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EP0921842A1 - Procede servant a controler des malades atteints d'insuffisance cardiaque congestive chronique - Google Patents

Procede servant a controler des malades atteints d'insuffisance cardiaque congestive chronique

Info

Publication number
EP0921842A1
EP0921842A1 EP97922343A EP97922343A EP0921842A1 EP 0921842 A1 EP0921842 A1 EP 0921842A1 EP 97922343 A EP97922343 A EP 97922343A EP 97922343 A EP97922343 A EP 97922343A EP 0921842 A1 EP0921842 A1 EP 0921842A1
Authority
EP
European Patent Office
Prior art keywords
calculated
chf
ecw
values
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97922343A
Other languages
German (de)
English (en)
Other versions
EP0921842A4 (fr
Inventor
Charles L. Feldman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zymed Medical Instrumentation Inc
Original Assignee
Zymed Medical Instrumentation Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zymed Medical Instrumentation Inc filed Critical Zymed Medical Instrumentation Inc
Publication of EP0921842A1 publication Critical patent/EP0921842A1/fr
Publication of EP0921842A4 publication Critical patent/EP0921842A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Definitions

  • Congestive heart failure results when the heart is unable to contract with sufficient vigor to meet the body's need for oxygen.
  • CHF Congestive heart failure
  • autoregulatory mechanisms allow the filling pressure in the ventricles to increase, thus elongating myocardial fibers at the start of systole and increasing the strength of contraction.
  • left and/or right filling pressures exceed approximately 15 mm Hg, blood components are forced out of the vasculature and into the interstitium, resulting in pulmonary edema (left heart failure) and/or peripheral edema and ascites (right heart failure). The end results is severe incapacitation and possibly death.
  • Lukaski & Bolonchuk have derived relationships between the components of the body's electrical impedance at either 50 kHz or 1000 Hz and either total body water or extracellular fluid. See Lukaski, et al., Estimation of Body Fluid Volumes Using Tetrapolar Bioelectrical Impedance Measurements. Aviation Space and Environmental Medicine; 1988; 59: 1163-1169.
  • the present invention resides in an "early warning" monitoring system for determining changes in the status of patients with chronic congestive heart failure (CHF), with the goal of intervening before the onset of acute congestive heart failure.
  • a process for monitoring patients with chronic congestive heart failure comprises the steps of applying electrodes to two points on the body, passing a current at one or more high frequencies between the electrodes, and then measuring the current (I) and voltage (V).
  • Congestive heart failure (CHF) indicia values are calculated based on the measured current (I) and voltage
  • the process comprises the steps of applying the electrodes to two limbs of a patient and then passing a i o high frequency current between the electrodes.
  • Current (I), voltage (V) and phase angle (+) are measured, and then congestive heart failure (CHF) indicia values, including resistance (R) and reactance (Z c ), are calculated.
  • CHF indicia values are then compared with baseline values, and intervention is initiated when the differences between the calculated CHF
  • the process is repeated at an interval determined by whether or not intervention was required.
  • the calculated CHF indicia values may include, in addition, impedance (Z).
  • indicia values of resistance (R), reactance (Z c ) or impedance (Z), is an indicator of the need to initiate intervention.
  • the tolerances from baseline values for the calculated CHF indicia values are on the order of five percent (5%) for resistance (R) and impedance (Z), ten percent (10%) for reactance (Z c ), and twenty percent (20%) for phase angle (f).
  • the calculated CHF indicia values may also include total body water (TBW) and extracellular water (ECW).
  • TW total body water
  • ECW extracellular water
  • the tolerances from baseline values are on the order of five percent (5%) for total body water (TBW) and extracellular water (ECW).
  • Total body water may be calculated utilizing the formula:
  • Extracellular water may be calculated utilizing the formula:
  • the calculated CHF indicia values may further include a figure of merit which is indicative of the hydration status of the patient.
  • the figure of merit may be derived from the ratio of extracellular water (ECW) over fat-free mass (FFM).
  • Fat-free mass (FFM) may be calculated utilizing the formula:
  • FFM - 15.26 - .775(Ht 2 /R) + .146 Wt + .185 Z c . Intervention is indicated when the ratio of extracellular water (ECW) to fat-free mass (FFM) is greater than approximately 0.30. Moreover, an increase in the figure of merit on the order of one percent (1 %) is an additional indicator of the need to initiate intervention.
  • FIGURE 1 is the first of a two-part flow chart illustrating a process for monitoring patients with chronic congestive heart failure embodying the present invention.
  • FIGURE 2 is the second of the two-part flow chart illustrating the process of the present invention.
  • the present invention is concerned with a novel process for monitoring patients with congestive heart failure, generally indicated in FIGS. 1 and 2 by the reference number 10.
  • the process 10 comprises, generally, the steps of applying electrodes to two points on the body of a patient and, while passing a current at one or more high frequencies between the electrodes, measuring the current (I) and voltage (V).
  • Congestive heart failure (CHF) indicia values are then calculated based on the measured current (I) and voltage (V), which are compared with baseline values to determine if differences therebetween are within established tolerances. If those differences are outside of the established tolerances, intervention is initiated in accordance with sound medical practice.
  • the process 10 of the present invention provides an "early warning" monitoring system for determining changes in the status of patients with chronic congestive heart failure with the goal of intervening before the onset of acute CHF.
  • the process 10 of the present invention involves the tracking of total body impedance (Z), resistance (R), reactance (Z c ) and phase angle ( ⁇ r) in an abulatory patient with chronic congestive heart failure (CHF), and uses the decrease of any or all of these "indicia values" as predictors of the onset of acute CHF.
  • the measurement can be made using a commercial device, such as that manufactured by RJL Systems of Clinton Twp., Ml, to measure body composition, or a similar device designed for this purpose.
  • Significant intra-patient changes over time in the values of these parameters would be viewed as indicators of a deteriorating physical condition.
  • the electrodes may be placed on any two points on the body, but preferably are positioned on either the ipsilateral wrist and ankle or on the contralateral wrist and ankle as described in Subramanyan, et al., Total Body Water in Congestive Heart Failure. Jour. Asso. Phys. Ind., Vol. 28, September,
