# US 10,945,614 B2 · Systems and methods to determine HR, RR and classify cardiac rhythms based on atrial IEGM and atrial pressure signals

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- Number: US 10,945,614 B2
- Document ID: US10945614B2
- Status: Granted
- Kind: B2
- Application number: 16/385,769
- Filed: 2019-04-16
- Published: 2019-08-08
- Granted: 2021-03-16
- Earliest claimed: 2013-03-15
- Assignees: Pacesetter, Inc.
- Applicants: Pacesetter, Inc.
- Inventors: Yelena Nabutovsky; Neal L. Eigler; Lok Man Chu; James S. Whiting; Jenner Joseph
- Web page: https://patentgrep.com/patent/US10945614B2

## CPC

- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0215: by means inserted into the body
- A61B 5/076: {Permanent implantation}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/316: Modalities, i.e. specific diagnostic methods
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/366: Detecting abnormal QRS complex, e.g. widening
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/7253: {characterised by using transforms}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/0803: {Recording apparatus specially adapted therefor}
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

## Claims

### Claim 1

A method, comprising:
(a) subjecting an atrial intracardiac electrogram (IEGM) signal to a spectrum transform to obtain an atrial IEGM frequency spectrum;
(b) subjecting a signal indicative of atrial pressure (AP) to a spectrum transform to obtain an AP frequency spectrum, wherein the signal indicative of AP comprises an AP signal or a surrogate thereof; and
(c) detecting one or more arrhythmias and/or performing arrhythmia discrimination based on one or more peaks in the atrial IEGM frequency spectrum and one or more peaks in the AP frequency spectrum;
wherein steps (a), (b), and (c) are performed using at least one processor.

### Claim 2 (depends on 1)

The method of claim 1, wherein step (c) comprises classifying a patient's cardiac rhythm as one of sinus rhythm (SR), atrial fibrillation (AF), atrial flutter (AFI), ventricular tachycardia (VT) and supraventricular tachycardia (SVT) without obtaining and analyzing an intracardiac electrogram (IEGM) signal using an electrode implanted in a ventricle.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
determining a first measure of heart rate (HRIEGM) based on one or more peaks in the atrial IEGM frequency spectrum; and
determining a second measure of heart rate (HRAP) based on one or more peaks in the AP frequency spectrum.

### Claim 4 (depends on 3)

The method of claim 3, wherein step (c) comprises:
(c.1) identifying one or more peaks, if any, in the atrial IEGM frequency spectrum that is/are within an atrial fibrillation (AF) frequency range (frangeAF);
(c.2) in response to one or more peaks being identified at step (c.1), determining whether any of the peak(s) identified at step (c.1) is/are a harmonic of at least one of the first and second measures of heart rate; and
(c.3) in response to at least N peak(s) identified at step (c.1) being within the AF frequency range (frangeAF) and not being a harmonic of at least one of the first and second measures of heart rate as determined at step (c.2), determining that the atrial IEGM frequency spectrum is indicative of AF, wherein N is an integer that is equal to or greater than 1.

### Claim 5 (depends on 4)

The method of claim 4, wherein step (c) also comprises:
(c.4) identifying one or more peaks, if any, in the atrial IEGM frequency spectrum that is/are within an atrial flutter (AFI) frequency range (frangeAFI);
(c.5) in response to one or more peaks being identified at step (c.4), determining whether any of the peak(s) identified at step (c.4) is/are a harmonic of at least one of the first or second measures of heart rate; and
(c.6) in response to at least one peak identified at step (c.4) being within the AFI frequency range (frangeAFI) and not being a harmonic of at least one of the first or second measures of heart rate, determining that the atrial IEGM frequency spectrum is indicative of AFI.

### Claim 6 (depends on 5)

The method of claim 5, where step (c) includes determining that the AP frequency spectrum is not indicative of AF in response to there being a secondary peak in the AP frequency spectrum that is at least a specified percentage of a dominant peak in the AP frequency spectrum and the secondary peak corresponding to approximately twice the second measure of heart rate (HRAP).

### Claim 7 (depends on 5)

The method of claim 5, wherein:
in response to determining at step (c) that the atrial IEGM frequency spectrum is indicative of either AF or AFI, determining that an estimate of a patient's actual heart rate is equal to the second measure of heart rate (HRAP); or
in response to not determining at step (c) that the atrial IEGM frequency spectrum is indicative of either AF or AFI, determining that the estimate of the patient's actual heart rate is equal to the first measure of heart rate (HRIEGM).

### Claim 8 (depends on 5)

The method of claim 5, wherein in response to not determining at step (c) that the atrial IEGM frequency spectrum is indicative of either AF or AFI, using the first measure of heart rate (HRIEGM) to classify a cardiac rhythm as one of ventricular tachycardia (VT), supraventricular tachycardia (SVT), or sinus rhythm (SR).

