Clinical Outcomes In Women Research Articles

Correlations between elevated basal sperm DNA fragmentation and the clinical outcomes in women undergoing IUI.

ObjectiveThis study aimed to explore the impact of the sperm DNA fragmentation index (DFI) on the clinical outcomes in women undergoing artificial insemination by husband intrauterine insemination (AIH-IUI).MethodsIn this retrospective study, the value of sperm DFI was detected by sperm chromatin structure assay (SCSA) in a semen analysis collected before fertility treatment (basal DFI) in 1,500 IUI cycles at the infertility clinic of Northern Jiangsu People’s Hospital Reproductive Medicine Center from Jan 2016 to April 2021. Receiver operating characteristic (ROC) curves were used to calculate the cut-off value for the clinical outcomes of IUI, including the biochemical pregnancy rate, clinical pregnancy rate, delivery rate, and live birth rate, and multivariate logistic regression was conducted to analyse the risk factors for clinical outcomes after IUI.ResultIn 1,500 IUI cycles, the results showed that there were no statistically significant differences between the normal DFI group and the abnormal DFI group in biochemical pregnancy rate (14.41% vs. 11.3%, P = 0.386), clinical pregnancy rate (12.9% vs. 10.5%, P = 0.433), delivery rate (11.0% vs. 8.9%, P = 0.456), live birth rate (10.9% vs. 8.9%, P = 0.484) or pregnancy loss rate (14.6% vs. 15.4%, P = 1.000).ConclusionSperm DFI alone may have limited predictive power for IUI clinical outcomes.

Identifying Sex Dimorphism in Peripheral Artery Disease with Platelet Mapping

Clinical outcomes in women with peripheral artery disease (PAD) after revascularization procedures are worse compared to men, yet there is little in the existing literature as why this may be the case. Platelet Mapping is an emerging point-of-care viscoelastic technology that measures the comprehensive properties of a blood clot, including fibrin-platelet interactions. This prospective observational study aimed to characterize the clinical and Platelet Mapping profiles of female and male patients undergoing lower extremity revascularization, and to correlate Platelet Mapping distribution to thrombotic potential. All patients with a diagnosis of PAD undergoing named vessel open or endovascular revascularization to re-establish inflow, outflow, or both, during December 2020 and January 2022 were prospectively included. Patients were followed clinically for thrombosis for up to 1year. Platelet Mapping assays were performed in 3 clinical phases: preoperative, postoperative inpatient, and postoperative outpatient. Inferential analysis between female and male patient was performed. The quartile distribution of Platelet Mapping metrics associated with thrombosis was used to infer to thrombotic potential. One hundred seven patients were enrolled, of which 37 (34.6%) were female. Female patients had significantly lower rates of uncontrolled diabetes (2.7% vs. 18.6%), hypertension requiring combination therapy (37.8% vs. 58.6%), chronic kidney disease (27.0% vs. 51.4%), coronary artery disease (29.7% vs. 57.1%), and myocardial infarction (16.2% vs. 35.7%) (all P<0.05). Platelet reactivity was significantly higher in female patients with greater platelet aggregation (75.9±23.3 vs. 63.5±28.8) and lower platelet inhibition (23.8±23.4 vs. 36.8±28.9) (all P<0.01). This trend was consistent over time when stratified by the postoperative inpatient and postoperative outpatient clinical phases. There was no statistically discernible difference in the use of antiplatelet therapy between groups, yet female patients continued to exhibit greater platelet reactivity when analyzed by the type of pharmacologic regimen (platelet aggregation on mono-antiplatelet therapy: 80.6±21.0 in women versus 69.4±25.0 in men; platelet aggregation on dual antiplatelet therapy: 67.9±23.8 in women versus 44.8±31.8 in men) (all P<0.01). Twenty-one patients experienced postoperative graft/stent thrombosis within the study period. In relation to the overall study population, patients with thrombosis had Platelet Mapping metrics above the 50th percentile of overall platelet aggregation distribution. There is a growing appreciation for the differences in etiology, disease progression, and outcomes of cardiovascular conditions as they relate to sex. In this cohort, traditional cardiovascular risk factors were in lower prevalence in female patients. Platelet reactivity was found to be higher across clinical phases and antiplatelet regimens. High platelet reactivity was also associated with an increased incidence of thrombosis after lower extremity revascularization. These hypothesis-generating findings provide the basis for further exploration of sex-specific coagulation profiling in PAD patients.

TCT-459 Clinical Outcomes in Women and Men With Small Aortic Annuli Undergoing Transcatheter Aortic Valve Replacement: A Multicenter, Retrospective, Propensity-Matched Comparison

TCT-459 Clinical Outcomes in Women and Men With Small Aortic Annuli Undergoing Transcatheter Aortic Valve Replacement: A Multicenter, Retrospective, Propensity-Matched Comparison

Impact of endometrial scratching on reproductive outcome in patients: A systematic review and meta-analysis.

