Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves.

Importance: The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data. Objective: To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR. Design, Setting, and Participants: This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023. Interventions: ViV-TAVR vs redo SAVR. Main Outcomes and Measurements: The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis. Results: From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis. Conclusions and Relevance: Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.

Maternal Characteristics and Rates of Unexpected Complications in Term Newborns by Hospital.

Importance: The Joint Commission Unexpected Complications in Term Newborns measure characterizes newborn morbidity potentially associated with quality of labor and delivery care. Infant exclusions isolate relatively low-risk births, but unexpected newborn complications (UNCs) are not adjusted for maternal factors that may be associated with outcomes independently of hospital quality. Objective: To investigate the association between maternal characteristics and hospital UNC rates. Design, Setting, and Participants: This cohort study was conducted using linked 2016 to 2018 New York City birth and hospital discharge datasets among 254 259 neonates at low risk (singleton, ≥37 weeks, birthweight ≥2500 g, and without preexisting fetal conditions) at 39 hospitals. Logistic regression was used to calculate unadjusted hospital-specific UNC rates and replicated analyses adjusting for maternal covariates. Hospitals were categorized into UNC quintiles; changes in quintile ranking with maternal adjustment were examined. Data analyses were performed from December 2022 to July 2023. Main Outcomes and Measures: UNCs were classified according to Joint Commission International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) criteria. Maternal preadmission comorbidities, obstetric factors, social characteristics, and hospital characteristics were ascertained. Results: Among 254 259 singleton births at 37 weeks or later who were at low risk (125 245 female [49.3%] and 129 014 male [50.7%]; 71 768 births [28.2%] to Hispanic, 47 226 births [18.7%] to non-Hispanic Asian, 42 682 births [16.8%] to non-Hispanic Black, and 89 845 births [35.3%] to non-Hispanic White mothers and 2738 births [1.0%] to mothers with another race or ethnicity), 148 393 births (58.4%) were covered by Medicaid and 101 633 births (40.0%) were covered by commercial insurance. The 2016 to 2018 cumulative UNC incidence in New York City hospitals was 37.1 UNCs per 1000 births. Infants of mothers with preadmission risk factors had increased UNC risk; for example, among mothers with vs without preeclampsia, there were 104.4 and 35.8 UNCs per 1000 births, respectively. Among hospitals, unadjusted UNC rates ranged from 15.6 to 215.5 UNCs per 1000 births and adjusted UNC rates ranged from 15.6 to 194.0 UNCs per 1000 births (median [IQR] change from adjustment, 1.4 [-4.7 to 1.0] UNCs/1000 births). The median (IQR) change per 1000 births for adjusted vs unadjusted rates showed that hospitals with low (<601 deliveries/year; -2.8 [-7.0 to -1.6] UNCs) to medium (601 to <954 deliveries/year; -3.9 [-7.1 to -1.9] UNCs) delivery volume, public ownership (-3.6 [-6.2 to -2.3] UNCs), or high proportions of Medicaid-insured (eg, ≥90.72%; -3.7 [-5.3 to -1.9] UNCs), Black (eg, ≥32.83%; -5.3 [-9.1 to -2.2] UNCs), or Hispanic (eg, ≥6.25%; -3.7 [-5.3 to -1.9] UNCs) patients had significantly decreased UNC rates after adjustment, while rates increased or did not change in hospitals with the highest delivery volume, private ownership, or births to predominantly White or privately insured individuals. Among all 39 hospitals, 7 hospitals (17.9%) shifted 1 quintile comparing risk-adjusted with unadjusted quintile rankings. Conclusions and Relevance: In this study, adjustment for maternal case mix was associated with small overall changes in hospital UNC rates. These changes were associated with performance assessment for some hospitals, and these results suggest that profiling on this measure should consider the implications of small changes in rates for hospitals with higher-risk obstetric populations.

Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Choice of revascularization strategy for ischemic cardiomyopathy due to multivessel coronary disease.

