U.S. patent application number 14/637058 was filed with the patent office on 2015-06-25 for method for determining and monitoring a cardiac status of a patient.
The applicant listed for this patent is ST. JUDE MEDICAL AB. Invention is credited to Anders Bjorling, Karin Jarverud, Jay Snell.
Application Number | 20150173653 14/637058 |
Document ID | / |
Family ID | 43628231 |
Filed Date | 2015-06-25 |
United States Patent
Application |
20150173653 |
Kind Code |
A1 |
Jarverud; Karin ; et
al. |
June 25, 2015 |
METHOD FOR DETERMINING AND MONITORING A CARDIAC STATUS OF A
PATIENT
Abstract
The present invention relates to a method for accurately and
reliably determining a cardiac status of a patient. An implantable
medical device, IMD, comprises a sensor arrangement adapted to
sense signals related to mechanical activity of the heart and an
activity level sensor arrangement adapted to sense an activity
level of the patient. Further, the IMD calculates a percentage of
left ventricular diastolic time (PLVDT) for a cardiac cycle
corresponding to a relation between a diastolic time interval and a
cardiac cycle time interval using the determined systolic and
diastolic time intervals or a percentage of left ventricular
systolic time (PLVST) for a cardiac cycle corresponding to a
relation between a systolic interval time interval and a cardiac
cycle time interval using. A cardiac status is determined based on
the calculated PLVDT (or PLVST) and on an activity level of the
patient.
Inventors: |
Jarverud; Karin; (Solna,
SE) ; Bjorling; Anders; (Solna, SE) ; Snell;
Jay; (Los Angeles, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ST. JUDE MEDICAL AB |
Jarfalla |
|
SE |
|
|
Family ID: |
43628231 |
Appl. No.: |
14/637058 |
Filed: |
March 3, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13392395 |
Feb 24, 2012 |
8998820 |
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PCT/SE2009/000393 |
Aug 27, 2009 |
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14637058 |
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Current U.S.
Class: |
600/479 ;
600/486; 600/508; 600/509; 600/513; 600/528 |
Current CPC
Class: |
A61B 5/0452 20130101;
A61B 5/6846 20130101; A61B 5/7275 20130101; A61B 5/0215 20130101;
A61B 5/042 20130101; A61B 5/02 20130101; A61B 7/023 20130101; A61B
5/1102 20130101; A61B 5/02416 20130101; A61B 5/1118 20130101; A61B
5/7278 20130101; A61N 1/3627 20130101 |
International
Class: |
A61B 5/11 20060101
A61B005/11; A61B 5/00 20060101 A61B005/00; A61B 7/02 20060101
A61B007/02; A61B 5/0215 20060101 A61B005/0215; A61B 5/024 20060101
A61B005/024; A61B 5/042 20060101 A61B005/042 |
Claims
1. A method for determining a cardiac status of a patient in an
implantable medical device being connectable to at least one
medical lead for contact with tissue of a heart of the patient, the
method comprising: sensing signals related to mechanical activity
of the heart and producing an output signal related to the
mechanical activity; sensing an activity level of the patient;
identifying predetermined cardiac events in the cardiac signals and
determining a systolic time interval and a diastolic time interval
of a cardiac cycle using the identified cardiac events; calculating
a percentage of left ventricular diastolic time (PLVDT) for a
cardiac cycle corresponding to a relation between a diastolic time
interval and a cardiac cycle time interval using the determined
systolic and diastolic time intervals or a percentage of left
ventricular systolic time (PLVST) for a cardiac cycle corresponding
to a relation between a systolic interval time interval and a
cardiac cycle time interval using the determined systolic and
diastolic time intervals; calculating a rate of change of the PLVDT
(or PLVST) and the activity level; synchronizing the activity level
with the calculated PLVDT (or PLVST) over time; and determining a
cardiac status based on the calculated PLVDT (or PLVST) and on the
activity level and on a rate of change of the PLVDT (or PLVST) and
on a rate of change of the activity level.
2. The method according to claim 1, further comprising sensing a
heart rate of the patient, and wherein the determining a cardiac
status comprises synchronizing the heart rate with the PLVDT (or
PLVST) over time and determining a cardiac status based also on a
development of the heart rate over time.
3. The method according to claim 1, wherein the determining a
cardiac status comprises determining a gradually increasing or
decreasing PLVDT (or PLVST) over time synchronized with a stable or
gradually decreasing activity level to be an indication of an
impaired cardiac status.
4. The method according to claim 1, wherein the determining a
cardiac status comprises determining a stable PLVDT (or PLVST) over
time within a predetermined range defined by an upper and a lower
limit to be an indication of a normal cardiac status and wherein a
PLVDT (or PLVST) being outside the predetermined range at least a
predetermined period of time is determined to be an indication of
an impaired cardiac status.
5. The method according to claim 1, wherein the sensing signals
related to mechanical activity of the heart comprises emitting
light into an artery or on vascular tissue and receiving light
reflected in blood or transmitted in blood, and producing a signal
corresponding to a light absorption of the blood over time.
6. The method according to claim 5, wherein the identifying cardiac
events comprises: identifying a significant increase in a rate of
change of the light absorption in a light absorption waveform
obtained from the light sensing module as the closure of tricuspid
and mitral valves and to identify a first significant decrease in a
rate of change of the light absorption as a closure of the aortic
valve, and determining the diastolic period as the period of time
from the closure of the aortic valve of a cardiac cycle to the
closure of tricuspid and mitral valves of the subsequent cardiac
cycle and a cardiac cycle as the period of time from closure of
tricuspid and mitral vales of a cardiac cycle to the closure of
tricuspid and mitral valves of the subsequent cardiac cycle.
7. The method according to claim 1, wherein the sensing signals
related to mechanical activity of the heart comprises sensing heart
sounds and producing a signal corresponding to an amplitude of the
detected heart sounds over time.
8. The method according to claim 7, wherein the identifying cardiac
events comprises: identifying the first heart sound, S1, as the
closure of tricuspid and mitral valves in a heart sound amplitude
waveform and the second heart sound, S2, as the closure of the
aortic valve; and determining the diastolic period as the period of
time from the occurrence of the second heart sound of a cardiac
cycle to the occurrence of the first heart sound of the subsequent
cardiac cycle and a cardiac cycle as the period of time from the
occurrence of first heart sound of a cardiac cycle to the
occurrence of the first heart sound of the subsequent cardiac
cycle.
