implantable cardioverter defibrillators to prevent sudden cardiac death: background frederick a....
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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
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
Defibrillation Treats Malignant Cardiac Arrhythmias
Implantable Cardioverter Defibrillators (ICDs) : Preventing Sudden Cardiac Death (SCD)
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
ICDs for Secondary SCD Prevention
AVID Investigators. N Engl J Med 1997;337: 1576-83.
ICDs for Primary Prevention: Dual Evolution
1996 2010
Eligible Population for 1o Prevention ICD
ICDs: Rapidly Evolving Technology
http://commons.wikimedia.org/wiki/File:Edison_and_phonograph_edit2.jpghttp://commons.wikimedia.org/wiki/File:Ipod-icon.svg
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.
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.
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
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
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
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
Theory and Practice
“In theory there is no difference between theory and practice. In practice there is.”
--Yogi Berra
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.
Theory and Practice Collide
Al-Khatib SM et al. JAMA 2011;305:43-49.
Where are We Now?
http://commons.wikimedia.org/wiki/File:Demeter_Pio-Clementino_Inv254.jpghttp://commons.wikimedia.org/wiki/File:Maes_Old_Woman_Dozing.jpg
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