Rates Of Adverse Outcomes Research Articles

Dose escalation of biologics in biologic-naive patients with Crohn's disease: Outcomes from the ODESSA-CD study.

Dose escalation of biologics may restore response in patients with Crohn's disease (CD) who experience inadequate response or loss of response, but the rates of dose escalation and subsequent adverse clinical outcomes have not been well characterized. To evaluate the rate of dose escalation of biologics and associated adverse clinical outcomes and economic outcomes in biologic-naive patients with CD. ODESSA-CD (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients with Crohn's Disease) was a retrospective cohort study conducted using claims data from IBM MarketScan databases. Adults with CD with at least 1 claim for an index drug (adalimumab, infliximab, ustekinumab, or vedolizumab) between January 1, 2017, and December 31, 2018, and no claims for biologics in the 6 months prior (ie, biologic naive) were included. Follow-up ended on June 30, 2020. Cox proportional hazards models and logistic regression models were used to compare the rate of dose escalation and the likelihood of adverse clinical outcomes and costs after dose escalation, respectively. Of the 2,664 eligible patients, most (71.4%) were younger than 50 years and 50.5% were male. The rate of dose escalation was higher with the anti-tumor necrosis factor α (TNFα) treatments adalimumab (hazard ratio [HR] = 1.703; P < 0.0001) and infliximab (HR = 1.690; P < 0.0001) compared with vedolizumab, but there was no significant difference between ustekinumab and vedolizumab (HR = 0.842; P = 0.730). After dose escalation, the likelihood of infection, sepsis, and inflammatory bowel disease-related hospitalization did not differ among biologics (anti-TNFα vs vedolizumab: odds ratio [OR] = 1.141, P = 0.599; ustekinumab vs vedolizumab: OR = 0.891; P = 0.836); however, corticosteroid use was more likely with anti-TNFα treatment than with vedolizumab (OR = 1.740, P = 0.002). Among patients whose dose was escalated, index drug costs were likely to be higher with anti-TNFα treatment and ustekinumab than with vedolizumab (anti-TNFα vs vedolizumab: ratio of expected cost = 1.429, P = 0.002; ustekinumab vs vedolizumab: ratio of expected cost = 3.115, P < 0.0001). Patients who were biologic naive and received ustekinumab or vedolizumab were less likely to undergo dose escalation than those who received anti-TNFα treatment. Adverse clinical outcomes after dose escalation were similar among these biologics but with different costs. These analyses may inform providers and payers of the clinical and economic implications of dose escalation.

Development of a Practical Prediction Model for Adverse Neonatal Outcomes at the Start of the Second Stage of Labor.

To develop a prediction model for adverse neonatal outcomes using electronic fetal monitoring (EFM) interpretation data and other relevant clinical information known at the start of the second stage of labor. This was a retrospective cohort study of individuals who labored and delivered at two academic medical centers between July 2016 and June 2020. Individuals were included if they had a singleton gestation at term (more than 37 weeks of gestation), a vertex-presenting, nonanomalous fetus, and planned vaginal delivery and reached the start of the second stage of labor. The primary outcome was a composite of severe adverse neonatal outcomes. We developed and compared three modeling approaches to predict the primary outcome using factors related to EFM data (as interpreted and entered in structured data fields in the electronic health record by the bedside nurse), maternal comorbidities, and labor characteristics: traditional logistic regression, LASSO (least absolute shrinkage and selection operator), and extreme gradient boosting. Model discrimination and calibration were compared. Predicted probabilities were stratified into risk groups to facilitate clinical interpretation, and positive predictive values for adverse neonatal outcomes were calculated for each. A total of 22,454 patients were included: 14,820 in the training set and 7,634 in the test set. The composite adverse neonatal outcome occurred in 3.2% of deliveries. Of the three modeling methods compared, the logistic regression model had the highest discrimination (0.690, 95% CI, 0.656-0.724) and was well calibrated. When stratified into risk groups (no increased risk, higher risk, and highest risk), the rates of the composite adverse neonatal outcome were 2.6% (95% CI, 2.3-3.1%), 6.7% (95% CI, 4.6-9.6%), and 10.3% (95% CI, 7.6-13.8%), respectively. Factors with the strongest associations with the composite adverse neonatal outcome included the presence of meconium (adjusted odds ratio [aOR] 2.10, 95% CI, 1.68-2.62), fetal tachycardia within the 2 hours preceding the start of the second stage (aOR 1.94, 95% CI, 1.03-3.65), and number of prior deliveries (aOR 0.77, 95% CI, 0.60-0.99).

Exposure to Racism and Adverse Pregnancy Outcomes for Black Women: A Systematic Review and Meta-Analysis.

Research suggests that stress due to racism may underlie the disproportionately high rates of adverse pregnancy outcomes experienced by Black women in the US. Study objectives: (1) Identify forms of systemic racism affecting pregnancy outcomes and (2) increase understanding about the role of racism in adverse pregnancy outcomes for Black women. A systematic review was conducted to explore the relationship between systemic racism and pregnancy outcomes for Black women. Searches were performed using EBSCO Academic Search Complete, CINAHL Complete, and Consumer Health Complete first between January to April 2021 and subsequently between November 2023 to January 2024. Included studies were observational, written in English, had full-text availability, examined at least one form of systemic racism and pregnancy outcome, and reported results for Black women. A meta-analysis was performed using a random effects model, summary effect estimates were pooled by pregnancy outcome. The I2 statistic was used to measure heterogeneity between studies. A total of 32 studies were included in the review. Significant pooled effects of exposure to systemic racism were observed for preterm birth 0.30 (95% CI 0.12-0.48), small for gestational age 0.31 (95% CI 0.05-0.58), and low birth weight 0.24 (95% CI 0.11-0.37). Among studies that compared results by race, exposure to systemic racism had a significant and rather large effect on preterm birth for Black women (ds = 0.62; 95% CI 0.06-0.41). Exposure to systemic racism has a significant effect on preterm birth, small for gestational age, and low birth weight for Black women. Having knowledge of how racism contributes to stress and poor pregnancy outcomes can help health professionals improve delivery of quality care to Black women. Future research should continue identifying forms of racism positively related to adverse pregnancy outcomes.

