Subsequent Outcomes Research Articles

Advancing customer experience through service design in mega shopping malls

PurposeThis research aims to conceptualize and validate the mall service design as a multidimensional construct and then test a conceptual framework by investigating the impact of mall service design on customer mall experience and its subsequent outcomes, that is, intention to revisit and desire to stay in mega shopping malls.Design/methodology/approachThe survey data of 455 shopping visitors in Pakistan were collected using a mall intercept technique and tested through structural equation modeling in AMOS.FindingsThe study reveals that service design significantly impacts customer experience and subsequent outcomes. Customer mall experience mediates the relationships between mall service design and the intention to revisit and desire to stay at malls.Research limitations/implicationsData from a collectivist culture country (Pakistan) were collected. To explore the impact of service design on customer mall experience, researchers should conduct similar studies in individualistic societies like Europe and North America. Additionally, the authors recommend assessing the effect of each dimension of service design on customer experience separately.Practical implicationsThe research provides policy guidelines for the owners and operators of mega shopping malls in developing experience-oriented retailing strategies based on service design.Originality/valueThe research conceptualizes and validates the mall service design as a multidimensional construct using the service theater model and empirically tests its relationship with the customer mall experience.

Mediation analysis of public emotions in response to policy implementation performance during crises: the case of COVID-19 management policies in the UK

ABSTRACT Understanding public emotions in crises is crucial to effective public policy management for governments. This study examines the relationship between pandemic management policies, pandemic management performance, and fundamental emotions according to Plutchik’s Wheel of Emotion, in the context of COVID-19 in the UK. Our findings validate the role of emotions in shaping political events and then suggest the involvement of emotions, namely fear and surprise, as mediators in government policies and their subsequent outcomes in pandemic management. The study contributes to the public policy management literature by emphasizing the importance of the heterogeneity of emotions.

An Exploration of Tri-Axial Accelerometers in Assessing the Therapeutic Efficacy of Constraint-Induced Movement Therapy in Children with Unilateral Cerebral Palsy

This study aimed to elucidate the role of tri-axial accelerometers in assessing therapeutic interventions, specifically constraint-induced movement therapy (CIMT), in children with unilateral cerebral palsy (UCP). The primary focus was understanding the correlation between the actigraphy metrics recorded during CIMT sessions and the resultant therapeutic outcomes. Children with UCP, aged between 4 and 12 years, participated in this study from July 2021 to December 2022. In conjunction with in-clinic sessions, during which participants wore tri-axial accelerometers on both limbs, we analyzed actigraphy data over three days of routine activities pre- and post-CIMT. While not all metrics derived from the accelerometers indicated significant improvements post-intervention, there was a clear trend towards a more balanced usage of both limbs, particularly evident in Axis 3, associated with vertical movement (p = 0.017). Additionally, a discernible correlation was observed between changes in the magnitude ratio derived from actigraphy data during CIMT (Δweek3–week1) and variations in traditional assessments pre- and post-intervention (ΔT0–T1), specifically the Assisting Hand Assessment grasp and release. Using tri-axial accelerometers has helped clarify the potential impacts of CIMT on children with UCP. The preliminary results suggest a possible link between actigraphy metrics taken during CIMT and the subsequent therapeutic outcomes determined by standardized tests.

Social media users’ affective, attitudinal, and behavioral responses to virtual human emotions

Virtual humans’ communication of emotions in social media posts are considered heuristics of human behavior. The current study extends the Cognitive-Functional Model of Emotions to virtual influencers and investigates how social media users engage with virtual human emotions. In an experiment (N = 362), non-emotional and emotional (i.e., happy, sad, and lust) social media posts are examined for their influence on Generation Z and Millennial (18–40 years old) users’ affective responses and subsequent attitudinal and behavioral outcomes within the moderation of eeriness based on the uncanny valley paradigm. Findings indicate affective responses and attitudes are serial mediators between a virtual human’s display of emotion and social media users’ behavioral intentions, and eeriness was a significant moderator. Lust has the strongest effect, followed by happiness, sadness, and no emotion. This research elevates the Cognitive-Functional Model to discrete virtual human emotions with approach tendencies. Implications for understanding the impact of virtual humans’ emotions and sexual appeal on social media users’ engagement are discussed.

