RYTHMIQ

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RYTHMIQ™
INGENIO™ offers
RYTHMIQ, which is
designed to minimize
unnecessary RV
pacing without
clinically significant
pauses
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Feature Benefits
Minimize unnecessary RV Pacing without clinically significant pauses
Provide valuable diagnostic information with an EGM during RYTHMIQ events
Provide options for patients with varying levels of conduction block
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Managing RV Pacing
Studies suggest that unnecessary RV pacing can have
deleterious effects1,2
There is also a perception that ALL RV pacing has deleterious
effects
AHA/HRS guidelines3 recommend devices have automatic
pacing mode selecting algorithms to help reduce the amount of
unnecessary RV pacing
1. Wilkoff, Bruce and The DAVID Trial Investigators. Dual-Chamber Pacing or Ventricular Backup Paciing in Patients with an
Implantable Defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002; 288: 3115-3123.
2. MOST - Lamas, Gervasio, et. All. Ventricular Pacing or Dual-Chamber Pacing for Sinus-Node Dysfunction. N Engl J Med 2002; 346: 1854-62:
3. AHA/HRS/ESC guidelines Vol. 48, No. 5, 2006
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Design Goals
RYTHMIQ™ is designed to minimize unnecessary RV
pacing without clinically significant pauses
Temporary AV Block
AV Conduction Restored
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Operation
RYTHMIQ operates in AAI(R) pacing mode with VVI
backup during times of normal conduction, switching to
DDD(R) mode when a conduction block is detected
Loss of
AV
Synchrony
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
AV
Synchrony
Restored
RYTHMIQ™
Operation
During normal conduction, RYTHMIQ operates like two
pacemakers running concurrently – one in AAI(R)
mode and one in VVI mode.
• The device provides AAI(R) at the LRL and/or
sensor indicated rate with backup VVI pacing at a
rate of 15 bpm slower than the LRL
• When there is good conduction, ventricular pacing
does not occur as the VVI backup mode runs in the
background
Normal Conduction
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Operation
The device monitors for loss of AV synchrony to
determine when to switch to DDD(R) mode
•
Loss of AV
Synchrony
•
Loss of AV Synchrony
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
If 3 slow ventricular beats are
detected in a window of 11 beats,
then the device automatically
switches to DDD(R) mode.
A slow beat for RYTHMIQ is
defined as a ventricular pace or
ventricular sensed event that is at
least 150 ms slower than the
AAI(R) pacing rate.
RYTHMIQ™
Operation
INGENIO™ records a RYTHMIQ Episode along with
20 seconds of electrogram data when RYTHMIQ
detects loss of AV synchrony.
This can help the clinician to
diagnose patient rhythm
conduction disorders and
determine appropriate
algorithms and pacemaker
settings
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
#1
#2
#3
RYTHMIQ™
Operation
The device uses AV Search+ to periodically check for
a return of intrinsic conduction and determine when
to mode switch back to AAI(R) with VVI backup.
If AV Search+ remains in AV hysteresis
for at least 25 cardiac cycles, and less
than 2 of the last 10 cycles are
ventricular paced, then the device
automatically switches the pacing mode
back to AAI (R) with VVI backup.
AV Synchrony
Restored
Normal Conduction Restored
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Operation
RYTHMIQ is designed to adapt to a patient’s conduction
disorder, by mode switching when AV synchrony is lost or
restored, without clinically significant pauses
Loss of
AV
Synchrony
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
AV
Synchrony
Restored
RYTHMIQ™
Exception During ATR Mode Switch
If RYTHMIQ went directly from AAI(R) into ATR Mode
Switch, when the mode switch ends, it goes directly back
into AAI(R) mode
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Operation
RYTHMIQ is designed to minimize unnecessary pacing without
clinically significant pauses
RYTHMIQ operates like two pacemakers running concurrently—
one in AAI(R) and one in VVI
RYTHMIQ does not require dropped ventricular beats to switch to
DDD(R) pacing
Reference Guide, INGENIO Pacemaker, Page 2-53, 358577-001 EN US 11/10
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Why Use RYTHMIQ?
Studies have shown that long ventricular pauses can have
deleterious effects:
The use of MVP may cause unnecessary pauses in pacing therapy.
These pauses may be pro-arrhythmic or may be the cause of mild to
severe patient symptoms.1
MVP may allow ventricular cycle variations and occasional pauses of up
to twice the lower rate2
“This [MVP] pacing mode, while minimizing RV pacing may increase the
risk of pause mediated polymorphic VT/VF in patients at risk for
bradycardia-induced arrhythmias, particularly in those prone to AV block”3
1
2
3
May 2006 HRS (Heart Rhythm Society) journal abstract – Inappropriate application of Managed Ventricular Pacing (MV) in a patient with Brugada Syndrome.
Medtronic CDRM Product Performance Report — Interactions between Cardiac pacing and Ventricular Arrhythmia Initiation
Gray CJ, Basta MN, Sapp, JL, Parkash R, Gardner MJ. Inappropriate application of “MVP”. Heart Rhythm. 2006, May; 3(5): Supplement P1–89.
