Sex Differences In Outcomes Research Articles

Sex differences in outcomes among patients undergoing transcatheter atrial septal defect closure: Do they benefit equally?

Abstract Background Although sex differences in congenital heart disease are prevalent and relevant, there is limited research on their role in atrial septal defect (ASD) closure. We aimed to investigate sex differences in baseline characteristics, procedural and long-term outcomes of patients with transcatheter ASD closure. Methods Data from adult patients undergoing ASD closure between 2005-2016 were retrospectively analyzed. Results Of the 853 patients included, 281 (32.9%) were male and 572 (67.1%) were female. Females were more symptomatic at presentation than males (p < 0.001). Males had a higher frequency of cardiovascular comorbidities than females (p < 0.001). Although echocardiographic right ventricular (RV) diameter relative to body surface area was equal in males and females (2.49 cm/m2 versus 2.57 cm/m2; p = 0.072), males had more RV dysfunction (12.1% versus 7.6%; p = 0.028). In contrast, females had higher RV systolic pressures (39.71 mmHg versus 37.23 mmHg; p = 0.025), and were more likely to have moderate to severe tricuspid regurgitation (15.4% versus 8.9%; p = 0.007). Males had larger defects with use of larger implants (p < 0.05). Procedure-related complications were rare and did not differ by sex. At 12-month follow-up, both male and females showed comparable decreases in RV diameter (-0.57 cm versus -0.59 cm; p = 0.751), RV systolic pressure (-4.57 mmHg versus -6.31 mmHg; p = 0.094), and severity of tricuspid regurgitation (p = 0.173; Figure). After a mean follow-up of 3 years (SD = 5), no significant differences were observed in the incidence of death (incidence rate ratio (IRR) = 0.49 [95% CI 0.27-0.83]; p = 0.402), new onset atrial fibrillation (IRR = 3.22 [95% CI 2.57-3.99]; 0.063), cardioversion or ablation (IRR = 0.40 [95% CI 0.20-0.71], p = 0.335), stroke/TIA (IRR = 0.29 [95% CI 0.12-0.56]; p = 0.745), and pacemaker implantation (IRR = 0.29 [95% CI 0.12-0.57], p = 0.728). Conclusions Although patient profiles differed by sex, procedural and long-term outcomes were comparable, suggesting that transcatheter ASD closure can be safely performed in both males and females.Figure.Sankey Plot

Sex differences in outcomes of percutaneous left atrial appendage closure

Abstract Background Atrial fibrillation (AF) is the most common arrhythmia in adults and is associated with an increased risk of embolic stroke. In a previous survey, 91% of nonrheumatic AF-related left atrial thrombi was originated in the left atrial appendage (LAA). Percutaneous left atrial appendage closure (LAAC) with the Watchman device has been shown to be noninferior to anticoagulation therapy in clinical trials for stroke prevention in nonrheumatic AF. It has been used in Japan since September 2019 only for patients who are at the high risk of bleeding events. The WATCHMAN family is the only left atrial appendage closure (LAAC) device in Japan. Since long time ago, sex differences have been attracting attention in the cardiology. Due to the cardiovascular protective effects of endogenous estrogens, premenopausal women are thought to be less likely to develop cardiovascular disease. Whereas, in area of AF, Female with AF have higher stroke risk and female with AF have severe after effect. However, there are few studies on sex differences in LAAC implantation outcomes. Purpose We aimed to identify the sex differences of outcomes of LAAC in Japanese patients. Methods A total of 118 consecutive patients who underwent LAAC at our hospital from January 2020 to August 2023 were prospectively analyzed. Various patient characteristics, comorbidities, and outcomes were identified and compared between male and female. Results Results are shown in Table. Female were older (79 vs. 73 years, p = 0.0009), thinner (Body mass index 22 vs. 24 kg/m2, p = 0.0326), and less likely to have had diabetes (19 vs. 40%, p = 0.0340). Pulmonary embolism was significantly more common in female after LAAC. If anticoagulants are discontinued after LAAC, women’s susceptibility to coagulation may become apparent. Conclusions LAAC was feasible and safe for Japanese patients of both genders. However, these results could have a relevant impact on the antithrombotic management of patients who are at the high risk of embolic considering sex difference. Especially, we should pay great attention when discontinuing anticoagulants after LAAC in female.