Cancer chemotherapy in pregnancy and adverse pediatric outcomes: a population-based cohort study.

Administration of chemotherapy during pregnancy is often delayed, while preterm delivery is common. If in utero exposure to chemotherapy is associated with adverse pediatric outcomes, it is unknown whether that relationship is directly attributable to the chemotherapy or is mediated by preterm birth. Cases were identified from Canadian cancer registries and administrative data in Alberta, British Columbia, and Ontario, 2003-2017, with follow-up until 2018. The primary exposure was receipt of chemotherapy during pregnancy. Severe neonatal morbidity and mortality (SNM-M), neurodevelopmental disorders and disabilities (NDDs) and pediatric complex chronic conditions (PCCC) reflected short- and long-term pediatric outcomes. Modified Poisson and Cox proportional hazard regression models generated adjusted risk ratios (RR) and hazard ratios (HR), respectively. The influence of preterm birth on the association between exposure to chemotherapy in pregnancy and each study outcome was explored using mediation analysis. Of the 1150 incident cases of cancer during pregnancy, 142 (12.3%) received chemotherapy during pregnancy. Exposure to chemotherapy in pregnancy was associated with a higher risk of SNM-M (RR 1.67, 95% CI: 1.13-2.46), but not NDD (HR 0.93, 95% CI: 0.71-1.22) or PCCC (HR 0.96, 95% CI: 0.80-1.16). Preterm birth <34 and <37 weeks mediated 75.8% and 100% of the observed association between chemotherapy and SNM-M, respectively. Most children born to people with cancer during pregnancy appear to have favourable long-term outcomes, even following exposure to chemotherapy in pregnancy. However, preterm birth is quite common, and may contribute to increased rates of adverse neonatal outcomes.

Incidence and factors associated with immediate adverse neonatal outcomes among emergency obstetric referrals in labor at a tertiary hospital in Uganda: a prospective cohort study

BackgroundHigh rates of adverse neonatal outcomes in resource-limited settings are multifactorial, varying by country, region, and institution. In sub-Saharan Africa, the majority of adverse neonatal outcomes are intrapartum related, and studies in Uganda have shown that referral in labor is a major determinant of adverse neonatal outcomes. This study aimed to assess the incidence and factors associated with immediate adverse neonatal outcomes among emergency obstetric referrals in labor at a tertiary hospital in Eastern Uganda.Materials and methodsThis was a prospective cohort study involving 265 women who were referred in labor to Jinja Regional Referral Hospital in Uganda with emergency obstetric complications. The exposure of interest was being referred with obstetrical emergency, and the outcome variable was adverse neonatal outcomes. The study was conducted between July 5, 2023, and October 5, 2023. Consecutive sampling was used, and data on sociodemographic and obstetric factors, referral related factors, as well as the primary outcome variable (adverse neonatal outcome) were collected via interviewer-administered questionnaires. The data were then cleaned, coded, and analyzed using STATA version 14. Log-binomial regression determined risk ratios and associations for factors related to adverse neonatal outcomes. Variables with p-values < 0.2 in bivariable analysis were included in the multivariable analysis, where significance was set at p < 0.05.ResultsOf the 265 women exposed to emergency obstetrical referrals, 40% experienced adverse neonatal outcomes, a composite measure including neonatal intensive care admission (27.6%), low Apgar score (23.8%), fresh stillbirth (11.3%), early-onset neonatal infection (6.8%), and early neonatal death (2.3%). Factors significantly associated with adverse neonatal outcomes were; maternal age ≥ 35 years (aRR = 1.72, CI:1.194–2.477, p value = 0.004), APH (aRR = 2.48, CI: 1.859–3.311, p-value < 0.001), and non-reassuring fetal status (aRR = 1.90, CI: 1.394–2.584, p-value < 0.001).ConclusionsThe study found a high rate of adverse neonatal outcomes among emergency obstetric referrals, with 40% of participants facing issues like ICU admissions, low Apgar scores and fresh stillbirth. Key factors included maternal age over 35, antepartum hemorrhage, and non-reassuring fetal status. These results highlight the urgent need for targeted interventions in emergency obstetric care. Strategies should enhance referral systems, improve facility preparedness, train healthcare providers, and educate communities on timely referrals and managing high-risk pregnancies.

