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Background: The high-sensitivity HEART pathway (hs-HP) risk stratifies emergency department (ED) patients with chest pain. It is unknown if its safety and effectiveness vary by sex or race., Methods: We conducted a subgroup analysis of the hs-HP implementation study, a pre-post interrupted time series at five US EDs. The pre-implementation period (January 2019 to April 2020) utilized the traditional HEART pathway with contemporary troponin (Siemens) and the post-implementation period (November 2020 to February 2022) used the hs-HP using hs-cTnI (Beckman Coulter). Patients were risk-stratified using the hs-HP to rule-out, observation, and rule-in groups. Safety and effectiveness outcomes were 30-day all-cause mortality or myocardial infarction (MI) and 30-day hospitalization., Results: Twenty-six thousand and one hundred twenty-six patients were accrued (12 317 pre- and 13 809 post-implementation), of which 35.3% were non-White and 52.7% were female. Among 9703 patients with complete hs-HP assessments, 48.6% of White and 55.4% of non-White patients were ruled-out (p < 0.001). Additionally, 47.3% of males and 54.4% of females were ruled-out (p < 0.001). Among rule-out patients, 0.3% of White versus 0.3% of non-White patients (p = 0.98) and 0.3% of females versus males 0.3% (p = 0.90) experienced 30-day death or MI. Post-implementation, 30-day hospitalization decreased 17.2% among White patients (aOR 0.49, 95% CI: 0.45-0.52), 14.1% among non-White patients (aOR 0.53, 95% CI: 0.48-0.59), 15.6% among females (aOR 0.50, 95% CI: 0.46-0.54), and 16.6% among males (aOR 0.51, 95% CI: 0.47-0.56). The interactions for 30-day hospitalization between hs-HP implementation and race (p = 0.10) and sex (p = 0.69) were not significant., Conclusions: The hs-HP safely decreases 30-day hospitalizations regardless of sex or race. However, it classifies more non-White patients and women to the rule-out group., (© 2024 The Author(s). Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: To determine if the European Society of Cardiology 0/1-hour (ESC 0/1-h) algorithm with high-sensitivity cardiac troponin T (hs-cTnT) meets the ≥99% negative predictive value (NPV) safety threshold for 30-day cardiac death or myocardial infarction (MI) in older, middle-aged and young subgroups., Methods: We conducted a subgroup analysis of adult emergency department patients with chest pain prospectively enrolled from eight US sites (January 2017 to September 2018). Patients were stratified into rule-out, observation and rule-in zones using the hs-cTnT ESC 0/1-h algorithm and classified as older (≥65 years), middle aged (46-64 years) or young (21-45 years). Patients had 0-hour and 1-hour hs-cTnT measures (Roche Diagnostics) and a History, ECG, Age, Risk factor and Troponin (HEART) score. Fisher's exact tests compared rule-out and 30-day cardiac death or MI rates between ages. NPVs with 95% CIs were calculated for the ESC 0/1-h algorithm with and without the HEART score., Results: Of 1430 participants, 26.9% (385/1430) were older, 57.4% (821/1430) middle aged and 15.7% (224/1430) young. Cardiac death or MI at 30 days occurred in 12.8% (183/1430). ESC 0/1-h algorithm ruled out 35.6% (137/385) of older, 62.1% (510/821) of middle-aged and 79.9% of (179/224) young patients (p<0.001). NPV for 30-day cardiac death or MI was 97.1% (95% CI 92.7% to 99.2%) among older patients, 98.4% (95% CI 96.9% to 99.3%) in middle-aged patients and 99.4% (95% CI 96.9% to 100%) among young patients. Adding a HEART score increased NPV to 100% (95% CI 87.7% to 100%) for older, 99.2% (95% CI 97.2% to 99.9%) for middle-aged and 99.4% (95% CI 96.6% to 100%) for young patients., Conclusions: In older and middle-aged adults, the hs-cTnT ESC 0/1-h algorithm was unable to reach a 99% NPV for 30-day cardiac death or MI unless combined with a HEART score., Trial Registration Number: NCT02984436., Competing Interests: Competing interests: ACS receives funding from Abbott, HRSA (1H2ARH399760100) and AHRQ (R01HS029017). JS receives research funding from HRSA (H2ARH39976-01-00), The Duke Endowment, Roche Diagnostics, Abbott Laboratories, Pathfast, Genetesis, Cytovale, Forest Devices, Vifor Pharma and Chiesi Farmaceutici. SAM receives funding/support from Roche Diagnostics, Abbott Laboratories, QuidelOrtho, Siemens, Grifols, Pathfast, Genetesis, Cytovale, The Duke Endowment, Beckman Coulter, Comprehensive Research Associates, Brainbox, HRSA (1H2ARH399760100) and AHRQ (R01HS029017). He is a consultant