Sex differences in outcomes of patients with cardiogenic shock due to acute myocardial infarction: a systematic review and epidemiological meta-analysis

Abstract Background Women are at higher risk of mortality from ST-elevation myocardial infarction (1) when compared to men. There is a lack of consensus among studies examining the effect of sex on outcomes from cardiogenic shock due to acute myocardial infarction (AMI-CS) (2-5). In this systematic review and meta-analysis, we sought to assess the relationship between outcomes of AMI-CS and sex. Purpose To examine sex-related differences in mortality in patients with cardiogenic shock secondary to acute myocardial infarction (AMI-CS). Methods Cochrane Central, PubMed, MEDLINE and EMBASE were searched in February 2023 for studies reporting in-hospital or 30-day sex-specific mortality in patients with cardiogenic shock. Inclusion criteria consisted of observational or randomised controlled trials of adult patients with cardiogenic shock that reported unadjusted or adjusted (by odds or risk ratio) mortality rates by sex. In-hospital or 30-day mortality were treated as equivalent. Data were extracted for study size, number of men and women, unadjusted and adjusted mortality rates, and factors used in multivariable analysis. Studies were assessed for risk of bias and publication bias. Meta-analysis was performed using DerSimonian-Laird random effects model with inverse variant weighting, due to predicted high heterogeneity of included studies. Data are reported as odds ratios (ORs) with 95% confidence interval (CI). P values were adjusted for multiple comparison using Holm-Bonferonni correction. The primary outcomes were unadjusted and adjusted sex-specific mortality rates due to AMI-cardiogenic shock. Results 4,286 studies were identified and 37 met inclusion criteria, pooling a total of 630,890 patients. Raw 30-day/in-hospital mortality of females with AMI-cardiogenic shock was 41.2% compared to 32.3% in males. Unadjusted OR for mortality in females was 1.42 (95% CI 1.31–1.55, p <0.001, t2 = 0.02, I2 = 70.3%), and the adjusted OR was 1.11 (95% CI 1.04–1.20, p <0.001, t2 = 0.01, I2 = 76.8%). Eight studies included data on use of mechanical circulatory support (MCS), which was used in 31.2% of females compared to 39.9% of males. OR for use of MCS in females compared to males was 0.71 (95% CI 0.66–0.77, p < 0.001, t2 = 0.003, I2 = 35.2%). Conclusions Women with AMI-related cardiogenic shock are at greater risk of death compared to male patients and are less often treated with MCS. Potential explanations include residual confounding factors, differences in AMI-cardiogenic shock pathophysiology between men and women, and sex-related differences in healthcare behaviours, but we cannot exclude the effect of systemic bias on outcomes. Further research is required to address the causes of sex disparities in outcomes and ensure equitable management of AMI-cardiogenic shock in women.Unadjusted sex outcomes from AMI-CSAdjusted sex outcomes from AMI-CS

Sex differences in secondary prevention and outcomes post-myocardial infarction in Scotland