9. The method according to claim 1, wherein the sensing signals
related to mechanical activity of the heart comprises sensing
electrical signals of the heart and producing an IEGM signal.
10. The method according to claim 9, wherein the identifying
cardiac events comprises synchronizing the IEGM signal with the
heart sound amplitude signal, and using an identification of a
cardiac event in the IEGM signal to identify the first and second
heart sounds.
11. The method according to claim 1, wherein the sensing signals
related to mechanical activity of the heart comprises sensing an
intracardiac pressure and producing a pressure amplitude
signal.
12. The method according to claim 11, wherein the identifying
cardiac events comprises: identifying of a significant increase in
a rate of change of a pressure amplitude in the pressure amplitude
waveform as the closure of tricuspid and mitral valves and a
significant decrease of a rate of change of the pressure amplitude
as the closure of the aortic valve; and determining the diastolic
period as the period of time from the closure of the aortic valve
of a cardiac cycle to the closure of tricuspid and mitral valves of
the subsequent cardiac cycle and a cardiac cycle as the period of
time from closure of tricuspid and mitral vales of a cardiac cycle
to the closure of tricuspid and mitral valves of the subsequent
cardiac cycle.
13. The method according to claim 1, wherein the sensing signals
related to mechanical activity of the heart comprises sensing an
intracardiac impedance over at least one cardiac cycle using a
first electrode vector having at least two electrodes placed in a
right atrium, and/or a left ventricle, and/or a right ventricle and
to produce an impedance signal; and wherein the identifying cardiac
events comprises identifying the closure of the mitral and
tricuspid valve and the closure of the aortic valve using a
reference impedance waveform.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 13/392,395, filed Feb. 24, 2012, which is a 371
Application of PCT/SE09/00393, filed Aug. 27, 2009.
TECHNICAL FIELD
[0002] The present invention generally relates to implantable
medical devices, such as pacemakers, and, in particular, to
techniques for determining and monitoring a cardiac status of a
patient.
BACKGROUND OF THE INVENTION
[0003] The cardiac cycle has two phases; diastole and systole.
During the systolic phase, the heart ejects blood through a pumping
action requiring energy. During the diastolic phase, the heart
repolarizes electrically, relaxes mechanically and is refilled with
blood. In addition, the oxygen needed for the heart to perform its
systolic activity is delivered to the heart during diastole. If the
diastolic phase is disturbed or shortened in time, the performance
during systole is compromised.
[0004] In "Diastolic time--frequency relation in the stress echo
lab: filling timing and flow at different heart rates," by
Bombardini et al., Cardiovascular Ultrasound, 2008, Apr. 21; 6:15,
the diastolic and systolic time intervals were studied in normal
persons, i.e. persons that do not suffer from cardiac related
problems, and in patients suffering from stress induced ischemia
and severe mitral regurgitation. The time intervals were measured
by means of echocardiography. In particular, the different persons
were studied during rest and stress. It was found that, in normal
persons, the length of the diastolic time interval approached the
length of the systolic time interval during exercise at high heart
rates, i.e. heart rates above about 150-160 bpm. For lower heart
rates the diastolic time interval was found to be significantly
longer than the systolic time interval. Further, during rest, the
diastolic time interval was found to be significantly longer than
the systolic time interval. On the other hand, for patients
suffering from stress induced ischemia and severe mitral
regurgitation, the diastolic time interval was found to be
substantially equal to, or even shorter than, the systolic time
interval at both low and high heart rates.
[0005] Thus, the length of the diastolic phase or diastolic time
interval of the cardiac cycle seems to be an important parameter
which contains valuable information of the cardiac status of a
patient. Further, the diastolic time interval and the ratio between
the diastolic time interval and the systolic time interval seem to
be important and valuable measures for determining a cardiac status
of a patient.
[0006] There exist a large number of different solutions in which
these parameters are utilized for e.g. controlling the functioning
of a pacemaker and/or for determining a cardiac status of a
patient.
[0007] For example, in U.S. Pat. No. 6,792,308 to Corbucci, a
cardiac pacemaker for evaluating myocardial performance using
information of the diastolic and systolic intervals is disclosed.
In particular, the myocardial performance is assessed by
determining a QT interval based on electrogram (EGM) readings and
by detecting first and second heart sounds (S1 and S2). The QT
interval and the timing of the first and second heart sounds is
used to evaluate certain parameters related to myocardial
performance. Such parameters include a S1S2 interval which is the
difference between, on one hand, the interval between the Q-wave
and the onset of the first heart sound S1, and, on the other hand,
the interval between the Q-wave and the onset of the second heart
sound S2. The S1S2 interval serves as an estimate of the systolic
interval or the ejection time (ET). Another parameter is the S2S1
interval which is an estimate of the diastolic interval or the
filling time (FT). These intervals are used to determine a ratio of
the systolic interval to the diastolic interval, which ratio
indicates a systolic/diastolic balance. According to U.S. Pat. No.
6,792,308, this ratio is used to evaluate the upper rate limit in
paced patients and for evaluating the rate limit for patients with
rate dependent angina.
[0008] Yet, there is a need within the art of improved medical
devices and methods for determining a cardiac status of a
patient.
SUMMARY OF THE INVENTION
[0009] The present invention provides according to an object an
improved medical device and method for determining a cardiac status
of a patient.
[0010] According to another object of the present invention, there
is provided an improved medical device and method for accurately
and reliably determining a cardiac status of a patient.
[0011] According to a further object of the present invention,
there is provided a medical device and method capable of
determining a cardiac status of patient with an improved
specificity.
[0012] These and other objects of the present invention are
achieved by means of a method and an implantable medical device
having the features defined in the independent claims. Embodiments
of the invention are characterized by the dependent claims.
