Sudden Cardiac Death management challenges of a global problem Zayd A. Eldadah, MD, PhD Co-Director, Cardiac Electrophysiology, Washington Hospital Center Director, Cardiac Electrophysiology, Georgetown University Hospital Washington DC NAAMA International Medical Convention Beirut 26 June 2010
NAAMA s 24 th International Medical Convention Medicine in the Next Decade: Challenges and Opportunities Beirut, Lebanon June 26 July 2, 2010 I have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. I will inform the audience of any off-label uses discussed. Name of Presenter: Zayd A. Eldadah, MD, PhD Affiliation/Financial Interest Grant/Research Support Consultant Organization Medtronic, St. Jude Medical, Boston Scientific Boston Scientific
Objectives Recognize the public health significance of sudden cardiac death Review the preventive role of ICD therapy Recognize challenges to global prevention of sudden cardiac death, particularly in the developing world
Case Presentation 69 year-old academic cardiologist with no documented cardiac history Non-smoker, non-diabetic, mild hypertension An avid bicyclist Exercised regularly, robust & active life Particular fondness for Lebanese cuisine and Arab history
Case Presentation 69 year-old academic cardiologist with no documented cardiac history Found dead on his favorite bicycling route (with his feet still clipped in the bicycle pedals) Autopsy showed enlarged heart, coronary atherosclerosis, but no infarct Office desk drawers later found to be filled with antacids
Sudden Cardiac Death Unexpected death due to cardiac cause Abrupt loss of consciousness within one hour of the onset of acute symptoms If unwitnessed, death within 24 hours of being last known alive & asymptomatic
Sudden Cardiac Death Traditional estimate: ~1 SCD per 1,000 population per year in the U.S. and Western Europe Japanese data: ~1-2 SCDs per 1,000 population per year Single-county prospective study in Oregon: 0.53 SCDs per 1,000 population Smith and Cain. J Interv Card Electrophysiol. 2006. Chugh, et al. J Am Coll Cardiol. 2004
Global All-Cause Death 58 million deaths worldwide (2005) ~1% of human population Non-communicable diseases (cardiac, cancer, etc.): 60% of all deaths Cardiovascular disease is the leading cause of non-communicable human mortality 17 million (30% of all global deaths) World Health Organization. 2005
Sudden Cardiac Death The leading cause of death in developed countries: Worldwide U.S. Incidence (cases/year) 3.5m 7.0m 1 ~300,000 2 Survival <1% 5% W. Europe ~400,000 3 <5% An increasing cause of death in developing countries High recurrence rate Vast majority (>75%) due to VT / VF 1. Myerberg RJ, Catellanos A. Cardiac Arrest and Sudden Cardiac Death. In: Braunwald E, ed. Heart Disease: A Textbook of Cardiovascular Medicine. 5 th Ed. New York: WB Saunders. 1997: 742-779. 2. Circulation. 2001; 104: 2158-2163. 3. Vreede-Swagemakers JJ et al. J Am Coll Cardiol 1997; 30: 1500-1505. 4. MMWR Vol. 51 Feb 15, 2002.
Ventricular Tachycardia Ventricular Fibrillation
# deaths/year SCD in the U.S. impact relative to other major killers 500,000 400,000 300,000 200,000 100,000 0 AIDS 1 2 2 3 4 Breast Cancer Lung Cancer Stroke SCD 1. U.S. Census Bureau, Statistical Abstract of the United States: 2001. 2. American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001. 3. 2002 Heart and Stroke Statistical Update, American Heart Association. 4. Circulation. 2001;104:2158-2163.
Implantable Cardioverter- Defibrillator (ICD) Michel Mirowski (1924-1990)
ICD therapy for SCD Highly effective secondary prevention AVID Eight clinical trials assessed efficacy of ICD as primary prevention: MADIT-I, MADIT-II, SCD-HeFT, DEFINITE, DINAMIT, COMPANION, CABG-Patch, MUSTT Meta-analysis: primary-prevention ICDs reduce mortality by 28% at two years vs. conventional therapy AVID Investigators. N Engl J Med. 1997. Moss. Circulation. 2005.
