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Heartland Cardiology Dr. John Dongas. The Beat Goes On: Biventricular Devices. Disclosures. I have nothing to disclose. Agenda. Sudden Cardiac Death (SCD) and related clinical trials Cardiac Resynchronization Therapy (CRT) and related clinical trials. Sudden Cardiac Death in the US.

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Heartland Cardiology Dr. John Dongas

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Heartland cardiology dr john dongas

Heartland CardiologyDr. John Dongas

The Beat Goes On: Biventricular Devices


Disclosures

Disclosures

  • I have nothing to disclose


Agenda

Agenda

  • Sudden Cardiac Death (SCD) and related clinical trials

  • Cardiac Resynchronization Therapy (CRT) and related clinical trials


Sudden cardiac death in the us

Sudden Cardiac Death in the US

  • Approximately 460,000 people yearly will die of Sudden Cardiac Death

  • Other causes

    • Stroke2160,000

    • Lung cancer3 90,100

    • Breast cancer3 40,200

    • Automobile accident4 50,000

    • AIDS5 16,000

    • Fires6 4,000

4National Transportation Safety Board, 2000.

5Center for Disease Control, 2001.

6NFPA, U.S. Facts & Figures, 2000.

1NASPE, May 2000.

2American Heart Association, 2000.

3National Cancer Institute, 2001.


Heartland cardiology dr john dongas

1%

30%

40%

40%

  • Odds of Surviving Sudden Cardiac Death

  • Overall:

  • New York City or Chicago:

  • Seattle:

  • Hospital:

  • American Airlines in Flight:

  • Las Vegas Casino:

5%

70%

Presented by John D. Day, MD, University of Utah Medical Center, September 2003, Las Vegas, NV


Clinical overview

Clinical Overview

  • There is a large and growing body of scientific evidence demonstrating the benefits of both pharmacological and device therapies for patients with Left Ventricular Dysfunction who are at risk for SCD

    • MADIT1996n = 196

    • MUSTT 1999n = 704

    • MADIT II 2002n = 1,232 N = 6,173

    • COMPANION 2003n = 1,520

    • SCD-HeFT 2004n = 2,521


Madit ii trial design

MADIT II Trial Design

  • Population

  • 1,232 patients with:

    • Prior MI (> 1 month before enrollment)

    • EF  30%

    • No arrhythmia markers were required for inclusion in MADIT II

    • Medication in treatment arms was similar


Madit ii trial design1

MADIT II Trial Design

  • Prospective, multicenter, randomized design

Eligible patients

Noninvasive evaluation of LV function

Randomization

ICD+OPT (n=742)

OPT (n=490)

Average 20-month follow-up including OPT

  • Primary endpoint: All cause mortality


Madit ii addition of an icd improves survival

ICD + OPT group

OPT group

0

1

2

3

4

Years

MADIT II: Addition of an ICD Improves Survival

1.0

0.9

0.8

Probability of Survival

0.7

  • 31% relative reduction in all-cause mortality at average 20 month follow-up

  • 5.6% absolute reduction in all-cause mortality at average 20-month follow-up

0.6

P = 0.007

0.5

Moss AJ, et al. N Engl J Med 2002;346:877-883. (Permission for use requested)


Medicare icd approved indications

Medicare ICD Approved Indications

  • -Prior MI (>1 month) and

  • -EF< 30%


Sudden cardiac death scd

Sudden cardiac death (SCD)

High risk in heart failure patients

  • Heart failure patients experience SCD at six to nine times the rate of the general population1

  • Sudden death is the predominant mode of death in mild to moderate heart failure2

1American Heart Association. 2002 heart and stroke statistical update. American Heart Association, 2001.

2MERIT-HF study group. Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). LANCET. 1999;353:2001-07.


Scd heft

SCD-HeFT


The sudden cardiac death in heart failure trial scd heft

The Sudden Cardiac Death in Heart Failure Trial: SCD-HeFT

  • Design:

    • Prospective, Multi-center, Randomized

    • 2521 Patients enrolled

  • Inclusion Criteria:

    • NYHA class II/III Heart Failure due to ischemic or non-ischemic dilated cardiomyopathy

    • EF  35%

    • CHF  3 months

    • Age  18 years

    • CHF treatment with vasodilators

    • No cardiac arrest or episode of sustained VT

Bardy GH, et al. N Engl J Med. 2005;352:225-237


Scd heft tested icds or amiodarone on top of conventional therapy ct

Eligible Patients

Electrocardiography, Liver & Thyroid function tests,

Six Minute Walk, Holter Monitor and Chest Radiography

Randomization

1 Patient 1 Patient1 Patient

Conventional Therapy CT + Amiodarone CT + ICD

SCD-HeFT: Tested ICDs or Amiodarone on Top of Conventional Therapy (CT)

