Title of Invention

SYSTEM AND METHOD FOR PROMOTING INTRINSIC CONDUCTION THROUGH ATRIAL TIMING

Abstract An atria] based pacing protocol promotes intrinsic conduction. An entire cardiac cycle is monitored for ventricular activity and permitted to lapse with ventricular activity. Ventricular pacing is available in a cardiac cycle immediately subsequent to such a skipped beat. When monitoring for intrinsic ventricular events, an event is expected within a given window. If no such event is detected, the cardiac cycle in truncated, leading to a shorter cycle that is devoid of ventricular activity. The subsequent cycle has a high likelihood of a ventricular sensed event and a greater than normal AV interval is provided prior to pacing.
Full Text SYSTEM AND METHOD FOR PROMOTING INTRINSIC CONDUCTION
THROUGH ATRIAL TIMING
Field of the Invention
The present invention relates to medical devices and more specifically to
implantable medical devices.
Description of the Related Art
There are a variety of medical devices that sense data, provide diagnostic
information, and/or deliver therapy. When such a device is implantable (in whole or in
part), it is referred to as an implantable medical device (IMD). In the present application,
"IMD" refers to devices that sense cardiac events and deliver pacing therapy. Such
devices may or may not also include other functions such as defibrillation therapy (e.g.,
implantable cardioverter defibrillator (ICD)), other monitoring capabilities, alternate
cardiac therapies, or non-cardiac monitoring and/or therapies. Thus, the term pacemaker
may be used interchangeably with IMD in the present context with the understanding that
either term may refer to a device with capabilities beyond those required of a pacemaker
alone.
Recently, there has been a recognition that intrinsic conduction and ventricular
depolarization, even if somewhat prolonged, is preferable to ventricular pacing;
particularly pacing in or near the right ventricular apex. In general, this preference results
from the unnatural propagation of a depolarization wavefront that is generated from such a
pacing pulse (as compared to intrinsic depolarization).
Previous pacing modes tend to operate at one extreme or another. For example, in
a true, single chamber AAI/R device, atrial pacing and sensing is possible, but no ability to
provide ventricular pacing (or sensing) exists. On the other hand, DDD/R has historically
been the default selection for dual chamber devices. The DDD/R mode will operate to
maintain AV synchrony; however, the AV delay is necessarily such that intrinsic
conduction is precluded in most cardiac cycles. This results in ventricular pacing in a very
high percentage of cardiac cycles.
The present assignee has developed new modes that promote intrinsic conduction
and are referred to herein generally as ventricular pacing protocols (VPP). One such VPP

is Managed Ventricular Pacing™ (or MVP TM) which is commercially available. A
variety of VPP embodiments have previously been described, for example, as in U.S. Pat.
No. 6,772,005, issued August 3, 2004, to Casavant et al., (Atty. Docket No. P9039.00);
U.S. Appln. No. 10/246,816, filed September 17, 2002, (Arty. Docket No.P9039.02); U.S.
Appln. No. 10/755,454, filed January 12, 2004, (Atty. Docket No. P9039.06); U.S. Appln.
No. 10/850,666, filed May 21, 2004, (Atty. Docket No. P21161.00); U.S. Appln. No.
11/115,605, filed April 27, 2005, (Atty. Docket No. P21164.00); U.S. Appln. No.
11/096,436, filed March 31, 2005, (Atty. Docket No. P21166.00); U.S. Appln. No.
10/814,692, filed March 31, 2004, (Atty. Docket No. P20243.00); U.S. Appln. No.
11/364,290, filed February 28, 2006, (Atty. Docket No. P21506.00); and U.S. Appln. No.
10/971,686, filed October 25, 2004, (Atty. Docket No. P20851.00), which arc herein
incorporated by reference in their entirety. Other related applications include U.S. Appln.
No. 11,258,523, filed October 25, 2005, (Atty. Docket No. P20923.00) and U.S. Appln.
No. 11/257,643, filed October 25, 2005, (Atty. Docket No. P21974.00).
As a generalized explanation, a VPP operates in an atrial based pacing mode to
promote intrinsic conduction. Ventricular events are sensed and as long as a ventricular
event is sensed in a given cardiac cycle (e.g., A-A interval) the device continues to operate
in the atrial based pacing mode. This allows for ventricular sensing during the entire A-A
interval. Conversely, if there is no ventricular event, the device provides a ventricular
backup pace in the subsequent cycle, timed from the atrial event (paced or sensed) that
initiates this subsequent cardiac cycle. Thus, in a VPP it is possible to have an entire
cardiac cycle devoid of ventricular activity while ultimately maintaining AV synchrony.
There are, of course, many variations and embodiments provided that are not described
herein for the sake of brevity. It should be appreciated that operation in an atrial based
pacing mode includes mode switching a device into such a mode (e.g. AA1/R, AD1/R) and
into a mode that provides ventricular pacing (e.g., DDI/R, DDD/R, VVI/R, etc.) as
necessary and potentially on a beat by beat basis or alternatively, operation in a complex
mode that includes more comprehensive behavior (e.g., FIDDI) without necessitating
mode switching to achieve the functionality described.
One benefit of a VPP is that the protocol may be initiated with patients regardless
of the status of their AV conduction. Those having intact or partially intact conduction
will benefit in that conduction is promoted and ventricular pacing is reduced or eliminated.

For those patients with heart block, the VPP will quickly move to provide ventricular
pacing and periodically check to determine if conduction has returned. Both in initially
recognizing the need to pace and performing the conduction checks, the methodology
employed is transparent to the patient.
As previously indicated physicians implanting a dual chamber device often utilize
nominal settings and program the device to DDD/R due to its simplicity. The VPP allows
for the same type of comprehensive reliability across patient profiles and without the need
to program numerous parameters upon implant. The VPPs are preferable in that that they
reduce or minimize ventricular pacing when intact conduction is present.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic diagram illustrating an implantable medical device.
FIGS. 2A - 2C are timing diagrams illustrating operation according to various
VPPs.
FIGS. 3A - 3C are timing diagrams illustrating operation according to various
VPPs.
FIGS. 4A - 4C are timing diagrams illustrating operation according to various
VPPs.
FIGS. 5A and 5B illustrate a conduction delay table and graph.
FIGS. 6-7 are flowcharts describing a method consistent with the teachings of the
present invention.
FIGS. 8A - 8B are timing diagrams illustrating operation according to various
VPPs.
FIG. 9 is a flowchart describing a method consistent with the teachings of the
present invention.
FIG. 10 is a timing diagram illustrating boundary conditions for one embodiment.
FIG. 11 is a flowchart describing a process for conducting an atrial conduction test
according to one embodiment.
FIG. 12 is a sample data set of data collected from an atrial conduction test.

DETAILED DESCRIPTION
FIG. 1 is a schematic illustration of an implantable medical device (IMD) 10
having pacing capabilities. While not illustrated, IMD 10 may also include a variety of
other monitoring, diagnostic and therapeutic functions. Further, FIG. 1 is not meant to
comprehensively illustrate all components of an implantable pacemaker.
The IMD 10 includes a housing 12 that contains a microprocessor 14, memory 16,
a power supply (e.g., battery) 18, a communication module 20 that facilitates telemetry to
an external device and a pulse generator 22 for generating pacing pulses. A sensor
interface 30 is provided to collect data from one or more sensors/electrodes, one or more
of which may be disposed on leads 32, 34. The pacing stimuli generated by the pulse
generator 22 is deliverable via the leads 32, 34. Also illustrated in FIG. 1 is a VPP module
24. It should be appreciated that these functions may be algorithms stored in the memory
16 or incorporated into other hardware, software, or firmware.
In operation, the IMD 10 senses cardiac events and provides an appropriate
response. Most typically, cardiac events are sensed via electrodes on the leads 32, 34.
These electrodes pick up electrical signals indicative of specific activities within the heart,
typically represented as an electrogram (EGM) when generated from device data or an
electrocardiogram (ECG) when based upon surface collected data. As is well known, the
cardiac cycle includes an atrial depolarization represented electrically by a P wave,
ventricular depolarization represented by the QRS complex, and repolarization represented
by a T wave. While sensing algorithms can be relatively complex, in general a sensed P
wave indicates intrinsic atrial depolarization while a sensed R wave indicates intrinsic
ventricular depolarization. For a given pacing mode, if a P wave or R wave is not sensed
within a predetermined time frame, then the IMD 10 provides atrial or ventricular pacing
with appropriate timing, if supported by that mode. There are numerous variations to this
generalization such as overdrive pacing or various tachycardia pacing therapies. The main
point herein is that the IMD 10 senses data and responds in some fashion to that data.
As discussed, the present invention relates to an IMD 10 that selectively operates
according to a VPP, such as for example, the MVP™ mode. There arc many variations
among the various VPPs and for the sake of clarity not every variation will be separately
described. FIG. 2A illustrates a ladder diagram with sample timing data. The specific
example relates to how a premature ventricular contraction (PVC) is addressed under one

