System and method for determining a reference baseline for use in heart failure assessment

• US 8,888,698 B2
• Filed: 08/20/2007
• Issued: 11/18/2014
• Est. Priority Date: 07/26/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US11/894,514
• Publication Number:
  US 20070293741A1
• Time in Patent Office: 2,647 Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

A system and method for determining a stressor-based reference baseline for use in heart failure assessment is presented. A patient is monitored during an observation time period while the patient performs prescribed physical stressors and by applying pacing stimulus stressors to a medical device. Physiological measures are stored from the observation period, including at least one of direct measures regularly recorded on a substantially continuous basis by the medical device and measures derived therefrom. The measures that originate from the observation time period as a reference baseline for the patient are identified. The reference baseline and those measures originating subsequent to the observation period are evaluated. The measures are analyzed to detect any trends, including one of a status quo and a change in cardiac performance of the patient. Each trend is compared to parameters corresponding to worsening heart failure indications to generate a notification of parameter violations.

Claims

1. A system for determining a stressor-based reference baseline for use in heart failure assessment, comprising:

a programmer to receive monitoring of a patient that was performed during an observation time period while the patient performed prescribed physical stressors and while pacing stimulus stressors were applied to a medical device of the patient; and

a server, comprising,

a storage module to store physiological measures from the observation period into a patient care record comprising at least one of direct measures regularly recorded on a continuous basis by the medical device and measures derived therefrom;

a reference baseline module to identify those of the physiological measures that originate from the observation time period as a reference baseline for the patient; and

an evaluation module to evaluate the reference baseline and those physiological measures originating subsequent to the observation period, comprising;

an analyzer module to compare the direct measures and derived measures to the physiological measures from the observation period to detect a patient status comprising one of a status quo and a change in cardiac performance of the patient; and

a comparison module to compare the patient status to parameters corresponding to worsening heart failure indications to generate a notification of parameter violations.

2. A system according to claim 1, the server further comprising:

a reprogramming module to reprogram a medical device based on extended evaluation of the direct measures and the derived measures.

3. A system according to claim 1, the server further comprising:

a tracking module to track respiration rate of the patient on a regular basis through the medical device; and

a notification module to generate a notification triggered by an upper limit parameter applied over a short term.

4. The system according to claim 1, wherein the pacing stimulus stressors are applied via a reprogramming of at least one of pacing interventions and pacing modes of the patient'"'"'s implantable medical device.

5. A method for determining a stressor-based reference baseline for use in heart failure assessment, comprising:

monitoring a patient during an observation time period while the patient performs prescribed physical stressors and by applying pacing stimulus stressors to a medical device of the patient;

storing from the observation period physiological measures into a patient care record on a server, wherein the patient care record comprises at least one of direct measures regularly recorded on a continuous basis by the medical device and measures derived therefrom;

using the server to identify those of the physiological measures that originate from the observation time period as a reference baseline for the patient;

receiving, by the server, physiological measures originating subsequent to the observation period from a remote programmer; and

using the server to evaluate the reference baseline and the physiological measures originating subsequent to the observation period, comprising;

comparing the direct measures and derived measures to the physiological measures from the observation period to detect patient status comprising one of a status quo and a change in cardiac performance of the patient; and

comparing the patient status to parameters corresponding to worsening heart failure indications to generate a notification of parameter violations.

6. A method according to claim 5, further comprising:

using the server to reprogram a medical device based on extended evaluation of the direct measures and the derived measures.

7. A method according to claim 5, further comprising:

using the server to track respiration rate of the patient on a regular basis through the medical device; and

using the server to generate a notification triggered by an upper limit parameter applied over a short term.

8. The method according to claim 5, wherein the pacing stimulus stressors are applied via a reprogramming of at least one of pacing interventions and pacing modes of the patient'"'"'s implantable medical device.