30-day Serious Adverse Events Research Articles

Pilot trial of an electronic decision support to improve care for emergency department patients with acute heart failure.

Emergency department (ED) providers play an important role in the management of patients with acute heart failure (AHF). We present findings from a pilot study of an electronic decision support that includes personalized risk estimates using the STRIDE-HF risk tool and tailored recommendations for initiating guideline directed medical therapy (GDMT) among appropriate patients. Among ED patients treated for AHF who were discharged from the ED or the ED-based observation unit in two EDs from 1 January 2023 to 31 July 2023, we assess prescriptions to the four classes of GDMT at two intervals: (1) ED arrival and (2) ED discharge. Specifically, we report active prescriptions for beta-blockers (BBs), renin-angiotensin receptor system inhibitors (RASis), sodium-glucose transport protein 2 inhibitors (SGLT2is) and mineralocorticoid receptor antagonists (MRA) among patients with reduced ejection fraction (HFrEF) and mildly reduced (HFmrEF). Second, we describe rates of 30-day serious adverse events (SAE) (death, cardiopulmonary resuscitation, balloon-pump insertion, intubation, new dialysis, myocardial infarction or coronary revascularization) among patients predicted to be very low risk by STRIDE-HF and discharged home. Among 234 discharged patients, 55% were female and 76% were non-White. We found 51 (21.8%), 21 (9.0%) and 126 (53.8%) had HFrEF, HFmEF and HFpEF, respectively, while 36 (15.4%) were missing EF, and 51 (22%) were very low risk, 82 (35%) were low risk, 60 (26%) were medium risk and 41 (18%) were high risk. Among HFrEF patients, 68.6%, 66.7%, 25.5% and 19.6% were on a RASi, BB, SGLT2i and MRA, respectively, at ED arrival, while 42.9%, 66.7%, 14.3% and 4.8% of HFmrEF patients were on a RASi, BB, SGLT2i and MRA, respectively. Among patients with HFpEF, only 6 (4.8%) were on an SGLT2i at ED arrival. The most prescribed new medication at ED discharge was an SGLT2i, with a nearly 10% increase in the proportion of patients with an active prescription for SGLT2i at ED discharge among HFrEF and HFmEF patients. We observed no 30-day SAE among the 51 patients predicted to be very low risk and discharged home. Ongoing treatment with GDMT at ED arrival was sub-optimal. Initiation among appropriate patients at discharge may be feasible and safe.

Machine learning versus traditional methods for the development of risk stratification scores: a case study using original Canadian Syncope Risk Score data.

Artificial Intelligence and machine learning (ML) methods are promising for risk-stratification, but the added benefit over traditional statistical methods remains unclear. We compared predictive models developed using machine learning (ML) methods to the Canadian Syncope Risk Score (CSRS), a risk-tool developed with logistic regression for predicting serious adverse events (SAE) after emergency department (ED) disposition for syncope. We used the prospective multicenter cohort data collected for CSRS development at 11 Canadian EDs over an 8-year period to develop four ML models to predict 30-day SAE (death, arrhythmias, MI, structural heart disease, pulmonary embolism, hemorrhage) after ED disposition. The CSRS derivation and validation cohorts were used for training and testing, respectively, and the 43 variables used included demographics, medical history, vital signs, ECG findings, blood tests and the diagnostic impression of the emergency physician. Performance was assessed using the area under the receiver-operating-characteristics curve (AUC) and calibration curves. Of the 4030 patients in the training set and 3819 patients in the test set overall, 286 (3.6%) patients suffered 30-day SAE. The AUCs for model validation in test data were CSRS 0.902 (0.877-0.926), regularized regression 0.903 (0.877-0.928), gradient boosting 0.914 (0.894-0.934), deep neural network 0.906 (0.883-0.929), simplified gradient boosting 0.904 (0.881-0.927). The AUCs and calibration slopes for the ML models and CSRS were similar. Two ML models used fewer predictors than the CSRS but matched its performance. Overall,the ML models matched the CSRS in performance, with some models using fewer predictors.

External validation of the Canadian Syncope Risk Score for patients presenting with undifferentiated syncope to the emergency department.