[0013] According to a first aspect of the present invention, there
is provided an implantable medical device, IMD, for determining a
cardiac status of a patient, the medical device being connectable
to at least one medical lead for contact with tissue of a heart of
the patient. The IMD comprises a sensor arrangement adapted to
sense signals related to mechanical activity of the heart and an
activity level sensor arrangement adapted to sense an activity
level of the patient. Further, the IMD includes a cardiac event
identifying module adapted to identify predetermined cardiac events
in the cardiac signals and to determine a systolic time interval
and a diastolic time interval of a cardiac cycle using the
identified cardiac events, a calculation module adapted to
calculate a percentage of left ventricular diastolic time (PLVDT)
for a cardiac cycle corresponding to a relation between a diastolic
time interval and a cardiac cycle time interval using the
determined systolic and diastolic time intervals or a percentage of
left ventricular systolic time (PLVST) for a cardiac cycle
corresponding to a relation between a systolic interval time
interval and a cardiac cycle time interval using the determined
systolic and diastolic time intervals, and a cardiac status
determining module adapted to synchronize the activity level with
the calculated PLVDT (or PLVST) over time, i.e. to secure that a
certain activity level of the patient at a certain point of time is
synchronized to the PLVDT (or PLVST) for the same point of time in
order to allow, for example, a display of the PLVDT (or PLVST) and
the activity level as a function of time, and to determine a
cardiac status based on the calculated PLVDT (or PLVST) and on the
activity level.
[0014] According to a second aspect of the present invention, there
is provided a method for determining a cardiac status of a patient
in an implantable medical device being connectable to at least one
medical lead for contact with tissue of a heart of the patient. The
method comprises the steps of: sensing signals related to
mechanical activity of the heart, sensing an activity level of the
patient, identifying predetermined cardiac events in the cardiac
signals and determining a systolic time interval and a diastolic
time interval of a cardiac cycle using the identified cardiac
events, calculating a percentage of left ventricular diastolic time
(PLVDT) for a cardiac cycle corresponding to a relation between a
diastolic time interval and a cardiac cycle time interval using the
determined systolic and diastolic time intervals or a percentage of
left ventricular systolic time (PLVST) for a cardiac cycle
corresponding to a relation between a systolic interval time
interval and a cardiac cycle time interval using the determined
systolic and diastolic time intervals, synchronizing the activity
level with the calculated PLVDT (or PLVST) over time i.e. to secure
that a certain activity level of the patient at a certain point of
time is synchronized to the PLVDT (or PLVST) for the same point of
time in order to allow, for example, a display of the PLVDT (or
PLVST) and the activity level as a function of time, and
determining a cardiac status based on the calculated PLVDT (or
PLVST) and on the activity level.
[0015] In embodiments of the present invention, the signals
acquired reflecting the mechanical activity of the heart may
include intracardiac pressure signals, intracardiac impedance
signals, photoplethysmographic signals, and/or heart sound
signals.
[0016] The present invention is based on the insight that a metric
or measure including a percentage of left ventricular diastolic
time to total cardiac cycle time (PLVDT=percentage of left
ventricular diastolic time) contains valuable information of the
cardiac status of a patient. This metric provides an accurate and
reliable measure on how much of the cardiac work that is put in the
diastolic phase. The higher the PLVDT metric within predetermined
limits and for given situation, the better cardiac status of the
patient will be. If the PLVDT metric is reduced to a certain level,
the cardiac oxygen supply is in jeopardy. The PLVDT is defined as
LVDT (left ventricular diastolic time)/cardiac cycle time, i.e. the
percentage of the left ventriclar diastolic time of the total
cardiac cycle time, or
PLVDT=LVDT/(LVDT+LVST),
where LVST is Left Ventricular Systolic Time. The inventors have
found that a range for the PLVDT metric that signals a good cardiac
status may vary between different patients. However, a PLVDT (or
PLVST) exceeding an upper limit or being below a lower limit of
such patient specific range is an indication of an impaired cardiac
status. For example, a patient specific range may be between 55%
and 65%. In this case, If the PLVDT is lower than 55%, it might be
an indication of restrictive filling patterns or of the occurrence
of an elevated left ventricular end diastolic pressure. On the
other hand, a PLVDT metric that exceeds 65% may be an indication of
hypovolemia. Thus, this metric focuses on the diastolic portion of
the cardiac cycle and its relation to the total cardiac cycle.
PLVDT reflects both the patient's risk to develop ischemia and the
HF status and provides an objective measure of these aspects of the
patient's health status. However, even though PLVDT itself may
provide an accurate basis for a determination of a cardiac status
of a patient, at least for some patients, the inventors have found
that the accuracy and specificity of the status determination can
be significantly improved by taking further parameters into account
in the status determination. Studies have shown that the activity
level of the patient has a considerably impact on the conclusions
that can be drawn from a certain level of the PLVDT (or PLVST) or a
certain development of the PLVDT (or PLVST). For example, a period
of slowly decreasing PLVDT synchronized with a slowly decreasing
activity level may be an indication of an exacerbation of heart
failure. Further, a decreasing PLVDT occurring at a stable activity
level may be an indication of that the cardiac status is impaired
and the patient may be advised to visit the care giver for a
check-up. Thus, since the heart is unable to perfuse itself at a
too short diastole, i.e. a too low PLVDT, the risk of ischemia
increases as PLVDT decreases. Furthermore, an increased ventricular
asynchrony would lead to a decrease in PLVDT as well as to an
exacerbation of the patient's heart failure. Also, since heart
failure patients are unable to increase their stroke volume as much
as healthy individuals and thereby increase their rate and cardiac
output to a higher degree at even moderate exercise, and since
ischemia (both silent and non-silent) often make their debut at
physical activity, trending the PLVDT in combination with the
output from the activity sensor provides very important information
regarding the cardiac status of the patient. To even further
improve the specificity and accuracy of the status determination,
the heart rate may also be synchronized with the activity level and
PLVDT or PLVST. For example, in some situations the heart rate will
increase if PLVDT (or PLVST) decreases (or increases) due to an
impairment of the heart failure status in order to secure the blood
circulation.
[0017] The PLVDT (or PLVST), the activity level and/or the heart
rate as a function of time displayed on a programmer can be a very
useful diagnostic tool for the medical doctor when determining a
cardiac status of a patient in accordance with the discussion
above. For example, a regular follow-up visit by the patient, or at
a visit by the patient caused by an impairment of the experienced
state of health, the medical doctor can use PLVDT (or PLVST)
displayed simultaneously with the activity level and the heart rate
on a programmer to determine a cardiac status. Thus, by studying
the displayed graphs over time of the PLVDT (or PLVST), activity
level and/or the heart rate and the trends over time, the doctor
can, for example, determine whether a patient suffering from heart
failure is getting worse or not. For example, a period of slowly
decreasing PLVDT synchronized with a slowly decreasing activity
level may be an indication of an exacerbation of heart failure.
