Outcomes In Female Patients Research Articles

Robotic Female Radical Cystectomy.

Radical cystectomy is the standard of care for patients with nonmetastatic high-risk bladder cancer. Robotic approach to radical cystectomy has been developed to reduce perioperative morbidities and enhance postoperative recovery while maintaining oncologic control. Classically, radical cystectomy in female patient entails anterior pelvic exenteration with removal of the bladder, uterus, fallopian tubes, ovaries, anterior vaginal wall, and urethra. Pelvic organ-sparing radical cystectomy has been adopted in carefully selected patients to optimize postoperative sexual and urinary function, especially in those undergoing orthotopic urinary diversion. In this article, we describe our techniques of both classical and organ-sparing robot-assisted laparoscopic radical cystectomy in female patients. We also review patient selection criteria, perioperative management, and alternative approaches to improve operative outcomes in female patients.

A Retrospective Cohort Study of Oral Leukoplakia in Female Patients-Analysis of Risk Factors Related to Treatment Outcomes.

Background: The aim of this study was to make a comparison of clinicopathological characteristics of oral leukoplakia between male and female patients following carbon dioxide laser excision for oral leukoplakia and analyze the factors associated with the treatment outcomes in female patients. Methods: Medical records of patients with oral leukoplakia receiving laser surgery from 2002 to 2020 were retrospectively reviewed and analyzed statistically. Results: A total of 485 patients were enrolled, including 412 male (84.95%) and 73 female (15.05%). Regarding the locations, the predilection site of oral leukoplakia in male patients was buccal mucosa (p = 0.0001) and that for women patients was tongue (p = 0.033). The differences of recurrence and malignant transformation between both sexes were not significant (p > 0.05). Among female patients, area of oral leukoplakia was the risk factor related to recurrence (p < 0.05). Clinical morphology and postoperative recurrence were the risk factors related to malignant transformation (p < 0.05). Conclusions: In comparison with male patients, there was no significant difference of the postoperative recurrence and malignant transformation of oral leukoplakia in female patients. Among the female patients, clinicians should pay more attention to large-sized and non-homogeneous leukoplakia, and postoperative recurrent lesions.

Effects of chromosomal abnormalities on pregnancy outcomes in female undergoing artificial insemination with donor's sperm.

This study aimed to evaluate the clinical characteristics, pregnancy outcomes and prognostic factors for pregnancy of female with chromosomal abnormalities (CAs) after artificial insemination with donor's sperm (AID) treatment.A retrospective case–control study was analyzed by using the data of 29 female patients with CA and 116 controlled patients with normal karyotype (1:4 ratio) who underwent AID cycles at Guangdong Family Planning Special Hospital from January 2011 to December 2017. In all cases, reproductive histories were collected, and the cytogenetic analysis was performed by Trypsin-Giemsa banding and karyotyping. The embryos were fertilized via intracervical or intrauterine insemination. Clinical characteristic variables were compared.The prevalence of CA was found to be 0.29% in the whole AID population. The live birth rates of CA group and controlled group were 41.4% and 31.0% (P = .29) respectively. Compared to normal karyotype group, patients with CA showed higher rate of primary infertility (93.1% vs 75.9%, P = .049); Multivariate analysis demonstrated that ovarian stimulation (odds ratio, 3.055; 95% confidence interval, 1.421–6.568; P = .004) was associated with adverse pregnancy outcomes in female patients with AID treatment.For the infertility CA patients who were phenotypically normal, AID was a suitable choice, whereas ovarian stimulation results in an improvement in the pregnancy rate.

Pregnancy Outcomes Post-bariatric Surgery-a Single-Centre Retrospective Study from India.

