Clinical Evaluation of a New High-Sensitivity Cardiac Troponin I Assay for Diagnosis and Risk Assessment of Patients with Suspected Acute Myocardial Infarction.

INTRODUCTION: Current assays based on the 0-hour/1-hour (0-/1-h) algorithm using high-sensitivity cardiac troponin (hs-cTn) are limited to only Abbott Architect hs-cTnI, Siemens Vista hs-cTnI, and Roche Elecsys hs-cTnT. OBJECTIVE: This study aimed to evaluate this new hs-cTnI assay, LumipulsePresto hs Troponin I, for diagnosis of acute myocardial infarction (AMI) on admission and on 0-/1-h algorithm to stratify AMI patients precisely. METHODS: This prospective cohort study included 442 patients with suspected non-ST-elevation myocardial infarction in three hospitals in Japan and Taiwan from June 2016 to January 2019. We enrolled patients presenting to the emergency department with symptoms suggestive of AMI and collected blood samples on admission and 1 hour later. Two independent cardiologists centrally adjudicated final diagnoses; all clinical information was reviewed twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis) and Lumipulse Presto Lumipulse Presto, second, using the Lumipulse Presto hs-cTnI measurements. At first, we compared diagnostic accuracy quantified using receiver operating characteristic (ROC) curves for AMI. Then, we evaluated major adverse cardiovascular events (cardiac death, AMI) in the rule-out group according to a 0-hour/1-hour algorithm at the 30-day follow-up. RESULTS: Diagnostic accuracy at presentation by the ROC curve for AMI was very high and similar for the LumipulsePresto hs-cTnI and hs-cTnT,(area under the curve [AUC]: LumipulsePresto hs-cTnI, 0.89, 95% confidence interval [CI] 0.86-0.93; hs-cTnT, 0.89, 95% CI 0.85-0.93; p = 0.82). In early presenters, the LumipulsePresto hs-cTnI appeared to maintain the diagnostic performance of hs-cTn for patients with <3 h (AUC: LumipulsePresto hs-cTnI, 0.87, 95% CI 0.81-0.92; hs-cTnT, 0.86, 95% CI 0.80-0.92; p = 0.81). The algorithm using the LumipulsePresto hs-cTnI ruled out AMI in 200 patients with negative predictive value and sensitivity of 100% (95% CI 97.3%-100%) and 100% (95% CI 92.7%-100%), respectively, in the rule-out group. CONCLUSION: Diagnostic accuracy and clinical utility of the novel LumipulsePresto hs-cTnI assay are high and comparable with the established hs-cTn assays.

Elevated Heart Rate in Combination with Elevated Blood Pressure Predicts Lower Cardiovascular Mortality in Acute Decompensated Heart Failure.

Despite its clinical relevance, a subclass of acute decompensated heart failure (ADHF) with elevated blood pressure, known as hypertensive ADHF (HT-ADHF), has been less intensively evaluated. This study aimed to characterize the prognostic nature and pathophysiology of HT-ADHF. A total of 509 consecutive patients with first-time ADHF hospitalization were subjects of the study. Participants were divided into two groups: an HT-ADHF group (systolic blood pressure, SBP > 140 mmHg at presentation) and a non-HT-ADHF group (SBP ≤ 140 mmHg). Median follow-up duration measured 253 days. Unadjusted Kaplan-Meier analysis demonstrated both a lower cardiovascular mortality rate in the HT-ADHF group and similar incidences of heart failure rehospitalization in both groups. Adjusted Cox hazard analysis showed an association of elevated SBP at presentation with significantly lower cardiovascular mortality, though no such association was observed with heart failure rehospitalization. Moreover, elevated heart rate in combination with elevated SBP at presentation predicted a significantly lower risk of cardiovascular mortality (Hazard Ratio: 0.32, 95% CI: 0.14-0.77, P = 0.01). Also, significantly lower cardiovascular mortality was observed in this subtype, compared with other types of ADHF.

Transbrachial intra-aortic balloon pumping for a patient with fulminant myocarditis.

A 57-year-old man with acute myocarditis was transferred to our hospital from a local clinic. The patient experienced unexpected sudden cardiac arrest 16 h after admission. Mechanical cardiopulmonary support was started using percutaneous cardiopulmonary support, intra-aortic balloon pumping (IABP), continuous hemodialysis filtration, and temporary cardiac pacing with percutaneous cannulation of the femoral vessels. Hematoma developed at the IABP insertion site on the 5th day after admission. The IABP was removed, and another IABP system was inserted via the left brachial artery. The patient's condition improved, and the IABP was removed on the 9th day after admission. The remainder of the patient's in-hospital treatment was uneventful, and he showed near-normal left ventricular systolic function 1 year after discharge.

Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J).

BACKGROUND: A previous study reported that amlodipine retarded coronary plaque progression in patients with coronary artery disease. The goal of this multicenter study was to determine which calcium-channel blockers (CCBs) other than amlodipine attenuated the progression of plaque volume (PV) accessed by intravascular ultrasound (IVUS). METHODS AND RESULTS: ALPS-J was a prospective, randomized open-label study conducted at 5 centers. Patients who had hypertension and were scheduled for coronary intervention were enrolled. Subjects were randomly assigned to receive 16 mg/day of azelnidipine or 5mg/day of amlodipine administered for 48 weeks. The primary endpoint was the percent change in coronary PV measured by IVUS. Between 2007 and 2009, 199 patients were enrolled; 115 had evaluable IVUS images at both baseline and after 48 weeks of treatment. Blood pressure significantly reduced to 128/68 mmHg at follow-up. The lipid profiles in the 2 groups were comparable (low-density lipoprotein cholesterol: 97 mg/dl). The %change in PV showed a significant regression of 4.67 and 4.85% in the azelnidipine and amlodipine groups, respectively. The upper limit of the 95% confidence interval of the mean difference in %change PV between the 2 groups (0.18%, 95% confidence interval 4.62 to 4.98%) did not exceed the pre-defined non-inferiority margin of 6.525%. CONCLUSIONS: ALPS-J demonstrated that azelnidipine was not inferior to amlodipine for primary efficacy. In addition to standard medical therapy, dihydropyridine CCBs will retard PV progression in hypertensive patients.

Primary Cardiac Diffuse Large B-cell Lymphoma Promptly and Safely Diagnosed with Pericardial Effusion Cytology.

Primary cardiac lymphoma is a rare condition with a poor prognosis, and patients are at risk for sudden cardiac death. A prompt diagnosis and early treatment are therefore essential. A 68-year-old woman was admitted for shortness of breath and peripheral edema. Echocardiograms showed massive pericardial effusion and a mass on the free wall of the right atrium and ventricle. Subsequent pericardial effusion cytology revealed diffuse large B-cell lymphoma. We started chemotherapy with rituximab and achieved a good clinical course. This case is made unique by the use of pericardial effusion cytology, which allowed us to diagnose primary cardiac lymphoma promptly and safely.

Implementing the European Society of Cardiology 0-h/1-h algorithm in patients presenting very early after chest pain.

BACKGROUND: The European Society of Cardiology (ESC) recommends a 0-h/1-h (0/1-h) algorithm to classify patients with suspected non-ST-segment elevation myocardial infarction (NSTEMI). However, reliable evidence about patients who present early after the onset of symptoms is limited, likely because high-sensitivity cardiac troponin (hs-cTn) values cannot increase sufficiently within that time. This study aimed to evaluate the outcomes in real-world situations that utilized the 0/1-h algorithm. METHODS: In a prospective, international, multicenter cohort study that enrolled 1638 patients presenting with acute chest pain to the emergency department, we assessed the performance of the 0/1-h algorithm using hs-cTnT and the associated 30-day rates of major adverse cardiac events: death and acute myocardial infarction (AMI). RESULTS: Among 1074 patients, the prevalence of AMI was 16.0%. An approximately 60.1% (n = 645) of patients visited the hospital within 3 h after onset of chest pain (less than 1 h; 18.2% [n = 196], less than 2 h; 27.5% [n = 295], and less than 3 h; 14.3% [n = 154]). Moreover, the prevalence rates of AMI were similar at all times (1 h, 16.8%; 1-2 h, 20.7%; 2-3 h, 18.2%; p = .5). According to the ESC 0/1-h algorithm, the distribution patterns of rule-out, observe, and rule-in groups were similar; however, none of the patients was diagnosed with AMI or cardiac death in the rule-out group. CONCLUSION: This study revealed the applicability of the 0/1-h algorithm for the management of early presenters.

Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo university (ALPS-J).

PURPOSE: Many trials have shown that calcium channel blockers (CCBs) can reduce the cardiovascular (CV) events in patients with coronary artery disease (CAD). The mechanisms of this effect could be associated with plaque regression due to the anti-atherosclerotic properties of CCBs. The goal of this study is to determine the effects of CCB on volumetric quantitative changes of coronary plaques accessed by intravascular ultrasound (IVUS). To confirm this hypothesis, a multicenter randomized trial of CCBs treatment with azelnidipine or amlodipine will be conducted in hypertensive CAD patients undergoing elective percutaneous coronary intervention (PCI). METHODS AND RESULTS: Patients who have hypertension and are scheduled for PCI will be enrolled. Subjects will be randomized to azelnidipine or amlodipine and observed for 48 weeks. The primary endpoint will be the percent change of coronary plaque volume. The secondary endpoint will include inflammatory markers, antioxidant activity, and incidence of composite cardiovascular events. CONCLUSIONS: In this study, we will investigate the improvement of coronary plaque with IVUS by treatment with two dihydropyridine CCBs in hypertensive patients undergoing elective PCI. This result will lead to the discovery of more effective drug therapy for inhibition of coronary events.

