WO2005020025A2 - Methodes et appareil pour programmer automatiquement des dispositifs de therapie de resynchronisation cardiaque (crt) - Google Patents

Methodes et appareil pour programmer automatiquement des dispositifs de therapie de resynchronisation cardiaque (crt) Download PDF

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Publication number
WO2005020025A2
WO2005020025A2 PCT/US2004/027174 US2004027174W WO2005020025A2 WO 2005020025 A2 WO2005020025 A2 WO 2005020025A2 US 2004027174 W US2004027174 W US 2004027174W WO 2005020025 A2 WO2005020025 A2 WO 2005020025A2
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Prior art keywords
parameter
programming
crt
amd
myocardial
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PCT/US2004/027174
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English (en)
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WO2005020025A3 (fr
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Stuart Schecter
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Stuart Schecter
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Priority claimed from US10/779,162 external-priority patent/US7065400B2/en
Application filed by Stuart Schecter filed Critical Stuart Schecter
Priority to EP04781788.7A priority Critical patent/EP1665110A4/fr
Publication of WO2005020025A2 publication Critical patent/WO2005020025A2/fr
Publication of WO2005020025A3 publication Critical patent/WO2005020025A3/fr

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0883—Clinical applications for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • 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
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36521—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure the parameter being derived from measurement of an electrical impedance
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F2218/00—Aspects of pattern recognition specially adapted for signal processing

Definitions

  • the present invention is related to implantable cardiac devices such as pacemakers and defibrillators that deliver cardiac resynchronization therapy (CRT), and to a method of programming devices using ultrasound or other techniques such as transthoracic or intracardiac impedance measurements to determine specific parameters indicative of the response of a patient to variations in cardiac stimulation patterns. The parameters are then used to direct closed loop programming of interval timing within such CRT device.
  • CRT cardiac resynchronization therapy
  • Impaired cardiac performance can result from several abnormalities. Such abnormalities include alterations in the normal electrical conduction patterns and mechanical abnormalities in myocardial contractility. These abnormalities are often (though not necessarily) connected to one another and, as such, electro-mechanical impairments can cause an impairment in cardiac performance as well. Such impairment in cardiac performance often stems from premature or delayed electrical and/or mechanical events in different cardiac chambers and within specific cardiac chambers. Newly developed cardiac resynchronization therapy devices have been developed as to correct this problem. Unfortunately, such devices do not improve a significant percentage of patients. This is a result of a general inability of such CRT to appropriately correct dysynchronous properties in a customized fashion for each particular patient.
  • Newer ultrasonic imaging modalities such as color Doppler myocardial imaging (CDMI) that quantify myocardial velocity and strain allow for qualification and quantification of myocardial dysynchrony.
  • CDMI color Doppler myocardial imaging
  • CDMI is more accurate for tracking synchrony and symmetry of cyclical cardiac events than any other imaging modality and offers the clinician the ability to appropriately program interval timing between stimuli applied by multiple electrodes in CRT devices best suited for an individual patient.
  • CDMI does not provide any guidelines of how these timing intervals should be selected, and therefore the process of programming these intervals involves an effort based on trial and error and can be cumbersome and timely. Programming of appropriate interval timing will necessitate experienced physicians who are sub-specialized in the fields of electrophysiology and echocardiography. This will be difficult from a logistic standpoint especially at lower volume institutions or non-academic centers.
  • a method and apparatus that provides a closed loop between CRT devices, a programmer and ultrasound equipment used to generate CDMI.
  • the method and apparatus requires a shorter time to define optimal stimulation patterns (interval timing) and expedites programming of the CRT as multiple variables are able to be evaluated rapidly.
  • intracardiac impedance measurements are determined.
  • An advantage of using measurements of intracardiac impedance is that this modality can be implemented for true closed loop programming of CRT devices rather than via connectivity to extrinsic ultrasound equipment. Using an ultrasonic interface at periodic intervals will help optimize such true closed loop programming and aid in determining interval timing with increases in heart rate, for example, during exercise.
  • Fig. 1 shows a block diagram for an apparatus for programming a CRT device
  • Fig. 2 shows a general flow chart for the operation of the apparatus of Fig.