Dapagliflozin versus empagliflozin and major adverse cardiovascular events in type 2 diabetes: a nationwide cohort study

Abstract Background Large randomized clinical trials have shown that sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of adverse kidney and cardiovascular outcomes in patients with heart failure, chronic kidney disease, or type 2 diabetes mellitus (T2DM) at high risk of atherosclerotic cardiovascular disease. Whether these effects might differ between individual SGLT2-inhbitors remain unclear given the lack of head-to-head comparisons. Purpose To examine the association between treatment with dapagliflozin versus empagliflozin and the long-term rate of major adverse cardiovascular events (MACE) in patients with T2DM. Methods Using nationwide registries, all Danish residents with T2DM, who initiated treatment with dapagliflozin or empagliflozin from 2015 to 2020, were identified. Only treatment with dapagliflozin or empagliflozin was considered in the present analysis, since approximately 3% initiated treatment with other SGLT2-inhibitors (i.e., canagliflozin and ertugliflozin). Patients were followed from date of the first claimed prescription of dapagliflozin or empagliflozin until the outcome of interest, emigration, death, or end of study (December 31, 2021). The primary outcome was a composite endpoint of major adverse cardiovascular events (i.e., time to first heart failure hospitalisation, acute myocardial infarction (AMI), stroke, or all-cause mortality). The primary outcome was compared between the dapagliflozin and empagliflozin group, overall and in prespecified subgroups of interest, with multivariable Cox proportional hazards regression models. Results In total, 61,031 patients with T2DM initiated treatment with dapagliflozin (N=21,028; 34.5%) or empagliflozin (N=40,003; 65.5%). The median age of study population was 62.6 years (25th-75th percentile, 54.2-70.8 years), and 62.6% were men. There were no clinically significant differences between the dapagliflozin and empagliflozin group with respect to age, sex, and clinical characteristics. The median follow-up was 3.1 years (25th-75th percentile, 1.9-4.5 years). The adjusted long-term hazard ratios of the primary outcome, overall and in prespecified subgroups of interest, are displayed in the Figure. Compared with empagliflozin, treatment with dapagliflozin was not associated with a significantly different rate of the primary outcome (HR 1.02 [95% CI, 0.97-1.07]). The observed association was consistent across clinically relevant subgroups, including in patients with and without heart failure, chronic kidney disease, and atherosclerotic cardiovascular disease. Conclusion In a large, nationwide cohort of patients with T2DM, treatment with dapagliflozin was associated with a similar rate of major adverse cardiovascular outcomes compared with empagliflozin, and this association was consistent across clinically relevant subgroups. These findings suggest that the benefits of SGLT2-inhibitors can be characterized as a class-effect.

Menopausal status and clinical outcomes in women with heart failure with reduced ejection fraction: the GALACTIC-HF trial

Abstract Introduction Mechanisms driving disease progression and potential responsiveness to investigational therapies may theoretically differ among women with heart failure (HF) based on menopausal status. However, few data are available describing the clinical course of premenopausal and postmenopausal women with HF. We investigated differences in baseline characteristics, clinical outcomes, and response to omecamtiv mecarbil in premenopausal and postmenopausal women participants of the GALACTIC-HF trial. Methods The GALACTIC-HF trial randomized patients with symptomatic HFrEF with LVEF of 35% or less to omecamtiv mecarbil or placebo. Menopausal status at randomization was collected. When menopausal status was unknown/unreported, menopausal status was inferred based on the expected distribution of age at menopause in the general population. The risk of the primary endpoint, worsening HF event or cardiovascular death, was compared among women by menopausal status using Cox regression models adjusted for clinical covariates, including age and baseline EF. Treatment effect heterogeneity was evaluated by menopausal status. Results Of the 8,232 patients enrolled, 1,749 (21.2%) were women. Menopausal status was available at baseline in 1,483 (84.8%). One hundred women reported being potentially childbearing (pre-menopausal) and 1,383 women reported being post-menopausal. Among the 266 patients that had unknown menopausal status, those younger than 47 years were additionally classified as pre-menopausal and those older than 56 years as post-menopausal based on estimated 10th /90th percentiles extrapolated from the general population. Compared to post-menopausal women, pre-menopausal women were younger, had higher eGFR, and had fewer comorbidities. Premenopausal women also had slightly higher BMI and lower LVEF, but lower NTproBNP and troponin at baseline compared to postmenopausal women. Premenopausal and postmenopausal women had similarly high burden of symptoms as assessed by the KCCQ-total symptoms score (median 63.5 vs. 64.6; P=0.79). During a median follow-up of 22 months, premenopausal and postmenopausal women experienced similar rates of primary and secondary outcomes (Table 1). Omecamtiv mecarbil was beneficial across the entire female cohort with no effect modification by menopausal status (Pinteraction=0.39). Sensitivity analysis excluding all women with unknown menopausal status yielded similar results. Conclusions In this high-risk HFrEF cohort, premenopausal women experienced similar rates of adverse cardiovascular outcomes as post-menopausal women despite younger age, fewer comorbidities, and lower cardiac biomarkers. Additional research is necessary to understand how risk factors unique to females might influence outcomes in those with heart failure. The benefit of omecamtiv mecarbil on reducing cardiovascular risk was consistent regardless of menopausal status.Primary/secondary outcomes by menopausal

Impact of atrial fibrillation on mortality and non-fatal clinical outcomes in 28 492 patients who had undergone open-heart aortic versus mitral valve surgery: a statewide population-linkage study

