EP3934528A1 - Système de prédiction d'au moins un dysfonctionnement cardiaque d'un individu - Google Patents
Système de prédiction d'au moins un dysfonctionnement cardiaque d'un individuInfo
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- EP3934528A1 EP3934528A1 EP20711078.4A EP20711078A EP3934528A1 EP 3934528 A1 EP3934528 A1 EP 3934528A1 EP 20711078 A EP20711078 A EP 20711078A EP 3934528 A1 EP3934528 A1 EP 3934528A1
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Classifications
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- 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]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/35—Detecting specific parameters of the electrocardiograph cycle by template matching
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- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/346—Analysis of electrocardiograms
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- A61B5/353—Detecting P-waves
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- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/30—Input circuits therefor
- A61B5/307—Input circuits therefor specially adapted for particular uses
- A61B5/308—Input circuits therefor specially adapted for particular uses for electrocardiography [ECG]
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- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/333—Recording apparatus specially adapted therefor
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- 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]
- A61B5/346—Analysis of electrocardiograms
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- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/355—Detecting T-waves
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- 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]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/366—Detecting abnormal QRS complex, e.g. widening
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- A—HUMAN NECESSITIES
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- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
- A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
- A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
Definitions
- the invention relates to a system for predicting at least one cardiological dysfunction in an individual.
- Atrial fibrillation heart failure, or ischemic stroke can occur.
- Functional disorders of the heart muscle in the area of the atria are based on a pathological increase in connective tissue (fibrosis) and one with it
- Diagnostic techniques for identifying people with atrial cardiomyopathy are either based on magnetic resonance imaging
- Atrial sequence image recordings or on an invasive electroanatomical mapping using a special 3D system of a cardiac electrophysiological catheter laboratory Both diagnostic options are characterized by limited availability and high costs.
- gadolinium In the case of magnetic resonance-supported examinations, gadolinium must also be injected as a contrast medium. For the reasons mentioned, it's on the Hand that such examinations on patients with atrial cardiomyopathy are only carried out in exceptional cases, ie not systematically.
- Atrial fibrillation and stroke shows for the first time that the strongly amplified P-wave duration, which can be derived from a digitally amplified 12-channel surface ECG within a sinus rhythm, correlates very well with the extent of the fibrotic low-voltage substrate within the left atrium. Patients with a P-wave duration of> 150 ms are at an increased risk of a recurrence of arrhythmias.
- the invention is based on the object of specifying a system for predicting at least one cardiological dysfunction, in particular in the form of atrial fibrillation and / or ischemic stroke and / or heart failure, so that the reliability and resilience of a prediction about the
- the invention is based on the knowledge that the reliability with which a statement can be made about a potentially existing risk to which an individual is exposed of suffering atrial fibrillation or an ischemic stroke in the future is directly correlated with the accuracy of the
- the aim is to precisely determine the P wave duration with a time error of a maximum of ⁇ 2 ms, preferably a maximum of ⁇ 1 ms, particularly preferably a maximum of ⁇ 0.5 ms.
- the measurement quality on which the system according to the solution is based for the temporal acquisition of the P-wave duration enables person-specific predictions with regard to future cardiovascular dysfunction with a probability of at least 80% up to over 90%.
- the system comprises a means for providing an EKG recorded on a person, which has a number n of time-synchronous EKG leads which each comprise a time sequence of the sinus rhythm of a heartbeat of the person representing time signals.
- the means for providing the EKG is preferably in the form of a digital 12-channel standard EKG recording device or a body surface EKG recording system that uses multiple electrodes to record the electrical cardiac excitations.
- the means for providing the n time-synchronous EKG leads can only be designed in the form of a storage medium on which the n-EKG leads are stored in digital form.
- n 3 derivations are necessary, which are used as the basis for further evaluation.
- Stimulus formation spreads from the sinus node in the right atrium over the left atrium in the direction of the AV node (atrioventricular node).
- the temporal end of the P-wave is defined by the achievement of the complete electrical excitation of the atria, which usually precedes the ventricular excitation defined in the sinus rhythm by the QRS complex.
- the system includes a selection means which selects those EKG leads from the number n provided EKG leads which are preferably suitable for a P-wave duration determination.
- the EKG leads present in digital form enable the use of a program evaluating image data and / or numerical evaluation algorithms within the framework of the processor-supported selection means, which, with additional use of stored expert information, for example in the form of Reference data, as well as optional use of self-learning
- ECG leads select those that contain characteristic and complete P-wave components. From all ECG leads, at least two or, if the selection criteria are met, preferably all ECG leads are to be selected. The selection of suitable EKG leads is thus based on a certain degree of similarity between the EKG leads present on the part of the provision means and a predetermined reference as the first decision criterion E1.
