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WO2024238876A2 - Systèmes et méthodes de traitement d'arythmies ventriculaires - Google Patents

Systèmes et méthodes de traitement d'arythmies ventriculaires Download PDF

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Publication number
WO2024238876A2
WO2024238876A2 PCT/US2024/029834 US2024029834W WO2024238876A2 WO 2024238876 A2 WO2024238876 A2 WO 2024238876A2 US 2024029834 W US2024029834 W US 2024029834W WO 2024238876 A2 WO2024238876 A2 WO 2024238876A2
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Prior art keywords
patient
heart
model
location
therapeutic
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WO2024238876A3 (fr
Inventor
Shijie ZHOU
Harikrishna Tandri
John SAPP
Nikolas WILSON
Jinjuan SHE
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Miami University
University of Miami
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Miami University
University of Miami
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Anticipated expiration legal-status Critical
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • 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
    • 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]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/363—Detecting tachycardia or bradycardia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • 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
    • A61B5/7246—Details of waveform analysis using correlation, e.g. template matching or determination of similarity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/743—Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients

Definitions

  • the present disclosure is in the field of compositions, systems and methods of providing one or more cardiac medical interventions. More particularly, the present disclosure provides systems for planning and providing treatment for arrhythmias, including ventricular arrhythmias.
  • ICDs implantable cardioverter-defibrillators
  • catheter ablation offers a therapeutic treatment for certain types of VT and has been suggested to have a benefit for patients who have suffered prior MI in many case studies.
  • mapping techniques are utilized to help locate and perform a successful catheter ablation.
  • many of these mapping techniques are hampered by a variety of factors endemic to external measurement of internal body processes and the transient nature of some arrhythmias/tachycardias.
  • RF catheter ablation is often the therapy employed. This procedure utilizes energy to create scars in the problematic tissue, effectively preventing the occurrence of abnormal electrical activity within the heart. With its high effectiveness and low complication rates, RF catheter ablation has been proven successful in treating various VTs and PVCs.
  • the current locating procedure faces challenges that need to be addressed, such as limited accuracy in localizing ventricular arrhythmias and time-consuming aspects of the processes.
  • the general inventive concepts are based, in part, on the discovery that determining similarity between a subject and prior patients that have undergone a successful VA therapy (i.e., catheter ablation to treat VT) can provide insight on location of treatment and enable faster and more accurate treatment.
  • a successful VA therapy i.e., catheter ablation to treat VT
  • Such similarity can be found by comparing and assessing one or more relevant clinical variables from the prior patient with those of a subject who will undergo VA therapy.
  • the most appropriate match is determined by an algorithm that weighs various relevant clinical variables from the prior patients and compares those to that of the subject to form a (similarity) match.
  • the method comprises an initial comparison of an ECG of the prior patients with that of the current subject for finding a prior patient whose ECG is the most appropriate match (i.e., best similarity). Subsequently, the method comprises accessing and assessing the prior patient’s procedure to determine a best mapping location for the current subject based on these known mapping locations of therapy of the prior patient.
  • the map of location can be displayed as a 3D model of the subject’s heart (a whole LV-RV patient-specific ventricle model) for the user on e.g., augmented reality glasses.
  • a 3D model of the subject’s heart a whole LV-RV patient-specific ventricle model
  • the area to be mapped by the operator is limited, thereby reducing the time spent in performing the procedure.
  • the general inventive concepts contemplate a method of identifying an estimated location for ablation therapy.
  • the method comprises receiving an ECG from a subject. Comparing relevant clinical variables from the subject to relevant clinical variables of prior patients who have received ablation therapy. Identifying a match based on similarity parameters from the comparison of relevant clinical variables. Locating an estimated therapeutic location based on the identified prior patient’s therapeutic location with the current subject’s clinical variables. Displaying the estimated therapeutic location.
  • the general inventive concepts contemplate a method of localizing a treatment site to an area of the heart of a subject.