OBJECTIVE: Limited comparative data guide the decision between coronary artery bypass grafting and percutaneous coronary intervention for multivessel revascularization in ischemic cardiomyopathy. The study objective was to compare the long-term outcomes of coronary artery bypass grafting and percutaneous coronary intervention for ischemic cardiomyopathy. METHODS: Clinical registries from the New Jersey Department of Health linked to administrative databases were used to compare all-cause mortality, repeat revascularization, heart failure readmissions, myocardial infarction, and stroke using Cox proportional hazards and propensity matching with competing risk analysis in 5988 patients with ejection fraction 35% or less who underwent coronary artery bypass grafting (3673, 61.3%) or percutaneous coronary intervention (2315, 38.6%) for multivessel coronary disease between 2007 and 2018. Median follow-up time was 5.2 years (range, 0-13 years); the last follow-up date was December 31, 2020. RESULTS: After controlling for completeness of revascularization, at 13 years, mortality was 57% (95% CI, 51-63) after percutaneous coronary intervention and 60% (95% CI, 53-66) after coronary artery bypass grafting (hazard ratio [HR], 1.10; 95% CI, 0.93-1.31; P = .28); risk of repeat revascularization was 18% for percutaneous coronary intervention versus 14% for coronary artery bypass grafting (HR, 1.62; 95% CI, 1.17-2.25; P = .003); risk of readmission for heart failure was 16% after percutaneous coronary intervention and coronary artery bypass grafting (HR, 1.13,95% CI, 0.84-1.51, weighted P = .10); risk of myocardial infarction was 10% versus 6%, respectively (HR, 1.91; 95% CI, 1.18-3.09; P = .007); and stroke risk was 3% versus 4%, respectively (HR, 0.79; 95% CI, 0.41-1.53; P = .52). Rate of complete revascularization was lower after percutaneous coronary intervention than after coronary artery bypass grafting and associated with higher mortality after percutaneous coronary intervention (HR, 1.35; 95% CI, 1.20-1.52; P < .001). CONCLUSIONS: Coronary bypass was associated with similar mortality, stroke, and heart failure readmissions, and reduced repeat revascularization compared with percutaneous coronary intervention in patients with ischemic cardiomyopathy if similar rates of complete revascularization were achieved. These findings support consensus recommendations for coronary artery bypass grafting and medical therapy in patients with multivessel coronary disease and left ventricular dysfunction.

Predictive value of the G8 screening tool for postoperative complications in older adults undergoing cancer surgery: A systematic review and meta-analysis.

INTRODUCTION: Older adults with cancer who are being considered for cancer surgery are heterogenous, with variation in their physical, mental, and social baselines and risk of postoperative complications. Due in part to the complex nature of this population, the optimal preoperative evaluation method is not clearly defined. In this study we investigated whether geriatric-8 (G8), a screening tool for older patients with cancer that determines the need for a full geriatric assessment, is suitable for assessing the risk of postoperative complications in this population being considered for surgery. MATERIALS AND METHODS: Studies that enrolled older patients undergoing cancer surgery and compared prevalence of postoperative complications in G8 "high" (≥15) patients and G8 "low" (<15) patients were identified using PubMed and EMBASE. A meta-analysis was conducted to calculate the risk ratio of postoperative complication rate. Postoperative mortality was systematically reviewed. RESULTS: Eleven studies published between 2017 and 2022 were included in our analysis with a total of 2,691 older patients who underwent various types of cancer surgery and were characterized by their G8 scores: 1,255 G8 high (≥15) patients and 1,436 G8 low (<15) patients. G8 low patients had a significantly higher prevalence of postoperative complications than G8 high patients (risk ratio [95% confidence interval]: 1.56 [1.18-2.07], p = 0.002, I2 = 79%). DISCUSSION: G8 can be an effective and efficient preoperative tool to assess risk of postoperative complications in older adults undergoing cancer surgery and identify potential need for further evaluation of an individual's risk with a comprehensive geriatric assessment.

National trend in failure to rescue after cardiac surgeries.

