IP Library Granted Patent US 9,149,195
Granted Patent B2
US 9,149,195 · App. 11/733,699 · Granted Oct 6, 2015

Methods and apparatus for quantifying the risk of cardiac death using exercise induced heart rate recovery metrics

Inventor: David M. Hadley (Woodinville, WA)
Assignee: Mortara Instrument, Inc.
A61B5/024A61B5/0452A61B5/4035A61B5/4884A61B5/7275G06F19/3431G06F19/3437G06F19/3487A61B5/222
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Quick Facts
Patent No.
US 9,149,195
App. No.
11/733,699
Filed
Apr 10, 2007
Granted
Oct 6, 2015
Kind
B2
Art Unit
3766
USPC
600/519
Abstract

Methods and apparatus for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient. An embodiment of a method comprises determining a prognostic period of the heart activity data after a time t 0 after a peak heart rate of the exercise test, and ascertaining a risk indicator. The risk indicator is based on (a) the heart rate activity data during the recovery stage only after time t 0 and (b) a post-exercise heart rate reserve based on a post-exercise resting heart rate. This embodiment of the method further includes providing an assessment of cardiac risk of a specific patient based on the ascertained risk indicator.

Claims (54)

1. A method for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising:

determining a prognostic period of the heart activity data after a time t 0 after a peak heart rate of the exercise test;

ascertaining a risk indicator based on (a) the heart activity data during the recovery stage only after time t 0 and (b) a post-exercise heart rate reserve based on a post-exercise resting heart rate; and

providing an assessment of cardiac risk of the specific patient based on the ascertained risk indicator wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and a subsequent physiological start of the recovery stage after termination of exercise.

2. The method of claim 1 wherein the method further comprises:

determining the time t 0 and the post-exercise resting heart rate by (a) measuring the peak heart rate (HRpeak) at a time t at which the patient terminates exercising and (b) fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage;

determining a compensated curve of the heart activity data defined by a heart rate and the post-exercise resting heart rate; and

determining a risk indicator based upon the compensated curve during the prognostic period.

3. The method of claim 2 wherein fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage comprises iteratively fitting the post-exercise resting heart rate (HR rec), a decay coefficient (k), and the time t 0 to the heart rate activity data according to a curve defined by:

HR=HRrec+(HRpeak−HRrec) e−k ( t−t 0)

4. The method of claim 3 wherein the post-exercise heart rate reserve is defined by (HRpeak−HRrec).

5. The method of claim 2 wherein fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage comprises iteratively fitting the post-exercise resting heart rate (HRrec), a decay coefficient (k), and the time t 0 to the heart rate activity data according to an iterative damped generalized inverse approach using partial derivatives of a post-exercise resting heart rate, k and t 0 .

6. The method of claim 2 further comprises generating a curve of the heart activity data by (a) defining time windows of the heart activity data, (b) sorting heart rates within the time windows, and (c) averaging at least a portion of the heart rates in each window centered on a median heart rate in each window.

7. The methods of claim 2 further comprising generating a compensated curve by subtracting the post-exercise resting heart rate from the heart activity data to provide a differenced result and dividing the differenced result by the post-exercise heart rate reserve.

8. The method of claim 2 wherein:

ascertaining the risk indicator comprises determining a slope of the compensated curve during the prognostic period; and

providing an assessment of cardiac risk comprises comparing the risk indicators for a cohort having experienced a cardiac event with the risk indicator of the patient.

9. A method for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising:

determining a post-exercise resting heart rate and prognostic period after a time t 0 after a peak heart rate, wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and a subsequent physiological start of the recovery stage after terminating exercise;

determining a slope of a post-exercise heart rate recovery after time t 0 based on the post-exercise resting heart rate; and

providing a cardiac risk assessment of the patient based on the determined slope of the post-exercise heart rate recovery.

10. The method of claim wherein determining the time t 0 and the post-exercise resting heart rate comprises (a) measuring the peak heart rate (HRpeak) at a time t at which the patient terminates exercise and (b) fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage, and the method further comprises determining a compensated curve of the heart rate activity defined by a heart rate during the prognostic period and the post-exercise resting heart rate.

11. The method of claim 10 wherein fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage comprises iteratively fitting the post-exercise resting heart rate (HRrec), a decay coefficient (k), and the time t 0 to the heart rate activity data according to a curve defined by:

HR=HRrec+(HRpeak−HRrec) e−k ( t−t 0)

12. The method of claim 11 wherein the post-exercise heart rate reserve is defined by (HRpeak-HRrec).

13. The method of claim 10 wherein fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage comprises iteratively fitting the post-exercise resting heart rate (HRrec) a decay coefficient (k), and the time t 0 to the heart rate activity data according to an iterative damped generalized inverse approach using partial derivatives of the post-exercise resting heart rate, k and t 0 .

14. The method of claim 12 further comprising:

ascertaining a heart rate recovery value comprising determining a slope of the compensated curve wherein the compensated curve is generated by subtracting the post-exercise resting heart rate from the heart rate during the prognostic period to provide a differenced result and dividing the differenced result by the post-exercise heart rate reserve.

15. A method for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising:

providing heart rate recovery slopes of a sample of a cohort that has experienced a cardiac event (HRRScv);

providing heart rate recovery slopes of a sample of the cohort that has not experienced a cardiac event (HRRSlive);

selecting a prognostic period of the recovery stage for the specific patient where HRRSlive is statistically separate from HRRScv;

determining a heart rate recovery slope of the patient during the prognostic period; and

ascertaining a cardiac risk for the patient based on the heart rate recovery slope of the patient, HRRSlive, and HRRScv wherein providing a prognostic period comprises selecting a prognostic period start time after a time t 0 wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and a subsequent physiological start of the recovery stage after termination of exercise.

16. A method for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising: providing a prognostic period during the recovery stage after sympathetic control of a heart is subordinate to vagal control of the heart; and ascertaining a cardiac risk for the patient based on a slope of the heart activity data during only the prognostic period wherein providing a prognostic period comprises selecting a prognostic period start time after a time t 0 wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and the subsequent physiological start of the recovery stage after termination of exercise.

17. A system for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising:

a cardiographic device configured to measure the heart activity data; and

a computer having a computer-operable medium containing instructions that—

(a) determines a prognostic period of the heart activity data after a time t 0 after a peak heart rate of the exercise test;

(b) ascertains a risk indicator based on (a) the heart rate activity data during the recovery stage only after time t 0 and (b) a post-exercise heart rate reserve value based on a post-exercise resting heart rate; and

(c) provides an assessment of cardiac risk of the specific patient based on the ascertained risk indicator

wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and a subsequent physiological start of the recovery stage after termination of exercise.

18. The system of claim 17 wherein the instructions of the computer-operable medium further:

determines the time t 0 and the post-exercise resting heart rate by (a) measuring the peak heart rate (HRpeak) at a time at which the patient terminates exercising and (b) fitting the time t 0 and the post-exercise resting heart rate to the heart activity data during the recovery stage; and

determines a compensated curve of the heart rate activity defined by a heart rate during the prognostic period and the post-exercise resting heart rate.

19. The system of claim 18 wherein instructions of the computer-operable medium further:

ascertain the risk indicator by determining a slope of the compensated curve; and

provide an assessment of cardiac risk by comparing a slope of a corresponding compensated curve for a cohort that has experienced a cardiac event and the slope of the compensated curve of the patient.

20. A system for assessing cardiac risks based on heart activity data obtained during a recovery stage of an exercise test of a specific patient, comprising:

a cardiographic device configured to measure the heart activity data; and

a computer having a computer-operable medium containing instructions that—

(a) determines a post-exercise resting heart rate and a start of a prognostic period after a time t 0 after a peak heart rate, wherein the time t 0 is an effective time delay between a protocol defined start of the recovery stage and a subsequent physiological start of the recovery stage after termination of exercise;

(b) determines a slope of a post-exercise heart rate recovery after time t 0 based on the post-exercise resting heart rate; and

(c) provides a cardiac risk assessment of the patient based on the determined slope of the post-exercise heart rate recovery.

