Four strategies for very early rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I (hs-cTnI) have been identified. It remains unclear which strategy is most attractive ...for clinical application.
We prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction. The final diagnosis was adjudicated by 2 independent cardiologists. Hs-cTnI levels were measured at presentation and after 1 hour in a blinded fashion. We directly compared all 4 hs-cTnI-based rule-out strategies: limit of detection (LOD, hs-cTnI<2 ng/L), single cutoff (hs-cTnI<5 ng/L), 1-hour algorithm (hs-cTnI<5 ng/L and 1-hour change<2 ng/L), and the 0/1-hour algorithm recommended in the European Society of Cardiology guideline combining LOD and 1-hour algorithm.
Among 2828 enrolled patients, acute myocardial infarction was the final diagnosis in 451 (16%) patients. The LOD approach ruled out 453 patients (16%) with a sensitivity of 100% (95% confidence interval CI, 99.2%-100%), the single cutoff 1516 patients (54%) with a sensitivity of 97.1% (95% CI, 95.1%-98.3%), the 1-hour algorithm 1459 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%), and the 0/1-hour algorithm 1463 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%). Predefined subgroup analysis in early presenters (≤2 hours) revealed significantly lower sensitivity (94.2%, interaction
=0.03) of the single cutoff, but not the other strategies. Two-year survival was 100% with LOD and 98.1% with the other strategies (
<0.01 for LOD versus each of the other strategies).
All 4 rule-out strategies balance effectiveness and safety equally well. The single cutoff should not be applied in early presenters, whereas the 3 other strategies seem to perform well in this challenging subgroup.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
Uncertainties regarding the most appropriate definition and treatment of type 2 myocardial infarction (T2MI) due to supply-demand mismatch have contributed to inconsistent adoption in clinical ...practice.
This study sought a better understanding of the effect of the definition of T2MI on its incidence, treatment, and event-related mortality, thereby addressing an important unmet clinical need.
The final diagnosis was adjudicated in patients presenting with symptoms suggestive of myocardial infarction by 2 independent cardiologists by 2 methods: 1 method required the presence of coronary artery disease, a common interpretation of the 2007 universal definition (T2MI2007); and 1 method did not require coronary artery disease, the 2012 universal definition (T2MI2012).
Overall, 4,015 consecutive patients were adjudicated. The incidence of T2MI based on the T2MI2007 definition was 2.8% (n = 112). The application of the more liberal T2MI2012 definition resulted in an increase of T2MI incidence of 6% (n = 240), a relative increase of 114% (128 reclassified patients, defined as T2MI2012reclassified). Among T2MI2007, 6.3% of patients received coronary revascularization, 22% dual-antiplatelet therapy, and 71% high-dose statin therapy versus 0.8%, 1.6%, and 31% among T2MI2012reclassified patients, respectively (all p < 0.01). Cardiovascular mortality at 90 days was 0% among T2MI2012reclassified, which was similar to patients with noncardiac causes of chest discomfort (0.2%), and lower than T2MI2007 (3.6%) and type 1 myocardial infarction (T1MI) (4.8%) (T2MI2012reclassified vs. T2MI2007 and T1MI: p = 0.03 and 0.01, respectively).
T2MI2012reclassified has a substantially lower event-related mortality rate compared with T2MI2007 and T1MI. (Advantageous Predictors of Acute Coronary Syndromes Evaluation APACE Study; NCT00470587)
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Background: Access to mental health services remains a challenge in many countries including Iraq, where mental illness is often stigmatized and marginalized. This can lead to negative outcomes such ...as decreased quality of life and increased morbidity and mortality.
Objectives: The present study aimed to explore the perceptions of general population in Iraq towards mental health services and identify the challenges facing patient access to these services. Methods: This qualitative study included face-to-face semi-structured interviews with general population in primary health care centers and private pharmacies in Baghdad between (December 2022 through February 2023). Thematic analysis was used to identify recurring themes and sub-themes. Results: Thirty participants were recruited in this study. The study found that the general population in Iraq have negative perceptions towards mental health services. The repeated themes were "public social stigma," "lack of privacy in public healthcare settings," and "lack of psychotherapy sessions in mental health services." The social stigma" was further divided into sub-themes including stigma from family, friends, or co-workers. Lack of privacy indicated there are too many interruptions in the environment of public healthcare settings. Lack of non-pharmacological therapy in mental health services, was expressed as a feeling that only medication therapy was offered, while psychotherapy was not available. Conclusion: The findings suggest that a cultural awareness is needed to reduce the social stigma associated with mental illness and to increase trust in the public mental health services. The results also highlighted the need for improved privacy and culturally-sensitive mental health services. To improve access to mental health services, it is crucial that healthcare providers, social workers, and society work together to promote and destigmatize mental illness.