  • the process 10 of the present invention also includes utilizing the techniques described above applied to separate portions of the body of the patient to separately track peripheral and pulmonary edema. For example, measuring and tracking ankle-to-ankle impedance (Z) and its components would highlight changes in peripheral fluid, primarily indicative of right heart failure. Wrist-to-wrist impedance (Z) components would be more indicative of changes in lung fluid and left heart failure. Changes in any of these component impedance values would be used as an indicator of instability and suggest changes in therapeutic regimen.
  • combining estimates 5 of total and extracellular water with estimates of body cell mass into a "figure of merit" indicative of the hydration status of the patient may be advantageously accomplished in accordance with the process 10 of the present invention.
  • Changes in the "figure of merit” would be used as an indicator of worsening condition of the CHF patient.
  • Typical figures of merit o would include the ratio of extracellular fluid (ECW)/fat-free mass (FFM), or the ratio of extracellular water (ECW)/total body weight.
  • An increases in the figure of merit of approximately one percent (1%) would be used as an indicator of worsening condition.
  • certain figures of merit, per se, rather than their change may be utilized as an indicator of congestive heart failure. For 5 example, when the ratio of extracellular water (ECW)/fat-free mass (FFM) is greater than approximately 0.30, it may be assumed that the patient is in congestive heart failure.
  • the process 10 begins by applying clinical criteria to evaluate the risk of acute heart failure (block 12).
  • 0 Factors to be evaluated are the patient's history of hospitalization for congestive heart failure (CHF), left ventricular ejection fraction (EF - the fraction of the left ventricle that is emptied in each cardiac contraction), and typical signs of CHF including neck vein distention, shortness of breath and swelling of the extremities.
  • CHF congestive heart failure
  • EF left ventricular ejection fraction
  • typical signs of CHF including neck vein distention, shortness of breath and swelling of the extremities.
  • High risk patients are those who have been hospitalized for CHF within the last three months, those who have been hospitalized for CHF within the last year and show new neck vein distention, those who have shortness of breath at rest or with minimal exertion, and/or those with an ejection fraction (EF) less than forty percent, for example. If the patient is not classified as a high risk, the physician may reevaluate the diagnosis as appropriate, for example, every three months or so (block 16).
  • the bioelectric impedance analysis of the present invention is conducted to enable the health care provider to determine the patient's congestive heart failure (CHF) indicia values for purposes of comparing those values with baseline values established when the patient is in a known stable condition (block 18).
  • CHF congestive heart failure
  • two electrodes are attached to each of two limbs (block 20).
  • the two more distal electrodes i.e., hand and foot
  • the two more proximal electrodes i.e., wrist and ankle
  • V voltage
  • the electrodes have sufficient surface area so that the contact impedance is very low compared to the impedance (Z) of the body (i.e., «500 ⁇ )
  • a single electrode on each of the two limbs can be used for both current injection and voltage measurement.
  • Any pair of limbs may be used (right arm to left leg, right arm to left arm, etc.), or multiple pairs can be used and results calculated pair-by-pair.
  • the electrodes are attached to the lower left extremity and the upper right extremity.
  • a high frequency current is passed between the electrodes (block 22).
  • a typical (preferred) current is 800 ⁇ amp at 50 kHz.
  • a current of up to 5 ma could be used as well as any single frequency from 10 kHz to 100 kHz.
  • the current (I) is measured (block 24) as well as the voltage (V) and phase angle ( ⁇ ) between the measured current (I) and voltage (V) (block 26).
  • the voltage (V) and current (I) can be measured with any conventional technique, analog or digital.
  • the delay between voltage and current in zero crossing (current lags voltage) bears the same relation to the waveform period as the phase angle ( ⁇ ) does to 360°.
  • phase angle (+ ⁇ ) 360 (t/T), where tange is the time by which current (I) lags voltage (V), and (T) is the waveform period (the inverse of frequency).
  • congestive heart failure (CHF) indicia values may then be calculated (blocks 28, 30 and 32).
  • the first indicia values calculated include impedance (Z), resistance (R) and reactance (Z c ).
  • Impedance (Z) is the rms voltage divided rms current.
  • the patient's total body water (TBW), extracellular water (ECW) and fat-free mass (FFM) may also be calculated to provide CHF indicia values.
  • Total body water (TBW) and extracellular water (ECW) can be calculated from the formulas of Lukaski H.C. & Bolonchuk W.W. Estimation of Bodv Fluid Volumes Using Tetrapolar Bioelectrical 5 Impedance Measurements. Aviation Space and Environmental Medicine,
  • Fat-free mass can be calculated from the formula provided in Huges, V.A., and Evans W.J. Assessment of Fat-Free Mass in an Older Population Using Bioelectric Impedance. Fed Proc 1987; 46 (Abstract), as follows:
  • Block 32 illustrates deriving a "figure of merit” from the ratio of extracellular water (ECW) over fat-free mass (FFM).
  • the baseline values are preferably measured when the patient is in a known, stable condition, such as when discharged from the hospital and/or entered into the monitoring program. If it is the baseline values that are being established (block 34), they are stored (block 36) for further reference.
  • the stored baseline values will typically include the weight (Wt) of the patient, the calculated impedance (Z), resistance (R), reactance (Z c ), phase angle (*), total body water (TBW), extracellular water (ECW), fat-free mass (FFM), and the ratio of extracellular water to fat-free mass (ECW/FFM).
  • a decrease in the phase angle ( ⁇ ) or any of the calculated CHF indicia values of resistance (R), reactance (ZJ or impedance (Z), is an indicator of the need to initiate intervention.
  • the tolerances from baseline values are on the order of five percent (5%) for resistance (R) and impedance (Z), ten percent (10%) for reactance (Z c ), and twenty percent (20%) for phase angle (+).
  • An increase in the calculated total body water (TBW) or extracellular water (ECW) is an indicator of the need to initiate intervention.
  • the tolerances from baseline values for such calculated CHF indicia values are on the order of five percent
  • the preferred delay before repeating the measurements is one to two weeks.
  • Interventions are based on medical judgment and form no part of the present invention. They might include counseling to reduce the amount of salt in the diet or reduce activity.
  • diuretics and/or angiotensin converting enzyme inhibitors could be increased.
  • intravenous diuretics could be started as could intravenous agents to increase the pumping action of the heart (inotropes such as dobutamine), or the patient could be advised to seek hospitalization.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

