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Medical Education 4 1 ICD Today Disclaimer Sudden Cardiac Death Future of ICD Therapy 5 7 2 Objectives 6 History of ICD Therapy 8 3 ICD Therapy Questions Fundamentals of ICD Therapy Evolution of ICD Therapy

Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

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Page 1: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

Medical Education

41 ICD TodayDisclaimer

Sudden CardiacDeath

Future of ICDTherapy

5 72 Objectives

6History of ICDTherapy

83 ICD Therapy Questions

Fundamentals of ICD Therapy

Evolution of ICD Therapy

Page 2: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

2 ©2007 Boston Scientific Corporation

Medical Education

Disclaimer

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

This presentation is provided with the understanding that the slide content must not be altered in any manner as the content is subject to FDA regulations.This presentation is to be used in conjunction with other resource material including the applicable Boston Scientific device physician’s manual and any implant accessories instructions for use.This presentation is not intended to replace implant training.Proper surgical procedures and techniques are the responsibilities of the medical professional.If this presentation is not used in its entirety, the following information must be included:• Appropriate Indications• Contraindications• Warnings• Precautions and Adverse Events

Page 3: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

3 ©2007 Boston Scientific Corporation

Medical Education

Objectives

Identify two key historical milestones in the history of ICD development

Describe the evolution of indications for ICD therapy

Identify the diagnostic studies performed prior to ICD implantation

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

When we complete this program you will be able to:

Page 4: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

4 ©2007 Boston Scientific Corporation

Medical Education

History of ICD TherapyInventor of the ICD

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Michel Mirowski, M.D.1924-1990

Page 5: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

5 ©2007 Boston Scientific Corporation

Medical Education

History of ICD TherapyFirst Working Model Electronics

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions Built from over-the-counter electronics

Page 6: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

6 ©2007 Boston Scientific Corporation

Medical Education

History of ICD TherapyEvolution

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

1966 Device conception1969 First experimental model1976 First animal implant1980 First human implant1982 Addition of cardioverting capability1985 FDA approval1988 First programmable device approved1993 ICD with tiered therapy single charge backup pacing approved1993 First endocardial defibrillation lead approved

1997 ICD with backup dual-chamber pacing and atrial rhythm discrimination approved

1998 ICD with backup adaptive-rate pacing approved2000 ICD with atrial therapies approved2002 Cardiac resynchronization defibrillator approved

1965 1970 1975 1980 1985 1990 1995 2000 2005

Page 7: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

7 ©2007 Boston Scientific Corporation

Medical Education

History of ICD TherapyFirst Clinical Model

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Short-lived

Shock only

250 g

Nonprogrammable

Required thoracotomy abdominal implant

Page 8: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

8 ©2007 Boston Scientific Corporation

Medical Education

The ICD Today

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Smaller, thinner

Multiprogrammable tiered therapy

Extended longevity (> 5 yrs)

Endocardial lead systems

Pectoral implant

Advanced rhythm discrimination

State-of-the-art pacing therapies

Powerful diagnostics

Atrial therapies

Page 9: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

9 ©2007 Boston Scientific Corporation

Medical Education

The ICD TodayPulse Generator Technology Focus

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Maximize reliability

Decrease size

Improve shape for patient comfort

Optimize longevity

Increase ease of use

Improve diagnostics

Enhance therapy / feature options and programmability

Page 10: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

10 ©2007 Boston Scientific Corporation

Medical Education

The ICD TodayBenefits of ICD Therapy Evolution

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Reduced implant risk

Increased system longevity

Decreased symptoms associated with arrhythmia recurrences

Increased quality of life

Improved diagnosis and management of inappropriate device therapy

Page 11: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

11 ©2007 Boston Scientific Corporation

Medical Education

Sudden Cardiac Death (SCD)Incidence

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

450,000 persons experience SCD in the U.S. annually

Only 20-30% survive

Most common mode of death

80-90% due to ventricular tachyarrhythmias

Outcome of SCD

Mortality

Survival20-30%

Causes of SCD

VentricularTachyarrhythmias

80-90%

Other

Page 12: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

12 ©2007 Boston Scientific Corporation

Medical Education

Sudden Cardiac Death (SCD)Current Therapeutic Options

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Antiarrhythmic drug therapy

Ablative techniques (surgical or transvenous)