Background:Endometrial scratching (ES) has demonstrated initial success in women with recurrent implantation failure, but the effect in women with 1 previous assisted reproductive technology (ART) failure is unknown. This meta-analysis aimed to evaluate the impact of ES as a treatment in clinical outcomes for women with at least 1 failed in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)/Intrauterine Insemination (IUI).Methods:PubMed, Medline, Embase, Cochrane Library, Web of Science, CNKI, and EMCC databases were searched for randomized controlled trial studies utilizing endometrial scratching for infertility women with at least 1 failed assisted reproductive technology (ART) to collect pregnancy outcomes, including clinical pregnancy rate (CPR), embryo implantation rate (IR), miscarriage rate (MR), live birth rate (LBR), and multiple pregnancy rate (MPR).Results:Sixteen randomized controlled trial (RCT) studies were included in this meta-analysis, including 1770 women in the intervention group and 1934 women in the control group. Overall, the CPR, IR and LBR were significantly higher in the intervention group than in the control group (for CPR, n = 1430, 16 studies, P = .0002, risk ratio (RR) = 1.59, 95% confidence interval [CI] [1.24, 2.03]; for IR, n = 859, 10 studies, P = .0003, RR = 1.67, 95% CI [1.26, 2.21]; for LBR, n = 156, 6 studies, P = .0005, RR = 1.59, 95% CI [1.22, 2.06]). Nonetheless, there was no significant difference in MR (n = 344, 11 studies, P = .62, risk ratio (RR) = 0.92, 95% confidence interval [CI] [0.66, 1.29]) and MPR (n = 98, 3 studies, P = .39, risk ratio (RR) = 0.81, 95% confidence interval [CI] [0.51, 1.30]) between the intervention group and the control group.Conclusion:Endometrial scratching is considered to enhance the reproductive outcomes of embryo implantation. Additional randomized controlled studies are recommended to identify the appropriate time of invasion and the applicable population to confirm whether it can become a routine operation.

Sex Differences in Clopidogrel Effects Among Young Patients With Acute Coronary Syndrome: A Role for Genetics?

BackgroundPoorer health outcomes experienced by young women with acute coronary syndrome may be related to sex differences in the safety and efficacy of antiplatelet agents, such as clopidogrel. Polymorphisms in drug metabolism enzyme (cytochrome P450 [CYP] family) genes are independent factors for the variability in response to clopidogrel. However, a sex-specific impact of genetics to explain worse clinical outcomes in women has not been explored extensively. Therefore, our objective was to determine whether an interaction of sex with CYP variants occurs among users of clopidogrel, and if so, its impact on 1-year adverse clinical outcomes. MethodsWe used data from a combined cohort of 2272 patients (median age 49 years; 56% female) hospitalized for acute coronary syndrome. We examined interactions between sex and CYP variants among clopidogrel users at admission and discharge to assess associations with 1-year readmission due to cardiac events. ResultsThe case-only analysis of 177 participants on clopidogrel at the time of presentation showed that the risk of an atherothrombotic event was greater in female carriers of the CYP2C9∗3 loss-of-function allele (odds ratio = 3.77, 95% confidence interval = 1.54-9.24). The results of the multivariable logistic regression model for users of clopidogrel at discharge (n = 1733) indicated that women had significantly higher risk of atherothrombotic readmissions at 1 year (odds ratio = 1.55, 95% confidence interval = 1.16-2.07), compared to the risk for men, but the loss-of-function alleles, either individually or through a genetic risk score, were not associated with 1-year readmissions. ConclusionThis study highlights the need for an improved understanding of the role of sex-by-gene interactions in causing sex differences in drug metabolism.

Prevalence and associated factors of oligohydramnios in pregnancies beyond 36 weeks of gestation at a tertiary hospital in southwestern Uganda

BackgroundOligohydramnios is associated with poor maternal and perinatal outcomes. In low-resource countries, including Uganda, oligohydramnios is under-detected due to the scarcity of ultrasonographic services. We determined the prevalence and associated factors of oligohydramnios among women with pregnancies beyond 36 weeks of gestation at Mbarara Regional Referral Hospital (MRRH) in Southwestern Uganda.MethodsWe conducted a hospital-based cross-sectional study from November 2019 to March 2020. Included were women at gestational age > 36 weeks. Excluded were women with ruptured membranes, those in active labour, and those with multiple pregnancies. An interviewer-administered structured questionnaire was used to capture demographic, obstetric, and clinical characteristics of the study participants. We determined oligohydramnios using an amniotic fluid index (AFI) obtained using an ultrasound scan. Oligohydramnios was diagnosed in participants with AFI ≤ 5 cm. We performed multivariable logistic regression to determine factors associated with oligohydramnios.ResultsWe enrolled 426 women with a mean age of 27 (SD ± 5.3) years. Of the 426 participants, 40 had oligohydramnios, for a prevalence of 9.4% (95%CI: 6.8–12.6%). Factors found to be significantly associated with oligohydramnios were history of malaria in pregnancy (aOR = 4.6; 95%CI: 1.5–14, P = 0.008), primegravidity (aOR = 3.7; 95%CI: 1.6–6.7, P = 0.002) and increasing gestational age; compared to women at 37–39 weeks, those at 40–41 weeks (aOR = 2.5; 95%CI: 1.1–5.6, P = 0.022), and those at > 41 weeks (aOR = 6.0; 95%CI: 2.3–16, P = 0.001) were more likely to have oligohydramnios.ConclusionOligohydramnios was detected in approximately one out of every ten women seeking care at MRRH, and it was more common among primigravidae, those with a history of malaria in pregnancy, and those with post-term pregnancies. We recommend increased surveillance for oligohydramnios in the third trimester, especially among prime gravidas, those with history of malaria in pregnancy, and those with post-term pregnancies, in order to enable prompt detection of this complication and plan timely interventions. Future longitudinal studies are needed to assess clinical outcomes in women with oligohydramnios in our setting.

