Relative Risk Reduction In Mortality Research Articles

Impact of postoperative cardiovascular complications on 30-day mortality after major abdominal surgery: an international prospective cohort study.

Cardiovascular complications after major surgery are associated with increases in morbidity and mortality. There is confusion over definitions of cardiac injury or complications, and variability in the assessment and management of patients. This international prospective cohort study aimed to define the incidence and timing of these complications and to investigate their impact on 30-day all-cause mortality. We performed a prospective, international cohort study between January 2022 and May 2022. Data were collected on consecutive patients undergoing major abdominal surgery in 446 hospitals from 28 countries across Europe. The primary outcome measure was cardiovascular complications as defined by the Standardised Endpoints for Perioperative Medicine-Core Outcome Measures for Perioperative and Anaesthetic Care initiative up to 30 days after surgery. The secondary outcome was 30-day postoperative mortality. This study included 24,203 patients, of whom 611 (2.5%) developed cardiovascular complications. In total, 458 (1.9%) patients died within 30 days of surgery, of which 123 (26.9%) deaths were judged to be cardiac-related. Mortality rates were higher in patients who developed postoperative cardiovascular complications than in those who did not (19.8% vs. 1.4%), which persisted after risk adjustment (hazard ratio (95%CI) 4.15 (3.14-5.48)). We estimated an absolute risk reduction (95%CI) of 0.4 (0.3-0.5) in mortality in the absence of all cardiovascular complications. This would confer a relative risk reduction in mortality of 21.1% if all cardiovascular complications were prevented. Postoperative cardiovascular complications are relatively common and occur early after major abdominal surgery. However, over 1 in 5 postoperative deaths were attributable to these complications, highlighting an important area for future randomised trials.

Atrial fibrillation ablation in patients with reduced left ventricular ejection fraction: does it only improve hemodynamics or does it affect the prognosis? (A systematic review)

Objective: To critically evaluate the results of studies concerning the impact of atrial fibrillation ablation on hemodynamics and prognosis in patients with heart failure with reduced left ventricular ejection fraction.Methods: We searched via keywords in the PubMed, Embase, Cochrane Library, and Web of Science databases and selected the most-cited studies containing data on the ablation treatment of patients with atrial fibrillation and heart failure with reduced left ventricular ejection fraction, including such treatment end points as left ventricular ejection fraction, mortality, etc. We analyzed the effect of ablation on changes in left ventricular ejection fraction and clinical outcomes in patients with atrial fibrillation compared with that of drug therapy.Results: We screened 4581 literature sources: of them, 48 were selected for the review. Compared with drug therapy in similar patients with atrial fibrillation and heart failure, there is a 4-fold absolute increase (P < .001) in left ventricular ejection fraction after endocardial catheter ablation, thoracoscopic or hybrid ablation of atrial fibrillation. Some studies show a relative risk reduction in mortality (max 47%; P = .01) following the ablation in patients with atrial fibrillation and baseline reduced left ventricular ejection fraction.Conclusion: After atrial fibrillation ablation (regardless of the technique used and left ventricular dysfunction severity), patients with heart failure with reduced left ventricular ejection fraction show a statistically significant improvement in systolic function probably due to a decreased arrhythmia burden. Further research could determine the population of heart failure patients who would benefit most from atrial fibrillation ablation. Received 20 April 2023. Revised 6 June 2023. Accepted 7 June 2023. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authors: The authors contributed equally to this article.

Identification of a novel survival predictor, CSF2RB, for female lung cancer in never smokers (LCNS) by a bioinformatics analysis.

Lung cancer in never smokers (LCNS) has been considered as a separate disease and the 7th cause of cancer-related death worldwide. However, limited research has focused on "female" cohorts, which have presented a higher incidence rate. In this study, the microarray data of lung cancer tissues derived from 54 female lung cancer patients, consisting of 43 nonsmokers and 11 smokers, were selected from GSE2109 dataset. A total of 249 differentially expressed genes (DEGs) including 102 up- and 147 down-regulated genes were identified and further analyzed for gene ontology (GO) terms and Kyoto encyclopedia of genes and genomes (KEGG) pathway enrichment. By constructing protein-protein interaction (PPI) network and calculating key modules, 10 hub genes were screened out. The module analysis of the PPI network presented that the progression of female LCNS was significantly associated with immune response as chemokine activity and lipopolysaccharide response, and these biological processes (BP) might be mediated by chemokine signaling pathway and cytokine-cytokine receptor interaction. Then, survival analysis by Kaplan-Meier (K-M) Plotter online platform presented down-regulated gene colony stimulating factor 2 receptor beta common subunit (CSF2RB) of female LCNS might be involved in poor clinical outcome. Female LCNS with high expression of CSF2RB might be relevant with relative risk reduction of mortality, longer median survival time and higher 5-year survival rate, while female LCNS with low expression of CSF2RB might be implicated in a poor clinical outcome. In short, our results support CSF2RB to be a candidate survival predictor for female LCNS.

