiography or systemic or topical severe adverse events were observed during the follow-up. Conclusions: The SMPL combined with intravitreal ranibizumab injections was effective and safe in treating DME patients. The combination treatment significantly reduced the number of injections and improved the vessel density of the DCP and macular ischemia, compared to the ranibizumab monotherapy.

Efficacy analysis of mechanical thrombectomy combined with prolonged mild hypothermia in the treatment of acute middle cerebral artery occlusion: a single-center retrospective cohort study.

To determine the efficacy of mechanical thrombectomy combined with prolonged mild hypothermia compared with conventional treatment in managing acute middle cerebral artery occlusion, and to explore whether extending the duration of hypothermia can improve neurological function. From 2018 to June 2023, a retrospective analysis was conducted on 45 patients with acute middle cerebral artery occlusion treated at the NICU of Suzhou Kowloon Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. After thrombectomy, patients were admitted to the neurological intensive care unit (NICU) for targeted temperature management. Patients were divided into two groups: the mild hypothermia group (34.5-35.9°C) receiving 5-7 days of treatment, and the normothermia group (control group) whose body temperature was kept between 36 and 37.5°C using pharmacological and physical cooling methods. Baseline characteristics and temperature changes were compared between the two groups of patients. The primary outcome was the modified Rankin Scale (mRS) score at 3 month after surgery, and the secondary outcomes were related complications and mortality rate. Prognostic risk factors were investigated using both univariate and multivariate logistic regression analyses. Among 45 patients, 21 underwent prolonged mild hypothermia, and 24 received normothermia, with no significant differences in baseline characteristics between the two groups. The duration of mild hypothermia ranged from 5 to 7 days. The incidence of chills (33.3% vs. 8.3%, p = 0.031) and constipation (57.1% vs. 20.8%, p = 0.028) was significantly higher in the mild hypothermia group compared with the control group. There was no significant difference in mortality rates between the mild hypothermia and the control group (4.76% vs. 8.33%, p = 1.000, OR = 1.75, 95% CI, 0.171-17.949). At 3 month, there was no significant difference in the modified mRS (0-3) score between the mild hypothermia and control groups (52.4% vs. 25%, p = 0.114, OR = 0.477, 95% CI, 0.214-1.066). Infarct core volume was an independent risk factor for adverse neurological outcomes. Prolonged mild hypothermia following mechanical thrombectomy had no severe complications and shows a trend to improve the prognosis of neurological function. The Infarct core volume on CTP was an independent risk factor for predicting neurological function.

Improving pressure ulcer care in intensive care units: Evaluating the impact of bundled care and silver nanoparticle dressings.

Pressure ulcer (PU) are prevalent among critically ill trauma patients, posing substantial risks. Bundled care strategies and silver nanoparticle dressings offer potential solutions, yet their combined effectiveness and impact on patient satisfaction remain insufficiently investigated. To assess the impact of bundled care along with silver nanoparticle dressing on PUs management and family satisfaction in critically ill trauma patients. A total of 98 critically ill trauma patients with PUs in intensive care unit (ICU) were included in this study. Patients were randomly assigned to either the control group (conventional care with silver nanoparticle dressing, n = 49) or the intervention group (bundled care with silver nanoparticle dressing, n = 49). The PU Scale for Healing (PUSH) tool was used to monitor changes in status of pressure injuries over time. Assessments were conducted at various time points: Baseline (day 0) and subsequent assessments on day 3, day 6, day 9, and day 12. Family satisfaction was assessed using the Family Satisfaction ICU 24 questionnaire. No significant differences in baseline characteristics were observed between the two groups. In the intervention group, there were significant reductions in total PUSH scores over the assessment period. Specifically, surface area, exudate, and tissue type parameters all showed significant improvements compared to the control group. Family satisfaction with care and decision-making was notably higher in the intervention group. Overall family satisfaction was significantly better in the intervention group. Bundled care in combination with silver nanoparticle dressings effectively alleviated PUs and enhances family satisfaction in critically ill trauma patients. This approach holds promise for improving PUs management in the ICU, benefiting both patients and their families.