The Clinical and Psychosocial Outcomes for Women Who Received Unexpected Clinically Actionable Germline Information Identified through Research: An Exploratory Sequential Mixed-Methods Comparative Study.

Background Research identifying and returning clinically actionable germline variants offer a new avenue of access to genetic information. The psychosocial and clinical outcomes for women who have received this ‘genome-first care’ delivering hereditary breast and ovarian cancer risk information outside of clinical genetics services are unknown. Methods: An exploratory sequential mixed-methods case-control study compared outcomes between women who did (cases; group 1) and did not (controls; group 2) receive clinically actionable genetic information from a research cohort in Victoria, Australia. Participants completed an online survey examining cancer risk perception and worry, and group 1 also completed distress and adaptation measures. Group 1 participants subsequently completed a semi structured interview. Results: Forty-five participants (group 1) and 96 (group 2) completed the online survey, and 31 group 1 participants were interviewed. There were no demographic differences between groups 1 and 2, although more of group 1 participants had children (p = 0.03). Group 1 reported significantly higher breast cancer risk perception (p < 0.001) compared to group 2, and higher cancer worry than group 2 (p < 0.001). Some group 1 participants described how receiving their genetic information heightened their cancer risk perception and exacerbated their cancer worry while waiting for risk-reducing surgery. Group 1 participants reported a MICRA mean score of 27.4 (SD 11.8, range 9–56; possible range 0–95), and an adaptation score of 2.9 (SD = 1.1). Conclusion: There were no adverse psychological outcomes amongst women who received clinically actionable germline information through a model of ‘genome-first’ care compared to those who did not. These findings support the return of clinically actionable research results to research participants.

P-799 To evaluate the effect of Intra-ovarian platelet rich plasma instillation on the clinical outcome of women with diminished ovarian reserve: A prospective interventional study

Abstract Study question Does intra-ovarian instillation of platelet rich plasma (PRP) improves the clinical outcome of IVF cycles in women with Diminished Ovarian reserve (DOR)? Summary answer PRP instillation leads to consistent improvement in Antral follicle count (AFC), thus achieving clinical pregnancy rate of 33.3% per cycle in women with DOR. What is known already There is rising incidence of females with diminished ovarian reserve (DOR) especially among Asian ethnicity. With the emergence of regenerative medicine, multiple studies have evaluated the role of intra-ovarian PRP, demonstrating a beneficial role in improving ovarian reserve parameters (serum Follicular stimulating hormone (FSH), serum anti-Mullerian hormone (AMH), AFC). Despite its’ favorable effects on biochemical markers and AFC, data regarding improvement in clinical outcome remains elusive and led to inception of this study. Study design, size, duration A prospective interventional study was conducted at Division of Reproductive Medicine of a tertiary care institute. 41 infertile females aged 20-39 years with DOR (AMH &amp;lt;1.2 ng /ml; AFC&amp;lt;5) were enrolled in the study during a 6-month period beginning from August 2021. Participants/materials, setting, methods After informed consent, patients received fresh autologous PRP, prepared from 30 ml venous blood. 1.5ml of PRP instilled in each ovarian stroma between day 7-10 of menstrual cycle under sedation. Patients were followed up for three-consecutive months to assess ovarian reserve parameters including serum FSH, AMH and AFC. Patients showing significant improvement in parameters were recruited for fresh IVF cycles using Antagonist protocol with 1% transdermal testosterone. Outcomes were analysed using linear mix effect model. Main results and the role of chance The average platelet concentration in PRP was ∼10,00,000 platelets/µL. The mean age of enrolled patients was 31.22±4.16 years. Linear improvement in AFC (3.63 vs 6.98 vs 7.97 vs 6.90, p&amp;lt;0.001) was observed from baseline to three consecutive follow-up months with maximal response witnessed in second month in 57.1% of those undergoing IVF cycle. However, there was no significant difference in Serum FSH (p=0.11) and AMH (p=0.16) from the baseline post intervention. Of the 41 patients, 35 (85.3%) responded to the treatment and underwent IVF antagonist cycle. 5 out of 35 IVF cycles were cancelled mid-cycle due to poor ovarian response. The mean dose of gonadotropin requirement was 2667.5±281.1 IU (Follicular stimulating hormone) and 1400±337.3 IU (Human menopausal gonadotropin). The average number of oocytes retrieved was 5.7±2.2 whereas mean number of MII oocytes was 4.63±1.85. The fertilization rate and the cleavage rate were 92.4% and 74.1% respectively. Of the thirty patients, eight patients underwent day 2 transfer due to poor grade of embryos. Mean number of grade 1- day 3 embryos was 1.25±0.55 with surplus embryos available for cryopreservation in 14 patients. The overall clinical pregnancy rate per transfer was 33.33%. No adverse events were reported. Limitations, reasons for caution This was a prospective single arm study. A randomized controlled trial comprising a “no-treatment” arm would establish a Level-I evidence. However, “no-treatment” arm in a developing country like ours, imposes financial burden on the couple with no guaranteed clinical success and thus raising ethical concern and need for ovarian rejuvenation. Wider implications of the findings With the impetus to provide a biological child to these DOR women, intra-ovarian PRP instillation as a method of ovarian rejuvenation holds promising results. Evidently, PRP is not only effective in improving ovarian reserve but this translates into an improved reproductive outcome in a population, previously limited to oocyte donation. Trial registration number REF/2022/01/051033

