阅读说明：本技术 用于在心内心电图中查找异常激动的方法 (Method for finding abnormal activation in an intracardiac electrocardiogram ) 是由 E·拉夫纳 Y·卡多什 R·伊塔 E·纳卡尔 M·A·利维 于 2020-11-13 设计创作，主要内容包括：本发明题为“用于在心内心电图中查找异常激动的方法”。本文公开了用于医疗规程的方法、设备和系统,并且方法、设备和系统包括检测心内区域的表现出诸如局部异常心室激动(LAVA)的异常激动的点。表现出此类异常激动的点可称为种子点,在本文所公开的方法的第一步骤期间识别种子点。可在使高特异度优先于灵敏度的第一步骤期间使用诸如单极标测信道和双极标测信道、体表ECG、过去的激动、相邻点等的一个或多个输入来识别种子点。在使高灵敏度优先的第二步骤期间,分析种子点附近的相邻点的电激动,以确定激动是否与对应于对应种子点的异常激动类似(例如,具有与之类似的时间)。(The invention provides a method for finding abnormal activation in an intracardiac electrocardiogram. Methods, devices, and systems for medical procedures are disclosed and include detecting points of an intracardiac region exhibiting abnormal activation, such as Local Abnormal Ventricular Activation (LAVA). Points exhibiting such abnormal activation may be referred to as seed points, which are identified during the first step of the methods disclosed herein. One or more inputs such as unipolar and bipolar mapping channels, surface ECG, past activations, neighboring points, etc. may be used to identify seed points during the first step of prioritizing high specificity over sensitivity. During the second step of prioritizing high sensitivity, electrical activation of neighboring points in the vicinity of the seed point is analyzed to determine whether activation is similar to (e.g., has a similar time to) abnormal activation corresponding to the corresponding seed point.)

1. A method for identifying abnormal activation in an intracardiac electrogram, the method comprising:

based on the high specificity, identifying seed points having abnormal activation at a first time;

identifying at least one neighboring point that is adjacent to the seed point;

determining that the neighboring point exhibits activation at a time similar to the first time; and

identifying the neighboring point as an outlier neighboring point based on determining that the neighboring point exhibits activation at a time similar to the first time.

2. The method of claim 1, further comprising: receiving input information, the receiving input information comprising one or more of: a bipolar ECG of the mapped channel, distal and proximal unipolar ECGs of the mapped channel, a lead surface ECG, and intracardiac spatial information are received.

3. The method according to at least one of claims 1-2, further comprising: providing the input information to one or more analysis modules, the analysis modules including one or more of: a QRS detection module, a wavefront activation module, a fragmentation detection module, and a Local Abnormal Ventricular Activation (LAVA) logic module.

4. The method of at least one of claims 1-3, wherein the seed point is identified based on an output of the one or more analysis modules.

5. The method according to at least one of claims 1-4, wherein the QRS detection module comprises one or more of: a preprocessing step and a QRS detection logic step.

6. The method according to at least one of claims 1-5, wherein said QRS detection step outputs a start of QRS and an end of QRS.

7. The method of at least one of claims 1-6, wherein the wavefront activation module comprises one or more of: the method comprises a preprocessing step, a wavefront logic step, a feature extraction step and a fuzzy logic step.

8. The method of at least one of claims 1-7, wherein the wavefront activation module outputs one or more sets of timestamps and blur scores.

9. The method of at least one of claims 1-8, wherein the fragmentation detection module outputs an interval comprising a start of fragmentation and an end of fragmentation.

10. The method of at least one of claims 1-9, wherein determining at least one of the seed point and the neighboring point is based on one or more of a blur score, temporal consistency, and location consistency.

11. The method according to at least one of claims 1-10, wherein the temporal consistency is based on identifying the abnormal activation for which a previous beat was within a cycle length based tolerance of deviation.

12. The method of at least one of claims 1-11, wherein the positional consistency is based on a distance between the seed point and the neighboring point divided by a wavefront speed.

13. The method of at least one of claims 1-12, wherein the positional consistency is further based on the cycle length based deviation tolerance.

14. The method according to at least one of claims 1-13, further comprising: a far-field distance is identified.

15. The method according to at least one of claims 1-14, further comprising: a far-field distance is identified.

16. The method according to at least one of claims 1-15, further comprising: determining that at least one of the neighboring points is within the far-field distance, and identifying the neighboring point within the far-field distance as a far-field neighboring point.

17. The method of at least one of claims 1-16, wherein the seed point is determined based on one or more of QRS time, temporal consistency, blur score, fragmentation period, and slope magnitude.

