Multicenter Retrospective Observational Study Research Articles

2753. Real-World Use of Cefiderocol Treating Non-COVID Patients with Confirmed Gram-Negative Infections in US Hospitals During January 2020-June 2022

Abstract Background Cefiderocol (CFDC) has broad activity against Gram-negative (GN) pathogens. This study describes the CFDC usage in treating non-COVID patients with microbiology data in US hospitals from Jan 2020-Jun 2022. Methods This retrospective multicenter observational study included adult non-COVID hospitalized patients treated with CFDC consecutively for ≥3 days after laboratory confirmed GN infections between Jan 2020 to Jun 2022, as captured by Premier Healthcare data. This study describes the patient characteristics, microbiological profile, and overall, as well as 14-day and 28-days, in-hospital all-cause mortality (IHACM). Index culture was defined as the first clinical culture with GN pathogens. Index pathogens were all pathogens identified from the index culture. Results Patient characteristics of 275 hospitalized patients who received ≥3 days CFDC after the microbiological results are shown in Table 1. For index culture, 61.1% were taken ≤3 days of admission, 53.1% were taken during ICU stay, 45.8% involved respiratory culture, followed by urinary (19.6%), wound (18.2%) and blood (16.4%). Also 65.8% of patients had one index pathogen and 34.2% had ≥2 index pathogens. The most common index pathogens were Pseudomonas aeruginosa (48.7%), Acinetobacter baumannii (23.6%), Klebsiella pneumoniae (14.2%), and Stenotrophomonas maltophilia (13.1%). On the index culture day, 62.2% of patients had one pathogen from a single site and 37.8% had either one pathogen identified in multiple culture sites or multiple pathogens from ≥1 culture site. CFDC was used as monotherapy in 92 (33%) patients, though 253 (92%) had used other GN antibiotics before starting CFDC. A total of 135 (49.1%) patients started CFDC ≤ 5 days of index culture, 108 (39.3%) patients between 6-20 days, and 32 (11.6%) patients > 20 days. Crude overall IHACM was 16.4% (95%CI:12.0%-20.7%): 10.4% for those who started CFDC ≤ 5 days of index culture, 19.4% for 6-20 days, and 31.3% for > 20 days. Crude 14-day and 28-day IHACM from index culture or starting CFDC had the same trend and were lower than overall IHACM (see Table 2). Conclusion The study demonstrated that CFDC is effective in treating patients with GN infections. Patients receiving CFDC earlier had lower IHACM than those receiving CFDC later but need further investigation. Disclosures Bin Cai, MD, PhD, Shionogi Inc.: Shionogi employee Christine M. Slover, PharmD, Shionogi,INC: Employee Jennifer D. copeland, MS, Shionogi, Inc.: Employee (Medical/Micro) Sean T. Nguyen, PharmD, Shionogi: Employee|Shionogi, Inc: Employee

202. Association of Neutrophil - Lymphocyte Ratio with Bacteremia and In-Hospital Mortality in Sepsis Patients: A Retrospective Multicenter Study

Abstract Background Early diagnosis, prognostication, and treatment initiation are the cornerstones of sepsis management. There remains an immense interest in exploring the diagnostic and prognostic roles of neutrophil-lymphocyte ratio (NLR) in the sepsis population. Methods We performed a retrospective multi-center observational study including patients admitted to different Mayo Clinic sites with a diagnosis of sepsis between October 2018 and August 2022. Patients were excluded if they were aged < 18 years, lacked research authorization, or had missing Neutrophil or Lymphocyte count at admission. Data were collected from an existing sepsis database and Mayo Data Explorer (MDE). Categorical variables were summarized as percentages and continuous variables were summarized as medians. Chi-square test for significance, independent sample t-test, and multivariate Cox Proportional Hazard models were performed on IBM SPSS Statistics v28.0. Results Our study cohort consisted of 13968 patients, of which the majority were males (55.9%), Caucasian (91.6%), and non-Hispanic or Latino (94.3%). The median age of the cohort was 71 (60, 80) years, and the median BMI was 27.7 (23.4, 33.3) kg/m2. Among all sepsis patients, 6.0% had a positive blood culture and the most common organisms were E. coli (26.5%), Klebsiella sp. (15.6%), Streptococcus sp. (12.8%) and Staphylococcus aureus (9.9%). 13131 patients (94.1%) survived the hospital stay and 837 (5.9%) did not. There was no difference in mortality based on blood culture positivity status (6.0% vs 6.6%, p=0.41). However, the median NLR was higher among patients with a positive blood culture (16.4 vs. 12.1, p< 0.001) and among non-survivors (14.3 vs 12.2, p< 0.001). NLR did not significantly vary based on the type of organism growing in the blood culture. A multivariate model revealed NLR as an independent predictor of mortality (HR 1.003, 95% CI: 1.000-1.006, p=0.029) after adjusting for comorbidities, baseline clinical and laboratory variables. (Tables 1 & 2) Conclusion Our retrospective multicentric study showed that the Neutrophil-Lymphocyte ratio at admission was higher among bacteremic sepsis patients and non-survivors. Further prospective studies are needed to explore its diagnostic and prognostic utility. Disclosures All Authors: No reported disclosures