of the current VPPs; however, this diagram will also be used to explain the basic operation
of a VPP.
The nomenclature presented will be consistently used throughout this description.
In each diagram, the atrial channel (A) and ventricular channel (V) are illustrated. Events
are indicated relative to one another according to time. In each example, atrial pacing
(AP) is presumed with an A-A interval of 1000 ms. It should be appreciated that intrinsic
atrial events (AS) may occur and are accounted for; however, they are not discussed in
these examples. At time Tl an atrial pace (AP) is delivered. At time T2, the atrial event
has conducted and intrinsic ventricular depolarization occurs (VS). The time between the
AP and the VS is the AV delay. While the timing of the AP is known, the VS occurs
naturally, thus, while expectations and averages may apply, the precise timing of the VS
and the duration of the AV delay are not known until they occur. At time T3, the next AP
is delivered; as indicated above the A-A interval is 1000 ms. The VA interval is the time
from the VS to the AP (T3).
At time T4, a premature ventricular contraction (PVC) occurs. A PVC is any
sensed ventricular event that is not triggered by a properly conducted atrial event or may
be a properly conducted ventricular event resulting from a premature atrial contraction
(which still leads to a ventricular event that is premature in overall timing). Thus, even
though the PVC occurs after the AP at T4, it is effectively "too early" to be a proper
ventricular event and is therefore considered a PVC. Nonetheless, the PVC is a
ventricular event / ventricular depolarization. As such, the time from the VS to the PVC is
referred to herein as the first V-V interval (V-V (1)). With the caveat that intrinsic
ventricular events may vary, if the A-A interval is steady at 1000 ms the V-V interval
(absent PVC's, conduction block, or other abnormalities) should also be approximately
1000 ms. Another type of PVC may also occur and would
Departing from the example for a moment, if the illustrated PVC were a properly
conducted VS (i.e., occurring later in the cycle), then V-V (1) would likely have been
about 1000 ms. The next AP would occur as illustrated at time T5; followed most likely
by an intrinsic ventricular event rather than the illustrated VP. In other words, this is how
the VPP would work if events were normal. In general, any sensed ventricular event
occurring during any portion of a given A-A interval satisfies the criteria to continue
normal operation. The exception to this is a PVC as will be explained in detail. Only

when a complete cycle (A-A interval) is devoid of proper ventricular sensed events, will
the next cycle include ventricular pacing.
In this example, the PVC occurs during a defined crosstalk window. That is, a
period of time following the AP where sensed ventricular events are effectively ignored (at
least the first such occurrence). Thus, for purposes of the VPP, the PVC at time T4 is
ignored and is effectively equivalent to not having a sensed a ventricular event occurring
in the A-A interval between times T3 and T5. As such, the response of the VPP is the
same in either instance (no V event or early PVC). That is, the A-A interval (T3 - T5) is
deemed devoid of ventricular activity. Thus, in the next A-A interval (T5 - T7), a
ventricular "backup" pace (VP) is delivered at time T6. In this example, in the cycle
beginning with the AP at time T7, conduction returns and the VS occurs at time T8. If
conduction had not returned, various options arc available based upon the specific VPP
embodiment. Such options would include, for example, conduction checks, and operation
in a dual chamber pacing mode for various amounts of time.
Returning to the specific example illustrated, when the PVC occurs and is ignored
under the current VPP, certain issues arise. That is, although the PVC is ignored as a
ventricular event, it does depolarize the ventricles, although at a less than optimal time and
with less than an optimal contraction. Again, in normal timing, V-V intervals (in this
example) should be approximately 1000 ms. Here, because of the PVC, the V-V timing is
1000 ms in the cycle prior to Tl (not illustrated), 800 ms for V-V(l), 1050 ms for V-V(2),
and then about 1000 ms for V-V(3). This sequence is normal, short, long, normal.
Furthermore, the long duration (or "pause" as used herein) following the short duration is
terminated with a ventricular pacing pulse. While this mode of operation is generally
appropriate, there is some belief that this type of pattern, particularly when terminated
with a ventricular pace may be proarrhythmic in a small patient population. This theory is
widely disputed and its validity is not known. However, the present invention provides
mechanisms to minimize this scenario if there is in fact validity to the concern.
In a first embodiment of the present invention, illustrated in FIG. 2B, the timing of
the events is substantially the same as that of FIG. 2A. The distinction here is that the
PVC, despite occurring in the crosstalk window is considered as a ventricular event; thus,
a ventricular pace is not provided in the next cycle (T5). Rather, intrinsic conduction
occurs and a VS is noted at time T6. The V-V variation is approximately the same (1000

ms, 800 ms (V-V (1)), 1200 ms (V-V (2)), 1000 ms (V-V (3))); however, the long pause is
not terminated with a ventricular pace. Rather, intrinsic conduction is permitted; thus,
reducing the disruptive effects that might result from pacing in such a situation for certain
patients. If the VS had not occurred at time T6 and none occurred at all in the A-A
interval (T5 - T7), then a ventricular pace would have been delivered following the AP at
T7. To summarize, in this embodiment the acceleration in ventricular timing (800 ms),
followed by a deceleration (1200 ms) is terminated by an intrinsic event as opposed to a
ventricular paced event.
FIG. 2C represent another embodiment referred to as a VPP with ventricular rate
stabilization (VRS) or rate smoothing. In dual chamber modes, (e.g., DDD/R) VRS
address the same type of acceleration/deceleration in V-V timing generated by PVCs.
However, in a dual chamber mode, ventricular pacing is almost always provided and
certainly always available. Thus, the AV interval and the VA interval are completely
controlled and in response to a PVC, these intervals are varied to gradually return to a
normal timing pattern. With the VPP, there is no control over ventricular timing; thus, this
approach is impossible.
At time Tl, the AP is delivered and a VS occurs at time T2. An A-A interval of
1000 ms expires and the next AP is delivered at T3. As in the previous examples, a PVC
occurs (during the crosstalk window) at time T4. To ultimately affect the V-V timing, the
A-A interval is modified. Thus, after the PVC the current A-A interval is truncated and an
AP is delivered "early" at time T5. In this example, the shortened A-A interval is about
750 ms. As an example, the VS has generally been occurring about 250 ms after the AP in
this "patient". Thus, at time T6 the VS occurs. By chance, this happens to approximately
align with the previously scheduled 1000 ms AP (which does not occur) at time T7. It
should be appreciated that these two times may or may not correspond. Another AP is
delivered at time T8 with a normal VS at time T9. The result is that the prior V-V interval
(not shown) is about 1000 ms, V-V (1) is about 800 ms (PVC is an early event, hence
some acceleration of V-V timing); V-V (2) is about 950 ms (because of the early AP and
resulting VS); and V-V (3) returns to the normal 1000 ms interval. The resultant V-V
intervals are substantially "smoother;" that is, their durations are relatively similar and
large accelerations and large decelerations are avoided. Once the A-A interval is
shortened, this approach allows a smoother, more gradual return to normal timing rather