Value of Algorithm-Enabled Process Innovation: The Case of Sepsis

Problem definition: Algorithm-enabled decision support has an increasingly important role in supporting the day-to-day operations of healthcare organizations. Yet, fully realizing the value of algorithmic decision support lies critically in the opportunity to re-engineer the related processes and redefine roles in ways that make organizations more effective. We study how and when algorithm-enabled process innovation (AEPI) creates value in light of dynamic operational environments (i.e., workload) and behavioral responses to algorithmic predictions (i.e., algorithmic accuracy). Our context is an AEPI effort around a rule-based decision-support algorithm for early detection of sepsis—a costly condition that is the leading cause of death for hospitalized patients. We collaborated with a large U.S.-based hospital system and examined whether AEPI developed for sepsis care (sepsis AEPI) impacts patient mortality and when this impact is stronger or weaker. Methodology/results: We utilize a rich set of clinical and nonclinical data in empirically examining the impact of sepsis AEPI on patient mortality. We leverage the staggered implementation of sepsis AEPI across hospital units and conduct our estimation on a carefully matched sample. The matching utilizes data on patient vitals and the logic behind the algorithm to create a robust comparison group consisting of patient visits for which sepsis AEPI would have triggered an alert if it had been in place. Our empirical analysis shows that sepsis AEPI reduces the likelihood of death from sepsis (45% relative reduction in mortality risk due to sepsis). A higher-than-usual workload and an increase in the average number of inaccurate alert experience at a hospital unit (e.g., an oncology unit, which provides care for cancer patients), in general, reduces the effectiveness of AEPI. We also identify diminishing mortality benefits over prolonged periods of adoption; evaluation of the moderators over time helps explain this diminishing impact. Managerial implications: Our findings suggest that streamlining sepsis-care processes through a predictive algorithm (i.e., algorithm-based monitoring of real-time patient data and providing predictions, streamlined communication channels for coordinating care for a patient with sepsis prediction, and a more standardized process for sepsis diagnosis and treatment) can reduce the loss of life from sepsis. For the 3,739 sepsis patients in our study period, AEPI’s benefits would translate to 181 lives saved. We show that such value, however, is sensitive to operational and behavioral factors as the algorithm becomes a routine part of the day-to-day operations of the hospital. Funding: Financial support from University Hospitals is gratefully acknowledged. Supplemental Material: The online appendix is available at https://doi.org/10.1287/msom.2023.1226 .

Barriers and enablers to kangaroo mother care prior to stability from perspectives of Gambian health workers: A qualitative study.

AimsKangaroo mother care (KMC) is an evidence-based intervention recommended for stable newborns <2,000 g. Recent trials have investigated survival benefits of earlier initiation of KMC, including prior to stability, with WHO's iKMC trial showing 25% relative risk reduction for mortality of neonates 1–1.8 kg at tertiary Indian and African neonatal units (NNU). However, evidence is lacking about how to safely deliver this intervention to the most vulnerable neonates in resource limited settings (RLS). Our study aimed to understand barriers and enablers for early KMC prior to stability from perspectives of neonatal health care workers (HCW) in a high neonatal mortality RLS.MethodsThis qualitative study was conducted at Edward Francis Small Teaching Hospital (EFSTH), the main neonatal referral unit in The Gambia. It was ancillary study to the eKMC clinical trial. Ten semi-structured interviews were conducted with all neonatal HCW cadres (4 nurses; 1 nurse attendant; 5 doctors; all Gambian). Study participants were purposively selected, and saturation was reached. Thematic analysis was conducted using Atun's conceptual framework for evaluation of new health interventions with methods to ensure data reliability and trustworthiness.ResultsHCW's perceptions of early KMC prior to stability included recognition of potential benefits as well as uncertainty about effectiveness and safety. Barriers included: Unavailability of mothers during early neonatal unit admission; safety concerns with concomitant intravenous fluids and impact on infection prevention control; insufficient beds, space, WASH facilities and staffing; and lack of privacy and respectful care. Enablers included: Education of HCW with knowledge transfer to KMC providers; paternal and community sensitization and peer-to-peer support.ConclusionsAddressing health systems limitations for delivery of KMC prior to stability is foundational with linkage to comprehensive HCW and KMC provider education about effectiveness, safe delivery and monitoring. Further context specific research into safe and respectful implementation is required from varied settings and should include perceptions of all stakeholders, especially if there is a shift in global policy toward KMC for all small vulnerable newborns.