  • Fig. 3 shows a time-dependant graph of a typical Doppler derived aortic velocity time integral, AoVTI, during a cardiac cycle obtained from a sample of blood flow coursing through the aortic valve. This integral describes the flow of blood through the aortic valve over time and is a representation of cardiac performance;
  • Fig. 4 shows details of a heart as seen on the monitor (apical 4 chamber (atria deleted for simplification purposes) of the apparatus of Fig. 1 ;
  • Fig. 4A shows typical strain curves for two regions of interest in the left ventricle;
  • Fig. 4B shows typical velocity curves for two regions of interest in the left ventricle; Figs.
  • FIG. 4C and 4D show two strain curves superimposed during the cardiac cycle for a normal (synchronous) and an abnormal (dysynchronous) heart, respectively;
  • Fig. 4E shows curved M-mode data acquisition and the line defining the end-diastolic turnaround time, EDTT, the time of aortic valve opening, AoVo, and the area between, systolic myocardial relaxation integral, SMRI.
  • Fig. 4F shows curved M-mode data acquisition and the line defining the end-systolic turnaround time, ESTT, the time of aortic valve closure, AoVc, and the area between, diastolic myocardial thickening integral, DMTI;
  • FIG. 4G shows multi-dimensional representation of curved M-mode data with interpolation as to create the end diastolic turnaround time surface, S, and volume, V, between surface S and plane, AoVc, which represents the volume of delayed dysynchronous myocardium in three dimensions as a triple integral calculated in polar coordinates;
  • Fig. 5 shows a block diagram for an alternate embodiment with an external transthoracic impedance sensor;
  • Fig. 6 shows a time dependent transthoracic impedance curve, 116, representing changes in blood volume within the aorta and great vessels which relate to measurements of cardiac performance;
  • Fig. 5 shows a block diagram for an alternate embodiment with an external transthoracic impedance sensor;
  • Fig. 6 shows a time dependent transthoracic impedance curve, 116, representing changes in blood volume within the aorta and great vessels which relate to measurements of cardiac performance;
  • FIG. 7 shows time-dependent curves of impedance derived from transmyocardial electrodes in a dysynchronous portion of the left ventricle, Z2p, (middle) and derived from electrodes positioned in a trans-valvular location, Zip, (top) as to delineate timing of aortic valve closure, wherein there is delayed systolic thickening and a corresponding increase in impedance after aortic valve closure (post-systolic positive impedance, PSPI) for impedance signal Z2, the intracardiac electrogram being denoted as a reference for all acquired signals as well (bottom);
  • Fig. 8 shows a block diagram for an alternate embodiment of the invention; Fig.
  • FIG. 9 shows a block diagram of an embodiment with parameter switching;
  • Fig. 10 A shows intracardiac electrograms and impedance curves derived from multiple transcardiac electrodes which demonstrate electro-mechanical dysynchrony relative to normal template data;
  • Fig. 10 B shows intracardiac electrograms obtained from a multi-site coronary sinus lead in a patient with dysynchrony;
  • Fig. 10 C shows intracardiac electrograms obtained from the same lead in 10B after resynchronization;
  • Fig. 11 shows the normal appearance of Z(t), top, which is usable as a normal template with a pathologic Z(t) signal, bottom, in a patient with advanced dysynchrony;
  • Fig. 12 shows bipolar electrodes radially located along a coronary sinus (CS) lead which describe the rotational or helical properties of the heart during the cardiac cycle.
  • CS coronary sinus
  • Fig. 1 shows an apparatus for programming a cardiac device such as a CRT (cardiac resynchronization therapy) device 12.
  • the device 12 includes a lead or leads 12A with several electrodes positioned to provide sensing and excitation in a patient's heart H, as discussed in more detail below, including sensing and pacing of at least the right atrium and right and left ventricles [left atrial leads not available but under development via stimulation through the coronary sinus or alternate form]. For the sake of simplicity, the electrodes have been omitted.
  • the apparatus 10 further includes a programmer 14 with a wand 14A. The wand 14A is used to transmit data from the programmer to the device 12.
  • the device 12 receives commands to send stimulation signals to the respective cardiac chambers, and to sense the corresponding cardiac response, as discussed in more detail below.
  • the apparatus 10 further includes ultrasonic equipment 16.
  • the ultrasonic equipment 16 includes a display 16A, an ultrasound generator 16B and an ultrasound echo sensor 16C. These elements are controlled by a processor 16D.
  • Ultrasonic display 16A displays images derived from reflected ultrasound waves generated by the ultrasound generator, 16B, and received by ultrasound sensor, 16 C, after processing in processor, 16D.