Assignments (15)
RELEASE OF SECURITY INTEREST AT REEL/FRAME 050260/0644 Recorded Dec 14, 2021
From: JPMORGAN CHASE BANK, N.A.
To: BREATHE TECHNOLOGIES, INC.; HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; WELCH ALLYN, INC.; HILL-ROM, INC.; VOALTE, INC.; BARDY DIAGNOSTICS, INC.; HILL-ROM HOLDINGS, INC.
Reel/Frame 058517/0001 →
SECURITY AGREEMENT Recorded Sep 4, 2019
From: HILL-ROM HOLDINGS, INC.; HILL-ROM, INC.; HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; ANODYNE MEDICAL DEVICE, INC.; VOALTE, INC.; WELCH ALLYN, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 050260/0644 →
RELEASE OF SECURITY INTEREST Recorded Sep 3, 2019
From: JPMORGAN CHASE BANK, N.A.
To: HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; WELCH ALLYN, INC.; HILL-ROM COMPANY, INC.; HILL-ROM, INC.; ANODYNE MEDICAL DEVICE, INC.; MORTARA INSTRUMENT, INC.; MORTARA INSTRUMENT SERVICES, INC.; VOALTE, INC.
Reel/Frame 050254/0513 →
MERGER Recorded Jul 12, 2018
From: MORTARA INSTRUMENT, LLC
To: WELCH ALLYN, INC.
Reel/Frame 046327/0713 →
CHANGE OF NAME Recorded Jul 12, 2018
From: MORTARA INSTRUMENT, INC.
To: MORTARA INSTRUMENT, LLC
Reel/Frame 046530/0516 →
SECURITY AGREEMENT Recorded Apr 17, 2017
From: MORTARA INSTRUMENT, INC.; MORTARA INSTRUMENT SERVICES, INC.
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 042268/0090 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY RECORDED: PATENTS: 5713515, 5666943, 5775268, 5772422, 7278379, D533263, 7299769, 7665427 APPLICATION: 13658934 PREVIOUSLY RECORDED ON REEL 034182 FRAME 0883. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jan 29, 2015
From: MORTARA INSTRUMENT BV
To: MORTARA INSTRUMENT, INC.
Reel/Frame 035026/0761 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 17, 2014
From: MORTARA INSTRUMENT BV
To: MORTARA INSTRUMENT, INC.
Reel/Frame 034182/0883 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2013
From: CARDIAC SCIENCE CORPORATION, A DELAWARE CORPORATION
To: MORTARA INSTRUMENT BV, A NETHERLANDS PRIVATE LIMITED LIABILITY COMPANY
Reel/Frame 030473/0461 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2013
From: CARDIAC SCIENCE CORPORATION, A DELAWARE CORPORATION
To: MORTARA INSTRUMENT BV, A NETHERLANDS CORPORATION
Reel/Frame 030142/0115 →
RELEASE OF SECURITY INTEREST Recorded Apr 3, 2013
From: DBS BANK LTD., BANGALORE BRANCH
To: CARDIAC SCIENCE CORPORATION, A DELAWARE CORPORATION
Reel/Frame 030141/0807 →
SECURITY AGREEMENT Recorded Feb 1, 2013
From: CARDIAC SCIENCE CORPORATION
To: DBS BANK LTD., BANGALORE BRANCH
Reel/Frame 029733/0425 →
RELEASE OF SECURITY INTEREST Recorded Dec 1, 2012
From: SILICON VALLEY BANK
To: CARDIAC SCIENCE CORPORATION
Reel/Frame 029389/0937 →
SECURITY AGREEMENT Recorded Jun 8, 2010
From: CARDIAC SCIENCE, INC.
To: SILICON VALLEY BANK
Reel/Frame 024492/0931 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 2, 2007
From: HADLEY, DAVID M.
To: CARDIAC SCIENCE CORPORATION
Reel/Frame 019508/0076 →
Continuity (2)
Provisional Application 60793744 · Apr 21, 2006
Related Publication 20070249949A1 · Oct 25, 2007