  • the method comprises acquiring patient specific clinical variables from the subject, accessing a library comprising patient specific clinical variables for a plurality of prior patients, identifying at least one patient that most closely resembles the subject based on the patient specific clinical variables (a VT- match), acquiring imaging of the subject (e.g., CT/MRI), mapping treatment location of the at least one prior patient to the imaging of the subject, calculating a case-specific catheter mapping based on the matching, and outputting the case-specific catheter mapping.
  • the output is in the form of a model that is displayed for a medical provider.
  • Figure 1 shows an exemplary paper ECG tracing, which is then digitized to form a searchable digital version of the ECG for comparison according to certain embodiments of the general inventive concepts.
  • Figure 2 shows a recorded ECG that can be used for comparison according to certain embodiments of the general inventive concepts. As shown in the figure, various portions of the ECG are highlighted for comparison with other ECGs.
  • Figure 3 shows a general embodiment of a VT-match platform according to the general inventive concepts.
  • Figure 4A shows a generic heart model wherein the ventricle is divided into 16 segments, the generic LV was subdivided into 238 triangles, with a therapeutic localization (marked with bullseye) based on comparison of relevant clinical variables.
  • Figure 4B is an image of a 3D model of the subject’s heart with a therapy location based on comparison and matching according to the general inventive concepts.
  • Figure 5 is an image of an exemplary display showing the results of a comparison of two ECG recordings.
  • the image also shows an indicator of total correlation coefficient average score of 84.
  • the specific image shows a correlation coefficient of 0.78 and a shift of 36.
  • Figure 6 is an image of a practitioner wearing display glasses for viewing an output of the VT-match results.
  • the display glasses provide an augmented reality display showing a model of the subject’s heart and the treatment location (e.g., as shown in Figure 4B.
  • Figure 7 is a flow chart for a method of VT -matching according to the general inventive concepts.
  • Figure 8A is an image of an exemplary paper ECG trace.
  • Figure 8B is an image of a digitized version of the paper ECG trace of Figure 8 A.
  • Figure 8C shows an image of a section of the digitized ECG trace of Figure 8B, wherein a PVC beat is selected, and compared it with prior patients in the database.
  • Figure 8D shows an image of a generic sectioned heart model with a therapeutic location marked based on calculations from Figure 8C and the comparison of relevant clinical variables.
  • a location of the inferior papillary muscle of the left ventricle is estimated and displayed.
  • Figure 9 is an illustration of an exemplary computing device for use with the systems and methods of the general inventive concepts.
  • Various technologies pertaining to a device, system, and for method treating VA including methods for catheter mapping leading to catheter ablation.
  • the general inventive concepts contemplate addressing the assisted catheter mapping and guidance of catheter ablation procedures for VAs.
  • the term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless specified otherwise, or clear from the context, the phrase “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, the phrase “X employs A or B” is satisfied by any of the following instances: X employs A; X employs B; or X employs both A and B.
  • the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from the context to be directed to a singular form.
  • Ranges as used herein are intended to include every number and subset of numbers within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.
  • the terms “component” and “system” are intended to encompass computer-readable data storage that is configured with computer-executable instructions that cause certain functionality to be performed when executed by a processor.
  • the computerexecutable instructions may include a routine, a function, or the like. It is also to be understood that a component or system may be localized on a single device or distributed across several devices.
  • the term “exemplary” is intended to mean serving as an illustration or example of something and is not intended to indicate a preference.
  • ameliorate means to eliminate, delay, or reduce the prevalence or severity of symptoms associated with a condition.
  • treating includes delaying the onset of a condition, reducing the severity of symptoms of a condition, or eliminating some or all of the symptoms of a condition.
  • therapeutic location refers to the identified portion of the heart for therapeutic intervention (e.g., ablation) and may refer to an origin or exit site of an ECG beat within the heart tissue.
  • localization points may refer to an onset point of PVC or an exit point of a VT beat.
  • the general inventive concepts seek to provide rapid and more accurate targeting of treatment location for ventricular arrhythmias and ventricular tachycardias.