To validate the accuracy and safety of the Canadian Syncope Risk Score (CSRS) for patients presenting with syncope. Single centre prospective observational study in Brisbane, Australia. Adults presenting to the ED with syncope within the last 24 h were recruited after applying exclusion criteria. Study was conducted over 1 year, from March 2018 to March 2019. Thirty-day serious adverse events (SAE) were reported based on the original derivation study and standardised outcome reporting for syncope. Individual patient CSRS was calculated and correlated with 30-day SAE and disposition status from ED. Two hundred and eighty-three patients were recruited to the study. Average age was 55.6 years (SD 22.7 years), 37.1% being male with a 39.9% admission rate. Thirty-day SAE occurred in seven patients (2.5%) and no recorded deaths. The CSRS performed with a sensitivity of 71.4% (95% confidence interval [CI] 30.3-94.9%), specificity 72.8% (95% CI 67.1-77.9%) for a threshold score of 1 or higher. Syncope patients in our study were predominantly very low to low risk (72%). The prevalence of 30-day SAE was low, majority occurring following hospital discharge. Sensitivity estimates for CSRS was lower than the derivation study but lacked robustness with wide CIs because of a small sample size and number of events observed. However, the CSRS did not miss any clinically relevant outcomes in low risk patients making it potentially useful in aiding their disposition. Larger validation studies in Australia are encouraged to further test the diagnostic accuracy of the CSRS.

Thirty-Day Outcomes of Bariatric Surgery in Adolescents: a First Look at the MBSAQIP Database.

IntroductionBariatric surgery is the only effective treatment of severe obesity. The number of adolescents undergoing bariatric surgery is increasing. However, bariatric surgery in adolescents is controversial.ObjectiveThe purpose of this study is to evaluate the outcomes of bariatric surgery in adolescents based on the MBSAQIP database (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Project).MethodsWe analyzed the 2015–2017 MBSAQIP database; patients ≤ 19 years of age were included in our analysis. Primary outcomes were 30-day serious adverse events (SAEs), organ space infection (OSI), re-intervention, and re-operation rates. Secondary outcomes included operation length, hospital stay, and re-admission rates. We conducted separate Mann-Whitney rank sums tests, chi-square, or Fisher’s exact tests as appropriate, with p < .05 denoting statistical significance.ResultsA total of 1983 adolescent patients were included in our analysis. The average age and BMI were 18.1 and 47.5, respectively. Of adolescent patients, 21.7% underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) and 78.3% underwent laparoscopic sleeve gastrectomy (LSG). The 30-day SAE and readmission rates were significantly lower for LSG compared with LRYGB (2.9% and 2.6% vs 6.5% and 5.6%, respectively; p < 0.05). The 30-day reoperation rate was also lower for LSG compared with LRYGB albeit not significant (1.1% and vs 2.3%; p = 0.05). The 30-day intervention rate for LSG was significantly lower, however, compared with LRYGB (1.2% vs 3%; p < 0.05). Compared with adult patients, > 19 years old (n = 353,726), we found no difference in our outcomes. However, adolescents had significantly shorter operation length.ConclusionIn adolescents, LSG had fewer SAE, re-intervention, and readmission rates compared with LRYGB. There was no difference in outcomes between adolescents and adults.

Outcomes of robotic surgery in revisional bariatric cases: a propensity score-matched analysis of the MBSAQIP registry.

In recent years, there has been a significant increase in the number of Revisional Bariatric Surgery (RBS) cases performed to address complications and weight recidivism. The use of the da Vinci robotic platform, considered controversial by many, may offer advantages in RBS. The objective of our study is to compare the outcomes of Robotic RBS (R-RBS) to Laparoscopic RBS (L-RBS). Using the 2015-2017 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database, we selected all RBS and we matched R-RBS to L-RBS using a propensity score matching system to create balanced groups. Our primary outcomes were 30-day Serious Adverse Events (SAE), 30-day Organ Specific Infection (OSI), 30-day reoperation and 30-day interventions. Our secondary outcomes included length of operation and 30-day readmission. We conducted separate Mann-Whitney rank sums tests or chi-square tests and Fisher exact test. R-RBS and L-RBS included 220 patients each. The overall incidence of 30-day SAEs, 30-day OSIs, 30-day reoperations, 30-day interventions were lower for R-RBS (6.4%, 0.9%, 2.7% and 2.3%, respectively) compared L-RBS (7.7%, 1.4%, 3.6% and 3.6%, respectively). Subgroup analysis showed that R-RBS had a lower rate of complications for the Gastric Bypass procedure but not for Sleeve gastrectomy cases. However, 30-day readmission was higher for R-RBS compared to L-RBS (9.1% vs 6.4% respectively). None of the analyses reached statistical significance. R-RBS took significantly longer compared to L-RBS (169min vs 138min, p < 0.05). Our study shows that R-RBS has lower complication rate albeit non-significant as compared to L-RBS.