Dose optimization of pancreatic enzyme replacement therapy is essential to mitigate muscle loss in patients with advanced pancreatic cancer and exocrine pancreatic insufficiency

Background & AimsExocrine pancreatic insufficiency (EPI) contributes to malnutrition, marked by muscle loss during chemotherapy for advanced pancreatic cancer (aPC). Pancreatic enzyme replacement therapy (PERT) is recommended for patients with EPI; however, it’s efficacy for attenuating muscle loss has not been demonstrated. We aimed to delineate the impact of PERT dose on muscle loss using a 7-year population-based cohort with aPC who were provided PERT at the discretion of their oncologist or dietitian according to clinical indications of EPI. MethodsAll patients treated with chemotherapy for aPC from 2013-2019 in Alberta, Canada (population ∼4.3 million) were included if they had computed tomography (CT) scans both prior to and 12 ± 4 weeks after chemotherapy initiation. Change in muscle area (cm2) was measured at 3rd lumbar level on repeated CT scans. Muscle loss was defined by measurement error (loss >2.3 cm2). Clinical and pharmaceutical data were retrieved from provincial registries. For patients who were dispensed PERT -8 to +6 weeks from chemo start (PERT users), estimated dose consumed per day was calculated as: (total dose dispensed)/(days, first to last dispensation). PERT users were categorized as high dose or low dose users according to the median estimated dose consumed. Non-users were classified as No PERT. Association between PERT use and muscle loss was analyzed with multivariable logistic regression. ResultsAmong 210 patients, 81 (39%) were PERT users. Median estimated dose consumed per day of 75 000 USP lipase units defined the cutoff between low dose and high dose uses. There were no significant differences in baseline characteristics between high dose and low dose groups. Muscle loss was more prevalent among low dose compared to both high dose and No PERT groups (88% vs. 58% and 67%, p < .05). In the multivariable model predicting muscle loss, low dose PERT was independently associated with greater odds of muscle loss (OR 5.4, p=.004) vs. high dose, independent of tumour response, disease stage, and chemotherapy regimen. ConclusionIn patients with clinical indications of EPI during chemotherapy for aPC, low doses of PERT were insufficient to prevent muscle loss. Patients with EPI consuming higher doses of PERT had similar odds of muscle maintenance to patients without clinical indications of EPI. Provider education for optimal PERT dosing in patients with EPI should be prioritized, and resources must be allocated to support dose titration.

Office- versus home-based evaluation of quality of life in heart failure with reduced ejection fraction: A randomized study

BackgroundHeart failure (HF) patients often experience poor health-related quality-of-life (HR-QoL). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is frequently used for assessing HR-QoL in HF. Whether KCCQ scores vary in a clinical meaningful manner according to the setting (home vs office) where patients respond to the questionnaire is currently unknown. AimsAssess the differences in the responses to KCCQ-23 questionnaire when completed at home or office. MethodsRandomized parallel-group study, including patients with HF with reduced ejection fraction (HFrEF). Primary outcome was home vs office comparison of overall summary score (KCCQ-OSS). Main secondary outcomes were clinical summary score (KCCQ-CSS) and total symptom score (KCCQ-TSS). ResultsA total of 100 patients were included in the study: 50 home vs 50 office. Mean age was 71 yrs. Most baseline characteristics were well balanced between groups, except male sex, MRA use, and prior HF hospitalizations which were more frequent in the home group. No statistically-significant between-group differences were found regarding KCCQ-OSS (median [percentile25–75]) scores: home 69.1 (42.0–86.5) vs office 63.1 (44.3–82.3) points, P-value = 0.59, or main secondary outcomes: KCCQ-CSS home 62.2 (46.5–79.9) vs office 68.1 (51.9–79.2) points, P-value = 0.69, and KCCQ-TSS home 84.7 (59.7–97.2) vs office 76.4 (66.7–94.4) points, P-value = 0.85. Results remained similar after adjustment for differences in baseline characteristics and using non-parametric regressions. ConclusionsNo major differences were found in KCCQ-23 scores regardless of whether the questionnaire was completed at home or office. These findings can be useful to make HR-QoL more accessible, allowing patients to respond at home using email or cell-phone applications.