  • the general inventive concepts contemplate: Converting ECG paper records into digital ECG data or an ECG VA has been recorded, which can be used for computing and search keyword to enable computer-assisted comparison between patients; To assist doctors and medical providers in quickly and non-invasively identifying the most similar and relevant location of a VA origin onto a model (e.g., a 3D model) of the patient’s heart geometry obtained from computerized tomography (CT) and/or Magnetic Resonance Imaging (MRI) scans, when the digital ECG VA/a recorded ECG VA is available; Searching a database of patients with similar ventricular problems to the current patient with the digital ECG VA/recorded ECG VA, identifying clinical variables and treatment options of relevance to the current subject based on the previous case analysis (preferably the previous cases underwent successful ablation therapy); return and display the best matching case(s) obtained from the large
  • CT computerized
  • Catheter ablation also known as cardiac ablation or radiofrequency ablation
  • cardiac ablation or radiofrequency ablation is the treatment of choice in patients with VT and/or certain PVCs. It is a procedure wherein a tube is guided through a blood vessel to into or near the heart. The catheter uses hot or cold energy to destroy small areas of tissue and create scars in the heart tissue where the arrhythmia is occurring. The scars help block abnormal electrical impulses and prevent abnormal rhythms.
  • catheter ablation is a minimally invasive procedure that usually doesn’t require a prolonged hospital stay, it does pose risks. The procedure can result in blood clot formation, damage to the vein from the catheter, unwanted damage to the heart tissue or valves, or infection, and the success rate of such procedures is only moderately satisfactory.
  • VA ablation procedures are typically carried out in large tertiary or academic centers as they require experienced operators.
  • the prolonged duration of VA ablation procedures can also lead to adverse outcomes.
  • the targets for ablation are locations in the heart where the PVCs or VTs are occurring. Because the treatment envisions scarring and destruction of tissue within the heart, minimization of unwanted damage is a primary concern. Thus, location of a proper ablation location is essential to successful treatment. There is an unmet need for improvements in the procedures for catheter mapping and planning for these procedures. Improvements in the procedure would be expected to enhance patient outcomes in one or more of the aforementioned areas.
  • ECG electrocardiogram
  • the general inventive concepts contemplate a non-invasive, data-driven method of contextualizing patient specific data (e.g., relevant clinical variables), comparing the patient specific data to a database of clinically relevant variable data from previously (successfully) treated patients, comparing relevant clinical variables of the subject to that of the prior patients to identify a similarity match, determining a proposed therapeutic location (e.g., VT exit site) based on the relevant clinical variables, and mapping the estimated/proposed therapeutic location.
  • patient specific data e.g., relevant clinical variables
  • a database of clinically relevant variable data from previously (successfully) treated patients comparing relevant clinical variables of the subject to that of the prior patients to identify a similarity match
  • determining a proposed therapeutic location e.g., VT exit site
  • the general inventive concepts contemplate a system for assisting in catheter mapping and calculating and/or planning of a cardiac ablation procedure for a subject.
  • the system comprises an algorithm for correlating clinically relevant variable data from prior patients to those of the current subject, a database of clinically relevant variable data of the prior patients, means for acquiring patient specific data of the individual (e.g., ECG, MRI, CT), a processor for processing and comparing the patient specific data of the current subject to that in the database, and means for outputting/displaying the comparison data.
  • patient specific data of the individual e.g., ECG, MRI, CT
  • a processor for processing and comparing the patient specific data of the current subject to that in the database, and means for outputting/displaying the comparison data.
  • the database of the system and method comprises data from e.g., electrocardiogram (ECG) measurements of prior patients (including simulations) that have been converted to digital data form.
  • ECG electrocardiogram
  • an ECG VA has been recorded.
  • the digital ECG data is modified or augmented for computing and search keyword. See e.g., Figures 1 and 2.
  • the ECG is a beat ECG with an emphasis on the QRS complex. As can be seen in Figure 2, a box is sown to highlight a 120 ms window of QRS complex.
  • the general inventive concepts contemplate a method of localizing a treatment site to an area of the heart of a subject.
  • the method comprises acquiring patient specific clinical variables from the subject, accessing a library or database comprising patient specific clinical variables for a plurality of patients, identifying at least one patient that most closely resembles the subject based on the patient specific clinical variables, acquiring imaging of the subject, matching treatment location of the at least one patient to the imaging of the subject, calculating a case-specific catheter mapping based on the matching, and outputting the case-specific catheter mapping.
