Adverse Events In Women Research Articles

Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023.

Donepezil in combination with memantine is a widely used clinical therapy for moderate to severe dementia. However, real-world population data on the long-term safety of donepezil in combination with memantine are incomplete and variable. Therefore, the aim of this study was to analyze the adverse events (AEs) of donepezil in combination with memantine according to US Food and Drug Administration Adverse Event Reporting System (FAERS) data to provide evidence for the safety monitoring of this therapy. We retrospectively analyzed reports of AEs associated with the combination of donepezil and memantine from 2004 to 2023 extracted from the FAERS database. Whether there was a significant association between donepezil and memantine combination therapy and AEs was assessed using four disproportionality analysis methods, namely, the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. To further investigate potential safety issues, we also analyzed differences and similarities in the time of onset and incidence of AEs stratified by sex and differences and similarities in the incidence of AEs stratified by age. Of the 2,400 adverse drug reaction (ADR) reports in which the combination of donepezil and memantine was the primary suspected drug, most of the affected patients were female (54.96%) and older than 65years of age (79.08%). We identified 22 different system organ classes covering 100 AEs, including some common AEs such as dizziness and electrocardiogram PR prolongation; fall, pleurothotonus and myoclonus were AEs that were not listed on the drug label. Moreover, we obtained 88 reports of AEs in men and 100 reports of AEs in women; somnolence was a common AE in both men and women and was more common in women, whereas pleurothotonus was a more common AE in men. In addition, we analyzed 12 AEs in patients younger than 18years, 16 in patients between 18 and 65years, and 113 in patients older than 65years. The three age groups had distinctive AEs, but lethargy was the common AE among all age groups. Finally, the median time to AE onset was 19days in all cases. In both men and women, most AEs occurred within a month of starting donepezil plus memantine, but some continued after a year of treatment. Our study identified potential and new AEs of donepezil in combination with memantine; some of these AEs were the same as in the specification, and some of the AE signals were not shown in the specification. In addition, there were sex and age differences in some of the AEs. Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.

First generation antipsychotic-associated serious adverse events in women: a retrospective analysis of a pharmacovigilance database.

Women have been under-represented in trials of antipsychotic medications. Our primary objective was toevaluate five adverse events (AE) associated with first-generation antipsychotics (FGAs) among women relative to menthrough an analysis of the FDA Adverse Event Reporting System (FAERS). We queried 24.6 million AE reports from 2000 to 2023 involving FGAs. The study cohort consisted of chlorpromazine (n = 3317), fluphenazine (n = 1124), haloperidol (n = 16,709), loxapine (n = 3151), perphenazine (n = 816), thioridazine (n = 665), thiothixene (n = 244), and trifluoperazine (n = 360). Cases of neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), Torsades de Pointes (TdP), agranulocytosis (AG), and cerebrovascular adverse events (CVAE) were identified. Reporting odds ratios (ROR) and associated 95% confidence intervals (CI) were calculated with logistic regression for each AE among women relative to men. A total of 2,857 serious AEs were evaluated in the study cohort (NMS = 1810, TD = 434, TdP = 260, AG = 149, CVAE = 204). The ROR for women compared to men was 0.79 (95% CI, 0.71-0.87) for NMS, 0.83 (0.68-1.01) for TD, 1.21 (0.94-1.53) for TdP, 0.71 (0.51-0.98) for AG, and 0.91 (0.68-1.19) for CVAE. A secondary analysis revealed a higher odds in women compared to men of hospitalization associated with reports of TD (ROR = 1.95, 1.29-2.94) and death associated with reports of AG (ROR = 2.46, 1.15-5.24). A subgroup analysis of haloperidol revealed an ROR = 1.67 (1.26-2.21) for women relative to men for TdP. The subgroup analysis of haloperidol AEs revealed a significantly higher reporting odds ratio for TdP. Additionally, the secondary study findings suggest that women were more vulnerable to worse outcomes associated with certain AEs of FGAs.