OBJECTIVES: Failure to rescue (FTR), defined as postoperative inpatient death after potentially treatable major complications, is a nationally endorsed quality of care measure, however, the effect of practice change on FTR is unknown. In this study, we aimed to define the FTR trend after cardiac surgery in the United States. METHODS: In this retrospective analysis of the National Inpatient Sample database we identified adult patients who underwent cardiac surgeries in the United States between 2000 and 2018, defined incidence and trends in FTR adjusted for sex, age, diagnosis-related group, and comorbidity. Trends were analyzed using Joinpoint (Statistical Methodology and Applications Branch, Surveillance Research Program, National Cancer Institute) regression software. RESULTS: The study included 6,185,032 hospitalizations for cardiac surgeries. Risk-adjusted FTR after deep venous thromboembolism/pulmonary embolism and sepsis has declined from 2000 to 2018 (annual percent change [APC] = -6.4% and -11.6%, respectively; P < .001). After pneumonia, FTR has increased significantly since 2011 (APC = 9.3%; P < .001). Since 2012, FTR due to gastrointestinal hemorrhage has increased substantially (APC = 15.9%; P < .001). The risk-adjusted FTR rate in patients 75 years of age or older significantly declined until 2011 (APC = -12.6%; P < .001) and became comparable with the FTR rate of younger patients by the end of the study. CONCLUSIONS: There have been significant reductions in FTR in elderly patients and a reduction in postprocedural mortality associated with sepsis and venous thromboembolism overall after cardiac surgery. This might provide evidence supporting national targeted quality metrics and care bundles for complications such as pneumonia and gastrointestinal bleeding, which had an increasing FTR.

Hospital factor and prognosis of COVID-19 in New York City, the United States of America: insights from a retrospective cohort study.

BACKGROUND: April 22nd, 2020, New York City (NYC) was the epicenter of the pandemic of Coronavirus disease 2019 (COVID-19) in the US with differences of death rates among its 5 boroughs. We aimed to investigate the difference in mortality associated with hospital factors (teaching versus community hospital) in NYC. DESIGN: Retrospective cohort study. METHODS: We obtained medical records of 6509 hospitalized patients with laboratory confirmed COVID-19 from the Mount Sinai Health System including 4 teaching hospitals in Manhattan and 2 community hospitals located outside of Manhattan (Queens and Brooklyn) retrospectively. Propensity score analysis using inverse probability of treatment weighting (IPTW) with stabilized weights was performed to adjust for differences in the baseline characteristics of patients initially presenting to teaching or community hospitals, and those who were transferred from community hospitals to teaching hospitals. RESULTS: Among 6509 patients, 4653 (72.6%) were admitted in teaching hospitals, 1462 (22.8%) were admitted in community hospitals, and 293 (4.6%) were originally admitted in community and then transferred into teaching hospitals. Patients in community hospitals had higher mortality (42.5%) than those in teaching hospitals (17.6%) or those transferred from community to teaching hospitals (23.5%, P < 0.001). After IPTW-adjustment, when compared to patients cared for at teaching hospitals, the hazard ratio (HR) and 95% confidence interval (CI) of mortality were as follows: community hospitals 2.47 (2.03-2.99); transfers 0.80 (0.58-1.09)). CONCLUSIONS: Patients admitted to community hospitals had higher mortality than those admitted to teaching hospitals.

The effect of obesity on in-hospital mortality among patients with COVID-19 receiving corticosteroids.

BACKGROUND AND AIMS: Obesity has been reported to be one of the most frequent comorbidities in COVID-19 patients and associated with higher rates of in-hospital mortality compared to non-obese patients. Acute kidney injury (AKI) is also known to be a complication associated with obesity in critically-ill COVID-19 patients. We aimed to investigate whether obesity was associated with increased risk of in-hospital mortality and AKI among patients with COVID-19 treated with corticosteroids. METHODS: We utilized 9965 hospitalized COVID-19 patient data and divided patients who were treated with corticosteroids into 6 groups by body mass index (BMI) (less than 18.5, 18.5-25, 25-30, 30-35, 35-40, 40 kg/m2 or greater). The association between BMI and in-hospital mortality and between BMI and incidence rate of AKI during admission among COVID-19 patients receiving corticosteroids were retrospectively investigated. RESULTS: There were 4587 study participants receiving corticosteroids (mean age 66.5 ± 15.5 years, men 56.6%, mean BMI 29.0 ± 7.2 kg/m2). The smooth spline curve suggested a J-shape association between BMI and in-hospital mortality. Patients with BMI above 40 kg/m2 exhibited a higher in-hospital mortality and higher incidence rate of AKI during admission compared to patients with BMI between 25 and 30 kg/m2. The differences in in-hospital mortality and the rate of AKI were larger among patients with severe COVID-19. CONCLUSIONS: Class III obesity was associated with high in-hospital mortality and AKI in patients with COVID-19 treated by corticosteroids. Clinicians must stay vigilant on the impact of class III obesity and development of AKI to disease trajectory of COVID-19 patients.