Bardy GH, et al. N Engl J Med. 2005;352:225-237


Scd heft conclusions

SCD-HeFT: Conclusions

  • In class II or III HF patients with EF < 35% on good background drug therapy, the mortality rate for placebo-controlled patients is 7.2% per year over 5 years

  • ICD's decrease mortality by 23%

  • Amiodarone, when used as a primary preventive agent, does not improve survival


Myocardial infaction

Myocardial Infaction


Ejection fraction

Ejection Fraction


Ventricular fibrillation

Ventricular Fibrillation


Synchronny vs dysynchronny in hf

Synchronny vs. Dysynchronny in HF


Comparison of medical therapy pacing and defibrillation in hf companion

Comparison of medical therapy, pacing and defibrillation in HF: COMPANION

  • Design

    • Open-label

    • Prospective

    • Multicenter

    • Randomized

    • Parallel

  • Objective

    • Compare OPT alone vs

      OPT with CRT/ICD vs

      OPT with CRT alone

  • 128 centers across the US

Bristow MR, et al. N Engl J Med. 2004;350:2140-2150


Companion key eligibility criteria

NYHA Class III or IV

NSR, QRS 120 ms, PR interval >150ms

LVEF 35%, LVEDD 60 mm

Optimal pharmacological therapy

Beta blocker (for at least 3 months)

Diuretic, ACEI/ARB, spironolactone (1 month), +/- digoxin

History of HF hospitalization (or pharmacologic equivalent)

<12 months, >1 month prior to enrollment

No indication for bradycardia or tachyarrhythmia device at the time of enrollment

COMPANION: Key eligibility criteria

Bristow MR, et al. N Engl J Med. 2004;350:2140-2150


Issues associated with heart failure

Issues associated with heart failure

Abnormal wall motion

Healthy

DCM - Intrinsic

Click for animations

Courtesy of C. Stellbrink, MD.


Conclusions

Conclusions

When added to optimal pharmacological therapy in patients with moderate to severe LV dysfunction, NYHA Class III or IV symptoms and QRS lengthening:

  • CRT or CRT-D reduce mortality and first hospitalization*

  • CRT-D reduces mortality

  •  2/3 of the reduction is attributed to CRT

  • * Hospitalization

  • Care provided at a hospital for any reason over a time period that involves a date change

  • In-patient or out-patient use of IV inotropes and/or vasoactive drugs for more than 4 hours

  • Hospitalizations associated with a device implant attempt or re-attempt are excluded

Bristow MR, et al. N Engl J Med. 2004;350:2140-2150


Companion primary endpoint

COMPANION – Primary Endpoint

~19% reduction with CRT

~20% reduction with CRT-D


Secondary endpoint all cause mortality

Secondary Endpoint – All cause mortality

~24% reduction with CRT

~36% reduction with CRT-D


Companion conclusions

COMPANION Conclusions

  • When added to optimal pharmacological therapy in

  • patients with moderate-severe LV dysfunction, NYHA

  • Class III or IV symptoms and QRS lengthening:

  • CRT or CRT-D reduces mortality + hospitalizations

  • CRT-D reduced the relative risk of mortality by 36%


Issues associated with heart failure1

Sinus node

AV

node

Conduction block

Stimulation therapy

Issues associated with heart failure

Mechanism II–ventricular resynchronization

  • Intraventricular Activation

  • Organized ventricular activation sequence

  • Coordinated septal and free-wall contraction

  • Improved pumping efficiency


Resynchronization therapy

Resynchronization Therapy


Heartland cardiology dr john dongas

CRT-D Indications

FDA Indications

  • Patients who are at high risk of sudden cardiac death due to ventricular arrhythmias

  • Moderate to severeheart failure, NYHA Class III/IV

  • Left ventricular dysfunction, EF  35%

  • QRS duration  120 ms and

  • Symptomatic despite stable, optimal heart failure drug therapy


Issues associated with heart failure2

Issues associated with heart failure

Cardiac resynchronization therapy (CRT)– global synchrony

DCM with CRT

Baseline

Click for animations

Courtesy of C. Stellbrink, MD.


Revised acc aha guidelines impact icd and crt therapies

The New Standard of Care

Revised ACC/AHA Guidelines impact ICD and CRT Therapies

The American College of Cardiology (ACC) and American Heart Association (AHA) have just announced they have incorporated revised treatment recommendations for ICD and CRT therapies into the heart failure guidelines. ICD and CRT therapies are now Class I for many patients who are indicated under the MADIT IIandCOMPANION trials(1).

(1) http://www.acc.org/clinical/guidelines/failure/index.pdf


Acc aha guidelines format

ACC/AHA Guidelines Format

  • Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful, and effective.

  • Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

    • Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.

    • Class IIb: Usefulness/efficacy is less well established by evidence/opinion.

  • Class III: Conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful.


Summary

Summary

  • ICD and CRT therapies are the standards of care recognized by the ACC and AHA


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