System and method for predicting a heart condition based on impedance values using an implantable medical device

• US 7,272,443 B2
• Filed: 12/15/2004
• Issued: 09/18/2007
• Est. Priority Date: 03/26/2004
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Min, Xiaoyi, Bornzin, Gene A., Park, Euljoon
• Primary Examiner(s): Layno; Carl
• Assistant Examiner(s): Johnson; Shevon E
• Application Number:
  US11/014,276
• Publication Number:
  US 20050216067A1
• Time in Patent Office: 1,007 Days
• Field of Search: 607/9, 607 17- 18, 607/28, 600/547
• US Class Current: 607/17
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation

Abstract

Techniques are provided for predicting the onset of a heart condition within a patient based on impedance measurements. Briefly, overloads in fluid levels in the thorax and in ventricular myocardial mass within the patient are detected based on impedance signals sensed using implanted electrodes. The onset of certain heart conditions is then predicted based on the overloads. For example, pulmonary edema arising due to diastolic heart failure is predicted based on the detection of on-going overloads in both fluid levels and ventricular mass. Ventricular hypertrophy is detected based on an on-going ventricular mass overload without a sustained fluid overload. Various other heart conditions may also be predicted based on specific combinations of recent or on-going overloads. Evoked response is exploited to corroborate the predictions. Appropriate warning signals are generated and preemptive therapy is initiated.

Claims

1. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient;

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein the implantable medical device includes a device can and is coupled to a cardiac electrode implanted in the heart and wherein detecting fluid overload is performed by detecting a sustained decrease in cardiac electrode—

can impedance over a predetermined period of time; and

wherein the predetermined period of time is at least three days.

2. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient;

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein the implantable medical device includes a device can and is coupled to a cardiac electrode implanted in the heart and wherein detecting fluid overload is performed by detecting a sustained decrease in cardiac electrode—

can impedance over a predetermined period of time; and

wherein the decrease is at least ten percent of a previous cardiac electrode—

can impedance value.

3. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein predicting the onset of a heart condition includes the step of identifying the combination of a sustained fluid overload without an on-going ventricular mass overload and without a recent decrease in ventricular mass overload and with either a constant of decreased evoked response as being indicative of an increased likelihood of the onset of pulmonary edema due to systolic heart failure (SHF) within the patient.

4. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads; and

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein predicting the onset of heart condition includes the step of identifying the combination of a sustained fluid overload along with an on-going ventricular mass overload and an increased evoked response as being indicative of an increased likelihood of onset of pulmonary edema due to diastolic heart failure (DHF) within the patient.

5. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein predicting the onset of heart condition includes the step of identifying the combination of a sustained fluid overload without an on-going ventricular mass overload but with a decreased evoked response as being indicative of an increased likelihood in the onset of SHF within the patient.

6. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein predicting the onset of heart condition includes the step of identifying the combination of a sustained fluid overload along with an on-going ventricular mass overload and either an increased evoked response or a lack of change in evoked response as being indicative of an increased likelihood of onset of DHF within the patient.

7. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits change if any, in ventricular evoked response; and

wherein the step of predicting the onset of heart condition includes the step of identifying the combination of a lack of sustained fluid overload along with an on-going ventricular mass overload and an increased evoked response as being indicative of an increased likelihood of onset of ventricular hypertrophy within the patient.

8. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein the step of predicting the onset of heart condition includes the step of identifying the combination of a lack of sustained fluid overload and a lack of an on-going ventricular mass overload is along with a recent drop in ventricular mass and a decrease in evoked response from a previously elevated level as being indicative of an increased likelihood of progression of mixed heart failure within the patient.

9. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient; and

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass;

wherein detecting values representative of thoracic fluid levels is performed to detect a fluid overload and wherein detecting values representative of ventricular mass is performed to detect mass overload;

wherein predicting the onset of a heart condition is performed based on the values representative of sustained fluid overloads in combination with the values representative of on-going ventricular mass overloads and recent decreases in ventricular mass overloads;

wherein detecting ventricular evoked response and wherein predicting the onset of a heart condition additionally exploits changes, if any, in ventricular evoked response; and

wherein the step of predicting the onset of heart condition includes the step of identifying the combination of a decrease in evoked response without an on-going ventricular mass overload and without any recent drop in ventricular mass as being indicative of an increased likelihood of ventricular dilation within the patient.

10. A method for predicting the onset of a heart condition within a patient having an implantable medical device, the method comprising:

detecting impedance values representative of thoracic fluid levels within the patient;

detecting impedance values representative of ventricular mass within the patient;

predicting the onset of the medical condition within the patient based on the values representative of thoracic fluid levels in combination with the values representative of ventricular mass; and

further including the step of initiating preemptive pacing in response to the prediction of the onset of heart condition.