The association of statins use with survival of patients with COVID-19.

BACKGROUND: Statins are frequently prescribed for patients with dyslipidemia and diabetes mellitus. These comorbidities are highly prevalent in coronavirus disease 2019 (COVID-19) patients. Statin's beneficial effect on mortality in COVID-19 infection has been reported in several studies. However, these findings are still inconclusive. METHODS: We conducted a retrospective observational study among 6,095 patients with laboratory confirmed COVID-19 hospitalized in Mount Sinai Health System between March 1st 2020 and May 7th 2020. Patients were stratified into two groups: statin use prior to or during hospitalization (N = 2,423) versus no statins (N = 3,672). We evaluated in-hospital mortality as a primary outcome using propensity score matching and inverse probability treatment weighted (IPTW) analysis. In additional analysis, we compared continuous use of statins (N = 1,108) with no statins, continuous use of statins with discontinuation of statins (N = 644), and discontinuation of statins with no statins. RESULTS: Among 6,095 COVID-19 patients, statin use prior to or during hospitalization group were older (70.8 ± 12.7 years versus 59.2 ± 18.2 years, p<0.001) and had more comorbidities compared to no statins group. After matching by propensity score (1,790 pairs), there were no significant differences in-hospital mortality between patients with statins and those without [28.9% versus 31.0%, p = 0.19, odds ratio (OR) 95% confidence interval (CI): 0.91 (0.79-1.05)]. This result was confirmed by IPTW analysis [OR (95% CI): 0.96 (0.81-1.12), p = 0.53]. In the additional analysis comparing continuous use of statins with no statins group, in-hospital mortality was significantly lower in continuous use of statins compared to no statins group [26.3% versus 34.5%, p<0.001, OR (95% CI): 0.68 (0.55-0.82)] after matching by propensity score (944 pairs), as well as IPTW analysis [OR (95% CI): 0.77 (0.64-0.94), p = 0.009]. Finally, comparison of continuous use of statins with discontinuation of statins showed lower in-hospital mortality in continuous use of statins group [27.9% versus 42.1%, p<0.001, OR (95% CI): 0.53 (0.41-0.68)]. CONCLUSIONS: Use of statins prior to or during hospitalization was not associated with a decreased risk of in-hospital mortality, however, continuous use of statins was associated with lower in-hospital mortality compared to no statin use and discontinuation of statins.

The association of anticoagulation before admission and survival of patients with COVID-19.

BACKGROUND: Severe coronavirus disease 2019 (COVID-19) is associated with systematic coagulopathy which might result in fatality. We aimed to investigate whether systematic anticoagulation before admission with COVID infection was associated with patients' survival. METHODS: We reviewed medical records of 6,095 hospitalized patients with laboratory confirmed COVID-19 from the Mount Sinai Health System. Patients were stratified into two groups: patients with therapeutic anticoagulation before admission (7.9%, N=480), or those without (92.1%, N=5,615). Propensity score matched analysis was conducted to assess the association of anticoagulation before admission and in-hospital mortality (N=296 in each group). Multiple imputation for missing data was conducted. RESULTS: A total of 480 patients (7.9%) received anticoagulation before admission. Patients with anticoagulation before admission were older (72.1±14.7 years vs. 63.1±17.2 years), and had more comorbidities including chronic pulmonary obstructive disease, hypertension, diabetes, chronic kidney disease, atrial fibrillation, and heart failure (all p< 0.05). Notably, patients with anticoagulation before admission had lower D-dimer [1.48 (IQR 0.75, 2.79) µg/mL vs 1.66 (0.89, 3.52) µg/mL, p=0.002]. In a propensity score matched analysis (N=296 in each group), in-hospital mortality was not significantly different in patients with anticoagulation before admission compared to those without (28.4% vs 31.1%, p=0.53). In addition, inverse probability weighted analysis and multiple imputation for missing data did not change the result. Furthermore, these differences were not significant after excluding endotracheal intubation from both groups. CONCLUSION: Anticoagulation before admission was not associated with lower risk of in-hospital mortality of COVID-19 patients. Further investigation is needed to confirm these findings.

