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1.
Europace ; 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33038231

RESUMO

AIMS : The aim of this study is to characterize recurrent syncope, including sex-specific aspects, and its impact on death and major adverse cardiovascular events (MACE). METHODS AND RESULTS: We characterized recurrent syncope in a large international multicentre study, enrolling patients ≥40 years presenting to the emergency department (ED) with a syncopal event within the last 12 h. Syncope aetiology was centrally adjudicated by two independent cardiologists using all information becoming available during syncope work-up and long-term follow-up. Overall, 1790 patients were eligible for this analysis. Incidence of recurrent syncope was 20% [95% confidence interval (CI) 18-22%] within the first 24 months. Patients with an adjudicated final diagnosis of cardiac syncope (hazard ratio (HR) 1.50, 95% CI 1.11-2.01) or syncope with an unknown aetiology even after central adjudication (HR 2.11, 95% CI 1.54-2.89) had an increased risk for syncope recurrence. Least Absolute Shrinkage and Selection Operator regression fit on all patient information available early in the ED identified >3 previous episodes of syncope as the only independent predictor for recurrent syncope (HR 2.13, 95% CI 1.64-2.75). Recurrent syncope carried an increased risk for death (HR 1.87, 95% CI 1.26-2.77) and MACE (HR 2.69, 95% CI 2.02-3.59) over 24 months of follow-up, however, with a time-dependent effect. These findings were confirmed in a sensitivity analysis excluding patients with syncope recurrence or MACE before or during ED evaluation. CONCLUSION : Recurrence rates of syncope are substantial and vary depending on syncope aetiology. Importantly, recurrent syncope carries a time-dependent increased risk for death and MACE. TRIAL REGISTRATION: BAsel Syncope EvaLuation (BASEL IX, ClinicalTrials.gov registry number NCT01548352).

3.
Swiss Med Wkly ; 150: w20320, 2020 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-32835386

RESUMO

Acute heart failure (AHF) is a complex and heterogeneous syndrome not only associated with a concerning rise in incidence, but also with still unacceptably high rates of mortality and morbidity. As this dismal outcome is at least in part due to a mismatch between the severity of AHF and the intensity of its management, both in-hospital and immediately after discharge, early and accurate risk prediction could contribute to more effective, risk-adjusted management. Biomarkers are noninvasive and highly reproducible quantitative tools that have improved the understanding of AHF pathophysiology. They can help guide the intensity of AHF management. In addition, using a statistical model to estimate risk from a combination of several predictor variables such as vital signs or demographics has gained more and more attention over recent years. In this context, the aim of a statistical model, which gives a so-called risk score, is to help clinicians to make more standardised decisions. This review highlights recent advances and remaining uncertainties regarding risk stratification in AHF by characterising and comparing the potential of biomarkers and risk scores.  .

4.
ESC Heart Fail ; 7(5): 3219-3224, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32578962

RESUMO

AIMS: Acute kidney injury (AKI) during acute heart failure (AHF) is common and associated with increased morbidity and mortality. The underlying pathophysiological mechanism appears to have prognostic relevance; however, the differentiation of true, structural AKI from hemodynamic pseudo-AKI remains a clinical challenge. METHODS AND RESULTS: The Basics in Acute Shortness of Breath Evaluation Study (NCT01831115) prospectively enrolled adult patients presenting with AHF to the emergency department. Mortality of patients was prospectively assessed. Haemoconcentration, transglomerular pressure gradient (n = 231) and tubular injury patterns (n = 253) were evaluated to investigate pathophysiological mechanisms underlying AKI timing (existing at presentation vs. developing during in-hospital period). Of 1643 AHF patients, 755 patients (46%) experienced an episode of AKI; 310 patients (19%; 41% of AKI patients) presented with community-acquired AKI (CA-AKI), 445 patients (27%; 59% of AKI patients) developed in-hospital AKI. CA-AKI but not in-hospital AKI was associated with higher mortality compared with no-AKI (adjusted hazard ratio 1.32 [95%-CI 1.01-1.74]; P = 0.04). Independent of AKI timing, haemoconcentration was associated with a lower two-year mortality. Transglomerular pressure gradient at presentation was significantly lower in CA-AKI compared to in-hospital AKI and no-AKI (P < 0.01). Urinary NGAL ratio concentrations were significantly higher in CA-AKI compared to in-hospital AKI (P < 0.01) or no-AKI (P < 0.01). CONCLUSIONS: CA-AKI but not in-hospital AKI is associated with increased long-term mortality and marked by decreased transglomerular pressure gradient and tubular injury, probably reflecting prolonged tubular ischemia due to reno-venous congestion. Adequate decongestion, as assessed by haemoconcentration, is associated with lower long-term mortality independent of AKI timing.