18. The method of at least one of claims 1-17, wherein the at least one neighboring point is within 12mm from the seed point.

19. The method of at least one of claims 1-18, wherein identifying the neighbor point as an outlier neighbor point is based on one or more of a position consistency, a blur score, and a slope magnitude between the seed point and the neighbor point.

Technical Field

Systems, devices, and methods for detecting abnormal intracardiac activity are provided.

Background

Medical conditions such as cardiac arrhythmias (e.g., Atrial Fibrillation (AF)) are typically diagnosed and treated by in vivo procedures. For example, pulmonary venous electrical isolation (PVI) from the Left Atrial (LA) body is performed using ablation for treating AF. Such in vivo procedures rely on the detection of regions of interest within an organ in vivo, such as the heart.

Detecting abnormal or targeted electrical activity at an intracardiac region may provide a region of the heart to be ablated in order to prevent the abnormal or targeted electrical activity from propagating within the heart, thereby mitigating the likelihood of a cardiac condition, such as an arrhythmia.

Disclosure of Invention

Methods, devices, and systems for medical procedures are disclosed and include detecting points of an intracardiac region exhibiting abnormal activation, such as Local Abnormal Ventricular Activation (LAVA). Points exhibiting such abnormal activation may be referred to as seed points, which are identified during the first step of the methods disclosed herein. One or more inputs such as unipolar and bipolar mapping channels, surface ECG, past activations, neighboring points, etc. may be used to identify seed points during the first step of prioritizing high specificity over sensitivity. During the second step of prioritizing high sensitivity, electrical activation of neighboring points in the vicinity of the seed point is analyzed to determine whether activation is similar to (e.g., has a similar time to) abnormal activation corresponding to the respective seed point.

Drawings

A more detailed understanding can be obtained from the following description, given by way of example, in conjunction with the accompanying drawings, in which:

FIG. 1 is an illustration of an exemplary system in which one or more features of the disclosed subject matter may be implemented;

FIG. 2 is a process for identifying abnormal activation;

FIG. 3 is a diagram for receiving intracardiac inputs to determine abnormal activity;

FIG. 4 is a diagram for applying intracardiac inputs to determine abnormal activity;

FIG. 5 is an illustration for determining abnormal activity based on intracardiac inputs;

FIG. 6 is a diagram for identifying adjacent anomalous activity;

FIG. 7A is an illustration of a seed point for identifying abnormal activity;

FIG. 7B is a diagram of neighboring points used to identify abnormal activity;

FIG. 8 is a diagram of a seed point for identifying abnormal activity;

FIG. 9 is an illustration of neighboring points used to identify abnormal activity based on seed points; and is

Fig. 10 is an experimental result of a technique implemented according to the subject matter disclosed herein.

Detailed Description

Identifying complex Electrocardiogram (ECG) activations, such as Local Abnormal Ventricular Activation (LAVA), fragmentation, and/or late potentials, with high sensitivity and high specificity can be challenging. Techniques such as feature extraction and dynamic thresholding may be used to identify such complex ECG activations and may be implemented based on one or more inputs and/or features. However, such techniques may sacrifice specificity (i.e., true negative rate) in an attempt to improve sensitivity (i.e., true positive rate).

According to an exemplary embodiment of the present invention, a catheter may be inserted into a cardiac chamber of a heart of a patient. The catheter may include one or more electrodes that may provide electrical activity of a region of the heart lumen in contact with the one or more electrodes. Seed points corresponding to abnormal activities can be identified with high specificity. Subsequently, the neighboring points of the seed point can be identified with high sensitivity. One or more complex ECG activations, such as LAVA, may be determined based on the seed point and the neighboring points. Notably, the techniques disclosed herein can be implemented to increase the sensitivity of the results without sacrificing specificity.

According to an exemplary embodiment of the invention, at a first step, abnormal activation of endocardial or epicardial tissue is recognized with a high specificity, as further disclosed herein. At a second step after identifying abnormal activation, points adjacent to the identified abnormal activation are evaluated to determine whether they contain activation at a time similar to the identified abnormal activation. If one or more points adjacent to the identified abnormal activation are determined to contain activation at a time similar to the identified abnormal activation, such one or more adjacent points are also labeled as having abnormal activation.