Prediction of in-hospital mortality with machine learning for COVID-19 patients treated with steroid and remdesivir.

We aimed to create the prediction model of in-hospital mortality using machine learning methods for patients with coronavirus disease 2019 (COVID-19) treated with steroid and remdesivir. We reviewed 1571 hospitalized patients with laboratory confirmed COVID-19 from the Mount Sinai Health System treated with both steroids and remdesivir. The important variables associated with in-hospital mortality were identified using LASSO (least absolute shrinkage and selection operator) and SHAP (SHapley Additive exPlanations) through the light gradient boosting model (GBM). The data before February 17th, 2021 (N = 769) was randomly split into training and testing datasets; 80% versus 20%, respectively. Light GBM models were created with train data and area under the curves (AUCs) were calculated. Additionally, we calculated AUC with the data between February 17th, 2021 and March 30th, 2021 (N = 802). Of the 1571 patients admitted due to COVID-19, 331 (21.1%) died during hospitalization. Through LASSO and SHAP, we selected six important variables; age, hypertension, oxygen saturation, blood urea nitrogen, intensive care unit admission, and endotracheal intubation. AUCs using training and testing datasets derived from the data before February 17th, 2021 were 0.871/0.911. Additionally, the light GBM model has high predictability for the latest data (AUC: 0.881) (https://risk-model.herokuapp.com/covid). A high-value prediction model was created to estimate in-hospital mortality for COVID-19 patients treated with steroid and remdesivir.

The association between famotidine and in-hospital mortality of patients with COVID-19.

Famotidine has been considered to be a potential treatment for COVID-19 but the current data is conflicting. This retrospective study was conducted by utilizing data of 9565 COVID-19 hospitalized patients. Patients treated with and without famotidine were matched by propensity score using a 1:1 matching scheme. A total of 1593 patients (16.7%) received famotidine. In-hospital mortality was similar in patients treated with and without famotidine in the propensity-matched cohorts (28.3% vs. 28.2%, p = 0.97), which remains similar irrespective of severity or concomitant treatment by steroids. Famotidine treatment was not associated with a lower risk of in-hospital mortality of COVID-19 patients.

U shape association of hemoglobin level with in-hospital mortality for COVID-19 patients.

Our hypothesis was that high hemoglobin (Hb) level might be associated with hypercoagulable state and death due to COVID-19. Of the 9467 hospitalized COVID-19 patients, patients were subdivided into 5 groups based on the level of Hb; Hb < 10 g/dL, 10 g/dL ≤ Hb < 12 g/dL, 12 g/dL ≤ Hb < 14 g/dL, 14 g/dL ≤ Hb < 16 g/dL, and Hb ≥ 16 g/dL. Compared to patients with 12 g/dL ≤ Hb < 14 g/dL, patients with Hb ≥ 16 g/dL had significantly higher adjusted in-hospital mortality (OR [95% CI] 1.62 [1.15-2.27], P = 0.005).

The Association of Timing of Tracheostomy and Survival of Patients with COVID-19.

Tracheostomy is performed for critically ill patients with prolonged endotracheal intubation including COVID-19 to mitigate the risk of airway complications. We analyzed the difference in mortality of COVID-19 patients undergoing early tracheostomy within 14 days of intubation compared to later tracheostomy than 14 days after intubation. The mortality was not significantly higher in early tracheostomy compared to later tracheostomy.

Measuring severe neonatal morbidity using hospital discharge data in France.

