Objective We aimed to prospectively derive and validate a novel 0-/1-hour algorithm using high-sensitivity cardiac troponin I (hs-cTnI) for the early “rule-out” and “rule-in” of acute myocardial ...infarction (AMI). Methods In a prospective multicenter diagnostic study, we enrolled 1,500 patients presenting with suspected AMI to the emergency department. The final diagnosis was centrally adjudicated by 2 independent cardiologists blinded to hs-cTnI concentrations. The hs-cTnI (Siemens Vista) 0-/1-hour algorithm incorporated measurements performed at baseline and absolute changes within 1 hour, was derived in the first 750 patients (derivation cohort), and then validated in the second 750 (validation cohort). Results Overall, AMI was the final diagnosis in 16% of patients. Applying the hs-cTnI 0-/1-hour algorithm developed in the derivation cohort to the validation cohort, 57% of patients could be classified as “rule-out”; 10%, as “rule-in”; and 33%, as “observe.” In the validation cohort, the sensitivity and the negative predictive value for AMI in the “rule-out” zone were 100% (95% CI 96%-100%) and 100% (95% CI 99%-100%), respectively. The specificity and the positive predictive value (PPV) for AMI in the “rule-in” zone were 96% (95% CI 94%-97%) and 70% (95% CI 60%-79%), respectively. Negative predictive value and positive predictive value of the 0-/1-hour algorithm were higher compared to the standard of care combining hs-cTnI with the electrocardiogram (both P < .001). Conclusion The hs-cTnI 0-/1-hour algorithm performs very well for early rule-out as well as rule-in of AMI. The clinical implications are that used in conjunction with all other clinical information, the 0-/1-hour algorithm will be a safe and effective approach to substantially reduce time to diagnosis.
The clinical availability of high-sensitivity cardiac troponin (hs-cTn) has enabled the development of several innovative strategies for the rapid rule-out of acute myocardial infarction (AMI). Due ...to the lack of direct comparisons, selection of the best strategy for clinical practice is challenging.
In a prospective international multicenter diagnostic study enrolling 3696 patients presenting with suspected AMI to the emergency department, we compared the safety and efficacy of 14 different hs-cTn-based strategies: hs-cTn concentrations below the limit of detection (LoD), dual-marker combining hs-cTn with copeptin, ESC 0 h/1 h-algorithm, 0 h/2 h-algorithm, 2 h-ADP-algorithm, NICE-algorithm, and ESC 0 h/3 h-algorithm, each using either hs-cTnT or hs-cTnI. The final diagnosis of AMI was adjudicated by two independent cardiologists using all available clinical information including cardiac imaging and serial hs-cTn concentrations.
AMI was the final diagnosis in 16% of patients. Using hs-cTnT, safety quantified by the negative predictive value (NPV) and sensitivity was very high (99.8–100% and 99.5–100%) and comparable for all strategies, except the dual-marker approach (NPV 98.7%, sensitivity 96.7%). Similarly, using hs-cTnI, safety quantified by the NPV and sensitivity was very high (99.7–100% and 98.9–100%) and comparable for all strategies, except the dual-marker approach (NPV 96.9%, sensitivity 90.4%) and the NICE-algorithm (NPV 99.1%, sensitivity 94.7%). Efficacy, quantified by the percentage of patients eligible for rule-out, differed markedly, and was lowest for LoD-algorithm (15.7–26.8%).
All rapid rule-out algorithms, except the dual-marker strategy and the NICE-algorithm using hs-cTnI, favorably combine safety and efficacy, and can be considered for routine clinical practice.
NCT00470587, http://clinicaltrials.gov/show/NCT00470587.
•All examined hs-cTn-based rapid rule-out strategies, except for the dual-marker strategy and the NICE-algorithm using hs-cTnI, provide high and comparable safety.•The efficacy of the different hs-cTn-based rapid rule-out strategies varied substantially among the different strategies.•The incidence of 30-day MACE among patients triaged towards rule-out was very low and comparable among the different strategies.•Findings in the subgroup of early presenters overall were similar to those obtained for the whole cohort for the different strategies.•No systematic difference was shown between the rule-out strategies according to the applied hs-cTn assay, except for the NICE algorithm.