Fig. 1 is an illustration of an exemplary mapping system 20 that may implement one or more features of the disclosed subject matter. The mapping system 20 may include a device, such as a catheter 40, configured to obtain electrical activity data according to an exemplary embodiment of the present invention. Although the catheter 40 is shown as having a basket shape, it should be understood that any shape of catheter including one or more elements (e.g., electrodes) may be used to implement the exemplary embodiments disclosed herein. The mapping system 20 includes a probe 21 having a shaft 22 that can be navigated by a medical professional 30 into a body part of a patient 28 lying on a table 29, such as the heart 26. As shown in fig. 1, a medical professional 30 can insert the shaft 22 through the sheath 23 while manipulating the distal end of the shaft 22 using a manipulator 32 near the proximal end of the catheter and/or deflecting from the sheath 23. As shown in inset 25, the catheter 40 may be fitted at the distal end of the shaft 22. Catheter 40 may be inserted through sheath 23 in a collapsed state, and may then be deployed within heart 26.

According to an exemplary embodiment of the invention, catheter 40 may be configured to obtain electrical activity within an intracardiac cavity of heart 26. Inset 45 shows catheter 40 in an enlarged view within the heart chamber of heart 26. As shown, the catheter 40 may include an array of elements (e.g., electrodes 48) coupled to the splines forming the shape of the catheter 40. The element (e.g., electrode 48) may be any element configured to obtain electrical activity, and may be an electrode, a transducer, or one or more other elements. It should be understood that although one catheter 40 is shown, multiple catheters may be used to collect electrical activity of an internal body organ, such as heart 26.

According to example embodiments disclosed herein, electrical activity may be any suitable electrical signal that may be measured based on one or more thresholds and may be sensed and/or enhanced based on a signal-to-noise ratio and/or other filters. Catheters, such as catheter 40, may also be configured to sense additional biometric data in addition to electrical activity. The data collected by catheter 40 may include one or more of the following: local Activation Time (LAT), topology, bipolar mapping, unipolar mapping, mapping based on body surface electrodes, dominant frequency, impedance, and the like. In addition, the catheter 40 may be used to obtain spatial information about the internal organs. The local activation time may be a time point corresponding to a threshold activity of the local activation calculated based on the normalized initial starting point. The topology may correspond to the physical structure of a body part or a portion of a body part, and may correspond to a change in the physical structure relative to a different portion of the body part or relative to a different body part. The dominant frequency may be a frequency or range of frequencies that are ubiquitous at one part of the body part, and may be different in different parts of the same body part. For example, the dominant frequency of the pulmonary veins of a heart may be different from the dominant frequency of the right atrium of the same heart. The impedance may be a measure of the resistance at a given region of the body site and may be calculated as an independent value based on frequency and/or in conjunction with additional considerations such as blood concentration.

As shown in fig. 1, the probe 21 and catheter 40 may be connected to a console 24. The console 24 may include a processor 41 (such as a general purpose computer) with suitable front end and interface circuitry 38 for transmitting and receiving signals to and from the catheter 40, as well as for controlling other components of the mapping system 20. In some exemplary embodiments of the invention, processor 41 may be further configured to receive the electrical activity data, assign clusters of points at different times, and provide a visual indication from a first cluster of points to an associated second cluster of points. According to an exemplary embodiment of the invention, the rendering data may be used to provide a rendering of one or more body parts (e.g., body part rendering 35) to the healthcare professional 30 on the display 27. According to an exemplary embodiment of the invention, processor 41 may be located external to console 24, and may be located, for example, in a catheter, in an external device, in a mobile device, in a cloud-based device, or may be a stand-alone processor.

As mentioned above, the processor 41 may comprise a general purpose computer that can be programmed with software to perform the functions described herein. The software may be downloaded to the general purpose computer in electronic form, over a network, for example, or it may alternatively or additionally be provided and/or stored on a non-transitory tangible medium, such as magnetic, optical, or electronic memory. The exemplary configuration shown in fig. 1 may be modified to implement the embodiments disclosed herein. The disclosed exemplary embodiments may be similarly applied using other system components and arrangements. In addition, the mapping system 20 may include additional components, such as elements for sensing biometric patient data, wired or wireless connectors, processing and display devices, and the like.

According to an exemplary embodiment of the invention, the display connected to the processor (e.g., processor 41) may be located at a remote location such as at a separate hospital or in a separate healthcare provider network. In addition, the mapping system 20 may be part of a surgical system configured to obtain anatomical and electrical measurements of an organ (such as the heart) of a patient, and perform a cardiac ablation procedure. An example of such a surgical system is marketed by Biosense WebsterProvided is a system.