ADA_ETA_BIO2021: real-world evaluation of adherence, persistence, and cost-effectiveness of originator and biosimilar biologic drugs in the treatment of rheumatoid arthritis: a multicenter study in Italy

Objectives The objective was to assess the adherence, persistence, and costs of bDMARDs through a multicentre study of nine Italian hospital pharmacies. Methods The drugs analysed were Abatacept, Adalimumab, Certolizumab, Etanercept, Golimumab and Tocilizumab. Adult subjects with Rheumatoid Arthritis were considered in the analysis. In this study, we calculated the following metrics: Adherence to treatment was evaluated as dose-intensity, which is the ratio between the amount of medication received and probably taken by the patient at home (Received Daily Dose, RDD) and the amount prescribed by the clinician (Prescribed Daily Dose, PDD). Persistence was calculated as the number of days between the first and last dispensing of the same drug. Lastly, costs were assessed based on persistence to treatment and normalized for adherence. Results Adherence to treatment was found to be above 0.8 for all drugs studied. The median persistence for a 5-year treatment period was 1.4 years for Abatacept, 1.7 years for Adalimumab, 1.8 years for Certolizumab, 1.4 years for Etanercept, 1.3 years for Golimumab, and 1.6 years for Tocilizumab. Conclusions This multicentre retrospective observational study of bDMARDs used in the treatment of RA showed that, for all the drugs studied, there was no problem with adherence to treatment but rather a difficulty in maintaining treatment with the same drug over time.

Clinical and Radiographic Outcomes of a Monoblock Fluted Titanium Tapered Stem Following Complex and Revision Total Hip Arthroplasty

AbstractAchieving femoral stem stability in complex primary and revision total hip arthroplasty (rTHA) cases is a challenging goal that monoblock fluted titanium tapered stems (FTTS) were designed to address. However, as more modern FTTS are developed, there are still questions regarding outcomes for these stems. The purpose of this study is to determine the radiographic and clinical outcomes of a modern monoblock FTTS. A multicenter retrospective observational study examined the hip databases of three institutions to obtain all monoblock FTTS with up to 5 years of radiographic follow-up. Stem subsidence and osteointegration were assessed on the most recent radiograph. All-cause re-revisions and survival of the stem at latest follow-up were recorded. Descriptive statistics were calculated for demographics and outcomes. Ninety-six monoblock FTTS were examined. Median clinical follow-up was 28.5 months (range: 18.0–57.8 months). Median subsidence was 1.4 mm (range: 0–15.0 mm). Sixteen (16.7%) and 3 (3.1%) stems had subsidence greater than 5 and 10 mm, respectively. Overall, thirteen hips (13.5%) required reoperations, of which 5 stems were revised (5.2%). Four stems were revised for periprosthetic joint infection (PJI), and one stem was explanted for exposure during acetabular revision. Kaplan–Meier analysis yielded an all-cause stem survivorship of 95.8% at 2 years and 88.5% at 4 years. Stem survivorship excluding septic causes for revision was 99.0% at both 2 and 4 years. Monoblock FTTS in complex primary and rTHA demonstrate encouraging clinical and radiographic results at up to 5 years of follow-up.

