Differences In Baseline Characteristics Research Articles

#1378 A single-center retrospective study on clinical characteristics and outcomes of extended-spectrum beta-lactamases positive acute pyelonephritis

Abstract Background and Aims The increase of extended-spectrum beta-lactamases (ESBL) releasing bacteria in acute pyelonephritis (APN) is a growing problem world-wide. Recently, little is known about the incidence, clinical features and outcomes of ESBL positive APN. This study intends to describe the epidemiology and clinical outcomes of ESBL positive APN. Method A retrospective study of 1631 culture positive patients with APN admitted from Jan, 2011 to Dec, 2019 in a single-center was performed. Adults over 18 years of age were included, and outpatient treatment, pregnant women, and transplant patients were excluded. Result A total of 2818 patients were diagnosed as APN during this period and causative bacteria was confirmed in1631 patients among them (57.9%). ESBL positive bacteria were found in 553 patients (33.9%). There were no differences in baseline characteristics between ESBL positive and negative groups. Most common strain was Escherichia coli, followed by Klebsiella and Pseudomonas species. The proportion of ESBL positive APN increased when evaluated at one-year intervals for 8 years (from 4.9% in 2011 to 20.9% in 2019). The rate of positive blood culture was higher in ESBL positive patients (39.2% vs 21.1%, p<0.001). Hospital stay was longer in ESBL positive patients (12.3 ± 2.2 vs. 5.4 ± 5.2, p<0.001) and the number of re-admission is higher (1.7 ± 1.3 vs. 1.2 ± 0.6, p<0.001). The incidence of acute kidney injury according to KDIGO was higher in ESBL positive groups (25.4% vs 12.3%, p<0.001). There was no hospital mortality between two groups. Conclusion We should attempt to detect ESBL positive bacteria through timely performing blood and urine culture and administer appropriate antibiotics if APN is clinically suspected because of poor clinical courses.

#2609 Comparison of baseline patient characteristics of the CONVINCE randomized controlled trial with existing trial and registry populations

Abstract Background and Aims The generalizability of randomized controlled trials (RCTs) results is based on representativeness of the population involved. Trial populations may have different baseline characteristics compared to the general population that could benefit from the intervention. We compare the baseline characteristics of patients involved in the CONVINCE trial with those involved in all previous RCTs and representative registries of patients receiving hemodialysis as renal replacement therapy. Method Based on world class methods for systematic reviews, we identified all RCTs comparing hemodiafiltration (HDF) with hemodialysis (HD) published up to January 2024 and extracted data on baseline patient characteristics. Where data were missing, authors have been contacted and data so far obtained were included in this analysis (Fig. 1). Additional contact attempts are being performed. In addition, a comprehensive search was conducted to identify renal registries from all geographic regions. Those without information in English, without information on HDF and registries focusing on special patient groups (e.g. transplantation only) were excluded. This registry data will not be analyzed in this abstract as we are in progress of extracting the patient data from the latest registry annual reports available up to January 2024 for further analysis. Results We have selected 11 RCTs for further analysis, with the selection criteria and outcomes presented in Fig. 1. Key patient characteristics from RCTs were compared with those of patients in the CONVINCE trial using descriptive statistics and forest plots (Fig. 1). Comparison of differences was analyzed with the Kruskal-Wallis-Test. Interpretation of the results are as follows: • Age: Mean age of 76.5 years noted in Morena et al. (2017) because study inclusion criterion was ≥65 years. Other RCTs ranged from 54.1 to 68 years, which is consistent with 62.4 years in the CONVINCE trial (χ2 = 10, df = 10, p = 0.44). • Sex: 16.7% and 50% female noted in Selby et al. (2006) and Meert et al. (2009) respectively probably due to limited sample size (12 patients and 14 patients respectively). Other RCTs ranges from 30.4% to 42.5%, which is consistent with 36.0% in the CONVINCE trial (χ2 = 11, df = 11, p = 0.44). • Diabetes comorbidities: Ranges from 17.8% to 45%. CONVINCE trial is 35.0% (χ2 = 6, df = 6, p = 0.42). • Cardiovascular diseases comorbidities: Range from 26.4% to 45%. CONVINCE trial is 45% (χ2 = 3, df = 3, p = 0.39). • AVF as vascular access: value of 100% in Pedrini et al. (2011) because it was an inclusion criterion. Other RCTs ranged from 79.4% to 90%, which is consistent with 82% in the CONVINCE trial (χ2 = 7, df = 7, p = 0.43). There were no significant differences between CONVINCE and other RCTs data regarding all 5 patient baseline characteristics. Conclusion Our analysis showed the CONVINCE trial has no significant differences in patient baseline characteristics compared to previous RCTs. For a more comprehensive evaluation of representativeness of the trial's population, we are currently retrieving missing data from the trial authors and analyzing data from hemodialysis registries.

Racial and Ethnic Characteristics and Outcomes of Patients Diagnosed with CLL/SLL in the USA.

This study was designed to compare outcomes among patients by race and ethnicity in the post-covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment era. A nationwide electronic health record (EHR)-derived de-identified database was utilized that included patients diagnosed with CLL from 2013 to 2022 who received systemic therapy for their disease. Use of cBTKi therapy, time to next treatment or death (TTNT-D), and overall survival (OS) were compared by race in unadjusted (Kaplan-Meier method) and adjusted analyses (Cox proportional hazards regression). This study included 4,572 White (71.8%) and 558 Black (8.8%) patients with CLL; 270 were Hispanic or Latino (4.2%). Patients who were Black were significantly younger, more were female, had later stage disease, were of lower socioeconomic status (SES), and were more likely to have unmutated immunoglobulin heavy chain gene (IGHV) and to have received cBTKi therapy than White patients (all p ≤ 0.002). SES was also significantly different by ethnicity. TTNT-D and OS were not different by race in either unadjusted or adjusted analyses (all p > 0.05). In unadjusted and adjusted analyses, TTNT-D and OS were not different by race. These data did not identify racial healthcare disparities in the era following the introduction of cBTKi therapy despite differences in baseline characteristics.

