IP Library Granted Patent US 11,869,668
Granted Patent B2
US 11,869,668 · App. 17/829,357 · Granted Jan 9, 2024

Artificial intelligence based cardiac event predictor systems and methods

Inventors: Arun Nemani (Chicago, IL); Greg Lee (Chicago, IL); Steve Steinhubl (Chicago, IL); Alvaro Ulloa-Cerna (Danville, PA)
Assignees: Tempus Labs, Inc.; Geisinger Clinic
G16H50/30A61B5/0006A61B5/28A61B5/318A61B5/7275G16H50/20G06F18/2155
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Quick Facts
Patent No.
US 11,869,668
App. No.
17/829,357
Filed
May 31, 2022
Granted
Jan 9, 2024
Kind
B2
Art Unit
3686
USPC
705/2
Abstract

A method and system for predicting the likelihood that a patient will suffer from a cardiac event is provided. The method includes receiving electrocardiogram data associated with the patient, providing at least a portion of the electrocardiogram data to a trained model, receiving a risk score indicative of the likelihood the patient will suffer from the cardiac event within a predetermined period of time from when the electrocardiogram data was generated, and outputting the risk score to at least one of a memory or a display for viewing by a medical practitioner or healthcare administrator. The system includes at least one processor executing instructions to carry out the steps of the method.

Claims (60)

1. A method for determining cardiac amyloidosis risk from electrocardiogram trace data, interventricular septal thickness (IVSD) data, and clinical data, comprising:

receiving electrocardiogram (ECG) trace data associated with a patient, the electrocardiogram trace data having an electrocardiogram configuration including a plurality of leads and a time interval and comprising, for each lead included in the plurality of leads, voltage data associated with at least a portion of the time interval;

providing a first portion of the ECG trace data to a feature extraction layer, the first portion of the ECG trace data consisting of ECG data acquired at a body surface of the patient, the feature extraction layer being trained to predict a representation of IVSD thickness from the voltage data of the ECG trace data;

outputting, from the feature extraction layer, a representation of IVSD thickness;

receiving clinical data associated with the patient;

providing the representation of IVSD thickness, the clinical data and at least a second portion of the electrocardiogram trace data to a second layer, the second layer being a layer of a trained machine learning model, the second layer trained to evaluate the representation of IVSD thickness, the clinical data, and the second portion of the electrocardiogram trace data with respect to cardiac amyloidosis;

generating, by the trained machine learning model and based on the evaluation, a risk score reflecting a likelihood of the patient being diagnosed with cardiac amyloidosis within a predetermined period of time from when the ECG trace data was generated; and

outputting the risk score to at least one of a memory or a display.

2. The method of claim 1 , wherein the clinical data comprises age and gender of the patient.

3. The method of claim 2 , further comprising:

providing the at least a second portion of the electrocardiogram trace data to a convolutional neural network; and

providing the age and gender to a boosting model.

4. The method of claim 1 , wherein the trained model further comprises:

training a convolutional neural network on a plurality of patients, wherein the plurality of patients include at least patients having a recorded ECG within a diagnosis threshold and patients having a recorded ECG outside a diagnosis threshold; wherein the diagnosis threshold is compared against the time between a date of diagnosis of cardiac amyloidosis and a date of the recorded ECG; and

providing the trained convolutional neural network as the trained model.

5. The method of claim 4 , wherein the trained model further comprises:

refining the trained neural network using only the plurality of patients having the recorded ECG outside of the diagnosis threshold, and wherein the diagnosis threshold is selected from a number of days.

6. The method of claim 1 , wherein the trained model is selected based at least in part on a severity of the cardiac amyloidosis the generated risk score represents.

7. The method of claim 6 , wherein the severity includes labels for one or more of normal, mild, moderate, and severe.

8. The method of claim 1 , wherein the predetermined period of time includes times at least one year from when the electrocardiogram trace data was generated.

9. The method of claim 1 , wherein the trained model comprises training data associated with a plurality of clinical sites.

10. The method of claim 9 , wherein the trained model comprises training the model using patient data associated with one site of the plurality of sites and testing the trained model on the remaining sites of the plurality of sites.

11. The method of claim 1 , wherein the outputting the risk score further comprises outputting the risk score to at least one of a display of an electrocardiogram monitor, wherein the received electrocardiogram trace data is received from the electrocardiogram monitor or an electronic health records management system.

12. The method of claim 1 , wherein the feature extraction layer is a layer of the trained machine learning model.

13. The method of claim 1 , wherein the clinical data is selected from demographic data, vitals data, laboratory data, or comorbidities data.

14. The method of claim 13 , wherein the vitals data comprises one or more of body mass index, systolic blood pressure, diastolic blood pressure, heart rate, height, weight, or smoking status.

15. The method of claim 13 , wherein the laboratory data comprises one or more of A1C, bilirubin, blood urea nitrogen, cholesterol, creatine kinase myocardial band, creatinine, C-reactive protein, D-dimer, glucose, high-density lipoprotein, hemoglobin, high-density lipoprotein, lactate dehydrogenase, lymphocytes, potassium, pro B-type natriuretic peptide, sodium, troponin I and T, triglyceride, uric acid, very low-density lipoprotein, or estimated glomerular filtration rate.

16. The method of claim 13 , wherein the comorbidities data comprises one or more of heart failure, prior myocardial infarction, diabetes mellitus, chronic obstructive pulmonary disease, renal failure, prior echocardiogram, coronary artery disease, or hypertension.