Associations of early pregnancy serum uric acid levels with risk of gestational diabetes and birth outcomes: a retrospective cohort study

BackgroundPrevious evidence suggests that higher blood uric acid (UA) levels are associated with adverse cardiovascular outcomes during pregnancy and subsequent birth outcomes. However, it has been relatively unclear whether these associations persist in normotensive pregnant women.MethodsThe study was based on a retrospective analysis of 18,250 mother-infant pairs in a large obstetric center in China. Serum UA concentrations in early pregnancy (median: 17.6, IQR: 16.3, 18.6 gestational weeks) were assessed. Hyperuricemia was defined as ≥ one standard deviation (SD) of the reference value for the corresponding gestational age. Outcomes of gestational diabetes mellitus (GDM), preterm birth (PB), low birth weight (LBW), macrosomia, small for gestational age (SGA) and large for gestational age (LGA) were extracted from the medical records.ResultsThe mean maternal UA level was 0.22 ± 0.05 mmol/L, and 2,896 (15.9%) subjects had hyperuricemia. After adjustment for several covariates, UA was associated with several adverse outcomes. The ORs (95%CI) per one SD increase in serum UA concentration were 1.250 (1.136, 1.277) for GDM, 1.137 (1.060, 1.221) for PB, 1.134 (1.051, 1.223) for LBW, and 1.077 (1.020, 1.137) for SGA, respectively. Similar adverse associations were found between hyperuricemia and GDM, PB (ORs: 1.394 and 1.385, P < 0.001), but not for LBW, macrosomia, SGA, and LGA. Adverse associations tended to be more pronounced in subjects with higher BMI for outcomes including PB, LBW, and SGA (P interaction = 0.001–0.028).ConclusionHigher UA levels in early pregnancy were associated with higher risk of GDM, PB, LBW, and SGA in normotensive Chinese women.

Impact of sex differences on cardiac injury in critically ill patients with COVID-19

BackgroundCOVID-19 infections are associated with accrued inflammatory responses which may result in cardiac injury. Immune response to infection appears different between men and women, suggesting that COVID-19 patients’ outcomes may differ according to biological sex. However, the impact of biological sex on the occurrence of cardiac injury during intensive care unit (ICU) stay in COVID-19 patients remain unclear.MethodsIn this multicenter and prospective study, we included consecutive patients admitted to ICU for severe COVID-19 pneumonia, during the first two pandemic waves. Biological, electrocardiogram (ECG) and echocardiographic variables were collected on ICU admission. Cardiac injury was defined by increased troponin above 99th percentile of upper norm value and newly diagnosed ECG and/or echocardiographic abnormalities. The primary endpoint was the proportion of patients with cardiac injury during ICU stay according to biological sex. The impact of biological sex on other subsequent clinical outcomes was also evaluated.ResultsWe included 198 patients with a median age of 66 (56–73) years, 147 (74%) patients were men and 51 (26%) were women. Overall, 119 (60%) patients had cardiac injury during ICU stay and the proportion of patients with cardiac injury during ICU stay was not different between men and women (60% vs. 61%, p = 1.00). Patients with cardiac injury during ICU stay showed more cardiovascular risk factors and chronic cardiac disease and had a higher ICU mortality rate. On ICU admission, they had a more marked lymphopenia (0.70 (0.40–0.80) vs. 0.80 (0.50–1.10) × 109/L, p < 0.01) and inflammation (C-Reactive Protein (155 (88–246) vs. 111 (62–192) mg/L, p = 0.03); D-Dimers (1293 (709–2523) vs. 900 (560–1813) µg/L, p = 0.03)). Plasmatic levels of inflammatory biomarkers on ICU admission correlated with SAPS-2 and SOFA scores but not with the different echocardiographic variables. Multivariate analysis confirmed cardiovascular risk factors (OR = 2.31; 95%CI (1.06–5.02), p = 0.03) and chronic cardiac disease (OR = 8.58; 95%CI (1.01–73.17), p = 0.04) were independently associated with the occurrence of cardiac injury during ICU stay, whereas biological sex (OR = 0.88; 95%CI (0.42–1.84), p = 0.73) was not. Biological sex had no impact on the occurrence during ICU stay of other clinical outcomes.ConclusionsMost critically ill patients with COVID-19 were men and experienced cardiac injury during ICU stay. Nevertheless, biological sex had no impact on the occurrence of cardiac injury during ICU stay or on other clinical outcomes.Clinical trial registration NCT04335162

HPB P41 The incidence and diagnostic potential of Extra-biliary findings on Magnetic Resonance Cholangiopancreatography