P-288 COVID vaccination in women and IVF treatment outcomes

Study questionDoes COVID-19 vaccination (mRNA or viral vector) in women affect outcomes following IVF treatment?Summary answerThere was no difference in both pre-clinical and IVF clinical outcomes in women who received vaccination (1 or 2 doses) compared to those unvaccinated.What is known alreadyThe COVID-19 vaccination rollout has been unprecedented and commenced in the UK in December 2020.Compared to the general population, pregnant women have higher risk of morbidity following COVID-19 infection. There is a drive by public health authorities for women of reproductive age to be vaccinated. However, there has been hesitancy in the uptake of vaccination amongst certain patient populations including those who are trying to conceive.Emerging data has shown that follicular function is unaffected by COVID-19 vaccination, although this data is limited. IVF treatment is unique as we can evaluate both pre-clinical embryological outcomes and clinical outcomes.Study design, size, durationWe conducted a retrospective analysis of 474 women undergoing IVF treatment between Jan and Dec 2021. COVID-19 vaccination status was recorded including: vaccination type, number of vaccine doses, and whether they had previously contracted COVID-19. We recorded pre-clinical and clinical outcomes: such as number of oocytes retrieved, fertilisation rate and clinical pregnancy.Participants/materials, setting, methodsWomen were categorised in the three cohorts- unvaccinated (Group 1), defined as the reference group, women who had first dose of COVID-19 vaccine (Group 2) and patients who had two doses of the vaccine (Group 3). Patients whose vaccination status were not known were excluded. Statistical analysis was performed through STATA software. Outcomes were modelled with multivariable logistic and negative binomial regressions and adjusted for the following confounders: age, BMI, parity and past COVID-19 infection.Main results and the role of chanceData from women was analysed, 22.6 % had completed 2 doses, 9.5 % had one vaccine and 9.7% were unvaccinated. Among these women 24.7% had previous COVID-19 infection prior to their IVF cycle.The median number of oocytes retrieved for the entire cohort collected was 10.0 (inter-quartile range (IQR) 6.0, 14.0). There was no significant difference in the number of oocytes retrieved between women who had 1 vaccination dose, 2 doses compared to unvaccinated women (Incidence rate ratios (IRR) 1.18, 95% Confidence Interval (CI) [0.93,1.50] and 0.94, 95% CI [0.76,1.15] respectively).There was no significance difference in the fertilisation rate between women who had one vaccination dose, 2 doses and unvaccinated women (IRR)1.02, 95% CI [0.83, 1.24] and 1.11 95% CI [0.93, 1.31] or failed fertiisation rates (Odds ratio (OR) 0.74, 95% CI [0.09, 6.09] and 0.71, 95% CI [0.12, 4.18].With regards to clinical outcomes, 51.7% of the cohort had a positive urine pregnancy test. There was no significant difference in clinical pregnancy rate between women who had first vaccination dose and those who had both doses compared to unvaccinated women (OR 3.06, 95% CI [0.37, 3.68] & OR 1.7, 95% CI [ 0.64, 4.52] respectively).Limitations, reasons for cautionThis is a retrospective study and further accumulated data is warranted to validate the findings. Many patients at the time of analysis were still pregnant, hence we await live birth outcomes.Wider implications of the findingsThis is the first study to analyse the impact of COVID-19 vaccination on IVF outcomes. These initial findings are reassuring to patients and fertility clinicians on the safety of vaccination.Trial registration numbernot applicable

P-523 rs2277698 Single nucleotides polymorphisms in tissue inhibitors of metalloproteinases 2 (TIMP2) affected clinical outcomes of women undergoing in vitro fertilization