Evaluating patient safety: Analysis of adverse events in hospitals in Hidalgo

This descriptive observational study analyzes adverse events in public hospitals in Hidalgo between 2013 and 2021. The main objective is to understand patient safety at the local level using data from the Adverse Event Recording System. Data from 1,830 surveys from 14 hospitals were collected, focusing on sociodemographic, clinical, and hospital service variables. The results indicate a higher prevalence of adverse events in women (59.78%) and in the age group of 21 to 30 years. The most common places of occurrence were Internal Medicine and Hospitalization, mainly during the morning shift. The most frequent incidents were medication-related, falls, and infections, with a majority classified as 'no harm'. Patient characteristics and the application of protocols were identified as factors most commonly present in adverse events. However, only 2.02% of the events underwent a root cause analysis. The study highlights the need to develop specific strategies for prevention and reporting, emphasizing continuous education of medical staff and the strengthening of hospital policies, and the consolidation of information on adverse events for future research.

Adverse events in women with neglected vaginal pessaries for pelvic organ prolapse: a case report and literature review

Adverse events in women with neglected vaginal pessaries for pelvic organ prolapse: a case report and literature review

Gender Specified In-Hospital Outcome after Left Atrial Appendage Closure with a Dual Occlusive Mechanism Device

Background: Recent studies have suggested an increased rate of adverse events in women following left atrial appendage occlusion (LAAO), particularly with dual occlusive mechanism devices. Objectives: This study aimed to investigate gender disparities in in-hospital adverse events and short-term device-related outcomes in an experienced center using dual occlusive mechanism devices exclusively. Methods: In a single-center retrospective study, patients who received dual occlusive mechanism devices (Amplatzer cardiac plug and Amulet) were analyzed. We assessed gender differences in patient characteristics, LAAO indications, procedural data, in-hospital complications, and short-term device-related outcomes in the form of one-month follow-up transesophageal echocardiography. Results: Among 474 patients, 211 (45%) were women. At device implantation, women were significantly older (77.45±6.98 years vs. 75.89±7.26; p = 0.01), with higher CHA2DS2Vasc scores (5.03±1.46 vs. 4.28±1.51; p < 0.01) and lower HASBLED scores (3.78±1.06 vs. 4.03±1.12; p = 0.01) compared to men. Men had a higher prevalence of coronary artery disease (52% vs. 32%; p < 0.01). LAAO indications did not significantly differ. Device success was 99% in men and 98% in women (p = 0.75). In-hospital complications, including deaths, major bleedings, and pericardial effusion, did not significantly vary by gender. Rates of device-related thrombus and device closure with a residual jet ≤ 5 mm were similar. Conclusions: In a large cohort of consecutive LAAO patients at an experienced center, gender was not linked to higher in-hospital complications.

Association of plasma Decorin levels and markers of glycocalyx disruption with adverse events in women with severe preeclampsia

Identifying preeclamptic women with an increased risk of severe maternal complications can aid in timely interventions to optimize pregnancy outcomes. Newer biomarkers such as Decorin and markers of endo glycocalyx disruption were assessed in earlier studies for its role in predicting preeclampsia, but their role in identifying those with adverse maternal outcomes is limited. This study aimed to evaluate the association of these biomarkers with adverse maternal outcomes in women with severe pre-eclampsia. Markers of glycocalyx disruption may be further explored for their role along with clinical features and other biomarkers in identifying women at higher risk of maternal complications.

Quantitation of diffuse myocardial ischemia with mental stress and its association with cardiovascular events in individuals with recent myocardial infarction

Microcirculatory dysfunction during psychological stress may lead to diffuse myocardial ischemia. We developed a novel quantification method for diffuse ischemia during mental stress (dMSI) and examined its relationship with outcomes after a myocardial infarction (MI). We studied 300 patients ≤ 61 years of age (50% women) with a recent MI. Patients underwent myocardial perfusion imaging with mental stress and were followed for 5 years. dMSI was quantified from cumulative count distributions of rest and stress perfusion. Focal ischemia was defined in a conventional fashion. The main outcome was a composite outcome of recurrent MI, heart failure hospitalizations, and cardiovascular death. A dMSI increment of 1 standard deviation was associated with a 40% higher risk for adverse events (HR 1.4, 95% CI 1.2–1.5). Results were similar after adjustment for viability, demographic and clinical factors and focal ischemia. In sex-specific analysis, higher levels of dMSI (per standard deviation increment) were associated with 53% higher risk of adverse events in women (HR 1.5, 95% CI 1.2–2.0) but not in men (HR 0.9, 95% CI 0.5–1.4), P 0.001. A novel index of diffuse ischemia with mental stress was associated with recurrent events in women but not in men after MI.

