implantable cardioverter defibrillators to prevent sudden cardiac death: background frederick a....
TRANSCRIPT
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Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death:
Background
Frederick A. Masoudi, MD, MSPHAssociate Professor of Medicine (Cardiology)
University of Colorado Denver & Colorado Cardiovascular Outcomes Research Group (C-COR)
AHRQ Annual Meeting, Bethesda, MDWednesday, September 21, 2011
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Disclosures
Frederick A Masoudi, MD, MSPH: Implantable Cardioverter Defibrillators for Primary Prevention
Research Grants: AHRQ, NHLBI
Contracts: American College of Cardiology Foundation (Senior Medical Officer, National Cardiovascular Data Registries); Oklahoma Foundation for Medical Quality
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Defibrillation Treats Malignant Cardiac Arrhythmias
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Implantable Cardioverter Defibrillators (ICDs) : Preventing Sudden Cardiac Death (SCD)
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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
fibrillationCannom DS and Prystowsky E. PACE 2004;27:419-431.
The Johns Hopkins Hospital
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ICDs for Secondary SCD Prevention
AVID Investigators. N Engl J Med 1997;337: 1576-83.
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ICDs for Primary Prevention: Dual Evolution
1996 2010
Eligible Population for 1o Prevention ICD
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ICDs: Rapidly Evolving Technology
http://commons.wikimedia.org/wiki/File:Edison_and_phonograph_edit2.jpghttp://commons.wikimedia.org/wiki/File:Ipod-icon.svg
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MADIT I: ICDs Prevent Death in Ischemic LVSD
Moss AJ et al. N Engl J Med 1996;335:1933-40.
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.
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More Studies, More Success
STUDY YEAR POPULATION OUTCOME RR/ARR
MUSTT(EPS vs. no AAR)
1999
•CAD•LVEF <0.40•NSVT•Inducible VT
•Death (arrhythmic)•Cardiac arrest
0.24 (0.13-0.45)*ARR 19.5%
MADIT-II 2002
•Prior MI•LVEF <0.30•NYHA I-III•No EPS required
•Death (any) 0.69 (0.51-0.93)ARR: 5.4%
SCD-HeFT 2005•NYHA II-III HF•LVEF <0.35•Includes non-ischemic
•Death (any) 0.77 (0.62-0.96)ARR: 7.2%
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.
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Primary Prevention ICDs:Cost-Effective
Sanders GD et al. NEJM 2005;353:1471-80.
ICD-Associated Reduction in Death Risk (%)
ICER
for
ICD
($ p
er
QA
LY)
MADIT IMUSTT
MADIT IISCD-HeFT
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ACC/AHA Guideline Recommendations for Primary Prevention ICD Therapy
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Jessup M et al. J Am Coll Cardiol 2009;53Epstein AE et al. Circulation. 2008;117
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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
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CMS Coverage for ICDs Expands in Response to RCTs
Year Covered Indication
1999 Documented familial or inherited high-risk conditions (HCM or LQTS)
2003 •Prior MI >40 days prior to implantation•LVEF <0.35•Inducible sustained VT/VF at EPS•If LVEF <0.30 and QRS>120 ms, then EPS not needed
2005 •Ischemic CM, NYHA II-III, LVEF <0.35•Non-ischemic CM >9 months, NYHA II-III, LVEF <0.35•Meeting CRT criteria and NYHA IV
http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.4&ncd_version=3&basket =ncd%3A20%2E4%3A3%3AImplantable+Automatic+Defibrillators
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Theory and Practice
“In theory there is no difference between theory and practice. In practice there is.”
--Yogi Berra
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Clinical Trials to the Real WorldBig “Voltage Loss”
Older HospitalizedPatients with HF
n=20,388
Subjects meeting SOLVD enrollment criteria
n= 3,579 (18%)
Preserved EFn=10,943 (54%)
Exclusionary condition
n= 523 (3%)
Contraindicationn=3,566 (17%)
Age > 80n= 1,777 (9%)
Masoudi FA et al. Am Heart J 2003;146:250–7.
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Theory and Practice Collide
Al-Khatib SM et al. JAMA 2011;305:43-49.
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Where are We Now?
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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