for Roche, QuidelOrtho, Abbott, Siemens, Genetesis, Inflammatix, Radiometer and Amgen and is the chief medical officer for Impathiq. BA receives research funding/support from Roche Diagnostics, Siemens and Beckman Coulter. He is a consultant for Roche Diagnostics. BM has research support from the NIH (5K08HL130546) and Roche Diagnostics. She has served as a consultant for Roche Diagnostics. JM receives research funding/support from Beckman Coulter, Roche Diagnostics, Abbott Laboratories and Siemens. He is a consultant for Beckman Coulter, Roche Diagnostics and Siemens. RGW received research funding from Regeneron Pharmaceuticals, Lilly USA, BioAge Labs, Roche Diagnostics, Global Blood Therapeutics, Novartis Pharmaceuticals, Egetis Therapeutics, EndPoint Health, Blade Therapeutics, Janssen R&D, ProvePharma and Pfizer. He has received research funding from CoapTech through an NIH/NIDDK grant (R44DK115325). He has received research support in the form of equipment and supplies from Cepheid and Eldon Biologicals. He is an uncompensated advisor to CSL Behring. RC is a consultant for and receives funding/support from Roche Diagnostics, Siemens Healthineers, Beckman Coulter Diagnostics, Becton Dickinson and Co, Quidel and Sphingotec., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The American College of Cardiology (ACC) recently published an Expert Consensus Decision Pathway for chest pain., Objectives: The purpose of this study was to validate the ACC Pathway in a multisite U.S., Methods: An observational cohort study of adults with possible acute coronary syndrome was conducted. Patients were accrued from 5 U.S. Emergency Departments (November 1, 2020, to July 31, 2022). ECGs and 0- and 2-hour high-sensitivity troponin (Beckman Coulter) measures were used to stratify patients according to the ACC Pathway. The primary safety outcome was 30-day all-cause death or myocardial infarction (MI). Efficacy was defined as the proportion stratified to the rule-out zone. Negative predictive value for 30-day death or MI was assessed among the whole cohort and in a subgroup of patients with coronary artery disease (CAD) (prior MI, revascularization, or ≥70% coronary stenosis)., Results: ACC Pathway assessments were complete in 14,395 patients, of whom 51.7% (7,437 of 14,395) were women with a median age of 56 years (Q1-Q3: 44-68 years). Known CAD was present in 23.5% (3,386 of 14,395) and 30-day death or MI occurred in 8.1% (1,168 of 14,395). The ACC Pathway had an efficacy of 48.1% (95% CI: 47.3%-49.0%). Among patients in the rule-out zone, 0.3% (22 of 6,930) had death or MI at 30 days, yielding a negative predictive value of 99.7% (95% CI: 99.5%-99.8%). In patients with known CAD, 20.0% (676 of 3,386) were classified to the rule-out zone, of whom 1.5% (10 of 676) had death or MI., Conclusions: The ACC expert consensus decision pathway was safe and efficacious. However, it may not be safe for use among patients with known CAD., Competing Interests: Funding Support and Author Disclosures This study was funded internally by Wake Forest University Health Systems. The Wake Forest Clinical and Translational Science Institute, supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through UL1TR001420. Dr Mahler has received funding/support from Roche Diagnostics, Abbott Laboratories, QuidelOrtho Clinical Diagnostics, Siemens, Grifols, Pathfast, Genetesis, Cytovale, Beckman Coulter, Brainbox, AHRQ (R01HS029017 and R21HS029234), The Duke Endowment, National Foundation of Emergency Medicine, and HRSA (1H2ARH399760100); is a consultant for Roche, Abbott, Siemens, QuidelOrtho, Genetesis, Inflammatix, and Radiometer; and is the Chief Medical Officer for Impathiq Inc. Dr Ashburn has received funding from AHRQ (R01HS029017). Dr Supples has received funding from the National Institutes of Health (UL1TR001420), HRSA (1H2ARH399760100), and the National Foundation of Emergency Medicine. Dr Snavely has received funding from Abbott Laboratories, AHRQ (R01HS029017), and HRSA (1H2ARH399760100). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac arrest guidelines recommend epinephrine every 3-5 minutes during cardiac arrest resuscitation. However, it is unclear if multiple epinephrine doses are associated with improved outcomes. The objective of this study was to determine if a single-dose epinephrine protocol was associated with improved survival compared to traditional multidose protocols., Methods: We conducted a pre-post study across five North Carolina EMS agencies from 11/1/2016 to 10/29/2019. Patients ≥18 years old with attempted resuscitation for non-traumatic prehospital cardiac arrest were included. Data were collected 1 year before and after implementation of the single-dose epinephrine protocol. Prior to implementation, all agencies used a multidose epinephrine protocol. The Cardiac Arrest Registry to Enhance Survival (CARES) was used to obtain patient outcomes. Study outcomes were survival to hospital discharge (primary) and return of spontaneous circulation (ROSC). Analysis was by intention to treat. Outcomes were compared pre- vs. post-implementation using generalized estimating equations to account for clustering within EMS agencies. Adjusted analyses included age, sex, race, shockable vs. non-shockable rhythm, witnessed arrest, automatic external defibrillator availability, EMS response interval, and bystander cardiopulmonary resuscitation., Results: During the study period there were 1,690 encounters (899 pre- and 791 post-implementation). The population was 74.7% white, 61.1% male, and had a median age of 65 (IQR 53-76) years. Survival to hospital discharge was similar pre- vs. post-implementation [13.6% (122/899) vs. 15.4% (122/791); OR 1.19, 95%CI 0.89-1.59]. However, ROSC was more common post-implementation [42.3% (380/899) vs. 32.5% (257/791); OR 0.66, 95%CI 0.54-0.81]. After adjusting for covariates, the single-dose protocol was associated with similar survival to discharge rates (aOR 0.88, 95%CI 0.77-1.29), but with decreased ROSC rates (aOR 0.58, 95%CI 0.47-0.72)., Conclusion: A prehospital single-dose epinephrine protocol was associated with similar survival to hospital discharge, but decreased ROSC rates compared to the traditional multidose epinephrine protocol.

Objective: Delays in care for patients with acute cardiac complaints are associated with increased morbidity and mortality. The objective of this study was to quantify rural and urban differences in prehospital time intervals for patients with cardiac complaints., Methods: The ESO Data Collaborative dataset consisting of records from 1332 EMS agencies was queried for 9-1-1 encounters with acute cardiac problems among adults (age ≥ 18) from 1/1/2013-6/1/2018. Location was classified as rural or urban using the 2010 United States Census. The primary outcome was total prehospital time. Generalized estimating equations evaluated differences in the average times between rural and urban encounters while controlling for age, sex, race, transport mode, loaded mileage, and patient stability., Results: Among 428,054 encounters, the median age was 62 (IQR 50-75) years with 50.7% female, 75.3% white, and 10.3% rural. The median total prehospital, response, scene, and transport times were 37.0 (IQR 29.0-48.0), 6.0 (IQR 4.0-9.0), 16.0 (IQR 12.0-21.0), and 13.0 (IQR 8.0-21.0) minutes. Rural patients had an average total prehospital time that was 16.76 min (95%CI 15.15-18.38) longer than urban patients. After adjusting for covariates, average total time was 5.08 (95%CI 4.37-5.78) minutes longer for rural patients. Average response and transport time were 4.36 (95%CI 3.83-4.89) and 0.62 (95%CI 0.33-0.90) minutes longer for rural patients. Scene time was similar in rural and urban patients (0.09 min, 95%CI -0.15-0.33)., Conclusion: Rural patients with acute cardiac complaints experienced longer prehospital time than urban patients, even after accounting for other key variables, such as loaded mileage., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: European data support the use of low high-sensitivity troponin (hs-cTn) measurements or a 0/1-hour (0/1-h) algorithm for myocardial infarction to exclude major adverse cardiac events (MACEs) among patients in the emergency department with possible acute coronary syndrome. However, modest US data exist to validate these strategies. This study evaluated the diagnostic performance of an initial hs-cTnT measure below the limit of quantification (LOQ: 6 ng/L), a 0/1-h algorithm, and their combination with history, ECG, age, risk factors, and initial troponin (HEART) scores for excluding MACE in a multisite US cohort., Methods: A prospective cohort study was conducted at 8 US sites, enrolling adult patients in the emergency department with symptoms suggestive of acute coronary syndrome and without ST-elevation on ECG. Baseline and 1-hour blood samples were collected, and hs-cTnT (Roche; Basel, Switzerland) was measured. Treating providers blinded to hs-cTnT results prospectively calculated HEART scores. MACE (cardiac death, myocardial infarction, and