Adverse events after left ventricular assist device implantation linked to psychosocial risk in women and men

Reasons for women's increased probability to experience adverse events (AEs) after left ventricular assist device (LVAD) implantation compared with men's remain uncertain. We explored the role of psychosocial risk in the experience of AEs in women and men. INTERMACS patients receiving a primary continuous-flow LVAD between July2006 and December 2017, median follow-up 13.6 months, were included (n=20,123, 21.3% women). Time-to-event was calculated with cumulative incidence functions for 10 types of AEs separately (e.g., infection, device malfunction), each time accounting for the competing outcomes death, heart transplant, and device explant due to recovery. Event-specific Cox proportional hazard models were run with a binary psychosocial risk variable (including substance abuse, psychiatric diagnosis, limited social support, limited cognition, repeated noncompliance), controlled for covariates. Psychosocial risk was more prevalent in men than in women (21.4% vs 17.5%, p<0.001). Seven out of 10 AEs were more likely in women than in men (e.g., infection 44.5% vs 39.2%, p<0.001). The association of psychosocial risk with each AE was either stronger in women than in men (e.g., device malfunction HRadj 1.29, 95% confidence interval (CI) (1.06-1.56) vs HRadj 1.10, 95% CI (0.97-1.25); rehospitalization HRadj 1.15, 95% CI (1.02-1.29) vs HRadj 1.03, 95% CI (0.97-1.10) or similar between sexes. Independent of clinical parameters, the presence of psychosocial risk is associated with increases in AEs. This suggests that early modification of psychosocial risk factors may have the potential to lower the risk for AEs in this patient population.

Early nutritional intervention does not prevent long-term adverse events in women with breast cancer: A pilot study

This study aims to evaluate the effect of early nutritional intervention on adverse clinical events in women with breast cancer undergoing neoadjuvant chemotherapy. This is a randomized clinical trial performed at the beginning of neoadjuvant chemotherapy for women with breast cancer treated at an oncology referral center (Brazil) and followed until the end of radiotherapy period, at least. Registered under ClinicalTrials.gov Identifier no. RBR-3SHHXS. Participants were allocated to a control group - CG (nutritional guidance on healthy eating practices) or an intervention group - IC (nutritional guidance and individualized food plan). Chemotherapy toxicity (primary endpoint) was considered a precocious adverse clinical event and it was evaluated by self-reported gastrointestinal symptoms observed at any time during the first three cycles of treatment. Post-surgical complications, radiotherapy toxicity, and weight change were considered long-term adverse events. 34 women (19 in the IG and 15 in the CG) were evaluated. The early nutritional intervention was associated with low gastrointestinal chemotoxicity (nausea, vomiting, and constipation, p<0.001, p<0.048, and p<0.024, respectively). However, there were no statically significant differences between both groups in the presence of long-term adverse events (radiotherapy toxicity-88.2% vs 76.9%, weight loss-21.1% vs 26.7% for IC and CG respectively, p>0.05 for both). The early nutritional intervention was associated with a low frequency of precocious events, but not with long-term adverse events in women with breast cancer during treatment.