Abstract Background Postoperative atrial fibrillation (AF) is common after cardiac surgery and has been associated with increased mortality and morbidity. Few studies have defined the impact of AF status (New-AF versus Prior-AF) on clinical outcomes during long-term follow-up and compared AF-related clinical outcomes between patients who had undergone isolated aortic valve surgery (AVSx) or mitral valve surgery (MVSx). Purpose This study aims to examine the impact of AF status on clinical outcomes in patients who had undergone AVSx versus MVSx using a statewide-population administrative database. Methods Patients who had open-heart cardiac valve surgery (1 January 2003 to 31 March 2021) identified from the Admitted-Patient-Data-Collection database in an Australian state, were stratified by AF status (No-AF vs New-AF vs Prior-AF during index admission for valve surgery) and followed up to 31 March 2022. A linkage look-back to year-2001 was performed to identify prior-AF history. Kaplan-Meier and multivariable Cox regression were performed to assess the impact of AF status on all-cause mortality. Fine-Gray competing risk analysis to account for the competing death events was used to assess non-fatal clinical outcomes. Results The overall cohort comprised 28 492 patients (median age 71.6yrs [interquartile range (IQR) 62.7–78.3yrs; 65.6% males): AVSx, n=18949; MVSx, n=9543 (Table 1). During a median follow-up of 6.6yrs (3.42–10.5yrs), Prior-AF and New-AF patients had significantly higher all-cause mortality (AVSx – Prior-AF: 1771 (57.9%) vs New-AF: 2854 (41.5%) vs No-AF: 2961 (32.8%); MVSx – Prior-AF: 1126 (41.0%) vs New-AF: 1034 (29.8%) vs No-AF: 747 (22.4%) (both Kaplan-Meier logrank P&amp;lt;0.001). After adjusting for differences in baseline characteristics and admission year-groups, in the AVSx subgroup, both new-AF and prior-AF were independently associated with all-cause mortality (aHR=1.16, 95%CI=1.10–1.22; aHR=1.69, 95%CI=1.59–1.79 respectively, both P&amp;lt;0.001) compared to no-AF patients. In the MVSx subgroup, only prior-AF was associated with increased risk of all-cause mortality (aHR=1.47, 95% CI=1.33–1.61, P&amp;lt;0.001). Competing risk analyses showed higher rehospitalisation rates for AF and congestive cardiac failure for new-AF and prior-AF groups compared to No-AF patients after both AVSx and MVSx, whereas the rehospitalisation rate for ischemic stroke was only significantly higher in the AVSx new-AF and prior-AF subgroups (all p &amp;lt; 0.05) (Table 2). Conclusions Patients undergoing open-heart aortic or mitral valve surgery are at risk of significant adverse clinical outcomes including death, heart failure and ischaemic stroke, with the target valve and baseline AF status having a differential impact on clinical outcomes. Drivers behind these high rates of adverse outcomes should be explored further and strategies should be developed and tailored accordingly to different surgical patient groups to improve their prognosis.

Association of lipid target achievement and cardiovascular outcomes following statin initiation: a population-based cohort study

Abstract Introduction Non-high density lipoprotein cholesterol (non-HDL-C) is increasingly incorporated into clinical practice guidelines along with low density lipoprotein cholesterol (LDL-C) to guide lipid-lowering therapy decisions. We aimed to examine patterns of LDL-C and non-HDL-C levels after statin initiation for primary prevention of cardiovascular disease (CVD), and their association with incident CV events. Methods We conducted a population-based cohort study of Ontario, Canada residents age ≥66 years who initiated a statin for primary prevention between January 1, 2012 and December 31, 2019. For those surviving 1-year after statin initiation, we determined the proportion with a lipid panel in the 1-year period after a statin was started. For those with a lipid panel, we used the lipid panel closest to the end of the 1-year period to categorize individuals based on the LDL-C and non-HDL-C thresholds in the 2021 Canadian Cardiovascular Society dyslipidemia guidelines (Table 1). We stratified by diabetes/chronic kidney disease (CKD) status. We evaluated the association between LDL-C/non-HDL-C category and a composite of all-cause mortality or hospitalization for myocardial infarction, stroke or revascularization (primary outcome). We also investigated the association between each category and each component of the primary outcome. The index date was the 365 days after a statin was initiated and follow-up was until December 31, 2020. We used a cause-specific hazards model for analysis, adjusted for clinical and sociodemographic confounders. Results Our cohort comprised 173,127 people. In the 1-year period after statin initiation, 72% of people had a follow-up lipid panel performed. Median follow-up after that was 2.5 years. Compared with those meeting both LDL-C and non-HDL-C targets, being above both targets was associated with an increased rate of the primary outcome for people without diabetes/CKD (HR 1.10, 95% CI 1.05 to 1.15) and those with diabetes/CKD (HR 1.16, 95% CI 1.09 to 1.23). Being at LDL-C target but above non-HDL-C target was associated with an increased rate of the primary outcome for people with diabetes/CKD (HR 1.16, 95% CI 1.03 to 1.30) but not for those without diabetes/CKD (HR 1.05, 95% CI 0.93 to 1.17). Conclusions In this population-based cohort, having an LDL-C and non-HDL-C above guideline-recommended targets after statin initiation was associated with an increased rate of adverse outcomes. These findings support the residual risk associated with incompletely controlled LDL-C or non-HDL-C levels after initiating statin therapy for primary prevention.Primary outcome associationsComponents of primary outcome

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.

Wait, What? What's Going On?- Pregnancy Experiences of Deaf and Hard of Hearing Mothers Who Do Not Sign.