Abstract Background Magnetic Resonance Cholangiopancreatography (MRCP) is increasingly utilised to assess the biliary tree. This imaging modality can potentially reveal extra-biliary findings that will warrant further urgent investigations. The primary aim of this study was to assess the prevalence of extra-biliary findings on MRCPs. The secondary aim was to assess the need for subsequent investigations and subsequent outcomes. Methods This was a retrospective cohort study of all consecutive MRCPs performed on adult patients in a single centre form September 2021 to September 2022. Patient demographics, indication(s) for MRCP, MRCP result including extra-biliary findings were analysed from electronic case notes. Further analysis of necessary investigations into these extra-biliary findings and outcomes was also undertaken. This study was registered with Clinical Quality Project (LanQIP 14742). Results 495 MRCPs were performed in the study period; 305 (61.6%) were female; median age was 63 years (IQR 50-74). 311 (62.8%) were inpatient and 200 (40.4%) were urgent. 61.2% (n=303) had at least one extra-biliary finding and 8.1% (n=44) required urgent follow-up with 12 having a new diagnosis of malignancy. 19.4% (n=96) had renal cysts, 12.7% (n=63) had hepatic cysts, 5.6% (n=28) had pancreatic cysts, 2.8% (n=14) had liver cirrhosis, 2.8% (n=14) had peripancreatic collections, 3.4% (n=17) had a hiatus hernia, 7.3% (n=36) had pleural effusions, 5.3% (n=26) had splenomegaly and 1.8% (n=9) had identified diverticular disease. Conclusions Each of the extra-biliary findings on MRCP were confirmed with further investigation, which again highlights the high accuracy of Magnetic Resonance Imaging (MRI). It is undeniable that MRCPs are revealing extra-biliary findings which indicate that the diagnosis potential of MRCPs is underestimated. Although MRIs are widely used and has no ionising radiation unlike Computerised Tomography (CT) scans, they are still more costly. Furthermore, it was also noted in previous studies that incidental findings are largely dependent on the reporting radiologist and a structured proforma might be beneficial moving forward.

The success rate of small renal mass core needle biopsy and its impact on lowering benign resection rate

BackgroundSmall renal mass (SRM) biopsy remains under-utilized due to stigma. Meanwhile, the alarmingly high benign findings in resected kidney masses highlight the need for improved preoperative diagnosis and patient selection.MethodsThe purpose of this study is to review the success rate of SRM biopsy and to evaluate its impact on patient management. A total of 168 percutaneous image-guided core needle biopsies (CNBs) of SRMs were retrieved at a tertiary academic center between 2015 and 2019. Subsequent treatment choices, side effects and outcomes were retrospectively reviewed.ResultsThe diagnostic rate of CNB was 86.9%. Benign neoplasms accounted for a significant portion (14.3%) of SRM. Renal cell carcinomas (RCCs) were the most common diagnoses (69.6%) as expected. In biopsy-resection correlation, the positive predictive value of CNB was 100%. Tumor typing and subtyping by CNB were highly accurate, 100% and 98.3% respectively. Nuclear grading for clear cell RCC was accurate in 83.8% cases. The CNB results had significant impact on treatment. Most patients with RCCs underwent either resection (54.1%) or ablation (33.9%), in contrast to observation in benign neoplasms (90.5%). Most importantly, the benign resection rate (3.2%) in this series was much lower than the national average.ConclusionCNB provided accurate diagnoses for the majority of SRMs and revealed benign diagnoses in a subset of clinically suspicious lesions. Employment of CNB in suspicious SRM may help avoid overtreatment for benign lesions.

Social Determinants of Health Among Pregnant Hispanic Women and Associated Psychological Outcomes.

There has been a concerning surge in maternal mortality among Hispanic women in recent years. Compromised mental health is present in nearly half of all maternal deaths, and risk factors include poor social support and depression. Among Hispanic women who were born in the USA versus those not born in the USA, we sought to describe and compare social determinants of health and maternal psychological outcomes. Hispanic pregnant women (n = 579) were recruited from two clinics in Tampa, FL, and completed various questionnaires related to social determinants of health, depression, stress, and social support. Descriptive statistics, t-tests, and chi-square analyses were used to compare relationships between maternal nativity and subsequent psychosocial outcomes. Pearson correlations were used to explore associations between variables. Hispanic pregnant women who were not born in the USA had lower incomes (χ2 = 5.68, p = 0.018, df = 1), were more likely to be unemployed (χ2 = 8.12, p = 0.004, df = 1), and were more likely to be married (χ2 = 4.79, p = 0.029, df = 1) when compared with those born in the USA. Those not born in the USA reported lower social support (t = 3.92, p<0.001), specifically the tangible (t = 4.18, p < 0.001) and emotional support subscales (t = 4.4, p<0.001). When compared with those born in the USA, foreign-born Hispanic women reported less stress (t = 3.23, p = 0.001) and depression (t = 3.3, p = 0.002). Pregnant Hispanic women not born in the USA are at increased risk for suboptimal social determinants of health, including less social support. US-born women were more stressed and depressed and had higher BMIs.