Home oxygen for moderate hypoxaemia in chronic obstructive pulmonary disease: a systematic review and meta-analysis

Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive pulmonary disease (COPD) and severe hypoxaemia. However, the best method of management of moderate hypoxaemia not qualifying for LTOT (including isolated nocturnal desaturation) is uncertain. We examined the effect of home oxygen (either LTOT or nocturnal oxygen therapy) on overall survival in patients with COPD and moderate hypoxaemia. In this systematic review and meta-analysis, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, CINHAL, and Web of Science from database inception to Jan 13, 2022, for parallel-group randomised trials of long-term or nocturnal oxygen in patients with COPD and moderate daytime hypoxaemia or isolated nocturnal desaturation, or both. Control groups received usual care or ambient air through sham concentrators (placebo) throughout the study period. The primary outcome of interest was 3-year mortality. Crossover trials and trials of oxygen in severe hypoxaemia were excluded. Two reviewers applied inclusion and exclusion criteria to titles and abstracts and screened the full-text articles and reference lists of relevant studies. Aggregate data were extracted manually in duplicate using structured data collection forms. Methodological quality was assessed using the Cochrane Risk of Bias tool. Random-effects meta-analysis was used to pool individual studies. We considered the minimal clinically important difference for home oxygen to be a relative risk reduction in mortality at 3-year follow-up of 30-40%. The meta-analysis is registered on PROSPERO, CRD42021225372. We identified 2192 studies and screened 1447 after removal of duplicates, of which 161 were subjected to full-text screening, and six were identified as being eligible for inclusion. These six randomised trials were published between 1992 and 2020 and the quality of evidence was high. In the primary meta-analysis (five trials; 1002 patients), we found the effect of home oxygen in reducing 3-year mortality to be small or absent (relative risk 0·91 [95% CI 0·72-1·16]; τ² = 0·00), hence the lower limit of the 95% CI did not meet the prespecified minimal clinically important difference. The results of our meta-analysis suggest that home oxygen probably makes little or no difference to 3-year mortality in patients with COPD and moderate hypoxaemia. The data do not support the widespread use of home oxygen in this patient population. None.

The Landscape of COVID-19 Research in the United States: a Cross-sectional Study of Randomized Trials Registered on ClinicalTrials.Gov.

ImportanceSARS-CoV-2 has infected over 200 million people worldwide, resulting in more than 4 million deaths. Randomized controlled trials are the single best tool to identify effective treatments against this novel pathogen.ObjectiveTo describe the characteristics of randomized controlled trials of treatments for COVID-19 in the United States launched in the first 9 months of the pandemic.Design, Setting, and ParticipantsWe conducted a cross-sectional study of all completed or actively enrolling randomized, interventional, clinical trials for the treatment of COVID-19 in the United States registered on www.clinicaltrials.gov as of August 10, 2020. We excluded trials of vaccines and other interventions intended to prevent COVID-19.Main Outcomes and MeasuresWe used descriptive statistics to characterize the clinical trials and the statistical power for the available studies. For the late-phase trials (i.e., phase 3 and 2/3 studies), we compared the geographic distribution of the clinical trials with the geographic distribution of people diagnosed with COVID-19.ResultsWe identified 200 randomized controlled trials of treatments for people with COVID-19. Across all trials, 87 (43.5%) were single-center, 64 (32.0%) were unblinded, and 80 (40.0%) were sponsored by industry. The most common treatments included monoclonal antibodies (N=46 trials), small molecule immunomodulators (N=28), antiviral medications (N=24 trials), and hydroxychloroquine (N=20 trials). Of the 9 trials completed by August 2020, the median sample size was 450 (IQR 67–1113); of the 191 ongoing trials, the median planned sample size was 150 (IQR 60–400). Of the late-phase trials (N=54), the most common primary outcome was a severity scale (N=23, 42.6%), followed by a composite of mortality and ventilation (N=10, 18.5%), and mortality alone (N=6, 11.1%). Among these late-phase trials, all trials of antivirals, monoclonal antibodies, or chloroquine/hydroxychloroquine had a power of less than 25% to detect a 20% relative risk reduction in mortality. Had the individual trials for a given class of treatments instead formed a single trial, the power to detect that same reduction in mortality would have been greater than 98%. There was large variability in access to trials with the highest number of trials per capita in the Northeast and the lowest in the Midwest.Conclusions and RelevanceA large number of randomized trials were launched early in the pandemic to evaluate treatments for COVID-19. However, many trials were underpowered for important clinical endpoints and substantial geographic disparities were observed, highlighting the importance of improving national clinical trial infrastructure.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07167-9.