Abstract Objectives The study sought to identify predictors for delayed high-degree atrioventricular block (AVB) in patients undergoing transcatheter aortic valve replacement (TAVR) and determine the ...need and required duration of telemetry monitoring. Background Little is known about predictors and timing of high-degree AVB. Methods A total of 1,064 patients (52% women) without a permanent pacemaker undergoing TAVR at 3 centers in Switzerland were investigated. Electrocardiograms (ECGs) at baseline and post-TAVR were analyzed to identify atrioventricular and interventricular conduction disorders. Results Periprocedural high-degree AVB occurred in 92 (8.7%), delayed high-degree AVB in 71 (6.7%), up to 8 days post-procedure. In multivariate analysis, delayed high-degree AVB occurred more frequently in men (odds ratio: 2.4, 95% confidence interval: 1.3 to 4.5; p < 0.01), and in patients with conduction disorders post-TAVR (odds ratio: 10.8; 95% confidence interval: 4.6 to 25.5; p < 0.01). Patients in sinus rhythm without conduction disorders post-TAVR did not develop delayed high-degree AVB (0 of 250, 0%). Similarly, the risk in patients with atrial fibrillation but no other conduction disorders was very low (1 of 102, 1%). There was no patient developing delayed high-degree AVB who had a stable ECG for 2 days or more. Conclusion Patients without conduction disorders post-TAVR did not develop delayed high-degree AVB. Such patients may not require telemetry monitoring. All other patients should be monitored until the ECG remains stable for at least 2 days. This algorithm should be validated in a separate patient population.
Abstract Objective The novel high-sensitivity cardiac troponin (hs-cTn) 0 h/1 h-algorithm substantially improves the early triage of patient's assigned “rule-out” or “rule-in” of acute myocardial ...infarction (AMI), while diagnostic uncertainty remains in that 25–30% of patients assigned to “observe”. We aimed to better characterize these patients. Methods In a prospective multicenter diagnostic study, we applied the hs-cTnT 0 h/1 h-algorithm in 2213 unselected patients presenting with symptoms suggestive of AMI to the emergency department. The final diagnosis was adjudicated by two independent cardiologists using all available information. Survival at 720-days was the prognostic endpoint. Findings were validated using a hs-cTnI 0 h/1 h-algorithm. Results Twenty-four percent (n = 523) of patients were assigned to “observe” by the hs-cTnT 0 h/1 h-algorithm. These patients differed significantly in multiple characteristics from “rule-out” and “rule-in” patients: they were older, in 75% male, and very often (57%) had pre-existing coronary artery disease (CAD). Diagnostic uncertainty for the presence of an AMI/UA was high. Only 39% of patients were suitable for coronary computed tomography angiography (CCTA). The most common final adjudicated diagnoses were non-cardiac disease (38%), non-coronary cardiac disease (24%), unstable angina (UA, 21%), and AMI (15%). Absolute hs-cTnT-changes within 3 h had the highest diagnostic accuracy for AMI (AUC 0.86). Cumulative 720-day survival rate was 86%, which was significantly lower as compared to “rule-out” (p < 0.001) and comparable to “rule-in” (p = ns). Findings were similar for the hs-cTnI “observe” zone. Conclusion “Observe” patients are typically elderly men with pre-existing CAD and high long-term mortality. Absolute hs-cTn-changes within 3 h, functional stress imaging and coronary angiography are the key diagnostic modalities.
The clinical utility of procalcitonin in the diagnosis and management of pneumonia remains controversial.
We assessed the clinical utility of procalcitonin in 2 prospective studies: first, a ...multicenter diagnostic study in patients presenting to the emergency department with acute dyspnea to directly compare the diagnostic accuracy of procalcitonin with that of interleukin 6 and C-reactive protein (CRP) in the diagnosis of pneumonia; second, a randomized management study of procalcitonin guidance in patients with acute heart failure and suspected pneumonia. Diagnostic accuracy for pneumonia as centrally adjudicated by 2 independent experts was quantified with the area under the ROC curve (AUC).