Labour agentry and subsequent adverse mental health outcomes: A follow-up study of the ARRIVE Trial.

Labour can be traumatic for women who perceive they are not involved in decisions affecting their care during labour. Our objective was to assess the relation between labour agentry and subsequent mental health. Follow-up cohort study. U.S. Tertiary care center. Participants from Utah who participated in the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) trial. During the ARRIVE trial, participants completed the Labor Agentry Scale twice, a validated questionnaire measuring perceived control of patients during childbirth. ARRIVE participants from Utah subsequently were asked to complete questions about mental health history and stressful events occurring since the trial, as well as surveys including the Primary Care Posttraumatic Stress Disorder (PC-PTSD) screen, Edinburgh Postnatal Depression Scale (EPDS) and Generalised Anxiety Disorder-7 (GAD-7) screen. The lower quartile of both agentry measurements defined a person's ordinal agentry category, used for assessing cohort characteristics by exposure category. Continuous minimum agentry was included in adjusted modelling. The primary outcome was a mental health composite including a positive screen for depression, anxiety, or PTSD or self-report of a diagnosis or exacerbation since their delivery. In all, 766 of 1042 (74%) people responded to the survey (median 4.4, range 2.5-6.4 years after delivery) and 753 had complete data for analysis. In unadjusted comparisons across ordinal agentry category, lower agentry was significantly associated with the primary composite endpoint, and depressive symptoms (test of trend p = 0.003 primary, p = 0.004 depression). Lower labour agentry scores were associated with incremental odds of the primary endpoint (1 SD [24 units], adjusted odds ratio [aOR] 1.21, 95% CI 1.41-1.03), driven by depressive symptoms or self-reported diagnosis (aOR 1.25, 95% CI 1.47-1.05). Lower labour agentry at the time of birth was associated with a greater risk for mental health conditions years after delivery, indicating a potential opportunity for primary prevention of subsequent depression.

High-risk admission prior to transcatheter aortic valve replacement and subsequent outcomes

Severe, symptomatic aortic stenosis may cause heart failure, acute myocardial infarction, or syncope; limited data exist on the occurrence of such events before transcatheter aortic valve replacement (TAVR) and their impact on subsequent outcomes. Thus, we investigated the association between a preceding event and outcomes after TAVR. From 2014 to 2021 all Danish patients who underwent TAVR were included. Preceding events up to 180 days before TAVR were identified. A preceding event was defined as a hospitalization for heart failure, acute myocardial infarction, or syncope. The 1-year risk of all-cause death, and cardiovascular or all-cause hospitalization was compared for patients with versus without a preceding event using Kaplan-Meier, Aalen-Johansen, and in Cox regression analyses adjusted for patient characteristics. Of 5,851 patients included, 759 (13.0%) had a preceding event. The median age was 81 years in both groups. Male sex and frailty were more prevalent in patients with a preceding event (males: 64.7% vs 55.2%, frailty: 49.6% vs 40.6%). The most common type of preceding event was a hospitalization for heart failure (n=524). For patients with a preceding event, the 1-year risk of death was 11.7% (95% CI: 9.4%-14.1%) versus 8.0% (95% CI: 7.2%-8.7%) for patients without. The corresponding adjusted hazard ratio (aHR) was 1.29 (95%CI: 1.01-1.64). Mortality was highest for patients with a preceding event of a heart failure admission (1-year risk: 13.5% [95%CI: 10.5%-16.5%]). Comparing patients with a preceding event to those without, the 1-year risk for cardiovascular rehospitalization was 15.0% versus 8.2% (aHR 1.60 [95%CI: 1.29-1.99]) and 57.6% versus 50.6% for all-cause rehospitalization (aHR 1.08 [95%CI: 0.87-1.20]). A hospitalization for heart failure, myocardial infarction, or syncope prior to TAVR was associated with a poorer prognosis and could represent a group to focus resource management on. Interventions to prevent preceding events and improvements in pre- and post-TAVR optimization of these patients are warranted.

Timing of Spinal Surgery in Polytrauma: The Relevance of Injury Severity, Injury Level and Associated Injuries.