than a one cycle jump. In addition, the ventricular event occurring between times T5 and
T8 is intrinsic, which as described above is preferable to relying upon ventricular pacing.
More atrial cycles could be relied upon to effectuate the smoothing, with each resultant V-
V interval varying by a smaller amount; thus, while taking longer to return to a given
value an even smoother transition is provided. The number of cycles and the delta
between consecutive intervals may be selected to provide the desired degree of
"smoothing."
Thus, this embodiment controls A-A timing to effectuate variations in V-V timing
without providing ventricular pacing. As such, this embodiment represents a VPP having
a ventricular rate stabilization or smoothing effect.
There are several factors to consider within the scope of the present invention in
varying A-A intervals to effectuate V-V timing. The "early" AP must not be too early so
as to pace when the atrium is refractory and/or similarly result in a conducted event
occurring when the ventricles are refractory. Furthermore, the amount of the adjustment is
based upon known or expected AV timing (which as explained, is not controlled by the
device). In other words, the desired effect is to achieve an intrinsic ventricular
depolarization at or about time T6 (in this example). Thus, the IMD 10 determines the
likely AV time that will result, and shortens the A-A interval by this amount.
FIG. 3A is an example of how the prior VPP(s) would treat a PVC occurring
approximately 400 ms after a properly sensed ventricular event and within the same A-A
interval. Again, the example assumes atrial pacing in every cycle with an A-A interval of
1000 ms. Thus, the A-A interval previous to the first illustrated (referred to as A-A (0))
was 1000 ms in duration, with a VS at about 250 ms and no PVC occurred.
At time Tl, the AP is delivered and an interval of 1000 ms is started. At time T2, a
VS occurs (about 250 ms). A PVC occurs at time T3, which is about 400 ms after the VS
and thus about 650 ms into the cycle. The notation at time T4 indicates when the next AP
was scheduled to be delivered (e.g., at the termination of the 1000 ms interval). In
general, the way that the previous VPPs treated a PVC occurring after a VS was to add an
interval or in other words delay the subsequent AP. This effectively means that a VA
interval is initiated at the PVC (T3). The value of this interval may be varied; in this
example a value of 920 ms is utilized (current A-A interval (1000 ms) - 80 ms (where 80

ms is the AV interval for a backup V pace). As such, an AP is delivered at time T5 and a
normal VS occurs at time T6, with the pattern normalizing through time T9.
The result is a 1000 ms V-V (0), a 400 ms V-V (1), an 1150 ms V-V (2), and 1000
ms interval for V-V (3) & (4). Thus, a long pause (1150 ms vs. 400 ms) occurs in V-V
timing. In this instance, the pause is terminated by a VS. In another scenario, no VS
occurs during the A-A interval defined by time T5 to T7. This would result in a VP
occurring proximate time T8, thereby extending V-V (2) to about 2000 ms. Thus, the
pause is longer and is terminated by a pacing pulse.
FIG. 3B illustrates an embodiment of the present invention that smoothes the V-V
intervals in response to the same PVC occurring at 400 ms by controlling A-A timing.
Again, an AP occurs at time Tl (initiating a 1000 ms interval) followed by a VS at time
T2. A PVC occurs at time T3. The current VPP embodiment attempts to have the V-V
intervals be relatively smooth, progressively larger, and gradually return to the appropriate
value (e.g., 1000 ms in this case). Thus, V-V (1) establishes the initial interval at 400 ms.
The IMD 10 determines what V-V (2) interval should be, based upon the value of V-V (1).
Based upon what this value is (550 ms in this example), the desired timing of the VS at T5
is determined. Since the IMD 10 cannot control when the VS will actually occur, it
calculates what the likely AV delay will be, subtracts this interval from the time T5 and
provides an atrial pace at this time (T4); contrasted with the example of FIG. 3A where a
long VA (920 ms) is added to the PVC before the next AP. The interval (VA) between T3
and T4 must be appropriate and non-refractory. Furthermore, the IMD 10 (based upon
patient historical data) determines that this VA is not likely to lead to conduction block.
The AP is delivered at time T4 and the VS occurs at time T5 (about 250 ms later in
this example). As indicated, V-V (2) is about 550 ms and a subsequent jump to 1000 ms
would be too large a delta; thus, the above process is repeated. A desired V-V value is
determined; the necessary timing of the VS is determined, the likely AV value is
subtracted, and the AP is delivered at that time. Here, the AP is delivered at T6 and V-V
(3) is 700 ms. The same process is repeated again and the next AP is delivered at time T8
with a resultant V-V(4) of about 850 ms. Finally, the AP at T9 returns the V-V interval to
the initial rate of 1000 ms. Correspondingly, the A-A interval from T4 - T6 is 700 ms, T6
- T8 is 850 ms, and from T8 - T9 is 1000 ms. Thus, by varying the A-A intervals using
the VPP smoothing function, the resulting intrinsic ventricular timing may be influenced

and the resultant V-V intervals adjusted to avoid large deltas between sequential cycles
without actually pacing the ventricles.
If an AP is scheduled following a PVC and another PVC occurs prior to delivery of
that AP, several options exist. First, the IMD 10 determines if the timing of the second or
subsequent PVC would still permit the scheduled AP to be delivered in an effective
manner. If so, the AP is delivered. If not, then a standard delay may be added to the AP
timing (e.g., delay by 400 ms); the delay may be set to the duration of the interval between
PVC's; or the above process is repeated in its entirety as the V-V intervals (may) have
been changed by the occurrence of a subsequent PVC.
It should be readily appreciated that the examples used herein are for illustrative
purposes only. The numerical values selected merely aid illustration and arc in no way
limiting. The specific values that would be chosen would vary depending upon patient
specific criteria.
FIG. 3C illustrates how the above embodiment would respond to an atrial
refractory event. Comparison is made between FIGS. 3B and 3C. At time T3 (in each
figure), the PVC occurs. At time T4 (FIG. 3C), an atrial refractory event (AR) occurs thus
prematurely depolarizing the atrium. Of course, if conducted the ventricles are refractory
so this does not affect ventricular depolarization. If the AP were delivered at the same
time it was in FIG. 3B, the atrium would be refractory and would not depolarize. Thus,
despite the desire to smooth the V-V variability, the AP must be delayed because of the
AR. In this example, the AP is delayed 400 ms from the AR. The delay may be a
determination of atrial repolarization or some surrogate such as A-V intervals (averaged,
median, etc.) for a given rate, or an A-V value plus an offset such as 50 ms to assure
reliability. The AP is delivered at time T5 and the VS occurs at time T6. The process then
continues as previously described. In this case, V-V (I) is still 400 ms, V-V (2) is 750 ms,
which is greater than 550 ms of FIG. 3B but still significantly shorter than the 1100 ms of
FIG. 3A, V-V (3) is 900 ms and V-V (4) returns to 1000 ms. Thus, an atrial refractory
event causes a somewhat longer pause, but the present embodiment is still able to smooth
V-V intervals by adjusting A-A timing and avoids ventricular pacing.
FIGS. 4A-4C are substantially similar to FIG. 3A-3C, however the PVC occurs
600 ms after the VS, rather than 400 ms. The resulting processes are the same and the V-
V intervals, in this example are as follow:

FIG. 4A Previous VPP(s)
V-V(l) 600 ms
V-V(2) 1200 ms
V-V(3) 1000 ms
FIG. 4B Present Embodiment
V-V(l) 600 ms
V-V(2) 750 ms
V-V(3) 900 ms
V-V(4) 1000 ms
FIG. 4C Atrial Refractory event
V-V(l) 600 ms
V-V(2) S50 ms
V-V(3) 1000 ms
In certain embodiments of the present invention, the A-A intervals are adjusted
during VPP operation so that resultant V-V intervals are influenced, without providing
ventricular pacing (as a general rule). The determination of values may be based on
various criteria. For example, once a given (short) V-V interval occurs (e.g., due to a
PVC), the next V-V interval (and each thereafter until the desired rate is achieved) may be
increased by some predetermined percentage such as 10, 15, 20, 25, 30, 35, 40 or 45
percent. Alternatively, a predetermined value may be added to the subsequent V-V
interval (and each thereafter until the desire rate is achieved) such as for example 50, 100,
150, 200 or 250 ms.
Thus, the desired V-V interval is selected. To implement this interval, the A-A
interval is calculated accordingly and the atrial pace is delivered at an appropriate time.
The determining factor is the AP to VS time value (AV delay or interval). In other words,
the desired time for a VS to occur is selected and the AV delay is subtracted to determine
when to pace. The present invention provides various mechanisms to determine this likely
AV delay.
In one embodiment, the AV delay times are recorded by the 1MD 10 over some
period of time. This may be for the overall implant life or some subset such as the last 12
hours, the previous 100 cardiac cycles or other predetermined period of time. The AV

delay is averaged or a median AV value is determined and utilized. By using a
statistically significant but relatively short time line, the median AV delay, for example, is
more likely to be accurate than over the lifetime of the implant. For example, the median
over the previous 100 cardiac cycles would account for the patient's current condition and
status.
In another embodiment, a table of AV delays is kept for various A-A intervals.
Such a table 100 is illustrated in FIG. 5A. A given data point may represent one of several
potential items. A data point may simply indicate what an AV delay for a given A-A
interval is, based upon patient experience. Alternatively, the data point may be an
averaged value, median, etc. of AV delays for the same A-A delay. Finally, the data point
may represent the shortest successful AV delay for a given A-A interval. This may be a
single event or alternatively, a plurality of successful conductions at this delay may be
required prior to entry into the table. The table is meant to indicate at least what AV
delays are likely to succeed (i.e., conduct successfully) at a given A-A interval and to the
extent the data is available, the shortest tolerable AV delay for any given A-A interval.
The table provides various discrete data points, from which other data may be
extrapolated. That is, if the above methodology requires an A-A interval of a given
duration to smooth V-V intervals and that A-A interval has no data in the table, the likely
AV delay may be extrapolated.
In another embodiment, the extrapolation of data takes into account the non-linear
relationship between A-A intervals and AV delay. In reality, the AV delay can only be
truncated so much (successfully) regardless of how short the duration of desired A-A
interval. Choosing between relatively long A-A intervals (e.g., 1100 ms vs. 1000 ms) has
different tolerances than relatively short A-A interval (e.g., 400 ms) variations. Thus, FIG.
5B illustrates a sample graph 200 where a non-linear component is added to an
extrapolation of the data obtained from e.g., the table 100 of FIG. 5A. This margin
increases the likelihood that a selected A-A interval will result in a conducted event. It is
generally preferable to err on the side of providing a longer A-A interval (resulting in a
longer V-V interval) than to try to have too short an A-A interval that fails to conduct.
In another embodiment, a decision is made to smooth V-V intervals. A calculation
is performed to determine what A-A interval is required to effectuate the desired V-V
interval. The IMD 10 then determines whether this A-A interval will successfully conduct

(that is, actual data supports the interval and its requirements). If so, then the A-A interval
is utilized. If not, then a ventricular pacing pulse is provided to ensure the desired V-V
interval. This embodiment is the least preferred, and distinct from the others, for the
above stated reason that ventricular pacing is always less preferable to conduction.
Generally, it would likely be more preferable to revert to the prior VPP (e.g., FIG. 2A).
However, the present invention provides for a variety of embodiments so that various
options may be provided to clinicians who may then select the most appropriate VPP for
their patient.
FIGS. 6-7 are flowcharts that present the methodology of various embodiments
consistent with the teachings of the present invention. The IMD 10 is programmed to
operate (300) according to a VPP (ventricular pacing protocol) such as, for example, the
MVP™ mode. As a general summary, the VPP operates by freely providing atrial pacing
as desired and of course, relying upon intrinsic atrial depolarization whenever appropriate.
Ventricular pacing is generally withheld and a full cardiac cycle (A-A interval) is
permitted to lapse without ventricular activity. If a cycle lapses without ventricular
activity, then a ventricular backup pace is provided in the next subsequent cycle,
appropriately timed from the atrial event. The next action(s) taken will vary based upon
the embodiment of the VPP. For example, in the following cycle (after a ventricular pace)
ventricular pacing may be withheld again to allow for intrinisic conduction. If this pattern
is repeated a certain number of times, a mode switch to a dual chamber mode (e.g.,
DDD/R) is made for some predetermined amount of time. This generalized description
addresses normal operation of the VPP when proper ventricular events are sensed and/or
no ventricular event is sensed.
Returning to the flowchart, this process is described. An entire A-A interval
(whether defined by atrial pacing at some rate and/or intrinsic atrial depolarization) is
monitored (310); that is, the ventricles are sensed for ventricular depolarization in
response to a conducted atrial event. It should be appreciated that various blanking
periods arc still utilized during a given A-A interval and should not lead to confusion
regarding monitoring over the "entire" A-A interval.
During the A-A interval, the ventricular channel is monitored for conducted events.
If no (320) ventricular event is sensed, then a ventricular pacing pulse is provided (330) in
the subsequent A-A interval. After that, the process returns and continues to operate

according the parameters of the VPP. Conversely, if a ventricular event is sensed (320) a
determination is made as to whether this event is a PVC (340). It should be appreciated
that during this monitored A-A interval, a first sensed ventricular event may be classified
as a PVC if it occurs so early in the cycle that it would not have resulted from conduction.
Conversely, a proper ventricular event may be sensed and then a second ventricular event
within the same A-A interval may also be sensed. This second (or subsequent) event
would be classified as the PVC (340).
If no PVC is detected (340), then the IMD 10 will operate (350) in the next
subsequent A-A interval as it has in this interval. That is, no ventricular pacing is
provided and the entire A-A interval is monitored. Thus, the process returns to normal
VPP operation (300).
If a PVC (340) is detected, then the VPP initiates (360) the ventricular interval
smoothing function, which is illustrated in FIG. 7. While the process is described in a
particular sequence, it should be appreciated this order is non-limiting and that various
actions may occur in a different sequence and/or simultaneously. Furthermore, while
various actions are called out for explanatory purposes, there may not be any specific
action taken as the result is the gathering of a known variable or value (e.g., determining
A-A intervals - this value is typically "known" to the IMD 10).
The IMD 10 determines (370) what the prevailing A-A interval is at the time of the
PVC. If atrial pacing has been prevalent, this is simply the escape interval for the atrial
pacing component, which will likely (but not necessarily) be rate responsive. In the above
examples, this was 1000 ms for illustrative purposes. If the atrial rhythm was intrinsic,
then the AS-AS intervals were sensed by the IMD 10 and while not controlled by the
device, the timing was known.
The IMD 10 then determines (380) a value for V-V(l) which is the time from the
previous ventricular event to the PVC. In order for the event to be a PVC it must have
either occurred too early in the cycle and absent the present methodology, the next V-V
interval would be too long (and likely terminated by a VP); or the PVC occurs after the VS
and therefore introduces a very short V-V interval which would be followed by a long V-
V interval. Therefore, the IMD 10 determines (390) what the appropriate value for V-
V(2) should be based upon the value of V-V(l) and the A-A prevailing rate. That is, the

objective is to return to the V-V prevailing rate in a smoother or gradual, stepped fashion
and avoid large variances.
The IMD 10 may utilize various methodologies in calculating V-V (2). As
illustrated, one example (A) is to add some incremental value to the V-V (1) interval. This
may be a standard value (e.g., 50 ms, 100 ms, etc.) or may be a value linked with the value
of V-V (1). For example, if V-V (1) is particularly short (200 ms) adding 50 ms may
result in an unworkable V-V (2). Therefore, there may be a minimum allowable V-V (2)
value. Thus, while various options are available the result is that some value is added to
V-V (1) to arrive at V-V (2). In the other example (B), V-V (2) is created by increasing
V-V (1) by some percentage (e.g., 10, 15, 20, 25, 30, 35, 40 %, etc.), with the same
caveats relating to the V-V(2) value being too short and therefore extended to a
predetermined minimum.
Once the value for V-V (2) is determined, the IMD 10 determines when an AP
would need to be delivered so that intrinsic conduction would lead to a VS at the
appropriate time. Thus, steps 400 and 410 arc effectively coincident as determining the
AP timing necessitates knowing the expected AP-VS timing and vice versa.
The IMD 10 evaluates (420) whether the A - AP timing is likely to permit/
facilitate conduction (430). If not, then the timing is reevaluated (440) or as indicated for
one embodiment, ventricular pacing is provided. In order to evaluate the likelihood of
conduction, various methods may be utilized. In one embodiment a table of known AV
delays is provided and either utilized or a value is extrapolated if no corresponding data
point is present. In another embodiment, average or median AV delays are stored and this
value is utilized. In another embodiment, a patient specific table is created (as above), and
a non-linear modifier is utilized for extrapolation to account for the non-linear
correspondence between A-A intervals and AV delays over the spectrum of possible A-A
intervals. Finally, another embodiment is to utilize a given value if the IMD 10 "knows"
(based on stored data) that conduction will very likely occur and to provide ventricular
pacing if this confidence in a specific value is unavailable
Assuming the timing of the AP and the expected V-V (2) arc satisfactory and
would reasonably lead to a conducted ventricular event, the AP is scheduled. During the
interim, the atrial channel is monitored for refractory events. If an AR occurs (450), then a