17. The method of claim 1 , wherein the electrocardiogram trace data comprises ECG data selected from one or more of acute myocardial infarction, atrial fibrillation, atrial flutter, complete block, early repolarization, fascicular block, first-degree atrioventricular block, intraventricular conduction block, left bundle branch block, right bundle branch block, ischemia, left anterior descending artery ischemia, right bundle branch block, low QRS, left ventricular hypertrophy, non-specific ST-T wave, Non-specific T wave, other bradycardia, premature atrial contractions, pacemaker, poor tracing, prior infarction, prior myocardial infarction anterior, prolonged QT, premature ventricular contractions, right axis deviation, second degree atrioventricular block, sinus bradycardia, supraventricular tachycardia, tachycardia, tachyarrhythmia, T inversion, or ventricular tachycardia.

18. The method of claim 1 , further comprising providing measurements from echocardiogram data to the trained model, the measurements including one or more of average R-R interval, P-R interval, P axis, QRS duration, QT, QTC, R axis, T axis, or ventricular rate.

19. The method of claim 1 , further comprising gathering the clinical data and electrocardiogram trace data based at least in part on a presence of International Classification of Diseases (ICD) codes associated with the patient.

20. The method of claim 1 , wherein the electrocardiogram trace data comprises at least 8 leads.

21. The method of claim 1 , wherein the electrocardiogram trace data is sampled at 250 hz or 500 hz.

22. The method of claim 1 , wherein the trained model is a composite model, and wherein training the composite model comprises:

generating a patient timeline for each patient;

anchoring each respective patient timeline to a date of occurrence of an echocardiogram; and

labeling each respective patient as having a positive or negative ECG based at least in part on a date of an ECG with respect to the date of occurrence of the echocardiogram.

23. The method of claim 22 , further comprises excluding patients from training after a censoring event is detected in the patient timeline.

24. A system comprising:

a computer including a processing device, the processing device configured to:

receive electrocardiogram (ECG) trace data associated with a patient, the electrocardiogram trace data having an electrocardiogram configuration including a plurality of leads and a time interval and comprising, for each lead included in the plurality of leads, voltage data associated with at least a portion of the time interval;

provide a first portion of the ECG trace data to a feature extraction layer, the first portion of the ECG trace data consisting of ECG data acquired at a body surface of the patient, the feature extraction layer being trained to predict a representation of interventricular septal thickness (IVSD) from the ECG trace data;

output, from the feature extraction layer, a representation of IVSD thickness to at least one of a memory or a display;

receive clinical data associated with the patient;

provide the representation of IVSD thickness, the clinical data, and at least a second portion of the ECG trace data to a second layer, the second layer being a layer of a trained machine learning model, the second layer being trained to evaluate the representation of IVSD thickness, the clinical data, and the second portion of the ECG trace data with respect to cardiac amyloidosis;

generate, by the trained machine learning model and based on the evaluation, a risk score reflecting a likelihood of the patient being diagnosed with cardiac amyloidosis within a predetermined period of time from when the ECG trace data was generated; and

output the risk score to at least one of the memory or the display.

25. The system of claim 24 , wherein the clinical data comprises age and gender of the patient.

26. The system of claim 24 , wherein the feature extraction layer is a layer of the trained machine learning model.

27. The system of claim 24 , wherein the predetermined period of time includes times at least one year from when the electrocardiogram trace data was generated.

28. A non-transitory computer readable medium, comprising instructions for causing a computer to:

receive electrocardiogram (ECG) trace data associated with a patient, the electrocardiogram trace data having an electrocardiogram configuration including a plurality of leads and a time interval and comprising, for each lead included in the plurality of leads, voltage data associated with at least a portion of the time interval;

provide a first portion of the ECG trace data to a feature extraction layer, the first portion of the ECG trace data consisting of ECG data acquired at a body surface of the patient, the feature extraction layer being trained to predict a representation of interventricular septal thickness (IVSD) from the ECG trace data;

output, from the feature extraction layer, a representation of IVSD thickness to at least one of a memory or a display;

receive clinical data associated with the patient;

provide the representation of IVSD thickness, the clinical data, and at least a second portion of the ECG trace data to a second layer, the second layer being a layer of a trained machine learning model, the second layer trained to evaluate the representation of IVSD thickness, the clinical data, and the second portion of the ECG trace data with respect to cardiac amyloidosis;

generate, by the trained machine learning model and based on the evaluation, a risk score reflecting a likelihood of the patient being diagnosed with cardiac amyloidosis within a predetermined period of time from when the ECG trace data was generated; and

output the risk score to at least one of the memory or the display.

29. The non-transitory computer readable medium of claim 28 , wherein the feature extraction layer is a layer of the trained machine learning model.

30. The non-transitory computer readable medium of claim 28 , wherein the clinical data comprises age and gender of the patient.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 13, 2026
From: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
To: TEMPUS AI, INC. (F/K/A TEMPUS LABS, INC.)
Reel/Frame 075608/0784 →
CHANGE OF NAME Recorded Feb 6, 2024
From: TEMPUS LABS, INC.
To: TEMPUS AI, INC.
Reel/Frame 066507/0793 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 23, 2022
From: NEMANI, ARUN; LEE, GREG; STEINHUBL, STEVE
To: TEMPUS LABS, INC.
Reel/Frame 061866/0544 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 23, 2022
From: ULLOA-CERNA, ALVARO
To: GEISINGER CLINIC
Reel/Frame 061866/0674 →
SECURITY INTEREST Recorded Sep 22, 2022
From: TEMPUS LABS, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 061506/0316 →
Continuity (4)
Provisional Application 63194923 · May 28, 2021
Provisional Application 63202436 · Jun 10, 2021
Provisional Application 63224850 · Jul 22, 2021
Related Publication 20220384045A1 · Dec 1, 2022
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