BACKGROUND: Measuring infant health at birth is key for surveillance and research in obstetrics and neonatology, but there is no international consensus on morbidity indicators. The Neonatal Adverse Outcome Indicator (NAOI) is a composite indicator, developed in Australia, which measures the burden of severe neonatal morbidity using hospital discharge data. OBJECTIVE: To evaluate the applicability of the NAOI in France for surveillance and research. METHODS: We constituted a cohort of live births ≥24 weeks' gestational age in Metropolitan France from 2014 to 2015 using hospital discharge, insurance claims and cause of death data. Outlier hospitals were identified using funnel plots of standardised morbidity ratios (SMR), and their coding patterns were assessed. We compared the NAOI and its component codes with published Australian and English data and estimated unadjusted and adjusted risk ratios for known risk factors for neonatal morbidity. RESULTS: We included 1,459,123 births (511 hospitals). Twenty-eight hospitals had SMR above funnel plot control limits. Newborns with NAOI morbidities in these hospitals had lower mortality and shorter stays than in other hospitals. Amongst within-limit hospitals, NAOI prevalence was 4.8%, comparable to Australia (4.6%) and England (5.4%). Most individual components had a similar prevalence, with the exception of respiratory support, intravenous fluid procedures and infection. NAOI was lowest at 39 weeks (2.2%) with higher risks for maternal age ≥40 (relative risk [RR] 1.47, 95% confidence interval [CI] 1.42, 1.51), state medical insurance (RR 1.60, 95% CI 1.52, 1.68), male sex (RR 1.21, 95% CI 1.19, 1.23) and birthweight <3rd percentile (RR 4.60, 95% CI 4.51, 4.69). CONCLUSIONS: The NAOI provides valuable information on population prevalence of severe neonatal morbidity and its risk factors. Whilst the prevalence was similar in high-income countries with comparable neonatal mortality levels, ensuring valid comparisons between countries and hospitals will require further work to harmonize coding procedures, especially for infection and respiratory morbidity.

Prophylactic versus therapeutic anticoagulation for survival of patients with COVID-19 on steroid.

Previous observational and randomized studies suggested potential benefit of therapeutic anticoagulation during hospitalization, but this treatment remains controversial. As of June 30th 2021, steroids is the standard treatment of COVID patients. We aimed to investigate the association of prophylactic and therapeutic anticoagulation with mortality for patients with COVID-19 who were treated with steroids. We retrospectively reviewed the medical records of 2533 patients discharged between March 1st, 2020 and March 30th, 2021, with laboratory-confirmed COVID-19 in the Mount Sinai Health System and treated with steroids. We evaluated the effect of therapeutic versus prophylactic anticoagulation on the outcomes using propensity score analyses. Subgroup analyses were conducted by stratification of patients by endotracheal intubation. Among the 2533 eligible patients, 465 (18.4%) received therapeutic anticoagulation. After 1:1 propensity score matching (N = 383 pairs), in-hospital mortality was similar between those with therapeutic versus prophylactic anticoagulation (36.0% versus 30.0%, P = 0.091). In-hospital mortality regardless of endotracheal intubation were not significantly different between the two groups. Therapeutic anticoagulation was not associated with reduced or increased risk of in-hospital mortality in patients with COVID-19 treated with steroids.

Do Patients With Multiple Myeloma Enrolled in Clinical Trials Live Longer?

OBJECTIVES: Enrollment in clinical trials is thought to improve survival outcomes through the trial effect. In this retrospective observational cohort study, we aimed to discern differences in survival outcomes by clinical trial enrollment and race-ethnicity. MATERIALS AND METHODS: Of 1285 patients receiving care for multiple myeloma at an National Cancer Institute designated cancer center from 2012 to 2018, 1065 (83%) were nontrial and 220 (17%) were trial participants. Time to event analyses were used to adjust for baseline characteristics and account for clinical trial enrollment as a time-varying covariate. We analyzed propensity-matched cohorts of trial and nontrial patients to reduce potential bias in observational data. RESULTS: Trial patients were younger (mean age in years: 60 vs. 63; P<0.001), underwent more lines of therapy (treatment lines ≥6: 39% vs. 17%; P<0.001), and had more comorbidities than nontrial patients. After controlling for baseline characteristics and clinical trial enrollment as a time-varying covariate, no significant difference in survival was found between trial and nontrial participants (hazard ratio [HR]=1.34, 95% confidence intervals [CIs]: 0.90-1.99), or between propensity-matched trial and nontrial participants (205 patients in each cohort, HR=1.36, 95% CIs: 0.83-2.23). Subgroup analyses by lines of therapy confirmed results from overall analyses. We did not observe survival differences by race-ethnicity (Logrank P=0.09), though hazard of death was significantly increased for nontrial Black/Hispanic patients compared with trial White patients (HR=1.76, 95% CIs=1.01-3.08). CONCLUSIONS: This study did not find evidence of a significant survival benefit to trial enrollment among patients with multiple myeloma. Patients enrolled in clinical trials underwent more lines of therapy, suggesting they may have had more treatment-resistant cancers. A small survival benefit in this cohort may be obscured by the lack of difference in survival between trial and nontrial patients.