predetermined delay value (e.g., 400 ms) is added to delay the AP until the atrium is
repolarized.
At the appropriate time, the AP is delivered (470) and the ventricular channel is
sensed (480) for a VS. If the VS does not occur, then ventricular pacing is provided in the
subsequent cycle according to the normal operation of the VPP. Assuming the VS docs
occur (490), the next A-A interval (and V-V (3)) is calculated (510) (using the described
methodology) and the appropriately timed AP is delivered (520). That is, V-V (3) is
longer than V-V (2), and each interval progresses toward the desired duration.
The current A-A interval (and effectively V-V interval) arc compared (530) to the
prevailing A-A interval. If they are the same or very close, then the process is complete
and operation returns to normal according to the VPP parameters (300). If the A-A
interval is not substantially equal to the prevailing (or desired) A-A interval, the process
returns to step 510 and another incremental V-V value is generated. This process is
repeated as often as necessary to return to the desired rate. In the examples previously
described, this would take 2-3 cycles; however, this is non-limiting.
FIG. 8A is a timing diagram again illustrating basic operation with one existing
embodiment of a VPP. Atrial events are paced and the A-A interval is 1000 ms, in this
example. Similarly, the VS - VS intervals arc also 1000 ms. At time T5 an AP is
delivered that is followed by a VS at time T6. At time T7, the next AP is delivered (1000
ms after T5). Because of the VS at T6, no ventricular pacing will be provided in the A-A
interval between T7 and T8. As illustrated, no ventricular event is sensed in this interval.
The AP is delivered as scheduled at time T8 and a ventricular pace VP is delivered at time
T9, in this example about 100 ms after the AP. The next AP is delivered 1000 ms after the
last, at time T10 and a VS occurs at time Til. The VS events are illustrated as occurring
about 250 ms after the AP.
The result of this pattern is that when conduction is present the V-V interval is
about 1000 ms. The VS-VP interval is about 1850 ms, the VP - VS interval is about 1100
ms (due to relatively short AP-VP interval, which is deliberate), and the next VS-VS is
again 1000 ms. This is normal operation and no PVCs or other extraneous events are
present. Operation in this manner is well tolerated by the patient population and results in
a dramatic reduction in ventricular pacing for patients having some degree of intact

conduction. That said, even absent a PVC there is a pause that is terminated with a
ventricular pace.
FIG. 8B illustrates a new embodiment of a VPP according to the present invention
that may be used in and of itself as well as in combination with the above ventricular
interval smoothing functions. At T5 the AP occurs, followed by the expected VS at T6.
At T7, the next AP is delivered. One of the basic principles of the VPP mode is that
ventricular pacing is precluded in a cycle following a cycle were ventricular activity was
sensed. That said, there is no requirement that a given A-A interval have any specified
value; intrinsic atrial events could always inhibit a scheduled AP. Thus, the present
embodiment utilizes the ability to "control" or rather influence intrinsic ventricular events
through the timing of atrial pacing.
Following the AP at time T7, there is some expected time during which a VS is
likely to occur and this range is illustrated as range Rl. This is patient specific and based
upon history (or demographical data when specific patient data is insufficient or
unavailable). Thus, the range Rl could provide for an AV delay that is much longer than
what would typically occur for dual chamber pacing modes. Nonetheless, even with
patients having prolonged conduction, there is generally some predictability. If no VS
occurs by the end of the range Rl, then the timing of next AP is advanced or accelerated
so that a VS is likely to occur at time T9. Time T10 indicates when the originally
scheduled AP would have occurred. The same calculation methodology previously
described may be used herein.
The A-A interval between T7 and T8 is truncated and devoid of ventricular
activity. As a practical matter, had the AP not been advanced this cycle would most likely
still be devoid of a VS. Now, in the cycle from T8 - Tl 1, ventricular pacing is available,
but the PAV (paced AV) interval is not set to the short (80 - 100 ms) duration as
previously used. Rather, sufficient time is given that intrinsic conduction leads to the VS
at time T9. In considering resultant V-V intervals, there is still a pause (though shorter
than in FIG. 8A); however, it is terminated with an intrinsic ventricular event rather than a
ventricular pace. For intermittent dropped beats, this is the most likely result; that is, if
given an opportunity intrinsic conduction will likely reemergc after a single skipped cycle.
The next AP is delivered at T11 (1000 ms after the early AP at T8). At T13 an AP
is delivered and no VS occurs during the expected range R2. Thus, the IMD 10 schedules

an early AP to occur at about time T14. In this example, a VS occurs after the expiration
of the range R2, but prior to delivering the early AP. Thus, the early AP is cancelled and
the originally scheduled AP is delivered at time T15.
As illustrated no VS occurs between T15 and T16 (a shortened A-A similar to T7-
T8). Thus, with the delivery of the AP at T16 it is hoped that a VS will occur as
previously described. There may be block or other issues and no VS occurs within the set
PAV interval. As such, a VP is delivered at T17. This simply illustrates that after a
truncated A-A devoid of ventricular activity, the next cycle will have ventricular activity;
either through an intrinsic event that is given a better chance to emerge due to the early AP
and delayed VP, or if necessary by the VP. It should be appreciated that these events are
illustrative and that no correlation is meant to be indicated by the proximity of events
having missed beats; they are proximate simply for illustrative convenience and are
otherwise unrelated. One could assume that numerous cycles elapsed between the
described cycles having accelerated atrial pacing. The VPP may take certain action based
upon patterns emerging over a number of cycles and the present embodiment does not
exclude such action and merely presents various possible scenarios in proximity for ease
of illustration.
FIG. 9 is a flowchart illustrating a VPP using A-A interval modulation to reduce
the occurrence of providing ventricular pacing following a skipped ventricular beat while
controlling V-V intervals. The IMD 10 begins operation (600) according to the VPP of
the present embodiment. Over time, the IMI) 10 will record data (605) indicative of the
patient's AV delays at various A-A intervals. Until that patient specific data has been
recorded, preprogrammed AV data may be utilized as a surrogate. For purposes of this
example, we assume that some number of previous A-A intervals (whether paced or not)
have had successful ventricular conduction. Thus, the initiation of the A-A interval (610)
simply represents a cardiac cycle following a cycle where a conducted ventricular event
occurred. Once again, the A-A interval may be paced or entirely intrinsic and an
assumption of consistency due to rate is made for illustrative purposes only.
This A-A interval begins and an AV range timer is initiated (620). This timer
represents when, for this rate, this patient will likely have a conducted ventricular
depolarization. The timer is referred to as a range timer as some margin may be added to
the expected timing to account for normal and/or tolerable variations. As a VS occurred in