259 Comparing the Use of Antibiotics Versus No Antibiotics in the Management of Acute Left-Sided Uncomplicated Diverticulitis: A Systematic Review and Meta-Analysis

Abstract Background Acute uncomplicated diverticulitis (AUD) is a common cause of acute abdominal pain. Recent guidelines advise selective use of antibiotics in AUD patients. This meta-analysis aimed to compare the effectiveness of no antibiotics versus antibiotics in AUD patients. Method This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify randomised controlled trials (RCTs) involving AUD patients which compared the use of antibiotics with no antibiotics. Pooled outcome data was calculated using a random effects model with 95% confidence intervals (CI). Results Five RCTs with 1934 AUD patients were included. 979 patients were managed without antibiotics (50.6%). Patients in the no antibiotic and antibiotic groups had comparable demographics (age, sex and body mass index) and presenting features (temperature, pain score and C-reactive protein levels). There was no significant difference in rates of complicated diverticulitis (OR: 0.61, 95% CI:0.27-1.36, p=0.23), abscess (OR: 0.51, 95% CI: 0.08-3.25, p=0.47) or fistula (OR: 0.33, 95% CI: 0.03-3.15, p=0.33) formation, perforation (OR: 0.98, 95% CI: 0.32-3.07, p=0.98), recurrence (OR: 0.96, 95% CI: 0.66-1.41, p=0.85) need for surgery (OR: 1.36, 95% CI: 0.47-3.95, p=0.37), mortality (OR: 1.27, 95% CI: 0.14-11.76, p=0.82) or length of stay (MD: 0.215, 95% CI: -0.43-0.73, p=0.61) between the two groups. However, the likelihood of readmission was higher in the antibiotics group (OR: 2.13, 95% CI: 1.43-3.18, p=0.0002). Conclusions There is no significant difference in baseline characteristics, clinical presentation and adverse health outcomes between AUD patients treated without antibiotics compared to those with antibiotics.

Is Antibiotic Prophylaxis Reasonable in Parotid Surgery? Retrospective Analysis of Surgical Site Infection.

Background: The prophylactic use of antibiotics in parotid region surgery continues to be a subject of debate. The aim of this study is to elucidate the impact of antibiotic prophylaxis on surgical site infections (SSIs) in parotid region surgery. Patients and Methods: Patients who received antibiotic prophylaxis during the peri-operative period were designated as group 1, whereas those who did not were categorized into group 2. Group 1 cases were further subdivided into three subgroups based on different antibiotic usage patterns. Patient individual information was collected. Clinical data such as surgical duration, post-operative hospital stay, incision infection status, and antibiotic usage were recorded. All data were compared and analyzed among different groups. Results: A total of 357 patients were included in the study, with no statistically significant differences in baseline characteristics. Pre-operative American Society of Anesthesiologists scores did not significantly differ between groups (p = 0.151), but there was a significant distinction in National Nosocomial Infection Surveillance (NNIS) index values (p = 0.044). Furthermore, surgical duration (p = 0.001) and pathology types (p = 0.016) differed significantly. The post-operative hospital stay in group 1 was longer than that in group 2 (p < 0.01). The post-operative SSI rate in group 1 was lower than that in group 2 without statistical significance (2.55% vs. 5.59%, p = 0.141). The logistic regression analysis showed that malignant tumors, longer surgical durations, and higher NNIS index scores correlated positively with post-operative SSI rates. Meanwhile, compared with non-use, all three different antibiotic use modes correlated negatively with SSI occurrence. Conclusions: Antibiotic prophylaxis in parotid gland surgery shows no significant reduction in SSI occurrence. If there is a compelling reason to administer prophylactic antibiotics, pre-operative single dose may be a relatively feasible measure for preventing SSIs.