5.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32451223

RESUMO

INTRODUCTION AND OBJECTIVES: Release kinetics of high-sensitivity cardiac troponin (hs-cTn) T and I in patients with acute myocardial infarction (AMI) are incompletely understood. We aimed to assess whether hs-cTnT/I release in early AMI is near linear. METHODS: In a prospective diagnostic multicenter study the acute release of hs-cTnT and hs-cTnI within 1 and 2hours from presentation to the emergency department was quantified using 3 hs-cTnT/I assays in patients with suspected AMI. The primary endpoint was correlation between hs-cTn changes from presentation to 1 hour vs changes from presentation to 2hours, among all AMI patients and different prespecified subgroups. The final diagnosis was adjudicated by 2 independent cardiologists, based on serial hs-cTnT from the serial study blood samples and additional locally measured hs-cTn values. RESULTS: Among 2437 patients with complete hs-cTnT data, AMI was the adjudicated diagnosis in 376 patients (15%). For hs-cTnT, the correlation coefficient between 0- to 1-hour change and 0- to 2 hour change was 0.931 (95%CI, 0.916-0.944), P <.001. Similar findings were obtained with hs-cTnI (Architect) with correlation coefficients between 0- to 1-hour change and 0- to 2 hour change of 0.969 and hs-cTnI (Centaur) of 0.934 (P <.001 for both). Findings were consistent among type 1 and type 2 AMI and in the subgroup of patients presenting very early after chest pain onset. CONCLUSIONS: Patients presenting with early AMI showed a near linear release of hs-cTnT and hs-cTnI. This near linearity provides the pathophysiological basis for rapid diagnostic algorithms using 0- to 1-hour changes as surrogates for 0- to 2 hour or 0- to 3 hour changes. Registered at ClinicalTrials.gov (Identifier: NCT00470587).

6.
ESC Heart Fail ; 7(4): 1817-1829, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32452635

RESUMO

AIMS: The aim of this study was to investigate the diagnostic and prognostic utility of the QRS-T angle, an electrocardiogram (ECG) marker quantifying depolarization-repolarization heterogeneity, in patients with suspected acute decompensated heart failure (ADHF). METHODS AND RESULTS: We prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of ADHF. The QRS-T angle was automatically derived from a standard 12-lead ECG recorded at presentation. The primary diagnostic endpoint was a final adjudicated diagnosis of ADHF. The primary prognostic endpoint was all-cause mortality during 2 years of follow-up. Among the 1915 patients enrolled, those with higher QRS-T angles were older, were more commonly male, and had a higher rate of co-morbidities such as arterial hypertension, coronary artery disease, or chronic kidney disease. ADHF was the final adjudicated diagnosis in 1140 (60%) patients. The QRS-T angle in patients with ADHF was significantly larger than in patients with non-cardiac causes of dyspnoea {median 110° [inter-quartile range (IQR) 46-156°] vs. median 33° [IQR 15-57°], P < 0.001}. The diagnostic accuracy of the QRS-T angle as quantified by the area under the receiver operating characteristic curve (AUC) was 0.75 [95% confidence interval (CI) 0.73-0.77, P < 0.001], which was inferior to N-terminal pro-B-type natriuretic peptide (AUC 0.93, 95% CI 0.92-0.94, P < 0.001), but similar to that of high-sensitivity troponin T (AUC 0.78, 95% CI 0.76-0.80, P = 0.09). The AUC of the QRS-T angle for discrimination between ADHF and non-cardiac dyspnoea remained similarly high in subgroups of patients known to be diagnostically challenging, including patients older than 75 years [0.71 (95% CI 0.67-0.74)], renal failure [0.79 (95% CI 0.71-0.87)], and atrial fibrillation at presentation [0.68 (95% CI 0.60-0.76)]. Mortality rates according to QRS-T angle tertiles were 4%, 6%, and 10% after 30 days (P < 0.001) and 24%, 31%, and 43% after 2 years (P < 0.001). After adjustment for clinical, laboratory, and ECG parameters, the QRS-T angle remained an independent predictor for 2 year mortality with a 4% increase in mortality for every 20° increase in QRS-T angle (P = 0.02). CONCLUSIONS: The QRS-T angle is a readily available and inexpensive marker that can assist in the discrimination between ADHF and non-cardiac causes of acute dyspnoea and may aid in the risk stratification of these patients.