  • the processor, 16D receives the echoes and provides various information for a user such as a cardiologist or a clinician through the display 16A.
  • the display 16A may include either a touch screen or ther means (not shown) through which the user can provide input to the processor 16D. For example, the user may select portions of an image on the display 16D and request further information associated with the selected portions, request further data processing associated with the selected portions, or request some other data manipulations as discussed below.
  • the display 16A may show, directly, or indirectly, a live picture of the heart and its tissues, the operation of the valves and some parameters such as blood flow, myocardial thickness, myocardial velocity / strain, ejection fraction, cardiac dimensions, and so on. Ultrasound equipment of this type is available, for example, from GE, ACUSON and Philips.
  • a program parameter calculator 18 that operates in an automatic or semi-automatic mode to determine the programming parameters for the device 12.
  • the calculator 18 is shown in Fig. 1 as a separate element, but it can be incorporated into the programmer 14, the ultrasound equipment 16 or even the device 12.
  • step 200 one set of AV (atrial-ventricular interval) and VrVI, interval (programmed delay time between stimulation between electrodes in the right and left ventricles) and, optionally, other delays which may relate to intraventricular time delays, VaVb, (e.g. the delay time between stimuli delivered to a posteriorly positioned coronary sinus LV lead, Va, and laterally positioned coronary sinus LV lead, Vb) associated with the operation of the CRT 12 are selected. This can occur either automatically by the program calculator 18, or manually. Alternatively, these delays may be preprogrammed parameters.
  • the AV delays are between the right or left atrial and the right or left ventricular pulses
  • the VrVI delays are between the left and the right ventricular pulses
  • VaVb are between other electrodes (e.g. multi-site coronary sinus left ventricular electrodes).
  • five AV delays may be selected at 90 + 20 msec in 10 msec intervals (e.g., 70, 80, 90, 100, 110) and five VrVI delays may be selected at 0 + 20 msec in 10 msec intervals.
  • any number M AV delays may be used and N VIVr delays may be used.
  • the one set of delays form MxN delays times. These delays may be arranged into a two dimensional array or matrix for computational purposes (step 202).
  • AV AV
  • VrVI, VaVb AV
  • AV can be predetermined using commonly employed equations (e.g. Ritter method) and not act as a variable for this matrix.
  • the AV delay programmed only variables VrVI and VaVb need be evaluated using a two rather than a three dimensional matrix. This will reduce the number of delay times evaluated by this methodology.
  • RA and LA the AV can reflect the time interval between the last stimulated atrial chamber (e.g. LA) and first stimulated ventricular chamber (e.g.
  • the CRT device is operated by the programmer 12 to stimulate the heart H sequentially using the set of delays defined in step 200.
  • the stimulation may be applied first using pulses with an AV delay of 70 msec and a VrVI delay of -20msec.
  • a predetermined cardiac performance parameter CPP is chosen. This parameter is indicative of the performance of the heart H responsive to these delays (e.g. Aortic Velocity Time Integral, AoVTI; TEI index).
  • the user can be signaled to obtain this CPP using the ultrasonic equipment 16.
  • the ultrasonic equipment may obtain CPP data automatically.
  • the heart is stimulated again using an AV of 80msec and a VrVI delay of -20msec, and another CPP is derived.
  • the heart is stimulated MxN times and a corresponding CPP is derived for each stimulation pattern (set of delays).
  • the CPP can be obtained over a specific number of cardiac cycles and a mean value of CPP is derived over this specific number of cardiac cycles.
  • these performance parameters are preferably collected automatically by the ultrasonic sensor (and/or by other means) and provided to the program parameter calculator.
  • the program parameter calculator identifies a cardiac performance parameter CPPo that provides the optimal cardiac performance (or, at least, the parameter that comes closest to optimal performance).
  • the pair of delays AVx, VIVrx corresponding to the optimal cardiac performance parameter is provided to the programmer 12.
  • the programmer 12 programs these delays into the CRT.
  • Many different cardiac characteristics could be used as the CPP.
  • the CPP may be the ejection fraction.
  • this characteristic is rather difficult to measure accurately and is subject to operator dependency. Therefore the present inventor has identified several other parameters that can be used as the CPP.
  • One of these characteristics is the aortic velocity time integral or AoVTI.
