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WO2012022680A1 - Calcul de modifications d'un signal identifiable au moins tridimensionnellement, apparaissant périodiquement dans un organisme - Google Patents

Calcul de modifications d'un signal identifiable au moins tridimensionnellement, apparaissant périodiquement dans un organisme Download PDF

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Publication number
WO2012022680A1
WO2012022680A1 PCT/EP2011/063898 EP2011063898W WO2012022680A1 WO 2012022680 A1 WO2012022680 A1 WO 2012022680A1 EP 2011063898 W EP2011063898 W EP 2011063898W WO 2012022680 A1 WO2012022680 A1 WO 2012022680A1
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Prior art keywords
signal
dimensionally
identifiable
identifiable signal
value
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English (en)
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Axel Bauer
Konstantinos Rizas
Georg Schmidt
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/339—Displays specially adapted therefor
    • A61B5/341—Vectorcardiography [VCG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/726—Details of waveform analysis characterised by using transforms using Wavelet transforms

Definitions

  • the present invention relates to a method for determining a change in a living organism over time periodically occurring, at least three-dimensionally identifiable signal to a corresponding signal in a reference organism, a device for performing this method, a computer program, designed to perform this method , as well as a computer readable medium.
  • the determination of a change in a living organism over time periodically occurring, at least three-dimensionally identifiable signal to a reference species is in many areas of technology and in particular medicine of relevance.
  • Three-dimensional signals occurring periodically over time can be found in biological systems.
  • An example of this is the accumulated electrical activity of the brain, which is measured in the context of so-called electroencephalography (EEG).
  • EEG electroencephalography
  • the potential differences generated by the heart are also such three-dimensional signals that occur periodically over time. These can be measured by means of vector electrocardiography or vector cardiography (VKG), with which the temporal course of the potential differences as they project on the body surface is spatially recorded. Changes in the potential differences over time that are generated by the heart compared with reference values determined in healthy organisms may allow conclusions to be drawn regarding the development of heart disease or even the presence of heart disease.
  • sudden cardiac death is one of the most frequent causes of death in the Western world.
  • the identification of endangered high-risk patients is a major clinical problem and currently succeeds only inadequately.
  • the reliable diagnosis of repolarization of the heart is therefore of great medical importance, since affected patients with the provision or implantation of a suitable medical device, for example.
  • a defibrillator, targeted help and the onset of sudden cardiac death could be prevented in many cases.
  • T-wave alternans describes a physiological phenomenon that is identifiable in individuals in the electrocardiogram.
  • T-wave alternans presents as a beat-to-beat variation of T-wave amplitude, also referred to as ABAB behavior.
  • ABAB behavior In order to induce a T-wave alternans, must the person to be examined is usually physically burdened, for example by physical activity on an ergometer. Only from high heart rates, this phenomenon may be observed. Due to the associated health risks, however, the burdening of potentially ill patients is hardly justified and requires a great deal of effort. In addition, in about one third of all patients, the test for T-wave alternans gives no result.
  • the invention has for its object to provide an improved method for detecting a change in a living organism over time periodically occurring, at least three-dimensionally identifiable signal against a corresponding signal in a reference organisms, in which in the prior art known disadvantages are avoided.
  • the object of the invention is completely solved by such a method.
  • an at least three-dimensionally identifiable or locatable signal is understood to mean such a signal, preferably biological phenomena or processes, which can be assigned a defined position in three-dimensional space.
  • this spatially identifiable signal may also be identifiable with respect to another 4th, 5th, 6th or nth dimension.
  • the spatially identifiable signal can, for example, change over time and consequently be identifiable at least four-dimensionally.
  • the spatially identifiable signal can be assigned further physical variables or dimensions, such as, for example, the temperature.
  • the provided in step 1 record contains all the information with which each signal spatially and preferably temporally located or identified.
  • the data record can have a multiplicity of the at least three-dimensionally identifiable signal in a consecutive time sequence.
  • the data may, for example, be Cartesian coordinates or else polar coordinates, by means of which the signal in space can be identified as a function of time.
  • a so-called weighted main vector is determined in step 2 for each at least three-dimensional identifiable signal, which may also be referred to as an amplitude-weighted mean main vector. This preferably results from the polar coordinates of the signal for each time point, ie the azimuth and elevation angles, which are weighted with the amplitude or the radius of the signal.
  • the direction vector may be defined by the direction of the signal at the time of the maximum amplitude.