Stability of intrinsic rhythm in pacemaker-dependent patients during pacemaker replacement: Can we predict the need for temporary pacing?

BACKGROUND: In pacemaker-dependent patients, the risk of asystole must be managed during device replacement. This study aimed to examine whether we could predict the indication for temporary pacing (TP) during the generator replacement. METHODS: We studied 105 consecutive patients who underwent pacemaker replacement due to battery depletion at Juntendo Nerima Hospital between September 2005 and December 2016. We examined the relationship between the stability of the intrinsic rhythm (IR) during pacemaker replacement and several clinical factors including age, gender, sick sinus syndrome or atrioventricular (AV) block, duration of pacing, structural heart disease, use of anti-arrhythmic drugs, and the presence/absence of a stable IR (>40 bpm) at the outpatient clinic (OPC) just before pacemaker replacement. RESULTS: Of the 105 patients, we excluded 1 patient who required TP because of bradycardia-dependent torsades de points. Therefore, we evaluated 104 patients for the indication for TP. TP was underwent in 19 patients (18%) because of an absence or instability of the IR during pacemaker replacement. The indication for TP was significantly correlated with AV block (84% vs 48%, P = .0044) and the absence of a stable IR at the last OPC visit (89% vs 24%, P < .0001). For predicting the indication for TP, the following values of no stable IR at the last OPC visit were obtained: 89% sensitivity, 77% specificity, 46% positive predictive value, and 97% negative predictive value. CONCLUSIONS: The presence of a stable IR at the last OPC visit was a good predictor (97%) of no indication for TP during pacemaker replacement.

Utility of the 0-hour/1-hour high-sensitivity cardiac troponin T algorithm in Asian patients with suspected non-ST elevation myocardial infarction.

BACKGROUND: A rapid rule-out or rule-in protocol based on the 0-hour/1-hour algorithm using high-sensitivity cardiac troponin T is recommended by the European Society of Cardiology. However, Asian data are not available. METHODS: This prospective cohort study included 413 patients with suspected non-ST elevation myocardial infarction in 3 hospitals in Japan and Taiwan from November 2014 to April 2017. Patients were divided into 3groups-rule-out, observe, and rule-in-according to the algorithm. Major adverse cardiovascular events were evaluated at the 30-dayfollow-up. RESULTS: The algorithm ruled out acute myocardial infarction (AMI) in 171 patients with a negative predictive value and sensitivity of 100% (95% confidential interval [CI], 96.8%-100%) and 100% (95% CI, 88.0%-100%), respectively, in the rule-out group. None of the patients were diagnosed with AMI. Among the 127 patients classified into the rule-in group, 47 were diagnosed as having AMI. The positive predictive value and specificity were 33.1% (95% CI, 25.1%-41.9%) and 66.3% (95% CI, 60.2%-72.0%), respectively. Elective catheter intervention was required in 13 patients (5 in the rule-out group, 8 in the observe group) by the 30-dayfollow-up. The Framingham Risk Score (FRS) identified moderate risk in 5 patients and high risk in 8, while the Global Registry of Acute Coronary Events (GRACE) 2.0 risk score identified low risk in 6 patients and moderate risk in 7. CONCLUSION: The ESC0-hour/1-hour algorithm could be sufficient in Asian patients. The combination with FRS may be more precise than that with the GRACE 2.0 risk score.

Reevaluation of cardiac risk scores and multiple biomarkers for the prediction of first major cardiovascular events and death in the drug-eluting stent era.