[0018] In embodiments of the present invention, the implantable
medical device may store the PLVDT (or PLVST), activity level and
heart rate output over time in its memory, for example, in a
control module. This trend may be used in the status determination
at the hospital and can also be transmitted via a communication
unit to, for example, a clinic to be viewed by the physician at the
next follow-up as discussed above.
[0019] In embodiments of the present invention, a rate of change
(derivative) of PLVDT or PLVST is calculated and that rate of
change also provides useful information in the status
determination. For example, a gradually increasing PLVDT (or
decreasing PLVST) over time synchronized with a stable or gradually
decreasing activity level is determined to be an indication of a
impaired cardiac status. Similarly, a gradually decreasing PLVDT
(or increasing PLVST) over time synchronized with a stable or
gradually decreasing activity level may also be determined to be an
indication of a impaired cardiac status. Consequently, a decreasing
or increasing PLVDT (or PLVST) is an indication of an impairment of
the cardiac status. However, the starting point must also be
considered when determining the cardiac status as well as the
activity level and/or heart rate. For example, a rather significant
increase or decrease of the PLVDT (or PLVST) from a predetermined
level within a predetermined range at a specific activity level
and/or heart rate for a specific patient may not be any indication
(or a weak indication) of an imparied cardiac status, while a
rather small increase or decrease from a level at a limit of the
predetermined range for that specific patient may be a strong
indication of an impaired cardiac status.
[0020] According to an embodiment of the present invention, a
prognosis based on a present rate of change of PLVDT (or PLVST) is
determined. For example, the present rate of change is extrapolated
and a future point of time when a lower or higher limit of a
predetermined range of the PLVDT (or PLVST), which may be patient
specific e.g. within 55%-65% (or 35%-45% for PLVST) at a specific
activity level and/or heart rate or a range of activity levels
and/or heart rates, is crossed can be calculated. The patient may,
for example, be alerted that a worsening of the heart failure
status can be expected within a certain period of time. Thus, this
gives the patient time to take measures or precautions to avoid the
potential event.
[0021] Furthermore, the implantable medical device may include an
alarm function, which may initiate an alarm based on the PLVDT
and/or the status determination. For example, if a PLVDT being
outside a predetermined range, which may be patient specific e.g. a
range of 55%-65%, has been observed for a period of time at certain
activity level and/or heart rate, the implantable medical device
may issue a warning to the patient instructing him or her to get in
contact with the hospital or clinic. The warning may be a message
to a home monitoring unit in the patient's home transmitted
wirelessly from the IMD, or a vibration of a vibrating unit in the
IMD. The warning may also, or instead, be transmitted to the clinic
instructing the physician to get in contact with the patient. For
example, clinical experience has shown that a too low PLVDT may in
some cases predict future VF (ventricular fibrillation). Thus, at a
very low PLVDT, it may be time critical to get the patient to the
hospital.
[0022] As the skilled person realizes, steps of the methods
according to the present invention, as well as preferred
embodiments thereof, are suitable to realize as computer program or
as a computer readable medium.
[0023] Further objects and advantages of the present invention will
be discussed below by means of exemplifying embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Exemplifying embodiments of the invention will be described
below with reference to the accompanying drawings, in which:
[0025] FIG. 1 is a simplified, partly cutaway view, illustrating an
implantable medical device according to the present invention with
a set of leads implanted into the heart of a patient;
[0026] FIG. 2 schematically illustrates a heart sound waveform,
where the time of mitral and tricuspid valves is marked, i.e.
corresponding to the first heart sound S1, and the closure of the
aortic valve, i.e. corresponding to the second heart sound S2, is
marked;
[0027] FIG. 3 schematically illustrates a photoplethysmographic
waveform, where the time of mitral and tricuspid valves is marked
and the closure of the aortic valve is marked;
[0028] FIG. 4 schematically illustrates a intracardiac pressure
waveform measured from inside the RV, where the time of mitral and
tricuspid valves is marked and the closure of the aortic valve is
marked;
[0029] FIG. 5 is a functional block diagram form of the implantable
medical device shown in FIG. 1, illustrating basic circuit elements
that provide, for example, pacing stimulation in the heart and
particularly illustrating components for calculating PLVDT (or
PLVST) and for determining a cardiac status according to the
present invention;
[0030] FIG. 6 schematically illustrates PLVDT synchronized with
activity level and heart rate over time;
[0031] FIG. 7 is a functional block diagram form of another
embodiment of an implantable medical device illustrating basic
circuit elements that provide, for example, pacing stimulation in
the heart and particularly illustrating components for calculating
PLVDT (or PLVST) and for determining a cardiac status according to
the present invention.
[0032] FIG. 8 is a functional block diagram form of a further
embodiment of an implantable medical device illustrating basic
circuit elements that provide, for example, pacing stimulation in
the heart and particularly illustrating components for calculating
PLVDT (or PLVST) and for determining a cardiac status according to
the present invention;
[0033] FIG. 9 is a functional block diagram form of another
embodiment of an implantable medical device illustrating basic
circuit elements that provide, for example, pacing stimulation in
the heart and particularly illustrating components for calculating
PLVDT (or PLVST) and for determining a cardiac status according to
the present invention; and
[0034] FIG. 10 schematically illustrates the general steps
performed in the method for determining a cardiac status according
to the present invention.
DESCRIPTION OF EXEMPLIFYING EMBODIMENTS
[0035] The following is a description of exemplifying embodiments
in accordance with the present invention. This description is not
to be taken in limiting sense, but is made merely for the purposes
of describing the general principles of the invention. It is to be
understood that other embodiments may be utilized and structural
and logical changes may be made without departing from the scope of
the present invention. Thus, even though particular types of
implantable medical devices such as heart stimulators will be
described, e.g. biventricular pacemakers, the invention is also
applicable to other types of cardiac stimulators such as dual
chamber stimulators, implantable cardioverter defibrillators
(ICDs), etc.
[0036] Turning now to FIG. 1, which is a simplified schematic view
of one embodiment of an implantable medical device ("IMD") 8
according to the present invention. IMD 8 has a hermetically sealed
and biologically inert case 10. In this embodiment, IMD 8 is a
pacemaker which is connectable to pacing and sensing leads 12, 14,
in this illustrated case two leads. However, as the skilled person
understands, the pacemaker may also be connected to one or several,
e.g. three or more, pacing and sensing leads. IMD 8 is in
electrical communication with a patient's heart 5 by way of a right
ventricular lead 12 having a right ventricular (RV) tip electrode
22, a RV ring electrode 24, RV coil electrode 26, and a superior
vena cava (SVC) coil electrode 28. Typically, the RV lead is
transvenously inserted into the heart 5 so as to place the RV coil
electrode 26 in the right ventricular apex and the SVC coil
electrode 28 in the superior vena cava. Accordingly, the right
ventricular lead 12 is capable of receiving cardiac signals, and
delivering stimulation in the form of pacing to the right ventricle
RV.
