Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study.

Aims: Many portable electrocardiogram (ECG) devices have been developed to monitor patients at home, but the majority of these devices are single lead and only intended for rhythm disorders. We developed the miniECG, a smartphone-sized portable device with four dry electrodes capable of recording a high-quality multi-lead ECG by placing the device on the chest. The aim of our study was to investigate the ability of the miniECG to detect occlusive myocardial infarction (OMI) in patients with chest pain. Methods and results: Patients presenting with acute chest pain at the emergency department of the University Medical Center Utrecht or Meander Medical Center, between May 2021 and February 2022, were included in the study. The clinical 12-lead ECG and the miniECG before coronary intervention were recorded. The recordings were evaluated by cardiologists and compared the outcome of the coronary angiography, if performed. A total of 369 patients were measured with the miniECG, 46 of whom had OMI. The miniECG detected OMI with a sensitivity and specificity of 65 and 92%, compared with 83 and 90% for the 12-lead ECG. Sensitivity of the miniECG was similar for different culprit vessels. Conclusion: The miniECG can record a multi-lead ECG and rule-in ST-segment deviation in patients with occluded or near-occluded coronary arteries from different culprit vessels without many false alarms. Further research is required to add automated analysis to the recordings and to show feasibility to use the miniECG by patients at home.

Electrocardiogram Devices for Home Use: Technological and Clinical Scoping Review.

BACKGROUND: Electrocardiograms (ECGs) are used by physicians to record, monitor, and diagnose the electrical activity of the heart. Recent technological advances have allowed ECG devices to move out of the clinic and into the home environment. There is a great variety of mobile ECG devices with the capabilities to be used in home environments. OBJECTIVE: This scoping review aimed to provide a comprehensive overview of the current landscape of mobile ECG devices, including the technology used, intended clinical use, and available clinical evidence. METHODS: We conducted a scoping review to identify studies concerning mobile ECG devices in the electronic database PubMed. Secondarily, an internet search was performed to identify other ECG devices available in the market. We summarized the devices' technical information and usability characteristics based on manufacturer data such as datasheets and user manuals. For each device, we searched for clinical evidence on the capabilities to record heart disorders by performing individual searches in PubMed and ClinicalTrials.gov, as well as the Food and Drug Administration (FDA) 510(k) Premarket Notification and De Novo databases. RESULTS: From the PubMed database and internet search, we identified 58 ECG devices with available manufacturer information. Technical characteristics such as shape, number of electrodes, and signal processing influence the capabilities of the devices to record cardiac disorders. Of the 58 devices, only 26 (45%) had clinical evidence available regarding their ability to detect heart disorders such as rhythm disorders, more specifically atrial fibrillation. CONCLUSIONS: ECG devices available in the market are mainly intended to be used for the detection of arrhythmias. No devices are intended to be used for the detection of other cardiac disorders. Technical and design characteristics influence the intended use of the devices and use environments. For mobile ECG devices to be intended to detect other cardiac disorders, challenges regarding signal processing and sensor characteristics should be solved to increase their detection capabilities. Devices recently released include the use of other sensors on ECG devices to increase their detection capabilities.

Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model.

Background: Portable, smartphone-sized electrocardiography (ECG) has the potential to reduce time to treatment for patients suffering acute cardiac ischemia, thereby lowering the morbidity and mortality. In the UMC Utrecht, a portable, smartphone-sized, multi-lead precordial ECG recording device (miniECG 1.0, UMC Utrecht) was developed. Objectives: The purpose of this study was to investigate the ability of the miniECG to capture ischemic ECG changes in a porcine coronary occlusion model. Methods: In 8 animals, antero-septal myocardial infarction was induced by 75-minute occlusion of the left anterior descending artery, after the first or second diagonal. MiniECG and 12-lead ECG recordings were acquired simultaneously before, during and after coronary artery occlusion and ST-segment deviation was evaluated. Results: During the complete occlusion and reperfusion period, miniECG showed large ST-segment deviation in comparison to 12-lead ECG. MiniECG ST-segment deviation was observed within 1 minute for most animals. The miniECG was positive for ischemia (ie, ST-segment deviation ≥1 mm) for 99.7% (Q1-Q3: 99.6%-99.9%) of the occlusion time, while the 12-lead was only positive for 79.8% (Q1-Q3: 81.1%-98.7%) of the time (P = 0.018). ST-segment deviation reached maxima of 10.5 mm [95% CI: 6.5-14.5 mm] vs 5.0 mm [95% CI: 2.0-8.0 mm] for the miniECG vs 12-lead ECG, respectively. Conclusions: MiniECG ST-segment deviation was observed early and was of large magnitude during 75 minutes of porcine transmural antero-septal infarction. The miniECG was positive for ischemia for the complete occlusion period. These findings demonstrate the potential of the miniECG in the detection of cardiac ischemia. Although clinical research is required, data suggests that the miniECG is a promising tool for the detection of cardiac ischemia.