  • the changes in the spatial position of the weighted main vector of a three-dimensionally identifiable signal to the spatial position of the weighted main vector of a temporally subsequent three-dimensionally identifiable signal are determined, whereby a time signal dT (t) P is obtained, in which it preferably by an angle.
  • dT (t) P is obtained, in which it preferably by an angle.
  • P stands for "patient”. This time signal is the decisive parameter which allows conclusions to be drawn regarding the presence of a change, for example a repolarization disorder of the heart.
  • the change of the spatial location of the weighted main vector of the three-dimensionally identifiable signal relative to the spatial position of the average weighted main vector over any period of time for example. 2, 3, 4, 5, 10, 15, 20 or 30 minutes, are determined to obtain the time signal dT (t) P.
  • a comparison of dT (t) P with a reference function dT (t) R determined in accordance with the reference species takes place.
  • R stands for "reference organisms”.
  • the reference creature is such a living being, for example, a human, the healthy, ie no Change, for example, has no repolarization disorder of the heart, or is long-term surviving and against which, if necessary, a temporal change of the patient at least three-dimensional identifiable signal is to be determined.
  • the reference animal has not died from the determination of dT (t) R for a longer period of preferably at least 5 years.
  • Determined accordingly means according to the invention that the method for determining dT (t) R is the one with which dT (t) P is determined.
  • the presence of a change is then diagnosed when dT (t) P is not equal to dT (t) R.
  • the inventors have recognized that the temporal changes of the spatial position of the weighted main vectors from a signal to the time lag, i. the time signals dT (t) between different groups of animals, for example healthy and those with repolarization disorders, surprisingly differ significantly from one another and therefore have diagnostic potential.
  • step 4 a quantification of dT (t) P to obtain an indicator value and a corresponding quantification of dT (t) R to obtain a corresponding reference value and a comparison of indicator value and reference value, and in step 5, a correlation of indicator value reference value with the presence of the change takes place.
  • corresponding quantification means that the methodology for quantifying dT (t) R is that with which dT (t) P is quantified.
  • the inventors have recognized that can be found in the time signal dT (t) periodicities or oscillations, for example, have a frequency of ⁇ 0.03Hz and are not detectable on the analysis of T-wave alternans.
  • the time signal dT (t) can therefore be analyzed by various time domain and frequency domain methods, such as spectral analysis, wavelet analysis or phase-rectified signal averaging (PRSA) analysis.
  • the determination of the change with time of a signal, which occurs periodically in a living organism over the time, of at least three-dimensionally identifiable signals relative to a corresponding signal in a reference species is the diagnosis of a repolarization disorder of the heart in a living being.
  • This measure has the advantage that a new method is provided, with which in a reliable manner repolarization disorders of the heart can be diagnosed.
  • a physical load on the living being or patient to be examined is not required, as a result of which the method according to the invention can also be used in persons who are already ill.
  • the inventors were able to show that by means of the new method or temporal function dT (t) P and the corresponding quantified value resulting from this function, the relative risk of a patient after a myocardial infarction in the subsequent period to die, clearly is more predictable than by the conventional risk factors.
  • the method according to the invention provides a significantly higher prognostic value than the methods currently used, and therefore allows a much more reliable therapeutic decision, for example, whether prophylactic measures such as the implantation of a defibrillator appear reasonable.
  • the inventors were able to check this in a retrospective clinical examination of 908 infarct patients who were observed over five years after the onset of infarction.
  • the method according to the invention not only repolarization disorders of the heart can be diagnosed as such. It is also possible to assign the examined living beings or patients to risk groups. Thus, for example, an assignment to so-called high-risk patients can take place if the indicator value reference value applies.
  • the at least three-dimensional identifiable signal is the development of tension in the heart during the ventricular repolarization (T-loop).
  • This measure according to the invention has the advantage that a signal is analyzed over time, which, according to findings of the inventors, appears to be causally related to sudden cardiac death.
  • the spatial course of the ventricular repolarization is also referred to as a T-loop or T-vector loop due to its representation in the vectorcardiogram and represents the three-dimensional counterpart to the T-wave in the two-dimensional ECG.
  • the at least three-dimensional identifiable signal corresponds to at least one part, ie a temporal section of the T-loop, for example at least the first / last temporal 1/8, at least the first / last temporal 1/4, at least the first / last temporal 1/3, at least the first / last temporal Hälte, preferably the temporally whole T-loop.
  • the at least three-dimensional identifiable signal corresponds to the temporal portion from the beginning (T start ) to the top of the T-loop or T-wave (T peak ) or from the top (T peak ) to the end of the T-loop or T-wave (T end ).