Comparison of lateral flank approach and low anterior access for single port (SP) retroperitoneal partial nephrectomy: an analysis from the single port advanced research consortium (SPARC).

Single Port (SP) robotic partial nephrectomy (RPN) can be performed via retroperitoneal and transperitoneal approach. We aim to compare outcomes of two commonly described incisions for retroperitoneal SP RPN: lateral flank approach (LFA) and low anterior access (LAA). We performed a retrospective study of patients who underwent SP retroperitoneal RPN from 2018 to 2023 as part of a large multi-institute collaboration (SPARC). Baseline demographic, clinical, tumor-specific characteristics, and perioperative outcomes were compared using χ2, t test, Fisher exact test, and Mann-Whitney U test. Multivariable analyses were conducted using robust and logistic regressions. A total of 70 patients underwent SP retroperitoneal RPN, with 44 undergoing LAA. Overall, there were no significant differences in baseline characteristics between the two groups. The LAA group exhibited significantly lower median RENAL scores (8 vs. 5, p < 0.001) and more varied tumor locations (p = 0.002). In the bivariate analysis, there were no statistically significant differences in ischemia time, estimated blood loss, or complication rates between the groups. However, the LAA group had longer operative times (101 vs. 134min, p < 0.001), but was more likely to undergo a same-day discharge (p < 0.001). When controlling for other variables, LAA was associated with shorter ischemia time (p = 0.005), but there was no significant difference in operative time (p = 0.348) and length of stay (p = 0.122). Both LFA and LAA are acceptable approaches for SP retroperitoneal RPN with comparable perioperative outcomes. This early data suggests the LAA is more versatile for varying tumor locations; however, larger cohort studies are needed to ascertain whether there is an overall difference in patient recovery.

Real-world effectiveness of dupilumab versus benralizumab and mepolizumab.

In the United States, this real-world study compared the effectiveness of dupilumab, benralizumab, andmepolizumab in reducing exacerbations and systemic corticosteroid (SCS) prescriptions among patients with asthma. Patients (12 years old) who initiated dupilumab, benralizumab, or mepolizumab (index) between November 2018 and September 2020 were identified by using electronic medical record data. Subjects were included if they had greater than or equal to 12 months of data before and after the index date and two or more severe asthma-related exacerbations before the index date. Differences in baseline characteristics were addressed by using inverse probability treatment weighting (IPTW). Pairwisecomparisons between dupilumab and benralizumab, or mepolizumab were conducted by using negative binomial regression, adjusting for baseline rates and unbalance characteristics (greater than or equal to 10% standardized differences) after IPTW. Overall, a total of 1737 subjects met all criteria: 825 dupilumab, 461 benralizumab, and 451 mepolizumab initiators.In the postindex period, dupilumab was associated with a 24% and 28% significant reduction in the risk of severe asthmaexacerbations versus benralizumab (incidence rate ratio [IRR] 0.76 [95% confidence interval {CI}, 0.67-0.86)] and mepolizumab(IRR 0.72 [95% CI, 0.63-0.82]), respectively. In addition, dupilumab treatment significantly reduced SCS prescriptionsby 16% and 25% versus benralizumab and mepolizumab, respectively (p < 0.05). This study represents one of the largest real-world comparisons of biologics (dupilumab, benralizumab, and mepolizumab) for asthma in the United States to date. This analysis shows that the use of dupilumab was associated with a significantly greater reduction in both severe asthma exacerbations and SCS prescriptions compared with benralizumab and mepolizumab.

DECENNIAL ANALYSIS OF AVNRT ABLATION IN A SINGLE CENTRE

Abstract Background Transcatheter ablation represents the first line therapy for atrio–ventricular nodal re–entrant tachycardia (AVNRT). Both radiofrequency (RF) and cryoablation (CRYO) have been shown to be effective, with a better safety profile for CRYO. Data on very long–term efficacy are scarces. Purpose To review our experience in AVNRT ablation performed in the last ten years and evaluate safety, efficacy and very long–term outcome of RF and CRYO. Methods We retrospectively analyzed all patients who underwent AVNRT ablation (RF or CRYO) between January 2013 and May 2023 at our centre. The majority of procedures were performed under electro–anatomical mapping (EAM) guidance to reduce radiation exposure. Acute efficacy endpoint was defined as slow pathway ablation, while long–term outcome was defined as the absence of AVNRT recurrence. Results A total of 387 consecutive patients (60,5% F; mean age 48 ± 19 years) were included; CRYO was performed in 241 patients (62%), RF in 131 patients (34%), hybrid approach (CRYO+RF) in 15 patients (4%). AVNRT induction was obtained during EPS in 295 cases (76%), in 25,4% after isoprotenerol administration. No significant differences for baseline characteristics were observed between the two groups except for age (CRYO: 42,2 ± 18 years vs RF 57,19 ± 16,5 years p &amp;lt;0.001). In pediatric population CRYO was performed in 93% of procedures. Figure 1 shows the distribution of RF/CRYO over 10 years at our centre, with a trend of significant increase in CRYO utilizations in the last years. Acute success was achieved in all 387 cases (100%; delta WP 28,5 ± 23,1 ms, delta AVN ERP 72,4 ± 44,7 ms). No permanent AV block or major periprocedural complications occurred, however transient AH prolongation was observed in 0.8% in CRYO pts vs 2,8% RF pts. The mean follow–up was 73±45 months, range 6–129 months. Overall long–term success rate was 93,3%, ranging from 91,3 % in CRYO and 96,6% in RF. Recurrence occurred in 26 cases (6,7%) after a median time of 20 months (4–40months). Recurrent AVNRT were treated with RF in the majority of cases, CRYO in 6 procedures, hybrid in only 1 case. Conclusions Transcatheter ablation is a safe and effective therapy for AVNRT. Our very long–term outcome data confirmed very high success rate even after 10 years follow–up. The increasing choice for CRYO may be due to the increasing number of pediatric and young patient referred to our centre.

Safety and efficacy of Yaobitong capsules for lumbar disc herniation: A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial.