[0037] In order to sense left atrial and ventricular cardiac
signals and to provide left chamber pacing therapy, IMD 8 is
coupled to a "coronary sinus" lead 14 designed for placement in the
coronary sinus region via the coronary sinus for positioning a
distal electrode adjacent to the left atrium. As used herein, the
wording "coronary sinus region" refers to the vasculature of the
left ventricle, including any portion of the coronary sinus, great
cardiac vein, left marginal vein, middle cardiac vein, and/or small
cardiac vein or any other cardiac vein accessible via the coronary
sinus. Accordingly, the coronary sinus lead 14 is designed to
receive atrial and ventricular pacing signals and to deliver left
ventricular pacing therapy using at least a left ventricular (LV)
tip electrode 21, a LV ring electrode 23 left atrial pacing therapy
using at least a LA electrode 25 and a LA electrode 27.
[0038] With this configuration bi-ventricular therapy can be
performed. Although only two medical leads are shown in FIG. 2, it
should also be understood that additional stimulation leads (with
one or more pacing, sensing, and/or shocking electrodes) may be
used in order to efficiently and effectively provide pacing
stimulation to the left side of the heart or atrial cardioversion.
For example, a right atrium (RA) lead implanted in the atrial
appendage having a RA tip electrode and a RA ring electrode may be
arranged to provide electrical communication between the right
atrium (RA) and the IMD 8.
[0039] IMD 8 is an exemplary device that may use the techniques
according to the invention. The invention is not limited to the
device shown in FIG. 1. For example, while the pacemaker 8 is
depicted as a three-chamber pacemaker, the invention can also be
practiced in a single-chamber, dual-chamber, or four-chamber
pacemaker. According to various embodiments of the present
invention, IMD 8 detects electrical cardiac signals, including e.g.
the T-wave and the R-wave.
[0040] According to an embodiment of the present invention, first
and second heart sounds S1 and S2, respectively, are detected,
either by the IMD 8 or by a sensor (not shown in FIG. 1) external
to the IMD 8 and connected to a programmer. The heart sounds may be
detected using, for example, a microphone, an accelerometer, a
pietzoelectric sensor, or a vibration sensor. In a preferred
embodiment, the heart sounds are detected by means of a microphone,
which detects the distinct sound arising from the closure of the
tricuspid and mitral valves, i.e. the first heart sound S1, and the
closure of the aortic valve, i.e. the second heart sound S2. From
these detected characteristic features, the PLVDT metric can be
calculated. The heart sound microphone can be placed inside the
device (as will be illustrated in FIG. 5 and discussed below with
reference to FIG. 5) or inside a specially adapted lead. In FIG. 2,
a typical EKG waveform and heart sound waveforms at different
frequencies are schematically illustrated. The PLVDT metric can be
calculated using the identified heart sounds S1 (corresponding to
the closure of the mitral and tricuspid valves) and S2
(corresponding to the closure of the aortic valve). Specifically,
the PLVDT metric can be calculated according to the following:
PLVDT=100.times.(A/RR),
where A is the diastolic time and RR the total heart cycle
time.
[0041] According to another embodiment of the present invention,
the PLVDT metric is calculated using data obtained by means of a
photoplethysmograph (PPG) (as will be illustrated in FIG. 8 and
discussed below with reference to FIG. 8). A light emitting device
emits light into blood and the colour is measured by means of a
light sensor. As arterial and venous blood have different colours,
a pulsatile waveform is acquired which reflects the heart's pumping
activity. By studying the PPG waveform, the time point of the
closure of the mitral and tricuspid valves and the closure of the
aortic valve, respectively, can be identified. In FIG. 3, a typical
PPG waveform is schematically illustrated. The time point of the
closure of the mitral and tricuspid valves can be identified as
well as the time point of the closure of the aortic valve. Thereby,
the start of the systolic and diastolic phase, respectively, can be
identified. Using the identified time points of the valve closures,
the PLVDT metric can be calculated. Specifically, the PLVDT metric
can be calculated according to the following:
PLVDT=100.times.(A/RR),
where A is the diastolic time and RR the total heart cycle
time.
[0042] In a further embodiment of the present invention, the IMD 8
includes an intracardiac pressure sensor (as will be illustrated in
FIG. 7 and discussed below with reference to FIG. 7). The
intracardiac pressure sensor may be placed in the RV, e.g.
integrated in the lead 12, or in the LV, e.g. integrated in the
lead 14. A pressure sensor in the RV would generate a pressure
waveform as schematically illustrated in FIG. 4. As can be seen,
the time point of the opening and closure of the mitral and
tricuspid valves and the aortic valve, respectively, can be readily
detected. The PLVDT metric can be calculated in a corresponding
manner as described above.
[0043] According to yet another embodiment of the present
invention, the IMD 8 includes an impedance measuring module (as
will be illustrated in FIG. 9 and discussed below with reference to
FIG. 9). The intracardiac impedance can be measured by means of a
number of different electrode configurations, for example, between
RA and LV using, for example, the electrode 28 located in right RA
and the electrodes 21 and/or 23 located in the LV in a bi- or
tri-polar configuration. The intracardiac impedance may be
correlated with IEGM measurements to identify the time point of the
opening and closure of the mitral and tricuspid valves and the
aortic valve, respectively. Then, the PLVDT metric can be
calculated in a corresponding manner as described above.
[0044] FIG. 5 is a block diagram illustrating the constituent
components of an IMD 8 in accordance with one embodiment of the
present invention. In the following, a number of different
embodiments of the present invention will be discussed and similar
or like part, components, modules, or circuits through the
different embodiments will only be described with reference to FIG.
5. Hence, in the description of the further embodiments, the
description of the similar or like part, components, modules, or
circuits through the different embodiments will be omitted.
[0045] The IMD 8 is a pacemaker having a microprocessor based
architecture. The IMD 8 includes an activity sensor or
accelerometer 40 (e.g. a piezoceramic accelerometer), which
preferably a sensor output that varies as a function a measured
parameter relating the physical activity and/or metabolic
requirements of the patient.