Retrospective database analysis. Polytraumatized patients with spinal injuries require tailor-made treatment plans. Severity of both spinal and concomitant injuries determine timing of spinal surgery. Aim of this study was to evaluate the role of spinal injury localization, severity and concurrent injury patterns on timing of surgery and subsequent outcome. The TraumaRegister DGU® was utilized and patients, aged ≥16years, with an Injury Severity Score (ISS) ≥16 and diagnosed with relevant spinal injuries (abbreviated injury scale, AIS ≥ 3) were selected. Concurrent spinal and non-spinal injuries were analysed and the relation between injury severity, concurrent injury patterns and timing of spinal surgery was determined. 12.596 patients with a mean age of 50.8years were included. 7.2% of patients had relevant multisegmental spinal injuries. Furthermore, 50% of patients with spine injuries AIS ≥3 had a more severe non-spinal injury to another body part. ICU and hospital stay were superior in patients treated within 48hrs for lumbar and thoracic spinal injuries. In cervical injuries early intervention (<48hrs) was associated with increased mortality rates (9.7 vs 6.3%). The current multicentre study demonstrates that polytrauma patients frequently sustain multiple spinal injuries, and those with an index spine injury may therefore benefit from standardized whole-spine imaging. Moreover, timing of surgical spinal surgery and outcome appear to depend on the severity of concomitant injuries and spinal injury localization. Future prospective studies are needed to identify trauma characteristics that are associated with improved outcome upon early or late spinal surgery.

Identification of genetic loci jointly influencing COVID-19 and coronary heart diseases

BackgroundComorbidities of coronavirus disease 2019 (COVID-19)/coronary heart disease (CHD) pose great threats to disease outcomes, yet little is known about their shared pathology. The study aimed to examine whether comorbidities of COVID-19/CHD involved shared genetic pathology, as well as to clarify the shared genetic variants predisposing risks common to COVID-19 severity and CHD risks.MethodsBy leveraging publicly available summary statistics, we assessed the genetically determined causality between COVID-19 and CHD with bidirectional Mendelian randomization. To further quantify the causality contributed by shared genetic variants, we interrogated their genetic correlation with the linkage disequilibrium score regression method. Bayesian colocalization analysis coupled with conditional/conjunctional false discovery rate analysis was applied to decipher the shared causal single nucleotide polymorphisms (SNPs).FindingsBriefly, we observed that the incident CHD risks post COVID-19 infection were partially determined by shared genetic variants. The shared genetic variants contributed to the causality at a proportion of 0.18 (95% CI 0.18–0.19) to 0.23 (95% CI 0.23–0.24). The SNP (rs10490770) located near LZTFL1 suggested direct causality (SNPs → COVID-19 → CHD), and SNPs in ABO (rs579459, rs495828), ILRUN(rs2744961), and CACFD1(rs4962153, rs3094379) may simultaneously influence COVID-19 severity and CHD risks.InterpretationFive SNPs located near LZTFL1 (rs10490770), ABO (rs579459, rs495828), ILRUN (rs2744961), and CACFD1 (rs4962153, rs3094379) may simultaneously influence their risks. The current study suggested that there may be shared mechanisms predisposing to both COVID-19 severity and CHD risks. Genetic predisposition to COVID-19 is a causal risk factor for CHD, supporting that reducing the COVID-19 infection risk or alleviating COVID-19 severity among those with specific genotypes might reduce their subsequent CHD adverse outcomes. Meanwhile, the shared genetic variants identified may be of clinical implications for identifying the target population who are more vulnerable to adverse CHD outcomes post COVID-19 and may also advance treatments of ‘Long COVID-19.’

Impact of prior coronavirus disease 2019 infection in females on assisted reproductive outcomes: A systematic review with meta‐analysis

AbstractObjectivesTo investigate the relationship between prior coronavirus disease 2019 (COVID‐19) infection in females and subsequent treatment outcomes of assisted reproductive technology (ART).MethodsA systematic literature review was carried out up to 16 December 2022, in PubMed, Web of Science, EMBASE, and Cochrane Library. Random‐effect models were adopted to estimate the pooled effects as mean differences (MDs) or odds ratios (ORs). I2 statistic and Egger's test were applied to assess heterogeneity and publication bias, respectively.ResultsAfter screening 1480 records, 15 cohort studies totalling 1905 cycles were included in this meta‐analysis. In a comparison of previously COVID‐19‐infected versus uninfected women, no significant differences were observed in the primary outcomes of the retrieved oocytes number (MD = 0.06; 95% confidence interval [CI]: ‐0.75–0.88; I2 = 0) and clinical pregnancy rate (OR = 0.96; 95% CI: 0.74–1.24; I2 = 0). Pooled analyses of other predefined outcomes, which encompassed four cycle characteristics, six laboratory indicators and four pregnancy results, also showed no adverse effects of prior COVID‐19 infection. Most outcomes remained consistent after further sensitivity and subgroup analyses, and no significant publication bias was observed.ConclusionsOur work provides the first systematic evidence that COVID‐19 infection history in females may have no measurable detrimental impact on the subsequent ART cycle. More data are needed to assess the live birth outcome and the optimal time interval from infection to assisted reproduction.

