* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download MADIT II - Primary Prevention of SCD - 2004
Survey
Document related concepts
Heart failure wikipedia , lookup
Electrocardiography wikipedia , lookup
Remote ischemic conditioning wikipedia , lookup
Antihypertensive drug wikipedia , lookup
Hypertrophic cardiomyopathy wikipedia , lookup
Coronary artery disease wikipedia , lookup
Management of acute coronary syndrome wikipedia , lookup
Arrhythmogenic right ventricular dysplasia wikipedia , lookup
Myocardial infarction wikipedia , lookup
Cardiac surgery wikipedia , lookup
Cardiac contractility modulation wikipedia , lookup
Dextro-Transposition of the great arteries wikipedia , lookup
Heart arrhythmia wikipedia , lookup
Transcript
Disclosures: John D. Hummel, M.D. Research Grants: Boston Scientific, Medtronic, EP Medsystems, and St Jude Medical Speakers Bureau/Honoraria: Boston Scientific, Medtronic, and St Jude Medical Advisory Boards: Boston Scientific, Medtronic, and St Jude Medical Personal Investment: None Prevention of Sudden Cardiac Death: Increasing Awareness In 2006 John D. Hummel, M.D. Mid-Ohio Cardiology and Vascular Consultants Riverside Methodist Hospital Columbus, Ohio Why We Talking About This Today? • There are patients currently in cardiology and primary care clinics who are at risk for Sudden Cardiac Arrest (SCA) • For those who have an arrest, 95% of them will die (without an ICD). • There is a simple indicator to assess who is at risk for SCA: Ejection Fraction (EF) Leading Causes of Death in the US Septicemia Nephritis Alzheimer’s Disease Influenza/pneumonia Diabetes Only after the deaths from ALL cancers are combined does anything cause more deaths each year than sudden cardiac arrest . Accidents/injuries Chronic lower respiratory diseases Cerebrovascular disease Other cardiac causes Sudden cardiac arrest (SCA) All cancers 0% 1 National 2 5% 10% 15% Vital Statistics Report, Vol 49 (11), Oct. 12, 2001 MMWR. State-specific mortality from sudden cardiac death – US 1999.Feb 15, 2002;51:123-126. 20% 25% Magnitude of SCA in the US - ~450,000 per year1 1200 per day • 50 every hour • 1 every 80 seconds - Although SCA is the first presentation of cardiac disease in 20-25% of patients, most cases occur in patients with clinically recognized heart disease.2 1Circulation. 2 2001;104:2158-2163. Myerburg RJ, Castellanos A. Cardiac Arrest and Sudden Cardiac Death, in Braunwald E, Zipes DP, Libby P, Heart Disease, A textbook of Cardiovascular Medicine. 6th ed. 2001. W.B. Saunders, Co. Treatments to Reduce SCA Correcting Ischemia Improving Pump Function – Revascularization – ACE inhibitor – Beta-blocker – Beta-blocker Preventing Plaque Rupture Prevention of Arrhythmias – Statin – Beta-blocker – ACE inhibitor – Amiodarone – Aspirin Stabilizing Autonomic Balance – Beta-blocker – ACE inhibitor Terminating Arrhythmias – ICDs – AEDs Prevent Ventricular Remodeling and Collagen Formation – Aldosterone receptor blockade Zipes DP. Circulation. 1998;98:2334-2351. Pitt B. N Engl J Med. 2003;348:1309-1321. Cause of SCA 12% Other Cardiac Cause 88% Arrhythmic Cause . Albert CM. Circulation. 2003;107:2096-2101 Underlying Arrhythmias of Sudden Cardiac Arrest Torsades de Pointes 13% Bradycardia 17% VT 62% Bayés de Luna A. Am Heart J. 1989;117:151-159. Primary VF 8% SCA Resuscitation Success vs. Time* 100 90 Chance of success reduced 7 - 10% each minute 80 70 60 % Success 50 *Non-linear 40 DFT 30 20 10 0 1 2 3 4 5 6 Time (minutes) Cummins RO. Annals Emerg Med. 1989;18:1269-1275. 7 8 9 SCA Chain of Survival Statistics • 5% estimated SCA out-of-hospital survival2,3 • Even in the best EMS/early defibrillation programs it is difficult to have high survival times due to many SCA events not being witnessed and the difficulty of reaching victims within 6-8 minutes. – 40% SCAs not witnessed or occur in sleep1 – 80% SCAs occur at home1 1 Swagemakers V. J Am Cardiol. 