The mapping system 20 may also, and optionally, use ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or other medical imaging techniques known in the art to obtain biometric data, such as anatomical measurements of the patient's heart. The mapping system 20 may use a catheter, Electrocardiogram (ECG), or other sensor that measures electrical characteristics of the heart to obtain electrical measurements. As shown in fig. 1, the biometric data including the anatomical and electrical measurements may then be stored in the local memory 42 of the mapping system 20. Notably, the memory 42 can store biometric data of a plurality of different modalities simultaneously. The biometric data may be transferred from the memory 42 to the processor 41. Alternatively or in addition, the biometric data may be transmitted to a server 60, which may be local or remote, using a network 62.

Network 62 may be any network or system known in the art, such as an intranet, a Local Area Network (LAN), a Wide Area Network (WAN), a Metropolitan Area Network (MAN), a direct connection or series of connections, a cellular telephone network, or any other network or medium capable of facilitating communication between mapping system 20 and server 60. The network 62 may be wired, wireless, or a combination thereof. The wired connection may be implemented using ethernet, Universal Serial Bus (USB), RJ-11, or any other wired connection known in the art. The wireless connection may be implemented using Wi-Fi, WiMAX and bluetooth, infrared, cellular networks, satellite or any other wireless connection method known in the art. In addition, several networks may operate individually or in communication with each other to facilitate communication in the network 62.

In some cases, the server 60 may be implemented as a physical server. In other cases, the server 60 may be implemented as a public cloud computing provider (e.g., Amazon Web Services)) The virtual server of (1).

The console 24 may be connected by a cable 39 to a body surface electrode 43, which may include an adhesive skin patch that is attached to the patient 28. Processor 41, in conjunction with the current tracking module, may determine the position coordinates of catheter 40 within a body part of a patient (e.g., heart 26). The position coordinates may be based on impedance or electromagnetic fields measured between electrodes 43 and 48 or other electromagnetic components of catheter 40.

The processor 41 may include real-time noise reduction circuitry, typically configured as a Field Programmable Gate Array (FPGA), followed by an analog-to-digital (a/D) ECG (electrocardiogram) or EMG (electromyogram) signal conversion integrated circuit. The processor 41 may transfer signals from the a/D ECG or EMG circuit to another processor and/or may be programmed to perform one or more of the functions disclosed herein.

The console 24 may also include an input/output (I/O) communication interface that enables the console to communicate signals from and/or to the electrodes 48, 43. Based on signals received from electrodes 48 and/or electrodes 43, processor 41 may generate rendering data that enables a display (such as display 27) to render a body part (such as body part rendering 35) and biometric data of multiple modalities as part of body part rendering 35.

During the procedure, processor 41 may facilitate the presentation of body part renderings 35 (including one or more point clusters that are active at a given time). Processor 41 may identify one or more clusters at a given time and one or more other related or unrelated clusters at a subsequent time. Processor 41 may also determine a propagation route based on two or more related clusters of points and provide a visual indication of the propagation route accordingly. The electrical activity may be stored in memory 42, and processor 41 may access the electrical activity stored in memory 42 to determine clusters of points and corresponding propagation routes. The travel route may be provided to a medical professional 30 on display 27.

The memory 42 may include any suitable volatile and/or non-volatile memory, such as random access memory or a hard disk drive. In some exemplary embodiments of the invention, medical professional 30 may be able to manipulate body part rendering 35 using one or more input devices, such as a touchpad, a mouse, a keyboard, a gesture recognition device, and the like. In an alternative exemplary embodiment of the present invention, the display 27 may include a touch screen that may be configured to accept input from the medical professional 30 in addition to presenting the body part rendering 35 (including the travel route).

Fig. 2 illustrates a process 200 for identifying and marking an abnormal activation point according to an exemplary embodiment of the present invention. As described herein, a seed point is a point of the heart lumen that exhibits abnormal activation. At step 210 of process 200, such seed points are identified with high sensitivity such that a true positive rate is emphasized in identifying such seed points. As understood in the art, when seed points are identified at step 210, the Receiver Operating Characteristic (ROC) curve is adjusted to bias towards specificity. The higher sensitivity is then emphasized at step 220-240 by identifying neighboring points that exhibit activation at times similar to the abnormal activation of the corresponding seed point, as further described herein. Notably, by identifying neighboring points at steps 220-240, the techniques disclosed herein effectively expand the area around the identified seed point by identifying abnormal activations corresponding to the neighboring points. When adjacent points are identified at step 220-240, the ROC curve is adjusted to bias towards sensitivity. The result of process 200 is to identify regions of abnormal activation of endocardial or epicardial tissue at a high level of specificity (e.g., via step 210) and a high level of sensitivity (e.g., via step 220-240).