  • the prior patient database is made up of patients for whom the VT exit site was clinically identified by entrainment mapping for hemodynamically-tolerated VTs or by combining substrate mapping and pace-mapping for hemodynamically unstable VTs.
  • clinically relevant variables include but are not limited to four categories: 1) age, gender, left ventricular ejection fraction (%), implantable cardioverterdefibrillator present, Heart Failure (%), Medication; 2) De-identified Raw MR.I/CT Images: CT/MRI imaging was performed within 24 hours before a catheter ablation procedure; 3) Induced VT 12-lead ECG: for each patient (at least have one or more monomorphic VT 12- lead ECG).
  • Electroanatomic mapping (EAM) data Carto 3 (Biosense Webster) or Ensite (Abbott) electroanatomic mapping system was used to map the VT by using standard techniques; 4) Clinically-identified VT exit sites: In certain embodiments, the VT exit site was clinically identified by entrainment mapping for hemodynamically-tol erated VTs or by combining substrate mapping and pace-mapping for hemodynamically unstable VTs. In certain exemplary embodiments, the individual variables are ranked by weighting relative to one- another. In certain embodiments, a VT 12-lead ECG has the most weight of the parameters/variables. In certain embodiments, the clinically relevant variables discussed herein are stored in and accessible in the database. In certain embodiments, a score is determined for each category to determine the most similar case for VT-matching and location of the therapy.
  • the system and method comprises quickly and non-invasively identifying the exact location of a VA origin onto the patient’s heart geometry obtained from imaging (e.g., computerized tomography (CT) and/or Magnetic Resonance Imaging (MRI) scans) when the digital ECG VA/a recorded ECG VA is available.
  • imaging e.g., computerized tomography (CT) and/or Magnetic Resonance Imaging (MRI) scans
  • the system and method comprises searching the database of prior patients with similar clinical variables (e.g., age, heart disease, ventricular problems) to that of the current subject patient with the digital ECG VA/recorded ECG VA and identifying clinical variables and treatment options that could be relevant for a match.
  • the system and method contemplate use of a smaller subset of clinically relevant variables based on a weighted score.
  • the system and method includes display means for displaying one or more identified relevant matching case(s) obtained after comparison with the database. Such comparison of relevant matching cases can then be reviewed by medical personnel based on one or more criteria to determine the course/map of therapy or displayed.
  • system and method comprise means for registering and overlay/projecting identified relevant matching case(s) onto a model of the individual’s heart geometry obtained from one or more relevant imaging procedures (e.g., CT/MRI scans).
  • relevant imaging procedures e.g., CT/MRI scans.
  • the general inventive concepts contemplate displaying the identified therapeutic location on a variety of display means including, but not limited to an augmented reality (AR) means (glasses), wherein the digital cardiac model is displayed with the real patient-specific geometry.
  • AR augmented reality
  • a 3D anatomical heart model having the closest similarity to the subject’s heart may be selected from a database including a plurality of 3D anatomical models.
  • the heart model may be optionally modified to include patientspecific features.
  • the selected and optionally modified 3D anatomical heart model may serve as the patient-specific 3D heart model.
  • Such a model may include detailed structures of the heart such as the aortic cusps, aortic root, aorta, aortic arch, coronary vascular structures, among others.
  • the 3D heart model (see e.g., FIG. 4B) may be based on CT scans of the subject.
  • This subject specific 3D heart model may be generated by comparing the subject’s digital to reference heart models obtained from a database of such models The best fitting reference heart model may be selected from the database and then adjusted (e.g., edited) to match to the subject’s geometry.
  • the edited subject-specific heart model may include a color-coding scale to represent various features of the heart muscle (e.g., electroanatomic mapping geometry (purple is >1.5 mv, red is ⁇ 0.5 mv, between red to purple is named border zone between 0.5 mv to 1.5 mv).
