Overview History of ICD Therapy by historyman

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									Overview & History
 of ICD Therapy
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.
             Goals of ICD Therapy

    TODAY                          FUTURE
• Termination of ventricular
                                – Prevention of life-
  tachycardia or fibrillation
                                  threatening
• Treatment of co-morbidities     episodes of VT/VF
  of AT/AF and heart failure



• Reduction of sudden
  cardiac death                 – Expanding the
                                  understanding and
• Improvement in quality          management of
  of life                         sudden cardiac death
• Prolongation of life            (SCD)
Evolution of ICD Therapy
    1980
    Large 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
Today
Small devices -
Pectoral site
• First-line therapy for VT/VF patients
• Treatment of atrial arrhythmias
• Cardiac resynchronization therapy for
  HF
• Transvenous, single incision
• Local anesthesia; conscious sedation
• Short hospital stays and few
  complications
• Perioperative mortality < 1%
• Programmable therapy options
• Single- or dual-chamber therapy
• Battery longevity up to 9 years
• More than 100,000 implants/year
Today Remote Follow-up is available


                  Medtronic CareLink Ⓡ
                  Network is the leading
                  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,
                      Maximo ™ DR/VR ICDs & InSync ICD ®
                      InSync Marquis ™ CRT,
                      InSync II Marquis ™
Medtronic Implantable Defibrillators (1989-2003)




  209 cc           120 cc       80 cc      80 cc     72 cc   54 cc




62 cc      49 cc      39.5 cc    39.5 cc   39.5 cc   38 cc   36 cc

           83% size reduction since 1989!
            Therapies Provided by Today’s
                 Dual-Chamber ICDs



  Atrium
   AT/AF tachyarrhythmia
     detection
   Antitachycardia pacing
   Cardioversion
                                    Atrium &
Ventricle                            Ventricle
 VT/ VF detection                  •   Bradycardia sensing

 Antitachycardia pacing            •   Bradycardia pacing

 Cardioversion
 Defibrillation
                                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)
                                                          30 Joule output
 Convenient patient management with In-Check ™ AT
  Patient Assistant                                39.7 cc, 78.1 g
                                Marquis® Family of ICDs

                                                                            Increase Clinical Productivity
                                                                              – Significant 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
Charge Time*: 5.9 sec BOL / 7.5 ERI                                           – Enhanced Dual Chamber PR Logic ™
                                                                                detection delivers up to 95.2% PPV
Longevity*:   8.0 years
                                                                              – Expanded Patient Alert ™ Device
Output:       30 Joules
Size:         36 cc, 75 g, 13.7 mm                                          Device Monitors Key Functions -
                                                                             Physician Manages Patient

* Marquis DR
  Longevity at 50% DDD Pacing, nominal cap reformation and 2 charge/year                                       11
        InSync Marquis ™ ICD & Cardiac
           Resynchronization System
                                         Powerful ICD & Resynchronization
                                          Therapy
                                           –   Powerful 30 J therapy
                                           –   Fast charge times
                                           –   Proven cardiac resynchronization therapy for
                                               patients with ventricular dysynchrony
                                         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
Charge Times: 5.9 sec BOL / 7.5 ERI        –   Most complete family of left-heart leads &
                                               delivery systems
Output:      30 Joules
                                           –   Lead placement flexibility, enhanced telemetry
Size:        38 cc, 77 g, 14 mm                distance, one-stop defibrillation testing



                                                                                   12
                       Evolution of ICD Therapy:
                            1980 to Present                                                           2002
                                                                                        2000             MADIT-II
                                                                                               ICDs
                                                                                               with
                                                                                               Cardiac   2004
                                                                         1997/8                Resynch
                                                                                                         SCD-HeFT
    Number of Worldwide ICD Implants Per Year
                                                                               Dual-Chamber
                                                                               ICDs                   COMPANION
                                                                               Size
                                                                               Reduction
             1980                               1989                           AVID
90,000                                                                         CASH
                First Human                       •Transvenous Leads
80,000          Implant
                                 1985              •Biphasic Waveform          CIDS

70,000                              FDA
60,000                              Approval of
                                    ICDs                 1993
                                                                                  1999
                                                             Smaller
50,000                                                       Devices
                                                                                      AT Therapies
                                                                                      MUSTT
40,000                                    1988

30,000                              Tiered                             1996
                                    Therapy                              MADIT
20,000                                                                   Steroid-eluting Leads
10,000                                                                   Increased Diagnostic and
                                                                          Memory Capacity
     0
   1980                1985                1990               1995                2000                   2005
           Future ICD Technology

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

Indications/Contraindications
Medtronic implantable cardioverter defibrillator (ICD) systems are indicated to provide ventricular
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular
arrhythmias. Contraindicated for patients with transient or reversible ventricular tachyarrhythmia or as the sole
treatment of atrial arrhythmia.

Medtronic leads are designed for use with a compatible implantable pulse generator or ICD as part of a cardiac
system. Leads are intended for delivering therapies and/or sensing in the atrium and/or ventricle of the heart.
Contraindicated for ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart
valve. Steroid eluting leads are contraindicated in patients for whom a single dose of 1.0 mg of dexamethasone
may be contraindicated.

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.

Warnings/Precautions
For Medtronic implantable cardioverter defibrillator systems are:


• Changes in patient’s disease and/or medications may alter the efficacy of the device’s 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.
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 Complications
Medtronic 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.
DISCLOSURE FOR INSYNC MARQUIS 7277 GENERATOR

Indications:

The InSync Marquis system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for
automated treatment of life threatening ventricular arrhythmias, and 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 less than or equal to 35%
and a QRS duration greater than or equal to 130 ms.


Contraindications:
The InSync Marquis is contraindicated in:
     Patients whose ventricular tachyarrhythmias may have transient or reversible causes.
     Patients with incessant VT or VF
     Patients who have a unipolar pacemaker

Warnings/Precautions:
     Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed
parameters.
     Patients should avoid 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.
     Certain programming and device operations may not provide cardiac resynchronization.
     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 and precautions, and potential adverse events.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
MEDTRONIC CARELINKⓇ PROGRAMMER SYSTEM

The 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

Indications/Contraindications



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.



Medtronic CareLink is currently available in the continental US, Alaska and Hawaii

								
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