Abstract Background Sex differences in outcomes after myocardial infarction (MI) are of increasing interest. Differential receipt of evidence-based treatments may contribute to such disparities. Purpose In this study, we investigate sex differences in the burden of risk factors, in-hospital and long-term treatment and outcomes in contemporary practice in Scotland, by analysing a nationwide sample of consecutive MI admissions. Methods All MI admissions centrally recorded between 2010-2016 by Public Health Scotland were included and followed up until the end of 2021. Poisson regressions analysed in-hospital outcomes (percutaneous coronary intervention (PCI), mortality and post-discharge secondary prevention medication). Models were adjusted for age, co-morbidities and ST-elevation on the electrocardiogram. Royston-Parmar models analysed long-term outcomes (all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE)) and were sequentially adjusted for confounders (age, comorbidities, secondary prevention medications). A 2:1 age and sex-matched general population were included as controls. Results Of a total 47,063 MI patients, 15,776 (33.5%) were women. They were matched with 81,641 controls free of major cardiovascular disease. Median (interquartile range) age was 64 (56-72) years for men and 69 (60-75) years for women. Obesity, hypertension and renal disease were the risk factors more prevalent amongst women, while men had higher rates of previous MI, peripheral vascular disease and atrial fibrillation. Compared to men, women were less likely to undergo PCI (risk ratio (95% confidence interval) – 0.87 (0.86-0.89)) or receive secondary prevention (0.94 (0.93-0.95)), but had similar in-hospital mortality (1.06 (0.99-1.13)), after multi-variable adjustment. Over a median follow-up of 8.4 (6.8-10.2) years, women had higher raw rates of adverse outcomes. However, after full confounder adjustment, this translated into lower risk for women of all cause-mortality 0.92 (0.89-0.95), cardiovascular mortality 0.82 (0.78-0.87) and MACE 0.92 (0.88-0.95) (Figure 1). The female survival advantage was attenuated post-MI in comparison to controls free of significant cardiovascular disease (Figure 2). Conclusions Women and men have different MI risk factor profiles. Women had overall worse crude outcome rates after MI, driven by age and comorbidities. This may have been driven further by undertreatment after MI, including PCI and secondary prevention. Urgent identification of drivers for such disparities in care is warranted in order to improve outcomes and ensure health equity.

Sex Differences in Outcomes After Elective and Acute Aortic Surgery—A Single-Centre Experience over the Last Two Decades

Background/Objectives: Recent studies show conflicting results regarding sex-related differences in outcomes following aortic surgery. This study primarily evaluated 20-year mortality rates, along with 30-day and one- and five-year rates, and postoperative complications in female and male patients who underwent elective and acute ascending aortic surgery at a tertiary care centre. Methods: This retrospective observational study analysed data from 676 adult patients who underwent ascending aortic surgery in Amsterdam UMC, between January 2001 and December 2020. Descriptive statistics, Fisher’s Exact test, Kaplan–Meier survival analysis, and logistic regression were used to assess differences in mortality rates. Results: Patient characteristics for elective and acute procedures were different. Females were generally older (elective: 69 vs. 62 years, p < 0.001, acute: 70 vs. 62 years, p = 0.002), with smaller body surface area (elective/acute: 1.8 vs. 2.1 m2, p < 0.001), lower preoperative haemoglobin (elective: 8.3 vs. 8.9 mmol/L, p < 0.001, acute: 7.8 vs. 8.4 mmol/L, p < 0.001) and estimated glomerular filtration rate (elective: 64 vs. 91 mL/min, p < 0.001; acute: 67 vs. 83 mL/min, p = 0.004). Females undergoing elective procedures had a lower body mass index (25.0 vs. 26.6 kg/m2, p = 0.006), better left ventricle function (p = 0.048) and higher incidence of chronic obstructive pulmonary disease (15 vs. 8%, p = 0.032). In elective procedures, the 20-year mortality rate (49% vs. 30%, p < 0.001) was significantly higher in females, especially those under 60 years (OR of 3.158 [1.2–8.6], p = 0.024). Mortality rates up to one year were comparable. Five-year mortality rate (26% vs. 16%, p = 0.027) was higher. Females had longer ventilation times (32% vs. 15%, p < 0.001) and intensive care unit stays (2 vs. 1 days, p = 0.005). For acute procedures, morbidity and mortality rates were comparable between sexes. Conclusions: Females under 60, undergoing elective ascending aortic surgery showed higher long-term all-cause mortality rates. Implementing sex-specific management strategies and extended follow-up could be essential for improving outcomes in this group.

Insights into sex differences in perioperative outcomes of non-small cell lung cancer patients.