Procédé (10) servant à contrôler des malades atteints d'insuffisance cardiaque congestive chronique et consistant à faire passer un courant haute fréquence entre des électrodes (20) appliquées à deux membres du malade. On mesure (18) le courant, la tension et l'angle de phase entre le courant et la tension mesurés afin de pouvoir calculer les valeurs d'indice de l'insuffisance cardiaque congestive (CHF). On compare ensuite les valeurs d'indice de CHF à des valeurs de départ établies quand le malade est dans un état stable connu. On commence l'intervention si les différences entre les valeurs d'indice calculées de CHF et les valeurs de départ sont situées en dehors de tolérances établies. Les valeurs d'indice de CHF peuvent comprendre la résistance, la réactance, l'impédance, la quantité totale d'eau corporelle et l'eau extracellulaire. De plus, les valeurs d'indice de CHF peuvent comprendre une indication de l'état d'hydratation du malade.
EP97922343A 1996-04-23 1997-04-22 Procede servant a controler des malades atteints d'insuffisance cardiaque congestive chronique Withdrawn EP0921842A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US1601596P 1996-04-23 1996-04-23
US16015P 1996-04-23
PCT/US1997/006466 WO1997039792A1 (fr) 1996-04-23 1997-04-22 Procede servant a controler des malades atteints d'insuffisance cardiaque congestive chronique

Publications (2)

Publication Number Publication Date
EP0921842A1 true EP0921842A1 (fr) 1999-06-16
EP0921842A4 EP0921842A4 (fr) 1999-12-15

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EP97922343A Withdrawn EP0921842A4 (fr) 1996-04-23 1997-04-22 Procede servant a controler des malades atteints d'insuffisance cardiaque congestive chronique

Country Status (5)