Genome Characterisation of Invasive Haemophilus influenzae in Pregnancy: The Noticeable Placental Tissue Tropism Is Distributed across the Species Rather Than Linked with Capsulation or Particular Clones.

Pregnancy is associated with a 5-26 times increased risk of invasive Haemophilus influenzae infection and subsequent adverse pregnancy outcomes. Incidence rate and outcome are published in some regions, but the characterisation of bacterial isolates is limited. We performed comparative genomic analyses of isolates from 12 pregnancy-associated cases, cultured from maternal bacteraemia in pregnancy (nine), postpartum bacteraemia (one), neonatal bacteraemia (one), and placental tissue (one). In two bacteraemia cases, identical isolates were also cultured from cervical swabs. Eight cases occurred early in pregnancy (gestational week 7-26), and seven of them resulted in miscarriage or neonatal death. All bacterial genomes were devoid of capsule loci, and they were evenly distributed in the major phylogenetic group I of the species. The conspicuous tropism of H. influenzae for pregnancy and placental tissue is associated with the species rather than specific clonal subtypes.

Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

An initial decline in estimated glomerular filtration rate (eGFR) is expected after initiating a sodium-glucose cotransporter-2 inhibitor (SGLT2i) and has been observed across patients with diabetes, chronic kidney disease, and heart failure. To examine the implications of initial changes in eGFR among patients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. This was a prespecified analysis of the results of the DELIVER randomized clinical trial, which was an international multicenter study of patients with EF greater than 40% and eGFR greater than or equal to 25. The DELIVER trial took place from August 2018 to March 2022. Data for the current prespecified study were analyzed from February to October 2023. Dapagliflozin, 10 mg per day, or placebo. In this prespecified analysis, the frequency of an initial eGFR decline (baseline to month 1) was compared between dapagliflozin and placebo. Cox models adjusted for baseline eGFR and established prognostic factors were fit to estimate the association of an initial eGFR decline with cardiovascular (cardiovascular death or heart failure event) and kidney (≥50% eGFR decline, eGFR<15 or dialysis, death from kidney causes) outcomes, landmarked at month 1, stratified by diabetes. Study data from 5788 participants (mean [SD] age, 72 [10] years; 3253 male [56%]) were analyzed. The median (IQR) change in eGFR level from baseline to month 1 was -1 (-6 to 5) with placebo and -4 (-9 to 1) with dapagliflozin (difference, -3; P < .001). A higher proportion of patients assigned to dapagliflozin developed an initial eGFR decline greater than 10% vs placebo (1144 of 2892 [40%] vs 737 of 2896 [25%]; odds ratio, 1.9; 95% CI, 1.7-2.1; P difference <.001). An initial eGFR decline of greater than 10% (vs ≤10%) was associated with a higher risk of the primary cardiovascular outcome among those randomized to placebo (adjusted hazard ratio [aHR], 1.33; 95% CI, 1.10-1.62) but not among those randomized to dapagliflozin (aHR, 0.90; 95% CI, 0.74-1.09; P for interaction = .01). Similar associations were observed when alternative thresholds of initial eGFR decline were considered and when analyzed as a continuous measure. An initial eGFR decline of greater than 10% was not associated with adverse subsequent kidney composite outcomes in dapagliflozin-treated patients (aHR, 0.94; 95% CI, 0.49-1.82). Among patients with HFmrEF or HFpEF treated with dapagliflozin, an initial eGFR decline was frequent but not associated with subsequent risk of cardiovascular or kidney events. These data reinforce clinical guidance that SGLT2is should not be interrupted or discontinued in response to an initial eGFR decline. ClinicalTrials.gov Identifier: NCT03619213.

High-risk admission prior to transcatheter aortic valve implantation and subsequent outcomes

