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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.

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what is 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
Termination of ventricular tachycardia or fibrillation

Treatment of co-morbidities of AT/AF and heart failure

Prevention of life-threatening episodes of VT/VF

Goals of ICD Therapy

TODAY

FUTURE

  • Reduction of sudden cardiac death
  • Improvement in quality
  • of life
  • Prolongation of life
  • Expanding the understanding and management of sudden cardiac death (SCD)
1980 large devices abdominal site
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
today small devices pectoral site
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 < 1%
  • Programmable therapy options
  • Single- or dual-chamber therapy
  • Battery longevity up to 9 years
  • More than 100,000 world-wide implants/year
today remote follow up is available
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

slide8

209 cc

80 cc

120 cc

80 cc

72 cc

54 cc

36 cc

62 cc

49 cc

39.5 cc

39.5 cc

Medtronic Implantable Defibrillators (1989-2003)

38 cc

39.5 cc

83% size reduction since 1989!

therapies provided by today s dual chamber icds
Therapies Provided by Today’sDual-Chamber ICDs

Atrium & Ventricle

  • Bradycardia sensing
  • Bradycardia pacing
  • Atrium
  • AT/AF tachyarrhythmia detection
  • Antitachycardia pacing
  • Cardioversion
  • Ventricle
  • VT/ VF detection
  • Antitachycardia pacing
  • Cardioversion
  • Defibrillation
gem iii at
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

maximo family of icds
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 Ω, biannual charges, EGM pre-storgae OFF

*** Willkoff JACC Abstract Feb 2001

insync ii marquis icd cardiac resynchronization system
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

evolution of icd therapy and adoption 1980 to present

Number of Worldwide ICD Implants Per Year

Evolution of ICD Therapy and Adoption: 1980 to Present

2004-5

2000

  • ICDs with Cardiac Resynch
  • SCD –HeFT

2002

1997/8

  • MADIT-II

1980

1989

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

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
future icd technology
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 or decreasing the delivered energy output.
future icd technology15
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.
slide16

DISCLOSUREIndicationsMedtronic 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.Warnings/PrecautionsChanges 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 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.

slide17

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.ContraindicationsDo not use the GEMIII AT system in patients whose tachyarrhythmias may have transient or reversible causes; patientswith 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/Precautions:Changes in the 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.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.

slide18

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.

slide19

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 Physician’s 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.

slide20

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.DISCLOSUREThe 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.

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