### Claim 9 (depends on 1)

The method of claim 1, wherein:
the atrial IEGM frequency spectrum comprises an atrial IEGM frequency power spectrum; and
the AP frequency spectrum comprises an AP frequency power spectrum.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
obtaining the atrial IEGM signal using at least two electrodes, at least one of which is implanted in an atrium of a patient's heart and none of which are implanted in a ventricle of the patient's heart; and
obtaining the signal indicative of AP using a sensor implanted in an atrium of the patient's heart.

### Claim 11 (depends on 10)

The method of claim 10, wherein the at least two electrodes used to obtain the atrial IEGM, the sensor used to obtain the signal indicative of AP, and the at least one processor are all part of a system that includes an implantable device, and wherein the system does not include an electrode in a ventricle of the patient's heart.

### Claim 12 (depends on 10)

The method of claim 10, wherein the performing arrhythmia discrimination includes discrimination of ventricular tachycardia (VT) from supraventricular tachycardia (SVT).

### Claim 13 (depends on 1)

The method of claim 1, wherein step (c) includes determining a cardiac rhythm classification, and the method further comprising:
(d) storing an indication of the cardiac rhythm classification along with at least one of a time stamp, data corresponding to one or more of the signals, or data corresponding to one or more of the frequency spectrums used to classify the cardiac rhythm.

### Claim 14 (depends on 1)

The method of claim 1, wherein step (c) includes determining a cardiac rhythm classification, and the method further comprising:
(d) displaying the cardiac rhythm classification.

### Claim 15 (depends on 1)

The method of claim 1, wherein step (c) includes determining a cardiac rhythm classification, and the method further comprising:
(d) displaying instructions to a patient to at least one of take a medication, adjust a dosage of the medication, or contact a physician.

### Claim 16 (depends on 1)

The method of claim 1, further comprising:
(d) obtaining the atrial IEGM signal using at least two electrodes; and
(e) obtaining the signal indicative of AP using a sensor implanted in an atrium of a patient's heart;
wherein
the at least one processor is part of a system that includes a cardiac rhythm management (CRM) device configured to provide an electrical stimulus to the patient's heart to provide pacing therapy;
step (c) includes determining a cardiac rhythm classification; and the pacing therapy is adjusted based on the cardiac rhythm classification.

### Claim 17 (depends on 1)

The method of claim 1, further comprising at least one of:
obtaining the atrial IEGM signal using at least two electrodes; or
obtaining the signal indicative of AP using a sensor.

### Claim 18

A system, comprising:
at least two electrodes configured to obtain an atrial intracardiac electrogram (IEGM), wherein at least one of the electrodes is configured to be implanted in an atrium of a patient's heart;
a sensor configured to obtain a signal indicative of atrial pressure (AP), wherein the signal indicative of AP comprises an AP signal or a surrogate thereof; and
one or more processors configured to
subject the atrial IEGM signal to a spectrum transform to obtain an atrial IEGM frequency spectrum;
subject the signal indicative of AP to a spectrum transform to obtain an AP frequency spectrum; and
detect one or more arrhythmias and/or perform arrhythmia discrimination based on one or more peaks in the atrial IEGM frequency spectrum and one or more peaks in the AP frequency spectrum.

### Claim 19 (depends on 18)

The system of claim 18, further comprising:
an atrial lead that includes the at least one of the electrodes that is configured to be implanted in the atrium of the patient's heart.

### Claim 20 (depends on 19)

The system of claim 19, wherein the atrial lead also includes the sensor that is configured to obtain the signal indicative of AP.

### Claim 21 (depends on 18)

The system of claim 18, wherein:
the at least two electrodes and the sensor are part of an implantable device;
the system further comprises a non-implantable device configured to wirelessly communicate with the implantable device; and
the non-implantable device includes a display that is configured to display information about one or more arrhythmias detected by the system.

### Claim 22 (depends on 21)

The system of claim 21, wherein the display of the non-implantable device is also configured to display instructions to a patient to at least one of take a medication, adjust a dosage of the medication, or contact a physician.

### Claim 23 (depends on 21)

The system of claim 21, wherein at least one processor of the one or more processors is part of the non-implantable device.

### Claim 24

A method, comprising:
(a) using at least two electrodes to obtain a first signal indicative of atrial electrical activity;
(b) using a sensor to obtain a second signal indicative of atrial pressure, wherein the second signal indicative of atrial pressure comprises an atrial pressure signal or a surrogate thereof;
(c) subjecting the first signal to a spectrum transform to obtain a first frequency spectrum;
(d) subjecting the second signal to a spectrum transform to obtain a second frequency spectrum; and
(e) detecting one or more arrhythmias and/or performing arrhythmia discrimination based on one or more peaks in the first frequency spectrum and one or more peaks in the second frequency spectrum;
wherein steps (c), (d), and (e) are performed using at least one processor.