P-291 In women with endometriosis, effective treatment of chronic endometritis with antibiotics lowers serum CA-125 levels

Abstract Study question To evaluate the effect of chronic endometritis treatment on serum CA-125 levels in women with endometriosis. Summary answer Cure of chronic endometritis leads to a reduction in serum Ca-125 levels in women with endometriosis. What is known already Endometriosis is a chronic inflammatory disease characterized by the ectopic growth of endometrial tissue outside the uterine cavity. It is hypothesized that the disease exerts direct inflammatory effects on the ovaries, fallopian tubes, and the eutopic endometrium. In endometriosis, CA-125 levels are often elevated. Literature reports a frequent coexistence of endometriosis and chronic endometritis (CE) in women undergoing hysterectomy for benign indications. CE, characterized by macroscopic and histological alterations of the endometrium, was present in 38.5%-42.3% of women with endometriosis, compared to lower prevalence rates in controls infertile patients without endometriosis, supporting a potential etiopathogenic link between endometriosis and CE. Study design, size, duration This retrospective case-control study was conducted at the Department of Obstetrics and Gynecology, University of Bari. The study included 51 patients suffering of both ovarian endometriosis and CE. The primary objective was to investigate whether CE cure modifies serum CA-125 levels among women with ovarian endometriosis. The secondary objective was to assess any modifications in the size of endometriotic cysts following the cure of CE. Recruitment period was from September 2021 to February 2023. Participants/materials, setting, methods All patients received antibiotic therapy (100 mg of doxycycline, twice daily for ten days) and, the following month, hysteroscopy with control biopsy. Of these, 36 women were cured of chronic endometritis (Group A), while 15 women showed persistent disease (Group B). Endometriosis was diagnosed by transvaginal ultrasound and chronic endometritis through hysteroscopy, histology, and immunohistochemistry for CD138. Serum CA-125 levels were measured before antibiotic therapy and approximately 3 months later. Main results and the role of chance The primary outcome was to compare the change in CA-125 values between women cured of chronic endometritis and women with persistent disease. There were no statistically significant differences in baseline characteristics between the groups (p=ns). The majority of patients in both groups had a single ovarian endometrioma and the micropolypoid endometrial appearance was the predominant finding of chronic endometritis observed during hysteroscopy in both Groups. In Group A, the mean CA-125 value significantly decreased after antibiotic therapy from 58.56 U/mL (± 32.45) to 38.25 U/mL (± 17.31) (p &amp;lt; 0.001). No significant changes in CA-125 values were observed in Group B before and after antibiotic therapy (69.70 ± 27.42 versus 67.47 ± 24.52 U/mL, p=ns). The absolute change in CA-125 values was significantly greater in terms of reduction in Group A compared to Group B (-20.31 ± 27.09 versus -2.13 ± 12.51 U/mL; p = 0.02). Adjustment for confounders in a multivariable regression model revealed that the cure of chronic endometritis was independently associated with a significant decrease in absolute serum CA-125 levels (p = 0.006). Cyst size did not significantly change after antibiotic therapy in both groups (p=ns). Limitations, reasons for caution The main weakness of our study is that CA-125 was only measured once before and once after treatment of CE with a course of antibiotics. Moreover, our study does not allow for inferences regarding the impact of the observed reduction in serum CA-125 on the subjective symptoms related to endometriosis. Wider implications of the findings Our study constitutes the first demonstration that effective treatment of CE results in a significant decrease in a non-invasive marker of endometriosis, CA-125 supporting the emerging concept that the endometriosis might have an infectious origin. Trial registration number not applicable

P-412 Elevated progesterone levels after hormone replacement therapy (HRT) for frozen embryo transfer (FET) does not impair IVF outcomes, a retrospective study