Lumbar disc herniation (LDH) is one of the most common diseases and is a global medical and socioeconomic problem characterized by leg or back pain, weakness in the lower extremities and paresthesia. A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial was conducted to evaluate the efficacy and safety of Yaobitong capsules (YBT) for LDH. Patients (n = 479) were recruited and randomized into YBT and Jingyaokang capsule (JYK) groups (the positive control), and received YBT or JYK at a dose of 3 capsules 3 times per day after a meal for 30 days. The primary efficacy outcome was the Oswestry Disability Index (ODI), with the visual analogue scale (VAS) used as the secondary efficacy outcome. The adverse events and adverse reactions were also evaluated. There was no significant difference in baseline characteristics between YBT (n = 358) and JYK groups (n = 120), and no difference was observed between groups for mean ODI score at day 0 (p = 0.064) or day 7 (p = 0.196), but there were differences at days 14, 21 and 30 (p < 0.001). The YBT showed more decline from baseline, and the decreased ODI score was substantially different from JYK (p < 0.001). The differences in decreased VAS scores between YBT and JYK were also significant at each time point (days 7, 14, 21, and 30), with better scores in the YBT group than in the JYK group (p < 0.001). In terms of safety, there was no obvious disparity in adverse events or adverse reactions between the 2 groups (p > 0.05). Yaobitong was better than JYK for LDH treatment, with no significant difference in safety. The study suggests that YBT is a promising and effective treatment for LDH.

Ejection Fraction-Related Differences of Baseline Characteristics and Outcomes in Troponin-Positive Patients without Obstructive Coronary Artery Disease.

Background: The development and course of myocardial infarction with non-obstructive coronary artery (MINOCA) disease is still not fully understood. In this study, we aimed to examine the baseline characteristics of in-hospital outcomes and long-term outcomes of a cohort of troponin-positive patients without obstructive coronary artery disease based on different left ventricular ejection fractions (LVEFs). Methods and results: We included a cohort of 254 patients (mean age: 64 (50.8-75.3) years, 120 females) with suspected myocardial infarction and no obstructive coronary artery disease (MINOCA) in our institutional database between 2010 and 2021. Among these patients, 170 had LVEF ≥ 50% (84 females, 49.4%), 31 patients had LVEF 40-49% (15 females, 48.4%), and 53 patients had LVEF < 40% (20 females, 37.7%). The mean age in the LVEF ≥ 50% group was 61.5 (48-73) years, in the LVEF 40-49% group was 67 (57-78) years, and in the LVEF < 40% group was 68 (56-75.5) years (p = 0.05). The mean troponin value was highest in the LVEF < 40% group, at 3.8 (1.7-4.6) µg/L, and lowest in the LVEF ≥ 50% group, at 1.1 (0.5-2.1) µg/L (p = 0.05). Creatine Phosphokinase (CK) levels were highest in the LVEF ≥ 50% group (156 (89.5-256)) and lowest in the LVEF 40-49% group (127 (73-256)) (p < 0.05), while the mean BNP value was lowest in the LVEF ≥ 50% group (98 (48-278) pg/mL) and highest in the <40% group (793 (238.3-2247.5) pg/mL) (p = 0.001). Adverse in-hospital cardiovascular events were highest in the LVEF < 40% group compared to the LVEF 40-49% group and the LVEF ≥ 50% group (56% vs. 55% vs. 27%; p < 0.001). Over a follow-up period of 6.2 ± 3.1 years, the all-cause mortality was higher in the LVEF < 40% group compared to the LVEF 40-49% group and the LVEF ≥ 50% group. Among the different factors, LVEF < 40% and LVEF 40-49% were associated with an increased risk of in-hospital cardiovascular events in the multivariable Cox regression analysis. Conclusions: LVEF has different impacts on in-hospital cardiovascular events in this cohort. Furthermore, LVEF influences long-term all-cause mortality.

Postoperative radiotherapy does not improve survival in patients with Masaoka-Koga stage IIB thymomas: A propensity score matching study based on the SEER database.

This study, based on a population, explored the prognostic value of postoperative radiotherapy (PORT) for Masaoka-Koga IIB stage thymomas. Patients diagnosed with thymoma from 2004 to 2017 in the Surveillance, Epidemiology, and End Results (SEER) database were included in the retrospective study. Through propensity score matching, the baseline characteristics of the patients were successfully matched to mitigate the selection bias of PORT. Survival rates and survival curves were compared between the PORT and non-PORT groups, with potential confounding factors addressed using a multivariate Cox regression model. In this study, 785 cases of IIB stage thymoma were included from the SEER database, and 303 patients were successfully matched between PORT and non-PORT groups through propensity score matching, with no significant differences in baseline characteristics. In the PORT and non-PORT groups, 10-year overall survival rates were 65.2% versus 59.6%, and cancer-specific survival rates were 87.0% vs. 84.4%, PORT did not yield statistically significant improvements in overall survival (P = .275) or cancer-specific survival (P = .336) for stage IIB thymomas. Based on the SEER database, the results of our study indicated that PORT does not confer a significant survival benefit for IIB stage thymomas.

Implementation of a geriatric in-reach service improves acute surgical unit outcomes; a retrospective before-and-after study.

Australia's ageing population is challenging for surgical units and there is a paucity of evidence for geriatric co-management in acute general surgery. We aimed to assess if initiating a Geriatric Medicine in-reach service improved outcomes for older adults in our Acute Surgical Unit (ASU). The Older Adult Surgical Inpatient Service (OASIS) was integrated into ASU in 2021. We retrospectively reviewed all patients over age 65 admitted to ASU over a 12-month period before and after service integration with a length of stay (LOS) greater than 24 h. There was no subsequent truncation or selection. Primary outcomes were 30-day mortality, LOS, and 28-day readmissions. Secondary outcomes were discharge disposition, in-hospital mortality, and hospital-acquired complications (HACs). 1339 consecutive patients were included in each group, with no differences in baseline characteristics. There was a significant decrease in 28-day readmissions from 20.2% to 16.0% (P < 0.05), greatest in patients undergoing non-EL operative procedures (21.9% pre-OASIS vs. 12.6% post-OASIS; P < 0.05). Trends towards reduced 30-day mortality (7.17% vs. 5.90%; P = 0.211), in-hospital mortality (3.88% vs. 2.91%; P = 0.201), permanent care placement (7.77% vs. 7.09%; P = 0.843) and HACs (8.14% vs. 7.62%; P = 0.667) were seen, although statistical significance was not demonstrated. LOS remained unchanged at 4 days (P = 0.653). The addition of a geriatric in-reach service to a tertiary ASU led to a significant reduction in 28-day readmissions. Downtrends were seen in mortality, permanent care placement, and HAC rates, while LOS remained unchanged.