  • the data set provided in step 1 comprises measurement data from vector cardiography.
  • This measure has the advantage that a proven in clinical routine, easy to perform and reliable measurement method is used, which provides all the data required for the implementation of the method according to the invention.
  • vector cardiography By means of vector cardiography, the temporal course of the potential differences generated by the heart, as they project on the body surface, can be measured and represented, for example, by means of a vectorcardiogram (VCG).
  • VCG vectorcardiogram
  • the vector cardiogram and the vectorcardiogram additionally give the spatial progression of the voltage changes at the time of atrial and ventricular depolarization as well as ventricular repolarization vectorial, ie in the form of so-called vector loops, again.
  • Vector cardiography therefore requires the use of certain delivery systems that compensate for the stress distortions of the organs located between the heart and body surface.
  • orthogonal Frank leads or conventional 12-lead ECG leads are mostly used.
  • the P and R loops represent the spatial progression of the voltage vectors of the atrial (P-loop) and ventricular (R-loop) depolarizations, respectively.
  • the T-loop represents the development of tension during ventricular repolarization.
  • the vector points with its arrowhead at any time from the electrical zero point of the heart in a certain direction in space.
  • the magnitude of the vector or sum potential, the magnitude is represented by the length of the arrow. Due to the angles that the sum vector forms with the frontal plane, the so-called elevation angle, and which forms the sum vector with the horizontal plane, the so-called azimuth angle, its spatial orientation is clearly defined.
  • step 3 of the method according to the invention by mathematical transformation of the Cartesian coordinates x, y, z of at least three-dimensionally identifiable signal or the T-loop in the polar coordinates azimuth angle, elevation angle and radius or Amplitude takes place. Further, it is preferable that, in step 3, dT (t) P is determined as an angle measure.
  • the at least three-dimensional identifiable signal or the T-loop is optimally imaged at any time and detects the maximum excitation.
  • step 3 the temporal change dT (t) P of the spatial position of the weighted main vector of each at least three-dimensionally identifiable signal or each T-loop relative to the spatial position of the weighted main vector of the temporally next following at least three-dimensionally identifiable signal or the temporally next following T-loop is determined.
  • step 4 dT (t) P is transformed into a PRSA P signal by means of "phase-rectified signal averaging" (PRSA) and a comparison with a correspondingly transformed into a PRSA R signal dT (t) R occurs.
  • PRSA phase-rectified signal averaging
  • the PRSA analysis is described, for example, in Bauer et al. (2006), phase rectified signal averaging detects quasi-periodicities in non-stationary data; Physica. A. 364: 423-434, or in Bauer et al. (2006), Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study; Lancet 367 (9523): 1674-81.
  • the content of the above publications is incorporated by reference in the disclosure of the present invention.
  • the PRSA analysis is especially useful for non-stationary, noisy signals, ie signals whose characteristics can change over time. This is the case with most biological signals, for example also with the repolarization signal in the heart or the T-loop.
  • the PRSA analysis transforms an arbitrarily long time signal into a new, much shorter time signal, the so-called PRSA signal. In this all periodic or oscillatory components of the original signal are included. However, non-periodicities and noise are largely eliminated. "Transformed accordingly" means according to the invention that the methodology for transforming the PRSA R signal is that used to transform the PRSAp signal.
  • the indicator value is a measure of the amplitude in the center of the PRSA P signal and the reference value is a measure of the amplitude in the center of the PRSA R signal.
  • This measure has the advantage that a particularly suitable indicator value or reference value is determined.
  • These can be determined, for example, by means of the Haar wavelet transformation.
  • the Haar wavelet transform quantifies the amplitude in the center of the PRSA signals, as it were. There, due to the method, all oscillations are in phase, and their amplitudes add up.
  • step 6 correlation of indicator value> reference value with the presence of the change or the diagnosis of a repolarization disorder of the heart.
  • This measure has the advantage that the fact recognized by the inventors that patients who died in the follow-up period have significantly greater indicator values than non-deceased patients is used diagnostically.
  • step 1 of the method according to the invention the provided data record at least 60, preferably at least 120, 180, 240, 300, 600, 900, 1200 and most preferably at least 2000 at least three-dimensional identifiable signals or T-loops represents.
  • vector cardiography was performed over a period of at least one minute, preferably at least over 2, 3, 4, 5, 10, 15, 20, and most preferably at least 30 minutes.
  • This measure has the advantage that a sufficient number of signals or T-loops are analyzed so as to obtain a particularly meaningful result.