Abstract Study question Does high serum progesterone (P) level on the day of FET after hormone replacement therapy affect IVF outcomes? Summary answer The supraphysiological serum progesterone levels on the day of FET after HRT do not impair reproductive outcomes. What is known already A proper synchronization between embryo and the endometrium is still required by controlling the timing and the dosage of exposure to exogenous hormones. Previous observational studies have highlighted the negative effects of serum hormone levels at the minimum threshold during FET cycles. However, based on existing research, the relationship between progesterone levels on FET day and pregnancy outcomes as well as the certain dose of progesterone ideally to achieve pregnancy and a live birth are debatable topics Study design, size, duration This is an observational, retrospective and cohort study including 7539 FET cycles that were performed under artificial endometrial preparation with HRT using exogenous estradiol and progesterone (vaginal, subcutaneous and intramuscular) between January 2017 and December 2022. Both euploid FET from autologous oocyte ICSI-PGT-A cycles (n = 1822) or FET from ICSI cycles using donated oocytes (n = 5724) were considered. Participants/materials, setting, methods Women were divided into three groups according to P4 level on the day of FET:P&amp;lt;20 ng/ml (n = 6623),P≥20-40 ng/ml (n = 770) and P &amp;gt; 40 ng/ml (n = 146).All ET were performed at the blastocyst stage.The primary outcome was live birth rate (LBR). Secondary outcomes evaluated were biochemical, clinical, and ongoing pregnancy, and miscarriage rate (MR) calculated per FET.Categorical variables were compared between groups with Fisher’s exact test. Logistic regression models adjusted (AOR) with several confounders. Main results and the role of chance There were no significant differences in baseline characteristics of the study population. The mean of P4 level was 15,66 ng/ml. Female age was P &amp;lt; 20:38.7 ±3.1, P ≥ 20-40: 39.0 ±3.0, and P &amp;gt; 40: 38.1 ±2.9 (p = 0.53) years old. The group with the highest progesterone levels always found lower biochemical pregnancy even no statistically significant [64.6% (P &amp;lt; 20) vs 63.7% (P ≥ 20-&amp;lt;40) vs 61.1% (P &amp;gt; 40); p = 0.62]; in clinical pregnancy [56.3% (P &amp;lt; 20) vs 56.8% (P ≥ 20-&amp;lt;40) vs 51.4% (P &amp;gt; 40); p = 0.5] and in ongoing [47.0% (P &amp;lt; 20) vs 47.0% (P ≥ 20-&amp;lt;40) vs 41.8% (P &amp;gt; 40); p = 0.47] pregnancy rates. The MR was also higher in the group with higher progesterone, although not significantly: 16.2% (P &amp;lt; 20) vs 15.0% (P ≥ 20-&amp;lt;40) vs 18.0% (P &amp;gt; 40) (p = 0.60). No statistically significant differences were reported for live birth rate, 41.8% (P &amp;lt; 20) vs 40.3% (P ≥ 20-&amp;lt;40) vs 34.2% (P &amp;gt; 40) (p = 0.2). The multivariate analysis showed an increased risk of miscarriage when P &amp;gt; 40ng/ml, aOR= 1.14 (0.75-1.74) (p = 0.55) whereas no such association was found with P4 ≥20-40 ng/ml, aOR=0.92 (0.74-1.15) (p = 0.46). Additionally, the probability of live birth is similar when the patient was P &amp;gt; 40 (aOR= 0.77 (0.51-1,15) (p = 0.20)) than when P ≥ 20-&amp;lt;40 (aOR=0.94 (0.79-1,11) (p = 0.47) compared with the references group. Limitations, reasons for caution The retrospective design and different female factors for IVF were included in the study leading to a possible biased population although the adjusted analysis. Different routes of progesterone administration were considered in the study. Currently, we don’t report the timing between the last P4 administration and dosage on the FET. Wider implications of the findings This information is useful for clinicians who monitor progesterone levels prior to FET to avoid reaching high levels that would undermine the chances of achieving a newborn. Trial registration number Not Applicable

Racial and Ethnic Disparity for Cancer Mortality in General and Single-Payer Healthcare Systems in the United States.