The appreciation of sex differences is substantial for precise cancer management. Surgery is the main treatment for non-small cell lung cancer (NSCLC). We aimed to identify sex differences on perioperative outcomes in NSCLC patients and to uncover the origins of sex effect in outcomes using a Chinese cohort. We retrospectively enrolled patients undergoing NSCLC surgery in the Western China Lung Cancer Database from January 2014 to April 2021. We compared baseline characteristics and perioperative outcomes between male and female. Multivariable analyses were performed. We conducted causal mediation analysis to identify drivers to sex differences in perioperative outcomes. Altogether, data of 10,181 patients (5,738 women and 4,443 men) were analyzed. Women had lower incidence of complications (5.05% vs. 12.15%), shorter postoperative length of stays (4.92 vs. 6.41 days), and less hospitalization cost (50,713.69 vs. 54,580.85, Chinese Yuan). Multivariable regression analysis identified sex as an independent factor of perioperative complications [odds ratio (OR), 1.843, 95% confidence interval (CI): 1.476-2.294], as well as of postoperative length of hospital stays (beta 0.123, 95% CI: 0.099-0.148), and hospitalization cost (beta 0.026, 95% CI: 0.026-0.026). Mediation analysis revealed that age, body mass index, prevalence of chronic obstructive pulmonary disease, predicted diffusion capacity for carbon monoxide, tumor size, pleural adhesion, and surgery duration were identified as mediators for sex differences in outcomes, while smoking status, surgery type, and resection extent were not. Female NSCLC patients demonstrated lower incidence of complications, shorter postoperative length of stays, and less hospitalization cost after surgery. Those differences between men and women could be explained by their inherent biological differences and baseline health status. Perioperative management strategies for NSCLC should prioritize recognizing the potentially poorer outcomes among male patients and implementing tailored precautions accordingly.

TCT-527 Sex Differences in Outcomes Following Optical Coherence Tomography and Intravascular Ultrasound-Guided PCI: A Subgroup Analysis of the OCTIVUS Trial

TCT-527 Sex Differences in Outcomes Following Optical Coherence Tomography and Intravascular Ultrasound-Guided PCI: A Subgroup Analysis of the OCTIVUS Trial

Fundamental movement skills proficiency in preschool-aged boys and girls: Family matters

ABSTRACT To investigate the associations of fundamental movement skill (FMS) proficiency with family factors, including socioeconomic status (SES) and caregiver characteristics, by sex in young children in China. Participants included 1,207 Chinese children aged 3–6 years in this cross-sectional study. Children’s FMS, consisting of locomotor skills and object control (OC) skills, were assessed. Information on family SES and caregiver characteristics was reported by the parents. Sex differences in outcomes and the associations of FMS with family factors by sex were examined using SPSS 26.0. Boys scored significantly higher than girls in terms of overall FMS and OC skills (both p < 0.01). There were significant and negative associations between children’s FMS and parental education level and parental body mass index (BMI), which varied by sex. Boys who were regularly cared for by parents had higher FMS and OC skill scores than did those who were primarily looked after by grandparents (both p < 0.01). This complex interplay between sex and family factors (i.e. parental education level, parental BMI, and the identity of primary caregiver) on FMS proficiency in young children underscores the urgent need for developing sex-tailored, family-involved, and socio-culturally adapted interventions to enhance FMS proficiency at the preschool stage.

Sex Differences in Long-term Heart Failure Prognosis: A Comprehensive Meta-Analysis.

Sex differences in the long-term prognosis of heart failure (HF) remain controversial, and there is a lack of comprehensive pooling of the sex differences in outcomes of HF. This study aims to characterize the sex differences in the long-term prognosis of HF and explore whether these differences vary by age, HF course, left ventricular ejection fraction, region, period of study, study design, and follow-up duration. A systematic review was conducted using Medline, Embase, Web of Science, and the Cochrane Library, from January 1, 1990, to March 31, 2024. The primary outcome was all-cause mortality (ACM), and the secondary outcomes included cardiovascular mortality (CVM), hospitalization for HF (HHF), all-cause hospitalization, a composite of ACM and HHF, and a composite of CVM and HHF. Pooled hazard risks (HRs) with corresponding 95% confidence intervals (CIs) were calculated using random effects meta-analysis. 94 studies (comprising 96 cohorts) were included in the meta-analysis, representing 706,247 participants (56.5% were men, the mean age was 71.0 years). Female HF patients had a lower risk of ACM (HR: 0.83, 95% CI: 0.80, 0.85; I2=84.9%), CVM (HR: 0.84, 95% CI: 0.79, 0.89; I2=70.7%), HHF (HR: 0.94, 95% CI: 0.89, 0.98; I2=84.0%), and composite endpoints (ACM+HHF: HR: 0.89, 95% CI: 0.83, 0.95; I2=80.0%; CVM+HHF: HR: 0.85, 95% CI: 0.77, 0.93; I2=87.9%) compared to males. Subgroup analysis revealed that the lower risk of mortality observed in women was more pronounced among individuals with long-course HF (i.e., chronic HF, follow-up duration >2 years) or recruited in the randomized controlled trials. (P for interaction <0.05). Female HF patients had a better prognosis compared to males, with lower risks of ACM, CVM, HHF, and composite endpoints. Despite the underrepresentation of female populations in HF clinical trials, their mortality benefits tended to be lower than in real-world settings. PROSPERO: CRD42024526100.