Can the Modified Frailty Index (mFI) Predict Intraoperative and Postoperative Complications in Older Women with Endometrial Cancer Undergoing Laparoscopic or Robotic Surgery? A Multicenter Observational Study

Background: This study aims to evaluate the strength of the association between frailty and intraoperative/postoperative complications in patients undergoing minimally invasive surgery (MIS) for endometrial cancer. Methods: In this retrospective observational multicenter cohort study, frailty was defined beforehand by a modified frailty index (mFI) score of ≥3. Multiple logistic regressions were performed to investigate possible preoperative predictors—including frailty, age, and body mass index—of intraoperative and early (within 30 days from surgery) or delayed (beyond 30 days from surgery) postoperative complications. Results: The study involved 577 women, of whom 6.9% (n = 40) were frail with an mFI ≥ 3, while 93.1% (n = 537) were non-frail with an mFI of 0–2. Frail women had a significantly higher rate of intraoperative complications (7.5% vs. 1.7%, p = 0.01), with odds 4.54 times greater (95% CI: 1.18–17.60, p = 0.028). There were no differences in the rate of early postoperative complications (15% vs. 6.9%, p = 0.06) and delayed postoperative complications (2.5% vs. 3.9%, p = 0.65) for frail versus non-frail patients. The odds of early postoperative complications increased by 0.7% (95% CI: 1.00–1.15) for every one-unit increase in age (p = 0.032). Conclusions: Frailty was associated with a significantly higher risk of intraoperative complications in older women undergoing MIS for endometrial cancer. Likewise, increasing age was an independent predictor of early postoperative complications. Our findings support the practice of assessing frailty before surgery to optimize perioperative management in this patient population.

The relationship between observation interval and prognosis in pancreatic cancer concomitant with intraductal papillary mucinous neoplasia

BackgroundIntraductal papillary mucinous neoplasia (IPMN) is a risk factor for pancreatic cancer (PC). PC concomitant with IPMN shows rapid progression similar to de novo PC, therefore, the appropriate observation interval (OI) is not yet clear. Patients and methodThis was a multicenter retrospective observational study, and patients with PC concomitant with IPMN were analyzed. OI was defined as the interval between the date of imaging at PC diagnosis and just before the diagnosis. Clinical factors of PC and prognosis were assessed according to OI. ResultsFrom January 2010 to December 2018, 73 patients from 11 institutions were enrolled. The images performed just before PC diagnosis were contrast-enhanced CT/magnetic resonance imaging/endoscopic ultrasonography in 44/27/2 patients, respectively. The median cyst size was 14.0 mm, and the median main pancreatic duct diameter was 3.0 mm. The median OI was 6.8 months. In OI 6 months or less (OI ≤ 6 M)/OI more than 6 months (OI > 6 M), the mean tumor size, the frequencies of metastatic PC, resectable PC and early-stage PC were 20.1/21.5 mm (P = 0.91), 12.1 %/32.5 % (P = 0.05), 72.7 %/52.5 % (P = 0.09) and 27.3 %/25.0 % (P = 1.00), respectively. The median overall survival was 35.5 months in OI ≤ 6 M and 16.2 months in OI > 6 M (P = 0.05). ConclusionIn OI 6 months or less, the rate of resectable PC was high, however, the rate of early PC was almost the same as that of OI more than 6 months. Approximately 10 % of cases found in the advanced stage with metastasis even if OI 6 months or less.

Factors influencing withdrawal of life-supporting treatment in cervical spinal cord injury: a large multicenter observational cohort study

BackgroundTraumatic spinal cord injury (SCI) leads to profound neurologic sequelae, and the provision of life-supporting treatment serves great importance among this patient population. The decision for withdrawal of life-supporting treatment (WLST) in complete traumatic SCI is complex with the lack of guidelines and limited understanding of practice patterns. We aimed to evaluate the individual and contextual factors associated with the decision for WLST and assess between-center differences in practice patterns across North American trauma centers for patients with complete cervical SCI.MethodsThis retrospective multicenter observational cohort study utilized data derived from the American College of Surgeons Trauma Quality Improvement Program database between 2017 and 2020. The study included adult patients (> 16 years) with complete cervical SCI. We constructed a multilevel mixed effect logistic regression model to adjust for patient, injury and hospital factors influencing WLST. Factors associated with WLST were estimated through odds ratios with 95% confidence intervals. Hospital variability was characterized using the median odds ratio. Unexplained residual variability was assessed through the proportional change in variation between models.ResultsWe identified 5070 patients with complete cervical SCI treated across 477 hospitals, of which 960 (18.9%) had WLST. Patient-level factors associated with significantly increased likelihood of WLST were advanced age, male sex, white race, prior dementia, low presenting Glasgow Coma Scale score, having a pre-hospital cardiac arrest, SCI level of C3 or above, and concurrent severe injury to the head or thorax. Patient-level factors associated with significantly decreased likelihood of WLST included being racially Black or Asian. There was significant variability across hospitals in the likelihood for WLST while accounting for case-mix, hospital size, and teaching status (MOR 1.51 95% CI 1.22–1.75).ConclusionsA notable proportion of patients with complete cervical SCI undergo WLST during their in-hospital admission. We have highlighted several factors associated with this decision and identified considerable variability between hospitals. Further work to standardize WLST guidelines may improve equity of care provided to this patient population.