Risk assessment by acute bedside echocardiography prior to acute coronary angiography in patients with ST-elevation myocardial infarction: a feasibility study

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Novo Nordisk Foundation. Background Early risk assessment by hemodynamic measurements in patients with ST-elevation myocardial infarction (STEMI) could be useful for early detection of patients at risk of developing hemodynamic instability after primary percutaneous coronary intervention (pPCI). Anterior STEMI patients have larger infarct size and may be of particular interest. Transthoracic echocardiography (TTE) is a quick, non-invasive, and available tool, however, evidence regarding the use of acute TTE prior to acute coronary angiography (CAG) is limited. Purpose To assess the feasibility of acute bedside hemodynamic assessment in the cath. lab. by TTE in addition to clinical examination, and blood samples in STEMI patients without CS at arrival in the cath. lab. Methods STEMI patients without CS at hospital arrival and treated with pPCI were included in the study during a five week period. Clinical examination (Killip class), blood sampling (lactate, troponin T (TNT), proB-type natriuretic peptide (proBNP), and focused bedside 2D TTE with Doppler were performed prior to the acute CAG. The TTE protocol was focused (approx. 5 minutes) on hemodynamic measurements, infarction related complications, and differential diagnoses e.g. aortic dissection. The TTE was performed during preparation for the acute CAG. Patients were stratified in anterior- vs. non-anterior STEMI based on the culprit artery and prehospital ECG. Feasibility was estimated by all of the following echocardiographic parameters; left ventricular ejection fraction (LVEF), left ventricular outflow tract (LVOT) velocity time integral (VTI), and right ventricular function (tricuspid annular plane systolic excursion (TAPSE)). Results A total of 60 STEMI patients (aged mean 63 years, 18% female) were included, and 47% had an anterior STEMI. No differences in baseline characteristics between the two groups were found including comorbidities, clinical parameters, and time from cath. lab. arrival to first wire over the culprit lesion (median (IQR) 28 (23; 38) vs 32 (24; 40) minutes). Admission biomarkers of blood glucose, lactate, and proBNP plasma concentrations were similar between the two groups. Whereas admission TNT were higher for patients with anterior STEMI (median (IQR) 110 (37; 449) vs. 37 (20; 94) ng/L, p=0.01). The feasibility of TTE-study protocol was 93%. Patients with anterior STEMI had lower LVEF (mean: 36±11 vs. 48±9%, p=0.0003; missing: n=0), and a trend to lower LVOT VTI (19 (6.4) vs. 22 (5.0) cm, p=0.06; missing: n=4). No difference in parameters of diastolic function or TAPSE (missing: n=0) were found. None of the included patients had echocardiographic visible complications related to the infarction. Conclusion Acute TTE is to a high degree feasible and does not delay time to acute revascularization in STEMI patients. Patients with anterior STEMI have significantly higher admission TNT levels, lower LVEF, and a trend to lower LVOT VTI compared with non-anterior STEMI patients.

Midazolam as mean sedative agent in out-of-hospital cardiac arrest shock: is it associated to increased mortality?

Abstract Funding Acknowledgements None. Background The choice of a sedative agent for patients undergoing invasive ventilation has been widely studied. However, data regarding the optimal sedation strategy after Out-of-Hospital Cardiac Arrest (OHCA) when the patients are suffering from post-OHCA shock is sparse. Aim To explore whether the use of midazolam in patients admitted for OHCA that are additionally haemodynamically unstable increases in-hospital mortality, cardiovascular (CV) mortality, cerebral performance status (CPC) at discharge, and days of intubation or admission, when used selectively during the acute phase of deteriorating post-OHCA shock patients. Methods We report a prospective, observational, single-centre cohort that included all-comers admitted due to OHCA of presumed cardiac cause between May-2019 and July-2023, that remained comatose at admission. Midazolam was only administrated as the mean sedation agent when the patient was in a hemodynamically deteriorating situation (SCAI D-E). Baseline characteristics, OHCA features, blood samples measurements, in-hospital treatments and neurological condition at discharge were registered. Primary outcome was in-hospital death from any cause. Secondary outcomes included CPC at discharge (1-2 VS 3-5), CV mortality, days of admission, days of intubation, need of tracheostomy, myopathy, enolase at 48h and heart transplant during admission. Patients were stratified according to whether they had received midazolam as mean sedation agent at some stage of admission or not. Results 103 patients of the 109 admitted were included (6 refused consent), 45 of them (43%) received midazolam at some stage of admission. No differences in baseline characteristics were found. Mean age was 60.6 years, 79.6% were male, most frequent comorbidities were hypertension (53.4%) and dyslipidaemia (46.6%), and 20,4% had had a previous myocardial infarction. OHCA characteristics, shock parameters and administered treatments did not significantly differ between the two groups (Table 1). In-hospital mortality was numerically higher in the midazolam group but did not reach statistical significance (56% vs. 38%, p=0.075) (Figure 1). There were no differences neither in secondary outcomes (CV mortality 4% vs. 5%, p=0.865; CPC 1-2 70% vs. 83%, p=0.244; days of intubation 6 vs. 4, p=0.203; tracheostomy 18% vs. 10%, p=0.275; days of admission 14 vs. 15, p=0.851; 48h enolase 38 vs. 29, p=0.919; heart transplant during admission 0% vs. 1,7%, p=0.376; myopathy 30% vs. 21% p=0.282). Conclusion In patients admitted due to OHCA, even though the administration of midazolam is given in unstable patients, it is not related to a higher in-hospital mortality nor poorer outcomes.Table 1.OHCA and shock characteristicsFigure 1.Cumulative Survival

