[Discussion on Technical Evaluation of Magnetocardiography].

There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.

Evaluation of standardized, computerized Dawes/Redman heart-rate analysis based on different recording methods and in relation to fetal beat-to-beat heart rate variability.

Dawes and Redman (DR) based their definition of short-term variation (STV) on the successive differences of mean inter-beat intervals dividing 1 min of cardiotocography recordings in 16 epochs of 3.75 s each. In contrast, heart rate variability (HRV) is based on the inter-beat intervals of discrete R peaks, also referred to as normal-to-normal (NN) intervals. Despite the historical achievements of DR in providing a robust method with the equipment available at the time to encourage the widespread use and creation of large databases, one must ask whether the STV (DR) parameter is reproducible using a different method of recording, and how much temporal information is actually lost by applying the averaging algorithm sketched above. We simultaneously performed both standard Oxford cardiotocography and transabdominal fetal electrocardiography recordings in 26 patients with low-risk singletons. In addition, we revisited our database of 418 standard fetal magnetocardiographic recordings, applying the DR algorithm to the fetal NN data and compared them to standard HRV parameters. The correlation between STV (DR) from cardiotocography and fetal electrocardiography was stronger that of either with short term fHRV from NN intervals. The methodological trade-off to gain STV as a robust parameter from heart rate traces of limited temporal resolution is accompanied by a loss of temporal information that, at the moment, only fetal magnetocardiography and, to a lesser extent, fetal electrocardiography may provide.

Fetal magnetocardiography (fMCG): moving forward in the establishment of clinical reference data by advanced biomagnetic instrumentation and analysis.

Cardiotocography and echocardiography are currently standard for fetal heart monitoring. However, both do not provide adequate temporal resolution to measure fetal cardiac time intervals and detect arrhythmias, which can occur during normal sinus rhythm. Fetal magnetocardiography (fMCG) is a non-invasive technique measuring magnetic signals generated by fetal heart activity. Most fMCG devices are installed in research institutions limiting the implementation of this method in a clinical setting. Several institutions made a step forward by installing devices, in particular for fetal investigations, in hospital sites to evaluate the clinical benefit. Based on instrumentation differences which can affect signal quality, there is still no established reference database for fetal cardiac time intervals. A new magnetograph dedicated to fetal recordings was implemented with improved patient comfort. The setting was optimized to establish a standard. A total of 103 healthy fetuses starting as early as possible after the first trimester were recorded and fMCG values of cardiac time intervals were compared to former studies. Data allowed high and reliable detection for all fMCG components starting at 17 weeks. The data were comparable to fMCG multicenter studies, fetal electrocardiography and neonatal ECG results and could serve as a database of norm values for further investigation of fetal arrhythmias.

Non-invasive magnetocardiography for the early diagnosis of coronary artery disease in patients presenting with acute chest pain.

BACKGROUND: Accurate identification of patients with acute coronary syndrome (ACS) is often difficult especially when an electrocardiogram (ECG) does not show typical elevation of ST segment. The aim of the present study was therefore to evaluate the efficacy of magnetocardiography (MCG) for diagnosis of ACS in patients with acute chest pain presenting without ST segment elevation. METHODS AND RESULTS: In the present retrospective study 364 patients with the suspected ACS without ST segment elevation were selected. Significant coronary artery disease (CAD) was defined as a stenosis > or =50% in at least one of 16 segments of the 3 major coronary arteries and their branches. The MCG recordings were obtained at resting state using a 64-channel MCG system in a magnetically shielded room. The patients were classified on the basis of the probability distribution. The presence of significant CAD was identified with a sensitivity of 84.0% and a specificity of 85.0%, compared to 44.7% and 89.8% on ECG. In the subgroup of patients without specific findings on ECG or biomarker test, MCG had a sensitivity of 73.5% and a specificity of 82.3%. CONCLUSIONS: MCG was acceptably sensitive and specific in identifying patients with ACS even in the absence of specific findings on ECG and positive biomarker tests. Thus, MCG seems beneficial for the early triage of patients with acute chest pain.

Detection of U wave activity in healthy volunteers by high-resolution magnetocardiography.

INTRODUCTION: The purpose of our study was to prove the existence of the U wave using magnetocardiograms (MCGs). METHODS: The 31-channel MCGs of 25 healthy volunteers were recorded. The onset of the U wave was defined by newly developed spatial correlation analysis; and the end, by different approaches. RESULTS: A U wave could be proved in all volunteers. In 10 volunteers (heart rate, 57 +/- 19 beats/min) in whom the U wave was found to be separated from the following P wave, the U wave's end could be determined as a threshold value (U wave duration, 310 +/- 24 milliseconds). In 15 volunteers (heart rate, 70 +/- 38 beats/min), the end of the U waves was concealed by a continuous transition of the U waves into the following P waves. CONCLUSIONS: The U wave seems to be a regular phenomenon and has a distinct spatiotemporal assembly.