  • the velocity of the blood through the aortic valve or aortic outflow tract is one of the parameters that is determined and displayed by the ultrasonic equipment 16 and shown in display 16A as a curve, as indicated on Fig. 3.
  • the processor 16D integrates under the velocity curve shown in Fig. 3 to obtain a parameter AoVTI.
  • This step may be performed either after a clinician selects the curve on the display and requests its integral, or can be performed automatically, by the processor 16D without any prompting by the clinician. In this manner respective values of AoVTI are calculated for each set of delays. These values are then provided to the calculator 18 and processed as discussed above.
  • the AoVTI having the largest value is determined, i.e., AoVTImax is determined as the optimal AoVTI.
  • the AoVTImax is the optimal cardiac performance parameter.
  • the present inventor has discovered that other types of parameters may be more useful for the programming of the CRT. More specifically, quantitative parameters indicative of myocardial dysynchrony or anisotropic myocardial deformation (AMD) in a patient are also important for CRT programming. Though any quantitative analysis of anisotropic myocardial deformation may be utilized, the inventor has identified several such parameters discussed below.
  • One parameter that is indicative of AMD is related to myocardial strain derived from myocardium using Color Doppler Myocardial Imaging, CDMI.
  • Fig. 4 shows diagrammatically a portion of the heart H as seen on the display 16A.
  • regions of interest, 34 and 36 are selected. These regions of interest can be selected manually by the user. Alternatively, the portions 34, 36 could be selected automatically by the ultrasonic equipment 16 or the calculator 18. Preferably these regions of interest, 34, 36 should be selected so that they are symmetrical with respect to a central longitudinal axis, L-L of the left ventricle. Determination of these regions of interest can be made automatically by ultrasonic equipment 16 determining the myocardial segments with the most significant dysynchrony (e.g.
  • the ultrasonic equipment 16 determines and displays myocardial strain curves on the display 16A associated with these portions during one or more cardiac cycles.
  • a typical ECG is represented by curve 102
  • the strain on portion 34 on the septum is represented by curve 104
  • the strain associated with lateral ventricular wall at the portion 36 is represented by curve 106 .
  • the two curves 104, 106 are substantially identical and occur during the systolic ejection phase, SEP, of the cardiac cycle.
  • the two curves are offset in time and may differ in other aspects as well.
  • the minimum amplitude As (this point on curve is actually maximal strain as the direction of relative myocardial velocities / strain is opposite to the transducer location) for curve 104 occurs at a time Ts from initial depolarization while the minimum amplitude Al for curve 106 occurs at a time TI from initial depolarization.
  • Initial depolarization is defined by the QRS complex on the simultaneously acquired ECG. It is believed that the reason for this intra-ventricular dysynchrony or anisotropic myocardial deformation within the left ventricle, is secondary to regional electro-mechanical abnormalities.
  • the heart H should be paced in such a manner that the peak strain or amplitudes occur at a similar time.
  • the region which manifests electromechanical delay is stimulated earlier (delta T in figure) in the cardiac cycle so that it behaves synchronously with a corresponding symmetrically located portion of normally activated myocardium.
  • a strain correction factor index SCFI
  • SCFI is defined as the AMD parameter.
  • SCFI could be Ts/TI.
  • An SCFI is calculated for each of the pair of delays discussed above.
  • the optimal AMD parameter in this case is the SCFI closest to unity.
  • Another characteristic that can be used as an AMD parameter associated with the ventricular chamber tissue portions 34, 36 portions is a parameter associated with their motion.
  • the various portions of tissues forming the ventricular chamber travel at different rates, with the tissues at the apex typically traveling at the lowest velocity.
  • Myocardial longitudinal velocity during systole is toward the apex of the heart and in the opposite direction during diastole.
  • the velocities of the regions can be measured by the ultrasonic equipment 16.
  • the resulting velocity profiles or typical for regions 34, 36 are shown in Figs. 4B.
  • the two points analyzed on these curves are maximum points A34 and A 36, occurring at T1 and T2 after the initial depolarization of the ventricle.
  • One can use an alternate point such as the point defining the initiation of motion in these regions of interest as well.