[0046] Further, the IMD includes a heart sound microphone 42 for
detection of heart sounds including first and second heart sounds
S1 and S2, respectively, for calculation of the PLVDT metric and to
produce a heart sound amplitude signal. In one embodiment, the
microphone is arranged in a lead and placed in or on epicardium. In
U.S. Published Application No. 2008/0091239 to Johansson et al. an
example of a suitable microphone for implantation in or on
epicardium is disclosed, which hereby is incorporated by reference
herein in its entirety. It is also conceivable to arrange a
microphone within the IMD 8, as disclosed in U.S. Pat. No.
6,064,910 to Andersson et al., which hereby is incorporated by
reference herein in its entirety.
[0047] However, as an alternative or complement, the activity
sensor 40 may detect heart sounds including first and second heart
sounds S1 and S2, respectively, for calculation of the PLVDT
metric.
[0048] The leads 12 and 14 comprises, as have been illustrated in
FIG. 1, one or more electrodes, such a coils, tip electrodes or
ring electrodes. These electrodes are arranged to, inter alia,
transmit pacing pulses for causing depolarization of cardiac tissue
adjacent to the electrode(-s) generated by a pace pulse generator
32 under influence of a control module or microcontroller 35. The
rate of the heart 5 is controlled by software-implemented
algorithms stored within a microcomputer circuit of the control
module 35. The microcomputer circuit may include a microprocessor,
a system clock circuit and memory circuits including random access
memory (RAM) and read-only memory (ROM). The microcomputer circuit
may further include logic and timing circuitry, state machine
circuitry, and I/O circuitry. Typically, the control module 35
includes the ability to process or monitor input signals (data)
from an input circuit 31 as controlled by a program code stored in
a designated block of memory. The details and design of the control
module 35 are not critical to the present invention. Rather, any
suitable control module or microcontroller 35 may be used that
carries out the functions described herein. The use of
micro-processor-based control circuits for performing timing and
data analysis functions are well known in the art.
[0049] Detected signals from the patient's heart 5, e.g. signals
indicative of natural and stimulated contractions of the heart 5,
are processed in an input circuit 31 and are forwarded to the
microprocessor of the control module 35 for use in logic timing
determination in known manner. The input circuit 31 may include,
for example, an EGM amplifier for amplifying obtained cardiac
electrogram signals.
[0050] IMD 8 comprises a communication unit 37 including an antenna
(not shown), for example, a telemetry unit for uplink/downlink
telemetry or RF transceiver adapted for bi-directional
communication with external devices.
[0051] Electrical components shown in FIG. 5 are powered by an
appropriate implantable battery power source 38 in accordance with
common practice in the art. For the sake of clarity, the coupling
of battery power to the various components of the IMD 8 is not
shown in the figures.
[0052] Furthermore, with reference to FIG. 5, a cardiac event
identifying module 43 is adapted to receive the heart sound
amplitude signal from the microphone 42. A first heart sound, S1,
is identified in the heart sound amplitude waveform, which
corresponds to the closure of tricuspid and mitral valves. Further,
the second heart sound, S2 is identified, which corresponds to the
closure of the aortic valve. The cardiac event identifying module
43 calculates the diastolic period as the period of time from the
occurrence of the second heart sound S2 of a cardiac cycle to the
occurrence of the first heart sound S1 of the subsequent cardiac
cycle and the cardiac cycle as the period of time from the
occurrence of first heart sound S1 of a cardiac cycle to the
occurrence of the first heart sound S1 of the subsequent cardiac
cycle. In order to improve the identification of the heart sounds,
the heart sound signal may be synchronized with an IEGM signal. For
example, a time from a detected R-wave to the first and second
heart sounds, respectively, can be calculated. This time should be
substantially constant over time. It the time to respective heart
sound are not substantially constant over time, this may be an
indication that a detected heart sound in fact is caused by another
extracardiac event. In such a case, the PLVDT calculation should be
inhibited and then restarted.
[0053] A calculation module 45 is adapted to calculate the PLVDT
metric using the identified heart sounds S1 (corresponding to the
closure of the mitral and tricuspid valves) and S2 (corresponding
to the closure of the aortic valve). Specifically, the PLVDT metric
is calculated according to the following:
PLVDT=100.times.(A/RR)
where A is the diastolic time and RR the total heart cycle time.
Alternatively, a PLVST metric can be calculated according to the
following:
PLVDT=100.times.(RR-A)/RR).
[0054] A cardiac status determining module 47 is adapted to
synchronize the activity level using the activity level signal
received from the activity sensing circuit 40 with the calculated
PLVDT (or PLVST) over time and to determine a cardiac status based
on the calculated PLVDT (or PLVST) and on the activity level,
wherein a gradually increasing or decreasing PLVDT (or PLVST) over
time synchronized with a stable or gradually decreasing activity
level is determined to be an indication of a impaired cardiac
status. For example, a gradually increasing PLVDT (or decreasing
PLVST) over time synchronized with a stable or gradually decreasing
activity level is determined to be an indication of a impaired
cardiac status. Similarly, a gradually decreasing PLVDT (or
incresing PLVST) over time synchronized with a stable or gradually
decreasing activity level may also be determined to be an
indication of a impaired cardiac status. Consequently, a decreasing
or increasing PLVDT (or PLVST) is an indication of an impairment of
the cardiac status. However, the starting point must also be
considered when determining the cardiac status as well as the
activity level and/or heart rate. For example, a rather significant
deviation (e.g. an increase or decrease) of the PLVDT (or PLVST)
from a predetermined level or within a predetermined range at a
specific activity level and/or heart rate for a specific patient
may not be any indication (or a weak indication) of an imparied
cardiac status, while a rather small deviation (e.g. an increase or
decrease) from a predetermined level at a limit of the
predetermined range for that specific patient may be a strong
indication of an impaired cardiac status.
[0055] Studies have shown that a period of a gradually decreasing
PLVDT correlated with a gradually decreasing activity level is an
indication of an exacerbation of heart failure, see FIG. 6. This is
an even stronger indication if the decreasing PLVDT is below a
lower predetermined limit. It has been shown that a PLVDT may be
between about 55%-65%, a range which however will vary between
different patients and for different activity levels and/or heart
rates. Further, a decreasing PLVDT correlated with a stable
activity level is an indication of a potentially impaired cardiac
status, and the patient may be given a notification advising him or
her to visit the care provider for a check-up.