ICD Implant Criteria ACC/AHA Guidelines Resuscitated VF / hemodynamically unstable VT (Class I) Ischemic or non-ischemic cardiomyopathy, LVEF 35%, NYHA Class II-III (Class I) Ischemic or non-ischemic cardiomyopathy, LVEF 35%, NYHA Class I Class IIa evidence for ischemic cardiomyopathy Class IIb evidence for non-ischemic cardiomyopathy
% SCD Victims Sudden Cardiac Death Incidence and LVEF 8 7 6 5 4 3 2 1 0 7.5% 5.1% 0-30% 31-40% 41-50% >50% LVEF 2.8% For post-infarct patients, mean interval between MI and SCD: 6.5 years 1.4% Vreede-Swagemakers JJ. J Am Coll Cardiol. 1997;30:1500-1505.
Sudden Cardiac Death in the general population General adult population Multirisk subgroup Any previous coronary event EF <35% or heart failure Cardiac arrest, VF/VT survivors High-risk post-mi subgroups Incidence (%/Year) Incidence (%/Year) Total Events (No./Year) Total Events (No./Year) ~450,000 MADIT-II, SCD-HeFT, COMPANION CARE-HF 0 1 2 5 10 20 30 40 0 100 200 300 x1,000 adapted from Myerburg et al, Circulation 1998; 97:1514
ICD Challenges Picking the Population to Treat LVEF as a risk marker a crude criterion alone will not capture the majority of SCDs Risk-stratification and cost-effectiveness strategies are direly needed, particularly in developing countries.
ICD Challenges Under-Use of Therapy in U.S. In 49,517 SCD survivors, only 31% received an ICD before discharge U.S. CMS & Managed Care data: 1,226 per million population found to be ICD candidates (ventricular arrhythmia or SCD) Yet actual ICD use rate is 416 per million In 20,511 potentially eligible HF patients, only 33% received ICD before discharge Voigt, et al. J Am Coll Cardiol. 2004. Ruskin, et al. J Cardiovasc Electrophysiol. 2002. Hernandez et al. JAMA. 2007.
ICD Challenges Gender, Race, Ethnicity Disparities in ICD Therapy Compared to ICD Usage Rates in White Men: -27% African-American Men -38% White Women -48% African-American Women Hernandez, et al. JAMA. 2007
Global ICD Usage New New Implants Americas Implants per million population Argentina 672 18 Brazil 1,413 8 Canada 3,000 91 USA 119,121 401 2005 World Survey of Cardiac Pacing and ICDs. Mond et al. PACE. 2008
Global ICD Usage New New Implants Europe Implants per million population Belgium 846 82 Denmark 540 105 Greece 345 31 Italy 7,439 129 Russia 151 2 Spain 1,400 32 Sweden 412 46 Switzerland 627 84 United Kingdom 2,835 47 World Survey of Cardiac Pacing and ICDs. Mond et al. PACE. 2008
Global ICD Usage New New Implants Asia Implants per million population Australia 2,864 142 China 186 <<1 Hong Kong 211 28 India 415 <<1 Japan 2,360 19 South Korea 148 3 World Survey of Cardiac Pacing and ICDs. Mond et al. PACE. 2008
Global ICD Usage ~80% of the global mortality of SCD is in middle- to low-income countries New New Implants Middle East / Africa Implants per million population UAE 13 4 Iran 314 5 Israel 683 98 South Africa 105 2 World Survey of Cardiac Pacing and ICDs. Mond et al. PACE. 2008
ICD Challenges economics Individual cost of SCD incalcuable Population cost can be measured as Quality- Adjusted Life Years (QALY) gained Six-trial analysis (MADIT-1, MADIT-2, MUSTT, SCD- HeFT, DEFINITE, COMPANION) ICDs added 1.01-2.99 QALYs Costs ranged from $34,000 - $70,200 per QALY gained Viable in developed economies, but not elsewhere Sanders, et al. N Engl J Med. 2005
Challenges to Global SCD Therapy Overcoming barriers to ICD therapy Education (patients, caregivers, broader population) Enhancing safety of implants Employing strategies to minimize inappropriate shocks
Challenges to Global SCD Therapy Strategies for resource-limited populations: Primary prevention with risk-factor modification (e.g., diet and anti-smoking campaigns) Genomic-based risk stratification Improving EMS, medical, and transportation infrastructure Home-based automatic external defibrillators (AEDs) for high-risk patients Reducing therapy costs (e.g., simpler devices, reused devices)
Summary Sudden cardiac death is a major global public health problem Weakened hearts predispose to sudden death. (Ejection Fraction 35%) When added to optimal medical therapy, ICDs reduce mortality in at-risk patients. ICD therapy remains under-utilized Effective strategies to address SCD will require more education, better risk-stratification, and creative focus on this worldwide killer