Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background

On September 21, 2011, Frederick Masoudi made this presentation at the 2011 Annual Conference. Select to access the PowerPoint® presentation (2.5 MB). Plugin Software Help.

Slide 1

Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background

Frederick A. Masoudi, MD, MSPH.
Associate Professor of Medicine (Cardiology).
University of Colorado Denver & Colorado Cardiovascular Outcomes Research Group (C-COR).
AHRQ Annual Meeting, Bethesda, MD.
Wednesday, September 21, 2011.

Slide 2

Disclosures

• Frederick A Masoudi, MD, MSPH: Implantable Cardioverter Defibrillators for Primary Prevention.
• Research Grants: AHRQ, National Heart, Lung, and Blood Institute (NHLBI) .
• Contracts: American College of Cardiology Foundation (Senior Medical Officer, National Cardiovascular Data Registries); Oklahoma Foundation for Medical Quality.

Slide 3

Defibrillation Treats Malignant Cardiac Arrhythmias

Image: An electrical defibrillation is shown.

Slide 4

Implantable Cardioverter Defibrillators (ICDs): Preventing Sudden Cardiac Death (SCD)

Image: An x-ray of a chest with an implanted ICD is shown.

Slide 5

The ICD: Revolution in Preventing Sudden Cardiac Death

• First ICD implantation: Johns Hopkins Hospital 2/4/1980.
• Implantation criteria:
  • ≥2 cardiac arrests.
  • Not associated with myocardial infarction.
  • Documented ventricular fibrillation.

Image: The Johns Hopkins Hospital is shown.

Cannom DS and Prystowsky E. PACE 2004;27:419-431.

Slide 6

ICDs for Secondary SCD Prevention

AVID Investigators. N Engl J Med 1997;337:1576-83.

Images: The headline from an article in the New England Journal of Medicine is shown: "A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias." A line graph from the article compares the survival rate of the defibrillator group with the antiarrhythmic-drug group.

Slide 7

ICDs for Primary Prevention: Dual Evolution

Eligible Population for 1^o Prevention ICD

Images: A yellow triangle captioned "Eligible Population for 1^o Prevention ICD" is placed between a photograph of a pacemaker and a graph showing survival rates for patients (in months).

Slide 8

ICDs: Rapidly Evolving Technology

Images: A photograph of Thomas Edison in 1877 and the iPod s shown.

http://commons.wikimedia.org/wiki/File:Edison_and_phonograph_edit2.jpg
http://commons.wikimedia.org/wiki/File:Ipod-icon.svg

Slide 9

MADIT I: ICDs Prevent Death in Ischemic LVSD

Enrollment criteria:

• NYHA functional class I-III.
• Prior myocardial infarction.
• LVEF <0.35.
• Documented asymptomatic non-sustained VT.
• Inducible, non-suppressible ventricular tachyarrhythmia on EP study (on procainamide).

Results:

• 54% relative reduction (23% absolute reduction) in the risk of death from all causes.

Moss AJ et al. N Engl J Med 1996;335:1933-40.

Slide 10

More Studies, More Success

Buxton AE et al. NEJM 1999;341:1882-1890.
Moss AJ et al. NEJM 2002;346:877-83.
Bardy GH et a. NEJM 2005;352:225-37.

Slide 11

Primary Prevention ICDs: Cost-Effective

Image: A line graph shows the following data:

Sanders GD et al. NEJM 2005;353:1471-80.

Slide 12

ACC/AHA Guideline Recommendations for Primary Prevention ICD Therapy

Image: Four colored blocks in a row are shown. The first, green, is captioned "I" and has the letter "A" inside. The second, yellow, is captioned "IIa." The third, orange, is captioned "IIb." The final block, red, is captioned "III."

Jessup M et al. J Am Coll Cardiol 2009;53.
Epstein AE et al. Circulation 2008;117.

Slide 13

Current Indications for ICDs

• "Secondary prevention" for patients who have been successfully resuscitated from SCD.
• "Primary Prevention" for patients without a history of SCD but at high risk, including some patients with:
  • Severe left ventricular dysfunction (LVSD).
  • Long QT syndrome.
  • Arrhythmogenic RV dysplasia.
  • Hypertrophic cardiomyopathy.

Slide 14

CMS Coverage for ICDs Expands in Response to RCTs

http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.4"ncd_version=3&basket =ncd%3A20%2E4%3A3%3AImplantable+Automatic+Defibrillators

Slide 15

Theory and Practice

"In theory there is no difference between theory and practice. In practice there is."
—Yogi Berra

Image: A picture of Yogi Berra is shown.

Photo: Googieman, Creative Commons,
http://commons.wikimedia.org/wiki/File:Yogi2.JPG

Slide 16

Clinical Trials to the Real World
Big "Voltage Loss"

Image: A chart shows connections between the following data in text boxes:

Older Hospitalized Patients with HF
n=20,388

↓

Subjects meeting SOLVD enrollment criteria
n= 3,579 (18%)

Preserved EF
n=10,943 (54%)

↑/↓

Contraindication
n=3,566 (17%)

Exclusionary condition
n= 523 (3%)

↑/↓

Age >80
n= 1,777 (9%)

Masoudi FA et al. Am Heart J 2003;146:250-7.

Slide 17

Theory and Practice Collide

Images: Two newpaper articles about ICD use are shown.

Al-Khatib SM et al. JAMA 2011;305:43-49.

Slide 18

Where Are We Now?

Images: A statue of the Greek goddess Demeter and a painting titled "Old Woman Dozing over a Book" by Dutch painter Nicolaes Maes are shown.

>http://commons.wikimedia.org/wiki/File:Demeter_Pio-Clementino_Inv254.jpg
http://commons.wikimedia.org/wiki/File:Maes_Old_Woman_Dozing.jpg

Slide 19

Expanding Knowledge of ICDs in the Real World

• Assessing ICD shocks: Cardiovascular Research Network (CVRN) Longitudinal Study of ICDs.
• Comparative effectiveness in the elderly: Outcomes of ICDs in Medicare population.
• Outcomes in Clinical Subgroups: Bayesian statistical methods with patient-level data from clinical trials.

Slide 20

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Current as of December 2011

Internet Citation:

Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background. Slide Presentation from the AHRQ 2011 Annual Conference (Text Version). December 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualconf11/greenlee_masoudi_sanders_setoguchi/masoudi.htm