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Managing RV Pacing – Two Algorithms
Patients may require different algorithms at various stages of their
conduction disease. RYTHMIQ adds another RV pacing algorithm
to Boston Scientific devices, because no one algorithm is
appropriate for every patient.
BSC also offers AV Search+
AV Search+ is designed to reduce unnecessary RV pacing by providing
backup ventricular pacing for every beat while searching for intrinsic activity
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Managing RV Pacing – Two Algorithms
INGENIO™ pacemakers have two algorithms to help
minimize unnecessary RV pacing
With both RYTHMIQ™ &
AV Search+, clinicians now
have options to appropriately
manage RV pacing in patients
with varying degrees of
conduction block
Patient’s AV
Conduction
Status
Boston
1
Scientific
Normal
RYTHMIQ™
1st Degree
Block
RYTHMIQ™
2nd Degree
Block
AV SEARCH+
3rd Degree
5
Block
Fixed AV Delay
Medtronic
2
MVP®
Nominally ON
for all patients
Search AV™
3
St. Jude
VIP™
Only
available
algorithm
1) Therapy recommendations made by Indications-Based Programming
2) Source: Medtronic Adapta/Versa/Sensia Pacemaker Programming Guide (M929948A001C 2008-01-18)
3) Source: St. Jude Medical Unity Platform Reference Guide (60020476A, 07/09)
Boston Scientific Indications-Based Programming would recommend paced/sensed AV delays. While not an algorithm, an equivalent setting would be available in competitor devices
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
Feature Benefits
Minimize unnecessary RV Pacing without clinically significant pauses
Provide valuable diagnostic information with an EGM during RYTHMIQ events
Provide options for patients with varying levels of conduction block
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
RYTHMIQ™
RYTHMIQ™ minimizes
unnecessary RV pacing
without clinically
significant pauses
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
Brief Summary
Pacing Systems from Boston Scientific
Indications
Pacemaker indications include: symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient
sinus node dysfunction with or without associated AV conduction disorders; bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic
tachyarrhythmias; neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence
and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Pacemakers’ dual-chamber and atrial tracking modes are
also indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for: conduction disorders that require restoration of AV
synchrony, including varying degrees of AV block; VVI intolerance (eg, pacemaker syndrome) in the presence of persistent sinus rhythm or low cardiac output or congestive heart failure
secondary to bradycardia.
Contraindications
Pacemakers are contraindicated for the following patients under the circumstances listed: patients who have a separate implanted cardioverter-defibrillator (ICD); use of Minute Ventilation
in patients with both unipolar atrial and ventricular leads single-chamber atrial pacing in patients with impaired AV nodal conduction; atrial tracking modes for patients with chronic refractory
atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing; dual-chamber and single-chamber atrial pacing in patients with chronic refractory atrial
tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competition between paced and intrinsic rhythms.
Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. For single use only. Do not reuse, reprocess or resterilize. Always have
external defibrillation protection available during implant and electrophysiologic testing. Do not use this pulse generator with another pulse generator. In response to applicable
nonrecoverable or repeat fault conditions, the pulse generator will switch irreversible to Safety Core operation. Do not kink, twist, or braid leads. Do not use atrial tracking modes inn
patients with chronic refractory atrial tachyarrhythmias. In devices with the lead safety switch programmed to On, the lead polarity will switch to unipolar in the presence of a lead
impedance of ≤ 200 or ≥ 2000 Ω. If programmed to a fixed atrial sensitivity value of 0.15 mV, the pulse generator may be more susceptible to electromagnetic interference. Advise patients
to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device. Do not expose a patient to MRI scanning. Do not
subject a patient with an implanted pulse generator and/or lead to diathermy.
Inappropriate sustained high-rate pacing occurred in the PULSAR™ MAX clinical study in 5 out of 130 patients with MV ON, 4 to 14 days after implant. If sustained high-rate pacing could
be of concern, consider programming a reduced Max Sensor Rate or MV to Passive. These programming recommendations are intended to assure that MV calibration is evaluated and, if
necessary, recalibrated (4 ON) when the patient and pacing system have stabilized post implant. Continued monitoring of the MV sensor performance should be performed at all followup visits until implant stabilization has occurred.
Precautions
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; lead evaluation and connection; implantation;
device programming; environmental and medical therapy hazards; hospital and medical environments ; home and occupational environments; follow up testing; explant and disposal;
TENS; electrocautery and RF ablation; ionizing radiation; elevated pressures. Advise patients to avoid sources of electric or magnetic interference (EMI). If the pacemaker inhibits or reverts
to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI, moving away from the source or turning it off will usually allow the pulse
generator to return to its normal mode of operation.
Potential Adverse Events
Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, lead or accessory breakage (fracture/insulation/lead
tip), hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device
failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. P)
© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA
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