RESUMO
BACKGROUND: The European Society of Cardiology (ESC) 0/1-h high sensitivity troponin T (hs-cTnT) algorithm does not differentiate risk based on known coronary artery disease (CAD: prior myocardial infarction [MI], coronary revascularization, or ≥ 70% coronary stenosis). We recently evaluated its performance among patients with known CAD at 30-days, but little is known about its longer-term risk prediction. The objective of this study is to determine and compare the performance of the algorithm at 90-days among patients with and without known CAD. METHODS: We performed a pre-planned subgroup analysis of the STOP-CP cohort, which prospectively enrolled ED patients ≥21 years old with symptoms suggestive of ACS without ST-elevation on initial ECG across 8 US sites (1/25/2017-9/6/2018). Participants with 0- and 1-h hs-cTnT measures (Roche, Basel, Switzerland) were stratified into rule-out, observe, and rule-in groups using the ESC 0/1-h algorithm. Algorithm performance was tested among patients with or without known CAD, as determined by the treating provider. The primary outcome was cardiac death or MI at 90-days. Fisher's exact tests were used to compare 90-day event and rule-out rates between patients with and without known CAD. Negative predictive values (NPVs) for 90-day cardiac death or MI with exact 95% confidence intervals were calculated and compared using Fisher's exact test. RESULTS: The STOP-CP study accrued 1430 patients, of which 31.4% (449/1430) had known CAD. Cardiac death or MI at 90 days was more common in patients with known CAD than in those without [21.2% (95/449) vs. 10.0% (98/981); p < 0.001]. Using the ESC 0/1-h algorithm, 39.6% (178/449) of patients with known CAD and 66.1% (648/981) of patients without known CAD were ruled-out (p < 0.001). Among rule-out patients, 90-day cardiac death or MI occurred in 3.4% (6/178) of patients with known CAD and 1.2% (8/648) without known CAD (p = 0.09). NPV for 90-day cardiac death or MI was 96.6% (95%CI 92.8-98.8) among patients with known CAD and 98.8% (95%CI 97.6-99.5) in patients without known CAD (p = 0.09). CONCLUSION: Patients with known CAD who were ruled-out using the ESC 0/1-h hs-cTnT algorithm had a high rate of missed 90-day cardiac events, suggesting that the ESC 0/1-h hs-cTnT algorithm may not be safe for use among patients with known CAD. TRIAL REGISTRATION: High-Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP-CP; ClinicalTrials.gov: NCT02984436; https://clinicaltrials.gov/ct2/show/NCT02984436).
Assuntos
Cardiologia , Doença da Artéria Coronariana , Humanos , Adulto Jovem , Adulto , Troponina T , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico , Estudos Prospectivos , Algoritmos , Morte , BiomarcadoresRESUMO
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.
Assuntos
Serviço Hospitalar de Emergência , Hospitalização , Humanos , Masculino , Feminino , Estudos Prospectivos , Estados Unidos/epidemiologia , Hospitalização/estatística & dados numéricos , Pessoa de Meia-Idade , Fatores Sexuais , Idoso , Serviço Hospitalar de Emergência/estatística & dados numéricos , Medição de Risco/métodos , Biomarcadores/sangue , Dor no Peito/etiologia , Infarto do Miocárdio/epidemiologia , Fatores de Risco , Fatores Raciais , Fatores de Tempo , Procedimentos ClínicosRESUMO
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.
Assuntos
Síndrome Coronariana Aguda , Cardiologia , Infarto do Miocárdio , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Síndrome Coronariana Aguda/complicações , Dor no Peito/diagnóstico , Dor no Peito/etiologia , Consenso , Serviço Hospitalar de Emergência , Infarto do Miocárdio/complicações , Estudos Prospectivos , Estados Unidos/epidemiologia , IdosoRESUMO
Background: Nipple-sparing mastectomy (NSM) preserves the natural nipple-areola complex and entire native breast skin, with the goal of better cosmetic outcomes in breast reconstruction. In bilateral TE/implant-based reconstruction requiring unilateral postmastectomy radiotherapy (PMRT), progressive radiation-induced fibrosis can lead to increasing nipple asymmetry with cosmetic dissatisfaction. Thus, PMRT may ultimately negate the intended positive cosmetic value of NSM compared with skin-sparing mastectomy (SSM). This study compares (1) surgical complications, (2) patient satisfaction, and (3) aesthetic outcomes between NSM versus SSM in bilateral implant-based reconstruction with unilateral PMRT. Methods: This retrospective matched cohort study included consecutive NSM patients with bilateral TE/implant breast reconstruction + unilateral PMRT matched 1:2 to SSM group. Patients completed PMRT and TE exchange to implants. Demographics, oncologic stage, comorbidities, and complications were collected. Patient satisfaction was evaluated by BREAST-Q. Aesthetic outcomes were assessed by blinded reviewers with a five-point Likert scale. Results: Among 58 patients who underwent bilateral TE/implant reconstruction with unilateral PMRT, 17 NSM patients were matched to 41 SSM patients by age, body mass index, and comorbidities. No significant differences existed in overall surgical complications and individual BREAST-Q questionnaire scores between cohorts. However, aesthetic outcomes scores were higher in SSM compared with NSM. Conclusions: Although NSM is generally associated with superior cosmetic outcomes compared with SSM, it has far less impact in bilateral implant-based breast reconstruction with unilateral PMRT due to the negative postradiotherapy effect on nipple symmetry.
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BACKGROUND: Data comparing the performance of sex-specific to overall (non-sex-specific) high-sensitivity cardiac troponin (hs-cTn) cut-points for diagnosing acute coronary syndrome (ACS) are limited. This study aims to compare the safety and efficacy of sex-specific versus overall 99th percentile high-sensitivity cardiac troponin T (hs-cTnT) cut-points. METHODS: We conducted a secondary analysis of the STOP-CP cohort, which prospectively enrolled emergency department patients ≥ 21 years old with symptoms suggestive of ACS without ST-elevation on initial electrocardiogram across eight U.S. sites (January 25, 2017-September 6, 2018). Participants with both 0- and 1-h hs-cTnT measures less than or equal to the 99th percentile (sex-specific 22 ng/L for males, 14 ng/L for females; overall 19 ng/L) were classified into the rule-out group. The safety outcome was adjudicated cardiac death or myocardial infarction (MI) at 30 days. Efficacy was defined as the proportion classified to the rule-out group. McNemar's test and a generalized score statistic were used to compare rule-out and 30-day cardiac death or MI rates between strategies. Net reclassification improvement (NRI) index was used to further compare performance. RESULTS: This analysis included 1430 patients, of whom 45.8% (655/1430) were female; the mean ± SD age was 57.6 ± 12.8 years. At 30 days, cardiac death or MI occurred in 12.8% (183/1430). The rule-out rate was lower using sex-specific versus overall cut-points (70.6% [1010/1430] vs. 72.5% [1037/1430]; p = 0.003). Among rule-out patients, the 30-day cardiac death or MI rates were similar for sex-specific (2.4% [24/1010]) vs. overall (2.3% [24/1037]) strategies (p = 0.79). Among patients with cardiac death or MI, sex-specific versus overall cut-points correctly reclassified three females and incorrectly reclassified three males. The sex-specific strategy resulted in a net of 27 patients being incorrectly reclassified into the rule-in group. This led to an NRI of -2.2% (95% CI -5.1% to 0.8%). CONCLUSIONS: Sex-specific hs-cTnT cut-points resulted in fewer patients being ruled out without an improvement in safety compared to the overall cut-point strategy.
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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.