A guide to the Adapta/Versa/Sensia/Relia pacemakers
Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for
information on software and programming.
The following are trademarks of Medtronic:
Adapta, Checklist, Find Patient, Marker Channel, Medtronic, Medtronic Carelink, MVP,
Quick Look, Relia, Search AV, Sensia, SessionSync, TherapyGuide, and Versa.
How to use this guide
Information is contained in two guides
Product information about Adapta/Versa/Sensia/Relia
pacemakers and the associated software for the 9790/C series
programmer and the 2090 programmer is presented in two
separate guides.
The Pacemaker Reference Guide (PRG) provides detailed
information on the pacemakers.
The Pacemaker Programming Guide (PPG) contains instructions
on how to use the programmer and the programming software.
About the Pacemaker Reference Guide
The Pacemaker Reference Guide describes in detail how the
pacemakers operate and specifies the capabilities of the
pacemakers. The PRG includes the following information:
■
Describes the pacing modes, rate response options, special
therapy features, telemetry types, and data collection options.
In some cases, guidelines are given on how to configure the
pacemaker operation.
■
Contains troubleshooting information for electrical and
hemodynamic problems.
■
Specifies parameter and data collection capabilities, longevity
projections, and mechanical and electrical specifications.
■
Provides general warnings and cautions, potential
interference sources, and general indications for pacing.
The Pacemaker Programming Guide describes how to program
Adapta, Versa, Sensia, and Relia pacemakers using a
programmer. The PPG presents the following information:
■
How to set up and configure the programmer and access
online help.
■
How to start a patient session, use the various follow-up
features during the session, and properly end the session.
■
How to use Checklist to streamline a follow-up session.
■
How to view and print the patient’s ECG and EGM waveform
traces.
■
How to configure the pacemaker to collect diagnostic data and
how to retrieve and view this information.
■
How to measure stimulation thresholds and sensing levels.
■
How to use TherapyGuide to obtain suggested parameter
values.
■
How to program parameter values and verify rate response
parameters settings.
■
How to run EP Studies.
The Implant Manuals supplement these guides
For each pacemaker model in the Adapta/Versa/Sensia/Relia
family, there is an Implant Manual. The Pacemaker Programming
Guide and the Pacemaker Reference Guide do not specify which
features apply to each individual pacemaker model. Refer to the
applicable implant manual for specific capabilities of individual
models.
Also, in various places throughout this manual, for example
“Programmable modes and parameters” on page 300, you are
asked to refer to the applicable implant manual for specific
capabilities of individual models
This manual uses a new nomenclature for certain terms related to
product battery life. This new nomenclature is defined in
CENELEC pacemaker standard EN 45502-2-1:2003, which
applies to Active Implantable Medical Devices (AIMD) intended to
treat bradyarrhythmias. This standard was approved and
published in December 2003.
Medtronic has adopted the new nomenclature to comply with the
CENELEC standard and in anticipation of the nomenclature
becoming an international standard.
The new nomenclature, and the terms replaced by the new
nomenclature, are presented in the following table:
This chapter provides an introduction to pacemaker modes as an
aid to pacing mode selection. The chapter is organized as follows:
Definition of basic pacing modes – The names for most of the
pacing modes are defined on the 1991 ACC/AHA guidelines for
pacemaker implantation.
1
Rationale for mode selection – In order to get pacing mode
suggestions, the use of TherapyGuide is recommended.
TherapyGuide is a programmer feature that suggests parameter
settings based on a patient's clinical conditions. For models which
do not contain TherapyGuide, refer to the device implant manual
for guidance in mode selection.
Mode descriptions – These descriptions provide indications and
contraindications for modes available with the pacemaker and
brief descriptions of how these modes operate.
NBG pacing codes
The pacemaker modes are defined in NBG Code.2 Each five-letter
NBG code describes a specific type of operation for implantable
pacemakers. For simplicity, this manual uses only the first three or
four letters, such as DDD, DDIR, DVIR, and so forth. Figure 1-1
describes the first four letters of the NBG code.
1
Dreifus LS, Fisch C, Griffin JC, et al. Guidelines for implantation of cardiac
pacemakers and antiarrhythmia devices. A report of the American College of
Cardiology/American Heart Association Task Force on Assessment of
Diagnostic and Therapeutic Cardiovascular Procedures (Committee on
Pacemaker Implantation). Journal of the American College of Cardiology. 1991;
18: 1-13.