High frequency of Enterococcus faecalis detected in urinary tract infections in male outpatients – a retrospective, multicenter analysis, Germany 2015 to 2020

BackgroundUrinary tract infections (UTI) in men differ relevantly to women by their pathogens. Gram-positive uropathogens play a relevant role in UTI in men. In this study, we aimed to analyze the epidemiology of Enterococcus faecalis in UTI in male outpatients.MethodsWe conducted a retrospective observational multicenter study during 2015 to 2020 consisting of urine samples of 99,415 adult male outpatients sent from 6,749 outpatient practices from Germany. Proportions were compared using the z-Test and 95% confidence intervals were calculated using the Clopper-Pearson method.ResultsE. faecalis is the 2nd most frequent bacteria (16%) detected in suspected UTI in male outpatients. Young men are predominantly at risk (17%) for isolation of E. faecalis in suspected UTI. In polymicrobial infections E. faecalis is isolated in 47% of all suspected UTI in men. Recurrency of suspected UTI is significantly more frequent when E. faecalis is isolated compared to Escherichia coli (22% vs 26%; p < .001). Recurrency rates of E. faecalis associated UTI increases by age from 12% (18–29 years) to 28% (ge 70 years); p < .001. Congruently the resistance of E. faecalis against ciprofloxacin increases by age from 22% (18–29 years; 2019) to 37% (ge 70 years; 2019); p < .001.ConclusionsE. faecalis is frequently isolated in suspected UTI in male patients. Consequently, Nitrate-sticks results cannot be recommended to exclude UTI in men. The empirical use of ciprofloxacin in young adults can be reasonable. Frequent recurrences in E. faecalis associated suspected UTI emphasizes the importance of microbiological pathogen identification and susceptibility testing in men suffering from UTI.

Infected Shoulder Arthroplasty in Patients Younger than 60 Years: Results of a Multicenter Study.

Background: Periprosthetic joint infection (PJI) after shoulder arthroplasty remains a significant complication. This study aimed to explore the epidemiology and risk factors of shoulder PJI in patients aged 60 and younger, analyze treatment options, and evaluate outcomes after 1-year follow-up. Methods: In this retrospective multicentric observational study, data from 1404 shoulders in patients under 60 who underwent primary shoulder arthroplasty were analyzed. Patients with PJI and at least 1-year follow-up after infection treatment were included. Results: The study identified 55 shoulders with PJI, resulting in a 2.35% infection rate after primary shoulder arthroplasty in the young population. Male gender and reverse shoulder arthroplasty were risk factors for infection, while previous surgeries did not significantly contribute. The most common causative agents were Cutibacterium acnes and Staphylococcus epidermidis. Open washout had a 52.9% success rate for acute infections, while one-stage and two-stage revisions achieved infection control rates of 91.3% and 85.7%, respectively. Resection arthroplasty had an 81.8% success rate but poorer functional outcomes. Conclusions: PJI following shoulder arthroplasty in young patients is a significant concern. Preoperative planning should be carefully considered to minimize infection risk. Treatment options such as open washout and one-stage and two-stage revisions offer effective infection control and improved functional outcomes. Resection arthroplasty should be reserved for complex cases where reimplantation is not a viable option.

Comparative Efficacy and Safety of Statin Monotherapy and Statin plus Ezetimibe Combination in a Real-World Setting.

The objective of this study was to conduct a comparative evaluation of the effectiveness of ezetimibe in combination with statins or statin monotherapy in patients with hypercholesterolemia in a real-world setting. It was a retrospective multicenter observational study conducted in Russia. We included patients who received statins or a combination of statins with ezetimibe for ≥3 months. The primary endpoint of this study was the frequency of achieving low-density lipoprotein cholesterol (LDL-C) goal levels at the time of enrollment in the study (%). The full analysis set consisted of 1000 patients: 250 subjects in the statin monotherapy group and 750 subjects in the combination group. The groups did not differ in clinical, demographic, or laboratory variables, except for a higher prevalence of hypertension and higher baseline lipid values in the statin monotherapy group. During treatment, the LDL-C concentration decreased by 1.10 ± 1.04 mmol/L (change of -27.5 ± 28.5% from baseline) in the statin monotherapy group and by 1.55 ± 1.17 mmol/L (change of -38.2 ± 25.6% from baseline) in the combination therapy group, p < 0.001. The target LDL-C level was achieved in 22.4% of the patients in the monotherapy group compared with 28.8% of the patients in the combination therapy group, p = 0.049. In real-world clinical practice, statin/ezetimibe combination therapy demonstrated a more frequent achievement of target LDL-C levels compared with statin monotherapy. The addition of ezetimibe to statin therapy increased the probability of achieving LDL-C level goals by 29%.