[0056] Thus, since the heart is unable to perfuse itself at a too
short diastole, i.e. a too low PLVDT, the risk of ischemia
increases as PLVDT decreases. Furthermore, an increased ventricular
asynchrony would lead to a decrease in PLVDT as well as to an
exacerbation of the patient's heart failure. Also, since heart
failure patients are unable to increase their stroke volume as much
as healthy individuals and thereby increase their rate and cardiac
output to a higher degree at even moderate exercise, and since
ischemia (both silent and non-silent) often make their debut at
physical activity, trending the PLVDT in combination with the
output from the activity sensor provides very important information
regarding the cardiac status of the patient. To even further
improve the specificity and accuracy of the status determination,
the heart rate may be synchronized with the activity level and
PLVDT.
[0057] IMD 8 may store the PLVDT, activity level and heart rate
output over time in its memory, for example, in the control module
35. This trend is used in the status determination and can also be
transmitted via the communication unit 37 to, for example, a clinic
to be viewed by the physician at the next follow-up.
[0058] The PLVDT (or PLVST), the activity level and/or the heart
rate as a function of time displayed on a programmer can be a very
useful diagnostic tool for the medical doctor when determining a
cardiac status of a patient in accordance with the discussion
above. For example, a regular follow-up visit by the patient, or at
a visit by the patient caused by a imthe pairment of the
experienced state of health, the medical doctor can use PLVDT (or
PLVST) displayed simultaneously with the activity level and the
heart rate on a programmer to determine a cardiac status. Thus, by
studying the displayed graphs over time of the PLVDT (or PLVST),
activity level and/or the heart rate and the trends over time, the
doctor can, for example, determine whether a patient suffering from
heart failure is getting worse or not. For example, a period of
slowly decreasing PLVDT synchronized with a slowly decreasing
activity level may be an indication of an exacerbation of heart
failure.
[0059] Furthermore, the IMD 8 may include an alarm function, which
may initiate an alarm based on the PLVDT and/or the status
determination. For example, if a PLVDT exceeding or being below a
predetermined range, e.g. above or below a range of 55%-65%, has
been observed for a period of time at certain activity level and/or
heart rate, the IMD 8 may issue a warning to the patient
instructing him or her to get in contact with the hospital or
clinic. The warning may be a message to a home monitoring unit in
the patient's home transmitted wirelessly from the IMD 8, or a
vibration of a vibrating unit in the IMD. The warning may also, or
instead, be transmitted to the clinic instructing the physician to
get in contact with the patient. For example, clinical experience
has shown that a too low PLVDT may in some cases predict future VF
(ventricular fibrillation). Thus, at a very low PLVDT, it may be
time critical to get the patient to the hospital
[0060] With reference now to FIG. 7, another embodiment of the
present invention will be discussed. IMD 58 includes an
intracardiac pressure sensor 50 adapted to produce a pressure
amplitude signal. The pressure sensor 50 may be integrated in a
lead 12, 14, or in a specialized lead and placed inside the RV or
inside the LV. Other locations may be inside the aorta or in close
contact with the LV. In U.S. Pat. No. 6,886,411 to Kjellman et al.
a suitable pressure sensor is disclosed, which hereby is
incorporated by reference herein in its entirety.
[0061] A pressure sensor in the RV would generate a pressure
amplitude waveform as schematically illustrated in FIG. 4. As can
be seen, the time point of the opening and closure of the mitral
and tricuspid valves and the aortic valve, respectively, can be
detected by the cardiac event identifying module 43. In particular,
the cardiac event identifying module 43 is adapted to identify of a
significant increase in a rate of change of pressure amplitude in
the pressure amplitude waveform as the closure of tricuspid and
mitral valves and a significant decrease of a rate of change of the
pressure amplitude as the closure of the aortic valve. The
diastolic interval and the cardiac cycle can be determined using
the identified valve closures as indicated in FIG. 4, where the
diastolic interval corresponds to the interval A and the cardiac
cycle corresponds to the interval RR.
[0062] The calculation module 45 is adapted to calculate the PLVDT
metric using the identified closure of the mitral and tricuspid
valves and the closure of the aortic valve. Specifically, the PLVDT
metric is calculated according to the following:
PLVDT=100.times.(A/RR),
where A is the diastolic time and RR the total heart cycle time.
Alternatively, a PLVST metric can be calculated according to the
following:
PLVDT=100.times.(RR-A)/RR).
The cardiac status determining module 47 is adapted to synchronize
the activity level using the activity level signal received from
the activity sensing circuit 40 with the calculated PLVDT (or
PLVST) over time and, as described above, to determine a cardiac
status based on the calculated PLVDT (or PLVST) and on the activity
level.
[0063] Referring now to FIG. 8, another embodiment of the present
invention will be discussed. IMD 68 includes an optical
photoplethysmopraphic unit 60 comprising a light emitting circuit,
for example, light emitting diodes (LED) 61 and a light receiving
circuit 62, for example, a photo-detector. For example, the
photoplethysmopraphic unit 60 may be incorporated into the IMD 68
and placed on the case of the IMD 68. Thereby, the blood flow in
the surrounding pocked can be measured. The light emitting diodes
61 emit light into the blood stream and the light receiver measures
the amount of received or transmitted light. The received light
will be a measure of the amount of light absorbed by the blood and
will essentially measure the colour of the blood. Arterial and
venous blood have different colours and thereby a pulsatile
waveform will be formed reflecting the heart's pumping activity. In
FIG. 3 a schematic waveform of a light signal produced by a
photoplethysmopraphic unit 60 is shown. In U.S. Pat. No. 7,447,533
to Fang et al. a suitable optical photoplethysmographic unit is
disclosed, which hereby which hereby is incorporated by reference
herein in its entirety.
[0064] The cardiac event identifying module 43 can identify the
time point of the closure of the mitral and tricuspid valves as
well as the time point of the closure of the aortic valve. In
particular, a significant increase in a rate of change of the light
absorption in a light absorption waveform obtained from the light
receiving circuit 62 is identified as the closure of tricuspid and
mitral valves and a first significant decrease in a rate of change
of the light absorption is identified as a closure of the aortic
valve. Further, a diastolic period, A, is determined as the period
of time from the closure of the aortic valve of a cardiac cycle to
the closure of tricuspid and mitral valves of the subsequent
cardiac cycle and a cardiac cycle as the period of time from
closure of tricuspid and mitral vales of a cardiac cycle to the
closure of tricuspid and mitral valves of the subsequent cardiac
cycle. Using the identified time points of the valve closures, the
PLVDT metric can be calculated. Specifically, the PLVDT metric can
be calculated according to the following:
PLVDT=100.times.(A/RR),
where A is the diastolic time and RR the total heart cycle time.