LO09: Role of hospitalization for detection of serious adverse events among emergency department patients with syncope: a propensity-score matched analysis of a multicenter prospective cohort

Introduction: Selecting appropriate patients for hospitalization following emergency department (ED) evaluation of syncope is critical for serious adverse event (SAE) identification. The primary objective of this study is to determine the association of hospitalization and SAE detection using propensity score (PS) matching. The secondary objective was to determine if SAE identification with hospitalization varied by the Canadian Syncope Risk Score (CSRS) risk-category. Methods: This was a secondary analysis of two large prospective cohort studies that enrolled adults (age ≥ 16 years) with syncope at 11 Canadian EDs. Patients with a serious condition identified during index ED evaluation were excluded. Outcome was a 30-day SAE identified either in-hospital for hospitalized patients or after ED disposition for discharged patients and included death, ventricular arrhythmia, non-lethal arrhythmia and non-arrhythmic SAE (myocardial infarction, structural heart disease, pulmonary embolism, hemorrhage). Patients were propensity matched using age, sex, blood pressure, prodrome, presumed ED diagnosis, ECG abnormalities, troponin, heart disease, hypertension, diabetes, arrival by ambulance and hospital site. Multivariable logistic regression assessed the interaction between CSRS and SAE detection and we report odds ratios (OR). Results: Of the 8183 patients enrolled, 743 (9.0%) patients were hospitalized and 658 (88.6%) were PS matched. The OR for SAE detection for hospitalized patients in comparison to those discharged from the ED was 5.0 (95%CI 3.3, 7.4), non-lethal arrhythmia 5.4 (95%CI 3.1, 9.6) and non-arrhythmic SAE 6.3 (95%CI 2.9, 13.5). Overall, the odds of any SAE identification, and specifically non-lethal arrhythmia and non-arrhythmia was significantly higher in-hospital among hospitalized patients than those discharged from the ED (p &lt; 0.001). There were no significant differences in 30-day mortality (p = 1.00) or ventricular arrhythmia detection (p = 0.21). The interaction between ED disposition and CSRS was significant (p = 0.04) and the probability of 30-day SAEs while in-hospital was greater for medium and high risk CSRS patients. Conclusion: In this multicenter prospective cohort, 30-day SAE detection was greater for hospitalized compared with discharged patients. CSRS low-risk patients are least likely to have SAEs identified in-hospital; out-patient monitoring for moderate risk patients requires further study.

LO22: Risk-stratification of emergency department syncope by artificial intelligence using machine learning: human, statistics or machine

Introduction: The Canadian Syncope Risk Score (CSRS) is a validated risk tool developed using the best practices of conventional biostatistics, for predicting 30-day serious adverse events (SAE) after an Emergency Department (ED) visit for syncope. We sought to improve on the prediction ability of the CSRS and compared it to physician judgement using artificial intelligence (AI) research with modern machine learning (ML) methods. Methods: We used the prospective multicenter cohort data collected for the CSRS derivation and validation at 11 EDs across Canada over an 8-year period. The same 43 candidate variables considered for CSRS development were used to train and validate the four classes of ML models to predict 30-day SAE (death, arrhythmias, MI, structural heart disease, pulmonary embolism, hemorrhage) after ED disposition. Physician judgement was modeled using the two variables, referral for consultation and hospitalization. We compared the area under the curve (AUC) for the three models. Results: The proportion of patients who suffered 30-day SAE in the derivation cohort (N = 4030) was 3.6% and in validation phase (N = 2290) was 3.4%. Characteristics of the both cohorts were similar with no shift. The best performing ML model, a gradient boosting tree-based model used all 43 variables as predictors as opposed to the 9 final CSRS predictors. The AUC for the three models on the validation data were: best ML model 0.91 (95% CI 0.87–0.93), CSRS 0.87 (95% CI 0.83–0.90) and physician judgment 0.79 (95% CI 0.74 - 0.84). The most important predictors in the ML model were the same as the CSRS predictors. Conclusion: A ML model developed using AI method for risk-stratification of ED syncope performed with slightly better discrimination ability though not significantly different when compared to the CSRS. Both the ML model and the CSRS were better predictors of poor outcomes after syncope than physician judgement. ML models can perform with similar discrimination abilities when compared to traditional statistical models and outperform physician judgement given their ability to use all candidate variables.