BACKGROUND: Risk scores and cardiac biomarker tests allow clinicians to accurately diagnose acute coronary syndrome (ACS) and perform early risk stratification. However, few investigations have evaluated the use of these risk scores and biomarkers for predicting risk of cardiovascular events in drug-eluting stent (DES) era. METHODS: This prospective cohort study included 861 patients with ACS. Three risk scores-Global Registry of Acute Coronary Events (GRACEs), Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin, and Thrombolysis In Myocardial Infarction-and levels of four biomarkers-N-terminal pro-B-type natriuretic peptide (NT pro-BNP), high-sensitivity troponin T, heart-fatty acid binding protein, and high-sensitivity C-reactive protein-were recorded on admission. Major adverse cardiac events (MACE) (death, cardiovascular events) were evaluated at 30-day and 1-year follow-up. RESULTS: At 30-day follow-up, there were 23 (3.1%) deaths from cardiovascular events and 4 (0.5%) cerebral accidents. NT pro-BNP levels and GRACE score were strong MACE predictors, with adjusted odds ratios (ORs) (95% CI) of 2.90 (1.63-5.20) and 1.01 (1.00-1.02), respectively, in logistic model. The C-statistic of NT pro-BNP (0.77; 95% CI, 0.67-0.86) was similar to that of GRACE score (0.76; 95% CI, 0.66-0.87); however, the combined C-statistic was higher (0.81), yielding a net reclassification improvement of 13% (p<0.01). At 1-year follow-up, there were 51 (6.8%) deaths and 10 (1.3%) cerebral accidents. CONCLUSION: In the DES era, GRACE score and biomarkers can still predict major cardiac events in patients with ACS for both acute and long-term prognoses.

Enormous Pedunculated Vegetation Originating in the Left Ventricular Apex in a Patient with Infective Endocarditis.

A healthy teenage Japanese girl was admitted to our hospital after experiencing out-of-hospital cardiac arrest. She had attempted to commit suicide by taking 4,950 mg of disopyramide and 12 mg of flunitrazepam. Mechanical cardiopulmonary support was started with percutaneous cannulation of the femoral vessels. Several days later, a blood culture tested positive for Staphylococcus aureus. Transthoracic echocardiography showed a large mobile and solid mass attached to the apical part of the left ventricle. To the best of our knowledge, the anatomical location of a pedunculated mass originating from the apex is a rare condition.

An adult case of polysplenia syndrome associated with sinus node dysfunction, dextrocardia, and systemic venous anomalies.

A 54-year-old woman was referred to our hospital for symptomatic sinus bradyarrhythmia with a sinus pause of 8 seconds. She was diagnosed with dextrocardia during childhood and discovered to have heterotaxy syndrome when she had an appendectomy during her teenager years. Chest and abdominal examinations by computed tomography showed multiple spleens located on the right side and abnormal drainages of the superior and inferior vena cava. Left isomerism was diagnosed by bilaterally bilobed lungs. Because of a patent bilateral superior vena cava, pacemaker leads were implanted using the right cephalic vein approach. Her fainting symptoms disappeared after pacemaker implantation.

Infective endocarditis associated with acute myocardial infarction caused by septic emboli.

A 53-year-old Japanese man presented with severe chest pain. He had suffered from persistent fever, muscle pain, arthralgia, and dyspnea on exertion (New York Heart Association class I) for two and half months prior to admission. He had been treated with several antibiotics for two months and prednisolone for almost one month prior to admission. On the day of admission, he had suffered from chest pain at rest, and had come to our hospital. Electrocardiography showed a normal sinus rhythm with significant ST segment elevation in leads V3-6 and abnormal Q waves in leads V4-6. Transthoracic echocardiography demonstrated left ventricular ejection fraction of 52% with severe mitral regurgitation and an 18-mm vegetation on the anterior mitral valve leaflet. Multiple blood cultures identified Streptococcus sanguis. The diagnosis was acute myocardial infarction and mitral regurgitation associated with infective endocarditis (IE). The incidence of acute coronary syndrome caused by IE is quite low in patients with native valves. After a 6-week course of antibiotics, mitral valve replacement and partial cardiomyotomy were performed. Two years after the surgery, follow-up echocardiography showed almost normal left ventricle function and no mitral regurgitation, and the patient has been living an active life without any complications.

Clinical significance of coronary calcification.

Coronary artery calcification (CAC) was assessed by cinefluoroscopy and its extent was scored (CAC score) in 2,163 consecutive patients undergoing coronary angiography, based on the angiographic and clinical data, the patients were categorized into 8 types of coronary artery disease (CAD). The CAC score was lowest in angiographically normal subjects (0.12+/-0.60) and highest in patients with silent myocardial ischemia (14.31+/-8.61). Risk factors for CAC were advanced age, male sex (at age <80 years), hypertension, diabetes mellitus, and a high grade of organic coronary stenosis. The CAC score in patients with acute coronary syndrome (unstable angina+acute myocardial infarction; 5.48+/-7.42) was significantly lower than that in those with chronic CAD (silent ischemia+stable angina; 9.72+/-8.73; p<0.0001), but was still higher than that in normal subjects or those with vasospastic angina (0.92+/-2.88; p<0.0001). The results indicate that CAC is a manifestation of coronary atherosclerosis and its appearance depends on the pathological type of ischemic heart disease. Fixed stenosis with a slow and chronic process tends to be associated with CAC. The clinical implication of extensive CAC in acute coronary syndrome compared with normal subjects should be further investigated.