2
Bernstein A., et al., “The NASPE/BPEG Pacemaker Code,” PACE, 10(4),
Jul-Aug 1987. (“NBG” stands for The North American Society of Pacing and
Electrophysiology [NASPE] and the British Pacing and Electrophysiology Group
[BPEG] Generic. NBG’s five-letter code supersedes the ICHD Code.
The mode descriptions in this chapter provide only a basic
overview of each mode. For further details on the rate response,
timing, and therapy capabilities, refer to “Rate response” on
page 36, “Pacemaker timing” on page 55, and “Special therapy
options” on page 133.
Rationale for mode selection
TherapyGuide offers a simple clinically-focused method for a
clinician to obtain suggested parameter values. At implant or an
early follow-up appointment, the clinician enters information about
the patient's clinical conditions. Based on those inputs the
programmer suggests parameter settings. The suggestions are
based on clinical studies, literature, current practice, and the
consensus of physicians.
For more information about TherapyGuide, refer to page 179.
For each pacemaker model, TherapyGuide suggests a
programmable mode. It bases the suggestion on clinical
conditions such as the condition of the sinus node and the quality
of AV conduction.
TherapyGuide offers a Rationale screen that shows the basis for
each setting of pacing modes and of other parameters. Figure 1-2
shows a typical Rationale screen. To access the screen, perform
the following steps:
Figure 1-2. Mode selection rationale used by TherapyGuide
1. Interrogate the pacemaker (before or after implant).
2. Select the Params icon. On the Therapy Parameters screen, select
the [TherapyGuide] button to open the TherapyGuide window.
3. Select the [Rationale…] button to open the Rationale window.
4. Select [Close] twice to return to the Therapy Parameters screen.
Note: It is not necessary to do any parameter programming at this
time. Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for instructions on programming parameters
using TherapyGuide.
Note: This section contains information for all models of the
Medtronic Adapta/Versa/Sensia/Relia implantable pulse
generators. For information about a specific model or series, refer
to the implant manual for that device.
These Medtronic Adapta/Versa/Sensia/Relia implantable pulse
generators (IPGs) are indicated for use to improve cardiac output,
prevent symptoms, or protect against arrhythmias related to
cardiac impulse formation or conduction disorders.
These devices are indicated for use in patients who are
experiencing exercise intolerance or exercise restrictions related
to an arrhythmia. Using rate response modes may restore heart
rate variability and improve cardiac output.
Adapta/Versa/Sensia/Relia implantable pulse generators are
indicated for single use only.
This device is also indicated for VDD pacing in patients who have
adequate rates and one or both of the following conditions.
■
A requirement for ventricular pacing when adequate atrial
rates and adequate intracavitary atrial complexes are
present. This includes the presence of complete AV block
when atrial contribution is needed for hemodynamic
benefit or when pacemaker syndrome had existed or is
anticipated.
■
A requirement for intermittent ventricular pacing despite a
normal sinus rhythm and normal AV conduction.
17
Contraindications
Note: This section contains information for all models of the
Medtronic Adapta/Versa/Sensia/Relia implantable pulse
generators. For information about a specific model or series, refer
to the implant manual for that device.
There are no known contraindications for the use of pacing as a
therapy to control heart rate. The patient’s age and medical
condition may influence the selection of the pacing system, the
mode of operation, and the implant technique used by the
physician.
Rate responsive modes may be contraindicated for patients who
cannot tolerate pacing rates above the programmed Lower Rate.
Medtronic Adapta/Versa/Sensia/Relia implantable pulse
generators (IPGs) are contraindicated for the following
applications:
■
Use of an implantable cardioverter defibrillator (ICD) with a
unipolar-only IPG or in those cases in which unipolar leads are
implanted for the other models described. Pacing in the
unipolar configuration may cause the ICD to deliver
inappropriate therapy or to withhold appropriate therapy.
■
Dual chamber pacing in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or
flutter.
■
VDD mode operation in patients with sinus disorders.
■
Single chamber atrial pacing in patients with AV conduction
disturbance.
Two MVP modes are available: AAIR<=>DDDR and AAI<=>DDD.