It remains unclear what factors significantly drive racial disparity in cancer survival in the United States (US). We compared adjusted mortality outcomes in cancer patients from different racial and ethnic groups on a population level in the US and a single-payer healthcare system. We selected adult patients with incident solid and hematologic malignancies from the Surveillance, Epidemiology, and End Results (SEER) 2011-2020 and Veteran Affairs national healthcare system (VA) 2011-2021. We classified the self-reported NIH race and ethnicity into non-Hispanic White (NHW), non-Hispanic Black (NHB), non-Hispanic Asian Pacific Islander (API), and Hispanic. Cox regression models for hazard ratio of racial and ethnic groups were built after adjusting confounders in each cohort. The study included 3,104,657 patients from SEER and 287,619 patients from VA. There were notable differences in baseline characteristics in the two cohorts. In SEER, adjusted HR for mortality was 1.12 (95% CI, 1.12-1.13), 1.03 (95% CI, 1.03-1.04), and 0.91 (95% CI, 0.90-0.92), for NHB, Hispanic, and API patients, respectively, vs. NHW. In VA, adjusted HR was 0.94 (95% CI, 0.92-0.95), 0.84 (95% CI, 0.82-0.87), and 0.96 (95% CI, 0.93-1.00) for NHB, Hispanic, and API, respectively, vs. NHW. Additional subgroup analyses by cancer types, age, and sex did not significantly change these associations. Racial disparity continues to persist on a population level in the US especially for NHB vs. NHW patients, where the adjusted mortality was 12% higher in the general population but 6% lower in the single-payer VA system.

Heparin-Induced Thrombocytopenia in Patients Suffering Cardiogenic Shock.

Cardiogenic shock (CS) is associated with high mortality. Patients treated for CS mostly require heparin therapy, which may be associated with complications such as heparin-induced thrombocytopenia (HIT). HIT represents a serious condition associated with platelet decline and increased hypercoagulability and remains a poorly researched field in intensive care medicine. Primary purpose of this study was to: 1) determine HIT prevalence in CS, 2) assess the performance of common diagnostic tests for the workup of HIT, and 3) compare outcomes in CS patients with excluded and confirmed HIT. Retrospective dual-center study including adult patients 18 years old or older with diagnosed CS and suspected HIT from January 2010 to November 2022. Cardiac ICU at the Ludwig-Maximilians University hospital in Munich and the university hospital of Bonn. In this retrospective analysis, adult patients with diagnosed CS and suspected HIT were included. Differences in baseline characteristics, mortality, neurologic and safety outcomes between patients with excluded and confirmed HIT were evaluated. In cases of suspected HIT, positive screening antibodies were detected in 159 of 2808 patients (5.7%). HIT was confirmed via positive functional assay in 57 of 2808 patients, corresponding to a prevalence rate of 2.0%. The positive predictive value for anti-platelet factor 4/heparin screening antibodies was 35.8%. Total in-hospital mortality (58.8% vs. 57.9%; p > 0.999), 1-month mortality (47.1% vs. 43.9%; p = 0.781), and 12-month mortality (58.8% vs. 59.6%; p > 0.999) were similar between patients with excluded and confirmed HIT, respectively. Furthermore, no significant difference in neurologic outcome among survivors was found between groups (Cerebral Performance Category [CPC] score 1: 8.8% vs. 8.8%; p > 0.999 and CPC 2: 7.8% vs. 12.3%; p = 0.485). HIT was a rare complication in CS patients treated with unfractionated heparin and was not associated with increased mortality. Also, HIT confirmation was not associated with worse neurologic outcome in survivors. Future studies should aim at developing more precise, standardized, and cost-effective strategies to diagnose HIT and prevent complications.

Evaluation of Pathological Response and Surgical Safety of Total Neoadjuvant Therapy for Patients with Clinical Stage III Gastric Cancer in a Real-world Setting

BackgroundPerioperative chemotherapy is the standard treatment for locally advanced gastric cancer. However, the potential benefit of extending therapy before surgery remains largely unknown. In this study, we aimed to evaluate the efficacy and safety of total neoadjuvant chemotherapy, with or without immune checkpoint blockade. MethodA cohort of 174 patients with clinical stage III gastric cancer who underwent D2 gastrectomy from October 2021 to March 2024 in the real-world setting were included in this study. Among these patients, 101 were treated with total neoadjuvant therapy (TNT) and 73 were treated with perioperative neoadjuvant therapy (PNT). We compared the pathological complete response (pCR) rate, ypN0 rate, recurrence-free survival (RFS), overall survival (OS), and postoperative complications between the two groups. Multivariate logistic regression analysis was conducted to identify factors associated with pCR or ypN0. ResultsCompared to the PNT group, the patients in the TNT group were more frequently treated with intensive chemotherapy with triplets + immunotherapy. Apart from this, there were no significant differences in baseline characteristics. There were no statistically significant differences in pCR (16.8% vs. 12.3%), ypN0 (49.5% vs. 38.4%), RFS, OS, and postoperative complications (27.7% vs. 26.0%) between the TNT and PNT group. Older age, diffuse type, and stable disease/ progressive disease based on clinical efficacy evaluation were independently associated with non-pCR. Stable disease / progressive disease, linitis plastica, and poor differentiation were independently associated with ypN+. Neither the number of neoadjuvant therapy cycles nor the specific regimens were associated with pCR or ypN0. In the subgroup analysis of patients receiving total gastrectomy, there were still no statistically significant differences in pCR (16.7% vs. 2.6%), ypN0 (43.8% vs. 39.5%), and postoperative complications (43.8% vs. 39.5%) between the two groups. ConclusionAlthough TNT did not increase the postoperative complication rate, it also did not provide anyadditional short-term benefits compared to PNT for clinical stage III gastric cancer.