Ustekinumab as induction and maintenance therapy for ulcerative colitis – national extended follow-up and a review of the literature

ABSTRACT Introduction Ustekinumab use in ulcerative colitis had shown low adverse event and high persistence rates to 3 years via the UNIFI long-term extension study. Outcomes beyond 3 years have not been previously described. We describe the safety signals of the entire UNIFI Australian population beyond 3 years. Methods This retrospective multicenter observational cohort study recruited from all Australian UNIFI centers. The primary outcome was safety via adverse events. Secondary outcomes included the clinical relapse rate on ustekinumab, and the need to switch from ustekinumab to an alternate agent. Results There were 14 patients [11 male, mean age 47 (±14) years], with a median diagnosis of 10.8 (±4.5) years prior to UNIFI enrollment. Median follow-up was 298 weeks (5.7 years) (Interquartile range (IQR): 220–311 weeks). Within the long-term extension, there were three serious adverse events and one minor event. 42.9% (6/14) patients had clinical relapses, of which clinical remission was recaptured in 83.3% (5/6). 85.7% (12/14) persisted on ustekinumab in the long-term, with 7.1% (1/14) electively ceasing ustekinumab and 7.1% (1/14) changed from ustekinumab due to clinical relapse. Conclusion For moderate-to-severe UC in Australia, ustekinumab maintained efficacy beyond 3 years with a high persistence rate and no new safety signals. Trial Registration The trial is registered at ANZCTR (identifier: ACTRN12622001332718).

Interventional rhythm control is associated with an improved long-term prognosis of patients with atrial fibrillation undergoing transcatheter edge-to-edge mitral valve repair

Abstract Background Atrial fibrillation (AF) is the most common concomitant disease in patients undergoing transcatheter edge-to-edge repair (TEER) for severe mitral regurgitation (MR) and detrimentally affects their long-term survival. While the prognostic improvement of catheter ablation (CA) of AF in the overall cohort of heart failure (HF) patients as well as that of surgical ablation of AF with concomitant MR surgery are well established, data on the outcomes of CA of AF in TEER patients are lacking. Methods In a multicenter retrospective observational cohort study, consecutive patients undergoing TEER were enrolled and long-term survival of patients receiving catheter ablation (CA) for AF was compared with that of patients on pharmacological AF treatment and with that of patients without a history of AF, using propensity score matching and multivariable Cox regression analyses. Results A total of 821 patients were identified who successfully underwent TEER procedure. Within this cohort, 608 (74.1%) had concomitant AF, of which 48 patients received CA. Patients with CA of AF showed significantly higher cumulative survival 5 years after the TEER procedure compared with propensity score-matched patients on pharmacological rhythm control of AF (64.6% [31/48] vs. 33.3% [64/192], p=0.01) or on rate control of AF (64.6% [31/48] vs. 25.0% [24/96], p=0.0015). Multivariable Cox regression analysis confirmed that CA of AF was independently associated with significantly better long-term outcome than pharmacological rhythm control and rate control of AF (hazard ratio [HR] 0.4, 95%-confidence interval [CI] 0.2-0.9, p=0.02 and HR 0.4, 95%-CI 0.2-0.7, p=0.004, respectively). CA even offsets the prognostic disadvantage of coexisting AF, as the cumulative survival 5 years after TEER intervention is not significantly different from propensity score-matched TEER patients without a history of AF (64.6% [31/48] vs. 38.9% [56/144], p=0.3). Conclusion Using established statistical methods of propensity score matching and multivariable Cox regression, we demonstrate a significantly improved long-term outcome of TEER patients undergoing CA of concomitant AF compared with pharmacological AF management. CA even offsets the prognostic disadvantage of coexisting AF, as the outcome is not significantly different from that of TEER patients without a history of AF. In light of the growing evidence of prognostic benefit and safety of CA of AF in the overall cohort of HF patients, our data, albeit not randomized, provide strong evidence for interventional rhythm control of AF as an essential part of a modern and holistic management of TEER patients. We alert to the importance of treating concomitant AF, as this is a very promising approach to improve the prognosis of this unique and continually growing HF population.Flow chart of the study designSurvival analyses of PSM cohorts

A clinical decision rule to rule out bloodstream infection in the emergency department: retrospective multicentric observational cohort study

BackgroundWe aimed to identify patients at low risk of bloodstream infection (BSI) in the ED.MethodsWe derived and validated a prediction model to rule out BSI in the ED without the...