Bariatric surgery presently is the best possible intervention for treatment of severe obesity and its related conditions. This study presents retrospective data on the pregnancy outcomes of Indian patients who underwent bariatric surgery before conception. This is a single-centre retrospective, observational study. Data on demographics, pre-surgery weight, body mass index (BMI), types of bariatric surgery, weight at conception, weight gain during pregnancy, type of delivery and the health of the baby were collected and analysed to study the weight loss pattern and pregnancy outcomes in female patients of childbearing potential. The study included 34 women of childbearing potential (BMI>30 kg/m2) who underwent bariatric surgery. The study population was followed up from the time of surgery until 1-year post-delivery of the baby. The mean weight gain during the pregnancy was 14.9±5.4 kg. Twenty-three underwent LSCS, and the rest had normal delivery with mean baby weight of 2.5±0.4 kg. Six babies required neonatal intensive care. In our series, only 4 of 35 cohorts that are only 11% had substantial weight retention (range 5-13 kg) at the end of 12 months which is significantly lower than the normal cohorts who did not undergo bariatric surgery. Bariatric surgery improves fertility with safe pregnancy and its outcomes in terms of preeclampsia, eclampsia, gestational diabetes, premature rupture of the membranes (PROM), postpartum haemorrhage (PPH) and puerperal sepsis in women with childbearing potential and safe for offspring in terms of shoulder dystocia, macrosomia, birth asphyxia and perinatal mortality. However, they should be well aware of the risks associated with bariatric surgery especially the mal-absorptive procedures.

Distal Biceps Repairs in Females: A Large Single-Center Case Series.

Distal biceps repair is a commonly reported procedure in male patients, with reliable outcomes and minimal long-term complications. Information on female patients, however, is limited, and variation in presentation and clinical outcomes is unknown. We sought to report on the presentation, treatment algorithm, and outcomes of a case series of female patients with distal biceps pathology. A retrospective evaluation was performed from a large, single specialty orthopedic group from 2005 to 2017. Inclusion criteria were surgical treatment of the distal biceps in female patients, with minimum 3 months of follow-up. The primary outcome variable was the Mayo Elbow Performance Score (MEPS). Of 26 patients who met inclusion criteria, 18 (70%) were available for follow-up with patient-reported outcomes. Median age at time of injury was 56.1 years; 46.2% of patients presented with a complete tear of the distal biceps, and the remaining 53.8% presented with a partial tear that failed nonoperative treatment. Six patients had lateral antebrachial cutaneous neuritis in early follow-up, which ultimately resolved. Median MEPS score was 100 (interquartile range: 20). This study represents the largest case series to date describing the presentation, treatment, and outcomes of female patients with distal biceps repair. Women tend to be older than men, have more insidious onset of pain, present with partial tearing, and may benefit from nonoperative treatment. Ultimately, based on this case series we believe distal biceps repair in female patients is a successful operation with minimal complications and high patient satisfaction.

The Impact of Endograft Selection on Mid-Term Outcomes in Female Patients Following Endovascular Aortic Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA).

BackgroundAbdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort.PurposeTo identify whether graft selection influences outcomes following AAA endoluminal repair in female patients.MethodologyA retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts.ResultsOf the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT.ConclusionThe newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

Preoperative Depression and Anxiety Impact on Inpatient Surgery Outcomes: A Prospective Cohort Study.

To determine the association of preoperative mood symptoms and postoperative adverse outcomes; to explore sex-specific differences. Depression and anxiety can increase postoperative mortality. Psychological stress is associated with a chronic inflammatory response unfavorable to postsurgical healing. Prospective cohort study. Patients were recruited from surgical preadmission clinics at a university hospital. Preoperative depression and anxiety were measured via the Beck Depression and Beck Anxiety Inventories (BDI-II and BAI). Our primary outcome was a composite of postoperative complications, extended length of stay (ELOS) and early readmission. Associated variables included demographics, preoperative pain, pain tolerance/catastrophizing, coping mechanisms, postoperative pain, and opioid use. We adjusted for age, comorbidities, and surgical specialty. Of 1061 recruited patients (ten surgical specialties, 2015-2020), 455 males and 486 females had preoperative and postoperative data available. Mean age was 62.9 (range 20.2-96.2). At baseline, 9.3% of patients had moderate or severe depression; 7.4% had moderate or severe anxiety. Females were more likely to be moderately or severely depressed (11% vs 7%, P = 0.036) and moderately or severely anxious (9% vs 6%, P = 0.034). Females had significantly fewer reported comorbidities and lower American Society of Anesthesiologists category (P < 0.001). Increasing BDI-II and BAI scores significantly increased likelihood of postoperative complications, ELOS, and/or hospital readmission in females (adjusted odds ratio [aOR] = 2.57 for BDI-II 1-19 vs 0, P = 0.041; aOR = 4.48 for BDI-II > 19 vs 0, P = 0.008; aOR = 1.54 for BAI ≤ 6 vs >6, P = 0.038) but not in males. Mood symptoms did not influence postoperative pain or opioid use. Preoperative depression and anxiety negatively impact surgical outcomes in female patients undergoing major surgery.