Abstract Study question Is there any association between clinical outcomes of women undergoing in vitro fertilization (IVF) and the polymorphic variants of matrix metalloproteinases (MMPs) or tissue inhibitors of metalloproteinases (TIMPs)? Summary answer Our findings suggested that clinical outcomes of women undergoing IVF were associated with rs2277698 SNPs in TIMP2. What is known already The extracellular matrix proteolytic machinery is one of the most important mechanisms for regulating trophoblast invasion. Matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs), which are involved in the extracellular matrix proteolysis process, have the ability to regulate the degradation of the extracellular matrix and play a critical role in trophoblast invasion. Study design, size, duration A prospective study was composed of 1014 women undergoing their first fresh IVF cycle with non-donor from January 2014 to December 2015. Participants/materials, setting, methods The present study was carried out in Lee Women’s Hospital, Taiwan. DNA was extracted from the peripheral blood of all participants, and the SNPs were genotyped by real-time polymerase chain reaction. The effects of the following three single nucleotide polymorphisms (SNPs) on IVF outcomes were explored: TIMP1 (rs4898 C/T), TIMP2 (rs2277698 C/T) and MMP2 (rs243865 C/T). The SNP genotype, correlation with clinical pregnancy, embryo implantation, abortion and live birth rates of IVF were analyzed. Main results and the role of chance In the analysis of 1014 patients attempting their first cycle of IVF, the genotypes frequencies of the study population showed a statistically significant association between TIMP2 (rs2277698 C/T) and clinical outcome. For TIMP2 polymorphisms, women with wild genotype (CC) hadhigher clinical pregnancy rate (34.8% v.s 28.0%; p = 0.032), embryo implantation rate (19.4% v.s 15.4%; p = 0.009), live birth rate (29.8% v.s 22.1%; p = 0.006), and lower abortion rate (7.0% v.s 17.1%; p = 0.005) compared women with CT/TT genotype. On the other hand, the clinical outcomes in different TIMP1 or MMP2 gene polymorphisms groups were no statistically significant difference. Limitations, reasons for caution The size number of the study samples. Wider implications of the findings This study showed that the TIMP2 SNP polymorphisms CT/TT was associated with low trend of clinical outcomes. The mechanism of TIMP2 gene T allele affected the outcomes of IVF remains to be determined. Further studies should focus on the mechanism of these associations in a larger, more heterogeneous cohort. Trial registration number CS13194

Pre- and Post-Operative Relationship between Radiological Measures and Clinical Outcomes in Women with Hallux Valgus.

The surgical correction of a hallux valgus (HV) deformity improves radiological parameters and clinical outcomes. However, it is not known how these improvements are related between themselves. In this retrospective study, 73 women were assessed preoperatively and 60 months after HV surgical correction. Several radiological parameters were measured: the hallux valgus angle (HVA), I–II intermetatarsal angle (IMA) and sesamoid position. The functional outcomes were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal (HMI) scale, and patient-reported outcomes (PROMs) were recorded with the Manchester–Oxford Foot Questionnaire (MOXFQ). A pre–post-surgery comparison of radiological and clinical values was performed, the correlation among them was studied and the differences pre–post-surgery in the radiological measurements compared with those for the clinical outcomes were studied. The results show that all the radiological parameters, functional outcomes and PROMs improved significantly from their pre-operative values to the follow-up values. Multivariate regression analysis showed a significant relationship (p < 0.001) between the differential pre–post-surgery AOFAS scoring only with two sesamoid position differential pre–post-surgery measures: position of medial sesamoid (PMS) and translation of the first metatarsal head (TMH). However, no significant association was observed between the pre–post-surgery radiological differences and the pre–post-surgery MOXFQ scoring.

Abstract 4124: Clinical outcomes in women with metastatic HER2-Low breast cancer in the real world

Abstract Background: The development of novel anti-HER2 drugs opens new treatment options for patients with breast cancers, including women with lower expression of HER2. The aim of this study was to compare the clinical outcomes of HER2-low and HER2-zero metastatic breast cancer in the real world. Methods: Female patients diagnosed with metastatic breast cancer and low HER2 expression or HER2-zero expression between 2010 and 2017, and who received systematic therapy, were identified from the National Cancer Database (NCDB). The National Cancer Data Base (NCDB) is a nationwide oncology outcomes database that collects information on approximately 70% of all new invasive cancer diagnoses in the United States.HER2-Low was defined as IHC1+ or 2+/ISH negative, whereas HER2-zero was defined as IHC0, based on the American Society of Clinical Oncology/College of American Pathologists guideline. The primary outcome was overall survival(OS). A multivariable Cox regression model was performed to estimate hazard ratios (HR), adjusting for age, race/ethnicity, education, comorbidities, grade, presence of visceral metastasis, and the type of cancer center where patients were treated. The analyses were stratified by hormone receptor status. Results: A total of 22817 of 33417 (68%) were HER2-low and 10600 (32%) were HER2-zero. Hormone receptor-positivity was in 19988 (88%) with HER2-low tumors, whereas 8112 (77%) was in HER2-zero tumors. Women with HER2-low tumors had significantly longer overall survival (OS) than did with Her2-zero tumors in both hormone receptor-positive (median OS 39.0 months vs 37.1 months; adjusted HR: 0.93, 95%CI (0.90-0.96), p&amp;lt;0.001) and hormone receptor-negative groups (median OS 15.8 months vs 14.1 months; adjusted HR: 0.92 95%CI (0.86-0.98), p=0.005). Conclusion: In the metastatic setting, HER2-low tumors have a better survival than HER2-zero tumors, irrespective of hormone receptor status. Specific therapies, such as trastuzmab deruxtecan, have activity in women with HER-low breast cancers and additional therapeutics for HER-2 low should be sought. Citation Format: Changchuan Jiang, Stuthi Perimbeti, Lei Deng, Charles L. Shapiro, Shipra Gandhi. Clinical outcomes in women with metastatic HER2-Low breast cancer in the real world [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 4124.