  • electroanatomic mapping geometry purple is >1.5 mv, red is ⁇ 0.5 mv, between red to purple is named border zone between 0.5 mv to 1.5 mv.
  • FIG. 3 shows a general embodiment of a VT-match platform according to the general inventive concepts.
  • the platform comprises an algorithm for localization of VA treatment and a VT ablation patient library/database.
  • the database includes data on a predetermined set of variables for prior patients including, but not limited to VT ablation data, 12-lead VT ECG, non-specific relevant clinical variables (e.g., age, gender, heart disease status, among others), and CT and/or MRI images.
  • the information in the database is accessed and compared by way of the algorithm to calculate/generate a similarity match, which then leads to a target location based on the identified prior patient’s location of therapy.
  • Figure 4A shows a generic heart model with a localization (marked with bullseye) marked based on comparison of relevant clinical variables.
  • the heart model shows the ventricle chambers divided into numbered segments.
  • the three-dimensional prototype model of the ventricles of the human heart is represented using planar triangles and divided into anatomical segments.
  • Figure 4B is an image of a 3D model of the subject’s heart with a therapy location estimated/ determined based on comparison and matching according to the general inventive concepts.
  • the therapeutic location is identified with a star in the figure.
  • Figure 5 is an image of an exemplary display showing the results of a comparison of two ECG recordings.
  • the image also shows an indicator of total correlation coefficient average score of 84.
  • the specific image shows a correlation coefficient of 0.78 and a shift of 36.
  • quantitative correlation to an ECG template was assessed.
  • a QRS window is used for calculating the correlation coefficient between two ECGs from a same ECG lead.
  • the shift of 36 means a horizontal shift to maximize overlap and correlation.
  • the correlation coefficient provides information on selecting a VT -match from prior patient data.
  • Figure 6 is an image of a practitioner wearing display glasses for viewing an output of the VT -match results.
  • the display glasses provide an augmented reality display showing a model of the subject’s heart and the treatment location (e.g., as shown in Figure 4B.
  • FIG. 7 shows a flow chart of an exemplary method according to the general inventive concepts.
  • an ECG of the subject is recorded, either in digital form or a paper readout is translated into digital form to aid in comparison.
  • the method includes accessing patient specific variables. These include the categories of relevant clinical variables discussed above, such as age, left ventricular ejection fraction (%), heart failure (%), among others.
  • the patient specific variables are compared and correlated against similar data of the current subject based on predetermined metrics to determine a match (e.g., by correlation coefficients). This step also contemplates specifically comparing ECG to determine similarity of therapy.
  • Therapeutic details e.g., ablation site for successful patient treatments
  • the therapeutic detail is a VT exit site.
  • the VT exit site was clinically identified by either entrainment mapping for hemodynamically-tol erated VTs or by combining substrate mapping and pacemapping for hemodynamically unstable VTs.
  • This outputting can take the form of a visual display on a screen or an augmented reality display (e.g., glasses).
  • the general inventive concepts contemplate the output will include overlaying/superimposing the estimated location on a model (e.g., 3D model, including a whole patient-specific ventricle model) of the subject’s heart and highlighting the estimated location.
  • a model e.g., 3D model, including a whole patient-specific ventricle model
  • the computing device 900 may be used in a system for guiding planning/guiding a cardiac procedure such as catheter ablation (e.g., system shown in Figure 1).
  • the computing device 900 includes at least one processor 902 that executes instructions that are stored in a memory 904.
  • the instructions may be, for instance, instructions for implementing functionality described as being carried out by one or more components discussed above or instructions for implementing one or more of the methods described above.
  • the processor 902 may access the memory 904 by way of a system bus 906.
  • the computing device 900 additionally includes a database 908 that is accessible by the processor 902 by way of the system bus 906.
  • the data store 908 may include executable instructions and/or clinically relevant variable data.
  • the computing device 900 also includes an input interface 910 that allows external devices to communicate with the computing device 900.
  • the input interface 910 may be used to receive instructions from an external computer device, from a user, etc.
  • the computing device 900 also includes an output interface 912 that interfaces the computing device 900 with one or more external devices.