HEART score performance in Asian and Caucasian patients presenting to the emergency department with suspected acute coronary syndrome.

BACKGROUND: The HEART score is a simple and effective tool to predict short-term major adverse cardiovascular events in patients suspected of acute coronary syndrome. Patients are assigned to three risk categories using History, ECG, Age, Risk factors and Troponin (HEART). The purpose is early rule out and discharge is considered safe for patients in the low risk category. Its performance in patients of Asian ethnicity is unknown. We evaluated the performance of the HEART score in patients of Caucasian, Chinese, Indian and Malay ethnicity. METHODS: The HEART score was assessed retrospectively in 3456 patients presenting to the emergency department with suspected acute coronary syndrome (1791 Caucasians, 1059 Chinese, 344 Indians, 262 Malays), assigning them into three risk categories. RESULTS: The incidence of major adverse cardiovascular events within six weeks after presentation was similar between the ethnic groups. A smaller proportion of Caucasians was in the low risk category compared with Asians (Caucasians 35.8%, Chinese 43.5%, Indians 45.3%, Malays 44.7%, p<0.001). The negative predictive value of a low HEART score was comparable across the ethnic groups, but lower than previously reported (Caucasians 95.3%, Chinese 95.0%, Indians 96.2%, Malays 96.6%). Also the c-statistic for the HEART score was not significantly different between the groups. CONCLUSIONS: These results show that the overall performance of the HEART score is equal among Caucasian and Asian ethnic groups. The event rate in the low risk group, however, was higher than reported in previous studies, which queries the safety of early discharge of patients in the low risk category.

Sex-Based Differences in the Performance of the HEART Score in Patients Presenting to the Emergency Department With Acute Chest Pain.

BACKGROUND: Sex-based differences in clinical presentation, pathophysiology, and outcomes of patients with acute chest pain are increasingly being recognized, but are not implemented in guidelines and clinical prediction tools. We evaluated the performance of the HEART score in women versus men, because sex-based differences may exist among the algorithm's components: history, electrocardiogram, age, risk factors, and admission troponin level. METHODS AND RESULTS: The HEART score was retrospectively assessed in 831 women and 1084 men presenting to the emergency department with acute chest pain, assigning patients to the low-, intermediate-, or high-risk category for the occurrence of major adverse cardiac events (MACE) within 6 weeks. MACE, consisting of myocardial infarction, coronary revascularization, and all-cause death, also included events during index visit. Six-week MACE rates were 2 times lower in women than men (10.0% versus 20.8%; P<0.01). Despite similar discriminatory accuracy of the HEART score among women and men (c-statistic, 0.80 [0.75-0.84] versus 0.77 [0.74-0.81]; P=0.43), 6-week MACE rates were significantly lower in women than men across all HEART risk categories: 2.1% versus 6.5% (P<0.01) in the low-risk category, 12.7% versus 21.3% (P<0.01) in intermediate-risk category, and 53.1% versus 77.0% (P=0.02) in the high-risk category. The HEART score-adjusted risk ratio for men was 1.6 (1.3-2.0; P<0.01). CONCLUSIONS: The markedly higher 6-week MACE risk in men across all HEART risk categories should be taken into account when using the HEART score to guide clinical decision making; early discharge with a low-risk HEART score appears less safe for men than women with acute chest pain.

Ethnic differences in clinical outcome of patients presenting to the emergency department with chest pain.