Sex Differences in Outcomes of Adults with Repaired Coarctation of Aorta and Concomitant Aortic Valve Disease

BackgroundAortic valve disease is common in adults with coarctation of aorta. However, no systematic comparative analyses have been performed of the clinical course of aortic valve disease for male vs female patients in this population. The purpose of this study was to compare cardiac remodelling, onset of symptoms, and incidence of aortic valve replacement (AVR) for male vs female patients. MethodsA retrospective study was conducted of adults with repaired coarctation of aorta and ≥ moderate aortic stenosis and/or aortic regurgitation. Cardiac remodelling (left ventricular [LV], left atrial, right ventricular [RV], and right atrial structure and function) and symptomatic and/or functional class were determined at the baseline encounter. Development of new-onset symptoms and the incidence of AVR were ascertained for the period from baseline to last encounter. ResultsWe identified 214 patients (121 male [57%], 93 female [43%]). Although both groups had a similar aortic valve gradient, aortic valve area indexed to body surface area, aortic regurgitation severity, and functional status at baseline, female patients had more LV concentric hypertrophy and remodelling, left atrial hypertension and dysfunction, elevated RV systolic pressure, and RV systolic dysfunction. Of 151 patients without symptoms at baseline,102 (72%) developed symptoms. Female sex was independently associated with new-onset symptoms (adjusted hazard ratio 1.14, [95% confidence interval 1.05-1.23]). Of 214 patients, 191 (89%) underwent AVR. Female sex was not associated with AVR upon multivariable analysis. However, LV concentric hypertrophy and remodelling (both of which were more common in female patients) were associated with new-onset symptoms and AVR. ConclusionsFemale patients, compared to male patients, had more-advanced cardiac remodelling, and more-rapid onset of symptoms, but a similar risk of AVR.

The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research

Abstract: In orthopaedic clinical research, as in other fields, sex and gender-specific analyses are not consistently performed, despite evidence of sex differences in outcomes. Both institutional review boards (IRBs) and journal editors have a role in impacting the rate at which such analyses are performed and reported. The authority, responsibilities, and potential actions of IRBs are discussed herein, with the aim of setting investigator expectations and propelling changes to the study plan before the research is initiated.

Long-Term Outcomes of Sex Differences in Three-Vessel Coronary Disease with Different Treatment Strategies: A Large Cohort Study.

The information assessing sex differences in outcomes of patients with three-vessel coronary disease (TVD) after different treatment strategies is sparse. This study aimed to investigate long-term outcomes of TVD among women compared with men after medical therapy (MT) alone, percutaneous coronary intervention (PCI), or coronary artery bypass grafting surgery (CABG). Consecutive 8943 patients with TVD were enrolled. Associations between sex and all-cause death and major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, myocardial infarction, or stroke) were assessed. Of the 8943 patients, 1821 (20.4%) were women. During a median follow-up of 6.6 years, women had comparable incidences of all-cause death (16.6% vs. 14.9%, P = 0.079) and MACCE (27.2% vs. 26.1%, P = 0.320) to men. After multivariable analysis, women showed lower adjusted risks of all-cause death (HR: 0.777; P = 0.001) and MACCE (HR: 0.870; P = 0.016) than men in the entire cohort. Subgroup analysis revealed that the less all-cause death risk of women relative to men was significant in PCI (HR: 0.702; P = 0.009), and CABG groups (HR: 0.708; P = 0.047), but not in MT alone group. Lower MACCE risk for women vs. men was significant only in PCI group (HR: 0.821; P = 0.037). However, no significant interaction between sex and three strategies was observed for all-cause death (P for interaction = 0.312) or MACCE (P for interaction = 0.228). The cardiovascular prognosis of TVD female patients is better than that of men, which has no interaction with the treatment strategies received (MT alone, PCI, or CABG).