Abstract
Glucose is a universally available inexpensive biomarker, which is increased as part of the physiological stress response to acute myocardial infarction (AMI) and may therefore help in its ...early diagnosis. To test this hypothesis, glucose, high-sensitivity cardiac troponin (hs-cTn) T, and hs-cTnI were measured in consecutive patients presenting with acute chest discomfort to the emergency department (ED) and enrolled in a large international diagnostic study (NCT00470587). Two independent cardiologists centrally adjudicated the final diagnosis using all clinical data, including serial hs-cTnT measurements, cardiac imaging and clinical follow-up. The primary diagnostic endpoint was index non-ST-segment elevation MI (NSTEMI). Prognostic endpoints were all-cause death, and cardiovascular (CV) death or future AMI, all within 730-days. Among 5639 eligible patients, NSTEMI was the adjudicated final diagnosis in 1051 (18.6%) patients. Diagnostic accuracy quantified using the area under the receiver-operating characteristics curve (AUC) for the combination of glucose with hs-cTnT and glucose with hs-cTnI was very high, but not higher versus that of hs-cTn alone (glucose/hs-cTnT 0.930 95% CI 0.922–0.937 versus hs-cTnT 0.929 95% CI 0.922–0.937; glucose/hs-cTnI 0.944 95% CI 0.937–0.951 versus hs-cTnI 0.944 95% CI 0.937–0.951). In early-presenters, a dual-marker strategy (glucose < 7 mmol/L and hs-cTnT < 5/hs-cTnI < 4 ng/L) provided very high and comparable sensitivity to slightly lower hs-cTn concentrations (cTnT/I < 4/3 ng/L) alone, and possibly even higher efficacy. Glucose was an independent predictor of 730-days endpoints. Our results showed that a dual marker strategy of glucose and hs-cTn did not increase the diagnostic accuracy when used continuously. However, a cutoff approach combining glucose and hs-cTn may provide diagnostic utility for patients presenting ≤ 3 h after onset of symptoms, also providing important prognostic information.
TAVI via the left subclavian artery is considered a bail-out strategy in cases where a transfemoral approach is not feasible. However, since this route is only scarcely used, major complications can ...arise. We describe such an adverse course and present our proceeding.
A 65-year-old man with severe aortic valve stenosis (AS) was referred for transcatheter aortic valve implantation (TAVI) via left subclavian artery. After uneventful deployment of the TAVI prosthesis, consequent valve assessment with transeosophageal echocardiography and angiography showed a highly mobile and tubular structure shifting within the valve. We went for a surgical extraction via sternotomy on cardiopulmonary bypass (CPB). A 6 cm longish intimal cylinder was hassle-free extracted. 4 days postoperatively the left sided radial pulse was missing. In a subsequent computed tomography angiography (CTA) scan a proximal dissection as well as an intimal flap, causing a subtotal stenosis of the left subclavian artery, was detected. Consecutively the intimal cylinder was removed using a Fogarty-balloon. Pre-discharge control revealed recurrence of peripheral radial pulse and an unimpeded function of the TAVI prosthesis. The patient presented no sequela at discharge.
Though TAVI is a well-advanced technique complications are not completely avertable. It is thus advisable to have patients discussed in the heart team encompassing all potentially involved specialties.
The increasing use of transcatheter aortic valves in patients with aortic stenosis has led to a higher number of valve-in-valve procedures due to gradual valve degeneration. We present a case of a ...72-year-old woman who received transcatheter aortic valve implantation (TAVI) using a Lotus valve due to severe aortic stenosis, which showed valve degeneration several years after the initial procedure. After heart-team discussion, TAVI-in-TAVI was planned using an Evolut pro+ valve, which allowed for full coverage of the Lotus valve and maintenance of coronary flow, resulting in a well-functioning valve with no regurgitation and normal performance. Despite high-risk anatomic features, valve-in-valve using an Evolut pro+ in a degenerated Lotus valve is feasible and overcomes pitfalls such as entanglement or coronary obstruction.