Risk of Ocular Adverse Events With Taxane-Based Chemotherapy

Taxane-based chemotherapy agents, such as docetaxel and paclitaxel, are used for treating a wide range of cancers. Although much has been published on adverse events related to taxanes, data on ocular outcomes with these very important drugs are scant. To quantify the risk of 3 mutually exclusive ocular adverse events of epiphora, cystoid macular edema (CME), and optic neuropathy with taxane-based chemotherapy agents by undertaking a large pharmacoepidemiologic study. This retrospective cohort study design used a private health-claims database from the US that captures health information of more than 150 million enrollees. The study team created a cohort of new users of women with cancer who were taking taxane-based chemotherapy (docetaxel or paclitaxel) and new users of tamoxifen as controls. Study members were observed to the first incidence of each of the 3 mutually exclusive outcomes. An analysis of taxane-only users was also undertaken. Tamoxifen (unexposed) and taxanes (ie, paclitaxel and docetaxel) as the exposed. First diagnosis of (1) epiphora, (2) cystoid macular edema (CME), or (3) optic neuropathy ascertained using International Statistical Classification of Diseases and Related Health Problems, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision. Among the 18 219 users in the epiphora analysis and optic neuropathy analysis, there were 1824 taxane users (paclitaxel and docetaxel) (age, mean [SD], 62.1 [12.7] years) and 16 395 tamoxifen users (age, mean [SD], 54.6 [12.8] years), respectively. The crude hazard ratio (HR) for epiphora was 5.55 (95% CI, 2.99-10.29) and adjusted HR was 5.15 (95% CI, 2.79-9.54). For optic neuropathy, the crude HR was 4.43 (95% CI, 1.10-17.82) and the adjusted HR was 4.44 (95% CI, 1.04-18.87). Among the 18 433 users in the CME analysis, there were 1909 taxane users (paclitaxel and docetaxel) (age, mean [SD], 62.5 years) and 16 524 tamoxifen users (age, mean [SD], 54.6 years). The crude HR for CME comparing taxane users with tamoxifen users was 1.37 (95% CI, 0.72-2.60) and adjusted HR was 1.33 (95% CI, 0.70-2.53). The HRs for epiphora and CME in the taxane cohort during the time of exposure compared with the period prior to use of the drugs were 2.86 (95% CI, 1.11-7.39) and 2.27 (95% CI, 0.68-7.54), respectively. In a cohort of women who were using taxane chemotherapy agents, there was an association with elevated risk for epiphora, CME, and optic neuropathy. Ophthalmologists and oncologists should be aware of these adverse events in women with breast cancer who receive these drugs.

Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial

BackgroundRisks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations.MethodsA total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination).DiscussionThis study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need.Trial registrationClinicaltrials.gov NCT04556526. September 21, 2020.

Central Apneas Are More Detrimental in Female Than in Male Patients With Heart Failure.

BackgroundCentral apneas (CA) are a frequent comorbidity in patients with heart failure (HF) and are associated with worse prognosis. The clinical and prognostic relevance of CA in each sex is unknown.Methods and ResultsConsecutive outpatients with HF with either reduced or mildly reduced left ventricular ejection fraction (n=550, age 65±12 years, left ventricular ejection fraction 32%±9%, 21% women) underwent a 24‐hour ambulatory polygraphy to evaluate CA burden and were followed up for the composite end point of cardiac death, appropriate implantable cardioverter‐defibrillator shock, or first HF hospitalization. Compared with men, women were younger, had higher left ventricular ejection fraction, had lower prevalence of ischemic etiology and of atrial fibrillation, and showed lower apnea‐hypopnea index (expressed as median [interquartile range]) at daytime (3 [0–9] versus 10 [3–20] events/hour) and nighttime (10 [3–21] versus 23 [11–36] events/hour) (all P<0.001), despite similar neurohormonal activation and HF therapy. Increased chemoreflex sensitivity to either hypoxia or hypercapnia (evaluated in 356 patients, 65%, by a rebreathing test) was less frequent in women (P<0.001), but chemoreflex sensitivity to hypercapnia was a predictor of apnea‐hypopnea index in both sexes. At adjusted survival analysis, daytime apnea‐hypopnea index ≥15 events/hour (hazard ratio [HR], 2.70; 95% CI, 1.06–7.34; P=0.037), nighttime apnea‐hypopnea index ≥15 events/hour (HR, 2.84; 95% CI, 1.28–6.32; P=0.010), and nighttime CA index ≥10 events/hour (HR, 5.01; 95% CI, 1.88–13.4; P=0.001) were independent predictors of the primary end point in women but not in men (all P>0.05), also after matching women and men for possible confounders.ConclusionsIn chronic HF, CA are associated with a greater risk of adverse events in women than in men.