7.
Eur J Clin Invest ; 50(6): e13248, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32306389

RESUMO

BACKGROUND: Acute heart failure (AHF) patients with high troponin levels have a worse prognosis. High-sensitive troponin T (hs-TnT) has been used as a tool to stratify prognosis in many scales but always as a qualitative and not as a quantitative variable. OBJECTIVES: The main objective of this study was to determine the best hs-TnT cut-off for prediction of 30-day all-cause mortality. METHODS: The EAHFE registry, a prospective follow-up cohort of patients with AHF, was analysed. We performed a propensity score analysis of the optimal hs-TnT cut-off point previously determined by receiver operating characteristic (ROC) curve analysis. RESULTS: Of the 13 791 patients in the EAHFE cohort, we analysed 3190 patients in whom hs-TnT determination was available. The area under the ROC curve for 30-day all-cause mortality was 0.70 (CI95% 0.68 to 0.71; P < .001), establishing an optimal cut-off of hs-TnT of 35 ng/L. The sensitivity and specificity of this cut-off were 76.2 and 55.5%, respectively, with a negative predictive value (NPV) of 95.3%. A propensity score was made with 34 variables showing differences based on the cut-off of 35 ng/L for hs-TnT. In the analysis of the population obtained with the propensity score, patients with hs-TnT > 35 ng/L showed a greater 30-day all-cause mortality, with a HR of 2.95 (CI95% 1.83-4.75; P < .001). External validation reported similar results. CONCLUSIONS: An hs-TnT value of 35 ng/L is an adequate cut-off to evaluate the prediction of 30-day all-cause mortality with a NPV of 95.3%.

8.
Eur J Emerg Med ; 27(6): 422-428, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32301800

RESUMO

OBJECTIVES: Investigating whether it is safe or not to administrate diuretics to patients arriving at emergency departments in a stage of acute dyspnea but without a final diagnosis of acute heart failure. METHODS: We analyzed an unselected multinational sample of patients with dyspnea without a final diagnosis of acute heart failure from Global Research on Acute Conditions Team (France, Lithuania, Tunisia) and Basics in Acute Shortness of Breath Evaluation (Switzerland) registries. Thirty-day all-cause mortality and 30-day postdischarge all-cause readmission rate of treated patients with diuretics at emergency departments were compared with untreated patients by unadjusted and adjusted hazard and odds ratios. Interaction and stratified analyses were performed. RESULTS: We included 2505 patients. Among them, 365 (14.6%) received diuretics in emergency departments. Thirty-day mortality was 4.5% (treated/untreated = 5.2%/4.3%, hazard ratio: 1.22; 95% confidence interval, 0.75-2.00) and 30-day readmission rate was 11.3% (14.7%/10.8%, odds ratio: 1.41; 95% confidence interval, 0.95-2.11). After adjustment, no differences were found between two groups in mortality (hazard ratio: 0.86; 95% confidence interval, 0.51-1.44) and readmission (odds ratio: 1.15; 95% confidence interval, 0.72-1.82). Age significantly interacted with the use of diuretics and readmission (P = 0.03), with better prognosis when used in patients >80 years (odds ratio: 0.27; 95% confidence interval, 0.07-1.03) than in patients ≤80 years (odds ratio: 1.56; 95% confidence interval, 0.94-2.63). CONCLUSIONS: Diuretic administration to patients presenting to emergency departments with dyspnea while they were undiagnosed and in whom acute heart failure was finally excluded was not associated with 30-day all-cause mortality and 30-day postdischarge all-cause readmission rate.

10.
J Am Coll Cardiol ; 75(10): 1111-1124, 2020 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-32164884

RESUMO

BACKGROUND: Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms. OBJECTIVES: This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI). METHODS: This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm. RESULTS: MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication. CONCLUSIONS: The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).