BACKGROUND: Ethnicity, although known to influence cardiovascular outcome in assorted clinical settings, has not been investigated previously as a risk factor in patients presenting to the emergency department with suspected acute myocardial infarction. METHODS: In this multi-ethnic cohort study conducted in Singapore and The Netherlands, 2784 patients presenting to the emergency department with chest pain were enrolled (788 Caucasians, 1281 Chinese, 404 Indians and 311 Malays) and were followed up for 1 year. RESULTS: Although Caucasian patients on average were older and had incurred more cardiovascular adverse events, the Asian ethnic groups carried a greater burden of cardiovascular risk factors. Caucasian and Malay patients were most frequently diagnosed with acute myocardial infarction (Caucasians 11.2%, Chinese and Indians 6.4%, Malays 10.6%, P<0.001), also after correction for baseline differences. Chinese and Indian patients, however, more often had unstable angina. Asian patients had strikingly more extensive coronary artery disease than Caucasian patients (triple-vessel disease: Caucasians 6.5%, Chinese 22.8%, Indians 32.4%, Malays 32.8%, P<0.001) and Chinese patients with myocardial infarction more frequently underwent coronary revascularisation compared with Caucasian patients (Caucasians 41.4%, Chinese 67.5%, Indians 62.5%, Malay 46.7%, P=0.005). Ethnicity was not an independent predictor of major adverse cardiovascular events during 1-year follow-up in all chest pain patients. CONCLUSIONS: The prevalence of myocardial infarction and unstable angina, revascularisation rate and extent of coronary artery disease differ significantly among chest pain patients of different ethnic groups. These findings have important clinical implications and support consideration of ethnicity in risk stratification and determination of the patient management strategy in patients with symptoms suggestive of myocardial infarction.

Suspected acute coronary syndrome in the emergency room: Limited added value of heart type fatty acid binding protein point of care or ELISA tests: The FAME-ER (Fatty Acid binding protein in Myocardial infarction Evaluation in the Emergency Room) study.

BACKGROUND: Timely recognition of acute coronary syndrome remains a challenge as many biomarkers, including troponin, remain negative in the first hours following the onset of chest pain. We assessed the diagnostic accuracy of heart-type fatty acid binding protein (H-FABP), a cardiac biomarker with potential value immediately post symptom onset. METHODS AND RESULTS: Prospective monocentre diagnostic accuracy study of H-FABP bedside point of care (CardioDetect®) and ELISA tests in acute coronary syndrome suspected patients presenting within 24 hours of symptom onset to the emergency department, in addition to clinical findings, electrocardiography and the currently recommended biomarker high sensitivity troponin-T (hs-cTnT). The final diagnosis of acute coronary syndrome was adjudicated by two independent cardiologists, blinded to H-FABP results. Acute coronary syndrome was diagnosed in 149 (32.9%) of 453 unselected patients with suspected acute coronary syndrome (56% men, mean age 62.6 years). Negative predictive values were similar for H-FABP point of care and ELISA tests (79% vs. 78% respectively), but inferior to initial hs-cTnT (negative predictive value 86%). The addition of H-FABP point of care results to hs-cTnT increased the negative predictive value to 89%. In a multivariable logistic regression model, H-FABP point of care and ELISA tests yielded relevant diagnostic information in addition to clinical findings and ECG (likelihood ratio test p<0.001) and increased area under the receiver operating characteristics curve (AUC; 0.82 vs. 0.84 and 0.84). This added value attenuated, however, after inclusion of hs-cTnT in the diagnostic model (AUC 0.88). CONCLUSIONS: In patients suspected of acute coronary syndrome presenting to the emergency department, H-FABP testing improves diagnostic accuracy in addition to clinical findings and electrocardiography. H-FABP, however, has no additional diagnostic value when hs-cTnT measurements are also available.

No Added Value of Novel Biomarkers in the Diagnostic Assessment of Patients Suspected of Acute Coronary Syndrome.