the previous cycle, ventricular pacing will not (615) be available in this cycle. The
ventricular channel is sensed (630) for a conducted event. The IMD 10 determines if a VS
has occurred (640), if a VS occurs then the next cardiac cycle will also be precluded from
having ventricular pacing (650) and the process returns to 610 for the next A-A interval.
If no VS occurs (640), the IMD 10 evaluates the status of the timer (660) and continues to
monitor until the timer's expiration.
If the timer expires without a VS occurring, then the protocol "assumes" that no
VS will likely occur in the current A-A interval (670). Ventricular pacing is precluded as
previously indicated. The IMD 10 evaluates (680) the timing of the previous VS and what
an appropriate V-V interval would be, assuming a skipped event in this interval. Next, a
calculation is made as to when an AP would need to be delivered (early, as compared to
the expected A-A interval) that would likely conduct and result in a VS as this time (690).
While described as separate steps, it should be appreciated that these calculations are
related. That is, the current rate, the likelihood of atrial capture, and the likelihood of
conduction leading to a VS, as well as the resulting V-V interval are all utilized in the
determination.
Once the timing has been calculated, this early AP is scheduled (700). Until that
time, the ventricular channel continues to be monitored (710) and if a VS (720) occurs, the
early AP is cancelled (730) and the process returns to step 650. In other words, the VS
occurred outside of the AV range timer but within the original A-A interval; thus, that
interval is considered as having a conducted ventricular event and the process proceeds
accordingly.
Assuming that no VS occurs prior to the scheduled delivery, the early AP is
delivered (740). In the A-A interval initiated by this AP, ventricular pacing is available as
the previous (truncated) cycle was devoid of a ventricular event. In other VPP
embodiments, the VP is delivered rather quickly post AP (e.g., 80 ms); in the present
embodiment, the AP was timed so that assuming normal conduction (preferably specific to
this patient), a VS is likely to occur at an appropriate time. Therefore, an AP-VP interval
is initiated (750) wherein upon expiration a VP will be delivered, unless inhibited by a VS.
The AP - VP interval is selected so that the VP is scheduled after the expected VS
(optionally plus some margin). In most cases, a VS will occur but in those rare instances
where it does not, ventricular pacing is provided.

As indicated, the ventricular channel is monitored (760) for a VS during the AP-
VP interval. If a VS occurs (770), then the VP is inhibited and the process returns to step
650 as this cycle is has a conducted ventricular event. As previously discussed, the
resulting V-V interval is somewhat longer than the preceding V-V intervals; however, this
pause is terminated by an intrinsic ventricular event rather than a paced event. If no VS
occurs (770), then the scheduled VP is delivered (790) and the next steps are taken (800)
according to the specific VPP.
Through the new embodiments discussed above, various VPPs have been provided
that alter atrial timing in order to effect a change in ventricular intervals. These VPPs
allow for intrinsic conduction to occur over an entire A-A interval and only if that interval
is devoid of a ventricular sensed event will ventricular pacing be provided in the next
cardiac cycle. This modification of atrial timing may be made in any cycle where it
appears unlikely that a ventricular event will conduct and/or in situations where a PVC
will create anomalous intervals. It should be appreciated that by utilizing these
embodiments, various arrhythmias arc likely avoided. As a consequence, the need to
deliver cardioversion or defibrillation shocks is reduced.
In general, patients tolerate one skipped ventricular beat well; however, a
ventricular event (paced/sensed) will occur in the cycle subsequent to the skipped beat.
Absent the above described atrial timing modifications, the existing VPP may result in a
V-V interval equal in duration to twice the lower rate minus the PAV (assuming
normal/consistent AP-VS durations). Ventricular timing is not controlled in this manner,
this is simply the numerical result. Referring to FIG. 8A, the VP at time T9 is scheduled
to be delivered at the end of a PAV that is initiated with the AP at time T8. Thus, the
timing of this VP is not related to the previous VS but in retrospect, the interval between
these two events may be measured. To be completely accurate, the maximum duration
(assuming fixed A-A intervals at the LRl) is twice the atrial lower rate interval (LRI) plus
the AP-VP interval minus the AP-VS interval (2*LRJ + (AP VP) - (AP VS)). As
indicated, in various circumstances it may be desirable to shorten this interval and/or end
the interval with an intrinsic event rather than a paced event. Thus, the A-A intervals arc
varied to achieve these effects.
As discussed, modifying atrial timing will likely result in conducted events
occurring at a desired time. In order to make this more likely, A-A intervals may be

selected based upon patient data that indicates previous successful conduction at that
interval. Despite this, the possibility remains that an accelerated atrial event will initiate a
cycle where conduction does not occur and a ventricular pace is delivered. Thus, there are
two factors in consideration. The first is the likelihood of successful conduction at a given
atrial rate. The second is the resultant VS to VP interval, when ventricular pacing is
required. These two factors will define the boundaries of the permissible atrial
acceleration as well as the PAV that is set.
Referring to FIG. 10, portions of two timing diagrams are illustrated. Timeline A
illustrates the prior VPP with a maximum V-V interval, in one scenario. It should be
appreciated that the illustrated timing of the VS is arbitrary and if it had occurred earlier in
the cycle, the resulting V-V interval would be longer. Thus, "maximum" is relative in the
sense that the actual AP-VS timing may vary, the A-A interval may vary, and a different
PAV may be set. However, the relationship defined by the variables, regardless of their
specific values in a given example, does in fact establish the relevant reference points.
In this example, the IMD 10 is providing atrial pacing at the lower rate interval
(LRI). An atrial AP is delivered, followed by a ventricular sensed event (VS). At the end
of the A-A interval, a second AP is delivered and no ventricular event occurs. A third AP
is delivered and the PAVA (e.g., 80 ms) is initiated. At the end of the PAVA, a ventricular
pace (VP) is delivered. In practice, a VA interval (not illustrated separately) begins and
upon expiration, the fourth AP is delivered (at the same time the LRJ would have expired).
This diagram simply illustrates normal operation upon skipping a ventricular beat for this
VPP.
Assuming the A-A interval is set to the LRI, the illustrated VS to VP interval is a
retrospective maximum, relative to the timing of the VS. As indicated, VS to VP may be
defined as:
V-V (max)= 2*LRI + PAV(A) - AV(S)
Thus, in some of the embodiments that seek to accelerate atrial timing this may be used as
the maximum V-V interval tolerated. As indicated, V-V timing is not controlled directly.
Another metric similarly defining a boundary condition, again referring to FIG. 8A, is the
AP(7) to AP(8) interval plus the PAV (AP - VP). This would equal the lower rate interval
plus, e.g., 80 ms.

Referring to timeline B in FIG. 10, the progression is the same as timeline A
through the delivery of the second atrial pace AP(2). As previously described, a range Rl
is provided that establishes the expected timing of a conducted ventricular event. As
illustrated, no such event occurs and the range interval Rl expires. As such, an
accelerated atrial pace AP(E) is scheduled. As previously explained, a desired timing for
an VS to occur (Target VS) is determined; the AV delay (target) is determined, and from
this the timing of the AP(E) is calculated. The AP(2) - AP(E) interval is evaluated to
determine if conduction is likely to occur in this patient; if so, the timing is utilized and if
not, then the values are reevaluated. Upon delivery of the AP(E), a PAV(B) is initiated;
upon expiration a ventricular pacing pulse VP will be delivered unless inhibited by a VS.
Assuming the VP is delivered, an optional AP( R) may be delivered simultaneously or at
approximately the same time. This prevents retrograde conduction into the atria from
affecting the efficacy of the next AP(5). As illustrated, the delivery of the VP in timeline
B corresponds to the delivery of the VP in timeline A and is therefore the maximum
acceptable in this embodiment. As such, timing parameters that result in the VP being
delivered as illustrated in timeline B or sooner are generally appropriate.
With this understanding, certain relationships may be established for the variables.
The use of the "↔" indicates the interval between the two items.
AP(2) ↔ AP(E) ≥ AP(2)↔ Rl (expiration); and
≤ LRI; and
≥ shortest known A-A w/ conduction
(optional)
(where known A - VS ≤ AP(E) - VP)
PAV(B) ≤ LRI - (AP(2) ↔ AP(E)) + PAV(A); and
≥ AP(E) ↔ Target VS
↓ PAV(B) ↓ VS-VP
↑ PAV(B) ↑ VS Opportunity
That is, the shorter the PAV(B), the shorter the VS-VP interval. Conversely,
the longer the PAV(B), the greater the opportunity to allow a conducted event; that is more
time is provided for conduction to occur. It should be appreciated that the usage of these