Alternatively, a PLVST metric can be calculated according to the
following:
PLVDT=100.times.(RR-A)/RR).
The cardiac status determining module 47 is adapted to synchronize
the activity level using the activity level signal received from
the activity sensing circuit 40 with the calculated PLVDT (or
PLVST) over time and, as described above, to determine a cardiac
status based on the calculated PLVDT (or PLVST) and on the activity
level.
[0065] With reference now to FIG. 9, yet another embodiment of the
present invention will be discussed. IMD 78 according to this
embodiment includes an impedance measuring unit 70 adapted to carry
out impedance measurements of the intra-cardiac impedance of the
patient, for example, by means of applying a current over the RA
electrode 28 (see FIG. 1) and the LV ring electrode 23 to measure
impedance signals. The resulting voltage can, in a bi-polar
configuration, be measured between the same electrodes. A tri- or
quadro-polar configuration in RA and LV is also conceivable.
Further configurations that have shown to provide accurate and
useful impedance waveforms for identifying the closure of the
mitral and tricuspid valves and the aortic valve, respectively,
include RV and LV (e.g. using electrodes 22, 24, and/or 26, 23,
and/or 21) in a bi-, tri-, or quadro-polar configuration, and LV
(e.g. using electrodes 21 and 23) in a bi-polar configuration. The
raw impedance data is then processed. To this end, the impedance
measuring unit 70 may comprise, for example, amplifiers and filters
e.g. FIR or IIR filters. Further, for example, amplitude
normalizing and synchronization of the measured impedance sets in
relation to a predetermined cardiac event may be performed.
[0066] In the cardiac event identifying module 43, the time point
of the closure of the mitral and tricuspid valves as well as the
time point of the closure of the aortic valve are identified in the
impedance waveform. In a preferred embodiment, a reference
impedance waveform for the patient has been recorded in which
characteristic events such as the time point of the closure of the
mitral and tricuspid valves as well as the time point of the
closure of the aortic valve have been identified. Hence, by
comparison with this reference waveform, the time point of the
closure of the mitral and tricuspid valves as well as the time
point of the closure of the aortic valve can be identified in a
newly recorded impedance waveform. Then, the PLVDT or PLVST can be
determined in the calculation module 45 in accordance with the
description given above, and a cardiac status can be determined in
the cardiac status determination module 47.
[0067] With reference to FIG. 10, the overall principles of a
method according to the present invention will be discussed. First,
in step S100, signals related to mechanical activity of the heart
are sensed and output signals related to the mechanical activity
are produced.
[0068] As discussed above, a number of different signals may be
sensed and used including intracardiac pressure, intracardiac
impedance, heart sound, and photoplethysmographic signals. At step
S110, an activity level of the patient is sensed. It should be
noted that step S100 and S110 can be performed in reversed order or
simultaneously. Thereafter, at step S120, predetermined cardiac
events in the cardiac signals are identified and a systolic time
interval and a diastolic time interval of a cardiac cycle using the
identified cardiac events is determined. Preferably, the time
points of the closure of the mitral and tricuspid valves and the
closure of the aortic valve are identified. Then, at step S130, a
percentage of left ventricular diastolic time (PLVDT) for a cardiac
cycle corresponding to a relation between a diastolic time interval
and a cardiac cycle time interval using the determined systolic and
diastolic time intervals or a percentage of left ventricular
systolic time (PLVST) for a cardiac cycle corresponding to a
relation between a systolic interval time interval and a cardiac
cycle time interval using the determined systolic and diastolic
time intervals are calculated. At step S140, the activity level is
synchronized with the calculated PLVDT (or PLVST) over time.
Further, at step S150, a cardiac status based on the calculated
PLVDT (or PLVST) and on the activity level is determined. It has,
for example, been found by the inventors that a gradually
increasing or decreasing PLVDT (or PLVST) over time synchronized
with a stable or gradually decreasing activity level is determined
to be an indication of a impaired cardiac status.
[0069] The PLVDT (or PLVST) may also be used for optimization of an
implantable medical device (IMD) such as a pacemaker. It has been
shown that a range for PLVDT may be about 55%-65%, and this may be
used to control of pacing parameters of the IMD, for example, AV
delay, W delay, rate response settings (slope, decay, rate
responsive AV delay) or pacing configuration. Since the heart is
perfused during diastole, a too small PLVDT would mean that the
time for the heart muscle to perfuse itself is too short and hence
the heart does not receive enough of the oxygen needed. An
optimization procedure may include the following steps:
[0070] 1. Measure PLVDT for a set of parameter settings--PLVDT1
[0071] 2. Perform a parameter setting adjustment--a new set of
parameter settings
[0072] 3. Measure PLVDT for the new set of parameter
settings--PLVDT2 [0073] a. If PLVDT2 is better than PLVDT1, i.e.
closer to a reference PLVDT within the range 55%-65%, the steps 1
and 2 are repeated. [0074] b. If PLVDT1 is better than PLVDT2, the
parameter settings are adjusted in another way. [0075] c. If PLVDT1
is identical to PLVDT2 (or within a small range about PLVDT2), the
optimization procedure is interrupted.
[0076] It should be stressed, that this optmization procedure is
merely an example and should not be viewed as limiting the scope of
the present invention. The optimization can be performed in the
hospital, e.g. at follow-up, or automatically by the IMD. An
automatic optimization can be made at regular time intervals (e.g.
every 8 hours, once a day, once a week, etc.) or it may be
triggered by a predetermined event (e.g. PLVDT exceeds or falls
below a predetermined upper or lower limit, respectively, a change
in heart failure status), etc.
[0077] If the optimization is performed in an in-clinic setting,
the interacting physician or nurse may control the manner in which
the parameter settings are adjusted and/or the initial parameter
setting.
[0078] Although an exemplary embodiment of the present invention
has been shown and described, it will be apparent to those having
ordinary skill in the art that a number of changes, modifications,
or alterations to the inventions as described herein may be made.
Thus, it is to be understood that the above description of the
invention and the accompanying drawings is to be regarded as a
non-limiting.
* * * * *