11.
Interact Cardiovasc Thorac Surg ; 30(5): 715-723, 2020 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-32159755

RESUMO

OBJECTIVES: Existing surgical sealants fail to combine design requirements, such as sealing performance, on-demand activation and biocompatibility. The aim of this study was to compare the effectiveness and safety of the SETALIUM™ Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlue®, for the repair of vascular defects. METHODS: In an in vivo porcine model, the use of SVS was compared with BioGlue, for sealing 2-mm defects of the carotid artery and jugular vein. Animals were followed for 7 days and 5 weeks (each time point and per experimental group, n = 4), respectively. The degree of stenosis and flow velocity was determined, and the local tissue response was evaluated. RESULTS: In vivo incision closure succeeded in all cases, and SVS was superior in clinical usability, enabled by its on-demand activation. Unlike BioGlue, SVS use did not induce stenosis and was associated with physiological blood flow in all cases. Moreover, closure with SVS was associated with a low inflammatory reaction and no thrombus formation or intima proliferation, in contrast to BioGlue. CONCLUSIONS: SVS demonstrated effective and rapid sealing of 2-mm vascular defects, with favourable biocompatibility compared to BioGlue. Thus, SVS seems to be an effective and safe vascular sealant.

12.
Eur Heart J Acute Cardiovasc Care ; : 2048872619853579, 2020 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-31976746

RESUMO

BACKGROUND: Recent advances in digital electrocardiography technology allow evaluating ST-segment deviations in all 12 leads as quantitative variables and calculating summed ST-segment deviation scores. The diagnostic and prognostic utility of summed ST-segment deviation scores is largely unknown. METHODS: We aimed to explore the diagnostic and prognostic utility of the conventional and the modified ST-segment deviation score (Better Analysis of ST-segment Elevations and Depressions in a 12- Lead-ECG-Score (BASEL-Score): sum of elevations in the augmented voltage right - lead (aVR) plus absolute, unsigned ST-segment depressions in the remaining leads) in patients presenting with suspected non-ST-segment elevation myocardial infarction. The diagnostic endpoint was non-ST-segment elevation myocardial infarction, adjudicated by two independent cardiologists. Prognostic endpoint was mortality during two-year follow up. RESULTS: Among 1330 patients, non-ST-segment elevation myocardial infarction was present in 200 (15%) patients. Diagnostic accuracy for non-ST-segment elevation myocardial infarction as quantified by the area under the receiver-operating-characteristics curve was significantly higher for the BASEL-Score (0.73; 95% confidence interval 0.69-0.77) as compared to the conventional ST-segment deviation score (0.53; 95% confidence interval 0.49-0.57, p<0.001). The BASEL-Score provided additional independent diagnostic value to dichotomous electrocardiogram variables (ST-segment depression, T-inversion, both p<0.001) and to high-sensitivity cardiac troponin (p<0.001) as well as clinical judgment at 90 min (p<0.001). Similarly, only the BASEL-Score proved to be an independent predictor of two year mortality. CONCLUSIONS: The modified ST-segment deviation score BASEL-Score focusing on ST-segment elevation in aVR and ST-segment depressions in the remaining leads provides incremental diagnostic and prognostic information.