Among 690 patients in the diagnostic study, 178 (25.8%) had an adjudicated final diagnosis of pneumonia. Procalcitonin, interleukin 6, and CRP were significantly higher in patients with pneumonia than in those without. When compared to procalcitonin (AUC = 0.75; 95% CI, 0.71-0.78), interleukin 6 (AUC = 0.80; 95% CI, 0.77-0.83) and CRP (AUC = 0.82; 95% CI, 0.79-0.85) had significantly higher diagnostic accuracy (
= 0.010 and
< 0.001, respectively). The management study was stopped early owing to the unexpectedly low AUC of procalcitonin in the diagnostic study. Among 45 randomized patients, the number of days on antibiotic therapy and the length of hospital stay were similar (both
= 0.39) in patients randomized to the procalcitonin-guided group (n = 25) and usual-care group (n = 20).
In patients presenting with dyspnea, diagnostic accuracy of procalcitonin for pneumonia is only moderate and lower than that of interleukin 6 and CRP. The clinical utility of procalcitonin was lower than expected.
Pneumonia has diverse and often unspecific symptoms. As the role of biomarkers in the diagnosis of pneumonia remains controversial, it is often difficult to distinguish pneumonia from other illnesses causing shortness of breath. The current study prospectively enrolled unselected patients presenting with acute dyspnea and directly compared the diagnostic accuracy of procalcitonin, interleukin 6, and CRP for the diagnosis of pneumonia. In this setting, diagnostic accuracy of procalcitonin for pneumonia was lower as compared to interleukin 6 and CRP. The clinical utility of procalcitonin was lower than expected.
NCT01831115.
Abstract Background The early and accurate diagnosis of AMI is an important medical and economic challenge. We aimed to prospectively evaluate the performance of the new ESC rapid 0 h/3 h-rule-out ...protocol for AMI. Methods We enrolled 2727 consecutive patients presenting with suspected AMI without persistent ST-segment elevation to the emergency department in a prospective international multicenter study. The final diagnosis was adjudicated by two independent cardiologists. The performance of the 0 h/3 h-rule-out protocol was evaluated using four high-sensitivity (primary analysis) and three sensitive cardiac troponin (cTn) assays). Results AMI was the final diagnosis in 473 patients (17.3%). Using the four high-sensitivity cTn assays, the 0 h-rule-out protocol correctly ruled-out 99.8% (95%CI, 98.7–100%), 99.6% (95%CI, 98.5–99.9%), 100% (95%CI, 97.9–100%) and 100% (95%CI, 98.0–100%) of late presenters (>6 h from chest pain onset). The 3 h-rule-out protocol correctly ruled-out 99.9% (95%CI, 99.1–100%), 99.5% (95%CI, 98.3–99.9%), 100% (95%CI, 98.1–100%) and 100% (95%CI, 98.2–100%) of early presenters (<6 h from chest pain onset). Using the three sensitive cTn assays, the 0 h-rule-out protocol correctly ruled-out 99.6% (95%CI, 98.6–99.9%), 99.0% (95%CI, 96.9–99.7%) and 99.1% (95%CI, 97.2–99.8%) of late presenters, and the 3 h-rule-out protocol correctly ruled-out 99.4% (95%CI, 98.3–99.8%), 99.2% (95%CI, 97.3–99.8%) and 99.0% (95%CI, 97.2–99.7%) of early presenters. Overall, the 0 h/3 h-rule-out protocol assigned 40–60% of patients to rule-out. None of the patients assigned rule-out died during 3-months follow-up. Conclusions The 0 h/3 h-rule-out protocol seems to allow the accurate rule-out of AMI using both high-sensitivity and sensitive cTn measurements in conjunction with clinical assessment. Additional studies are warranted for external validation.