  • a velocity correction factor index is then defined as T1/T2. As with SCFI, this parameter is optimal when it approaches unity. Analysis of measurements of myocardial velocity will be more representative of synchrony related to changes in interval timing while analysis of measurements of myocardial strain will be representative of both relative motion and properties of contractility. Differences in these data sets can be used to differentiate properties of electrical and mechanical dysynchrony and can be used to describe areas of myocardial scarring from heart attacks and areas of myocardial viability where resynchronization therapy will more favorably remodel ('heal") regional myocardium that has been deprived of normal electrical stimulation patterns. This vital data can be utilized for monitoring purposes. In another embodiment of the invention, other characteristics of the curves 104, 106 are used. Figs.
  • a difference integral function is derived by taking the integral of the difference between the two curves shown in Figs. 4C and 4D as a function of time over a cardiac cycle (or cardiac cycles using summation or ensemble averaging). Similar ensemble averaging techniques can be used to analyze myocardial segments (multiple neighboring regions of interest) where multiple strain curves are derived over a sequential number of cardiac cycles.
  • the optimal DIF is the index with the smallest value, minimal integral difference, MID. This MID is then used as the AMD parameter.
  • a correlation function that compares the two curves can be used to define an AMD parameter.
  • the MID can be determined using the velocity curves of Figs. 4A and 4B.
  • the ultrasonic sensor is operated in a 2D mode, and either the user manually selects regions of interest or such regions of interest are automatically selected from a myocardial segment that has the most prolonged time to peak velocity (or strain) and a normal segment that is located in a symmetric region of interest about the central longitudinal axis, LL.
  • Another mode of operation of the sensor is determined by signals generated by curved M-mode.
  • curved M-mode instead of two regions, a straight or a curved line M is selected that is traced around the left ventricle, through the myocardium as shown in Fig. 3.
  • the curve M is selected either manually by the user on the display 16A or automatically.
  • the ultrasound equipment 16 first detects the outline OL of the inner left ventricle using automatic edge or border detection algorithms and then selects the line M so that it lies outwardly of the outline and spaced therefrom by a predetermined distance, such as 3-5mm.
  • this line is provided to the processor or automatically determined by the processor 16D, then various graphical analyses are performed on this line, including, for example myocardial velocity data for all myocardial tissue that is sampled along this line during a cardiac cycle. This velocity defines how these segments are moving longitudinally (toward the apex during systole and away from the apex during diastole). This information yields more comprehensive data than the discrete regions 34, 36 discussed above. For example, in Figure the curve 110 occurs at the end of myocardial relaxation for all segments and is defined as the end diastole turnaround time, EDTT, or the time when all segments change direction and begin to move from base to apex.
  • EDTT end diastole turnaround time
  • the diastolic myocardial thickening integral can be derived by determining the area between the end of myocardial thickening for all segments (end systolic turnaround time, ESTT, or the time when all segments change direction and begin to move from apex to base, curve 112) and the time of aortic valve closure, AoVc. Either of these integrals can be used as the AMD parameter. The parameters are optimized when they have the smallest value. The timing of aortic valve opening and closure can be extrapolated to the surface ECG from the appropriate imaging planes and used as a reference in patients with regular rhythm.
  • Relative delays in electro-mechanical activation in certain myocardial segments may occur within the time frame of the systolic ejection period (not before or after aortic valve opening or closure, respectively) but remain dysynchronous. Such relative delays can be evaluated by adjusting the pulse repetition frequency as to cause aliasing of the myocardial Doppler signal at any point within the systolic time frame. Evaluating the symmetry or lack of symmetry of onset of aliasing with such curved M mode aliasing velocity data can provide a window into more subtle anisotropic myocardial deformation and can be used as a quantitative parameter in a similar fashion as the DMTI and SMRI described above.
  • curves 110 or 112 may also be performed on curves 110 or 112 (as is demonstrated using curve 110 in Figures 4G).
  • V volumetric parameter
  • This can be derived using newly developed ultrasound transducers that can provide three dimensional data by essentially rotating the line M through the heart tissues about axis L-L and obtaining a three dimensional shape indicative of the velocity of multiple myocardial segments about the left ventricle.
  • This shape may be analyzed using polar coordinates to obtain a multi-dimensional AMD parameter.
  • Myocardial radial distance, angle about L-L, and time represent the coordinates for such an analysis.
  • the time between aortic valve opening and EDTT's determined for multi-dimensional curved M mode data acquisitions represent the integral limits for such quantitative representation of AMD. Interpolation between the acquired EDTT lines will be necessary to form the upper surface representing the upper limit of integration.
  • the lower limit of integration is the plane describing aortic valve opening.