In step 210 of process 200 of FIG. 2, one or more abnormal activation points are identified with a high level of specificity. The abnormal activation points identified at step 210 may be referred to as seed points to distinguish them from neighboring points that are also identified as having abnormal activation, as further disclosed herein.

Fig. 3 shows an input 310 (e.g., input information) that may be applied to determine an abnormal activation point from a cardiac lumen. The inputs 310 may include, but are not limited to, a bipolar ECG that maps channels, a distal and/or proximal unipolar ECG that maps channels, a multi-lead (e.g., 12-lead) Body Surface (BS) ECG, special information, and adjacent point information, etc. One or more of the inputs 310 may be received by a processor, such as processor 41 of fig. 1. Additionally, user input 320 may be provided to a processor (such as processor 41) and may include location information for regions to be excluded when identifying abnormal activation, and may include limits and/or minimum and maximum voltages.

As shown in fig. 3, the processor may perform one or more techniques 330 (e.g., an analysis module) based on the input 310 and/or the user input 320. The one or more techniques 330 (e.g., analysis module) may include QRS detection, wavefront algorithm, fragmentation detection, LAVA logic, and the like. Application of one or more techniques 330 may provide electrical activity 340 that may include LAT values and may also include a determination of whether the points exhibit LAVA.

FIG. 4 provides additional information regarding the application of input 310 of FIG. 3. The QRS detection 410, wavefront activation 420, and fragmentation detection 430 of fig. 4 may be applied when determining the seed points at step 210 of fig. 2, as further provided in fig. 8.

The QRS detection 410 of fig. 4 may include a preprocessing step 412 and a QRS detection logic step 414. QRS detection 410 may be based on electrical activity received from an electrode of a catheter (such as catheter 40 of fig. 1) relative to a baseline electrical activity determined using one or more BS electrodes attached to the exterior of the patient. For example, a processor, such as processor 41, may receive baseline electrical activity from a plurality (e.g., twelve) of BS electrodes, and may extract a QRS signal based on comparing the electrical activity received from the electrodes of the catheter to the baseline electrical activity.

During the preprocessing step 412, electrical activity measurements for a given amount of time (e.g., 150ms) around the reference annotation may be collected. A high pass filter and/or a low pass filter may be applied to the received electrical activity. According to one example, the high pass filter may be applied at a threshold of 0.5Hz and the low pass filter may be applied at a threshold of 120 Hz.

During the QRS detection step 414, a QRS signal may be determined based on the change over time in the voltage of the received electrical activity provided during the preprocessing step 412. An additional low pass filter may be applied using the median measurement within a time window (e.g., 21 ms). Voltages having peak-to-peak measurements greater than a given voltage (e.g., 4mV) may be identified, and additional electrical activity may be observed for additional time periods (e.g., 20ms before and after the peak). QRS detection logic step 414 may provide an interval of the start of the QRS signal and the end of the QRS signal (StartOfQrs, EndOfQrs). Notably, these intervals can be used to determine whether electrical activity at a point on the interior surface exhibits abnormal activation (i.e., is a seed point), as further disclosed herein.

As shown in fig. 4, wavefront activation 420 may be determined based on the raw unipolar ECG signal and/or the bipolar ECG signal. During the preprocessing step 422, a high pass filter may be applied at a given frequency (10Hz) by a Finite Impulse Response (FIR) filter using a median measurement of a given time window (e.g., a 121ms window). The pre-processing input may be provided to wavefront logic 424, and feature extraction step 426 may be applied to the output of wavefront logic 424. The feature extraction step 426 may provide one or more of the following: unipolar derivative, unipolar active duration, unipolar amplitude, unipolar duration in amplitude, and/or bipolar amplitude. The output of the feature extraction step 426 may be applied to a fuzzy logic step 428 which produces a fuzzy score as a set of (timestamp, fuzzy score) pairs for a given point on the endocardial surface. Notably, the set of (timestamp, ambiguity score) pairs can be used to determine whether electrical activity at a point on the interior surface of the center exhibits abnormal activation (i.e., is a seed point), as further disclosed herein. The blur score may be calculated based on characteristics including the height, weight, and/or slope of the negative deflection of the bipolar signal and characteristics including the height, weight, and/or slope of the negative deflection of the unipolar signal. Each such feature may affect the fuzzy score according to a different fuzzy membership function. The iterative blur score for each feature may be multiplied to calculate a final blur score for a given point.