coronary revascularization) at 30 days was adjudicated. The proportion of patients with initial hs-cTnT measures below the LOQ and risk according to a 0/1-h algorithm was determined. The negative predictive value (NPV) was calculated for both strategies when used alone or with a HEART score., Results: Among 1462 participants with initial hs-cTnT measures, 46.4% (678 of 1462) were women and 37.1% (542 of 1462) were Black with an age of 57.6±12.9 (mean±SD) years. MACEs at 30 days occurred in 14.4% (210 of 1462) of participants. Initial hs-cTnT measures below the LOQ occurred in 32.8% (479 of 1462), yielding an NPV of 98.3% (95% CI, 96.7-99.3) for 30-day MACEs. A low-risk HEART score with an initial hs-cTnT below the LOQ occurred in 20.1% (294 of 1462), yielding an NPV of 99.0% (95% CI, 97.0-99.8) for 30-day MACEs. A 0/1-h algorithm was complete in 1430 patients, ruling out 57.8% (826 of 1430) with an NPV of 97.2% (95% CI, 95.9-98.2) for 30-day MACEs. Adding a low HEART score to the 0/1-h algorithm ruled out 30.8% (441 of 1430) with an NPV of 98.4% (95% CI, 96.8-99.4) for 30-day MACEs., Conclusions: In a prospective multisite US cohort, an initial hs-cTnT below the LOQ combined with a low-risk HEART score has a 99% NPV for 30-day MACEs. The 0/1-h hs-cTnT algorithm did not achieve an NPV >99% for 30-day MACEs when used alone or with a HEART score. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02984436.

Background: The HEART Pathway combines a History ECG Age Risk factor (HEAR) score and serial troponins to risk stratify patients with acute chest pain. However, it is unclear whether patients with HEAR scores of < 1 require troponin testing. The objective of this study is to measure the major adverse cardiac event (MACE) rate among patients with < 1 HEAR scores and determine whether serial troponin testing is needed to achieve a miss rate <1%., Methods: A secondary analysis of the HEART Pathway Implementation Study was conducted. HEART Pathway risk assessments (HEAR scores and serial troponin testing at 0 and 3 hours) were completed by the providers on adult patients with chest pain from three US sites between November 2014 and January 2016. MACE (composite of death, myocardial infarction (MI) and coronary revascularisation) at 30 days was determined. The proportion of patients with HEAR scores of < 1 diagnosed with MACE within 30 days was calculated. The impact of troponin testing on patients with HEAR scores of < 1 was determined using Net Reclassification Improvement Index (NRI)., Results: Providers completed HEAR assessments on 4979 patients and HEAR scores<1 occurred in 9.0% (447/4979) of patients. Among these patients, MACE at 30 days occurred in 0.9% (4/447; 95% CI 0.2% to 2.3%) with two deaths, two MIs and 0 revascularisations. The sensitivity and negative predictive value for MACE in the HEAR < 1 was 97.8% (95%CI 94.5% to 99.4%) and 99.1% (95% CI 97.7% to 99.8%), respectively, and were not improved by troponin testing. Troponin testing in patients with HEAR < 1 correctly reclassified two patients diagnosed with MACE, and was elevated among seven patients without MACE yielding an NRI of 0.9% (95%CI -0.7 to 2.4%)., Conclusion: These data suggest that patients with HEAR scores of 0 and 1 represent a very low-risk group that may not require troponin testing to achieve a missed MACE rate <1%. Trial registration number NCT02056964., Competing Interests: Competing interests: SAM receives research funding from Roche Diagnostics, Abbott Point of Care, Ortho Clinical Diagnostics, Creavo Medical Technologies, PCORI, AHRQ and NHLBI (1 R01 HL11826301). He is a consultant for Roche Diagnostics and Amgen. SAM is the chief medical officer for Impathiq. JPS receives research funding from Roche Diagnostics and Abbott Point of Care. LS receives research funding from Forest Devices and the NHLBI (1 R01 HL144624-01). CDM receives research funding from Abbott, Siemens, NHLBI 118263, Creavo Medical Technologies., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The HEART Pathway is an evidence-based decision tool for identifying emergency department (ED) patients with acute chest pain who are candidates for early discharge, to reduce unhelpful and potentially harmful hospitalizations. Guided by the Consolidated Framework for Implementation Research, we sought to identify important barriers and facilitators to implementation of the HEART Pathway., Study Setting: Data were collected at 4 academic medical centers., Study Design: We conducted semi-structured interviews with 25 