Abstract Objectives The aim of this study was to perform a meta-analysis of currently available data regarding the prognostic significance of soluble suppression of tumorigenecity–2 (sST2) ...concentration in acute heart failure (AHF). Background Concentration of sST2 may have prognostic value in AHF. A comprehensive assessment of all available studies regarding sST2 in AHF is lacking. Methods Three databases (MEDLINE, Cochrane Library, and Scopus) were searched. Inclusion criteria were follow-up studies, papers published in English, enrollment of patients with AHF, and availability of median hazard ratios for all-cause death and other outcome measures, when available. Results Ten studies were included, with a global population of 4,835 patients and a median follow-up duration of 13.5 months. The following global hazard ratios calculated for log2 (sST2) were admission sST2 and all-cause death, 2.46 (95% confidence interval CI: 1.80 to 3.37; p < 0.001); discharge sST2 and all-cause death, 2.06 (95% CI: 1.37 to 3.11; p < 0.001); admission sST2 and cardiovascular death, 2.29 (95% CI: 1.41 to 3.73; p < 0.001); discharge sST2 and cardiovascular death, 2.20 (95% CI: 1.48 to 3.25; p < 0.001); admission sST2 and heart failure (HF) hospitalization, 1.21 (95% CI: 0.96 to 1.52; p = 0.060); discharge sST2 and HF hospitalization, 1.54 (95% CI: 1.03 to 2.32; p = 0.007); admission sST2 and all-cause death or HF hospitalization, 1.74 (95% CI: 1.24 to 2.45; p < 0.001); and discharge sST2 and all-cause death or HF hospitalization, 1.63 (95% CI: 1.14 to 2.33; p < 0.001). Conclusions Plasma sST2 has prognostic value with respect to all-cause and cardiovascular death as well as the composite outcome of all-cause death or HF hospitalization, with both admission and discharge values having prognostic efficacy. Discharge sST2, but not admission sST2, is predictive of HF rehospitalization during follow-up.
We compared 2 high-sensitivity cardiac troponin (hs-cTn)-based 2-h strategies in patients presenting with suspected acute myocardial infarction (AMI) to the emergency department (ED): the 2-h ...accelerated diagnostic protocol (2h-ADP) combining hs-cTn, electrocardiogram, and a risk score, and the 2-h algorithm exclusively based on hs-cTn concentrations and their absolute changes.
Analyses were performed in 2 independent diagnostic cohorts European Advantageous Predictors of Acute Coronary Syndrome Evaluation (APACE) study, Australian-New Zealand 2-h Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker (ADAPT) study employing hs-cTnT (Elecsys) and hs-cTnI (Architect). The final diagnosis was adjudicated by 2 independent cardiologists.
AMI was the final diagnosis in 16.5% (95% CI, 14.6%-18.6%) of the 1372 patients in APACE, and 12.6% (95% CI, 10.7%-14.7%) of 1153 patients in ADAPT. The negative predictive value (NPV) and sensitivity for AMI were very high and comparable with both strategies using either hs-cTnT or hs-cTnI in both cohorts (all statistical comparisons nonsignificant). The percentage of patients triaged toward rule-out was significantly lower with the 2h-ADP (36%-43%) vs the 2-h algorithm (55%-68%) with both assays and in both cohorts (
< 0.001). The sensitivity of the 2h-ADP was higher for 30-day major adverse cardiovascular events.
Both algorithms provided very high and comparable safety as quantified by the NPV and sensitivity for AMI and major adverse cardiac events (MACE) at 30 days in patients triaged toward rule-out, although sensitivity for MACE at 30 days was lower with both algorithms in cohort 2. Although the 2-h algorithm was more efficacious, not all patients ruled out for AMI by this algorithm were appropriate candidates for early discharge. The 2h-ADP seems superior in the selection of patients for early discharge from the ED.
APACE: http://clinicaltrials.gov/show/NCT00470587ADAPT: Australia-New Zealand Clinical Trials Registry ACTRN12611001069943.
To derive and validate a hybrid algorithm for rule-out and rule-in of acute myocardial infarction based on measurements at presentation and after 2 hours with a novel cardiac troponin I (cTnI) assay.
...The algorithm was derived and validated in two cohorts (605 and 592 patients) from multicentre studies enrolling chest pain patients presenting to the emergency department (ED) with onset of last episode within 12 hours. The index diagnosis and cardiovascular events up to 30 days were adjudicated by independent reviewers.
In the validation cohort, 32.6% of the patients were ruled out on ED presentation, 6.1% were ruled in and 61.3% remained undetermined. A further 22% could be ruled out and 9.8% ruled in, after 2 hours. In total, 54.6% of the patients were ruled out with a negative predictive value (NPV) of 99.4% (95% CI 97.8% to 99.9%) and a sensitivity of 97.7% (95% CI 91.9% to 99.7%); 15.8% were ruled in with a positive predictive value (PPV) of 74.5% (95% CI 64.8% to 82.2%) and a specificity of 95.2% (95% CI 93.0% to 96.9%); and 29.6% remained undetermined after 2 hours. No patient in the rule-out group died during the 30-day follow-up in the two cohorts.
This novel two-step algorithm based on cTnI measurements enabled just over a third of the patients with acute chest pain to be ruled in or ruled out already at presentation and an additional third after 2 hours. This strategy maximises the speed of rule-out and rule-in while maintaining a high NPV and PPV, respectively.
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