  • Another object of the present invention relates to an apparatus for performing the method according to the invention, which further preferably comprises a data carrier containing the data set from step 1 of the method according to the invention, as well as an evaluation device which is used to determine the weighted main vector for each T-loop, for determining the time function dT (t) P , for quantifying the time function dT (t) P and obtaining an indicator value, for correlating the indicator value with a reference value, and for setting the diagnosis.
  • the data set is obtained via a discharge system, preferably an orthogonal or bipolar derivative, for example a Frank derivative.
  • This measure has the advantage that in this way the potential differences generated by the heart in the course of time can be detected spatially.
  • the evaluation device preferably has a processor.
  • the evaluation device can consequently be a computer.
  • Another object of the present invention relates to a computer program which is designed to carry out the method according to the invention, and a computer-readable data carrier having the computer program according to the invention.
  • Fig. 1 illustrates the spatial representation of a three-dimensional
  • FIG. 2 shows the time profile of a T-loop, represented in the Cartesian coordinate system (partial images A, B and C) or in the polar coordinate system (partial images D, E and F), on the x-axis is the time in milliseconds ( ms), the voltage in millivolts (mV) is plotted on the y-axis;
  • FIG 3 illustrates the determination of the weighted average azimuth (WAA) and the weighted average elevation (WEE) from the polar coordinates for each measured value of a T-loop (A) and shows by way of example the mathematical determination on the basis of 6 measured values (B);
  • WAA weighted average azimuth
  • WEE weighted average elevation
  • FIG. 4 shows by way of example the weighted main vector of a T-loop in FIG.
  • Fig. 5 illustrates the detection of the time signal dT (t) by calculating the angle between two adjacent T-waves
  • FIG. 6 illustrates the temporal variation of dT (t) determined for FIG. 3
  • Fig. 7 shows typical dT (t) time signals one within five years after
  • Fig. 10 illustrates the different TWR values for survivors
  • 11 shows the result of a log-rank test statistic for determining the optimal separation value between surviving and deceased patients.
  • Figure 12 shows the mortality rates in patients with normal TWR as well as with abnormal TWR.
  • a vector electrocardiogram or vectorcardiogram is recorded over a period of several minutes, preferably 20 to 30 minutes, in the resting state. This is done by derivations that allow a three-dimensional reconstruction of the repolarization processes, as is possible, for example, by an ordinary 12-channel recording or an orthogonal Frank derivative and a McPhee derivative.
  • the T-loop as a three-dimensional process can be represented at any time in the Cartesian coordinate system, i. At any given time, the process is defined by an x, y, and z value.
  • the spatial direction of the repolarization can alternatively be described for each time point in the polar coordinate system by means of two angles, namely the azimuth and elevation angle; see. Fig. 1.
  • the conversion of data of the Cartesian coordinate system into data of the polar coordinate system is described in the prior art.
  • Each repolarization event consists of a certain number of measurements according to the drawing frequency. With a drawing frequency of 1000 Hz and a duration of the T-loop of 300 ms, approximately 300 measured values are obtained. Consequently, for each time point of the T-loop one obtains a value for the polar coordinates azimuth, elevation and amplitude.
  • weighted main vector For each repolarization event of the T-loop, based on the data obtained, a so-called weighted main vector is calculated, which should characterize the repolarization event.
  • the weighted main vector consists of two values, a weighted average azimuth and a weighted average elevation.
  • the weighted average azimuth and the weighted average elevation determine the main direction of repolarization in three-dimensional space, corresponding to an arrow in a sphere; see. Fig. 4. It is understood that the main vector characterizing the repolarization can be calculated in other ways.
  • the temporal change dT (t) of the spatial position of the weighted main vector of each T-loop with respect to the spatial position of the weighted main vector of a temporally following T-loop is determined as an angle measure. This is illustrated in FIG. 5A.
  • dT (t) acos (dT (t) x + dT (t) + dT (t) 2 )
  • the result for the values determined in FIG. 3B is shown in FIG. 5B.
  • the angular change dT (t) between the first and second T-turns is 6.86 °.
  • FIG. 6 shows the time signal dT (t) or the angle change for three consecutive T loops which follow one another at a time.
  • the determined time signal dT (t) can be graphically displayed over time.
  • Fig. 7 shows the dT (t) signal of a patient who has died within five years of a heart attack (upper curve, solid line; dT (t) P ). It also shows the dT (t) signal of a patient who survived a five-year period after a heart attack (lower curve, unexhausted line, dT (t) R ).