Impact of the Obesity Paradox Between Sexes on In‐Hospital Mortality in Cardiogenic Shock: A Retrospective Cohort Study

BackgroundSeveral studies have shown that obesity is associated with better outcomes in patients with cardiogenic shock (CS). Although this phenomenon, the “obesity paradox,” reportedly manifests differently based on sex in other disease entities, it has not yet been investigated in patients with CS.Methods and ResultsA total of 1227 patients with CS from the RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock) registry in Korea were analyzed. The study population was classified into obese and nonobese groups according to Asian Pacific criteria (BMI ≥25.0 kg/m2 for obese). The clinical impact of obesity on in‐hospital mortality according to sex was analyzed using logistic regression analysis and restricted cubic spline curves. The in‐hospital mortality rate was significantly lower in obese men than nonobese men (34.2% versus 24.1%, respectively; P=0.004), while the difference was not significant in women (37.3% versus 35.8%, respectively; P=0.884). As a continuous variable, higher BMI showed a protective effect in men; conversely, BMI was not associated with clinical outcomes in women. Compared with patients with normal weight, obesity was associated with a decreased risk of in‐hospital death in men (multivariable‐adjusted odds ratio [OR], 0.63; CI, 0.43–0.92 [P=0.016]), but not in women (multivariable‐adjusted OR, 0.94; 95% CI, 0.55–1.61 [P=0.828]). The interaction P value for the association between BMI and sex was 0.023.ConclusionsThe obesity paradox exists and apparently occurs in men among patients with CS. The differential effect of BMI on in‐hospital mortality was observed according to sex.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.

Atrial fibrillation is associated with worse outcomes in patients with breast cancer.

e13043 Background: The incidence of atrial fibrillation (AF) is higher in women with breast cancer (BC) compared to aged-matched controls. A better understanding of the clinical outcomes in women with BC and AF can help stratify patients’ risk and inform clinical decision making. Methods: Females with active BC diagnosis hospitalized from January 2010 to December 2018 for any cause were identified in the Nationwide Readmissions Database (NRD). Hospitalizations were divided to females with AF and those without a known diagnosis of AF. The primary outcome was in-hospital mortality. Multivariate logistic regression analysis was performed to adjust for differences in baseline characteristics. All statistical analyses were conducted using the weighted values of observations as provided by the NRD to measure national estimates. Results: A total of 1,596,853 hospitalizations of BC were identified. Out of those, 119,307 (7.5%) had AF. Females with AF were older, median age 77 [IQR 69-84] versus 61 [51-71]. AF patients had higher rates of chronic pulmonary disease, 23.0% versus 14.3%, p &lt; 0.001; hypothyroidism, 20.9% versus 13.1%, p &lt; 0.001; peripheral vascular disease, 6.8% versus 2.5%, p &lt; 0.001; pulmonary hypertension, 4.8% versus 1.6%, p &lt; 0.001; cardiac valvular disease, 9.5% versus 2.3%, p &lt; 0.001; hyperlipidemia, 39.9% versus 24.0%, p &lt; 0.001; diabetes mellitus, 28.9% versus 19.8%, p &lt; 0.001; heart failure, 37.0% versus 7.5%, p &lt; 0.001; prior bypass surgery, 4.1% versus 1.2%, p &lt; 0.001; prior stroke, 7.8% versus 2.5%, p &lt; 0.001; and prior myocardial infarction, 6.0% versus 2.2%, p &lt; 0.001. In-hospital mortality was significantly higher in patients with AF, 7.1% versus 4.1%, p &lt; 0.001. Adjusted Odds Ratio (aOR) for in-hospital mortality was higher in AF, aOR 1.42, 95% CI (1.38-1.46), p &lt; 0.001. Conclusions: Atrial fibrillation is associated with a higher risk of in-hospital mortality in patients with breast cancer regardless of the reason of hospitalization. Stratifying patients based on AF presence can help inform clinicians and patients of the patients’ risk of mortality during hospitalization.