Abstract Background Severe symptomatic aortic stenosis may cause heart failure, acute myocardial infarction, or syncope; however, limited data exist on the occurrence of such events before transcatheter aortic valve implantation (TAVI) and their impact on subsequent outcomes. Purpose To investigate the association between a preceding event (hospitalization for heart failure, acute myocardial infarction, or syncope) and outcomes after TAVI. Methods Using nationwide registries, all Danish patients undergoing TAVI from 2014 through 2021 were identified. Preceding events up to 180 days before TAVI were identified. Patients were then stratified into two groups: 1) patients with a preceding event. 2) patients without a preceding event. The primary outcome of interest was 1-year risk of all-cause death estimated with Kaplan-Meier for patients with a preceding event compared with patients without. The secondary outcome of interest was 1-year cardiovascular rehospitalization amongst patients discharged alive. Here, we used Aalen-Johansen with the competing risk of death among patients alive at discharge. Finally, adjusted analyses were performed with Cox regression analyses. Results The main findings are summarized in Figure 1. The study population comprised 5,851 patients. Of these, 759 (13.0%) had a preceding event. Median age was 81 years in both groups. Frailty and male sex were more prevalent among patients with a preceding event (males: 64.7%, intermediate/high frailty: 49.6%) compared with patients without a preceding event (males: 55.2%, intermediate/high frailty 40.6%). A hospitalization for heart failure was the most common preceding event (n=524). The risk of 1-year all-cause death was 11.7% (95% CI: 9.4%–14.1%) for patients with a preceding event compared with 8.0% (95%CI: 7.2%–8-7%) for patients without a preceding event (Figure 2). This resulted in an adjusted hazard ratio of 1.29 (95%CI: 1.01–1.64). Moreover, the 1-year risk of cardiovascular rehospitalization was 15.0% (95 CI: 12.4%–17.6%) versus 8.2% (95 CI: 7.4%–8.9%) for patients with and without a preceding event (adjusted hazard ratio 1.60 [95%CI: 1.29–1.99]) (Figure 2). Conclusion A hospitalization for heart failure, acute myocardial infarction, or syncope prior to TAVI is associated with a higher risk of mortality and cardiovascular rehospitalization. These patients should be carefully evaluated prior to and after TAVI to improve outcomes.

Impact of intracoronary imaging-guided percutaneous coronary intervention on procedural outcomes among patients with cardiogenic shock

Abstract Background Intracoronary imaging (ICI), including intravascular ultrasound (IVUS) or optical coherence tomography (OCT), is known to correlate with a reduction in rates of cardiac death after percutaneous coronary intervention (PCI), driven by lower rates of reinfarction and stent thrombosis. [1,2] However, there are limited data around its utility amongst patients with acute coronary syndrome (ACS) and cardiogenic shock, who are inherently at a high risk of stent thrombosis. Aims To examine the frequency of utilisation of ICI among ACS patients with cardiogenic shock, and their subsequent outcomes, in a national cohort of PCI procedures over a six-year period. Methods All PCI procedures for ACS patients with cardiogenic shock in England and Wales between 2014 and 2020 were retrospectively analysed, stratified into two groups: ICI and non-ICI groups. Multivariable logistic regression analyses were performed to examine the odds of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE; composite of all-cause mortality, acute stroke/transient ischaemic attack (TIA), and reinfarction) and major bleeding (BARC 3-5) in the ICI-guided group, compared with the non-ICI group, as well as predictors of receipt of ICI-guided PCI. Results Of 15,738 PCI procedures performed between 2014 and 2020, 1,240 procedures (7.9%) were ICI-guided. Overall, the rate of ICI use amongst those with cardiogenic shock has more than doubled from 2014 (5.7%) to 2020 (13.3%). The ICI-guided group were predominantly younger, males, with a higher proportion of non-ST elevation ACS and stent thrombosis. The rate of MACCE was significantly lower in the ICI-guided group compared with the non-ICI group (29.8% vs. 38.2%, p&amp;lt;0.001), driven by lower rate of all-cause mortality (28.6% vs. 37.0%, p&amp;lt;0.001). (Figure 1) There were no differences for other secondary outcomes between groups. In multivariable analysis, the odds of MACCE and all-cause mortality in those undergoing ICI-guided PCI remained significantly lower than in the non-ICI group (OR 0.65 95% CI 0.56, 0.76 and OR 0.65 95% CI 0.55, 0.75, respectively, p&amp;lt;0.001 for both). (Figure 2). Advanced age (OR 0.98) and STEMI presentation (OR 0.54) negatively correlated with ICI use while stent thrombosis presentation (OR 2.66), previous PCI (OR 2.02), intervention on LMS (OR 4.19) and proximal LAD lesions (OR 1.62) and need for calcium modification (OR 2.13) positively correlated with increased ICI use. Conclusion The utilisation of ICI among patients with cardiogenic shock has more than doubled over a 6-year period on a national level but remains significantly under-utilised, with less than 1-in-6 patients in receipt of ICI-guided PCI in 2020. ICI use is associated with a prognostic benefit in terms of reduction of in-hospital MACCE and all-cause mortality in this high-risk patient group and should be more frequently utilised to increase their long-term survival.Figure 1.In-hospital crude outcomesFigure 1B.Adjusted odds ratios (OR)

