Overview

1
Overview History of ICD Therapy
2
What is ICD Therapy?

• ICD Therapy consists of pacing, cardioversion,
  and defibrillation therapies to treat brady and
  tachy arrhythmias.
• An external programmer is used to monitor and
  access the device parameters and therapies for
  each patient.

3
Goals of ICD Therapy
TODAY
FUTURE

• Termination of ventricular tachycardia or
  fibrillation
• Treatment of co-morbidities of AT/AF and heart
  failure

• Prevention of life-threatening episodes of VT/VF

• Reduction of sudden cardiac death
• Improvement in quality
• of life
• Prolongation of life

• Expanding the understanding and management of
  sudden cardiac death (SCD)

4
Evolution of ICD Therapy
5
1980Large devices -Abdominal site

• First human implants
• Thoracotomy, multiple incisions
• Primary implanter cardiac surgeon
• General anesthesia
• Long hospital stays
• Complications from major surgery
• Perioperative mortality up to 9
• Nonprogrammable therapy
• High-energy shock only
• Device longevity ? 1.5 years
• Fewer than 1,000 implants/year

6
TodaySmall devices - Pectoral site

• First-line therapy for VT/VF patients
• Treatment of atrial arrhythmias
• Cardiac resynchronization therapy for Heart
  Failure
• Transvenous, single incision
• Local anesthesia conscious sedation
• Short hospital stays and few complications
• Perioperative mortality lt 1
• Programmable therapy options
• Single- or dual-chamber therapy
• Battery longevity up to 9 years
• More than 100,000 world-wide implants/year

7
Today Remote Follow-up is available

• Medtronic CareLink
• Network is the leading internet-based remote
  monitoring service for patients with implanted
  cardiac devices.
• Devices currently available on the Network GEM,
  GEM DR, GEM II DR/VR, GEM III DR/VR, Marquis
  DR/VR ICD, Maximo DR/VR, InSync ICD, InSync
  Marquis, InSync II Marquis

8
Medtronic Implantable Defibrillators (1989-2003)
38 cc
39.5 cc
83 size reduction since 1989!
9
Therapies Provided by TodaysDual-Chamber ICDs

• Atrium
• AT/AF tachyarrhythmia detection
• Antitachycardia pacing
• Cardioversion

• Atrium Ventricle
• Bradycardia sensing
• Bradycardia pacing

• Ventricle
• VT/ VF detection
• Antitachycardia pacing
• Cardioversion
• Defibrillation

10
GEM III AT
Total Arrhythmia Management in a Second
Generation Device

• VT/VF Detection and Therapies
• AT/AF Detection and Therapies
• AT Monitoring
• Episode Data, Marker Channel and Stored EGM
• Atrial Episode Duration Histogram
• Ventricular Rate during Atrial Episodes
• AT Intervention
• Atrial Rate Stabilization (ARS)
• Post-Mode Switch Overdrive Pacing
• AT Termination
• ATP (Ramp, Burst and 50 Hz Burst)
• Cardioversion shocks (automatic, timed and
  patient activated)
• Convenient patient management with In-Check AT
  Patient Assistant

30 Joule output 39.7 cc, 78.1 g
11
Maximo Family of ICDs

• Increase Clinical Productivity
• Ease-of-use features
• Cardiac Compass long term trends
• Optimum Performance Package
• Best combination of output, size, longevity, and
  charge time
• Safety by Design
• Wavelet Dynamic Discrimination criterion,
  exclusive to Marquis VR and Maximo VR
• Enhanced Dual Chamber PR Logic detection
  delivers up to 95.2 PPV
• Expanded Patient Alert Device
• Device Monitors Key Functions - Physician Manages
  Patient

Charge Time 7.0 sec BOL / 8.9
ERI Longevity 7.9 years Output 35
Joules Size 38.9 cc, 75 g, 15 mm Maximo DR
Longevity at 50 DDD Pacing, 60 bpm, 3.0V,
0.4 ms, 500 O, biannual charges, EGM pre-storgae
OFF Willkoff JACC Abstract Feb 2001
12
InSync II Marquis ICD Cardiac
Resynchronization System

• Powerful ICD Resynchronization Therapy
• Powerful 30 J therapy
• Fast charge times
• Better, Faster Easier
• Heart Failure Patient Management
• 14 months of patient specific data provided by
  Cardiac Compass trends
• Follow up efficiency with RapidRead telemetry,
  Leadless ECG, Painless High Voltage lead
  impedance
• Implant Confidence Efficiency
• Most complete family of left-heart leads
  delivery systems
• Lead placement flexibility, enhanced telemetry
  distance, one-stop defibrillation testing