Association Between Right Ventricular Dysfunction and Adverse Outcomes in Peripartum Cardiomyopathy: Insights From the BRO-HF Quebec Cohort Study

BackgroundPeripartum cardiomyopathy (PPCM) is associated with severe morbidity and mortality, and the significance of right ventricular (RV) involvement is unclear. We sought to determine whether RV systolic dysfunction or dilatation is associated with adverse clinical outcomes in women with PPCM. MethodsWe conducted a multicentre retrospective cohort study examining the association between echocardiographic RV systolic dysfunction or dilatation at the time of PPCM diagnosis and clinical outcomes. Clinical endpoints of interest were the need for mechanical support, recovery of left ventricular ejection fraction at follow-up, and a combined endpoint of hospitalization for heart failure, cardiac transplant, or death. ResultsA total of 67 women, median age 30 years (interquartile range: 7), were diagnosed with PPCM between 1994 and 2015 in 17 participating centres. Twin pregnancies occurred in 11%; 62% of women were multiparous; and 24% had preeclampsia. RV systolic function was impaired in 18 (27%) and dilated in 8 (12%). Seven women required ventricular assistance, and 8 experienced the composite outcome during follow-up (25 [interquartile range 61] months). RV dysfunction was associated with the need for mechanical support (odds ratio 10.10 (95% confidence interval: 1.86-54.81), P = 0.007), but neither RV dysfunction nor dilatation was associated with left ventricular ejection fraction recovery, the need for cardiac transplant, heart failure hospitalization, or death. ConclusionsRV dysfunction is associated with the need for mechanical support in women with PPCM. These findings may improve risk stratification of complications and clinical management.

Objective Coagulation Profiling Provides Novel Insight into Potential Risk Factors for Peripheral Artery Disease in Women

The prevalence and burden of peripheral artery disease (PAD) is equal, if not higher, in women as compared with men, and it is known that clinical outcomes in women after revascularization procedures are worse. However, women are notably under-represented in existing PAD studies, contributing to a significant gap in clinical knowledge regarding the risk factors and nature history of female-specific disease. Traditional comorbidities associated with cardiovascular disease and PAD are more prevalent in men than women, suggesting that alternative etiologies may be contributing to atherosclerosis in female patients. Thromboelastography with platelet mapping (TEG-PM) measures the viscoelastic properties of a blood clot as a dynamic process and may provide an integral key to the next stage of patient-centered hypercoaguability assessment. This prospective observational study aimed to characterize the clinical and TEG-PM profiles of female and male patients prior to lower extremity revascularization procedures. All patients undergoing named vessel revascularization during December 2020 to December 2021 at a large tertiary institution were prospectively included. TEG-PM assays were performed on patients prior to surgery. These data, along with clinical metrics, were compared between men and women. Univariate analysis was performed using the Student t test for continuous variables and the Fisher exact test for binary variables. One hundred twenty-one patients were enrolled, of which 40 (39.6%) were female. Female patients had significantly lower rates of hypertension (62.5% vs 88.9%; P < .01) and diabetes (25.0% vs 54.3%; P < .01) as compared with men. There were no significant differences in age at time of enrollment, body mass index, smoking status, or hyperlipidemia between groups (Table I). TEG-PM data demonstrated significantly higher levels of platelet aggregation in female patients compared with male patients (62.8 ± 36.6 vs 43.6 ± 34.9; P = .03) and significantly lower levels of platelet inhibition in female patients (37.2 ± 36.6 vs 56.4 ± 34.9; P = .03) (Fig 1). There was no significant difference in the use of monoantiplatet therapy (62.5% vs 61.7%; P = 1.00), dual antiplatelet therapy (22.5% vs 38.2%; P = 1.00), or anticoagulation (30.0% vs 46.9%; P = .08) between groups (Table I). In this preoperative cohort, we found traditional PAD risk factors, such as hypertension and diabetes, to be significantly higher in men compared with women. Viscoelastic data, however, showed significantly greater platelet reactivity in women compared with men. This important insight demonstrates that the prevailing paradigm of risk stratification and disease modification may not fit the female population with PAD, and provides an important basis for further research into gender-specific coagulation profiles.TableClinical and thromboelastography with platelet mapping metrics between female and male patients with peripheral arterial diseaseFemaleMean (SD) or No.(%)MaleMean (SD) or No.(%)PTotal patients4081Clinical factors Age, y69.1 (±11.7)67.4 (±10.2).50 BMI, kg/m226.8 (±8.9)27.5 (±4.9).65 Ever smoker19 (46.3)36 (44.4).85 HTN25 (62.5)72 (88.9)<.01 HLD27 (67.5)44 (54.3).18 DM10 (25.0)44 (54.3)<.01TEG values R time6.5 (±2.6)6.5 (±3.0).94 K time2.0 (±1.5)1.8 (±1.2).50 α-angle66.9 (±10.0)69.3 (±12.2).33 MA57.6 (±8.1)60.8 (±8.5).46Platelet mapping values % Platelet aggregation62.8 (±36.6)43.6 (±34.9).03 % Platelet inhibition37.2 (±36.6)56.4 (±34.9).03Anthrombotic therapy MAPT25 (62.5)50 (61.7)1.00 DAPT9 (22.5)31 (38.2)1.00 Full-dose AC12 (30.0)38 (46.9).08AC, Anticoagulation; BMI, body mass index; DAPT, dual antiplatelet therapy; DM, diabetes mellitus; HLD, hyperlipidemia; HTN, hypertension; MAPT, mono antiplatelet therapy; SD, standard deviation; TEG, thromboelastography.Boldface P indicates statistical significance. Open table in a new tab