  • the volumetric parameter, V represents all dysynchronous myocardial tissue that is relaxing (should be contracting) after the aortic valve has opened.
  • several different types of AMD parameters are calculated for each set of delays (such as SCFI, VCFI, MID, DTMI, SRMI, etc.). The AMD from each parameter is determined and then the AMDs from the different parameters are compared.
  • an apparatus 10A in which the cardiac performance parameter is derived by means of transthoracic impedance cardiographic equipment 20 instead of the ultrasonic equipment 16.
  • the impedance cardiographic equipment 20 is similar to ultrasonic equipment 16. It has a display 20A, a current generator 20B, electrodes 20C and a processor 20D.
  • the electrodes 20C are first placed across the thoracic area of the patient and the current generator 20B applies a current between the electrodes. Sensors within the electrodes 20C are then used to determine the voltages induced by this current.
  • Transthoracic impedance monitors of this type are available from Cardiodynamics of San Diego, California. Using this monitor, a time dependent impedance curve is derived, as shown in Fig. 6, with the curve 116 representing impedance changes related to changes in blood volume within the aorta and great vessels. One or more characteristics of this parameter are then used as a CPP. These characteristics may include cardiac output, cardiac index, stroke volume or any other data obtained or calculated from the transthoracic impedance equipment.
  • the timing of data acquisition with impedance cardiographic equipment 20 can be optimally triggered by intracardiac electrograms obtained from electrodes derived from a specified lead, 12A.
  • Such timing is best initiated by defining the onset of the cardiac cycle, systole, measured by ventricular electrograms obtained from the latest activated electrode. This will require such electrogram data to be transmitted to impedance cardiographic equipment 20 via electronic interface 20E which transmits such data between CRT device external programmer and processor 20D.
  • the parameters described so far are determined using extemal means, i.e., ultrasonic equipment as described and shown in Fig. 1 or impedance cardiography equipment as described and shown in Fig. 5.
  • parameters are determined using internal means. This latter approach has several advantages. One is that additional equipment is not required.
  • a second advantage is that the programming of the CRT can be updated dynamically as a true closed loop system and will not require outside intervention.
  • Parameters that can be derived in this manner are based on intra-thoracic or intra-cardiac impedance measurements. It is conventional to measure intra-thoracic impedance using two spaced electrodes. A current is applied between one electrode and a reference electrode and the corresponding induced voltage is then measured at a second set of electrodes. If bipolar electrodes are used, the reference electrode can be the tip or the ring of bipolar electrode. The measurement can be repeated throughout the cardiac cycle thereby generating a time dependent impedance curve Z(t). As shown in Fig.
  • Z1(t) starts with ventricular depolarization, and normally has a peak value Zip disposed between the AoVo, the time when the aortic valve opens and AoVc, the time that the aortic valve closes, referenced to a specific intracardiac electrogram signal, EGM.
  • Certain optimally positioned electrodes will generate impedance signals such as Zip where timing of aortic valvular events by notches on the upslope, NU, and downslope, ND, of the impedance signal can be identified. Similar Z curves can be generated between different electrodes attached to various myocardial segments. For example, turning back to Fig.
  • two electrodes 40 and 42 may be provided with electrode 40 being attached to the lateral wall of the left ventricle (coronary sinus lead), near region 36 and electrode 42 being attached to the right ventricular portion of the interventricular septum symmetrically with respect to electrode 40, near region 34.
  • the peak of the resulting impedance curves Z1 , Z2 should occur at a synchronous point in time for symmetrically stimulated myocardial segments, at a time between aortic valve opening and aortic valve closure.
  • the two peaks may be shifted significantly. Therefore, in one mode of operation, the relative times to respective peak impedances Zip, Z2p ( TP1, TP2 in Fig.
  • EMCFI electromechanical correction factor index
  • EMCF TP1/TP2 electromechanical correction factor index
  • This factor is optimized in accordance with the technique described above, for the other embodiments of the invention, and is optimized when it is closest to unity.
  • the parallel to EMCFI is the SCFI using ultrasound technology.
  • the impedance curves are Z1 and Z2 with Z1 being associated with a right ventricular lead and Z2 being associated with a coronary sinus left ventricular lead. In this embodiment, the two ventricles are synchronized.