Country Link
EP (1) EP0921842A4 (fr)
JP (1) JP3325273B2 (fr)
AU (1) AU2804397A (fr)
CA (1) CA2251718C (fr)
WO (1) WO1997039792A1 (fr)

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US6607485B2 (en) 1999-06-03 2003-08-19 Cardiac Intelligence Corporation Computer readable storage medium containing code for automated collection and analysis of patient information retrieved from an implantable medical device for remote patient care
US6312378B1 (en) 1999-06-03 2001-11-06 Cardiac Intelligence Corporation System and method for automated collection and analysis of patient information retrieved from an implantable medical device for remote patient care
US7134996B2 (en) 1999-06-03 2006-11-14 Cardiac Intelligence Corporation System and method for collection and analysis of patient information for automated remote patient care
US6221011B1 (en) 1999-07-26 2001-04-24 Cardiac Intelligence Corporation System and method for determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system
CA2314517A1 (fr) 1999-07-26 2001-01-26 Gust H. Bardy Systeme et methode de determination du niveau de reference de l'etat d'un patient pour utilisation dans un systeme automatise de collecte et d'analyse de donnees sur les soins aux patients
CA2314513A1 (fr) 1999-07-26 2001-01-26 Gust H. Bardy Systeme et methode de normalisation de la retroaction vocale d'un patient dans un systeme automatise de collecte et d'analyse de donnees sur les soins aux patients
US7127290B2 (en) * 1999-10-01 2006-10-24 Cardiac Pacemakers, Inc. Cardiac rhythm management systems and methods predicting congestive heart failure status
US6440066B1 (en) 1999-11-16 2002-08-27 Cardiac Intelligence Corporation Automated collection and analysis patient care system and method for ordering and prioritizing multiple health disorders to identify an index disorder
US8369937B2 (en) 1999-11-16 2013-02-05 Cardiac Pacemakers, Inc. System and method for prioritizing medical conditions
US6336903B1 (en) 1999-11-16 2002-01-08 Cardiac Intelligence Corp. Automated collection and analysis patient care system and method for diagnosing and monitoring congestive heart failure and outcomes thereof
US6411840B1 (en) 1999-11-16 2002-06-25 Cardiac Intelligence Corporation Automated collection and analysis patient care system and method for diagnosing and monitoring the outcomes of atrial fibrillation
US6398728B1 (en) 1999-11-16 2002-06-04 Cardiac Intelligence Corporation Automated collection and analysis patient care system and method for diagnosing and monitoring respiratory insufficiency and outcomes thereof
US6368284B1 (en) 1999-11-16 2002-04-09 Cardiac Intelligence Corporation Automated collection and analysis patient care system and method for diagnosing and monitoring myocardial ischemia and outcomes thereof
US7009511B2 (en) 2002-12-17 2006-03-07 Cardiac Pacemakers, Inc. Repeater device for communications with an implantable medical device
US7488290B1 (en) 2004-02-19 2009-02-10 Cardiac Pacemakers, Inc. System and method for assessing cardiac performance through transcardiac impedance monitoring
US8025624B2 (en) 2004-02-19 2011-09-27 Cardiac Pacemakers, Inc. System and method for assessing cardiac performance through cardiac vibration monitoring
US7329226B1 (en) 2004-07-06 2008-02-12 Cardiac Pacemakers, Inc. System and method for assessing pulmonary performance through transthoracic impedance monitoring
US7386345B2 (en) 2005-01-27 2008-06-10 Cardiac Pacemakers, Inc. Apparatus and method for temporary treatment of acute heart failure decompensation
WO2010032252A1 (fr) * 2008-09-22 2010-03-25 Cheetah Medical Ltd. Système et procédé de détermination du débit sanguin
US9999352B2 (en) 2013-09-27 2018-06-19 General Electric Company System and method for determining a hydration level of a tissue region
AU2017220382B2 (en) * 2016-02-16 2022-04-07 Impedimed Limited Heart failure indicator
KR101823496B1 (ko) 2016-08-22 2018-01-31 조선대학교산학협력단 부종 지수의 측정을 위한 웨어러블 디바이스 및 이를 이용한 부종 지수 측정 방법
JP7204740B2 (ja) * 2018-03-26 2023-01-16 テルモ株式会社 診断支援システム、診断支援方法、および診断支援プログラム
KR102484225B1 (ko) * 2020-10-15 2023-01-03 계명대학교 산학협력단 패치형 임피던스 측정 장치 및 방법

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Also Published As

Publication number Publication date
CA2251718C (fr) 2001-07-10
JP2000510005A (ja) 2000-08-08
CA2251718A1 (fr) 1997-10-30
WO1997039792A1 (fr) 1997-10-30
EP0921842A4 (fr) 1999-12-15
AU2804397A (en) 1997-11-12
JP3325273B2 (ja) 2002-09-17

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