Charge Times 5.9 sec BOL / 7.5 ERI Output 30
Joules Size 38 cc, 77 g, 14 mm
13
Evolution of ICD Therapy and Adoption 1980 to
Present
2004-5
2000

• ICDs with Cardiac Resynch

• SCD HeFT

2002
1997/8

• MADIT-II

• Dual-Chamber ICDs
• Size Reduction
• AVID
• CASH
• CIDS

1980
1989
2003

• First Human Implant

• COMPANION

• Transvenous Leads
• Biphasic Waveform

1985

• FDA Approval of ICDs

1993

• Smaller Devices

1988

• 1999
• AT Therapies

• Tiered Therapy

1996

• MUSTT

• MADIT

• Steroid-eluting Leads
• Increased Diagnostic and Memory

14
Future ICD Technology

• Enhanced automaticity
• Device software that suggests programming options
  to the clinician based on the patients history
  and demographics
• Continued reductions in device size
• Will require advancements in battery, capacitor
  and circuitry technology or decreasing the
  delivered energy output.

15
Future ICD Technology

• Enhanced diagnostics
• Monitoring of the progression of both arrhythmias
  and concomitant cardiac conditions
• Enhanced lead technology
• Thinner leads with increased diagnostic
  capabilities, e.g., pressure sensing.
• Patient follow-up modifications
• Broadly available programmer technology that
  enables remote transfer of data, reducing the
  need for in-clinic visits.

16
DISCLOSURE  IndicationsMedtronic implantable
cardioverter defibrillators (ICDs) are indicated
to provide ventricular antitachycardia pacing and
ventricular defibrillation for automated
treatment of life-threatening ventricular
arrhythmias.  ContraindicationsMedtronic ICDs
are contraindicated in Patients with transient
or reversible ventricular tachyarrhythmia or as
the sole treatment of atrial arrhythmia. Warning
s/PrecautionsChanges in patients disease and/or
medications may alter the efficacy of the
devices programmed parameters.Patients should
stay away from sources of magnetic and
electromagnetic radiation, including MRI,
diathermy, and electrosurgical units, to avoid
possible under detection, inappropriate therapy
delivery, and/or electrical reset of the
device.Do not place transthoracic defibrillation
paddles directly over the device. See the
appropriate technical manuals for detailed
information regarding instructions for use,
indications, contraindications, warnings,
precautions, and potential adverse events.
 Caution Federal law (USA) restricts this
device to sale by or on the order of a
physician. 
17
DISCLOSUREIndicationsThe Medtronic GEM III AT
system is indicated for use in ICD patients with
atrial tachyarrhythmias, or who are at
significant risk of developing atrial
tachyarrhythmias. The implantable
cardioverter-defibrillator is intended to provide
ventricular antitachycardia pacing and
ventricular defibrillation for automated
treatment of life-threatening ventricular
arrhythmias. In addition, the GEM III AT system
is also intended to provide pacing,
cardioversion, and defibrillation for treatment
of patients with symptomatic, drug-refractory,
atrial fibrillation, and/or life-threatening
ventricular tachyarrhythmias.ContraindicationsD
o not use the GEM III AT system in patients whose
tachyarrhythmias may have transient or reversible
causes patients with incessant ventricular
tachyarrhythmias patients with chronic atrial
tachyarrhythmias and no concomitant ventricular
tachyarrhythmias patients who have a unipolar
pacemaker or patients whose primary disorder is
bradyarrhythmias.Warnings/PrecautionsChanges
in the patients disease and/or medications may
alter the efficacy of the devices programmed
parameters.Patients should stay away from sources
of magnetic and electromagnetic radiation,
including MRI, diathermy, and electrosurgical
units, to avoid possible underdetection,
inappropriate therapy delivery, and/or electrical
reset of the device. Do not place transthoracic
defibrillation paddles directly over the
device.Use of the ICD system should not change
the application of established anticoagulation
protocols.Following an ischemic or
cerebrovascular accident, disable atrial
defibrillation therapies until the patient has
stabilized.Potential Complications include, but
are not limited to, failure to detect and/or
terminate tachyarrhythmia episodes, acceleration
of tachyarrhythmia episodes, and lead system
complications.See the appropriate technical
manual for detailed information regarding
instructions for use, indications,
contraindications, warnings, precautions, and
potential complications or adverse events. See
warranty card for warranty information.
Caution Federal law (USA) restricts this
device to sale by or on the order of a physician.
 