As shown in fig. 4, the fragmentation detection 430 may be determined based on the raw unipolar ECG signal and/or the bipolar ECG signal. During the fragmentation window detection step 432, the fragmentation window of electrical activity at a point on the endocardial surface may be determined. The determination may be based on the raw unipolar ECG signal and/or the bipolar ECG signal and the fragmentation window may be determined based on any suitable technique for detecting a fragmentation window. Such techniques may include, but are not limited to, applying one or more steps such as preprocessing, differentiation and squaring, moving window integration, thresholding, post-processing, evaluation with a non-linear energy operator (NELO), gaussian low pass filtering, or a combination thereof. It is noted that the interval of the start of the fragmentation window and the end of the fragmentation window may be used to determine whether electrical activity at a point on the interior surface exhibits anomalous activation (i.e., is a seed point), as further disclosed herein.

As shown in fig. 5, a processor (such as processor 41 of fig. 1) may determine whether electrical activity at a point on the endocardial surface is abnormal based on one or more of an ambiguity score, temporal consistency, and location consistency. As shown in fig. 5, for each union of the far-side and near-side wavefront activations 510 (including activations 512, 514, 516, 518, 520, and 522), the processor may determine the blur score, whether temporal consistency exists between adjacent beats, and whether positional consistency exists between adjacent points. A threshold ambiguity score (e.g., 65) can be applied such that a calculated ambiguity score for a given point on the endocardial surface corresponds to abnormal electrical activity if it exceeds the threshold ambiguity score.

According to an exemplary embodiment of the invention, if the detected electrical activation is present in one or more of the previous cycles, there may be temporal consistency for that activation. The presence of detected electrical activation in one or more of the previous cycles may indicate: the detected electrical activation is generated by the heart and not noise. Temporal consistency can be detected if the electrical activation was present in the previous cycle, with a tolerance of up to 1% deviation for the previous cycle, up to 2% deviation for two cycles prior to a given electrical activation, etc. For clarity, there may be temporal consistency if the electrical activity detected during a given cycle is also present at the same time in a previous cycle, where there is a tolerance deviation of 1% of the temporal deviation. Similarly, there may be temporal consistency if the electrical activity detected during a given cycle is also present at the same time of two cycles before the given cycle, where there is a tolerance amount of 2% of the temporal offset in the two cycles before the given cycle. As shown in fig. 5, activations 512, 514, 518, and 522 may exhibit temporal consistency.

At step 220 of the process 200 of fig. 2, the electrical activity of neighboring points within a given threshold distance (e.g., 12mm) of the seed point identified in step 210 may be identified. At step 230, it may be determined that: one or more of the neighboring points exhibit abnormal electrical activity similar to the corresponding seed point identified at step 210. The neighboring points exhibiting abnormal electrical activity may be determined based on the same process as applied at step 210 and as disclosed herein. At step 240, neighboring points that exhibit anomalous activity may be marked as anomalous neighboring points.

According to an exemplary embodiment of the invention, neighboring points up to a given threshold distance (e.g., 12mm), which may be constant or may be user-defined, may be identified at step 220. The given threshold distance may be the euclidean distance between two points. Alternatively, the given threshold distance may be the shortest path between two points on the endocardial surface, as determined, for example, by the dyxter algorithm.

According to an exemplary embodiment, the region or points may be excluded from being considered seed points and/or outlier neighbors. Such regions or points may be excluded based on user input, such as where the user marks anatomical locations to be excluded and/or points near the anatomical locations. Such exclusion points may be part of the bundle of His, which includes wide, rapidly conducting muscle fibers that carry the heart beat through the insulating annulus fibrosis into the fibrous upper portion of the ventricular septum.

As shown in fig. 5, a position consistency indication of neighboring points of the seed point may be determined. The positional consistency may provide an indication that abnormal electrical activity exhibited at the seed point is also present at an adjacent point. Notably, for neighboring points that are adjacent to the seed point, abnormal electrical activity may be expected to be exhibited at a similar time as the seed point. The position consistency may be determined based on the distance between the seed point and the neighboring point divided by the wavefront speed plus a percentage (e.g., 1%) of the cycle length of a given cycle (i.e., similar time ═ 1% CL (distance/wavefront speed) + 1%) such that if the neighboring point exhibits electrical activation in a similar time as the electrical activation of the seed point, position consistency may exist. As indicated by the formula provided above, and in general, the tolerance for considering two activation times as similar times (e.g., 1% CL) may be a function of CL, such that if CL is shorter, a smaller deviation is allowed, and if CL is longer, a larger deviation is allowed. Especially in case the actual wavefront speed is unknown, a default wavefront speed of 0.5mm/ms may be applied. A tolerance of a certain percentage (e.g., 1%) of CL may account for the deviation in wavefront velocity. For example, the wavefront velocity in healthy tissue may be 0.9mm/ms and the wavefront velocity in scar tissue may be 0.1 mm/ms. As shown in fig. 5, activations 512, 518, and 520 may exhibit positional consistency such that at least two activations at similar times are present within adjacent points of the seed point. Notably, the location consistency may indicate: abnormal electrical activity at the seed point is confirmed by electrical activity at neighboring points. According to one embodiment, the wavefront speed may be 1 mm/ms. According to one embodiment, the similar time may be a predetermined value or a user-provided value. Neighboring points having electrical activation at a similar time as the seed point may be considered anomalous neighboring points, such that the seed point and the anomalous neighboring points may correspond to regions of complex ECG activation (e.g., LAVA, fragmentation, late potential, etc.).