13.
Ann Intern Med ; 172(3): 175-185, 2020 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-31905377

RESUMO

Background: The optimal noninvasive method for surveillance in symptomatic patients with stable coronary artery disease (CAD) is unknown. Objective: To apply a novel approach using very low concentrations of high-sensitivity cardiac troponin I (hs-cTnI) for exclusion of inducible myocardial ischemia in symptomatic patients with CAD. Design: Prospective diagnostic cohort study. (ClinicalTrials.gov: NCT01838148). Setting: University hospital. Patients: 1896 consecutive patients with CAD referred with symptoms possibly related to inducible myocardial ischemia. Measurements: Presence of inducible myocardial ischemia was adjudicated using myocardial perfusion imaging with single-photon emission computed tomography, as well as coronary angiography and fractional flow reserve measurements where available. Staff blinded to adjudication measured circulating hs-cTn concentrations. An hs-cTnI cutoff of 2.5 ng/L, derived previously in mostly asymptomatic patients with CAD, was assessed. Predefined target performance criteria were at least 90% negative predictive value (NPV) and at least 90% sensitivity for exclusion of inducible myocardial ischemia. Sensitivity analyses were based on measurements with an hs-cTnT assay and an alternative hs-cTnI assay with even higher analytic sensitivity (limit of detection, 0.1 ng/L). Results: Overall, 865 patients (46%) had inducible myocardial ischemia. The hs-cTnI cutoff of 2.5 ng/L provided an NPV of 70% (95% CI, 64% to 75%) and a sensitivity of 90% (CI, 88% to 92%) for exclusion of inducible myocardial ischemia. No hs-cTnI cutoff reached both performance characteristics predefined as targets. Similarly, using the alternative assays for hs-cTnI or hs-cTnT, no cutoff achieved the target performance: hs-cTnT concentrations less than 5 ng/L yielded an NPV of 66% (CI, 59% to 72%), and hs-cTnI concentrations less than 2 ng/L yielded an NPV of 68% (CI, 62% to 74%). Limitation: Data were generated in a large single-center diagnostic study using central adjudication. Conclusion: In symptomatic patients with CAD, very low hs-cTn concentrations, including hs-cTnI concentrations less than 2.5 ng/L, do not generally allow users to safely exclude inducible myocardial ischemia. Primary Funding Source: European Union, Swiss National Science Foundation, Kommission für Technologie und Innovation (Innosuisse), Swiss Heart Foundation, Cardiovascular Research Foundation Basel, University of Basel, University Hospital Basel, Roche, Abbott, and Singulex.


Assuntos
Doença da Artéria Coronariana/sangue , Isquemia Miocárdica/sangue , Isquemia Miocárdica/diagnóstico , Troponina I/sangue , Troponina T/sangue , Idoso , Biomarcadores/sangue , Estudos de Coortes , Angiografia Coronária , Feminino , Reserva Fracionada de Fluxo Miocárdico , Humanos , Masculino , Pessoa de Meia-Idade , Imagem de Perfusão do Miocárdio , Valor Preditivo dos Testes , Tomografia Computadorizada de Emissão de Fóton Único
14.
Clin Chem ; 65(11): 1426-1436, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31570633

RESUMO

BACKGROUND: We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. RESULTS: AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93-0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92-0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90-0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94-0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1-100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. CONCLUSIONS: The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. CLINICALTRIALSGOV IDENTIFIER: NCT00470587.

15.
Clin Chem ; 65(11): 1437-1447, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31570634

RESUMO

BACKGROUND: We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay. METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion. RESULTS: AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3-100) and sensitivity of 99.4% (95% CI, 96.5-99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1-79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3-100) and sensitivity of 97.7% (95% CI, 92.0-99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8-86) in the validation cohort. CONCLUSIONS: Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high. TRIAL REGISTRATION: APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.

16.
Clin Chem ; 65(12): 1532-1542, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31615771

RESUMO

BACKGROUND: The clinical utility of procalcitonin in the diagnosis and management of pneumonia remains controversial. METHODS: 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). RESULTS: 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 (P = 0.010 and P < 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 P = 0.39) in patients randomized to the procalcitonin-guided group (n = 25) and usual-care group (n = 20). CONCLUSIONS: 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. SUMMARY: 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. CLINICALTRIALSGOV IDENTIFIER: NCT01831115.


Assuntos
Pneumonia/diagnóstico , Pró-Calcitonina/análise , Idoso , Área Sob a Curva , Biomarcadores/sangue , Biomarcadores/metabolismo , Proteína C-Reativa/análise , Calcitonina , Testes Diagnósticos de Rotina , Dispneia/diagnóstico , Feminino , Insuficiência Cardíaca/diagnóstico , Humanos , Interleucina-6/análise , Interleucina-6/sangue , Masculino , Pessoa de Meia-Idade , Pró-Calcitonina/metabolismo , Estudos Prospectivos , Precursores de Proteínas/metabolismo , Curva ROC
17.
JACC Heart Fail ; 7(10): 834-845, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31521676