BACKGROUND: Despite the availability of high-sensitive troponin (hs-cTnT), there is still room for improvement in the diagnostic assessment of patients suspected of acute coronary syndrome (ACS). Apart from serial biomarker testing, which is time-consuming, novel biomarkers like copeptin have been proposed to expedite the early diagnosis of suspected ACS in addition to hs-cTnT. We determined whether placenta derived growth factor (PlGF), soluble Fms-like tyrosine kinase 1 (sFlt-1), myoglobin, N-terminal prohormone B-type Natriuretic Peptide (NT-proBNP), growth-differentiation factor 15 (GDF-15) and copeptin improved early assessment of chest pain patients. METHODS: This prospective, single centre diagnostic FAME-ER study included patients presenting to the ED with symptoms suggestive of ACS. Blood was collected to measure biomarkers, notably, hs-cTnT was retrospectively assessed. Added value of markers was judged by increase in AUC using multivariable logistic regression. RESULTS: Of 453 patients enrolled, 149 (33%) received a final diagnosis of ACS. Hs-cTnT had the highest diagnostic value in both univariable and multivariable analysis. PPVs of the biomarkers ranged from 23.5% (PlGF) to 77.9% (hs-cTnT), NPVs from 67.0% (PlGF) to 86.4% (hs-cTnT). Only myoglobin yielded diagnostic value in addition to clinical symptoms and electrocardiography (ECG) (AUC of clinical model 0.80) with AUC of 0.84 (p<0.001). However, addition of hs-cTnT was superior (AUC 0.89, p<0.001). Addition of the biomarkers to our clinical model and hs-cTnT did not or only marginally (GDF-15) improved diagnostic performance. CONCLUSION: When assessing patients suspected of ACS, only myoglobin had added diagnostic value beyond clinical symptoms and ECG. However, when combined with hs-cTnT, it yields no additional diagnostic value. PlGF, sFlt-1, NT-proBNP, GDF-15 and copeptin had no added value to the clinical model or hs-cTnT.

Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial.

AIM: The disturbed circadian rhythm in haemodialysis patients results in perturbed sleep. Short term melatonin supplementation has alleviated these sleep problems. Our aim was to investigate the effects of long-term melatonin supplementation on quality of life and sleep. METHODS: In this randomized double-blind placebo-controlled trial haemodialysis patients suffering from subjective sleep problems received melatonin 3 mg day(-1) vs. placebo during 12 months. The primary endpoint quality of life parameter 'vitality' was measured with Medical Outcomes Study Short Form-36. Secondary outcomes were improvement of three sleep parameters measured by actigraphy and nighttime salivary melatonin concentrations. RESULTS: Sixty-seven patients were randomized. Forty-two patients completed the trial. With melatonin, no beneficial effect on vitality was seen. Other quality of life parameters showed both advantageous and disadvantageous effects of melatonin. Considering sleep, at 3 months sleep efficiency and actual sleep time had improved with melatonin compared with placebo on haemodialysis days (difference 7.6%, 95% CI 0.77, 14.4 and 49 min, 95% CI 2.1, 95.9, respectively). At 12 months none of the sleep parameters differed significantly from placebo. Melatonin salivary concentrations at 6 months had significantly increased in the melatonin group compared with the placebo group. CONCLUSIONS: The high drop-out rate limits the strength of our conclusions. However, although a previous study reported beneficial short term effects of melatonin on sleep in haemodialysis patients, in this long-term study the positive effects disappeared during follow up (6-12 months). Also the quality of life parameter, vitality, did not improve. Efforts should be made to elucidate the mechanism responsible for the loss of effect with chronic use.

Early statin treatment prior to primary PCI for acute myocardial infarction: REPERATOR, a randomized placebo-controlled pilot trial.

OBJECTIVE: The aim of this pilot study was to determine whether early atorvastatin treatment will reduce left ventricle (LV) remodeling, infarct size, and improve microvascular perfusion. BACKGROUND: In animal studies, early statin therapy reduces reperfusion injury after a percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). METHODS: Forty-two consecutive patients (82% male, mean age 61.2 ± 9.8) who underwent a primary PCI for a first ST-elevated AMI were randomized for pretreatment with atorvastatin 80 mg (n = 20) or placebo (n = 22) and continued with the same dosage daily for 1 week. All patients received atorvastatin 80 mg once daily 7 days after primary PCI. The LV function and infarct size were measured by magnetic resonance imaging within 1 day, at 1 week, and 3 months follow up. The primary endpoint was the end-systolic volume index (ESVI) at 3 months. Secondary endpoints were global LV function measurements, myocardial infarct size, biochemical cardiac markers, TIMI flow, and ST-T elevation resolution. RESULTS: ESVI 3 months after AMI was 25.1 mL/m(2) in the atorvastatin arm and 25.0 mL/m(2) in the placebo arm (P = 0.74). The differences in change from baseline to 3 months follow up in global LV function and myocardial infarct size did not differ between both treatment arms. Furthermore, biochemical markers, TIMI flow, and ST-T elevation resolution did not differ between atorvastatin and placebo arm. CONCLUSIONS: In this pilot study, pretreatment with atorvastatin in an acute myocardial infarction does not result in an improved cardiac function, microvascular perfusion, or decreased myocardial infarct size.