Does N-Terminal Pro-B-Type Natriuretic Peptide Improve the Risk Stratification of Emergency Department Patients With Syncope?

Studies have reported that natriuretic peptides provide prognostic information for emergency department (ED) syncope. To evaluate whether adding N-terminal pro-B-type natriuretic peptide (NT-proBNP) to the Canadian Syncope Risk Score (CSRS) improves prediction of 30-day serious adverse events (SAEs). Prospective cohort study. 6 EDs in 2 Canadian provinces. 1452 adult ED patients with syncope. Serum NT-proBNP was measured locally at 1 site and batch processed at a central laboratory from other sites. The concentrations were not available to treating physicians or for adjudication of outcomes. An adjudicated composite outcome of 30-day SAEs, including death and cardiac (arrhythmic and nonarrhythmic) and noncardiac events. Of 1452 patients enrolled, 152 (10.5% [95% CI, 9.0% to 12.1%]) had 30-day SAEs, 57 (3.9%) of which were identified after the index ED disposition. Serum NT-proBNP concentrations were significantly higher among patients with SAEs than those without them (median, 626.5 ng/L vs. 81 ng/L; P < 0.001). Adding NT-proBNP values to the CSRS did not significantly improve prognostication (c-statistic, 0.89 and 0.90; P= 0.12 for difference), regardless of SAE subgroup or whether the SAE was identified after the index ED visit. The net reclassification index shows that NT-proBNP would have correctly reclassified 3% of patients with SAEs at the expense of incorrectly reclassifying 2% of patients without SAEs. Our study was powered to detect a 3% difference in the area under the curve. The heterogeneity of outcomes and robust baseline discrimination by the CSRS will make improvements challenging. Although serum NT-proBNP concentrations were generally much higher among ED patients with syncope who had a 30-day SAE, this blood test added little new information to the CSRS. Routine use of NT-proBNP for ED syncope prognostication is not recommended. Physicians' Services Incorporated Foundation, Canadian Institutes of Health Research, and The Ottawa Hospital Academic Medical Organization.

Frailty score for elderly patients is associated with short-term clinical outcomes in patients with ST-segment elevated myocardial infarction treated with primary percutaneous coronary intervention.

ObjectiveConsistent with the aging population in the Western world, there is a growing number of elderly patients with ST-segment elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) is the recommended reperfusion strategy in elderly patients; risk models to determine which of these patients are prone to have poor clinical outcomes are, however, essential. The purpose of this study was to assess the association between frailty and short-term mortality and PCI-related serious adverse events (SAE) in elderly patients.MethodsAll STEMI patients (aged ≥70 years) treated with primary PCI in 2013–2015 at the Leiden University Medical Centre were assessed. The Safety Management Programme (VMS) score was used to identify frail elderly patients. The primary endpoint was 30-day all-cause mortality; the secondary endpoint included 30-day clinical death, target vessel failure, major bleeding, contrast induced kidney insufficiency and stroke.ResultsA total of 206 patients were included (79 ± 6.4 years, 119 [58%] male). The VMS score was ≥1 in 28% of all cases. Primary and secondary endpoint rates were 5 and 23% respectively. VMS score ≥1 was an independent predictor for both 30-day mortality (odds ratio [OR] 9.6 [95% confidence interval, CI 1.6–56.9] p-value = 0.013) and 30-day SAE (OR 2.9 [95% CI 1.1–7.9] p-value = 0.038).ConclusionsVMS score for frailty is independently associated with short-term mortality and PCI-related SAE in elderly patients with STEMI treated with primary PCI. These results suggest that frailty in elderly patients is an important feature to measure and to be taken into account when developing risk models.Electronic supplementary materialThe online version of this article (10.1007/s12471-019-1240-7) contains supplementary material, which is available to authorized users.