Does preemptive transjugular intrahepatic portosystemic shunt improve survival after acute variceal bleeding? Systematic review, meta-analysis, and trial sequential analysis of randomized trials.

A preemptive transjugular intrahepatic portosystemic shunt (p-TIPSS) after acute variceal bleeding (AVB) is advocated. However, when compared with the current standard of care, the survival benefit of p-TIPSS is questionable. We performed a systematic review, meta-analysis, and trial sequential analysis of randomized control trials (RCTs) to assess the survival benefit of p-TIPSS in patients with cirrhosis and AVB. Comprehensive literature search of three bibliographic databases (MEDLINE, Embase, and Cochrane) was conducted from inception till May 2021. All study types evaluating the survival benefit of p-TIPSS in AVB were considered for inclusion. The relative risk (RR) of mortality and rebleeding at 6weeks and mortality at 1year with a random-effects model was computed. Trial sequential analysis was performed for the primary outcome of 6-week mortality. A total of nine studies (four RCTs and five cohort studies) comprising 2861 patients with AVB were included. The overall pooled risks of mortality at 6weeks and 1year were 17.9% (95% confidence interval [CI]: 16.5-19.3%) and 26.7% (95% CI: 25.0-28.3%), respectively. Although p-TIPSS was associated with lower 6-week rebleeding risk (RR=0.20; 95% CI=0.13-0.29, I2 =0%), data from pooled RCTs showed no significant difference in mortality at 6weeks (RR=0.33; 95% CI=0.08-1.36, I2 =63%) or at 1year (RR=0.76; 95% CI=0.51-1.14, I2 =30%). Using trial sequential analysis, required sample size to detect a 20% relative risk reduction in mortality at 6weeks with p-TIPSS was estimated to be 6317, which is beyond the total number of patients available for analysis. This meta-analysis found that the available data from RCTs are insufficient to confer 6-week mortality benefit with p-TIPSS compared with standard of care; thus, adequately powered RCTs are required.

The effects of dapagliflozin on kidney and cardiovascular outcomes in patients with chronic kidney disease with and without heart failure

Abstract Background Heart failure (HF) is highly prevalent in patients with chronic kidney disease (CKD) and the severity of kidney impairment increases risk of HF, highlighting the deleterious interplay between the conditions. The DAPA-CKD trial showed that dapagliflozin reduced the risk of kidney failure and HF hospitalization in patients with CKD. Purpose This prespecified analysis of DAPA-CKD aimed to determine the effects of dapagliflozin on kidney, cardiovascular and mortality outcomes according to presence or absence of HF. Methods DAPA-CKD (NCT03036150) was a randomized, double blind, controlled trial, which enrolled 4,304 participants with CKD. Participants were randomized to dapagliflozin 10 mg/day or placebo, as adjunct to standard care, and were followed for a median 2.4 years. The primary endpoint was a composite of sustained decline in eGFR ≥50%, end-stage kidney disease, or renal or cardiovascular death. Key secondary endpoints included a composite of cardiovascular death or HF hospitalization and all-cause mortality. Results Overall, 468 (11%) participants had a HF diagnosis at baseline. Participants with HF were older (65.3 vs 61.4 years) and more frequently diagnosed with type 2 diabetes (77% vs 66%) compared with those without HF; mean eGFR was similar (43.2 vs 43.1 mL/min/1.73m2) in the two groups. The primary outcome occurred more frequently in those with versus without HF (8.8 vs 5.7 events per 100 patient-years, respectively). The effect of dapagliflozin on the primary outcome was consistent among those with (hazard ratio [HR] 0.58; 95% CI 0.37, 0.91) or without HF (HR 0.62; 95% CI 0.51, 0.75; p-interaction 0.59). The composite of cardiovascular death or HF hospitalization (HR 0.68; 95% CI 0.44, 1.05 vs 0.70; 95% CI 0.51, 0.97; p-interaction 0.90), and the relative risk reduction for mortality (HR 0.56; 95% CI 0.34, 0.93; vs 0.73; 95% CI 0.54, 0.97; p-interaction 0.39) were also consistent in those with or without HF. Conclusion Patients with co-existing CKD and HF are at high risk of kidney and cardiovascular events and premature mortality. Dapagliflozin consistently reduced the proportional risk of these events, regardless of the presence or absence of HF. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): AstraZeneca

Hispanic Ethnicity and Breast Cancer: Disaggregating Surgical Management and Mortality by Race.