RESUMO

OBJECTIVES: This study investigated whether systemic corticosteroids (new onset) administered to patients with acute heart failure (AHF) have any association with outcomes, with differentiated analyses for patients with and without chronic obstructive pulmonary disease (COPD) as a comorbidity. BACKGROUND: Patients with undiagnosed dyspnea frequently receive corticosteroids in emergency departments while determining a final diagnosis, but their effect on the outcomes of patients with AHF without overt COPD exacerbation is unknown. METHODS: We selected patients with AHF from the EAHFE (Epidemiology of Acute Heart Failure in the Emergency Departments) registry, recording key data (new-onset corticosteroid therapy, COPD condition). Patients with and without COPD were analyzed separately. We calculated unadjusted and adjusted ratios for corticosteroid-treated compared with corticosteroid-untreated patients for 2 coprimary endpoints: 90-day all-cause mortality (from index episode) and 90-day post-discharge combined endpoint (all-cause mortality or readmission for AHF), with intermediate time-point estimations. Other secondary endpoints were calculated, and some sensitive and stratified analyses were performed. RESULTS: We analyzed 11,356 patients: 8,635 without COPD (841 corticosteroid-treated, 9.7%) and 2,721 with COPD (753 corticosteroid-treated, 27.7%). There were several differences between treated and untreated patients, essentially because corticosteroid-treated patients were sicker. Although unadjusted outcomes were worse in corticosteroid-treated patients, especially in patients without COPD, these differences disappeared after adjustment: hazard ratios for 90-day mortality (without/with COPD) were 0.91 (95% confidence interval (CI): 0.76 to 1.10)/0.99 (95% CI: 0.78 to 1.26), and 1.09 (95% CI: 0.93 to 1.28)/1.02 (95% CI: 0.86 to 1.21) for the post-discharge combined endpoint. Analyses of intermediate time-point coprimary endpoints and secondary outcomes rendered similar estimations. Sensitivity and stratified analysis did not significantly modify these results. CONCLUSIONS: There is no evidence of harm related to the new onset of systemic corticosteroid therapy during an episode of AHF, either in patients with or without concomitant COPD.

18.
J Am Coll Cardiol ; 74(7): 842-854, 2019 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-31416527

RESUMO

BACKGROUND: Early and accurate detection of short-term major adverse cardiac events (MACE) in patients with suspected acute myocardial infarction (AMI) is an unmet clinical need. OBJECTIVES: The goal of this study was to test the hypothesis that adding clinical judgment and electrocardiogram findings to the European Society of Cardiology (ESC) high-sensitivity cardiac troponin (hs-cTn) measurement at presentation and after 1 h (ESC hs-cTn 0/1 h algorithm) would further improve its performance to predict MACE. METHODS: Patients presenting to an emergency department with suspected AMI were enrolled in a prospective, multicenter diagnostic study. The primary endpoint was MACE, including all-cause death, cardiac arrest, AMI, cardiogenic shock, sustained ventricular arrhythmia, and high-grade atrioventricular block within 30 days including index events. The secondary endpoint was MACE + unstable angina (UA) receiving early (≤24 h) revascularization. RESULTS: Among 3,123 patients, the ESC hs-cTnT 0/1 h algorithm triaged significantly more patients toward rule-out compared with the extended algorithm (60%; 95% CI: 59% to 62% vs. 45%; 95% CI: 43% to 46%; p < 0.001), while maintaining similar 30-day MACE rates (0.6%; 95% CI: 0.3% to 1.1% vs. 0.4%; 95% CI: 0.1% to 0.9%; p = 0.429), resulting in a similar negative predictive value (99.4%; 95% CI: 98.9% to 99.6% vs. 99.6%; 95% CI: 99.2% to 99.8%; p = 0.097). The ESC hs-cTnT 0/1 h algorithm ruled-in fewer patients (16%; 95% CI: 14.9% to 17.5% vs. 26%; 95% CI: 24.2% to 27.2%; p < 0.001) compared with the extended algorithm, albeit with a higher positive predictive value (76.6%; 95% CI: 72.8% to 80.1% vs. 59%; 95% CI: 55.5% to 62.3%; p < 0.001). For 30-day MACE + UA, the ESC hs-cTnT 0/1 h algorithm had a higher positive predictive value for rule-in, whereas the extended algorithm had a higher negative predictive value for the rule-out. Similar findings emerged when using hs-cTnI. CONCLUSIONS: The ESC hs-cTn 0/1 h algorithm better balanced efficacy and safety in the prediction of MACE, whereas the extended algorithm is the preferred option for the rule-out of 30-day MACE + UA. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE]; NCT00470587).