The role of rhythm control in patients with first diagnosed atrial fibrillation in a real world collective

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Bayer. Background There has been conflicting evidence regarding the importance of rhythm control as opposed to rate control in patients with atrial fibrillation (AF). Thus, no clear recommendation on early rhythm control for risk reduction is given in the current guidelines. However, some evidence suggests that rhythm control is superior to rate control in patients with a recent diagnosis of AF. Purpose We aim to characterize patients with first diagnosed AF and evaluate the effect of a rhythm control strategy at the time of diagnosis on long term cardiovascular outcomes. Methods This is a single center, retrospective observational sub study based as a part of the HERA-FIB project. HERA-FIB included 10.222 patients presenting to the emergency department (ED) of the department of cardiology of a university hospital from June 2009 to March 2020. We consecutively included all patients with a history AF or current AF upon presentation, regardless of the reason for presentation. A structured follow-up regarding survival and major cardiovascular events was performed. Mean follow up was 23 months (IQR 12-35). Patient care was not influenced. The project was performed according to the declaration of Helsinki and was approved by the local ethics committee and registered at ClinicalTrials.gov (Identifier: NCT05995561). Results. After adjudication we included 10.222 patients in this study. Of those 2758 (27%) had no previous history of AF and were first diagnosed with AF upon presentation. There were major differences in baseline characteristics as patients with first diagnosed AF were younger (73 years vs 76 years, p&amp;lt;0.0001), showed a normal left ventricular function more often (47.9% vs 40.2%, p&amp;lt;0.0001) and had fewer histories of coronary artery disease (CAD) (30.2% vs 48.0%, p&amp;lt;0.0001) and fewer histories of stroke or transient ischemic attack (TIA) (9.0% vs 14.0%, p&amp;lt;0.0001). In contrast they had higher heart rates (113 bpm vs 84 bpm, p&amp;lt;0.0001) on admission. Among the patients with first diagnosed AF 24.6% received a cardioversion (either pharmacological of electrical). Patients with first diagnosed AF undergoing rhythm control treatment showed lower rates for all-cause mortality (10.4% vs 18.2%, p&amp;lt;0.0001) and myocardial infarction (2.4% vs. 5.2%, p=0.0045) as compared to patients first diagnosed with AF not recieving a cardioversion. However, no differences for strokes (2.7% vs 3.3%, p=0.6158) or severe bleeding according to ISTH major bleeding criteria (4.0% vs. 5.3%, p=0.2252) could be detected. Conclusions Patients presenting to an ED with first diagnosed AF are younger and show fewer comorbidities compared to patients with pre-existing AF. Patients with first diagnosed AF seem to profit from early rhythm control strategies showing a reduction for the rates of all-cause mortality and myocardial infarction. However, no difference for stroke or major bleeding events could be detected. Additional, prospective studies are required to verify this hypothesis.

The Association Between Early Initiation of Systemic Corticosteroids and the Hospital Length of Stay in Patients With Multisystem Inflammatory Syndrome in Children.

Patients with multisystem inflammatory syndrome in children (MIS-C) often require hospital admission. Treatment of MIS-C has included intravenous immunoglobulin, systemic corticosteroids, and/or immunomodulators. There is no standardized approach to when steroids should be initiated during treatment. The study objective was to determine whether early initiation of steroids in patients with MIS-C is associated with the duration of hospital length of stay (LOS). This is a single-center retrospective cohort study of patients younger than 21 years who were hospitalized with MIS-C between March 2020 and September 2021 and received steroids. Cases were obtained from an institutional MIS-C log. Patients with culture proven sepsis and/or those who received intravenous immunoglobulin or steroids within the previous 30 days were excluded. We used a multivariable linear regression model, controlling for potential confounders, to assess the association between early steroids and LOS. A total of 56 patients hospitalized with MIS-C were identified; 38 received systemic corticosteroids and were included in the study. The mean time from admission to steroid administration was 9.8 hours (SD = 7.7) in the early group and 44.6 hours (SD = 14.2) in the late group. There was a statistically significant difference in baseline characteristics of patients receiving early versus late steroids in initial C-reactive peptide, procalcitonin, brain natriuretic peptide, and cardiac dysfunction. After controlling for confounders, initiating steroids within 24 hours of admission for MIS-C was associated with a decreased hospital LOS: in patients treated with early steroids, LOS was 58.3 hours less (95% confidence interval, -100.0 to -16.6; P = 0.007) than in those who received late steroids. Among patients with MIS-C, initiating systemic corticosteroids within 24 hours of admission was associated with decreased hospital LOS.

Differences in clinical features according to survival and gender in patients admitted for cardiac arrest

Abstract Funding Acknowledgements None. Introduction Cardiac arrest (CA) is a condition with poor vital and neurological prognosis. Although there are widely known clinical features modifying prognosis –such as time to return of spontaneous circulation (ROSC) and neuron-specific enolase values-, there is uncertainty around whether gender, ischemic etiology or classic cardiovascular risk factors may influence in the management and prognosis. Purpose The aim of this study was to analyze the differences in baseline characteristics and management between survivors and non survivors, among patients admitted for CA in an Intensive Cardiac Care Unit. Methods A prospective unicentric registry was performed from January 2010 to December 2021, including all consecutive cardiac arrest patients admitted to an intensive cardiac care unit of a university hospital. Patients were classified into survivors –to hospital discharge- and non-survivors –deceased during hospital admission, irrespective of time of death. Univariate analysis were performed using Chi-square and Student t tests, and logistic regression was used for a multivariate analysis to compare both groups. Results A total of 324 patients were included, mean age 59.7 (DE 12.2) years, 17.9% were women. In-hospital mortality was 42% (136 patients) and 188 patients survived to hospital discharge. Survivors were significantly younger (mean of 57,37 vs 62,98 years) and had less prevalence of diabetes (17 vs 33%) and previous myocardial infarction (15 vs 25%) than non-survivors. Among survivors, there was a higher prevalence of in-hospital CA (26,6 vs 12,5%), CA due to acute coronary syndrome (68,62 vs 57,78%) and shockable first rhythm (90,43 vs 72,06%). They also had shorter ROSC (mean 22,13 vs 34,25 minutes) and no flow times (mean 2,54 vs 5,67 minutes). Gender, arterial hypertension, dyslipidemia and smoking habit did not modify prognosis. When comparing genders, women had significantly less prevalence of smoking habit and previous ischemic heart disease, their time to ROSC was lower and they received less coronary angiographies than men. The multivariate analysis showed significant in-hospital mortality risk increase with age (OR 1,04 per year), ROSC (OR 1,04 per minute) and no-flow (OR 1,09 per minute) times, out of hospital CA (OR 2,26) and non shockable rhythm. Conclusions In a consecutive cohort of 324 patients admitted after cardiac arrest, survivors were significantly younger, and had less prevalence of diabetes mellitus and previous myocardial infarction. In-hospital arrest, shockable rhythm, and shorter ROSC and no-flow times were associated with better survival. No differences in survival were found between genders, although women had significantly shorter resuscitation times.Univariate analysisMultivariate analysis