Sex- related differences in the factors associated with outcomes among patients with strokes of undetermined source: a hospital-based follow-up study

ABSTRACT Objective: Sex-related differences are well established among stroke patients, including the incidence and prevalence of stroke being higher among men than among women. However, the sex-related factors for differences in the outcomes of strokes of undetermined source (SUSs) have not been well described, especially in the Chinese population. We assessed the sex-related differences in the factors associated with outcomes among patients with SUSs in China. Method: Between January 2011 and December 2018, we recruited 205 patients diagnosed with SUSs from Kailuan General Hospital (China). The clinical features, risk factors, and outcome data were collected for the patients at 3 and 12 months after their strokes. Results: There were higher frequencies of hyperlipidemia (27.8% vs. 26.4%), smoking (41.4% vs. 5.6%), and alcohol consumption (21.8% vs. 0%) for male patients than for female patients. However, women were more likely than men to have hypertension (63.9% vs. 46.6%), diabetes (27.8% vs. 20.3%), and atrial fibrillation (9.7% vs. 5.3%); they were also more likely to be obese (16.7% vs. 12.0%). There were no significant differences in outcome between the sexes. Among men, severe strokes were associated with higher case fatality and disability risks at 12 months after stroke onset; hyperlipidemia was a risk factor for recurrence within 3 months of the initial stroke. Among women, severe strokes also increased the risk of disability; in women, high total cholesterol (TC) and age were associated with poor outcomes. Conclusion: The factors associated with outcomes in SUS differed by sex. For male patients, more severe stroke and hyperlipidemia were associated with poor outcomes in SUS. Risk factors for poor outcomes in female patients were stroke severity, age, and TC level. These findings suggest that taking measures to manage blood lipid levels and severe stroke among patients with SUS is important for both male and female patients and is crucial for reducing the burden of stroke in China.

Sex Disparities in MGMT Promoter Methylation and Survival in Glioblastoma: Further Evidence from Clinical Cohorts.

Introduction: Recent studies suggest an overrepresentation of MGMT promoter methylated tumors in females with IDHwt glioblastoma (GBM) compared to males, with a subsequent better response to alkylating treatment. Methods: To reveal sex-bound associations that may have gone unnoticed in the original analysis, we re-analyzed two previously published clinical cohorts. One was the multicenter Nordic trial of elderly patients with GBM, randomizing patients into three different treatment arms, including 203 cases with known MGMT promoter methylation status. The other was a population-based study of 179 patients with IDHwt GBM, receiving concomittant radiotherapy and chemotherapy with temozolomide. Cohorts were stratified by sex to test the hypothesis that female sex in combination with MGMT promoter methylation constitutes a subgroup with more favorable outcome. Results: There was a significantly larger proportion of MGMT promoter methylation and better outcome for female patients with MGMT promoter methylated tumors. Results were confirmed in 257 TCGA-derived IDHwt GBM with known sex and MGMT status. Conclusions: These results confirm that patient sex in combination with MGMT promoter methylation is a key determinant in GBM to be considered prior to treatment decisions. Our study also illustrates the need for stratification to identify such sex-bound associations.

Determining the association between the radiographic parameters and the SRS-22 scores in Chinese female patients with adolescent idiopathic scoliosis: does curve pattern matter?