- a processor-based arithmetic unit which serves as an analysis unit and communicates with the selection means, analyzes the preselected EKG leads with respect to the beginning and end of the P-wave in at least one sinus rhythm per EKG lead.
- An iso-electrical signal level that can be assigned to the time signals of a selected EKG lead is preferably characterized in that, within a predetermined time span, the EKG time signals have no technically evaluable signal levels that are higher than the noise component.
- a time period before the P-wave within a is suitable
- Sinus rhythm which is at least 10 ms, preferably at least 20 ms, particularly preferably at least 30 ms long.
- the analysis unit determines that first point in time which is before the QRS complex and from which the subsequent time signals of the EKG lead are one of the iso-electrical signals
- Signal level have different signal levels.
- This signal level which deviates from the iso-electrical signal level, preferably has at least twice the signal level compared to the iso-electrical signal level.
- a further criterion can be used to determine the first point in time defining the beginning of the P-wave, according to which, within a first time period immediately following the first point in time, subsequent time signals each have a positively increasing signal level, that is, those caused by the time signals Mathematically, the P-wave defined within the second point in time has positive first derivatives.
- the end of the P-wave i. E. as the second point in time, that point in time whose assigned time signal corresponds to the iso-electrical signal level and which is directly related to this time signal
- preceding time signal has at least twice the signal level compared to the iso-electrical signal level.
- a second point in time which determines the second point in time, can advantageously be used
- Decision criterion can be used according to which the time signals lying within a second time period following the second point in time must have the isoelectric signal level or are limited by the temporal start of the temporally following QRS complex, which corresponds to the so-called chamber complex.
- the second time span should be at least 4 ms.
- Another optional decision criterion which can be used in combination or as an alternative to the above decision criteria to determine the respective first and second point in time, which time-limit the P-wave, uses the comparison of the EKG leads with a reference time signal pattern from a sinus rhythm -P wave. A numerical pattern recognition is carried out as part of the comparison.
- the analysis unit selects that first point in time that was recorded as the earliest in time from all selected EKG leads, which each comprise time-synchronized time signals. In contrast, the
- EKG time signals selected that second point in time which has been determined chronologically as the latest second point in time.
- the analysis unit determines the actual (maximum) P-wave duration, which is necessary for further considerations of an exact measurement duration of the P-wave within the
- the system according to the solution also includes a comparator which determines a deviation between the determined P-wave duration and a reference value and generates a signal on the basis of a second decision criterion.
- the second decision criterion is a maximum
- Time span Atmax is based, for which the following applies: 100 ⁇ Atmax ⁇ 140 ms.
- the comparator In the event that the determined P-wave duration is greater than Atmax, the comparator generates the signal in the form of an acoustic, visual or haptically perceptible signal.
- At least two, preferably all of the following EKG leads are suitable for determining the respective second point in time: I, II, III, aVR, aVL, aVF, V2 to V6. It is also possible to use only at least three EKG leads according to the solution in order to determine the P-wave duration with sufficiently high reliability. In this case it is important to arrange the EKG electrodes so that the measurement of at least one inferior or one lateral or one inferolateral or one superolateral or one anterior EKG lead is possible. To derive the lateral or inferior or inferolateral or superolateral EKGs, the EKG electrodes can be attached to the right and left of the sternum or the central sagital axis of the body. To derive the anterior or posterior EKG electrodes, the EKG electrodes can be attached to the front and rear of the chest. In all cases, the EKG electrodes must be on opposite sides of the zero potential line of the Flerzfeld according to Augustus Waller (1887).
- the distance between two electrodes should be greater than 1 cm in order to adequately record the cardiac signals and to make them accessible for the diagnosis of atrial cardiomypathy, e.g. right and left of the sternum or on the right and left clavicle ("collarbone") or on the right Ear and the left clavicle (each on the other side of the zero potential line) or right hand and left hand.
- atrial cardiomypathy e.g. right and left of the sternum or on the right and left clavicle ("collarbone") or on the right Ear and the left clavicle (each on the other side of the zero potential line) or right hand and left hand.
- the analysis unit performs the superimposition and mathematical averaging separately on all selected ECG leads. On the basis of the superimposed and averaged time signals per EKG lead, the analysis unit carries out the determination steps explained above for obtaining the first and second time.
- an integrator which, on the basis of the determined P-wave duration, generates an integral value, a so-called Area-Under-The- Curve value, created over the time sequence of the time signals within the determined P-wave duration.
- the existing comparator or a further, additional comparator compares the determined integral value with a
- the quotient of the mean or maximum amplitude of the total P-wave to the total P-duration and the quotient of the mean or maximum amplitude of a predetermined portion of the P-wave to the duration of this portion or to the total duration of the P-wave can be determined. These parameters are compared with the existing comparator or another with a reference value, which generates a signal on the basis of a further decision criterion.