Sex Differences in Outcome of Aneurysmal Subarachnoid Hemorrhage and Its Relation to Postoperative Cerebral Ischemia.

Whether there is a sex difference in the outcome of aneurysmal subarachnoid hemorrhage (aSAH) remains controversial, and clarifying the role of women in postoperative cerebral ischemic events can help us to understand its relationship with poor prognosis. Therefore, the purpose of this study was to elucidate the relationship between the three aspects of sex differences, postoperative cerebral ischemia, and poor prognosis after aSAH. A total of 472 patients admitted within 72h after aSAH between January 2018 and December 2022 were included. We systematically analyzed the characteristics of sex differences in aSAH and explored the relationship between delayed cerebral ischemia (DCI), surgery-related cerebral infarction (SRCI), and poor prognosis (modified Rankin Scale > 2). Compared with women, men were in worse condition and had more intracerebral hematoma (p = 0.001) on admission, whereas women were older (p < 0.001) and had more multiple aneurysms (p = 0.002). During hospitalization, men were more likely to experience emergency intubation (p = 0.036) and tracheotomy (p = 0.013). Women achieved functional independence at discharge at a similar rate to men (p = 0.394). Among postoperative complications, the incidence of DCI (22% vs. 12%, p = 0.01) and urinary tract infection (p = 0.022) was significantly higher in women. After adjusting for age, multivariable regression analysis showed that hypertension (odds ratio [OR] 2.139, 95% confidence interval [CI] 1.027-4.457), preoperative rerupture (OR 12.240, 95% CI 1.491-100.458), pulmonary infection (OR 2.297, 95% CI 1.070-4.930), external ventricular drainage placement (OR 4.382, 95% CI 1.550-12.390), bacteremia (OR 14.943, 95% CI 1.412-158.117), SRCI (OR 8.588, 95% CI 4.092-18.023), venous thrombosis (OR 5.283, 95% CI 1.859-15.013), higher modified Fisher grades (p = 0.003), and Hunt-Hess grades (p = 0.035) were associated with poor prognosis, whereas DCI (OR 1.394, 95% CI 0.591-3.292) was not an independent risk factor for poor prognosis. The proportion of patients who fully recovered from cerebral ischemia was higher in the DCI group (p < 0.001) compared with the SRCI group, and more patients were discharged with modified Rankin Scale > 2 in the SRCI group (p = 0.005). Women have a higher incidence of DCI, but there is no sex difference in outcomes after aSAH, and poor prognosis is associated with worse admission condition and perioperative complications. SRCI is a strong independent risk factor for poor prognosis, whereas DCI is not.

Impact of Chronic Kidney Disease on the Outcomes of Patients Undergoing Left Atrial Appendage Occlusion: Insights from a Large National Database.

Studies exploring the effectiveness and safety of left atrial appendage occlusion (LAAO) in patients with chronic kidney disease (CKD) are limited. We utilized the National Inpatient Sample (NIS) to identify hospitalizations for LAAO from 2016 to 2020 and further identified cases with concomitant CKD. The primary outcome was mortality, and secondary outcomes were cerebrovascular accidents, major bleeding, vasopressor requirements, percutaneous coronary intervention, cardiac arrest, acute respiratory failure, transfusion, length of stay (LOS), and total hospital charges. Multivariable logistic regression was performed to further adjust for covariates. A total of 89,309 LAAO procedures from 2016 to 2020 were identified, of which 21,559 (24.1%) reported concomitant CKD, with males comprising the majority (62.2%). An increasing trend in LAAO procedures was seen from 2.24 to 13.9 per 10,000 patients from 2016 to 2020. Despite patients with CKD having a higher rate of most comorbidities, there was no difference in mortality (non-CKD vs. CKD, 0.07% vs. 0.42%; aOR: 1.3, 95% CI: 0.4-4.4, p = 0.686) and complications for CKD and non-CKD patients, while CKD patients had longer LOS and higher total hospital charge. No significant sex differences in outcomes among CKD patients were observed except for a longer LOS in females. Despite generally having more comorbidities, outcomes of patients with CKD following LAAO are similar to those without CKD, suggesting that LAAO can be offered as a safe option for the treatment of atrial fibrillation in eligible patients with CKD.