values / rules as boundary conditions is not a requirement of the present invention, and
may be selectively utilized in various embodiments.
In a given patient, there may be multiple cardiac cycles where the range
timer Rl expires and an accelerated atrial pace (AP(E)) occurs. As indicated, this will
typically result in an appropriately timed ventricular sensed event. However, if it does not
the ventricular pace will be delivered. If a ventricular pace is delivered under this scenario
multiple times, then a decision may be made to forego the above described PAV(B)or more
accurately to shorten it so that a ventricular pace is delivered as the desired target VS time.
That is, if it becomes apparent that intrinsic ventricular conduction will fail under these
conditions based upon past attempts, then there is still benefit in accelerating the atrial
timing and providing ventricular pacing to smooth the V-V intervals. The number of
attempts that should be made prior to taking this action may be selected by the caregiver.
As general guideline, sufficient attempts should be made to establish whether intrinsic
conduction will emerge when accelerated atrial pacing is utilized. In an extremely
conservative setting, one failed attempt may be utilized as a basis to accelerate atrial
pacing and provide ventricular pacing to achieve the smoothing interval. Alternatively,
more attempts may be made such as 5, 10, 20, 100, etc., before changing the approach. Of
course, this numbers are merely exemplary and are non-limiting. As another variable, the
number of failed attempts may be cumulative over time and a successful attempt may
restart the count. Alternatively, having a high number of failures with a minimal number
of successful attempts may also change the pattern. Finally, the timing of the failed
attempts may increase or decrease the relevance on the decision. That is, if a number of
attempts have failed and there has been a long interval (e.g., days) without a skipped
interval, the algorithm may attempt to promote intrinsic conduction and accelerate the
atrial interval despite the number of previously failed attempts as the patient's status may
have changed in the interim. All of these variables may be programmed by the caregiver,
set to default values, or may be disabled.
As previously noted, a desired timing for a sensed ventricular event is
calculated. The appropriate AV delay is subtracted to determine when to deliver the
accelerated atrial pace (AP(E)). The AP-AP(E) interval is evaluated to determine whether
this is feasible. Of course, this is merely exemplary and the ordering or steps taken may
vary. In some embodiments, whether or not to attempt the accelerated timing is based

upon data if available, extrapolations of available data, generalized patient demographic
data, or device determination (i.e., trial and error).
In other embodiments, the decision whether to accelerate atrial pacing and
the specific A-A interval chosen is made only if patient specific data is available and/or if
the extrapolation required is highly probable. One way of collecting data is by making
observations at different atrial rates implemented when the device is in a rate responsive
mode. While data obtained in this manner is perfectly acceptable, several issues exist.
First, at the time of an event requiring this determination, the patient may not have
experienced an atrial rate (due to rate responsiveness) or one sufficiently close to provide
relevant data. Second, many patients will not have the rate response function enabled.
For example, certain heart failure patients may simply rely on atrial pacing at the LRI. For
those patients, there is never an ability to collect data at the varying atrial rate (absent
intrinsic atrial rate changes).
FIG. 11 is a flowchart describing one process for collecting data so that
patient specific data is available for the calculations. The process is referred to herein as
AV conduction testing and would be performed by a clinician at implant and/or during
selected follow up appointments. The IMD 10 may also automate some or all of this
testing and perform the testing on a periodic basis; likewise, such testing may be done via
remote programming, assuming appropriate safeguards are in place.
The AV conduction testing is initiated (900) and the first issue is to
determine if the patient has intact conduction (905) to warrant proceeding with the test. If
not, e.g., the patient has complete heart block, the test is terminated (910). The issue may
be transient and the test may be reattempted at a later time. If intact conduction is
present, at least to some degree, the test proceeds. The IMD 10 is programmed to pace at
the LRI (915) and the AV delay (AP-VS or AS-VS) at this rate is recorded (920) into
memory. If a patient has intact conduction, then operation at the LRI has the highest
probability of success and is thus a logical starting point for the test; this is not, however, a
requirement of the test. A number of cardiac cycles may pass at the test rate and the
recorded AV delay may be an average of those values.
Once sufficient data at the LRI has been recorded, the atrial rate is
increased (925). The test determines whether there was AV conduction (930). If not, the
test may be terminated (910). Though not separately shown, rather than terminating the

test, multiple attempts may be made at this rate or at other atrial rates. However, at some
point a lack of AV conduction will result in the termination of the testing (910).
Assuming there was AV conduction at the higher atrial rate, the AV delay is recorded and
stored in memory (940). Again, multiple cardiac cycles may be monitored and averaged,
or data may be obtained from a single cycle. Assuming progressively increasing atrial test
rates, the next determination is whether a maximum atrial test rate has been achieved and
tested (945). The maximum test rate may correlate with the 1MD 10 upper rate limit
(URL); however, as the testing is for purposes other than providing sustained pacing at a
given rate, this maximum may exceed the URL. If the maximum atrial rate is achieved
(945), the test is terminated (910). Alternatively, testing may occur until conduction fails
rather than terminating at a predetermined atrial rate. Assuming the maximum atrial rate
has not yet been reached (945), testing continues.
As illustrated by the "OR" box, (950), testing may take one of two
pathways (and multiple test may be performed so that both approaches are taken). In a
first approach, the atrial rate is again increased (925) with the remainder of the test
continuing as described. In this manner, with each successive iteration, the atrial rate is
rising. The amount of each increase will determine the "resolution" of the results. That is,
the smaller the increment the more data collected. Conversely, the less data collected, the
more extrapolation required. Increments may be made in timer interval adjustment (e.g.,
10, 20, 30, 40, 50 ms increments) or by adjusting beats per minute (bpm). At 60 bpm, the
A-A interval is 1000 ms, at 70 bpm the A-A interval is about 857 ms, and at 120 bpm the
A-A interval is 500 ms. Thus, whatever gradation is desired in terms of direct variation of
the A-A interval or in terms of bpm is utilized.
As an alternative (950), the A-A interval may be returned to the LRI for a
period of time before each successive test cycle at a higher rate. This alternative may be
utilized as the exclusive test mechanism or a complete test may be performed by
iteratively increasing atrial rate and then separately performing a second test with a return
to the LRI with each iteration. As an example, the test may for measure AV delay at the
LRI (e.g., 60, bpm), then 61 bpm, then return to 60 bpm, then 62, bpm, then 60 bpm ... 80
bpm, then 60 bpm, etc. until the maximum atrial rate is tested. Again, the time spent at the
LRI and/or the test rate may be independently selected and may be one cycle or any
number of cycles. The purpose of returning to the LRI is to simulate the effect of an

accelerated atrial pace which would be a one cycle change from e.g., the LRI to the
calculated atrial rate for one cycle. It is under these conditions that conduction and the AV
delay data will most likely actually be utilized.
As indicated, the testing is performed by a clinician, most likely in a
medical office setting. The results will provide data that is patient specific across the
range of permissive atrial rates. In addition, those patients using a rate responsive function
may also generate data on an on-going basis. Thus, at step (960) certain patients will have
their IMDs operating with a rate response function. As the atrial rate varies, the
corresponding AV delay and success or failure of conduction are monitored (965) and
updated in memory (970). When available, this data may be more useful than the initial
test results if the patient's condition has changed. Finally, it should be appreciated that the
results of accelerated atrial pacing can provide data and this data may optionally be
weighted due to the relevance of the results in context.
FIG. 12 is a partially completed, sample table of data that may be collected
during AV conduction testing or through rate response monitoring. The first column is
atrial rate in milliseconds. The second column indicates whether conduction was
successful at this rate. The third column indicates what the AV delay of successful
conduction was at this rate (averaged if more than one data point). It should be
appreciated that at the LRI or at common rates with rate responsiveness many data points
will be collected at a given rate over time. As the patient's condition may vary, these
frequently updated data points may be limited to a recent subset to reflect current data
(e.g., data collected in the last day, last week, etc.) rather than over the lifetime of the
implant. The fourth column indicates whether the data point(s) were obtained during AV
conduction testing or through rate response (may indicate the temporal relevance of the
data). The fifth column indicates whether the atrial rate was reached progressively or
through a single change. While not necessarily limiting, an indication that successful
conduction was achieved with a large change, the likelihood of success with the
accelerated atrial pace may be increased. The next column indicates whether there were
multiple confirmations at this rate. This may simply indicate that during testing, the atrial
rate was maintained for some number of cycles (as opposed to one); this may indicate
success during rate response as well as during AV conduction testing; and/or this may
indicate success during more than one AV conduction test. The end result is that success