  • the computing device 900 may display text, images, etc. by way of the output interface 912.
  • the external devices that communicate with the computing device 900 via the input interface 910 and the output interface 912 can be included in an environment that provides substantially any type of user interface with which a user can interact.
  • user interface types include graphical user interfaces, natural user interfaces, AR interfaces, and so forth.
  • a graphical user interface may accept input from a user employing input device(s) such as a keyboard, mouse, remote control, or the like and provide output on an output device such as a display.
  • a natural user interface may enable a user to interact with the computing device 900 in a manner free from constraints imposed by input devices such as keyboards, mice, remote controls, and the like. Rather, a natural user interface can rely on speech recognition, touch and stylus recognition, gesture recognition both on screen and adjacent to the screen, air gestures, head and eye tracking, voice and speech, vision, touch, gestures, machine intelligence, and so forth.
  • the computing device 900 may be a distributed system. Thus, for instance, several devices may be in communication by way of a network connection and may collectively perform tasks described as being performed by the computing device 900.
  • Computer-readable media includes computer-readable storage media.
  • a computer-readable storage media can be any available storage media that can be accessed by a computer.
  • such computer-readable storage media can comprise RAM, ROM, EEPROM, CD- ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer.
  • Disk and disc include compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk, and Blu- ray disc (BD), where disks usually reproduce data magnetically and discs usually reproduce data optically with lasers. Further, a propagated signal is not included within the scope of computer-readable storage media.
  • Computer-readable media also includes communication media including any medium that facilitates transfer of a computer program or data from one place to another. A connection, for instance, can be a communication medium.
  • the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave
  • coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio and microwave
  • the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio and microwave
  • the functionally described herein can be performed, at least in part, by one or more hardware logic components.
  • illustrative types of hardware logic components include Field-programmable Gate Arrays (FPGAs), Application-specific Integrated Circuits (ASICs), Application-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), etc.
  • the present invention provides a system and method for localizing therapeutic sites of origin, such as VT exit site or site of origin, based on algorithmic comparison of relevant clinical variables to determine a (best case) similarity match).
  • the site of origin may first be localized to a segment or segments of the heart by comparing relevant clinical variables and successful therapies of prior patients (including therapeutic location of the prior patients) and then displayed to aid in providing a therapeutic intervention (i.e., ablation).
  • Figure 8A-D shows a paper ECG trace (8A) which is converted into digital form (8B).
  • a beat premature ventricular contraction (PVC) is identified from the digitized ECG information and highlighted (shown in the box). This information is used to estimate a therapeutic location via the claimed algorithm and relevant clinical variables from prior patients.
  • An image of a generic heart model with an estimated therapeutic location (bullseye) is then displayed as in Figure 8D (shown here in the inferior papillary muscle of the left ventricle).

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Abstract

L'invention concerne des systèmes et des méthodes permettant de comparer des informations d'ECG et des données cliniques pertinentes provenant de patients antérieurs avec celles d'un sujet actuel ayant besoin d'un traitement contre l'arythmie ventriculaire (VA). Les systèmes et les méthodes fournissent une localisation précise et rapide où effectuer le traitement de la VA (par exemple, un site d'ablation) par détermination de la meilleure correspondance sur la base de variables cliniques pertinentes et par corrélation de l'emplacement réel du traitement pour le patient antérieur avec un modèle du sujet actuel. En localisant le site de traitement dans une région spécifique du cœur, la zone à cartographier par l'opérateur est limitée, ce qui permet de réduire le temps passé à réaliser la procédure.
PCT/US2024/029834 2023-05-18 2024-05-17 Systèmes et méthodes de traitement d'arythmies ventriculaires Pending WO2024238876A2 (fr)

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WO2016014949A1 (fr) * 2014-07-24 2016-01-28 Blake Robert C Système et procédé d'ablation cardiaque
US9433363B1 (en) * 2015-06-18 2016-09-06 Genetesis Llc Method and system for high throughput evaluation of functional cardiac electrophysiology
US10319144B2 (en) * 2015-12-22 2019-06-11 The Regents Of The University Of California Computational localization of fibrillation sources
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