- Fig. 1 a schematic representation of a system according to the solution for
- Fig. 1 sinus rhythm of a heart beat of an individual
- Figure 1 a shows in a schematic compilation of components
- the means 1 for providing a person or Individual acquired ECG's typically in the form of a digital n-lead ECG recording device, provides the electrical stimulus potentials at the heart of the person is who are sorted by cardiac ECG lead defined spatial areas assigned.
- Each of the individual EKG leads 2 is made up of digitally recorded
- FIG. 1 b shows the classic morphology of a sinus rhythm 3 which, in chronological order, is composed of at least the P wave, a subsequent QRS complex and a concluding T wave.
- the system according to the solution determines the P-wave duration PWD of the person with a high-precision quality, whereby for the first time reliable statements about the stroke risk of a person can be made with a reliability of at least 80%.
- the time beginning ti and the time end t2 of the P wave must be determined with high precision and without errors. This assumes that the means 1 for providing the on
- S the n-ECG leads 2 preferably provides individual acquired ECG 'at a sampling rate of at least 500 Hz of at least 1000 Hz.
- a sampling rate of 1000 Hz a time signal can be recorded per millisecond. If a finer time resolution is to be achieved, the digital one would have to be
- electrocardiographic recording take place at a correspondingly higher sampling rate.
- Sampling rates of 2000 Hz or 5000 Hz are particularly desirable.
- the means ECG leads n-2 provides for the provision of a person recorded ECG's 1 in amplified form in which the n-ECG leads 2 on the assignable the timing signals with respect
- Signal levels are amplified with a gain factor of at least 4, preferably of at least 8, both in the time axis (x-axis) and in the voltage amplitude (Y-axis). Likewise is the gain of the time axis of
- the time axis should be displayed with at least 100mm / sec and preferably 200mm / sec.
- the n-EKG leads 2 recorded digitally in the above manner and optionally processed using signal technology are fed to a computer-based selection means 4 in the form of a digital data record, which, on the basis of a first decision criterion E1, selects those EKG leads 2 from the number of n-EKG leads 2 ' , on the basis of which the most precise possible time determination of the respective first point in time ti and second point in time t2 is possible.
- the time range that precedes the QRS complex corresponds to the start of the P wave at the point in time ti at which the signal level of the time signals from the ISO electrical signal level is characterized by a technically verifiable signal level that is positively different from the electrical ISO signal level.
- This technically verifiable signal level is preferably doubled
- the first time period typically corresponds to a maximum of half the P-wave duration in which the P-wave rises positively.
- the first time span should therefore preferably be between 40 and 80 ms.
- the time signals lying within a second time period following the second point in time t2 should again have the isoelectric time signal level ISO.
- the isoelectric time interval At2 following the second point in time t2 should be at least 4 ms.
- the comparison of the metrologically detected sinus rhythm with a reference time signal pattern or a set of reference time signal patterns is advantageous Framework of a software-based pattern recognition.
- a pattern recognition enables the typical morphology of a sinus rhythm P wave within the respective metrologically recorded EKG leads.
- the pattern recognition lead to a negative result the corresponding EKG lead is not suitable for determining exactly the beginning and the end of the P-wave.
- the following characteristics are currently regarded as morphologically relevant criteria:
- the P-wave morphology is compared within each of the 12 ECG leads among the 10 (up to 1000) consecutively recorded P-waves. The most common, i.e. dominantly recurring, P-wave morphology is determined. If the P-wave morphology deviates by more than 15% from the “dominant” P-wave morphology in at least one derivative, these deviating morphologies are not used for the analysis.
- the above cases specify criteria for performing the analysis, in each case in the absence of the criteria listed under 1 and 2, and for excluding derivations from the analysis which are not suitable for determining the P-wave duration.
- LA left atrium
- Fibrosis in the left atrium is present if the total duration of the sinus P wave from the selected leads is greater than 143 ms in women and greater than 153 ms in men.
- LA fibrosis is present if the sinus P-wave morphology is positive-negative in two of three leads II, III, aVF, regardless of the P-wave duration.
- Pronounced LA fibrosis is present if the sinus P wave morphology has a late P component. In these cases there is a
- Component is usually greater than 170 ms.
- the time synchronicity of all EKG leads is determined in each case by the earliest first point in time from all of the first points in time determined for the respectively selected EKG leads and a latest second point in time from all of the second times determined for the respectively selected EKG leads.
- the earliest first as well as the latest second point in time define the actual start and end of the P-wave and thus determine the exact P-wave duration PWD.