  • the electrode pairs may be defined between electrode 44 attached near the apex in the right ventricle and electrodes 40, 46, 48 placed radially along the coronary sinus, CS. Electromechanical timing sequences between such multiple electrode pairs can be compared to templates derived in the electrophysiology lab or from devices implanted in patients with favorable remodeling and reversibility of dysynchrony.
  • Such a multi-site CS lead can measure pure intracardiac electrogram signals along the CS lead electrodes devoid of impedance data or data related to electromechanical delay times by using both electrogram and impedance signals. Data acquired in this fashion can direct programming of interval timing between such electrodes or be used for pure sensing purposes as to more accurately describe dysynchrony along the radial course of the coronary sinus lead. Such data will provide a window into the helical nature of systolic and diastolic coiling and uncoiling of the heart in multiple dimensions. Similarly located electrodes can be used to identify electrical activation patterns without use of impedance data and serve to monitor AMD. Such an embodiment will require analysis of intracardiac electrogram signals along a multi-site coronary sinus lead.
  • Such internally derived impedance data is associated with a baseline constant impedance value not related to dynamic changes in impedance during the cardiac cycle. As such this offset, which does not represent physiologically relevant data, is subtracted from the data acquired. Importantly, variations in impedance related to changes in lung volume from the respiratory cycle need to be removed from the impedance signal as well. This can be done in part by using higher frequency current pulses as to derive impedance data which in essence creates a band pass filter or by deriving impedance data at a specific time during the respiratory cycle (e.g. end- expiration). Similar signal processing is performed for impedance-derived determinations of AMD.
  • an AMD parameter is determined that quantifies or otherwise indicates the degree of dysynchrony or a cardiac performance parameter, CPP, is determined which relates to cardiac output.
  • CPP cardiac performance parameter
  • both CPP and AMD parameters can be used as to describe the output of the heart, such as dZ/dt, and the degree of dysynchrony such as the EMCFI.
  • the therapeutic system utilizes blended measurements of cardiac performance and anisotropic myocardial deformation. This embodiment is useful as the selected AMD parameter may not necessarily represent synchrony at the appropriate time during the cardiac cycle.
  • the optimal AMDo is calculated using any of the embodiments discussed above.
  • a determination is made whether the AMDo is acceptable. This determination is made, for example, by checking how close is the AMDo to a test or threshold value.
  • step 302 a check is performed to determine if AMDo is within a predetermined range. If the AMD is EMCFI, the target for these parameters is 1.0 and therefore a check in step 302 is made to determine whether 0.8 ⁇ AMDo ⁇ 1.2.
  • a subset of intervals (AVa- VrVIa, AVb-VrVlb, AVc-VrVlc) which represent AMDo's that fall within one or two standard deviations of the mean EMCFI (in this example, EMCFIa, EMCFIb, EMCFIc) can become variables evaluated in step 308 using an internal CPP such as dZ/dt, peak Z, or J Z(t)dt. If the AMDo is within this range, then it is accepted and a CPP parameter is evaluated for each AMDo within the specified range.
  • a CPP parameter is determined for each of the delay pairs in accordance, for example, the process is set forth as in Fig. 2.
  • the optimized CPPo is selected.
  • the corresponding delays are determined and the CRT is programmed using these delays as operational parameters.
  • comparisons of the morphology of optimal impedance waveforms ( Figure 11 ) and timing relationships relative to intracardiac electrograms along specific electrode vectors in a given patient ( Figure 10A) to those obtained in patients with normal electromechanical properties can be made.
  • Fig. 9 A mode of operation for the CRT is shown in Fig. 9.
  • the CRT 12 calculates an AMD parameter (e.g. EMCFI), as discussed above.
  • the parameter is used to determine the operational parameters of the CRT. At certain predetermined intervals, for example, once a day, or even dynamically after several cardiac cycles, or after any other programmable or
  • step 404 it is found that the CRT is not operating in an optimal fashion, for example, if measurements of intra-thoracic and /or intracardiac impedance are consistent with values indicative of congestive heart failure (decreases in relative intra-thoracic impedance secondary to pulmonary vascular congestion and / or the presence of a marked discrepancy between impedance waveform morphology and the normal template) then in step 406 a new AMD parameter is implemented and used in step 402. If this second AMD is not acceptable, then the CRT can implement a different AMD parameter.
  • the optimal AMD parameter for monitoring and directing programming of interval timing within the CRT device is identified and applied in the methodologies described above.
  • This describes an automatic optimization algorithm, which serves as a control system for the CRT.