Background: The Scoliosis Research Society (SRS)-22 outcomes have been shown to be correlated with radiographic parameter of adolescent idiopathic scoliosis (AIS). A recent study suggested that curve patterns might play a role in assessing the influence of deformity on patient’s reported outcomes. The aim of this study was to examine the relationship between radiographic parameters and SRS-22 questionnaire outcomes in female patients with adolescent AIS among the Chinese population based on five curve patterns. Patients and Methods: The radiographic data and SRS-22 questionnaires of 259 female AIS patients were reviewed. Radiographic measurements included: Cobb angle of the major curve, T1 tilt angle, apical vertebral rotation, apical vertebral translation (AVT), thoracic kyphosis, and lumbar lordosis. Curve patterns included single thoracic (T), single thoracolumbar/lumbar (TL), double thoracic (DT), double major (DM), and triple major (TM). The correlation between radiographic measurements and each domain in SRS-22 was determined by Pearson’s correlation coefficient. Results: The curve magnitude and AVT of the major curve were found to be significantly correlated with the self-image domain in all cases (Cobb angle: r = –0.426, p = 0.002; AVT: r = –0.281, p=0.006) and in all curve patterns except for TM. Compared to other groups, the TM group had a significantly larger major curve than the DT group and TL group (p ≤ 0.004). In TM group, the self-image scores were lower than TL group (p =0.018), and the function scores were lower than that in T, TL (p < 0.001) and DM groups (p =0.013). In the DT group, the T1 tilt was significantly correlated with the self-image domain (r = –0.376, p =0.004). In the T group, coronal curve magnitude was significantly correlated with function domain (r = −0.397, p < 0.001). Conclusion: Our findings suggested curve patterns should be considered in evaluating the correlations between radiographic parameters and SRS-22 outcomes in patients with AIS.

Use of extracorporeal membrane oxygenation in postpartum patients with refractory shock or respiratory failure

Although extracorporeal membrane oxygenation (ECMO) is increasingly utilized, only a limited level of experience has been reported in postpartum cardiopulmonary failure. Ten critically ill postpartum patients who received ECMO were included between January 2010 and December 2018 in this retrospective observational study. The main indication for ECMO support was peripartum cardiomyopathy (n = 5), followed by postpartum hemorrhage (n = 2). Nine patients initially received veno-arterial ECMO, and one patient received veno-venous ECMO. Major bleeding occurred in six patients. The median number of units of red blood cells (RBC) transfused during ECMO was 14.5 units (interquartile range 6.8–37.8 units), and most RBC transfusions occurred on the first day of ECMO. The survival-to-discharge rate was 80%. Compared to the survival outcomes in female patients of similar age who received ECMO, the survival outcomes were significantly better in the study population (56% versus 80%, P = 0.0004). Despite the high risk of major bleeding, ECMO for patients with postpartum cardiac or respiratory failure showed excellent survival outcomes. ECMO is feasible in these patients and can be carried out with good outcomes in an experienced centre.

Pregnancy Outcomes in Female Patients with Alopecia Areata: A Nationwide Population-Based Study

Pregnancy Outcomes in Female Patients with Alopecia Areata: A Nationwide Population-Based Study

Pregnancy outcomes in female patients exposed to cyclosporin-based versus tacrolimus-based immunosuppressive regimens after liver/kidney transplantation: A systematic review and meta-analysis.

Pregnancy after transplantation is a challenge owing to the high risk of adverse maternal and foetal outcomes, and immunosuppressants may further impact these outcomes. There are no head-to-head randomized controlled trials comparing influences of cyclosporin and tacrolimus on pregnancy outcomes. Thus, we systematically reviewed and meta-analysed observational studies assessing the comparative influences of these two drugs on pregnancy outcomes in liver/kidney transplant recipients. Relevant studies comparing pregnancy outcomes with tacrolimus and cyclosporin head-to-head were searched in PubMed, EMBASE and Web of Science (from 1 January 2000 to 20 March 2020). The weighted mean difference and odds ratio (OR) were calculated to compare continuous and dichotomous variables, respectively, with 95% confidence intervals (CIs). Publication bias was estimated using funnel plots. The study quality was assessed according to the modified Newcastle-Ottawa scale. Overall, 10 observational studies of low quality, including a total of 1080 post-liver or kidney transplant pregnancies, were identified. Tacrolimus-treated recipients experienced a lower risk of gestationalhypertension (28.0%; OR: 1.74; 95% CI: 1.27-2.39; p<0.01). Cyclosporin-treated recipients showed a lower incidence of caesarean section (40.3%; OR: 0.62; 95% CI: 0.46-0.82; p<0.01). Additionally, cyclosporin performed better in terms of the live birth rate (78.0%; OR: 1.38; 95% CI: 1.02-1.88; p=0.04). No significant differences in the incidences of pre-eclampsia, gestational diabetes, preterm delivery and birth weight were observed. Tacrolimus performed better in patients with gestational hypertension, while cyclosporin was associated with a lower incidence of caesarean section and a higher incidence of live birth. The findings are based on relatively low-quality evidence, but may provide a reference for clinicians in their clinical monitoring and obstetric care for post-transplant pregnancies.