Comparison of Mitral Valve Repair Versus Percutaneous Mitral Balloon Commissurotomy for Patients With Rheumatic Heart Disease: A Single-Centre Study

Percutaneous mitral balloon commissurotomy (PMBC) is the standard treatment option for patients with rheumatic mitral stenosis (MS), according to current guidelines. This study aimed to compare the outcomes of rheumatic mitral valve repair (rMVR) and PMBC in this patient population. Baseline, clinical, and follow-up data from 703 patients with rheumatic heart disease who underwent PMBC or rMVR at the current centre were collected and analysed. A 1:1 propensity score (PS) matching method was used to balance the differences in baseline characteristics between the two groups. The primary outcome was mitral valve reoperation, and the secondary outcome was all-cause mortality. Propensity score matching generated 101 patient pairs for comparison. In the matched population, there were no significant differences in the early clinical outcomes between the groups. The median follow-up time was 40.9 months. Overall, patients in the rMVR group had a statistically significantly lower risk of mitral valve reoperation than those in the PMBC group (HR 0.186; 95% CI 0.041-0.835; p=0.028). Regarding all-cause mortality, no statistically significant differences were observed between the rMVR and PMBC groups (HR 4.065; 95% CI 0.454-36.374; p=0.210). Compared with PMBC, rMVR has more advantages for the correction of valve lesions; therefore, it may offer a better prognosis than PMBC in select patients with rheumatic MS. However, this finding needs to be verified in future studies with larger sample sizes and longer follow-up periods.

Venous thromboembolism in women with hormone-dependent breast cancer. To continue or discontinue hormonal treatment? Insights from the RIETE registry

IntroductionHormone therapy (HT) for breast cancer is associated with an increased risk of venous thromboembolism (VTE). This study examines the effects of continuing versus discontinuing HT on VTE recurrence, major bleeding, and mortality, after an acute VTE event. MethodsUsing data in the RIETE-registry from March 2001 through September 2021, we calculated incidence rates and rate-ratios (RR) for VTE events in patients on- and off HT. Cox regression models assessed the impact of HT continuation. ResultsAmong 479 women with breast cancer on HT who developed VTE (pulmonary embolism 279, isolated deep vein thrombosis 200), 350 (73 %) continued HT. These women were slightly older (70 ± 13 vs. 67 ± 16 years) than those discontinuing HT, with no significant differences in other baseline characteristics. Over a median follow-up of 294 days, 25 (5.2 %) developed VTE recurrences, 18 (3.7 %) had major bleeding, and 73 (15.2 %) died. Rates of VTE recurrence did not differ significantly between groups (RR: 1.28, 95 % CI 0.44–3.75), except in the first three months post-VTE, where a higher rate was observed in those continuing HT (6.02/100 patients-year vs. no events). On multivariable analysis, HT continuation showed no association with VTE recurrences after adjusting for other thromboembolic risk factors (adjusted hazard ratio [aHR] 1.49, 95 % CI 0.5–4.45). ConclusionContinuing HT after a VTE event in women with breast cancer does not generally affect the long-term risk of VTE recurrences but is associated with a higher risk in the first three months. These findings highlight the need for careful monitoring during this period.