Pregnancy in Women With Preexisting Glomerular Diseases: A Single-Center Experience.

AimWomen with glomerular diseases are often of childbearing age. Besides lupus nephritis, data regarding pregnancy in patients with glomerular diseases are limited, posing a challenging task to attending nephrologists. This study aimed to investigate the pregnancy outcomes and the impact on the underlying glomerular disease among women followed in our institution.MethodsA single-center retrospective cohort study of women with biopsy-proven glomerular diseases who experienced pregnancy between 2010 and 2020. We analyzed data before, during, and after gestation.ResultsA total of 22 women, 13 women with primary and 9 women with secondary glomerular diseases, were included in this study. Most patients (82%) had received immunosuppressive treatment at various times before pregnancy. All the women were in remission, either complete (62%) or partial (38%), with well-preserved renal function (82%) before conception. A total of 30 live births and 1 stillbirth were recorded; the rate of preterm delivery was 23%. Renal function and proteinuria remained stable during pregnancy. Preeclampsia was observed in 6.7% of patients and disease relapse in 6.9% of the pregnancies.ConclusionPregnancy was associated with a low frequency of adverse events in women with underlying glomerular diseases, provided they have quiescent disease and preserved renal function.

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials.

PURPOSEWomen have more adverse events (AEs) from chemotherapy than men, but few studies have investigated sex differences in immune or targeted therapies. We examined AEs by sex across different treatment domains.METHODSWe analyzed treatment-related AEs by sex in SWOG phase II and III clinical trials conducted between 1980 and 2019, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events. Symptomatic AEs were defined as those aligned with the National Cancer Institute's Patient-Reported Outcome–Common Terminology Criteria for Adverse Events; laboratory-based or observable/measurable AEs were designated as objective (hematologic v nonhematologic). Multivariable logistic regression was used, adjusting for age, race, and disease prognosis. Thirteen symptomatic and 14 objective AE categories were examined.RESULTSIn total, N = 23,296 patients (women, 8,838 [37.9%]; men, 14,458 [62.1%]) from 202 trials experiencing 274,688 AEs were analyzed; 17,417 received chemotherapy, 2,319 received immunotherapy, and 3,560 received targeted therapy. Overall, 64.6% (n = 15,051) experienced one or more severe (grade ≥ 3) AEs. Women had a 34% increased risk of severe AEs compared with men (odds ratio [OR] = 1.34; 95% CI, 1.27 to 1.42; P < .001), including a 49% increased risk among those receiving immunotherapy (OR = 1.49; 95% CI, 1.24 to 1.78; P < .001). Women experienced an increased risk of severe symptomatic AEs among all treatments, especially immunotherapy (OR = 1.66; 95% CI, 1.37 to 2.01; P < .001). Women receiving chemotherapy or immunotherapy experienced increased severe hematologic AE. No statistically significant sex differences in risk of nonhematologic AEs were found.CONCLUSIONThe greater severity of both symptomatic AEs and hematologic AEs in women across multiple treatment modalities indicates that broad-based sex differences exist. This could be due to differences in AE reported, pharmacogenomics of drug metabolism/disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving immunotherapy, suggesting that studying AEs from these agents is a priority.

Does Influenza Vaccination during Pregnancy Have Effects on Non-Influenza Infectious Morbidity? A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

The recommendation to provide inactivated influenza vaccine (IIV) to pregnant women is based on observed protection against influenza-related morbidity in mother and infant. Non-live vaccines may have non-specific effects (NSEs), increasing the risk of non-targeted infections in females. We reviewed the evidence from available randomised controlled trials (RCTs) of IIV to pregnant women, to assess whether IIV may have NSEs. Four RCTs, all conducted in low- and middle-income settings, were identified. We extracted information on all-cause and infectious mortality and adverse events in women and their infants. We conducted meta-analyses providing risk ratios (RR). The meta-analysis for maternal all-cause mortality provided a RR of 1.48 (95% CI = 0.52–4.16). The estimates for miscarriage/stillbirth and infant all-cause mortality up to 6 months of age were 1.06 (0.78–1.44) and 1.11 (0.87–1.41), respectively. IIV was associated with a higher risk of non-influenza infectious adverse events, with meta-estimates of 2.01 (1.15–3.50) in women and 1.36 (1.12–1.67) in infants up to 6 months of age. Thus, following a pattern seen for other non-live vaccines, IIV was associated with a higher risk of non-influenza infectious adverse events. To ensure that scarce resources are used well, and no harm is inflicted, further RCTs are warranted.