Background When acute aortic syndromes (AASs) are suspected, pretest clinical probability assessment and d-dimer (DD) testing are diagnostic options allowing standardized care. Guidelines suggest use ...of a 12-item/3-category score (aortic dissection detection) and a DD cutoff of 500 ng/mL. However, a simplified assessment tool and a more specific DD cutoff could be advantageous. Methods and Results In a prospective derivation cohort (n=1848), 6 items identified by logistic regression (thoracic aortic aneurysm, severe pain, sudden pain, pulse deficit, neurologic deficit, hypotension), composed a simplified score (AORTAs) assigning 2 points to hypotension and 1 to the other items. AORTAs≤1 and ≥2 defined low and high clinical probability, respectively. Age-adjusted DD was calculated as years/age × 10 ng/mL (minimum 500). The AORTAs score and AORTAs≤1/age-adjusted DD rule were validated in 2 patient cohorts: a high-prevalence retrospective cohort (n=1035; 22% AASs) and a low-prevalence prospective cohort (n=447; 11% AASs) subjected to 30-day follow-up. The AUC of the AORTAs score was 0.729 versus 0.697 of the aortic dissection detection score (
=0.005). AORTAs score assessment reclassified 16.6% to 25.1% of patients, with significant net reclassification improvement of 10.3% to 32.7% for AASs and -8.6 to -17% for alternative diagnoses. In both cohorts, AORTAs≥2 had superior sensitivity and slightly lower specificity than aortic dissection detection ≥2. In the prospective validation cohort, AORTAs≤1/age-adjusted DD had a sensitivity of 100%, a specificity of 48.6%, and an efficiency of 43.3%. Conclusions AORTAs is a simplified score with increased sensitivity, improved AAS classification, and minor trade-off in specificity, amenable to integration with age-adjusted DD for diagnostic rule-out.
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.
Introduction: Transcatheter aortic valve replacement (TAVR) has become an efficient and safe alternative to surgical aortic valve replacement (SAVR). While severe aortic stenosis as well as severe ...aortic regurgitation (AR) are known to negatively impact left ventricular ejection fraction (LVEF), prior studies have shown that TAVR can lead to an improvement in LVEF. Thus far, little is known about the prognostic implication of LVEF improvement as a sole predictor of outcomes. Therefore, the aim of this study was to assess the prognostic impact of LVEF impairment before TAVR, as well as early LVEF improvement in patients undergoing TAVR. Materials and Methods: Patients undergoing TAVR in a large tertiary university hospital were consecutively included in a prospective registry. Transthoracic echocardiography (TTE) was performed at baseline, after 1 month and annually thereafter. Significant LVEF improvement was defined as a relative increase of ≥10% in LVEF at 30 days compared to baseline LVEF. The primary outcome was all-cause mortality at 1 year. Secondary outcomes were major adverse cardiovascular events (MACEs) including cardiovascular death, non-fatal myocardial infarction, stroke, bleeding and unplanned re-interventions of the aortic valve at 5 years. Results: Among 1655 patients who underwent TAVR between September 2011 and April 2024, the LVEF at baseline was available for 1556 patients. Of these, 1031 patients (66.2%) had preserved LVEF at baseline (LVEF ≥ 53%), whereas 303 patients (19.5%) had moderately reduced LVEF (40–52%) and 222 patients (14.3%) had severely reduced LVEF (<40%). Out of the patients with impaired LVEF, 155 (40.4%) patients showed a significant improvement in LVEF ≥10% after 30 days, while 229 (60.6%) patients showed no significant LVEF improvement (<10%). Patients with preserved LVEF at baseline had significantly better mortality outcomes than those with severely reduced LVEF (p < 0.001). LVEF improvement was associated with a survival benefit after 1 year (p = 0.009, HR 2.68, 0.95 CI 1.23–5.85) which diminished after 5 years (p = 0.058), but patients with LVEF improvement showed lower MACE rates at 5 years (p < 0.001). Conclusions: Preserved LVEF before TAVR is an independent predictor for improved outcomes. Additionally, early improvement in LVEF is associated with beneficial outcomes in patients undergoing TAVR.
PDF