Implantation of a cardioverter defibrillator system

A combination of drugs, ICD therapy and/or ablation

Page 13: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

13 ©2007 Boston Scientific Corporation

Medical Education

Sudden Cardiac Death (SCD)Typical Sequence

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Page 14: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

14 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyClinical Efficacy

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Ventricular fibrillation (VF) is converted successfully 98.6-98.8% of the time1

Ventricular tachycardia (VT) is converted with antitachycardia pacing (ATP) in 89.4-91.2% of episodes, with increased conversion success using shock therapy2

1Sakena S, for the PCD Investigators. Clinical outcome of patients with malignant ventricular tachyarrhythmias and a multiprogrammable implantable cardioverter-defibrillator implanted with or without thoracotomy: an international multicenter study. J Am Coll Cardio. 1994;23:1521-30.2Zipes DP, Roberts D. Results of the international study of the implantable cardioverter-defibrillator : a comparison of epicardial and endocardial lead systems. Circulation. 1995;92:59-65.

Page 15: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

15 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapySafety of ICD therapy implantation

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Average procedural mortality is 0.5-0.8%*

* Saksena S, for the PCD Investigators. Clinical outcome of patients with malignant ventricular tachyarrhythmias and a multiprogrammable implantable cardioverter-defibrillator implanted with or without thoracotomy: an international multicenter study. J Am Coll Cardiol. 1994:23:1421-30.

Page 16: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

16 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapySurvival Benefit with ICDs

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Among survivors of VF or nonsustained VT (NSVT) causing severe symptoms, the ICD is superior to antiarrhythmic drugs for increasing overall survival1

1The Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest and near-fatal ventricular arrhythmias. N Engl J Med. 1997;337:1576-83.

Page 17: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

17 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyIdentifying the High-risk Substrate

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Majority have coronary artery disease (CAD)1

>80% have no acute precipitating acute coronary occlusion2

1 Myerburg R J, Zaman L, Luceri R.M., et al. Clinical characteristics of sudden cardiac death: implications of survival. Sudden Cardiac Death. 1985;107-117.

2 Panidis IP, Morganroth J. Initiating events of sudden cardiac death. Sudden Cardiac Death. 1985;81-92.

Page 18: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

18 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyHigh-risk Patient Profile

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Syncope

Heart failure

Hypertension

Known or silent coronary artery disease (CAD)

Page 19: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

19 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyMost Powerful Predictor of SCD

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Degree of depression of the left ventricular ejection fraction (LVEF)1

1 Saksena S, Camm JA. Implantable defibrillators for prevention of sudden death: technology at a medical and economic crossroad. Circulation. 1992;85:2316-21.

Page 20: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

20 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapySCD in Patients with Heart Failure

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Half of all deaths in this population are due to SCD . . .

Is this preventable?

Page 21: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

21 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyIdentifying the High-risk Patient

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Identify need for revascularization; evaluate cause of depressed EF, if present

Coronary Angiography

Determine EF and assess for regional wall motion abnormalities, valvular heart disease, dilated hypertrophic cardiomyopathy

Echocardiography

Evaluate for Brugada syndrome, congenital long QT interval and exercise-induced VT

Electrocardiogram (ECG)

Evaluation of syncope Tilt Testing

Assess inducibility Electrophysiology Study (EPS)

Page 22: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

22 ©2007 Boston Scientific Corporation

Medical Education

ICD TherapyExamples of Current ICD Indications1

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia

Recurrent, poorly tolerated sustained VT

Prior myocardial infarction (MI), LVEF of ≤ 35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia2

• Patients suppressible with IV procainamide or an equivalent antiarrhythmic have not been studied

Prior myocardial infarction (MI), LVEF of ≤ 30%3

1 Indications are specific to particular manufacturers and devices2 MADIT indication3 MADIT II indication

Page 23: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

23 ©2007 Boston Scientific Corporation

Medical Education

The Future of ICD Therapy

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions

Improved programmer/user interface

Additional sensors for health monitoring

Advance patient management capabilities

Page 24: Medical Education Fundamentals of ICD Therapy of ICD... · Fundamentals of ICD Therapy ... Medical Education Disclaimer Evolution ICD Therapy Disclaimer Objectives History of ICD

24 ©2007 Boston Scientific Corporation

Medical Education

Questions

Evolution ICD Therapy

Disclaimer

Objectives

History of ICD Therapy

ICD Today

Sudden Cardiac Death

ICD Therapy

Future of ICD Therapy

Questions