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.
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)
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
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 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
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’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 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 • 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 • 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
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 • 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 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.
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.
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.
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.
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.
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.