Deaf and hard of hearing (DHH) women experience higher rates of reproductive healthcare barriers and adverse birth outcomes compared to their hearing peers. This study explores the pregnancy experiences of DHH women who do not sign to better understand their barriers and facilitators to optimal perinatal health care. Qualitative study using thematic analysis. Semi-structured, individual remote, or in-person interviews in the United States. Twenty-two DHH English speakers (non-signers) who gave birth in the United States within the past 5 years. Semi-structured interviews explored how DHH women experienced pregnancy and birth, including access to perinatal information and resources, relationships with healthcare providers, communication access, and their involvement with the healthcare system throughout pregnancy. A thematic analysis was conducted. The barriers and facilitators related to a positive perinatal care experience among DHH women. Five key themes emerged. For barriers, healthcare communication breakdowns and loss of patient autonomy highlighted DHH women's struggle with perinatal health care. In contrast, DHH participants outlined the importance of accessible health communication practices and accommodations, use of patient advocacy or self-advocacy, and assistive technologies for DHH parents for more positive perinatal care experiences. Perinatal healthcare providers and staff should routinely inquire about ways to ensure an inclusive and accessible healthcare experience for their DHH patients and provide communication accommodations for optimal care. Additionally, healthcare providers should be more aware of the unique parenting needs and resources of their DHH patients.

Microsurgical Clipping of Unruptured Middle Cerebral Artery Bifurcation Aneurysms: A Single-Center Experience

Background/Objectives: Microsurgical clipping has traditionally been considered a standard treatment for middle cerebral artery (MCA) aneurysms. Recently, a caseload reduction related to improved endovascular treatment options has occurred in cerebrovascular neurosurgery. Therefore, studies that report the clinical and radiological outcomes after clipping are highly warranted. Methods: Patients with an unruptured MCA bifurcation aneurysm, who were surgically treated at the Department of Neurosurgery in Linz between 2002 and 2019, were included in this study. Clinical and radiological outcome parameters were evaluated for each patient. Results: Overall, 272 patients were eligible for inclusion. Complete aneurysm occlusion was demonstrated in 266 (99.3%) of the 268 (98.5%) patients who underwent postoperative digital subtraction angiography. In six (2.2%) patients, a permanent new neurological deficit (pNND) persisted after treatment. Intraoperative aneurysm rupture was a significant factor (p = 0.0049) in the logistic regression. At the last follow-up, only two patients (0.7%) had an unfavorable outcome (mRS &gt; 2). More recent surgeries were associated with fewer cases of pNND (p = 0.009). A transient new neurological deficit occurred in 13 patients (4.8%), with aneurysm size being a significant risk factor (p = 0.009). Surgical site infections were reported in four patients (1.5%), with patient age (p = 0.039) and time (p = 0.001) being significant factors. Two patients died (0.7%) perioperatively and two patients (0.7%) needed a retreatment in the long-term follow-up. Conclusions: The findings indicate that microsurgical clipping is a safe procedure with minimal need for retreatment. It achieves a high occlusion rate while maintaining a very low rate of adverse outcomes. Continuous intraoperative enhancements over time have contributed to a progressive improvement in clinical outcomes in recent years. This trend is exemplified by the absence of detectable pNND in the era of ICG angiography. Consequently, these data support the conclusion that microsurgical clipping should still be considered an appropriate treatment option for unruptured MCA bifurcation aneurysms.

Incidence of Compartment Syndrome Following Peri-Pandemic Intervention for Non-traumatic Acute Limb Ischemia.

During the pandemic, our institution anecdotally observed a significant proportion of acute limb ischemia (ALI) patients developing compartment syndrome (CS) following revascularization compared to pre-pandemic rates. To determine whether this perceived increase was occurring globally, we utilized the TriNetX database to evaluate the incidence of CS secondary to ALI intervention in both the pre-pandemic (2017-2019) and pandemic eras (2020-2022). We conducted a multicenter query using the TriNetX global research network for ALI patients receiving treatment. Incidence of CS diagnosis within 1 calendar day of ALI intervention was calculated for each era. Demographics and comorbidities were then compared between CS and non-CS patients within each era. Risk of adverse outcomes within 30 days of CS diagnosis was also determined for each era, including mortality, major amputation, and re-intervention. The pre-pandemic cohort contained 7736 patients while the pandemic era cohort included 8,306, for 16,042 total patients. A significant increase in CS incidence (risk ratio (RR) = 1.23, P = 0.0026) was demonstrated within the pandemic era. An increased prevalence of comorbidities such as dyslipidemia (pre-pandemic: P = 0.0022; pandemic: P = 0.0026) and peripheral vascular disease (P < 0.0001, both eras) was observed in the non-CS cohort within both eras. 30-day mortality was significantly increased in CS patients (pre-pandemic: RR = 3.057; pandemic: RR = 2.710; P < 0.0001 both eras) compared to non-CS patients. CS patients were more likely to receive major amputation (pre-pandemic: RR = 3.734; pandemic: RR = 2.809; P < 0.0001 both eras) and/or re-intervention within 30 days (pre-pandemic: RR = 1.871, P < 0.0001; pandemic: RR = 1.370, P = 0.0218) over non-CS patients. The incidence of CS following revascularization for ALI rose worldwide during the pandemic. Patients who developed CS are younger with fewer comorbidities than non-CS patients. Despite a more favorable comorbid profile, CS patients demonstrate significantly higher rates of adverse outcomes. Further investigation is necessary to determine the specific underlying mechanisms driving this increased incidence in CS among ALI patients.

Beyond the numbers: Impact of obesity on obstetric anal sphincter injury (OASI) outcomes in women.