Abstract 373: Traumatic Bleeding Severity Score: An External Validation Study for the Predictive Accuracy of the Need for Massive Transfusion

Background: The Traumatic Bleeding Severity Score (TBSS) was developed to predict the need for massive transfusion (MT). The aim of this study was to conduct the first external validation study about the TBSS in Japan, and to compare its prediction value to other pre-existing MT prediction scores. Methods: A multicenter retrospective observational study was conducted in Japan (Japanese observational study for coagulation and Thrombolysis in Early Trauma 2 : J-OCTET 2). Twenty-five tertiary critical care centers in Japan participated in this study, and severe trauma patients (Injury Severity Score : ISS ≥ 16) admitted from 2018 to 2019 were enrolled. At the analysis of the TBSS external validation, patients with isolated head injuries were excluded from the analysis. In this study, MT was defined as 10 units or more of red blood cells transfusion within 24 hours from injuries. The TBSS on admission was retrospectively calculated and its accuracy in predicting MT was analyzed by the area under the receiver operating characteristic curve (AUROC). To compare the predictive value between the TBSS and the pre-existing scores, the Trauma Associated Severe Hemorrhage score (TASH score) and the Assessment of Blood Consumption score (ABC score) on admission was similarly calculated, and the ROC comparison analysis was performed. Results: Totally, 1202 severely injured trauma patients were enrolled in the J-OCTET 2 study, and 889 patients were analyzed after the matching of the exclusion criteria. The median age was 66 years (IQR: 47-77), 71.4 % was male, 97.9% was blunt trauma, median ISS was 22 (IQR:16-29), and 13.8% received MT. The AUROC of the TBSS for was 0.848 (95% CI:0.81-0.88). According to the ROC comparison, the AUROC of the TASH score was 0.848 (95% CI: 0.81-0.88) and there was no significant difference between both prediction scores. (Bonferroni adjusted p=1.00). The AUROC of the ABC score was 0.751(95% CI: 0.70-0.80), which was significantly lower to TBSS’s (Bonferroni adjusted p&lt;0.01). Conclusion: This TBSS external validation study showed that the accuracy of TBSS in the MT prediction was moderate accuracy. The predictive value of the TBSS was comparable to that of the TASH score and superior to the ABC score.

Management and outcomes of COVID-19 patients admitted in a newly created ICU and an expert ICU, a retrospective observational study

BackgroundThe COVID-19 pandemic abruptly increased the inflow of patients requiring intensive care units (ICU). French health institutions responded by a twofold capacity increase with temporary upgraded beds, supplemental beds in pre-existing ICUs, or newly created units (New-ICU). We aimed to compare outcomes according to admission in expert pre-existing ICUs or in New-ICU. MethodsThis multicenter retrospective observational study was conducted in two 20-bed expert ICUs of a University Hospital (Expert-ICU) and in one 16-bed New-ICU in a private clinic managed respectively by 3 and 2 physicians during daytime and by one physician during the night shift. All consecutive adult patients with COVID-19-related acute hypoxemic respiratory failure admitted after centralized regional management by a dedicated crisis cell were included. The primary outcome was 180-day mortality. Propensity score matching and restricted cubic spline for predicted mortality over time were performed. ResultsDuring the study period, 165 and 176 patients were enrolled in Expert-ICU and New-ICU respectively, 162 (98%) and 157 (89%) patients were analyzed. The unadjusted 180-day mortality was 30.8% in Expert-ICU and 28.7% in New-ICU, (log-rank test, p = 0.7). After propensity score matching, 123 pairs (76 and 78%) of patients were matched, with no significant difference in mortality (32% vs. 32%, OR 1.00 [0.89; 1.12], p = 1). Adjusted predicted mortality decreased over time (p < 0.01) in both Expert-ICU and New-ICU. ConclusionsIn COVID-19 patients with acute hypoxemic respiratory failure, hospitalization in a new ICU was not associated with mortality at day 180.