Adverse events in women giving birth in a labor ward: a retrospective record review study

BackgroundChildbirth could negatively affect the woman’s health through adverse events. To prevent adverse events and increase patient safety it is important to detect and learn from them. The aim of the study was to describe adverse events, including the preventability and severity of harm during planned vaginal births, in women giving birth in the labor ward.MethodsThe study had a descriptive design with a retrospective birth record review to assess the preventability of adverse events using the Swedish version of the Global Trigger Tool. The setting was a labor ward in Sweden with low-risk and risk childbirths. Descriptive statistics, Pearson’s Chi-square test and Student’s t-test were used.ResultsA total of 38 adverse events (12.2%) were identified in 311 reviewed birth records. Of these, 28 (73.7%) were assessed as preventable. Third- or fourth-degree lacerations and distended urinary bladder were most prevalent together with anesthesia-related adverse events. The majority of the adverse events were classified into the harm categories of ‘prolonged hospital care’ (63.2%) and ‘temporary harm’ (31.6%). No permanent harm were identified, but over two-thirds of the adverse events were assessed as preventable.ConclusionsThis first study using Global Trigger Tool in a labor ward in Sweden identified a higher incidence of adverse events than previous studies in obstetric care. No permanent patient harm was found, but over two-thirds of the adverse events were assessed as preventable. The results draw particular attention to 3rd-or 4th-degree lacerations, distended urinary bladder and anesthesia-related adverse events. The feedback on identified adverse events should be used for systematic quality improvement and clinical recommendations how to prevent adverse events must be implemented.

Outcomes Following Aortic Stenosis Treatment (Transcatheter vs Surgical Replacement) in Women vs Men (From a Nationwide Analysis)

Gender-differences in survival following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) have been suggested. The objective of this study was to analyze outcomes following TAVR according to gender and to compare outcomes between TAVR and SAVR in women, at a nationwide level. Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with TAVR and SAVR between 2010 and 2019. Outcomes were analyzed according to gender and propensity score matching was used for the analysis of outcomes. In total 71,794 patients were identified in the database. After matching on baseline characteristics, we analyzed 12,336 women and 12,336 men treated with TAVR. In a second matched analysis, we compared 9,297 women treated with TAVR and 9,297 women treated with SAVR. Long term follow-up showed lower risk of all-cause death (12.7% vs 14.8%, hazard ratio (HR) 0.85, 95% CI 0.81 to 0.90) in women than men. Although the difference in cardiovascular death remained non-significant (5.8% vs 6.0%, HR 0.96, 95% CI 0.88 to 1.05), non-cardiovascular death was less frequent in women than in men following TAVR (6.9% vs 8.8% HR 0.78, 95%CI 0.72 to 0.84).When TAVR was compared with SAVR in women, long-term follow-up with TAVR showed higher rates of all-cause death (11.2% vs 6.5%, HR 1.91, 95%CI 1.78 to 2.05), cardiovascular death (5.0% vs 3.2%, HR 1.44, 95%CI 1.30 to 1.59), and non-cardiovascular death (6.2% vs 3.3%, HR 2.48, 95% CI 2.25 to 2.72). In conclusion, we observed that women undergoing TAVR have lower long-term all-cause mortality as compared with TAVR in men, driven by non-cardiovascular mortality. SAVR was associated with lower rates of long-term cardiovascular adverse events in women as compared with TAVR.

102 Is advanced preoperative imaging associated with lower perioperative adverse outcomes in women undergoing laparoscopic hysterectomy?