Sex-Associated Differences in Cytomegalovirus Prevention: Prophylactic Strategy is Potentially Associated With a Strong Kidney Function Impairment in Female Renal Transplant Patients.

Post-transplantation cytomegalovirus (CMV) syndrome can be prevented using the antiviral drug (val)ganciclovir. (Val)ganciclovir is typically administered following a prophylactic or a pre-emptive strategy. The prophylactic strategy entails early universal administration, the pre-emptive strategy, early treatment in case of infection. However, it is not clear which strategy is superior with respect to transplantation outcome; sex-specific effects of these prevention strategies are not known. We have retrospectively analyzed 540 patients from the multi-centre Harmony study along eight pre-defined visits: 308 were treated according to a prophylactic, 232 according to a pre-emptive strategy. As expected, we observed an association of prophylactic strategy with lower incidence of CMV syndrome, delayed onset and lower viral loads compared to the pre-emptive strategy. However, in female patients, the prophylactic strategy was associated with a strong impairment of glomerular filtration rate one year post-transplant (difference: −11.8 ± 4.3 ml min−1·1.73 m−2, p = 0.006). Additionally, we observed a tendency of higher incidence of acute rejection and severe BK virus reactivation in the prophylactic strategy group. While the prophylactic strategy was more effective for preventing CMV syndrome, our results suggest for the first time that the prophylactic strategy might lead to inferior transplantation outcomes in female patients, providing evidence for a strong association with sex. Further randomized controlled studies are necessary to confirm this potential negative effect.

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated. Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death (adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke (adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level. Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.

Association between Thiopurines Use and Pregnancy Outcomes in Female Patients with Inflammatory Bowel Disease: A Meta-Analysis.

Conflicting data exist regarding the influence of thiopurines exposure on adverse pregnancy outcomes in female patients with inflammatory bowel disease (IBD). The aim of this study was to provide an up-to-date and comprehensive assessment of the safety of thiopurines in pregnant IBD women. All relevant articles reporting pregnancy outcomes in women with IBD received thiopurines during pregnancy were identified from the databases (PubMed, Embase, Cochrane Library, and ClinicalTrials.gov) with the publication data up to April 2020. Data of included studies were extracted to calculate the relative risk (RR) of multiple pregnancy outcomes: congenital malformations, low birth weight (LBW), preterm birth, small for gestational age (SGA), and spontaneous abortion. The meta-analysis was performed using the random-effects model. Eight studies matched with the inclusion criteria and a total of 1201 pregnant IBD women who used thiopurines and 4189 controls comprised of women with IBD received drugs other than thiopurines during pregnancy were included. Statistical analysis results demonstrated that the risk of preterm birth was significantly increased in the thiopurine-exposed group when compared to IBD controls (RR, 1.34; 95% CI, 1.00-1.79; p=0.049; I2 =41%), while no statistically significant difference was observed in the incidence of other adverse pregnancy outcomes. Thiopurines used in women with IBD during pregnancy is not associated with congenital malformations, LBW, SGA, or spontaneous abortion, but appears to have an association with an increased risk of preterm birth.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Potential Influence of Menstrual Status and Sex Hormones on Female Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Cross-sectional Multicenter Study in Wuhan, China.