18
For Medtronic leads are It has not been
determined whether the warnings, precautions, or
complications associated with injectable
dexamethasone apply to its use in this device.
Do not attempt to use the lead with any device
other than a commercially available implantable
defibrillator system with which it has been
tested and demonstrated to be safe and
effective. Potential ComplicationsMedtronic
implantable cardioverter defibrillator systems
include, but are not limited to, failure to
detect and/or terminate tachyarrhythmia episodes,
acceleration of ventricular tachycardia, and lead
system complications. Related to the use of
transvenous leads include, but are not limited to
the following patient- related conditions
cardiac perforation, cardiac tamponade,
constrictive pericarditis, embolism,
endocarditis, fibrillation or other arrhythmias,
heart wall rupture, hemothorax, infection,
pneumothorax, thrombosis, and tissue necrosis.
 See the technical manual for detailed uses,
indications, contraindications, warnings,
precautions, and potential complications. See the
warranty card or technical manual for information
concerning warranties. Caution Federal law
(USA) restricts these devices to sale by or on
the order of a physician. 
19
InSync System Disclosure(InSync ICD
7272/InSync Marquis 7227/InSync II
Marquis) Indications The InSync ICD Model
7272, InSync Marquis Model 7277 and InSync II
Marquis Model 7289 devices are indicated for the
reduction of the symptoms of moderate to severe
heart failure (NYHA Functional Class III or IV)
in those patients who remain symptomatic despite
stable, optimal medical therapy, and have a left
ventricular ejection fraction ? 35 and a QRS
duration ? 130 ms. The InSync ICD Model 7272,
InSync Marquis Model 7277 and InSync II Marquis
Model 7289 are also intended to provide
ventricular antitachycardia pacing and
ventricular defibrillation for automated
treatment of life-threatening ventricular
arrhythmias. Contraindications The InSync
ICD, InSync Marquis and InSync II Marquis are
contraindicated for patients whose ventricular
tachyarrhythmias may have transient or reversible
causes. The InSync ICD, InSync Marquis and
InSync II Marquis are contraindicated for
patients with incessant VT or VF. Asynchronous
pacing is contraindicated in the presence (or
likelihood) of competitive or intrinsic
rhythms. Unipolar pacing is contraindicated in
patients with an implanted defibrillator or
cardioverter defibrillator (ICD) because it may
cause unwanted delivery or inhibition of
defibrillator or ICD therapy. Warnings and
Precautions Patients implanted with these
systems should avoid sources of magnetic
resonance imaging, diathermy, high sources of
radiation, electrosurgical cautery, external
defibrillation, lithotripsy, and radiofrequency
ablation. These may result in underdetection of
VT/VF, inappropriate therapy delivery, and/or
electrical reset of the device. Certain
programming and device operations may not provide
cardiac resynchronization. Output pulses,
especially from unipolar leads, may adversely
affect device sensing capabilities. Previously
implanted pulse generators, implantable
cardioverter defibrillators, and leads should
generally be explanted. Backup pacing should be
readily available during implant. Use of leads
may cause heart block. For a list of potential
adverse effects, refer to the Physicians Desk
Reference. See the appropriate technical manuals
for detailed information regarding instructions
for use, indications, contraindications, warnings
and precautions, and potential adverse
events. Caution Federal law (USA) restricts
these devices to sale by or on the order of a
physician.
20
MEDTRONIC CARELINK? PROGRAMMER SYSTEMThe
Medtronic CareLink programmer system is comprised
of prescription devices indicated for use in the
interrogation and programming of implantable
medical devices. Prior to use, refer to the
Programmer Reference Guide as well as the
appropriate programmer software and implantable
device technical manuals for more information
related to specific implantable device models.
Programming should be attempted only by
appropriately trained personnel after careful
study of the technical manual for the implantable
device and after careful determination of
appropriate parameter values based on the
patient's condition and pacing system used. The
Medtronic CareLink programmer must be used only
for programming implantable devices manufactured
by Medtronic or Vitatron. See the appropriate
technical manuals for detailed information
regarding instructions for use, indications,
contraindications, warnings and precautions, and
potential adverse events. Caution Federal law
(USA) restricts these devices to sale by or on
the order of a physician. DISCLOSURE The
Medtronic CareLink Monitor is a prescription
device indicated for use in the transfer of
patient data from some Medtronic implantable
cardiac devices based on physician instructions
and as described in the product manual. This
product is not a substitute for appropriate
medical attention in the event of an emergency
and should only be used as directed by a
physician. The Medtronic CareLink Network is
currently available for use in the continental
US, Alaska, and Hawaii.