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Heart Failure & Co. La stratificazione del rischio aritmico oltre la frazione di eiezione. Milano 17 Aprile 2009. Prof. Luigi Padeletti. Get With The Guidelines-Heart Failure (GWTG-HF). Shah et al. J Am Coll Cardiol 2009. Potential barriers to the dissemination of ICD therapy.
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Heart Failure & Co La stratificazione del rischioaritmico oltre la frazione dieiezione Milano 17 Aprile 2009 Prof. Luigi Padeletti
Get With The Guidelines-Heart Failure (GWTG-HF) Shah et al. J Am Coll Cardiol 2009
Potential barriers to the dissemination of ICD therapy Al-Khatib et al. Am Heart J 2008
Potential barriers to the dissemination of ICD therapy Al-Khatib et al. Am Heart J 2008
Potential barriers to the dissemination of ICD therapy Al-Khatib et al. Am Heart J 2008
Beta-blocker and Amiodarone utilization can affect the outcome of ICD trials
Cumulative Benefit of ACEI and Beta Blockers P < 0.01 P < 0.05 Exner DV et al. JACC; 1999; 33: 916-23
Beta - Adrenergic Blocking Agents MERIT-HF SCD - Treated pts MERIT-HF 3.6% CIBIS II 4% US Carvedilol 1.7% MOCHA 2.3% • AVERAGE SD decrease 30% Lancet 1999; 353: 2001-7
Outcome of recent major Beta-blocker trials Siddiqui et al Curr Opin Cardiol 2006
Beta-Blockers to reduce sudden death in HF Adamson et al J Cardiac Fail 2006
Beta-Blockers and ICD therapy Brodine et al. Am J Cardiol 2005
Tung R et al. J Am Coll Cardiol 2008;52:1111–21 Amiodarone :not an innocent drug!
MADIT I In the conventional-therapy group, overall mortality was slightly higher among those who were receiving amiodarone at one month than among those who were not receiving the drug (36 percent vs. 26 percent) Moss et al N Engl J Med 1996
Guidelines for ICD implantation for the secondary And primary prevention of SCD Al-Khatib et al. Am Heart J 2008
Meta-analysis of ICD secondary prevention trials Connolly et al Eur Heart J 2000
Meta-analysis of ICD secondary prevention trials Connolly et al Eur Heart J 2000
Meta-analysis of ICD secondary prevention trials The prolongation of life by the ICD over amiodarone was 2.1 months at 3 years of follow-up and 4.4 months at 6 years Connolly et al Eur Heart J 2000
Guidelines for ICD implantation for the secondary And primary prevention of SCD Al-Khatib et al. Am Heart J 2008
The optimal timing of defibrillator insertion after myocardial infarction remains unresolved
Dinamit-trial Hohnloser et al N Engl J Med 2004
Dinamit-trial Hohnloser et al N Engl J Med 2004
MADIT II Specifically, 73 patients (14.9 percent) in the conventional-therapy group and 148 in the defibrillator group (19.9 percent) were hospitalized with heart failure, representing 9.4 and 11.3 patients so hospitalized per 1000 months of active follow-up, respectively (nominal p=0.09) Moss et al N Engl J Med 2002
Inclusion criteria:…myocardial infarction one month or more before entry…
Time Dependence of Mortality Risk and Defribrillator Benefit After Myocardial Infarction * * p 0.02 for HR Wilber et al Circulation 2004;109:1082
MADIT II – Inclusion/Exclusion Criteria • Inclusion criteria • MI > 4 weeks • LVEF < 30% • > 21 years • Exclusion criteria • Previous cardiac arrest • Sustained VT • NYHA Class IV • CABG or PTCA < 3 months • CABG or PTCA planned • Life-threatening diseases • < 21 years
PCI in SCD-Heft Al-Khatib et al J Cardiovasc Electrophysiol 2008
CABG in SCD-Heft Al-Khatib et al J Cardiovasc Electrophysiol 2008
SCD-Heft trial Amiodarone or ICD for congestive heart failure Hohnloser et al N Engl J Med 2004
SCD-Heft trial Amiodarone or ICD for congestive heart failure Hohnloser et al N Engl J Med 2004
SCD-Heft trial Amiodarone or ICD for congestive heart failure Hohnloser et al N Engl J Med 2004
ACC/AHA/ESC Guidelines EF cutoff: 2006 < 40% 2008 < 35%
Prediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era EF (%) 37 ± 11 NYHA I 24% EF (%) 41 ± 11 NYHA I 55% Huikuri et al JACC 2003;42:652
VALIANT MADIT II NEJM 352;2581
Influence of Ejection Fraction on Cardiovascular Outcomes in a Broad Spectrum of Heart Failure Patients CHARM study Solomon et al Circulation 2005;112:3738
Clincal Trials and Clinical Indications for ICD Bunch TJ et al Circulation 2007;115:2451
Ejection fraction by imaging modality: An analysis of SCD-Heft Gula et alAm Heart J 2008
Clincal Trials and Clinical Indications for ICD Bunch TJ et al Circulation 2007;115:2451
Clincal Trials and Clinical Indications for ICD Bunch TJ et al Circulation 2007;115:2451
Sudden cardiac death The role of risk stratification There is currently no single test capable of accurate prediction of the SCD risk in various clinical settings and patient populations. The risk itself is nonlinear and changes dynamically with the progression of disease and therapies applied. Kusmirck and Gold Am Heart J 2007;153:S252S33
Amiodarone Trials Meta-Analysis on 6553 Pts “The most potent single predictor of arrhythmic/sudden death was the presence of symptomatic CHF (NYHA class III - IV) which carried a 12,2% annual risk of arrhythmic/sudden compared to 5.0% for those without symptoms.” Lancet 1997; 350:1417-24
The problem is that trials were designed to demonstrate that the ICD reduces mortality in selected populations; they were not designed to test how best to use the ICD. That is the task before us. Buxton 2005