According to an exemplary embodiment, to be considered similar times when considering activation times of two or more points, the start or center of the activation window may be compared and a threshold may be applied to the center or start of the signal. In the case of a fractionated ECG signal, the activation time may be a window rather than a single point. Furthermore, when considering similar activation times, the duration of activation may also need to be similar. According to an embodiment, the tolerance of activation times for times considered similar may be a function of peak-to-peak voltage, such that a high peak-to-peak bipolar voltage may correspond to healthy tissue with a relatively high wavefront velocity, as disclosed herein. Similarly, a low peak-to-peak bipolar voltage may correspond to unhealthy tissue (such as scar tissue) having a relatively low wavefront velocity, as disclosed herein. Thus, for high peak-to-peak voltage regions, activation times may propagate faster between adjacent points, and conversely, may propagate slower between adjacent points of low peak-to-peak voltage regions.

According to an exemplary embodiment, when identifying neighboring points with anomalous activity (e.g., step 220 of process 200 of fig. 2 and 240), the radio for finding neighboring points may be limited to a relatively large number, but the ROC may be adjusted to favor less sensitivity and greater specificity for points farther away from the seed point found in step 210. It will be appreciated that at any point on the ROC curve, the time of a given activation at a neighboring point still needs to be at a similar time as the corresponding seed point, as disclosed herein.

As shown in fig. 6, neighboring points affected by the far field may be removed from the determination of neighboring points at step 230 of the process 200 of fig. 2. Neighboring points affected by the far field may be determined by detecting neighboring points within a given radius (e.g., 15mm) from the seed point at 610. The strongest negative deflection value below QRS may also be determined at 610 for each neighboring point within a given radius. An upper limit value (e.g., 90 th percentile) for the strongest-dV/dt of neighbors may be determined at 620, where the strongest-dV/dt is below the QRS. At 630, the median of the LAT values of the strongest-dV/dt below QRS can be identified, and at 640, this median can be assumed to be the LAT value of the possible far field. At 650, the median distance of neighboring points contributing to the LAT values determined at 640 may be stored as the far-field distance, such that the far-field distance is the median distance of neighboring points having a percentage (e.g., 10%) of the strongest negative deflection amplitude.

Fig. 7A shows a graphical representation of identified seed points 710 with high specificity determined based on step 210 of process 200 of fig. 2. FIG. 7B shows a graphical representation of identified neighboring points 720 having electrical activation at a similar time as the seed points 710 of FIG. 7A, determined based on step 220 and 240 of the process 200 of FIG. 2. Notably, the seed points 710 are LAVA points with high specificity, and the neighboring points 720 allow for increased sensitivity and electrical activation at similar times as the corresponding seed points 710.

Fig. 8 shows variants 810, 820 and 830 for determining seed points based on step 210 of process 200 of fig. 2. When identifying seed points, conditions to be satisfied for the most recent variant in time (i.e., from variants 810, 820, and 830) may be applied. Variants 810, 820, and 830 may utilize as inputs the outputs of QRS detection 410, wavefront activation 420, and fragmentation detection 430 of fig. 4.

At variation 810, if conditions 812 and 814 are satisfied, a seed point may be identified. As shown, if the corresponding electrical activity is exhibited after or before QRS at 812, if there is temporal consistency as discussed with reference to fig. 5, and if the ambiguity score corresponding to the electrical activity is greater than a threshold ambiguity score (e.g., 65) at 814, a seed point may be identified at variation 810. Seed points identified based on variant 810 may, for example, have a specificity of 96% and a Positive Predictive Value (PPV) of 72%.