was achieved on more than one attempt. The next column indicates the percentage of
successful conducted events out of the number attempted. Finally, the last column
indicates whether there was success at this atrial rate recently. Recent is subjective, but
will be established for a given device or by a caregiver as clinically relevant. Whether
conduction needed to occur in the last day, week, month, etc. to be considered recent is a
selectable parameter. This table is not meant to be limiting; the sample data shown is not
required and alternative data may be included or substituted.
By using this data, a determination can be made as to whether to attempt an
accelerated atrial pace at a given A-A interval. For example, testing on this patient
indicates that conduction was never successful at 400ms. Thus, logically there is no
reason to attempt accelerated atrial pacing at this rate. The LRI (1000 ms), 975 ms, and
700 ms all have been shown to be successful and would be acceptable. At 650 ms, there is
a high degree of success; however, no recent success. This is not necessarily troubling.
First, rate response may not be enabled thereby precluding pacing at this rate (hence
precluding recent success). Second, rate response may be enabled (and is since column 4
so indicated), but this rate simply has not be reached with no negative implication.
Though not shown, other relevant data points could be recent failure at this rate and/or if
this rate has been recently attempted. The 600 ms rate has almost the same data except
that success was only achieved during initial AV conduction testing. Again, this alone is
non-problematic; however, if recent failure occurred (again not illustrated) at this rate that
would counsel against using this value.
Finally, at 500 ms conduction was successfully achieved but only 65% of
the time attempted and there were no recent successful attempts. Again, there may not
have been recent success because the rate response function never attempted to pace at this
rate. Whether or not a value of 65% would permit accelerated pacing at this rate would
depend on the hierarchy of values programmed by the clinician. In the simplest form, a
numerical value may selected (e.g., 80 %) and conduction must have been successful at
this rate or higher in order to be utilized. More complex evaluations may be made. For
example, a lower percentage may be acceptable if recently successful or some other factor
mitigates the "low" rate of success. Of course, what value is actually selected may be
clinician specific. In some cases, relatively high rates of success may be warranted
(90+%); alternatively, for some a 50% rate may warrant an attempt. Finally, in some

cases any degree of success may warrant an attempt at that rate. Ultimately, the data is
collected and provided and the various cutoff parameters are selected by the clinician.
The present invention has been shown and described with respect to various
illustrated examples, embodiments and figures. These are not meant to be limiting and
one of ordinary skill in the art would appreciate that numerous variations are within the
scope of the present invention.

CLAIMS:
1. A method comprising:
operating an implantablc medical device according to a ventricular pacing protocol
(VPP) wherein ventricular pacing is precluded in a given cardiac cycle where a ventricular
event occurred in a cardiac cycle immediately prior to the given cardiac cycle;
establishing an A-A interval;
initiating a first AV interval timer at the initiation of the given cardiac cycle;
sensing for ventricular events;
scheduling an atrial pacing pulse prior to the termination of the A-A interval if no
ventricular event is sensed within the duration of the AV interval timer.
2. The method of claim 1, further comprising:
canceling the atrial pacing pulse and reverting to the A-A interval if a ventricular
event is sensed prior to the atrial pacing pulse.
3. The method of claim 1, further comprising:
initiating a second AV interval timer upon delivery of the atrial pace;
delivering a ventricular pace at the expiration of the second AV interval timer
unless inhibited by a sensed ventricular event.
4. The method of claim 3, wherein the first and second AV intervals have the same
duration.
5. The method of claim 1, wherein establishing the A-A interval includes measuring
intervals between sensed intrinsic atrial events.
6. The method of claim 1, wherein establishing the A-A interval includes identifying
an atrial escape interval.
7. The method of claim 1, wherein the first AV interval timer has a duration
determined by patient specific intrinisic AV conduction time.

8. The method of claim 7, wherein the first AV interval timer is an average of AV
conduction times over a plurality of cardiac cycles.
9. The method of claim 7, wherein then patient specific AV conduction times are
correlated to cardiac rate.
10. An implantable medical device comprising:
means for operating an implantable medical device (IMD) according to a
ventricular pacing protocol (VPP) wherein ventricular pacing is precluded in a given
cardiac cycle wherein a ventricular event occurred in a cardiac cycle immediately
subsequent to the given cardiac cycle;
means for establishing an A-A interval;
means for initiating a first AV interval timer at the initiation of the given cardiac
cycle;
means for sensing for ventricular events;
means for scheduling an atrial pacing pulse prior to the termination of the A-A
interval if no ventricular event is sensed within the duration of the AV interval timer.
11. The IMD of claim 10, further comprising:
means for canceling the atrial pacing pulse and reverting to the A-A interval if a
ventricular event is sensed prior to the atrial pacing pulse.
12. The IMD of claim 10, further comprising:
means for initiating a second AV interval timer upon delivery of the atrial pace;
means for delivering a ventricular pace at the expiration of the second AV interval
timer unless inhibited by a sensed ventricular event.
13. The IMD of claim 12, wherein the first and second AV intervals have the same
duration.
14. The IMD of claim 10, wherein the first AV interval timer has a duration
determined by patient specific intrinisic AV conduction time.

15. The IMD of claim 14, wherein the first AV interval timer is an average of AV
conduction times over a plurality of cardiac cycles.
16. The IMD of claim 14, wherein then patient specific AV conduction times are
correlated to cardiac rate.
17. A computer readable medium having instructions that when executed on a
processor of an implantable medical device have cardiac pacing capabilities cause the
IMD to:
establish an A-A interval for a first cardiac cycle;
initiate an AV interval timer concurrent with the initiation of the A-A interval;
sense for a conducted ventricular event; and
schedule an atrial pace to shorten the A-A interval if no conducted ventricular
event occurs prior to the expiration of the AV interval timer.
18. The computer readable medium of claim 17, wherein the instruction further cause
the processor to:
cancel the atrial pace that shortens the A-A interval if a ventricular event is sensed
prior to delivery of the atrial pace.
19. The computer readable medium of claim 17, wherein the instruction further cause
the processor to:
initiate an AV interval approximately equal in duration to the AV interval timer
concurrent with the atrial pace that shortens the A-A interval; and
deliver a ventricular pacing pulse at the expiration of the AV interval, unless
inhibited by a sensed ventricular event.
20. The computer readable medium of claim 17, wherein the AV interval timer has a
duration determined by patient specific intrinisic AV conduction times.

An atria] based pacing protocol promotes intrinsic conduction. An entire cardiac cycle is monitored for ventricular
activity and permitted to lapse with ventricular activity. Ventricular pacing is available in a cardiac cycle immediately subsequent to
such a skipped beat. When monitoring for intrinsic ventricular events, an event is expected within a given window. If no such event
is detected, the cardiac cycle in truncated, leading to a shorter cycle that is devoid of ventricular activity. The subsequent cycle has
a high likelihood of a ventricular sensed event and a greater than normal AV interval is provided prior to pacing.

Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=nTkiDDxQ/b8TLO7/JN1zIg==&loc=wDBSZCsAt7zoiVrqcFJsRw==


Patent Number 272923
Indian Patent Application Number 112/KOLNP/2009
PG Journal Number 19/2016
Publication Date 06-May-2016
Grant Date 03-May-2016
Date of Filing 09-Jan-2009
Name of Patentee MEDTRONIC, INC.
Applicant Address 710 MEDTRONIC PARKWAY, MS LC340 MINNEAPOLIS, MINNESOTA
Inventors:
# Inventor's Name Inventor's Address
1 TRIEU, HAI, H. 1323 GRAYSTONE LANE, CORDOVA, TN 38016
PCT International Classification Number A61N 1/368
PCT International Application Number PCT/US2007/074304
PCT International Filing date 2007-07-25
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 11/424,410 2006-06-15 U.S.A.