BackgroundRecent studies have indicated that females with coronavirus disease 2019 (COVID-19) have a lower morbidity, severe case rate, and mortality and better outcome than those of male individuals. However, the reasons remained to be addressed.MethodsTo find the factors that potentially protect females from COVID-19, we recruited all confirmed patients hospitalized at 3 branches of Tongji Hospital (N = 1902), and analyzed the correlation between menstrual status (n = 509, including 68 from Mobile Cabin Hospital), female hormones (n = 78), and cytokines related to immunity and inflammation (n = 263), and the severity/clinical outcomes in female patients <60 years of age.ResultsNonmenopausal female patients had milder severity and better outcome compared with age-matched men (P < .01 for both). Menopausal patients had longer hospitalization times than nonmenopausal patients (hazard ratio [HR], 1.91 [95% confidence interval {CI}, 1.06–3.46]; P = .033). Both anti-Müllerian hormone (AMH) and estradiol (E2) showed a negative correlation with severity of infection (adjusted HR, 0.146 [95% CI, .026–.824], P = .029 and 0.304 [95% CI, .092–1.001], P = .05, respectively). E2 levels were negatively correlated with interleukin (IL) 2R, IL-6, IL-8, and tumor necrosis factor alpha in the luteal phase (P = .033, P = .048, P = .054, and P = .023) and C3 in the follicular phase (P = .030).ConclusionsMenopause is an independent risk factor for female COVID-19 patients. AMH and E2 are potential protective factors, negatively correlated with COVID-19 severity, among which E2 is attributed to its regulation of cytokines related to immunity and inflammation.

369 Pregnancy outcomes in female patients with alopecia areata: A nationwide population based study in Korea

Alopecia areata (AA) is a common hair loss disorder characterized by an autoimmune reaction against hair follicles. Several autoimmune disorders are associated with adverse pregnancy outcomes, but the effect of AA on pregnancy outcome is unknown. To investigate pregnancy outcomes in female patients with AA, we performed a nationwide, population-based retrospective case-control study using the Korean National Health Insurance claims database from 2011 to 2017. The pregnancy outcomes of 4552 female patients with AA and 508,345 control subjects were analyzed.

Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety.

IntroductionAlthough use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur.ObjectiveThis analysis reports on pregnancy outcomes in the cladribine clinical development program.MethodsPregnancy outcomes in female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis) were evaluated from an integrated safety analysis of ten studies of cladribine in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with cladribine tablets, parenteral cladribine, or placebo (all-exposed cohort; 1976 patients received cladribine and 802 received placebo). Pregnancies that occurred during the ‘at-risk’ period for cladribine (during treatment or within 6 months thereafter) are reported as a separate group.ResultsIn the all-exposed cohort, 70 direct pregnancies occurred among 62 female patients (cladribine, n = 49; placebo, n = 21). Pregnancy outcomes were: live births (cladribine, n = 19 [38.8%]; placebo, n = 9 [42.9%]), elective terminations (cladribine, n = 14 [28.6%]; placebo, n = 4 [19.0%]), spontaneous abortions (cladribine, n = 11 [22.4%]; placebo, n = 5 [23.8%]), and therapeutic terminations (cladribine, n = 5 [10.2%]; placebo, n = 2 [9.5%]); in the remaining placebo recipient, the pregnancy outcome was unknown. There were two reports of congenital malformations (cladribine, n = 1; placebo, n = 1), both of which occurred with pregnancies arising > 2 years after exposure to the last dose of study medication. Sixteen direct pregnancies occurred during the ‘at-risk’ period for cladribine; outcomes for these were: live births, n = 3 (18.8%); elective terminations, n = 10 (62.5%); spontaneous abortions, n = 2 (12.5%); and therapeutic terminations, n = 1 (6.2%). Corresponding findings for direct pregnancies among placebo recipients were (n = 11): live births, n = 5 (45.5%); elective terminations, n = 2 (18.2%); spontaneous abortions, n = 3 (27.3%); and unknown, n = 1 (9.1%). No cases of congenital malformation were reported for pregnancies during the ‘at-risk’ period. There were an additional nine partner pregnancies in female partners of cladribine-treated male patients, all of which resulted in live births; of these, two pregnancies occurred within the ‘at-risk’ period for cladribine.ConclusionsWhile limited by the small number of pregnancies and related data from the cladribine clinical development program, highlighting the need for further study, the observations made in the present analysis were generally consistent with epidemiological data on pregnancy outcomes for the general population or women with multiple sclerosis. There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose. As the data available for cladribine-exposed pregnancies in patients with multiple sclerosis are limited, a non-interventional post-authorization safety study has been initiated to obtain more information on this subject.Clinical Trial RegistrationCLARITY: NCT00213135; CLARITY Extension: NCT00641537; ORACLE MS: NCT00725985; ONWARD: NCT00436826; PREMIERE: NCT01013350.