At variation 820, if conditions 822 and 824 are satisfied, a seed point may be identified. At 822, it may be determined that: whether the electrical activation at a given point is within a fragmentation window (e.g., whether there are at least two wavefront candidates within the fragmentation window). At 824, a seed point may be determined based on a last activation within the fragmentation window having a blur score greater than a threshold blur score (e.g., 65), and if no such activation exists, the seed point may be determined based on the strongest-dV/dt in the fragmentation window. Seed points identified based on variant 820 may, for example, have a specificity of 94% and a PPV of 71%.

At variation 830, if conditions 832 and 834 are satisfied, a seed point may be identified. At 832, it may be determined: whether the electrical activation at a given seed point is below the QRS and not within the fragmentation window. At 834, a seed point may be determined if the electrical activation at a given point is temporally coincident, if the electrical activation is coincident with a neighboring point location, if the ambiguity fraction is above a threshold ambiguity fraction (e.g., 65), if the slope magnitude between the positive magnitude and the adjacent negative magnitude of the ECG signal (i.e., negative slew magnitude) is greater than a given voltage (e.g., 30 μ ν), and if the electrical activation at a given point is not a possible far field effect determined by, for example ((far field distance/wavefront velocity) + 1% CL), as disclosed herein. Seed points identified based on variant 830 may, for example, have a specificity of 99% and a PPV of 70%.

FIG. 9 illustrates a process 900 for determining outlier neighbors based on step 220 and 240 of the process 200 of FIG. 2. Notably, the process 900 may allow for increased sensitivity. At step 910 of the process 900, points within a given radius (e.g., 12mm) from the seed point may be identified. At 920, it may be determined: whether there is a positional correspondence between the seed point and each of the points identified in step 910, as described with respect to fig. 5. For clarity, the distance between each neighboring point and the seed point may be divided by the wavefront speed (e.g., 0.5 mm/ms). Variance may be added to the resulting time (e.g., 1% CL). At step 930, a blur score may be determined for the point at which activation was present (i.e., where there was location consistency) within the time determined by step 920. At step 930, points where the blur score exceeds a threshold blur score (e.g., 65) may be identified. At step 940, a slope magnitude of electrical activity may be identified for points where the ambiguity score exceeds a threshold ambiguity score. Points having a slope magnitude that exceeds a threshold slope magnitude (e.g., 30 μ V) may be determined as outlier neighbors. As described at step 950, if there are more than one activations at a given point that satisfy steps 910-940, the most recent of such activations may be applied in determining abnormally neighboring points.

Fig. 10 shows experimental results of applying the process 200 of fig. 2 according to fig. 3-9. Fig. 10 is a result of fifteen unique cases based on a data set and an analysis of a total of 41,953 points according to the subject matter disclosed herein. As shown in table 1010, an average sensitivity of 75% (77% after QRS, 75% before/below QRS) was exhibited over the entire data set. An average specificity of 83% (100% after QRS, 83% before/after QRS) was shown on the entire data set. As noted, the results in table 1010 are provided assuming that the physician is interested in LAVA in regions of up to 1.5mV peak-to-peak bipolar amplitude. For the data set, LAT accuracy up to 20ms in true positive of 85% (80% after QRS, 88% before/below QRS) was demonstrated. Graph 1020 shows LAT accuracy in true positives. Graph 1030 shows LAT accuracy in false positives. Graph 1040 shows LAT accuracy in false negatives.

Any of the functions and methods described herein may be implemented in a general purpose computer, processor, or processor core. Suitable processors include, by way of example, a general purpose processor, a special purpose processor, a conventional processor, a Digital Signal Processor (DSP), a plurality of microprocessors, one or more microprocessors in association with a DSP core, a controller, a microcontroller, Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any other type of Integrated Circuit (IC), and/or a state machine. Such processors may be manufactured by configuring the manufacturing process with the results of processed Hardware Description Language (HDL) instructions and other intermediate data comprising netlist, such instructions being capable of being stored on a computer readable medium. The result of such processing may be a mask work (mask) that is subsequently used in a semiconductor manufacturing process to manufacture a processor that implements features of the present disclosure.

Any of the functions and methods described herein may be implemented in a computer program, software, or firmware incorporated in a non-transitory computer-readable storage medium for execution by a general purpose computer or a processor. Examples of non-transitory computer readable storage media include read-only memory (ROM), random-access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media (e.g., internal hard disks and removable disks), magneto-optical media, and optical media (e.g., CD-ROM disks and Digital Versatile Disks (DVDs)).

It should be understood that many variations are possible based on the disclosure herein. Although features and elements are described above in particular combinations, each feature or element can be used alone without the other features and elements or in various combinations with or without other features and elements.