Breast cancer is the leading cause of cancer death among Hispanic women. Unfortunately, few studies disaggregate Hispanic patients by race to understand its implications on treatment and clinical outcomes such as mortality. The aim of this study is to examine surgical management and overall mortality among different subgroups of women who self-identify as Hispanic. Hispanic female patients, ages 18-90, stages I-III, diagnosed with breast cancer between 2010 and 2015 from the National Cancer Data Base were identified. The study cohort was divided into three ethnoracial categories: (1) Hispanic White (HW), 2) Hispanic Black (HB), and 3) Hispanic Other (HO). Descriptive statistics and multivariate models were constructed to determine the relationship between sociodemographic factors, clinical variables, surgical management, and mortality when disaggregated by race. There were 56,675 Hispanic women who met the study criteria. Most where HW (n=50,599, 89.3%) and the rest were HB (n=1,334, 2.4%) and HO (n=4,742, 8.3%). There was no difference between the three groups on receipt of breast conservation therapy (P=0.12). HB (48.5%) and HO (46.6%) women were more likely to undergo reconstruction than those who identified as HW (38.7%) (P<0.001). Additionally, HB (38.3%) women were more likely to undergo tissue-based reconstruction than HW (29.0%) and HO women (30%) (P=0.0008). There was no difference between the groups in the utilization of contralateral prophylactic mastectomy (CPM) (P=0.078). On multivariable analysis, there was no difference in mortality between HB and HW patients (HR 1.18, 95%CI 0.92-1.51; Ref HW). However, HO women had a 24% relative risk reduction in mortality (HR 0.76, 95% CI 0.63-0.92; HW ref). Findings from this study suggest there are ethnoracial disparities in reconstruction utilization and mortality among Hispanic women. Future studies should examine how culture, language, healthcare access, and patient preferences contribute to these disparities.

Antioxidant treatment to reduce mortality and serious adverse events in adult surgical patients: A systematic review with meta-analysis and trial sequential analysis.

Hyperoxia during anesthesia can increase cellular oxidative stress, and perioperative antioxidant treatment may reduce the resulting damage. The aim of this review was to evaluate risks and benefits of antioxidant treatment in surgical patients. We hypothesized that antioxidant treatment reduced mortality compared to placebo/no intervention. This systematic review with meta-analyses and trial sequential analysis (TSA) was conducted using Cochrane standards and GRADE methodology. Randomized clinical trials comparing perioperative antioxidant treatment vs. placebo/no intervention in adults were included. Primary outcome was mortality at longest follow-up. Ninety-seven trials with 8156 patients were included. The most common interventions were N-Acetylcysteine (36 trials) and vitamin C (29 trials). Trials were primarily performed during cardiac surgery (53 trials). Fifty-six trials with 4890 patients reported information on mortality (243 events). The meta-analysis of mortality at longest follow-up showed a reduced mortality in antioxidant treated patients (RR 0.74, 95% CI 0.59; 0.94, I2 0%), however, TSA-adjusted CI was broadened (0.55-1.02) and only 31% of the required information size was reached. Furthermore, in the subgroup of three trials with overall low risk of bias the RR for mortality was 1.18 (95% CI 0.39, 3.63). Based on GRADE, our findings are of low quality of evidence due to high risk of bias, imprecision, and indirectness. We found a 26% relative risk reduction of mortality in surgical patients treated with antioxidants but the quality of evidence supporting our findings is low and influenced by clinical heterogeneity and high risk of systematic- and random errors.

P577Effect of adding an implantable cardioverter defibrillator on long-term survival in non-ischemic CRT patients stratified by Goldenberg risk score

Abstract Background There are limited and incomprehensive long-term data on the effects of adding an implantable cardioverter defibrillator (ICD) to cardiac resynchronization therapy (CRT) in patients with non-ischemic heart failure. Purpose We compared the long-term all-cause mortality and relative risk reduction in mortality of non-ischemic patients after CRT-P vs. CRT-D implantation stratified by their Goldenberg risk score. Methods In our retrospective registry, data of 1196 non-ischemic patients who underwent CRT implantation between 2000 to 2018 were collected. Goldenberg sudden cardiac risk score was calculated by the presence of atrial fibrillation, NYHA class &amp;gt; 2, age &amp;gt; 70 years, blood urea nitrogen &amp;gt; 26mg/dl and QRS width. Results In our registry from 1196 CRT implanted patients with non-ischemic heart failure, 716 patients had all the required data to calculate the Goldenberg score. From this cohort 379 (53%) had CRT-P and 337 (47%) CRT-D implantation. The mean value of the Goldenberg score was 2.7 in the total cohort, while a significantly higher score was found in the CRT-P group (CRT-P 2.9 ± 1.1 vs. CRT-D 2.5 ± 1.1 p &amp;lt; 0.001). During the median follow-up time of 4.9 years, 345 (48%) patients reached the primary endpoint, 220 patients (64%) with CRT-P and 125 patients (36%) with CRT-D. After comparing patients by low (≤3) and high (&amp;gt;3) Goldenberg score, we found that CRT-D patients with lower risk score showed mortality benefit compared to CRT-P (HR 0.69; 95%, CI 0.53-0.89; p = 0.001). In the contrary there was no apparent mortality benefit in CRT-D patients compared to CRT-P when high Goldenberg score subgroup was analyzed (HR 0.99; 95%, CI 0.67-1.45; p = 0.95). Conclusions In non-ischemic heart failure patients, Goldenberg sudden cardiac risk score can be also applied. In CRT-D patients those with less co-morbidities and lower (≤3) Goldenberg risk score showed mortality benefit compared to CRT-P patients, while among patients with higher score (&amp;gt;3) adding an ICD had no additional effect on all-cause mortality.