C-43 | Impact of Severe Patient-Prosthesis Mismatch in Women with Severe Aortic Stenosis Following Aortic Valve Replacement With a Self-Expanding, Supra-Annular Transcatheter Bioprosthesis or Surgery

Previous studies have identified female sex as an independent predictor of patient-prosthesis mismatch (PPM) following transcatheter or surgical aortic valve replacement (TAVR or SAVR) in patients with severe aortic stenosis. However, the clinical impact of severe PPM in women has not been well characterized. Our objective was to evaluate the impact of severe PPM on 2-year clinical outcomes in women following TAVR or SAVR.

Long-termsafety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study.

Aim: Clinical outcomes of women who become pregnant during/after facilitated subcutaneous immunoglobulin (fSCIG) treatment are not well characterized. Materials & methods: This noninterventional, prospective, open-label, postauthorization, pregnancy registry study assessed safety outcomes in mothers with primary immunodeficiency diseases who had ever received fSCIG before/during pregnancy and their infants (n=7). Enrolled women received alternative treatment (arm 1: n=2) or continued fSCIG (arm 2: n=7) during pregnancy. Results: No treatment-related adverse events (AEs)/serious AEs (SAEs) were reported. 13AEs occurred in mothers, including two SAEs (thrombocytopenia, pre-eclampsia; arm 2). A total of 17AEs occurred in infants, including two SAEs (cleft lip, talipes calcaneovalgus; arm 2) with normal growth/development. Conclusion: Findings provide limited but useful safety data regarding women who received fSCIG before/during pregnancy and the growth/development of their infants. Clinical Trial registration: NCT02556775 (ClinicalTrials.gov); EUPAS5798.

An Observational Study to Correlate Maternal Serum and Cord Blood Zinc with Fetal Growth Restriction

Objectives: To study maternal serum and cord blood zinc as causal factor in fetal growth restriction and to find out correlation, if any, between birth weight and maternal serum and cord blood zinc levels. Material and methods: This prospective observational study was carried out on 120 term pregnant women who attended the Department of Obstetrics and Gynaecology, Pt. B. D. Sharma PGIMS, Rohtak, of which, 60 had FGR babies and 60 had normal growth babies. Serum zinc levels were studied in these women and cord blood zinc levels in their neonates. Results: After adjusting for other variables in the multivariable model we found that the mean serum zinc level in study group women was 115.65±6.36µg/dL at term and 116.91±6.39µg/dL in late preterm neonates. Also, we found that the mean cord blood zinc levels were 136.03±9.25µg/dL in study group and 135.24±4.72µg/dL in control group in term neonates while in late preterm neonates, it was 135.06±9.52µg/dL in study group and 133.18±6.58µg/dL in control group. A statistically significant positive correlation was found between birth weight of FGR babies with the maternal serum zinc levels at term and between cord blood zinc levels and birth weight in both preterm and term neonates. Conclusion: Zinc is an essential micronutrient during pregnancy and is needed for fetal development and placental functions. Its role in fetal growth and development, need of supplementation in pregnant women needs to be studied further to demonstrate better clinical outcomes in women with growth retarded fetus. Keywords: Cord blood zinc, Fetal growth restriction, late preterm neonates, maternal zinc, micronutrients, term neonates.

Role of Sex on the Clinical Outcomes of Coronary Artery Diseases Treated with Drug-Eluting Stents

Background: With consideration of differing cardiac characteristics between women and men, such as coronary vessel sizes, this study was constructed to investigate if sex-based differences are present following drug-eluting stent implantation. Methods: Using PubMed and MeSH search tags, published data analyzing the potential sex differences in clinical outcomes following drug-eluting stent implantation was collected. Results: As compared to male patients, women had similar incidences of major adverse cardiac events and stent thrombosis at long-term follow-up despite being found to consistently have smaller vessels, higher incidences of advanced age, diabetes mellitus, and hypertension at hospital admission. At short-term follow-up, however, women had an increase of major adverse cardiac events as compared to men with complex lesions. Furthermore, height may play a role in clinical outcomes following treatment with a drug-eluting stent. Additionally, women may have superior healing responses with lower neointimal obstruction and lower maximum cross-sectional narrowing following drugeluting stent implantation. Conclusions: When differing baseline characteristics were corrected for with multivariate analysis, drug-eluting stents demonstrate similar clinical outcomes in women and men at long-term follow-up. Cardiovasc j 2022; 14(2): 157-167