Traditionally, ultrasound is the gold standard imaging study prior to pelvic surgery. It is not well characterized how advanced imaging affects rates of perioperative adverse events in women undergoing laparoscopic hysterectomy for benign indications. Our goal was to compare the rate of perioperative adverse events in women who underwent ultrasound only versus advanced imaging (ultrasound plus CT or MRI) prior to laparoscopic hysterectomy for benign indications. We conducted a retrospective cohort study of patients undergoing either total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), or robotic assisted total laparoscopic hysterectomy (RA-TLH) between January 2016 and December 2018 who have undergone ultrasound only or advanced imaging within one year prior to their procedure. Subjects were identified through the billing query of the electronic medical record based on Current Procedural Terminology codes. Patients with a diagnosis of malignancy prior to surgery or intraoperatively were excluded. After screening, demographic and perioperative data were extracted from patient records. Postoperative adverse events were categorized according to the Clavien-Dindo classification. Our primary outcome was the rate of intraoperative and postoperative adverse events with Clavien-Dindo grade II or greater. Data were analyzed using unpaired t-test and two sample test of proportions where appropriate. Query of the medical record resulted in 151patients who met inclusion criteria with 51 patients in the advanced imaging and 100 patients in ultrasound only cohorts. Patients in the advanced imaging cohort had lower Charlson Comorbidity Index scores as compared to patients without advanced imaging. These were nonassociated with decreased likelihood of adverse events. The occurrence of adverse perioperative events among ultrasound only and advanced imaging were 31.00% (n = 31) and 17.64% (n = 9), respectively. Using chi square analysis for correlation, there is no statistically significant difference in perioperative adverse events in ultrasound only and advanced imaging cohorts (P = 0.20). There was no statistically significant difference in the overall rate of perioperative adverse events Clavien-Dindo Grade II or higher. The time increases from first imaging study to day of surgery and overall operative time for the advanced imaging groupware statistically significant (P = 0.02, P = 0.17). Women undergoing advanced imaging for laparoscopic hysterectomies do not have increased rates of adverse events when compared to their ultrasound only counterparts. Ultrasound only imaging can be safely offered to patients as the only imaging modality prior to laparoscopic hysterectomy without delay in delivery of care, increased operative time, or increased rate of adverse events.

Perioperative adverse events in women undergoing rectovaginal fistula repair in the United States

Perioperative adverse events in women undergoing rectovaginal fistula repair in the United States

Perioperative Adverse Events in Women Undergoing Vaginal Prolapse Repair With Uterine Preservation Versus Concurrent Hysterectomy: A Matched Cohort Study.

The objective of this study is to compare the incidence of perioperative adverse events (AEs) in women undergoing vaginal prolapse repair with uterine preservation (hysteropexy) versus concurrent hysterectomy. This was a retrospective matched cohort study between 2012 and 2019. Patients who received a sacrospinous or uterosacral hysteropexy or colpopexy with hysterectomy were matched by surgeon, surgical year, and age. The electronic medical record was queried for demographic and perioperative data. Strict definitions were used for all clinically relevant AEs. One hundred and thirty hysteropexy (89 sacrospinous, 41 uterosacral) patients were matched to 260 concurrent hysterectomy (6 sacrospinous, 253 uterosacral, 1 both) patients. Mean age and body mass index were 58 years (±13 years) and 27.9 kg/m2 (±6 kg/m2). Compared with hysteropexy, cases with hysterectomy were longer, had higher blood loss, and a longer hospital stay. The overall incidence of AEs was 29.0% for concurrent hysterectomy versus 10.5% in hysteropexy cases (P = 0.02); on logistic regression, concurrent hysterectomy remained a statistically significant predictor of AEs, with an adjusted odds ratio of 4.03 (95% confidence interval, 1.48-11.01). There was no difference in Dindo grade 3 complications between concurrent hysterectomy and hysteropexy procedures (0.8% vs 1.3%, P = 0.12). In a subanalysis examining the 2 hysteropexy types, there were no significant differences in AEs. The overall incidence of serious AEs is low in women with uterovaginal prolapse undergoing vaginal native tissue repair with or without hysterectomy. Vaginal hysteropexy is associated with lower odds of experiencing AEs, shorter operating times, a shorter length of stay, and less blood loss.