To compare the risk profiles, anatomical, and functional outcomes between obese and non-obese women who experienced obstetric anal sphincter injury (OASI). A retrospective electronic database study was conducted at Cork University Maternity Hospital (CUMH). Women with missing data/repairs conducted outside CUMH were excluded. Participants were categorized into obese (BMI ≥30 kg/m2) and non-obese (BMI <30 kg/m2) groups. Primary measure was a composite adverse outcome assessed 6 months post-delivery, including one or more of the following: resting pressure <40 mmHg, squeezing pressure <100 mmHg, defects in the internal and/or external anal sphincter. Statistical analyses were performed using SPSS version 28. Among the 349 women included in the study, 285 (81.7%) had a BMI <30 kg/m2 and 64 (18.3%) had a BMI ≥30 kg/m2. Gestational diabetes was significantly higher in obese women. No significant differences were observed in newborn weight or mode of delivery. The majority of tears were classified as grade 3B in both groups. Attendance rates at the OASI clinic did not differ between the groups. Among those attending, no statistical differences were noted in manometry results, which were reduced in both groups. Rates of internal anal sphincter defects were lower in the obese group (7.0% vs 15.6%, P = 0.15) and external anal sphincter defects were significantly lower in obese women (0% vs 9.1%, P = 0.04). No difference was found in the rates of composite adverse outcomes between the groups. Functional outcomes and manometry results did not differ, but non-obese women had higher rates of anatomical defects in OASI, requiring further study.

Optimal risk thresholds for prescribing statins as primary prevention of cardiovascular disease in Iranian general population: a benefit-harm modelling study

PurposeThe use of statins for the primary prevention of cardiovascular diseases (CVD) is associated with various beneficial outcomes, alongside certain undesirable effects. This study aims to determine optimal risk thresholds above which statin therapy yields a net benefit, considering both the positive effects and potential adverse effects, as well as their probabilities and patient preferences.MethodsQuantitative benefit-harm balance modeling was applied to the Iranian general population aged 40 to 75 years with no history of CVD. The analysis utilized data from prior studies, including statin effect estimates for different outcomes from a meta-analysis, patient preferences obtained from an Iranian survey, and baseline incidence rates of adverse outcomes sourced from the Global Burden of Disease study for Iran. Outcomes were defined as angina, myocardial infarction, fatal coronary heart disease, fatal or non-fatal stroke, and heart failure. Benefit-harm balance indices were calculated for various combinations of age, sex, and 10-year CVD risk.ResultsStatin therapy was found to be advantageous at a lower 10-year CVD risk threshold in men (18–23%) compared to women (24–28%). Furthermore, individuals aged 40–45 years exhibited a lower risk threshold (18% in men, 24% in women) than those aged 70–75 years (23% in men, 28% in women).ConclusionThe desirable 10-year risk thresholds for statin prescription in the primary prevention of CVD vary by age and gender, ranging from 18 to 28%, encompassing a spectrum of outcomes from angina to CVD mortality. These results suggest hard-CVD risk thresholds of 7.5% to 10% for both sexes.

Prognostic value of Ki67 in phyllodes tumor of the breast: A systematic review and meta‑analysis.

Numerous clinicopathological features have been examined as predictive factors for adverse outcomes in patients with phyllodes tumor (PT) of the breast, but there are still no definitive predictive markers to guide management, despite the persistent risk of recurrence, even in benign disease. Whether Ki67 has prognostic value in PT remains uncertain. Therefore, a systematic review and meta-analysis were performed to examine whether Ki67 is associated with adverse clinical outcomes, particularly recurrence, in patients with PT. The PubMed/MEDLINE, Web of Science, Scopus, Embase and Cochrane Library databases were searched from inception to July 2024. Study characteristics and outcomes (recurrence and overall survival) according to Ki67 status were extracted from each eligible study, and pooled log odds ratios (OR) with 95% CI were derived using a random-effects model. A total of five studies comprising 280 cases were eligible for inclusion. The adverse outcome rate for the Ki67high (Ki67 >10 or >11.2%) population was 28.7% (95% CI, 20.1-38.6%), while the adverse outcome rate for the Ki67low population was 9.4% (95% CI, 5.4-13.5%). Ki67high was associated with an increased odds of an adverse outcome [log OR, 1.26 (95% CI, 0.38-2.15; P=0.005)] compared with a Ki67low status. All five studies scored 8 points on the Newcastle-Ottawa Scale, equivalent to 'good' quality according to Agency for Healthcare Research and Quality standards, and no significant publication bias was noted. This was the first meta-analysis of the predictive value of Ki67 in PT of the breast. A relatively high Ki67 index (>10%) is associated with recurrence. It is timely to re-evaluate the prognostic value of Ki67 in large retrospective cohorts with long follow-up to firmly establish whether it could contribute to identifying patients at risk of recurrence, particularly those with histologically benign disease. Doing so could impact clinical practice by refining follow-up recommendations based on quality evidence.

Patient outcomes following buprenorphine treatment for opioid use disorder: A retrospective analysis of the influence of patient- and prescriber-level characteristics in Massachusetts, USA.