- the exact P-wave duration PWD determined in the context of the analysis unit 5 is fed to a comparator 6, which determines a deviation between the determined P-wave duration PWD and a reference value and is based on this a second decision criterion E2 generates a signal 7.
- the comparator 6 In the event that the P-wave duration PWD determined is greater than a maximum predetermined time period At max , the comparator 6 generates the signal 7.
- the maximum time period Atmax is typically in a range between 100 and 140 ms.
- FIGS. 2a to d each show images of twelve-channel electrocardiograms which are affected by people with differently pronounced atrial cardiomyopathies.
- the individual ECG leads correspond to the following standard ECG leads: I, II, III, aVR, aVL, aVF, V1 to V6.
- Low voltage substrate with a reduced rate of activation of the left atrium i.e. H. the electrical stimulus signal propagation, which is initiated at the sinus node and spreads over the right and left atrium in the direction of the AV node, is reflected in a longer duration of the P-wave duration recorded with the help of a 12-channel EKG.
- FIGS. 2 a to d each show 12-channel surface EGKs from patients that are representative of different degrees of severity with regard to the formation of arrhythmogenic, fibrosis-rich, slower conduction points within the left atrial low-voltage substrate.
- the signal levels of two intracardiac signals are at the top in FIGS. 2 a-d
- Catheter leads are shown which, as reference signals, mark the actual end of the P wave.
- the P-wave can be seen in the EKG leads II, III, aVF, V2-V6 as a P-wave with normal morphology, in the form of a positive P-wave.
- the EKG lead II is used to determine the start of the P wave, ie the first point in time t1 and the EKG lead V4 to determine the end of the P - wave, ie the second point in time.
- Fig. 2b shows an EKG of a patient with incipient fibrotic
- Tissue changes in the left atrium which on the one hand lead to a change in the developing P-wave morphology, in the sense of a multi-peak wave course, see ECG leads II, III, aVF as well as an extension of the P-wave duration, in this case from 174 ms.
- the EKG lead I & V2 is used to determine the temporal start of the P-wave, i.e. the first point in time t1 as well as the EKG lead V5 to determine the end of the P-wave, i.e. the second point in time.
- Fig. 2c shows an EKG of a patient with advanced fibrotic
- EKG leads reveals terminal P-wave components in leads I, aVL, V3-V6, which can only be visually recognized by means of strong amplification.
- the EKG lead V4 is used here to determine the start of the P-wave, i.e. the first point in time h as well as the EKG lead I to determine the end of the P-wave, i.e. the second point in time.
- the P-wave duration in this case is 172 ms.
- Fig. 2d shows an EKG of a patient with very advanced fibrotic
- An exact analysis of the ECG leads can still detect P-wave components in leads I, V5, which only get in the way a strong amplification are visually recognizable.
- the EKG lead V5 is used to determine the beginning of the P-wave, i.e. the first point in time ti and the EKG lead I, V4 - V6 to determine the end of the P-wave, ie the second point in time.
- the P-wave duration in this case is 160 ms.
- Time signals characterizing signal levels are not taken into account in a superficial analysis, so that the P-wave duration would be defined as too short. In such a case, the diagnosis would completely wrongly assess the patient as not at risk for health.
- Atrial heart activities associated with the P-wave can be precisely recorded and used to determine the end of the P-wave.
Abstract
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102019203155.2A DE102019203155A1 (de) | 2019-03-08 | 2019-03-08 | System zur Prädiktion wenigstens einer kardiologischen Dysfunktion eines Individuums |
PCT/EP2020/055845 WO2020182609A1 (fr) | 2019-03-08 | 2020-03-05 | Système de prédiction d'au moins un dysfonctionnement cardiaque d'un individu |
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EP3934528A1 true EP3934528A1 (fr) | 2022-01-12 |
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EP20711078.4A Pending EP3934528A1 (fr) | 2019-03-08 | 2020-03-05 | Système de prédiction d'au moins un dysfonctionnement cardiaque d'un individu |
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US (1) | US20220175299A1 (fr) |
EP (1) | EP3934528A1 (fr) |
DE (1) | DE102019203155A1 (fr) |
WO (1) | WO2020182609A1 (fr) |
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FI113835B (fi) * | 2003-04-10 | 2004-06-30 | Pentti Korhonen | Menetelmä ja järjestelmä sydänanalyysiä varten |
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2019
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- 2020-03-05 US US17/436,852 patent/US20220175299A1/en active Pending
- 2020-03-05 EP EP20711078.4A patent/EP3934528A1/fr active Pending
- 2020-03-05 WO PCT/EP2020/055845 patent/WO2020182609A1/fr active Application Filing
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WO2020182609A1 (fr) | 2020-09-17 |
DE102019203155A1 (de) | 2020-09-10 |
US20220175299A1 (en) | 2022-06-09 |
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