Sex Differences in Outcomes of an Intensive Risk Factor Modification Program in Patients With Atrial Fibrillation.

The outcomes of atrial fibrillation (AF) seem to be variable between males and females. We therefore aimed to determine sex differences in weight loss, cardiorespiratory fitness gain, and recurrence and progression of AF following risk factor management. Of 1415 consecutive patients referred for electrophysiology management of AF, 825 had a body mass index of ≥27 kg/m2; after exclusions, 355 (males, 234; females, 121) were offered risk factor management and participation in a tailored exercise program. Females were older than males (65.5±10.4 versus 62.5±10.6 years; P=0.013) with a higher body mass index (34.1±5.4 versus 32.6±4.1 kg/m2; P=0.003) and more commonly paroxysmal AF (67.8% versus 48.3%; P<0.001). There was no sex difference in clinic attendance (58.7% versus 60%; P=0.82), weight loss (P=0.86), fitness gain (P=0.44), or improvement in AF symptoms (P=0.35). Weight loss (≥10% compared with <10%) was associated with lower total AF recurrence in males (hazard ratio, 0.41 [95% CI, 0.23-0.73]) and females (hazard ratio, 0.41 [95% CI, 0.20-0.83]). Fitness gain (≥2 metabolic equivalents compared with <2 metabolic equivalents) was associated with lower total AF recurrence in females (hazard ratio, 0.13 [95% CI, 0.05-0.30]) but not in males (hazard ratio, 0.63 [95% CI, 0.38-1.04]; P=0.002). There was a trend toward more reversal from persistent to paroxysmal AF in males compared with females (21.8% versus 14.0%; P=0.079). Males and females with AF demonstrate a similar degree of weight loss and fitness gain through structured risk factor management. However, fitness had a much greater benefit for total arrhythmia recurrence in females compared with males, whereas there was a trend toward more AF reversal in males. URL: https://anzctr.org.au; Unique identifier: ACTRN12614001123639.

Sex Differences in Outcomes after Endovascular Thrombectomy for Patients with Acute Ischemic Stroke

Introduction: Endovascular thrombectomy (EVT) is the standard of care for patients with large-vessel occlusion acute ischemic stroke (AIS). There may be differing recanalization effectiveness based on patients’ sex, and understanding such variations can improve patient outcomes by adjusting for differences. We aimed to assess the sex differences in outcome after EVT for patients with AIS. Methods: We retrospectively analyzed 250 consecutive AIS patients who underwent EVT from July 2019 to February 2022 across two large comprehensive tertiary care stroke centers in China. Outcomes of male patients were compared to females, where poor outcome was defined as a modified Rankin score (mRS) of 3–6 at 90 days. Results: Male patients had higher rates of symptomatic intracranial hemorrhage (sICH) (12.50% vs. 4.05%, p = 0.042) and higher hospitalization costs (114,541.08 vs. 105,790.27 RMB, p = 0.024). Male patients also had a longer median onset-to-needle time (ONT) (146.00 [104.00, 202.00] versus 120.00 [99.25, 144.75], p = 0.026). However, there were no differences in hospitalization length (p = 0.251), 90-day favorable outcome (p = 0.952), and 90-day mortality (p = 0.931) between the sexes. Conclusion: Female patients had lower hospitalization costs and sICH rates than males after EVT for AIS. Identifying such differences and implementing measures, including adaptations to workflow optimization, would help to reduce the ONT and last known normal-to-puncture time seen in males to improve patient outcomes. Despite such variations, favorable outcomes and mortality are similar in female and male AIS patients.