Opioid use disorder (OUD) is treatable with buprenorphine/naloxone (buprenorphine), but many patients discontinue treatment prematurely. The aim of this study was to assess the influence of patient- and prescriber-level characteristics relative to several patient outcomes following the initiation of buprenorphine treatment for OUD. This was a retrospective observational investigation. We used the Public Health Data Warehouse from the Massachusetts Department of Public Health to construct a sample of patients who initiated buprenorphine treatment between 2015 and 2019. We attributed each patient to a prescriber based on information from prescription claims. We used multilevel models to assess the influence of patient- and prescriber-level characteristics on each outcome. Massachusetts, USA. The study cohort comprised 37 955 unique patients and 2146 prescribers. Among patients, 64.6% were male, 52.6% were under the age of 35 and 82.2% were White, non-Hispanic. For insurance coverage, 72.1% had Medicaid. The outcome measures were poor medication continuity, treatment discontinuation and opioid overdose, all assessed within a 12-month follow-up period that began with a focal prescription for buprenorphine. Each patient had a single follow-up period. Poor medication continuity was defined as medication gaps totaling more than 7days during the initial 180 days of buprenorphine treatment and treatment discontinuation was defined as having a medication gap for 2 consecutive months within the 12-month follow-up period. The patient-level rates for poor medication continuity, treatment discontinuation and opioid overdose were 59.7% [95% confidence interval (CI) = 59.2-60.2], 57.4% (95% CI = 56.9-57.9) and 10.3% (95% CI = 10.0-10.6), respectively, with 1.1% (95% CI = 1.0-1.2) experiencing a fatal opioid overdose. At the patient level, after adjustment for covariates, adverse outcomes were associated with race/ethnicity as both Black, non-Hispanic and Hispanic patients had worse outcomes than did White, non-Hispanic patients (Black, non-Hispanic -- poor continuity: 1.50, 95% CI = 1.34-1.68; discontinuation: 1.44, 95% CI = 1.30-1.60; Hispanic -- poor continuity: 1.21, 95% CI = 1.12-1.31; discontinuation: 1.38, 95% CI = 1.28-1.48). Patients with insurance coverage through Medicaid also had worse outcomes than those with commercial insurance (poor continuity: 1.18, 95% CI = 1.11-1.26; discontinuation: 1.09, 95% CI = 1.03-1.16; overdose: 1.98, 95% CI = 1.75-2.23). Pre-treatment mental health conditions and other types of chronic illness were also associated with worse outcomes (History of mental health conditions -- poor continuity: 1.11, 95% CI = 1.06-1.17; discontinuation: 1.05, CI = 1.01-1.10; overdose: 1.47, 95% CI = 1.36-1.60; Chronic health conditions -- poor continuity: 1.15, 95% CI = 1.05-1.27; discontinuation: 1.15, 95% CI = 1.05-1.26; overdose: 1.83, 95% CI = 1.60-2.10; History of substance use disorder other than for opioids -- poor continuity: 1.54, 95% CI = 1.46-1.62; discontinuation: 1.54, 95% CI = 1.47-1.62; overdose: 1.93, 95% CI = 1.80-2.07). At the prescriber level, after adjustments for covariates, adverse outcomes were associated with clinical training, as primary care physicians had higher rates of adverse outcomes than psychiatrists (poor continuity: 1.12, 95% CI = 1.02-1.23; discontinuation: 1.04, 95% CI = 1.01-1.09). A larger prescriber panel size, based on number of patients being prescribed buprenorphine, was also associated with higher rates of adverse outcomes (poor continuity: 1.36, 95% CI = 1.27-1.46; discontinuation: 1.21, 95% CI = 1.14-1.28; overdose: 1.10, 95% CI = 1.01-1.19). Between 9% and 15% of the variation among patients for the outcomes was accounted for at the prescriber level. Patient- and prescriber-level characteristics appear to be associated with patient outcomes following buprenorphine treatment for opioid use disorder. In particular, patients' race/ethnicity and insurance coverage appear to be associated with substantial disparities in outcomes, and prescriber characteristics appear to be most closely associated with medication continuity during early treatment.

Hereditary Hemorrhagic Telangiectasia: Pregnancy and Delivery-Specific Considerations and Outcomes.

Prior studies have evaluated maternal outcomes in patients with hereditary hemorrhagic telangiectasia (HHT), yet pregnancy- and delivery-specific data remain limited. This study aims to evaluate pregnancy and delivery outcomes in patients with HHT. This retrospective cohort study used the Nationwide Readmissions Database to identify patients with HHT diagnosis on delivery between 2010 and 2021. The primary outcome was severe maternal morbidity (SMM). Secondary outcomes included nontransfusion SMM, preterm birth, stillbirth, prelabor rupture of membranes or preterm prelabor rupture of membranes, cesarean delivery, respiratory bleeding, cerebrovascular complications, patient disposition, and length of stay. Trends in the prevalence of HHT at delivery were assessed with logistic regression. Logistic regression analyses, adjusting for age, payer, zip code income, hospital size, and teaching status, were also used to produce adjusted relationships between HHT status and outcomes. The cohort of 21,698,861 delivered pregnancies corresponded to a national estimate of 44,325,599. Of those, 612 (national estimate: 1,265; 2.8 per 100,000) had a diagnosis of HHT. A steady rise in the HHT diagnosis rate during pregnancy from 2010 to 2021 (1.7 per 100,000 in 2010, 3.8 per 100,000 in 2021, p < 0.001 for trend) was seen. Patients with HHT were significantly more likely to experience SMM compared with patients without HHT (7.8 vs. 1.7%, adjusted relative risk [aRR]: 4.49 [95% confidence interval, CI: 3.06, 6.58]). Rates of preterm birth (14.2 vs. 8.5%, aRR: 1.57 [95% CI: 1.22, 2.03]), cesarean delivery (41.0 vs. 32.9%, aRR: 1.23 [95% CI: 1.07, 1.41]), respiratory bleeding (2.1 vs. <0.1%, aRR: 94.44 [56.64, 157.46]), and cerebrovascular complications (0.9 vs. <0.1%, aRR: 22.89 [9.89, 52.96]) were higher in patients with HHT than non-HHT patients. There was no difference in stillbirth rates between groups. Patients with HHT have higher rates of SMM and adverse delivery outcomes when compared with the baseline population. · There was a steady rise in the rates of HHT during pregnancy from 2010 to 2021.. · Patients with HHT are more likely to experience SMM.. · Patients with HHT are more likely to have a preterm delivery and cesarean delivery..