Abstract PS02-01: Efficacy, safety, and quality of life with ribociclib + endocrine therapy in elderly patients with HR+/HER2– advanced breast cancer across the MONALEESA-2, -3, and -7 trials

Abstract Background: Ribociclib (RIB) + endocrine therapy (ET) showed statistically significant progression-free survival (PFS) and overall survival (OS) benefits in MONALEESA-2, -3, and -7 in patients (pts) with HR+/HER2− advanced breast cancer (ABC). Here, we report efficacy, safety, and quality of life (QOL) with RIB + ET in elderly pts in the MONALEESA trials. Methods: Data were pooled from the MONALEESA-2, -3, and -7 trials of pre- and postmenopausal pts with HR+/HER2− ABC treated with first-line RIB + ET or placebo (PBO) + ET. The tamoxifen cohort in MONALEESA-7 and pts with early relapse were excluded from this analysis. PFS, OS, and time to first chemotherapy (TTC) were analyzed in pts &amp;lt;65 y, 65- &amp;lt;75 y, and ≥75 y using Kaplan-Meier methods. Time to definitive deterioration (TTD) by ≥10 points in global health status (GHS) was analyzed across age subgroups using Kaplan-Meier methods. Results: Of the 1229 pts included in this analysis, 773 (62.9%) were &amp;lt;65 y, 335 (27.3%) were 65- &amp;lt;75 y, and 121 (9.8%) were ≥75 y. There were minor differences in baseline characteristics between the age groups: slightly higher % of pts in the ≥75 y group with a ECOG status of 1 and slightly higher % of de novo disease in the &amp;lt;65 y group (Table). Regardless of age, a PFS and OS benefit was seen with RIB + ET vs PBO + ET (Table). RIB + ET also delayed the median TTC in all age groups. In the RIB + ET group, the most common first subsequent antineoplastic treatment was hormonal therapy alone ( &amp;lt;65 y, 26.3%; 65- &amp;lt;75 y, 41.6%; ≥75 y, 38.1%). In the ≥75 y subgroup, pts in the RIB + ET arm (6.3%) less frequently used chemotherapy alone as the first subsequent antineoplastic treatment vs the PBO + ET (24.5%) arm. In pts &amp;lt;65 y, safety results were consistent with those in the overall trial population. In pts 65- &amp;lt;75 y and ≥75 y, the most common any grade adverse events (AEs) with RIB + ET vs PBO + ET were neutropenia (67.6% vs 5.4% and 52.9% vs 3.8%), nausea (52.7% vs 32.0% and 52.9% vs 40.4%), fatigue (42.0% vs 38.1% and 36.8% vs 21.2%), and diarrhea (39.9% vs 30.6% and 48.5% vs 32.7%). For RIB + ET vs PBO + ET, rates of grade 3/4 febrile neutropenia ( &amp;lt;65 y, 1.2% vs 0.3%; 65- &amp;lt;75 y, 1.1% vs 0; ≥75 y, 2.9% vs 0), all grade interstitial lung disease ( &amp;lt;65 y, 1.0% vs 0.6%; 65- &amp;lt;75 y, 2.7% vs 0.7%; ≥75 y, 7.4% vs 0), and all grade QT prolongation ( &amp;lt;65 y, 9.1% vs 2.9%; 65- &amp;lt;75 y, 11.2% vs 4.1%; ≥75 y, 16.2% vs 1.9%) were numerically higher in pts 65- &amp;lt;75 y and ≥75 y than in pts &amp;lt;65 y. Rates of discontinuation due to AEs with RIB + ET vs PBO + ET were 14.6% vs 3.1% in pts &amp;lt;65 y, 19.7% vs 6.8% in pts 65- &amp;lt;75 y, and 41.2% vs 7.7% in pts ≥75 y. In pts who discontinued treatment due to AEs, the percentage of pts without prior dose reduction was 34.4% in pts &amp;lt;65 y, 40.5% in pts 65- &amp;lt;75 y, and 50.0% in pts ≥75 y. TTD in GHS was prolonged with RIB + ET vs PBO + ET in pts &amp;lt;65 y. In pts 65- &amp;lt;75 y and ≥75 y, TTD was generally similar with RIB + ET vs PBO + ET (Table). Conclusions: This pooled analysis of the MONALEESA-2, -3, and -7 trials demonstrated PFS and OS benefits with RIB + ET in elderly pts consistent with those observed in younger pts. Across age subgroups, treatment with RIB + ET also delayed TTC. Overall, RIB was well tolerated in elderly pts, with a safety profile consistent with what is anticipated for an older patient population. Additionally, there was no difference in TTD in GHS with RIB + ET vs PBO + ET in pts 65- &amp;lt;75 y and pts ≥75 y. Citation Format: Lowell Hart, Seock-Ah Im, Sara Tolaney, Mario Campone, Timothy Pluard, Berta Sousa, Gilles Freyer, Thomas Decker, Kevin Kalinsky, Astrid Thuerigen, Melissa Gao, Huilin Hu, Sherko Küemmel. Efficacy, safety, and quality of life with ribociclib + endocrine therapy in elderly patients with HR+/HER2– advanced breast cancer across the MONALEESA-2, -3, and -7 trials [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-01.