2099. Use of Infectious Diseases Source-Specific Electronic Sepsis Order Sets is associated with Improved Survival in Sepsis: An Evaluation of 46 Hospitals in a Large Health Care System

BackgroundCompliance with evidence-based treatment bundles in patients with sepsis can lead to improved survival in persons with sepsis or septic shock. A way to ensure the adoption of best practices is the early use standardized order sets based on suspected source of infection.MethodsThe patient population was built by connecting electronic health record (EHR) to administrative data. In the EHR, we identified patients who had a sepsis discharge diagnosis code based on the International Statistical Classification of Disease and Related Health Problems (ICD−10), from August 1, 2018 to February 28, 2019. We evaluated the empiric use of sepsis order sets and patient outcomes. We adjusted for age, gender, Elixhauser Comorbidity Score (ECS), intensive care unit (ICU) status, and admission type. For the analysis, we included patients age 18 and older from facilities where we were able to match greater than 70 percent of patients. Matching was done by facility on medical record number and discharge date.ResultsThere were 26,604 patients included in the analysis. The overall mortality rate was 10.67% (n = 2,839). Mortality associated with sepsis in patients that had a sepsis order set used was 8.92% (791/8,872), while for those whom a sepsis order set was not used was 11.55% (2,048/17,732). When mortality data were adjusted for age, gender, ECS, ICU status, admission type and hospital size, the use of sepsis order sets was associated with an adjusted odds ratio of 0.793 (95% CI 0.722, 0.868). In addition, in all sepsis patients who had an ICU admission, the use of the sepsis order sets was associated with an adjusted odds ratio of 0.804 (95% CI 0.725, 0.890). Similarly, in all sepsis patients who did not have an ICU admission, the use of the sepsis order sets was associated with an adjusted odds ratio of 0.688 (95% CI 0.556, 0.847).ConclusionThe use of the standardized sepsis order sets in patients with sepsis was associated with a 20.7% relative risk reduction in mortality. In conjunction with rapid recognition of sepsis, early initiation of the sepsis order sets may lead to improved mortality in patients with sepsis. Disclosures All authors: No reported disclosures.

Saving Lives With Algorithm-Enabled Process Innovation for Sepsis Care

Predictive algorithms have an increasingly important role in supporting the day-to-day operations of healthcare organizations. Yet, fully realizing the value of algorithms lies critically in the opportunity to re-engineer the related processes and redefine roles in ways that make organizations more effective. We study whether and how algorithm-enabled process innovation (AEPI) creates value in the context of early diagnosis of sepsis, an infection in the bloodstream. Sepsis is a costly condition that is the leading cause of death for hospitalized patients. It is estimated that 11.0 million people died from sepsis globally in 2017. We collaborated with a large U.S. based hospital system and examined how AEPI developed for sepsis care (sepsis AEPI) impact patient mortality and related process outcomes (e.g., timely diagnosis and treatment). Our findings provide guidance for providers and policy makers. We utilize a rich set of clinical and nonclinical data in empirically examining the impact of sepsis AEPI on patient mortality and process outcomes. We leverage the staggered implementation of sepsis AEPI across hospital units and conduct our estimation on a carefully matched sample. The matching utilizes data on patient vitals and the logic behind the algorithm to create a robust comparison group consisting of patient visits for which sepsis AEPI would have triggered an alert if it had been in place. Our empirical analysis shows that sepsis AEPI reduces the likelihood of death from sepsis (43% relative reduction in mortality risk due to sepsis). This reduction occurs in parallel with a 21% relative improvement in the likelihood of timely diagnostic (lactate measurement) and clinical interventions (antibiotics administration) for sepsis patients. We identify lapses in process outcomes in parallel to a lapse in AEPI's propensity to reduce sepsis-related mortality over extended periods of implementation. Our findings suggest that streamlining sepsis care processes through a predictive algorithm (i.e., algorithm-based monitoring of real-time patient data and providing predictions, streamlined communication channels for coordinating care for a patient with sepsis prediction, and a more standardized process for sepsis diagnosis and treatment) holds significant promise in reducing the loss of life from sepsis. We show that such value, however, requires adherence to process changes even after the algorithm becomes a routine part of the day-to-day operations of the hospital.