key stakeholders (e.g., health system leaders, ED physicians). We conducted interviews before implementation of the HEART Pathway tool to identify potential barriers and facilitators to successful adoption at other regional academic medical centers. We also conducted postimplementation interviews at 1 medical center, to understand factors that contributed to successful adoption., Data Collection: Interviews were recorded and transcribed verbatim. We used a Consolidated Framework for Implementation Research framework-driven deductive approach for coding and analysis., Principal Findings: Potential barriers to implementation include time and resource burden, challenges specific to the electronic health record, sustained communication with and engagement of stakeholders, and patient concerns. Facilitators to implementation include strength of evidence for reduced length of stay and unnecessary testing and iatrogenic complications, ease of use, and supportive provider climate for evidence-based decision tools., Conclusions: Successful dissemination of the HEART Pathway will require addressing institution-specific barriers, which includes engaging clinical and financial stakeholders. New SMART-FHIR technologies, compatible with many electronic health record systems, can overcome barriers to health systems with limited information technology resources.

Background: The Emergency Department Assessment of Chest pain Score-Accelerated Diagnostic Protocol (EDACS-ADP) is a decision aid designed to safely identify emergency department (ED) patients with chest pain for early discharge. Derivation and validation studies in Australasia have demonstrated high sensitivity (99%-100%) for major adverse cardiac events (MACE)., Objectives: To validate the EDACS-ADP in a cohort of US ED patients with symptoms suspicious for acute coronary syndrome (ACS)., Methods: A secondary analysis of participants enrolled in the HEART Pathway Randomized Controlled Trial was conducted. This single-site trial enrolled 282 ED patients≥21 years old with symptoms concerning for ACS, inclusive of all cardiac risk levels. Each patient was classified as low risk or at risk by the EDACS-ADP based on EDACS, electrocardiogram, and serial troponins. Potential early discharge rate and sensitivity for MACE at 30 days, defined as cardiac death, myocardial infarction (MI), or coronary revascularization were calculated., Results: MACE occurred in 17/282 (6.0%) participants, including no deaths, 16/282 (5.6%) with MI, and 1/282 (0.4%) with coronary revascularization without MI. The EDACS-ADP identified 188/282 patients [66.7%, 95% confidence interval (CI): 60.8%-72.1%] as low risk. Of these, 2/188 (1.1%, 95% CI: 0.1%-3.9%) had MACE at 30 days. EDACS-ADP was 88.2% (95% CI: 63.6%-98.5%) sensitive for MACE, identifying 15/17 patients. Of the 2 patients identified as low risk with MACE, 1 had MI and 1 had coronary revascularization without MI., Conclusions: Within a US cohort of ED patients with symptoms concerning for ACS, sensitivity for MACE was 88.2%. We are unable to validate the EDACS-ADP as sufficiently sensitive for clinical use.

The primary development of moricizine as an antiarrhythmic agent has occurred in the Soviet Union and the United States. The data in this presentation are based on the 1,844 subjects/patients (1,817 adults and 27 pediatric patients) who participated in 34 controlled studies and 3 uncontrolled compassionate-use programs conducted in the United States. Of the 1,817 adults, 443 received only placebo or comparative agents and 1,374 received moricizine in daily doses of 50 to 1,800 mg. A total of 1,190 adult patients (mean age 59 years) had ventricular arrhythmias classified as either benign (8%), potentially lethal (58%) or lethal (33%). Most patients had a history of greater than or equal to 1 cardiovascular disease, including coronary artery disease, previous myocardial infarction and congestive heart failure. Antiarrhythmic activity was assessed by four methods: 24-hour ambulatory electrocardiographic monitoring, programmed electrical stimulation, exercise tolerance tests, and global evaluation (only for some patients in the compassionate-use program). In addition, the effects of moricizine on symptoms associated with ventricular arrhythmias were assessed. The safety variables evaluated included adverse experiences, proarrhythmia, congestive heart failure, other cardiovascular effects, death, chest x-ray, ophthalmic examinations, neuroleptic phenothiazine effects and clinical laboratory tests.