The association between fracture and short-term adverse health outcomes among children with cerebral palsy

BackgroundChildren with cerebral palsy (CP) have a high risk of fracture; yet, little is known about their post-fracture health outcomes. A fracture is an unplanned event in contrast to surgeries or procedures where there is a pre-operative period to optimize body composition and health and planned post-operative follow-up care. Fractures may be associated with significant outcomes due to the unplannable nature and reactionary care. The objective of this study was to determine if fractures were associated with an increased rate of short-term adverse health outcomes among children with CP, and if these associations were dependent on age. MethodsThis retrospective cohort study used commercial claims from 01/01/2001–12/31/2018. The primary cohort was children 2–18 years old with CP and an incident fracture (CP + Fx). Comparison cohorts were propensity score matched 1:1 to CP + Fx on demographic and health-related indicators: CP without fractures (CPw/oFx); without CP with (w/oCP + Fx) or without (w/oCPw/oFx) a fracture. The incidence rate (IR) and IR ratios (IRR) of 30-day and 31–90-day pneumonia and 90-day emergency department (ED) visit were estimated. Cox regression tested for effect modification by age and sex. ResultsThe CP + Fx cohort (n = 1670) had higher IRs of 30-day pneumonia (IRR range, 1.53–4.54) and 90-day ED visit (IRR range, 1.45–2.37) (all P < 0.05), and higher IRs of 31–90-day pneumonia but this did not reach statistical significance (IRR, 1.41 to 2.32, all P > 0.05). Notably, there was evidence of effect modification by age. The rate of 30-day pneumonia became more problematic for CP + Fx with older age relative to comparison cohorts and for 90-day ED visit compared to CPw/oFx. The rate of 90-day ED visit for CP + Fx was more problematic at younger ages compared to w/oCP + Fx. ConclusionsFractures among children with CP were associated with an increased rate of short-term pneumonia and ED visit, which was more problematic with older age.

A-313 Use of the Preeclampsia Ratio in the Prognosis of Preterm Delivery and Adverse Outcomes

Abstract Background Preeclampsia (PE) is a hypertensive disorder of pregnancy that is characterized by high blood pressure and end-organ dysfunction with or without proteinuria after 20 weeks gestation. PE occurs in 6-8% of pregnancies and contributes to significant fetal, neonatal, and maternal morbidity and mortality. The ratio of two angiogenic placental proteins, soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF), are used in the management of PE. The purpose of this study was to evaluate use of the sFlt-1/PlGF ratio (PE ratio) generated using the ADVIA Centaur® and Atellica® IM sFlt-1 assay and the ADVIA Centaur and Atellica IM PlGF assays in the prognosis of preterm delivery and adverse outcomes in women presenting with signs and symptoms of PE. Methods A total of 654 females with singleton pregnancies between gestational weeks 20+0 days and 35+6 days and who had signs and symptoms of PE, but without severe features of PE were enrolled at 24 collection sites and followed prospectively for two weeks. Serum samples were collected at enrollment and adverse outcomes that included preterm delivery were prospectively collected within the two weeks after enrollment. Serum samples from approximately half of the population (n=316) were tested in singlicate using the sFlt-1 and PlGF assays on the ADVIA Centaur system in a derivation study that determined the optimal cutoff of the PE ratio in relation to adverse outcome. The remaining serum samples (n=338) were subsequently tested on the ADVIA Centaur system in a cut-off validation study that evaluated the clinical performance (sensitivity [SE], specificity [SP], positive predictive value [PPV], negative predictive value [NPV]) of the PE ratio at the derived cutoff in relation to adverse outcome. Method comparison studies were performed between the ADVIA Centaur versus the Roche Elecsys sFlt-1 and PlGF assays (n=255) and the ADVIA Centaur versus the Atellica IM sFlt-1 and PlGF assays (n=316). Results The rate of maternal adverse outcomes within two weeks was similar in the derivation study (32.3%) and validation study (28.1%). Using a receiver operating characteristic (ROC) curve analysis with the derivation cohort, a derived cutoff of 38 showed optimal clinical performance of the PE ratio in relation to adverse outcome (SE=72.5%, SP=94.7%, PPV=84.6%, NPV=89.5%). Similar clinical performance results of the PE ratio at the cutoff of 38 in relation to adverse outcome were found with the verification cohort (SE=88.42%, SP=87.65%, PPV=73.68%, NPV=95.09%). Weighted Deming regression analysis demonstrated equivalency between the Centaur, Roche, and Atellica PE ratios with correlation coefficients (r) of 0.9242 (Centaur vs Roche) and 0.995 (Centaur vs Atellica). Conclusions Measurement of sFlt-1 and PlGF to determine PE ratio can be performed on either the ADVIA Centaur or Atellica Analyzer and can be used to identify women presenting with PE or signs and symptoms of PE who are at high risk of experiencing an adverse event in the subsequent two weeks. Not available for sale in the U.S.A. The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed.