Patient identification for the pacing therapy using LV-RV pressure loop

• US 6,280,389 B1
• Filed: 11/12/1999
• Issued: 08/28/2001
• Est. Priority Date: 11/12/1999
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Yu, Yinghong, Ding, Jiang, Spinelli, Julio
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/439,228
• Time in Patent Office: 655 Days
• Field of Search: 600/508, 600/485, 600/510, 600/526
• US Class Current: 600/485
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

A method and apparatus for determining whether a patient with congestive heart failure (CHF) will benefit from pacing therapy through the use of an implantable cardiac rhythm management device. A patient'"'"'s right ventricular and left ventricular pressures are measured, and the patient'"'"'s PP_Area is calculated for each normal heartbeat that occurs during the testing period. Depending upon the value of the patient'"'"'s mean PP_Area, it can be determined whether the patient will or will not respond well acutely to pacing therapy. A mean PP_Area value of greater than or equal to a predetermined threshold, which is about 0.3, indicates that the patient is a responder to pacing therapy, while a value of less than the predetermined threshold of about 0.3 indicates that the patient is a non-responder.

Claims

1. A method for determining whether a patient with congestive heart failure (CHF) will benefit from pacing therapy, said method comprising the steps of:

(a) measuring right ventricular (RV) and left ventricular (LV) pressures;

(b) calculating a value based on the RV and LV pressures; and

(c) determining whether the patient is a responder or a non-responder to pacing therapy based on the value.

2. The method as defined in claim 1 wherein calculating the value includes calculating PP_Area, and wherein determining whether the patient is a responder or a non-responder to pacing therapy includes comparing the PP_Area to a predetermined threshold.

3. The method as defined in claim 2 wherein the predetermined threshold is about 0.3, with the PP_Area being greater than or equal to about 0.3 indicating that the patient is a responder, and with the PP_Area being less than about 0.3 indicating that the patient is a non-responder.

4. The method as defined in claim 2 wherein the step of measuring the RV and LV pressures is performed over a predetermined time period, and wherein the step of calculating PP_Area is conducted for each heart beat occurring during the predetermined time period, and further comprising the step of calculating a mean PP_Area of the PP_Areas only from normal heart beats during the predetermined time period, said mean PP_Area being used in determining whether the patient is a responder or non-responder to pacing therapy by comparing the mean PP_Area to said predetermined threshold.

5. The method as defined in claim 4 wherein the predetermined threshold is about 0.3, with the mean PP_Area being greater than or equal to about 0.3 indicating that the patient is a responder, and with the mean PP_Area being less than about 0.3 indicating that the patient is a non-responder.

6. The method as defined in claim 4 wherein the predetermined time period is about thirty (30) seconds.

7. The method as defined in claim 6 wherein said predetermined threshold is about 0.3, with the mean PP_Area being greater than or equal to about 0.3 indicating that the patient is a responder, and with the mean PP_Area being less than about 0.3 indicating that the patient is a non-responder.

8. The method as defined in claim 6 wherein after the step of calculating the PP_Area for each heart beat occurring during the thirty second time period, a further step of determining whether at least five (5) PP_Areas have been calculated from data collected during a given thirty (30) second time period, and if so, proceeding with the further steps of calculating the mean of at least five PP_Areas, comparing the mean PP_Area to the predetermined threshold, and determining whether the patient is a responder or a non-responder, and if at least five (5) PP_Areas have not been calculated, then further comprising a step of disregarding earlier collected data and repeating the step of calculating the PP_Area for each heart beat during a next thirty (30) second time period until at least five (5) PP_Areas are calculated from five (5) normal heart beats occurring during a next thirty (30) second time period.

9. The method as defined in claim 8 wherein said predetermined threshold is about 0.3, with the mean PP_Area being greater than or equal to about 0.3 indicating that the patient is a responder, and with the mean PP_Area being less than about 0.3 indicating that the patient is a non-responder.

10. The method as defined in claim 4 and further comprising the step of storing the PP_Area of each normal heart beat and the mean PP_Area as data in a memory for later readout.

11. The method as defined in claim 10 and further comprising the step of displaying the data in graph form.

12. The method as defined in claim 10 and further comprising the step of displaying the data in table form.

13. An apparatus for determining whether a patient with CHF will benefit from pacing therapy comprising:

(a) means for sensing pressure variations in the left and right ventricle of patient'"'"'s heart and producing an electrical signal proportional thereto;

(b) means for converting the electrical signal to a digital quantity;

(c) a microprocessor having a memory for storing samples of the digital quantities over a predetermined time period;

(d) means for determining how many heart beats occur during the predetermined time period;

(e) means for determining whether a heart beat is normal or not;

(f) means for calculating PP_Areas for heart beats occurring during the predetermined time period, and a mean value of the PP_Areas;

(g) means for determining whether the mean PP_Area of a given pacing therapy is above or below a predetermined threshold, as an indicator of whether the patient is a responder or a non-responder to the given pacing therapy.

14. The apparatus as defined in claim 13 wherein the means for sensing pressure variations is an external device.

15. The apparatus as defined in claim 13 wherein the means for sensing pressure variations is an internal device.

16. The apparatus as defined in claim 13 wherein the means for sensing pressure variations is a micromanometer.

17. An apparatus for determining whether a patient with CHF will benefit from pacing therapy, comprising:

(a) an implantable electronics module containing a microprocessor and a memory coupled to the microprocessor for storing a program of instructions and calculated operands;

(b) pressure transducers positioned to sense left and right ventricular pressures and for producing electrical signals proportional thereto;

(c) means for applying the electrical signals as digital quantities to the microprocessor;

(d) means responsive to the execution of the program for computing a mean value of pulse pressure areas from the digital quantities over a predetermined time interval; and

(e) means including the microprocessor for determining whether the computed mean value is greater than, equal to or less than a predetermined threshold as an indicator of whether the patient will benefit from pacing therapy.