System and method for decompensation detection and treatment based on patient hemodynamics

• US 8,825,156 B2
• Filed: 04/12/2013
• Issued: 09/02/2014
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Liu, Lili, Alvarez, Guy, Maskara, Barun, Meyer, Scott A.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/861,947
• Publication Number:
  US 20130226258A1
• Time in Patent Office: 508 Days
• Field of Search: 607/9, 607/11, 607/17
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

A system and method for detecting and treating symptoms of early decompensation utilizing a cardiac rhythm management. The system applies an electrical stimulus to the patient'"'"'s heart at a first set of pacing parameters including a lower rate limit (LRL) setting, and acquires a coronary venous pressure (CVP) signal from a pressure sensor implanted in a coronary vein of the patient. An average coronary venous end diastolic pressure (CV-EDP) value is calculated from the CVP signal. The system monitors the average CV-EDP value over a predetermined interval, and dynamically adjusts the LRL setting responsive to the detection of a first or a second predetermined event based on the average CV-EDP value.

Claims

1. A method of operating an implanted cardiac rhythm management system in a patient, the method comprising:

applying an electrical stimulus to the patient'"'"'s heart at a first set of pacing parameters including a lower rate limit (LRL) setting;

acquiring a coronary venous pressure (CVP) signal from a pressure sensor implanted in a coronary vein of the patient;

calculating an average coronary venous end diastolic pressure (CV-EDP) value from the CVP signal;

monitoring the average CV-EDP value, such monitoring including detecting an increase in the average CV-EDP value above a threshold indicative of decompensation and subsequently detecting a reduction in the average CV-EDP value below the threshold indicative of termination of the decompensation; and

dynamically adjusting the LRL setting based on the average CV-EDP value by increasing the LRL setting in response to detecting the increase in the average CV-EDP value above the threshold and reducing the LRL setting in response to detecting the reduction in the average CV-EDP value below the threshold.

2. The method of claim 1 further comprising initiating a prescribed time limit based on the LRL setting being increased in response to detecting the increase in the average CV-EDP value above the threshold, wherein dynamically adjusting the LRL setting includes lowering the LRL setting based on expiration of the prescribed time limit if the reduction in the average CV-EDP value below the threshold is not detected during the prescribed time limit.

3. The method of claim 1 wherein dynamically adjusting the LRL setting comprises further increasing the LRL setting if the reduction in the average CV-EDP value below the threshold has not been detected following the LRL setting being increased in response to detecting the increase in the average CV-EDP value above the threshold.

4. The method of claim 1 wherein dynamically adjusting the LRL setting comprises further increasing the LRL setting a predetermined number of times if the reduction in the average CV-EDP value below the threshold has not been detected following one or more previous increases of the LRL setting.

5. The method of claim 1 further comprising reducing the LRL setting in response to an expiration of a predetermined time period for applying the electrical stimulus at the increased LRL setting.

6. The method of claim 1 wherein calculating the average CV-EDP value includes generating a CVP waveform based on the CVP signal and calculating an average CV-EDP value over a predetermined interval based on the CVP waveform.

7. An implantable rate adaptive cardiac rhythm management system configured for applying pacing stimuli to a patient'"'"'s heart, the pacing stimuli defined by pacing parameters including a pacing rate and an LRL setting, the system comprising:

a plurality of implantable medical electrical leads configured to sense cardiac electrical activity and to deliver the pacing stimuli, at least one of the leads being configured for chronic implantation within a coronary vein of the patient'"'"'s heart and including a pressure sensor configured to generate a coronary venous pressure (CVP) signal indicative of fluid pressure within the coronary vein;

an implantable pulse generator operatively coupled to the leads configured to generate the pacing stimuli, the pulse generator including a control system configured to;

acquire the CVP signal from the pressure sensor;

calculate an average coronary venous end diastolic pressure (CV-EDP) value from the CVP signal;

monitor the calculated average CV-EDP value, such monitoring including detecting an increase in the average CV-EDP value indicative of decompensation symptoms and detecting a reduction in the average CV-EDP value indicative of termination of the decompensation symptoms; and

dynamically adjust the LRL setting based on the calculated average CV-EDP value by increasing the LRL setting in response to detecting the increase in the average CV-EDP value, maintaining the LRL setting at the increased setting for a prescribed time interval, and further increasing the LRL setting if the reduction in the average CV-EDP value is not detected during the prescribed time interval.

8. The system of claim 7 wherein the pulse generator is further configured to estimate and monitor average left ventricular end diastolic pressure (LV-EDP) values based on the CVP signal.

9. The system of claim 7 wherein the pulse generator is further configured to dynamically adjust the LRL setting by increasing the LRL setting a predetermined number of times but preventing the LRL setting from exceeding a maximum pacing rate limit.

10. The system of claim 7 wherein the pulse generator is further configured to dynamically adjust the LRL setting by reducing the LRL setting in response to detecting the reduction in the average CV-EDP value indicating the termination of early decompensation symptoms.

11. The system of claim 7 wherein the pulse generator is configured to:

detect the increase in the average CV-EDP value indicative of decompensation symptoms by detecting the average CV-EDP value increasing above a threshold indicative of decompensation,

detect the reduction in the average CV-EDP value by detecting a reduction in the average CV-EDP value below the threshold.

12. An implantable rate adaptive cardiac rhythm management system configured for applying pacing stimuli to a patient'"'"'s heart, the pacing stimuli defined by pacing parameters including a LRL setting, the system comprising:

a pressure sensor configured for chronic implantation within a coronary vein of the patient'"'"'s heart to generate a coronary venous pressure (CVP) signal indicative of fluid pressure within the coronary vein; and

an implantable pulse generator operatively coupled to the pressure sensor and configured to generate a pacing stimuli, the pulse generator including a control system configured to;

acquire the CVP signal from the pressure sensor;

calculate an average coronary venous end diastolic pressure (CV-EDP) value from the CVP signal;

monitor the calculated average CV-EDP value, such monitoring including detecting an increase in the average CV-EDP value above a threshold indicative of decompensation symptoms and detecting a reduction in the average CV-EDP value below the threshold; and

dynamically adjust the LRL setting based on the calculated average CV-EDP value by increasing the LRL setting in response to detecting the increase in the average CV-EDP value above the threshold and reducing the LRL setting in response to detecting the reduction in the average CV-EDP value below the threshold.

13. The system of claim 12 wherein the control system is configured to initiate a prescribed time limit based on the LRL setting being increased, and lower the LRL setting based on expiration of the prescribed time limit if the reduction in the average CV-EDP value below the threshold is not detected during the prescribed time limit.

14. The system of claim 12 wherein the control system is configured to increase the LRL setting if the reduction in the average CV-EDP value below the threshold has not been detected following the LRL setting being increased in response to detecting the increase in the average CV-EDP value above the threshold.

15. The system of claim 12 wherein the control system is configured to increase the LRL setting a predetermined number of times if the reduction in the average CV-EDP value below the threshold has not been detected following one or more previous increases of the LRL setting.