Assuntos
Algoritmos , Infarto do Miocárdio/epidemiologia , Troponina/sangue , Idoso , Angina Instável/diagnóstico , Angina Instável/epidemiologia , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/epidemiologia , Bloqueio Atrioventricular/diagnóstico , Bloqueio Atrioventricular/epidemiologia , Biomarcadores/sangue , Eletrocardiografia , Serviço Hospitalar de Emergência , Feminino , Parada Cardíaca/diagnóstico , Parada Cardíaca/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Revascularização Miocárdica , Valor Preditivo dos Testes , Estudos Prospectivos , Sensibilidade e Especificidade , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/epidemiologia
19.
Eur Heart J Acute Cardiovasc Care ; 8(7): 667-680, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31436133

RESUMO

BACKGROUND: The aim of this study was to describe the prevalence and prognostic value of the most common triggering factors in acute heart failure. METHODS: Patients with acute heart failure from 41 Spanish emergency departments were recruited consecutively in three time periods between 2011 and 2016. Precipitating factors were classified as: (a) unrecognized; (b) infection; (c) atrial fibrillation; (d) anaemia; (e) hypertension; (f) acute coronary syndrome; (g) non-adherence; and (h) two or more precipitant factors. Unadjusted and adjusted logistic regression models were used to assess the association between 30-day mortality and each precipitant factor. The risk of dying was further evaluated by week intervals over the 30-day follow-up to assess the period of higher vulnerability for each precipitant factor. RESULTS: Approximately 69% of our 9999 patients presented with a triggering factor and 1002 died within the first 30 days (10.0%). The most prevalent factors were infection and atrial fibrillation. After adjusting for 11 known predictors, acute coronary syndrome was associated with higher 30-day mortality (odds ratio (OR) 1.87; 95% confidence interval (CI) 1.02-3.42), whereas atrial fibrillation (OR 0.75; 95% CI 0.56-0.94) and hypertension (OR 0.34; 95% CI 0.21-0.55) were significantly associated with better outcomes when compared to patients without precipitant. Patients with infection, anaemia and non-compliance were not at higher risk of dying within 30 days. These findings were consistent across gender and age groups. The 30-day mortality time pattern varied between and within precipitant factors. CONCLUSIONS: Precipitant factors in acute heart failure patients are prevalent and have a prognostic value regardless of the patient's gender and age. They can be managed with specific treatments and can sometimes be prevented.


Assuntos
Insuficiência Cardíaca/mortalidade , Sistema de Registros , Medição de Risco/métodos , Doença Aguda , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Fatores Desencadeantes , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Espanha/epidemiologia , Taxa de Sobrevida/tendências
20.
J Am Coll Cardiol ; 74(6): 744-754, 2019 08 13.
Artigo em Inglês | MEDLINE | ID: mdl-31395124

RESUMO

BACKGROUND: The prevalence of pulmonary embolism (PE) in patients presenting with syncope to the emergency department (ED) is largely unknown. This information, however, is necessary to balance the potential medical benefit or harm of systematic PE screening in patients presenting with syncope to the ED. OBJECTIVES: This study sought to determine the prevalence of PE in patients with syncope. METHODS: Unselected patients presenting with syncope to the ED were prospectively enrolled in a diagnostic multicenter study. Pre-test clinical probability for PE was assessed using the 2-level Wells score and the results of D-dimer testing using age-adapted cutoffs. Presence of PE was evaluated by imaging modalities, when ordered as part of the clinical assessment by the treating ED physician or by long-term follow-up data. RESULTS: Long-term follow-up was complete in 1,380 patients (99%) at 360 days and 1,156 patients (83%) at 720 days. Among 1,397 patients presenting with syncope to the ED, PE was detected at presentation in 19 patients (1.4%; 95% confidence interval [CI]: 0.87% to 2.11%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.5% to 1.5%). In the subgroup of patients hospitalized (47%), PE was detected at presentation in 15 patients (2.3%; 95% CI: 1.4% to 3.7%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.4% to 2.0%). CONCLUSIONS: PE seems to be a rather uncommon cause of syncope among patients presenting to the ED. Therefore, systematic PE-screening in all patients with syncope does not seem warranted. (BAsel Syncope EvaLuation Study [BASEL IX]; NCT01548352).


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Embolia Pulmonar/epidemiologia , Síncope/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Saúde Global , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Estudos Prospectivos , Embolia Pulmonar/etiologia , Fatores de Risco , Taxa de Sobrevida/tendências
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