The association of remdesivir and in-hospital outcomes for COVID-19 patients treated with steroids.

BACKGROUND: Remdesivir has been shown to decrease SARS-CoV-2 viral loads and the duration of COVID-19 symptoms. However, current evidence regarding the association between remdesivir and in-hospital mortality for patients with COVID-19 steroid treatments is limited. We aimed to investigate whether remdesivir reduces in-hospital mortality among patients with COVID-19 treated with steroids. METHODS: In this retrospective multicentre study, we reviewed the medical records of 3372 patients discharged between 1 March 2020 and 30 March 2021, with laboratory confirmed COVID-19 in the Mount Sinai Health System and treated with steroids. We evaluated the effect of remdesivir on the outcomes using propensity score analyses. Subgroup analyses were conducted by stratification of patients by endotracheal intubation and COVID-19 antibody status. Acute kidney injury (AKI) was defined as an absolute serum creatinine increase of 0.3 mg/dL or a relative increase of 50%. RESULTS: Of the 3372 eligible patients, 1336 (39.6%) received remdesivir. After 1:1 propensity score matching (N = 999 pairs), in-hospital mortality was similar between those with and without remdesivir (21.4% versus 21.6%, respectively, P = 0.96). Remdesivir was not significantly associated with in-hospital mortality regardless of endotracheal intubation or COVID-19 antibody status. However, there was a signal that remdesivir was associated with a reduced risk of AKI in the propensity matched analysis (17.5% versus 23.4%, respectively, P = 0.001). CONCLUSIONS: Remdesivir was not associated with reduced risk of in-hospital mortality in patients with COVID-19 treated with steroids but potentially associated with decreased risk of AKI. These findings should be confirmed in prospective studies focusing on COVID-19 patients treated with steroids.

The association of COVID-19 antibody with in-hospital outcomes in COVID-19 infected patients.

We aimed to investigate whether hospitalizations of patients who tested positive for coronavirus disease 2019 (COVID-19) antibodies are associated with reduced in-hospital mortality. Of the 2459 patients admitted due to COVID-19 and tested for antibodies, 937 (38.1%) had positive tests. After adjustment for patient characteristics and treatments, patients with positive COVID-19 antibody test had lower in-hospital mortality compared with those with negative test results (odds ratio [OR]: 0.62; 95% confidential interval [95% CI] 0.46-0.83, p = 0.001). In conclusion, positive COVID-19 antibody test results were associated with the reduced risk of in-hospital mortality for COVID-19 patients.

Hospital Quality of Care and Racial and Ethnic Disparities in Unexpected Newborn Complications.

OBJECTIVES: To investigate racial and ethnic differences in unexpected, term newborn morbidity and the influence of hospital quality on disparities. METHODS: We used 2010-2014 birth certificate and discharge abstract data from 40 New York City hospitals in a retrospective cohort study of 483 834 low-risk (term, singleton, birth weight ≥2500 g, without preexisting fetal conditions) neonates. We classified morbidity according to The Joint Commission's unexpected newborn complications metric and used multivariable logistic regression to compare morbidity risk among racial and ethnic groups. We generated risk-standardized complication rates for each hospital using mixed-effects logistic regression to evaluate quality, ranked hospitals on this measure, and assessed differences in the racial and ethnic distribution of births across facilities. RESULTS: The unexpected complications rate was 48.0 per 1000 births. Adjusted for patient characteristics, morbidity risk was higher among Black and Hispanic infants compared with white infants (odds ratio: 1.5 [95% confidence interval 1.3-1.9]; odds ratio: 1.2 [95% confidence interval 1.1-1.4], respectively). Among the 40 hospitals, risk-standardized complications ranged from 25.3 to 162.8 per 1000 births. One-third of Black and Hispanic women gave birth in hospitals ranking in the highest-morbidity tertile, compared with 10% of white and Asian American women (P < .001). CONCLUSIONS: Black and Hispanic women were more likely to deliver in hospitals with high complication rates than were white or Asian American women. Findings implicate hospital quality in contributing to preventable newborn health disparities among low-risk, term births. Quality improvement targeting routine obstetric and neonatal care is critical for equity in perinatal outcomes.