  • the CRT is provided with an emergency default mode.
  • the purpose of this feature is to detect and to take action if the heart H has undergone a sub-critical change (for example, dramatic reduction in transthoracic impedance secondary to acute pulmonary edema, and/or significant increases in minute ventilation) and therefore requires a different type of optimization algorithm or alternate pacing modality. Under this circumstance, instead of seeking to minimize AMD the system will switch as to maximize a CPP. This is depicted in Figure 9.
  • the cardiac output of the heart is evaluated (e.g. JZ(t)dt), in step 408 as a measure of cardiac performance. If in step 408 it is determined that the heart has not improved, then in step 412 the CRT chooses a different CPP.
  • a parameter is chosen that has been selected to optimize cardiac output rather than a parameter meant to minimize AMD.
  • intra-thoracic impedance measurements can be made at periodic intervals and re-evaluated as delay times are varied without assessment of an AMD or CPP parameter.
  • This automatic optimization algorithm relies on more chronic monitoring data than use of an AMD parameter or CPP as trends in pulmonary vascular congestion as a result of variations in interval timing will occur over more extended periods of time.
  • Such an algorithm will be less dependent on multiple electrodes and impedance signals and be less prone to impaired functionality.
  • Such an algorithm will also have less demands on microprocessor robustness and may be pragmatic in many situations but will not have the sensitivity and specificity of the more complex embodiments described.
  • a system will not be as capable of making dynamic changes in programmed parameters but will still serve to improve the functionality of current CRT systems without the need for more complex algorithms.
  • means are provided for quantifying and comparing cardiac performance and/or anisotropic myocardial deformation using electrical and/or mechanical properties analyzed either extrinsically or intrinsically. This information is used for providing a resynchronization device with a control system capable of optimizing cardiac performance and/or minimizing anisotropic myocardial deformation both in the acute and chronic setting. Moreover the resulting operation is optimized for a given patient, based on measurements specific for the individual patient.

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Abstract

L'invention concerne un équipement de surveillance extérieure ou intérieure, utilisé pour déterminer automatiquement des paramètres de programmation optimaux pour une CRT, en fonction de mesures extérieurement ou intérieurement dérivées, de la performance cardiaque, de la déformation myocardique anisotropique (AMD), ou des deux. Le paramètre de programmation idéal, paramètre fonctionnel, représente la synchronisation d'intervalle optimale entre plusieurs électrodes situées à l'intérieur du dispositif CRT, et est généré par un système de commande à boucle fermée de l'invention. Ce système à boucle fermée peut être semi-automatique et permet une connectivité vers un équipement à ultrasons extérieurs ou des mesures extérieurement dérivées de l'impédance transthoracique. De préférence, le paramètre fonctionnel est déterminé par un système à boucle fermée au moyen de mesures d'impédance et d'électrogrammes intracardiaques et intrathoraciques intérieurement dérivés, décrivant une performance cardiaque et une dysynchronie électromécanique en temps réel. Un tel dispositif CRT présente un système de commande permettant d'optimiser automatiquement la performance à l'aide d'un système de vérifications et d'équilibrage.
PCT/US2004/027174 2003-08-20 2004-08-20 Methodes et appareil pour programmer automatiquement des dispositifs de therapie de resynchronisation cardiaque (crt) WO2005020025A2 (fr)

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US7653436B2 (en) 2003-08-20 2010-01-26 Pacesetter, Inc. Global cardiac performance
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Publication number Priority date Publication date Assignee Title
US7653436B2 (en) 2003-08-20 2010-01-26 Pacesetter, Inc. Global cardiac performance
US8214039B1 (en) 2006-10-09 2012-07-03 Pacesetter, Inc. Individually adapted cardiac electro-mechanical synchronization therapy
US8972011B2 (en) 2006-10-09 2015-03-03 Pacesetter, Inc. Individually adapted cardiac electro-mechanical synchronization therapy
US7805194B1 (en) 2006-11-03 2010-09-28 Pacesetter, Inc. Matrix optimization method of individually adapting therapy in an implantable cardiac therapy device
US9446246B2 (en) 2008-11-07 2016-09-20 Pacesetter, Inc. Identification of electro-mechanical dysynchrony with a non-cardiac resynchronization therapeutic device
US10078893B2 (en) 2010-12-29 2018-09-18 Dia Imaging Analysis Ltd Automatic left ventricular function evaluation

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