Cost Consequence Analysis for Optimising Medical Therapy in an Australian Heart Failure with Reduced Ejection Fraction (HFrEF) Cohort

Heart failure poses a substantive economic burden on the Australian healthcare system, with known underutilisation of evidence-based pharmacotherapy. Herewith, we estimate the annual cost of optimising pharmacotherapy for heart failure with reduced ejection fraction (HFrEF) in an Australian adult cohort across 6 metropolitan hospitals in NSW. This retrospective cohort study applied best available data to determine the relative risk reduction in mortality and heart failure-related rehospitalisation for guideline-based medical therapies (Beta-blockers, ACE-Inhibitors, Neprilysin Inhibitors, Diuretics, Aldosterone Antagonists and Ivabradine). Our cohort comprised ≈ 26% of annual heart failure admissions across NSW, of which 815 met inclusion criteria for HFrEF. Cost estimates were calculated from the Pharmaceutical Benefits Scheme (PBS) data for the cheapest agent within a drug class. The cost of hospital admission for heart failure was estimated using The National Efficient Price (NEP) 2018 calculator issued by the Independent Hospital Pricing Authority (IHPA) in Australia. Of the 815 patients that met inclusion criteria for hospital admission due to HFrEF, the annual rate of readmission for heart failure was 52%, with all cause mortality rate being 14%. We found a 77% average reduction in mortality benefit and a 71% average increase in rehospitalisation due to suboptimal pharmacotherapy. In our cohort, 28 deaths and 123 rehospitalisations could have been prevented by pharmacotherapy optimisation. The annual cost per patient of optimising pharmacotherapy was $135.35, resulting in a total projected cost of $303387.48 to optimise HFrEF pharmacotherapy across NSW. The gap in optimal pharmacotherapy prescription for heart failure is a major contributing factor to hospital readmission, thus posing a significant economic burden to the NSW healthcare system. More comprehensive Australia-specific cost-benefit analyses including recommended device therapies will better elucidate this major public health burden.

An analysis of publicly reported pediatric heart surgery data and patient mortality implications

Background: An association exists between higherhospital volumes and better patient outcomes for high-risk pediatric andcongenital heart surgery. This relationship suggests that patient deaths couldpotentially be avoided if the highest complexity operations performed in low-and medium-volume hospitals were shifted to high-volume hospitals. Usingpublicly available data, this study investigates the number of deaths ofpediatric and congenital heart surgery patients in the USA that theoreticallycould be avoided if highest complexity patients had surgery at high-volumehospitals. Methods: Data were extracted from The Societyof Thoracic Surgeons website for 61 hospitals that voluntarily publiclyreported their outcomes. Each hospital was categorized based on their meanannual volume of pediatric and congenital heart surgeries. For each volume andpatient risk category combination, we calculated an observed-to-expectedmortality ratio. Using high-volume hospitals as the reference, we calculatedthe theoretical difference in number of deaths in medium- and low-volumehospitals if they had the same mortality performance as high-volume hospitals. Results: Over the 4-year reporting period, 104deaths (overall 26% reduction in observed deaths) theoretically might have beenprevented if higher-risk operations done at low- and medium-volume hospitalswere performed with outcomes comparable to those of high-volume hospitals. Conclusions: This analysisidentified a large relative risk reduction in mortality of high-risk pediatricand congenital heart surgery patients that theoretically could be achieved ifhigher-risk operations performed at low- and medium-volume hospitals couldshift to high-volume hospitals. A number of potential solutions exist to reducethese potentially preventable deaths, including regionalization.

Radial artery versus saphenous vein as the second conduit for coronary artery bypass surgery: A meta-analysis