D-13 | Sex Differences in Outcomes Among Impella Patients: A Retrospective cohort study

D-13 | Sex Differences in Outcomes Among Impella Patients: A Retrospective cohort study

OR11-2 | Sex Differences in Outcomes Among Patients who Underwent Catheter-Directed Thrombolysis for Pulmonary Embolism: A Retrospective Cohort Study

OR11-2 | Sex Differences in Outcomes Among Patients who Underwent Catheter-Directed Thrombolysis for Pulmonary Embolism: A Retrospective Cohort Study

Abstract 1108: Sex And Racial Differences In The Outcomes Of Intravascular Ultrasound-guided Percutaneous Coronary Intervention: A Five-year Retrospective Analysis

Introduction: Studies have shown the superiority of intravascular ultrasound-guided percutaneous coronary intervention (IVUS-PCI) over angiographic PCI alone. We studied the racial and sex differences in outcomes. Methods: Using the National Inpatient Sample database (2016-2020) and ICD-10 codes, we identified the IVUS-PCI population. Chi-square and student T-tests were used to compare categorical and mean differences. Multivariate logistic regression analysis was used to account for potential confounding variables such as sex, age, comorbidities, hospital size, and teaching status and to estimate the probability of outcomes. Our primary outcome was mortality. A p≤0.05 was significant. Results: Of the 271,530 PCI hospitalizations, 12% (32,675) got IVUS-PCI (63.7 years ± 11.7), of which 30.4% (9,925) were females. The probability of receiving IVUS-PCI was similar among all races: 1.04 (0.9-1.1, p=0.7) and sex 1.01 (0.9-1.03, p=0.6). Compared to Whites, Blacks 0.8 (0.6-1.2), Hispanics 0.9 (0.7-1.4), and Asians 1.3 (0.8-2.2), (p&gt;0.05, each) did not differ in mortality. Also, no sex differences in mortality, with females 1.2 (1.0-1.5, p&gt;0.05). Post-procedural shock 2.5 (1.5-4.0), bleeding 1.8 (1.3-2.6), and anemia 1.5 (1.3-1.8) (p&lt;0.05, each) were more likely in females. No racial differences were noted. Conclusion: In our IVUS-PCI population, there was no difference in mortality among race or sex. However, females were more likely to suffer peri and post-procedural complications. More research is needed to identify the drivers of these disparities.

Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD

BackgroundAttention-deficit/hyperactivity disorder (ADHD) remains underdiagnosed and undertreated in girls. Inattentive symptoms, often predominant in girls with ADHD, represent a key driver of impairment and often persist into adulthood. AKL-T01 is a regulated digital therapeutic targeting inattention. We examined potential sex differences in the efficacy of AKL-T01 in three separate trials for 1) children, 2) adolescents, and 3) adults.MethodsWe conducted secondary analyses of clinical outcomes by sex in three AKL-T01 randomized clinical trials in ADHD (n1 = 180 children 30.6% female, M(SD) age = 9.71 (1.32); n2 = 146 adolescents; 41.1% female, M(SD) age = 14.34 (1.26); n3 = 153 adults; 69.9% female, M(SD) age = 39.86 (12.84)). Active treatment participants used AKL-T01 for 25 min/day over 4–6 weeks. Primary outcomes included change in attention on the Test of Variables of Attention (TOVA) and symptom change on the clinician-rated ADHD Rating Scale (ADHD-RS). To evaluate study hypotheses, we conducted a series of robust linear regressions of TOVA and ADHD-RS change scores by sex, adjusting for baseline scores.ResultsIn children, girls demonstrated greater improvement in objective attention relative to boys following AKL-T01 (TOVA Attentional Composite Score; Cohen’s d = .36 and Reaction Time Mean Half; Cohen’s d = .54), but no significant sex differences in ADHD rating scale change. We did not observe significant sex differences in outcomes in the adolescent or adult trials. Limitations include binary sex categorization and slight study design variation across the three samples.ConclusionAKL-T01 might notably improve attentional functioning in girls with ADHD relative to boys. Objective attention measures may be particularly important in the assessment of attentional improvement in childhood, given known gender biases in ADHD symptom reporting. We emphasize the importance of considering sex and gender-specific factors in ADHD treatment evaluation.Trial registrationsSTARS ADHD CHILD: ClinicalTrials.gov ID NCT03649074;STARS ADHD ADOLESCENT: ClinicalTrials.gov ID NCT04897074;STARS ADHD ADULT: ClinicalTrials.gov ID NCT05183919.