The impact of worsening heart failure (WHF) status on subsequent outcomes among patients with HFrEF: History of WHF events is associated with worse subsequent outcomes regardless of extent of GDMT

Abstract Background Patients with worsening heart failure (WHF) have increased risk of future WHF events and death. Guideline directed medical therapy (GDMT) reduces this risk in clinical trials, but few patients in the real-world receive optimal GDMT, leaving its comparative effectiveness unclear. Methods Using Optum’s de-identified Clinformatics® Data Mart Database, we identified patients with heart failure with reduced ejection fraction (HFrEF) who filled HF prescriptions for components of GDMT ("Conventional GDMT:" i.e., ACEi or ARB, and beta-blocker) or first-line therapy from the most recent US guidelines ("2022 GDMT:" i.e., ARNi, MRA, beta-blocker, SGLT2i) between Jan2020 and Mar2022. The ongoing risk of HF hospitalizations (HFH), receipt of IV diuretics, and all-cause death, was assessed by history of (HFH, receipt of IV diuresis in past 12 months) WHF. Event rates reflect counts of first events, whereas cumulative incidence is first and recurrent events. Both are presented per 1,000 person-years. Results Conventional GDMT Cohort: Overall, 26,517 were in the cohort and 51% had WHF. Patients with and without WHF were alike in age (72 vs. 73 years) and a similar proportion were female (43% vs. 40%), and white (67% vs. 67%) (Table). Per 1,000 person-years, the event rates for death, HFH, and IV diuresis were 109, 404, and 106 among patients with WHF and 38, 194, and 29 among patients without WHF, respectively. The cumulative incidence, per 1,000 person-years, for HFH and IV diuretics use among those with WHF were 622 and 241 compared to 258 and 44 among those without WHF (Table). The time to WHF event or death was shorter for patients with WHF (Figure) and HR for all-cause death or WHF was 1.91 for those with WHF compared to those without. 2022 GDMT Cohort: There were 2,775 patients receiving 2022 GDMT and just under half (47%) had WHF. Patients with and without WHF were both an average of 66 years of age, one-third were female, and 60% were white (Table). The event rates (per 1,000 person-years) for death, HFH, and IV diuretic use among those with WHF were 176, 395, and 87 compared to 106, 179, and 40, among those without WHF, respectively (Table). The cumulative incidence (per 1,000 person-years) for HFH and IV diuresis were 577 and 157 among patients with WHF and 268 and 63 among patients without WHF. The time to WHF event or death was also shorter for patients with WHF (Figure). The HR for all-cause death or WHF event comparing patients with and without WHF was 2.28. Conclusion Our study quantified the excess risk of HF morbidity and all-cause death associated with WHF, regardless of extent of GDMT. WHF resulted in higher hospitalizations, morbidity, and deaths and was the strongest predictor of subsequent WHF and all-cause death. This places patients with WHF in a high-risk group. Results can help clinicians better assess the clinical trajectory of their patients and underscore the need for additional therapies and optimized care.Table.Patient CharacteristicsFigure.Clinical Trajectory

The relationship between changes of antithrombotic drug regimen after ischemic stroke and risks of clinical outcomes in patients with atrial fibrillation

Abstract Background Stroke prevention is central to the management of patients with atrial fibrillation (AF), but the impact of changes in antithrombotic regime following presentation with an ischaemic stroke on subsequent clinical events is unceratin. Methods From 2012 to 2018, 23,165 AF patients who experienced ischemic stroke and survived longer than 90 days after stroke were identified from Taiwan National Health Insurance Research Database. The relationships between post-stroke antithrombotic drug regimen and subsequent clinical outcomes were analyzed. Results Compared to NOACs (reference), there was a significant increase in ischaemic stroke in non-anticoagulated and antiplatelet users (both aHR approx 1.8), with no significant differences to warfarin. The same was evident for a higher mortality in non-anticoagulated and antiplatelet users (aHRs 3.441 and 1.483, respectively). Addition of antiplatelets to NOAC or warfarin resulted in non-significant differences in ischaemic stroke or mortality (Figure 1). Among 769 pateints who received NOACs before and continuously stayed on NOACs after stroke, the shifting to a different NOAC post-stroke was associated with a higher risk of ischaemic stroke (aHR 2.07) as well as the composite outcomes (aHRs between 1.359-1.849), with no difference in major bleeding, mortality or ICH (Figure 2). Conclusions Adding antiplatelet agents to NOACs for AF patients after ischemic stroke did not provide additional clinical benefits. For patients under NOACs who experienced ischemic stroke, the change to a different NOAC post-stroke was not associated with a better clinical outcome.