Space-time database for standardization of adult magnetocardiogram-making standard MCG parameters.

BACKGROUND: The magnetocardiogram (MCG) is a promising medical tool for detecting and visualizing abnormal cardiac electrical activation in heart-disease patients. However, there is no large-scale MCG database of healthy subjects, and there is little knowledge of gender- and age-related influences on MCG data. METHODS AND RESULTS: We obtained MCG data from 869 subjects (554 men, 315 women) using a conventional 64-channel MCG system, which covers the whole heart. Electrocardiogram (ECG) data were also obtained; 464 people (268 men, 196 women) were identified as a normal group using ECG data. Time intervals (PQ, QRS, QT, and QTc), current distributions (maximum current vector (MCV), and the total current vector (TCV)) of MCG data of the 464 normal subjects were analyzed to obtain basic MCG parameters. Although mean values of PQ and QRS intervals of the male subjects were slightly longer than those of the female subjects, no intervals were correlated with gender or age. The correlation between PQ intervals of ECG and those of MCG was better than the correlation between QRS and QT intervals of ECG and those of MCG. Both MCV and TCV angles were much smaller than the electrical-axis angle in ECG. Although TCVs of the QRS and T waves were stable, the women's mean T-wave-TCV angles significantly increased with age. The maximum amplitude of the P wave was about 1.7 pT, and the value of the QRS complex was about 20-25 pT. Moreover, the T-wave amplitude decreases with age. CONCLUSION: The MCG standard space-time parameters determined here provide a normal range for MCG parameters.

Standardization of magnetocardiography in nonhuman primates.

To establish the electrophysiological mappings of nonhuman primates by using magnetocardiogram (MCG) data and obtain the normal values of MCG parameters, we used 64-channel superconducting quantum interference devices to measure 8x8 MCG data for 95 cynomolgus monkeys (Macaca fascicularis, 51 female and 44 male). The PQ interval, QRS duration, QT interval and QTc were respectively 79+/-14 ms, 42+/-7 ms, 222+/-23 ms and 363+/-25 (mean+/-SD), and these parameters did not differ significantly between female and male monkeys. These results indicate the normal values of the MCG parameters of the cynomolgus monkey and should facilitate animal experiments in magnetocardiography.

Magnetic dispersion of the late repolarization in Brugada syndrome.

BACKGROUND: Magnetocardiography (MCG) is a new noninvasive modality for recording cardiac depolarization and repolarization and was used in the present study to evaluate abnormalities in patients with Brugada syndrome (BS). METHODS AND RESULTS: The MCG findings of 10 BS, 21 right bundle branch block (RBBB), and 34 normal patients were compared. On the horizontal spatiotemporal activation graph (STAG), the r' waves were more frequently located on the right side in the RBBB than in the normal (p=0.001) or BS groups (p=0.001). The maximum current angles of the r' wave fell into the northwest axis in all BS patients as compared to having a right axis deviation in 19 of 21 RBBB patients (90.4%, p=0.001). In the magnetic field and current density vector maps during late repolarization, the BS group had a non-dipole pattern more frequently and a higher number of poles compared with the normal (p=0.001) and RBBB groups (p=0.001). CONCLUSIONS: During depolarization, the horizontal STAG location and maximum current angle of the r' wave were beneficial in differentiating BS from RBBB and normal. The magnetic dispersion was a more frequently observed finding in BS patients than in RBBB and normal patients during late repolarization.

Spatiotemporal correlation analyses: a new procedure for standardisation of DC magnetocardiograms.

There is a lack of standard methods for the analysis of magnetocardiograms (MCGs). MCG signals have a shape similar to the ECG (P wave, QRS complex, T wave). High-quality multichannel recordings can indicate even slight disturbances of de- and repolarisation. The purpose of our study was to apply a new approach in the analysis of signal-averaged DC-MCGs. DC-MCGs (31-channel) were recorded in 182 subjects: 110 patients after myocardial infarction and 72 controls. Spatiotemporal correlation analysis of the QRS complex and T wave patterns throughout the entire heart cycle was used to analyse homogeneity of de- and repolarisation. These plots were compared to standard ECG analyses (electrical axis, Q wave, ST deviation, T polarity and shape). Spatiotemporal correlation analyses seem to be applicable in assessing the course of electrical repolarisation with respect to homogeneity. MCG provided all diagnostic information contained in common ECG recordings at high significance levels. The ECG patterns were included in 5/8 of our parameters for electrical axis, 6/8 for Q-wave, 7/8 for ST deviation and 5/8 for T-polarity based on two time series of correlation coefficients. We conclude that our spatiotemporal correlation approach provides a new tool for standardised analysis of cardiac mapping data such as MCG.