Note: For information about AAIR<=>DDDR and AAI<=>DDD
modes, refer to “Managed Ventricular Pacing (MVP)” on page 142.
DDDR mode
Note: For information about the AAIR<=>DDDR mode, refer to
“Managed Ventricular Pacing (MVP)” on page 142.
In the DDDR mode, the pacemaker tracks the faster of the intrinsic
atrial rate or the sensor-indicated rate. If the intrinsic rate is faster,
the DDDR mode provides atrial synchronous pacing; otherwise,
AV sequential pacing occurs at the sensor-indicated rate.
■
Rate limits for atrial tracking (Upper Tracking Rate)1 and
sensor tracking (Upper Sensor Rate) are separately
programmable.
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value. Refer to Chapter 3 for more information on TARP.
The AV intervals that follow sensed atrial events (SAV) and
paced atrial events (PAV) are separately programmable, and
they can be programmed to shorten with increasing rates
(Rate Adaptive AV) or to change with intrinsic conduction
times (Search AV+).
■
A nonrefractory sensed event in either chamber inhibits
pacing in that chamber. A ventricular nonrefractory sensed
event in the VA interval that is not preceded by an atrial sense
(AS or AR) is a pacemaker-defined PVC and starts a new VA
interval.
Note: For information about the AAI<=>DDD mode, refer to
“Managed Ventricular Pacing (MVP)” on page 142.
The DDD mode provides atrial synchronous pacing in the
presence of intrinsic atrial activity; otherwise, AV sequential
pacing occurs at the Lower Rate.
■
Each atrial paced or nonrefractory atrial sensed event starts
an AV interval and a lower rate interval. The AV intervals that
follow sensed atrial events (SAV) and paced atrial events
(PAV) are separately programmable, and the SAV may be
optionally programmed to shorten with increasing rate (Rate
Adaptive AV) or to change with intrinsic conduction times
(Search AV+).
■
A ventricular paced event may track an atrial sensed event up
to the programmed Upper Tracking Rate.
■
A ventricular nonrefractory sensed event in the VA interval that
1
is not preceded by an atrial sense (AS or AR) is a
pacemaker-defined PVC and starts a new VA interval.
Lower Rate Interval
A
P
V
P
Parameters:
Lower Rate = 60 min
-1
(1000 ms)PAV Interval = 200 ms
A
P
V
S
SAV Interval = 170 ms
Figure 1-4. Example of DDD mode operation
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
The DDIR mode provides dual chamber, sensor-driven,
atrioventricular (AV) sequential pacing for heart rate variation
without atrial tracking.
■
Atrial pacing occurs at the sensor-indicated rate. If it is not
inhibited, ventricular pacing occurs at the end of the PAV
interval.
■
The AV intervals that follow paced atrial events (PAV) are
separately programmable, and they can be programmed to
shorten with increasing rates (Rate Adaptive AV) or to change
with intrinsic conduction times (Search AV+).
■
An atrial event sensed outside the PVARP will inhibit a
scheduled atrial stimulus but will not start an AV interval. That
is, ventricular paced events after such sensed atrial events
occur at the sensor-indicated rate. The following
ventriculoatrial (VA) interval may be extended slightly to avoid
an increasing atrial paced rate.
■
A ventricular nonrefractory sensed event in the VA interval
starts a new VA interval.
The DDI mode provides dual chamber atrioventricular (AV)
sequential pacing with atrial sensing but without atrial tracking.
■
Atrial pacing occurs at the Lower Rate. If it is not inhibited,
ventricular pacing occurs at the end of the PAV interval.
■
The AV intervals that follow paced atrial events (PAV) are
separately programmable, and they can be programmed to
change with intrinsic conduction times (Search AV+).
■
An atrial event sensed outside the PVARP will inhibit a
scheduled atrial stimulus but will not start an AV interval.
Ventricular paced events after such sensed atrial events occur
at the Lower Rate.
■
A ventricular nonrefractory sensed event in the ventriculoatrial
(VA) interval starts a new VA interval.
The DVIR mode provides AV sequential pacing at the
sensor-indicated rate unless inhibited by ventricular sensed
events.
■
Atrial pacing occurs at the sensor-indicated rate. If it is not
inhibited, ventricular pacing occurs at the end of the PAV
interval.