Abstract 14454: Catheter Ablation of Atrial Fibrillation Reverses Morphological Changes of the Mitral Valve and Ameliorates Atrial Functional Mitral Regurgitation

Background: We previously reported that atrial functional mitral regurgitation (A-FMR) occurs with morphological changes of the mitral valve and can be improved by catheter ablation (CA) of atrial fibrillation (AF). However, it is unclear whether the unique morphological changes in the time-course of AF persistence are reversible with sinus rhythm restoration with CA. Aims: The aims of this study were 1) to compare morphological differences among paroxysmal AF (PAF) w/o MR, non-paroxysmal AF (NPAF) w/o MR, and A-FMR, and 2) to examine changes in degree of MR and morphology of the mitral valve after CA in patients with A-FMR. Methods: This is a multicenter (4 hospitals in Fukuoka) retrospective observational study. Protocol 1 : Eighty-four patients undergoing initial CA for AF (from 2010.January to 2021.May) were selected and divided into 3 groups after matching on age (68±8 y.o), sex (19 males), and body surface area (1.7±0,2 m 2 ); PAF w/o MR, NPAF w/o MR, and A-FMR (n=28 in each group). A-FMR was defined as at least mild MR accompanying with NPAF, preserved LVEF (≧ 50%), and no evidence of valve degeneration and other structurally heart diseases. Protocol 2 : Fifty-five patients with A-FMR (19 males, 71±9 y.o.) undergoing initial CA were enrolled. Clinical variables and echocardiographic parameters were analyzed. Results: In protocol 1, tethering angles of anterior and posterior mitral leaflet (AML and PML) were smaller in patients with A-FMR compared with PAF w/o MR (Table1). PML length was shorter in A-FMR than other groups (Table1). In protocol 2, the degree of MR was significantly reduced (Figure, p=0.0013) associated with reduction in MR vena contracta width and MR area (p&lt;0.001) at 11±7 months after CA. Tethering angles of AML and PML were increased after CA (Table2). Conclusion: A-FMR occurs via unique morphological changes of the mitral apparatus along with AF persistence and can be improved by CA of AF with significant reversals of the morphological changes.

Flowchart for predicting achieving the target area under the concentration-time curve of vancomycin in critically ill Japanese patients: A multicenter retrospective study

IntroductionIn therapeutic drug monitoring (TDM) of vancomycin (VCM), the area under the concentration-time curve (AUC) is related to the clinical efficacy and toxicity. Therefore, herein, we examined the factors associated with achieving the target AUC at follow-up and developed a decision flowchart for achieving the target AUC in critically ill patients. MethodsThis multicenter retrospective observational study was conducted at eight hospitals. We retrospectively analyzed data from patients who had received VCM in the intensive care unit from January 2020 to December 2022. Decision-tree (DT) analysis was performed using factors with p < 0.1 in univariate analysis as the independent variables. Case data were split up to two times, and four subgroups were included. The primary endpoint was achieving the target AUC at the follow-up TDM (AUCfollow-up) and target AUCfollow-up achievement was defined as an AUC of 400–600 μg‧h/mL. The initial AUC values were calculated with the 2-point concentrations (peak and trough) using the Bayesian estimation software Practical AUC-guided TDM (PAT). ResultsAmong 70 patients (median age [interquartile range], 66 [56, 79] years; 50 % women), the AUCfollow-up was achieved in 70 % (49/70). Three factors were selected for the decision flow chart: predicted AUCfollow-up of 400–600 μg‧h/mL, dosing at 12-h intervals, and CCr of 130 mL/min/1.73 m2 or higher; the accuracy was adequate (92 %, R2 0.52). ConclusionWe successfully identified the factors associated with achieving the target AUC of VCM at follow-up TDM and developed a simple-to-use DT model. However, the validity of the findings needs to be evaluated.

Association between ventilatory ratio and mortality in patients with acute respiratory distress syndrome and COVID 19: A multicenter, retrospective cohort study