ObjectiveIndividual studies may be limited by sample size to detect differences in late survival between radial artery (RA) or saphenous vein graft (SVG) as a second conduit for coronary artery bypass surgery. Here we undertook a meta-analysis of the best evidence available on the comparison of early and late clinical outcomes of the RA and the SVG. MethodsMEDLINE and EMBASE were searched for studies comparing use of the RA versus SVG for isolated coronary artery bypass surgery. Time-to-event outcomes for long-term mortality, repeat revascularization, and myocardial infarction (MI) were extracted as incidence rate ratios (IRR) with 95%confidence intervals (95% CI). Odds ratios (OR) were extracted for perioperative mortality, stroke, and MI. A random effects meta-analysis was performed. Sensitivity analyses included leave-one-out-analyses and meta-regression. ResultsAmong 1201 articles, 14 studies (20,931 patients) were included (mean follow-up: 6.6 years). Operative mortality was 1.25% in the RA versus 1.33% in the SVG group (OR, 0.93; 95% CI, 0.68-1.28). No difference in perioperative MI (OR, 0.96; 95% CI, 0.59-1.56) or stroke (OR, 0.70; 95% CI, 0.43-1.13) was found between RA and SVG. Long-term mortality (mean follow-up 6.6 years) was 24.5% in RA versus 34.2% in SVG group (IRR, 0.74; 95% CI, 0.63-0.87, P < .001). No difference in follow-up MI or repeat revascularization was found (IRR, 0.76; 95% CI, 0.42-1.36 and IRR, 0.68; 95% CI, 0.42-1.09 respectively). At meta-regression, RA survival advantage was independent of age, sex, diabetes, and ventricular function. ConclusionsCompared with the SVG, using the RA as the second conduit is associated with a 26% relative risk reduction in mortality at 6.6-year follow-up.

Identifying optimal candidates for early TIPS among patients with cirrhosis and acute variceal bleeding: a multicentre observational study

ObjectivesEarly placement of transjugular intrahepatic portosystemic shunt (TIPS) has been shown to improve survival in high-risk patients (Child-Pugh B plus active bleeding at endoscopy or Child-Pugh C 10–13) with cirrhosis...

PO448 Evaluation of Mortality Trends From Cardiac Arrest In Brazil and the Southeast Region, and the Importance of First Aid to Victims

Each encounter of asymptomatic individuals with the healthcare system presents an opportunity for improvement of cardiovascular disease (CVD) awareness and sudden cardiac death (SCD) risk assessment. ECG sign deep terminal negativity of the P wave in V1 (DTNPV1) was shown to be associated with an increased risk of SCD in the general population.To evaluate association of DTNPV1 with all-cause mortality and newly diagnosed atrial fibrillation (AFib) in the large tertiary healthcare system patient population.Retrospective double cohort study compared two levels of exposure (automatically measured amplitude of P-prime (Pp) in V1): DTNPV1 (Pp from − 100 μV to − 200 μV) and ZeroPpV1 (Pp = 0). An entire healthcare system (2010–2014) ECG database was screened. Medical records of children and patients with previously diagnosed AFib/atrial flutter (AFl), implanted pacemaker or cardioverter–defibrillator were excluded. DTNPV1 (n = 3,413) and ZeroPpV1 (n = 3,405) cohorts were matched by age and sex. Primary outcome was all-cause mortality. Secondary outcomes were newly diagnosed AFib/AFl. Median follow-up was 2.5 y.DTNPV1 was associated with all-cause mortality (HR 1.95(1.64–2.31); P < 0.0001) and newly diagnosed AFib (HR 1.29(1.04–1.59); P = 0.021) after adjustment for CVD, comorbidities, other ECG parameters, medications, and index ECG referral. Index ECG referral by a cardiologist was independently associated with 34% relative risk reduction of mortality (HR 0.66(0.52–0.84); P = 0.001), as compared to ECG referral by a non-cardiologist.DTNPV1 is independently associated with twice higher risk of all-cause death, as compared to patients without P prime in V1. Life-saving effect of the index ECG referral by a cardiologist requires further study.

Implantable Cardioverter Defibrillator for the Primary Prevention of Sudden Cardiac Death in Patients With Nonischemic Cardiomyopathy.

The benefit of implanting patients with nonischemic cardiomyopathy (NICMP) with an implantable cardioverter defibrillator (ICD) for primary prevention has not been demonstrated in any randomized controlled trial. This also holds true for the most recent study on the subject. This systematic review and meta-analysis aims to examine the effectiveness of primary prevention using an ICD in the NICMP population. We searched the literature for randomized controlled trials examining the effectiveness of ICD in reducing all-cause mortality in patients with NICMP. The primary outcome of our analysis was all-cause mortality. A fixed-effects model was used for the primary analysis. A total of 5 randomized controlled trials focused on primary prevention of sudden cardiac death for patients with NICMP that met our inclusion and exclusion criteria. They have individually failed to consistently show a benefit for the use of an ICD in this population. However, the cumulative effect of ICD implantation in patients with NICMP demonstrated a 21% relative risk reduction in mortality (Relative risk [RR]: 0.79; confidence interval: 0.66-0.95). There is a decrease in mortality with the use of ICD for primary prevention in patients with NICMP having left ventricular ejection fraction <35%.