  • the lower curve represents the reference value, with the upper curve is compared.
  • the signals are clearly different.
  • the deceased patient's signal shows a much more pronounced variability, which allows the diagnosis of a repolarization disorder.
  • the time function dT (t) can be analyzed by various time and frequency domain methods.
  • One possibility is spectral analysis; see. Fig. 8A.
  • Another possibility is the wavelet analysis.
  • the so-called "phase rectified signal averaging" - or PRSA analysis offers; see. Fig. 8B.
  • the PRSA signal shows a clear oscillation with a wavelength of about 40 beats.
  • the PRSA signal can be quantified by a Haar wavelet transformation.
  • the resulting parameter is referred to by the inventors as TWR (T-Wave Rhythmicity).
  • FIG. 9 shows the TWR value of a patient who has survived without complications for at least five years after a myocardial infarction (left, PRSA R ). The data were obtained shortly after the onset of myocardial infarction. In contrast, the TWR value of a patient who died within five years of a heart attack (right, PRSA P ) is shown. The data was also obtained shortly after the onset of myocardial infarction. In both PRSA signals, there are low-frequency oscillations, ie repolarization processes of both patients are periodically modulated.
  • the amplitudes of the oscillations in the PRSA signal of the deceased patient are significantly higher.
  • the TWR value obtained by quantifying the PRSA signal quantifies the amplitude in the center of the PRSA signal and can be used as a risk parameter.
  • the TWR value of the survivor is 1.08 ° and the TWR value of the deceased is 6.18 °.
  • the TWR value of the deceased is thus significantly larger than that of the surviving patient.
  • the prognostic value of the method according to the invention was confirmed in a clinical study. 908 patients who had survived an acute myocardial infarction were studied. 335 patients (37%) were older than 65 years. 85 patients (9%) showed a left ventricular ejection fraction (LVEF) of ⁇ 35%. 47 patients (5%) had an LVEF of ⁇ 30%. 179 patients (20%) had diabetes mellitus. Eighty-six patients (9%) had a heart attack earlier.
  • LVEF left ventricular ejection fraction
  • the TWR value was determined for each patient by means of the method according to the invention.
  • the result is shown in FIG. 10 in the form of a box plot.
  • FIG. 10 there is a statistically highly significant difference in TWR between both groups of patients.
  • the deceased patients have significantly higher TWR values.
  • the reference value or separation value between the two groups can be determined. This is done, for example, by means of the maximization of the so-called Logrank or Mantel-Cox test.
  • the optimal cutoff value ie the reference value, between survivors and deceased was 4.2 °.
  • the logrank test statistic is maximal. Patients with one TWR values> 4.2 ° are therefore considered to be at risk, and patients ⁇ 4.2% are considered to be at low risk; see. Fig. 11.
  • FIG. 12 shows the mortality rates of patients of the investigated collective stratified according to TRW> 4.2 ° (upper curve, solid line) and ⁇ 4.2 ° (lower curve, open line). Patients with TWR> 4.2 ° are much more likely to die in the aftermath of infarction, compared to patients with TWR ⁇ 4.2 °.
  • the TWR value of> 4.2 ° proves to be a strong predictor independent of conventional risk factors.
  • the Cox regression analysis provides a statistical model for predicting 5-year mortality using the risk markers entered into the analysis. All values with a p-value of ⁇ 0.05 are included in the model. The relative risk shows the relative importance of each parameter.
  • Table 1 The result of a Cox regression analysis for the clinical study performed is shown in Table 1 below.
  • CI confidence interval
  • p significance value
  • TWR T-wave rhythmicity value
  • LVEF left ventricular ejection fraction
  • HI heart attack
  • the TWR value is the strongest parameter with a relative risk of 6.5 in this analysis. This means that the TWR value according to the invention is an extremely strong and conventional risk factors Independent predictor, which has a much greater significance than the current standard predictor LVEF.

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Abstract

La présente invention concerne un procédé de calcul d'une modification d'un signal identifiable au moins tridimensionnellement, apparaissant périodiquement dans le temps dans un organisme, par rapport à un organisme de référence, un dispositif pour la réalisation de ce procédé, un programme informatique configuré pour la réalisation de ce procédé, ainsi qu'un support de données pouvant être lu par un ordinateur.
PCT/EP2011/063898 2010-08-18 2011-08-12 Calcul de modifications d'un signal identifiable au moins tridimensionnellement, apparaissant périodiquement dans un organisme Ceased WO2012022680A1 (fr)

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