Abstract PO3-12-10: Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet

Abstract Background: Taxane based chemotherapy (chemo) forms a critical part of breast cancer (BC) treatment in early and metastatic settings. Taxanes can cause peripheral neuropathy (CIPN)-sensory and motor, primarily of the hands and feet, resulting in quality of life decline and negaive impact on BC survival. Acral cryotherapy has shown benefit in reducing in in minimizing the incidence and severity ofcidence and severity of CIPN. However, these studies have included limited number of patients (pts) with inconclusive evidence to change US practice guidelines, have been primarily conducted in Asia, and did not include racially diverse patients. Methods: We conducted a single arm non randomized study at Mayo Clinic that included early BC pts who underwent standard of care paclitaxel or docetaxel based chemo. Pts had ECOG performance status 0-2, no sensory peripheral neuropathy at study entry and were able to give signed informed consent. Pts with metastatic BC, Raynaud's and peripheral vascular disease, cryoglobulinemia, cold intolerance, prior exposure to neurotoxic or taxane chemotherapy were excluded. Participating pts wore frozen gloves and socks (−20 to −10°C) on both hands and feet, 15 min before, during and until 15 min post taxane infusion. During chemo, grade (G) of CIPN (sensory) per CTCAE v5 was collected prior to each cycle of chemo, end of and 3 months after chemo. Schedule of events is listed in Table 1. Continuous variables were summarized using mean and standard deviation, and categorical variables were summarized with number and percentage of patients. Numeric variables were compared with t tests (paired and unpaired), and categorical variables were compared with Chi-Squared test for independent data and Mcnemar’s test for dependent data. All statistical tests were two-sided and were performed using R Statistical Software (version 4.1.2; R Foundation for Statistical Computing). Results: A total of 95 patients were included in this study. Median age is 54 years, 66.3% pts were White (W), 23.2% African American (AA), 4.2% Asian (A) and 4.2% Hispanic (H). Median BMI was 27.7. Most pts had stage I/II (75.8%), ER positive (64.9%) and HER2 negative (55.3%) BC and got adjuvant chemo (52.6%). Only 10.6% pts had diabetes, 55.3% used alcohol. Vitamin D3 use seen in 65.6%, B12 in 6.2% and folate, B12 and D3 in 6.2% pts. A total of 41 pts (44.1%) developed neuropathy at some point during chemo, of which 27 pts were W (43%), 10 pts AA (45%), 2 pts H, 1 Asian and 1 other. CIPN was G1 in 37 pts (90%). G2 CIPN was seen in 4 pts, at or after cycle 10 of weekly paclitaxel. Cold intolerance was seen in 24 pts (25%), G1 in 20 and G2 in 4 pts, all seen in cycle 1 with 1 pt withdrawal. Recovery to G0 was seen in 15 W pts at chemo end and 2 additional pts at 3 month after chemo. None of the AA pts, one H and one A pt had CIPN recovery to G0. In 4 AA pts who had G1 CIPN during chemo, G2 CIPN was noted at 3 month follow up. No Statistically significant differences in baseline characteristics and neuropathy results for W vs nonwhites (NW) were seen except Charleson score (p-value 0.023). Conclusion: Acral cryotherapy was found to be effective in reducing the incidence and severity of CIPN from taxane in our study. This is the only study with diverse racial/ethinic pt inclusion and incidence of CIPN was similar in W and NW. However, majority of G2 CIPN pts were AA and recovery to G0 CIPN was not seen in AA pts. Majority (63%) of W pts recovered to G0 at end of follow up. Analysis of objective testing of all pts is underway. Continued research into risk factors for AA pts to develop CIPN and its mitigation are warranted. XX XX Citation Format: Pooja Advani, Jinky Harvey, Ivy Vilches, Alex Hochwald, David Hodge, Amanda Arnold, Morgan Weidner, Dana Haley, Tanmayi Pai, Saranya Chumsri, Rohit Rao, Kostandinos Sideras, Cindy Tofthagen, Alvaro Moreno-Aspitia. Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-12-10.

Abstract PO2-16-09: Dose-dense versus 3-weekly AC during Neoadjuvant Chemoimmunotherapy for Early-Stage Triple-Negative Breast Cancer (TNBC): a Real-World Safety and Efficacy Data Analysis