BackgroundMortality rates in patients with COVID-19 undergoing mechanical ventilation in the intensive care unit are high. The causes of this mortality have been rigorously investigated. The aim of the present study is to establish mortality risk factors related to lung mechanics measured at days 1 and 5 in patients with covid-19 ARDS managed with invasive mechanical ventilation in the intensive care unit.MethodsA retrospective observational multicenter study including consecutive patients with a confirmed diagnosis of COVID-19-induced ARDS, admitted to three institutions and seven intensive care units in the city of Bogota between May 20, 2020 and May 30, 2022 who required mechanical ventilation for at least five days. Data were collected from the medical records of patients who met the inclusion criteria on day 1 and day 5 of mechanical ventilation. The primary outcome assessed was mortality at day 30.ResultsA total of 533 consecutive patients admitted with ARDS with COVID-19 were included. Ventilatory ratio, plateau pressure and driving pressure measured on day 5 were significantly higher in non-survivors (p < 0.05). Overall, 30-day follow-up mortality was 48.8%. The increases between day 1 and day 5 in the ventilatory ratio (OR 1.42, 95%CI 1.03–2.01, p = 0.04), driving pressure (OR 1.56, 95%CI 1.10–2.22, p = 0.01); and finally plateau pressure (OR 1.9, 95%CI 1.34–2.69, p = 0.001) were associated with an increased risk of death. There was no association between deterioration of PaO2/FIO2 index and mortality (OR 1.34, 95%CI 0.96–1.56, p = 0.053).ConclusionsVentilatory ratio, plateau pressure, driving pressure, and age were identified as independent risk factors for 30-day mortality in patients with ARDS due to COVID-19 on day 5 of invasive mechanical ventilation.

Retrospective Observational Study of Patients With Subdural Hematoma Treated With Idarucizumab.

Use of anticoagulants is increasing with the aging of societies. The safe first-line drug is likely to be a direct oral anticoagulant (DOAC), but outcomes of treatment of traumatic brain injury (TBI) with anticoagulants are uncertain. Therefore, we examined the clinical effect of idarucizumab as reversal therapy in elderly patients with TBI who were treated with dabigatran. A retrospective multi-center observational study was performed in patients ≥65 years of age who developed acute traumatic subdural hematoma during treatment with dabigatran and underwent reversal therapy with idarucizumab. The items examined included patient background, neurological and imaging findings at arrival, course after admission, complications, and outcomes. A total of 23 patients were enrolled in the study. The patients had a mean age of 78.9 years. Cause of TBI was fall in 60.9% of the subjects. Mean Glasgow Coma Scale score at arrival was 8.7; anisocoria was present in 31.8% of cases. Exacerbation of consciousness was found in 30.4%, but only in 13.3% of subjects treated with idarucizumab before consciousness and imaging findings worsened. Dabigatran was discontinued in 81.8% of cases after hematoma development, with a mean withdrawal period of 12.1 days. The favorable outcome rate was 21.7%, and mortality was 39.1%. In multi-variate analysis, timing of idarucizumab administration was associated with a favorable outcome. There were ischemic complications in 3 cases (13.1%), and all three events occurred ≥7 days after administration of idarucizumab. These findings suggest that in cases that develop hematoma during treatment with dabigatran, it is important to administer idarucizumab early and restart dabigatran after conditions stabilize.

Editor's Choice – External Validation of a Prognostic Model for Survival of Patients With Abdominal Aortic Aneurysms Treated by Endovascular Aneurysm Repair

Current guidelines recommend diameter monitoring of small and asymptomatic abdominal aortic aneurysms (AAAs) due to the low risk of rupture. Elective AAA repair is recommended for diameters ≥ 5.5 cm in men and ≥ 5.0 cm in women. However, data supporting the efficacy of elective treatment for all patients above these thresholds are diverging. For a subgroup of patients, life expectancy might be very short, and elective AAA repair at the current threshold may not be justified. This study aimed to externally validate a predictive model for survival of patients with asymptomatic AAA treated with endovascular aneurysm repair (EVAR). This was a multicentre international retrospective observational cohort study. Data were collected from four European aortic centres treating patients between 2001 and 2021. The initial model included age, estimated glomerular filtration rate (eGFR), and chronic obstructive pulmonary disease (COPD) as independent predictors for survival. Model performance was measured by discrimination and calibration. The validation cohort included 1 500 patients with a median follow up of 65 months, during which 54.6% of the patients died. The external validation showed slightly decreased discrimination ability and signs of overfitting in model calibration. However, a high risk subgroup of patients with impaired survival rates was identified: octogenarians with eGFR < 60 OR COPD, septuagenarians with eGFR < 30, and septuagenarians with eGFR < 60 and COPD having survival rates of only 55.2% and 15.5% at five and 10 years, respectively. EVAR is a valuable treatment option for AAA, especially for patients unsuitable for open repair. Nonetheless, not all these patients will benefit from EVAR, and an individualised treatment recommendation should include considerations on life expectancy. This study provides a risk stratification to identify patients who may not benefit from EVAR under the present diameter threshold.