■
The AV intervals that follow paced atrial events (PAV) are
separately programmable, and they can be programmed to
shorten with increasing rates (Rate Adaptive AV) or to change
with intrinsic conduction times (Search AV+).
■
The DVIR mode ignores intrinsic atrial events. Sensing occurs
only in the ventricle. A ventricular nonrefractory sensed event
during the ventriculoatrial (VA) interval starts a new VA
interval.
The DVI mode provides dual chamber AV sequential pacing
without atrial sensing/tracking.
■
Atrial pacing occurs at the Lower Rate. If it is not inhibited,
ventricular pacing occurs at the end of the PAV interval.
■
The AV intervals that follow paced atrial events (PAV) are
separately programmable, and they can be programmed to
change with intrinsic conduction times (Search AV+).
■
Sensing occurs only in the ventricle, and intrinsic atrial events
are ignored. A ventricular nonrefractory sensed event during
the VA interval starts a new ventriculoatrial (VA) interval.
The VDD mode provides atrial synchronous pacing (or VVI pacing
at the Lower Rate). The ventricle is paced synchronously up to the
programmed Upper Tracking Rate.
1
Sensing occurs in both the
atrium and ventricle, but pacing occurs only in the ventricle.
■
To promote atrial synchronous pacing at slow rates, a sensed
atrial event occurring near the end of the Lower Rate interval
will be followed by the programmed SAV interval. The result is
an extension of the ventricular lower rate.
■
The AV intervals that follow sensed atrial events (SAV) are
separately programmable, and they can be programmed to
shorten with increasing rates (Rate Adaptive AV) or to change
with intrinsic conduction times (Search AV+).
■
A ventricular nonrefractory sensed event in the V-V interval
that is not preceded by an atrial sense (AS or AR) is a
pacemaker-defined PVC, and it starts a new V-V interval.
Lower Rate Interval
SAV
Interval
25
A
S
V
P
Parameters:
Lower Rate = 60 min
Upper Tracking Rate = 120 min
-1
(1000 ms)SAV Interval = 200 ms
Figure 1-9. Example of VDD mode operation
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
Note: For information about the AAIR<=>DDDR mode, refer to
“Managed Ventricular Pacing (MVP)” on page 142.
The AAIR mode provides atrial-based rate responsive pacing in
patients with intact AV conduction. Sensing and pacing occur only
in the atrium. In the absence of sensed events, the chamber is
paced at the sensor-indicated rate.
The ADIR mode operates the same as the AAIR mode except that
events sensed in the ventricle are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the
conducted ventricular rhythm without affecting atrial pacing.
Note: In the AAIR and ADIR modes, atrial refractory sensed
events do not restart the Upper Sensor Rate interval.
Note: For information about the AAI<=>DDD mode, refer to
“Managed Ventricular Pacing (MVP)” on page 142.
The AAI mode provides single chamber inhibited atrial pacing.
Sensing and pacing occur only in the atrium. Pacing occurs at the
programmed Pacing Rate unless inhibited by sensed events.
The ADI mode operates the same as the AAI mode except that
events sensed in the ventricle are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the
conducted ventricular rhythm without affecting atrial pacing.
The VVIR mode provides ventricular rate responsive pacing in
patients for whom atrial-based pacing is deemed unnecessary or
inappropriate. In the absence of sensed events, the ventricle is
paced at the sensor-indicated rate.
The VDIR mode operates the same as the VVIR mode except that
events sensed in the atrium are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the
underlying atrial rhythm without affecting ventricular pacing.
Note: In the VVIR and VDIR modes, ventricular refractory sensed
events restart the Upper Sensor Rate interval.
The VVI mode provides single chamber inhibited pacing at the
programmed Pacing Rate unless inhibited by sensed events.
Sensing occurs only in the ventricle.
The VDI mode operates the same as the VVI mode except that
events sensed in the atrium are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the
underlying atrial rhythm without affecting ventricular pacing.
In the AAT and VVT modes, pacing occurs at the programmed
Lower Rate, but a nonrefractory sensed event triggers an
immediate pacing output (rather than inhibiting such output). With
the exception that pacing outputs occur when events are sensed,
the triggered modes operate identically to the corresponding
inhibited modes.
Note: Programmed triggered pacing will not occur faster than
300 ms (200 min
programmed triggered pacing is not limited to 300 ms (200 min