Abstract Background: The Keynote-522 (KN-522) study established the use of pembrolizumab in combination with neoadjuvant carboplatin-paclitaxel, followed by 3-weekly (3w) anthracycline-cyclophosphamide (AC), as the standard of treatment for stage II-III TNBC. However, dose-dense chemotherapy (CT) improves survival rates compared to the standard schedule in early-stage breast cancer and several groups have been modifying the KN-522 regimen with dose-dense AC (ddAC). The objective of this study was to compare the safety and effectiveness of ddAC versus the q3w schedule. Methods: We conducted a multicentric real-world analysis of patients (pts) with early-stage TNBC who received neoadjuvant CT plus pembrolizumab at nine cancer centers. Safety endpoints included grade ≥ 3 adverse events (AEs), drug discontinuation, hospitalization due to AEs, and the use of antibiotics during neoadjuvant therapy. Pathologic complete response (pCR) was used as the effectiveness endpoint, and we performed univariate and multivariable logistic regression to evaluate factors associated with pCR. Results: To date, we included 168 pts in this study of which 137 pts have finished the neoadjuvant therapy phase and constituted our safety cohort. Among them, 86 pts (62.8%) received ddAC and 51 pts (37.2%) were treated with the 3w schedule. The two groups exhibited no significant differences in baseline characteristics; the median age was 42 years (range 29 - 75), 70.8% had stage II and 25.5% had stage III TNBC, 46.7% had positive lymph nodes, and 74.4% had a Ki67-index ≥ 50%. Overalls, 30.2% and 27.4% presented grade ≥ 3 AEs with ddAC and 3w AC, respectively, with no significant difference between the two groups (p=0.177). Grade ≥ 3 immune-related AEs (irAEs), occurred in 8.1% with ddAC and 3.9% with 3w AC (0.335). The most common grade ≥ 3 irAEs were pneumonitis (n=4) and hepatitis (n=2). The ddAC group had a higher rate of any drug discontinuation due to toxicities (24.4% vs. 11.8%, p=0.043) and a greater use of antibiotics (27.9% vs. 11.8%, p=0.009) compared to the 3w group. There was a trend toward more rates of hospitalization due to AEs in the ddAC group, although this was not statistically significant (17.4% vs 11.8%, p=0.131). At the time of data analysis cutoff, a total of 119 pts underwent surgery and have pathology report available and were included in the efficacy cohort. In the univariate analysis, the pCR rates were 65.8% with ddAC and 55.8% with 3w AC (OR 1.52, 95% CI 0.70-3.27, p=0.282). The rates of RCB (residual cancer burden) 0-1 were 81.2% and 67.6%, respectively (OR 2.06, 95% CI 0.82 – 5.16, p=0.120). Factors influencing rates of pCR were Ki67 index ≥ 50% and tumor staging, which remained significant in the multivariable analysis (Table). In the 3w AC group, no difference in pCR was observed between pts who used or not granulocyte colony stimulating-factors (61.1% vs 52%, p=0.553). Conclusion: No difference in grade ≥ 3 AEs was observed between ddAC and 3w AC in pts with early-stage TNBC receiving neoadjuvant CT plus pembrolizumab. Nevertheless, the dose-dense regimen was linked to higher rates of drug discontinuation and antibiotic use. Although the pCR rates numerically favored ddAC, the difference was not statistically significant. Thus, the medical community should consider carefully risks and benefits of using ddAC within the KN522 regimen. Larger studies and longer follow-up are warranted to assess the long-term outcomes of the CT schedules. Multivariable regression of factors associated with pCR Citation Format: Renata Colombo Bonadio, Fernanda Madasi, José Bines, Rafael Ferreira, Daniela Rosa, Candice Santos, Zenaide Souza, Daniele Assad-Suzuki, Julio Araujo, Débora Gagliato, Carlos dos Anjos, Bruna Zucchetti, Anezka Ferrari, Mayana Lopes, Renata Cangussu, Maria Marcela Monteiro, Paulo Hoff, Laura Testa, Romualdo Barroso-Sousa. Dose-dense versus 3-weekly AC during Neoadjuvant Chemoimmunotherapy for Early-Stage Triple-Negative Breast Cancer (TNBC): a Real-World Safety and Efficacy Data Analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-16-09.

Enteral Access Outcomes in Patients Hospitalized With Cardiac Disease: A Retrospective Cohort Study

IntroductionPatients admitted with principal cardiac diagnosis (PCD) can encounter difficult inpatient stays that are often marked by malnutrition. In this setting, enteral feeding may improve nutritional status. This study examined the association of PCD with perioperative outcomes after elective enteral access procedures. MethodsAdult patients who underwent enteral access procedures between 2018 and 2020 at a tertiary care institution were reviewed retrospectively. Differences in baseline characteristics between patients with and without PCD were adjusted using entropy balancing. Multivariable logistic and linear regressions were subsequently developed to evaluate the association between PCD and nutritional outcomes, perioperative morbidity and mortality, length of stay, and nonelective readmission after enteral access. Results912 patients with enteral access met inclusion criteria, of whom 84 (9.2%) had a diagnosis code indicating PCD. Compared to non-PCD, patients with PCD more commonly received percutaneous endoscopic gastrostomy by general surgery and had a higher burden of comorbidities as measured by the Charlson comorbidity index. Multivariable risk adjustment generated a strongly balanced distribution of baseline covariates between patient groups (standardized differences ranged from −2.45 × 10−8 to 3.18 × 108). After adjustment, despite no significant association with in-hospital mortality, percentage change prealbumin, length of stay, or readmission, PCD was associated with an approximately 2.25-day reduction in time to meet goal feeds (95% CI -3.76 to −0.74, P = 0.004) as well as decreased odds of reoperation (adjusted odds ratio 0.28, 95% CI 0.09-0.86, P = 0.026) and acute kidney injury (adjusted odds ratio 0.24, 95% CI 0.06-0.91, P = 0.035). ConclusionsDespite having more comorbidities than non-PCD, adult enteral access patients with PCD experienced favorable nutritional and perioperative outcomes.

Lower extremity arterial disease vs. coronary artery disease: mortality differences after revascularization.

Patients undergoing revascularization for lower extremity arterial disease (LEAD) may face a higher risk of mortality than those with coronary artery disease (CAD). This study aimed to characterize the difference in mortality risk between patients undergoing revascularization for LEAD and CAD and identify associated factors. The 1-year database of 10 754 patients undergoing revascularization for CAD (n = 6349) and LEAD (n = 4405) was analysed. Poisson regression models were used to characterize interpopulation differences in mortality, adjusting for baseline clinical features, including age, sex, polyvascular disease, comorbidities, medications, and vulnerabilities. Individuals with LEAD were older, were more likely to have polyvascular disease, had more comorbidities, and received fewer cardioprotective drugs than those with CAD. Vulnerabilities remained more common in the LEAD group even after adjusting for these clinical features. The crude risk ratio of mortality incidence for LEAD vs. CAD was 2.91 (95% confidence interval, 2.54-3.34), attenuated to 2.14 (1.83-2.50) after controlling for age, sex, and polyvascular disease. The percentage attenuation in the excessive mortality associated with LEAD was 29%. The stepwise addition of comorbidities, medications, and vulnerabilities as adjusting factors attenuated the incidence risk ratio to 1.48 (1.26-1.72), 1.33 (1.12-1.58), and 1.17 (0.98-1.39), respectively, and increased the percentage attenuation to 64%, 73%, and 86%, respectively. Mortality risk was almost three-fold higher in patients undergoing revascularization for LEAD than in those with CAD. The excessive mortality was considerably attributable to inter-group differences in baseline characteristics, including potentially clinically or socially modifiable factors.