Outcomes and emergency medical services resource utilization among patients with syncope arriving to the emergency department by ambulance

Syncope accounts for 1% of emergency department (ED) visits, yet few experience a serious adverse event (SAE). Two-thirds of syncope patients are transported to the ED by ambulance, placing considerable burden on emergency medical services (EMS), and many of these transports may be unnecessary. We estimated the proportion of syncope patients who fell into a low-risk category based on an ED diagnosis of vasovagal syncope and the absence of EMS intervention, hospitalization, or SAE. We conducted a multicentre prospective cohort study enrolling adult syncope patients transported to the ED by ambulance over 13 months. We collected demographics and EMS interventions, and followed patients for 30 days to identify all SAE, including death, dysrhythmia, myocardial infarction, aortic dissection, pulmonary embolism, subarachnoid hemorrhage, significant hemorrhage, and related procedural interventions. Of 990 (67.2%) patients transported to the ED by ambulance, 121 had EMS interventions, 137 suffered 30-day SAE, 393 (39.7%; 95%CI 36.6, 42.8) were deemed low risk, 41 patients with vasovagal syncope were lost to follow-up, and 298 patients were diagnosed with non-vasovagal syncope. During transport, 121 (12.2%; 95%CI 10.2, 14.3) patients underwent some EMS intervention, and 137 (14.6%; 95%CI 12.4, 16.9) suffered SAEs within 30 days. About 40% of patients transported to the ED by ambulance are at low risk and may not benefit from paramedic care or transport to a hospital. A robust clinical decision tool would help identify patients safe for treat-and-release, diversion to alternative care, or rapid offload into low-acuity ED areas, potentially reducing EMS workload and cost.

LO03: Application and usefulness of outpatient cardiac testing among emergency department patients with syncope

Introduction: 2.6% of emergency department (ED) syncope patients will have underlying cardiac serious conditions (e.g. arrhythmia, serious structural heart disease) identified within 30-days of disposition. If those at risk are discharged home, outpatient cardiac testing can detect underlying arrhythmias and structural heart disease, and thereby improve patient safety. We describe the frequency of outpatient referrals for cardiac testing and the proportion of cardiac serious adverse events (SAE) among high risk and non-high (low and medium) risk ED syncope patients, as defined by the Canadian Syncope Risk Score (CSRS). Methods: We conducted a multicenter prospective cohort study to enroll adult syncope patients across five large tertiary care EDs. We collected demographics, medical history, disposition, CSRS value, outpatient referrals and testing results (holter, echocardiography), and cardiac SAE. Adjudicated 30-day SAE included death due to unknown cause, myocardial infarction, arrhythmia, and structural heart disease. We used descriptive analysis. Results: Of 4,064 enrolled patients, a total of 955 patients (23%) received an outpatient referral (mean age 57.7 years, 52.1% female). Of the 299 patients (7%) hospitalized, 154 received outpatient cardiac testing after discharge. Among the 3,765 patients discharged home from the ED, 40% of the non-high risk patients (305/756) and 56% of the high risk patients (25/45) received outpatient cardiac testing. Of all patients who received outpatient cardiac testing, 4 patients (0.8%) had serious cardiac conditions identified and all were arrhythmias. Among those with no cardiac testing, 5 patients (0.9%) suffered cardiac SAE (80% arrhythmias) outside the hospital. Of the 20 (44%) high risk patients who did not receive outpatient cardiac testing, 2 (10%) patients suffered arrhythmias outside the hospital. While among the 451 non-high risk patients, only 0.8% suffered arrhythmia outside the hospital. Conclusion: Outpatient cardiac testing among ED syncope patients is largely underutilized, especially among high risk patients. Better guidelines for outpatient cardiac testing are needed, as current practice is highly variable and mismatched with patient risk.