1997;30:1500-1505 2 Ginsburg W. Am J Emer Med. 1998;16:315-319. 3 Cobb LA. Circ. 1992;85:I98-102. Community Survival Rates Before and After Early Defibrillation Programs (AED’s) 30 26% Before Early DF After Early DF VF Survival 25 19% 20 17% 15 10 11% 10% 7% 5 3% 4% 3% 4% 0 King County, WA Iowa SE Minnesota NE Minnesota Ornato JP. Community experience in treating out-of-hospital cardiac arrest. In: Akhtar M. Sudden Cardiac Death. Baltimore, Md: Williams & Wilkins; 1994:450-462. Wisconsin What About the High Risk Population? “People who’ve had a heart attack have a sudden death rate that’s 4-6 times that of the general population.”1 1American Heart Association. Heart Disease and Stroke Statistics—2003 Update. Dallas, Tex.: American Heart Association; 2002. In people diagnosed with CHF, sudden cardiac death occurs at 6-9 times the rate of the general population.1 American Heart Association. Heart and Stroke Statistical –2003 Update. Dallas, Tex.: American Heart Association: 2002. 1 Survival After Acute MI 1.0 A Survivorship 0.8 B C 0.6 D 0.4 0.2 0 A B C D N 536 113 80 37 EF 30% 30% 30% 30% VPD 10/hr 10/hr < 10/hr 10/hr 1 2 Year Bigger JT. Am J Cardiology. 1986;57:12B. 3 CAST TRIAL CONCLUSIONS This is your Heart This is your Heart on Drugs Primary Prevention ICD Trials • MUSTT • MADIT – II • SCD-HeFT Post-MI Ischemic and Non-ischemic MUSTT Results, Total Mortality: Pts With EF≤40%, NSVT EP (Inducible VT) 0.6 Best Medical Therapy Best Medical Therapy + AA drugs Best Medical Therapy + ICD Surveillance Event Rate 0.5 0.4 0.3 p < 0.001 0.2 0.1 0 0 1 2 3 Time after Enrollment (Years) 4 5 Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factor for overall mortality and sudden cardiac arrest. 1.00 1.00 0.98 p log-rank 0.002 0.96 Survival Survival 0.96 0.94 0.92 0.94 0.92 0.90 0.90 0.88 0.88 p log-rank 0.0001 A B 0.86 0.86 0 30 60 90 Patients without LV Dysfunction 120 150 180 0 30 Days (LVEF >35%) 60 90 120 Days No PVBs 1-10 PVBs/h > 10 PVBs/h Maggioni AP. Circulation. 1993;87:312-322. Patients with LV Dysfunction (LVEF < 35%) 150 180 MADIT II Protocol Inclusion: Q-wave MI > 4 weeks, LVEF <30% ICD implant n=742 No-ICD implant n=490 (EPS after implant) (Conventional Post-MI drug Rx) 20 months mean follow- up • Avoid AAD • Optimize: B, ACE-I, Diuretics Moss AJ. N Engl J Med. 2002;346:877-83. MADIT-II Survival Results 31% Relative Reduction in Mortality Study Stopped Early 1.0 Probability of Survival 0.9 Defibrillator 14% Mortality 0.8 0.7 p = 0.007 0.6 Conventional Medical Therapy 20% Mortality 0.0 0 1 2 Year 3 4 MADIT II: All-Cause Mortality 19.8% 20.00% 31% Relative Reduction Hazard Ratio= 0.69 (p= 0.016) 14.2% 10.00% 0.00% Conventional Therapy N= 490 Moss AJ. N Engl J Med. 2002;346:877-83. ICD Therapy N= 742 Risk of Sudden Death in HF Trials Study HF Class Control (n) Treatment (n) MERIT-HF1 2-4 2001 1990 Total Mortality Reduction w/Treatment Sudden Death as % of Total Death in Control Arm Sudden Death- as a % of Total Death in Treatment Arm 34% (60%) (54%) 132/217 79/145 (45%) (44%) 203/449 182/411 (36%) (31%) 83/228 48/156 (48%) (54%) 15/31 12/22 (28%) (29%) 110/386 162/478 (36%) (34%) 201/554 162/478 (Metroprolol) BEST2 3,4 1354 1354 10% (Bucindolol) CIBIS-II3 3,4 1320 1327 34% (Bisoprolol) CARVEDILOL(U.S.)4 2-4 RALES5 3, 4 EPHESUS6 2-4 398 841 3313 696 882 3319 65% 30% 15% References in slide notes. SCD-HeFT: The Sudden Cardiac Death in Heart Failure Trial • Gust Bardy, MD et al, NEJM January 27, 2005 • Largest and longest follow-up ICD trial ever conducted – 2521 patients – 148 centers – 41 month median follow-up – Vital status known on 100% of patients • Sponsored by NIH • 70% of Patients were Class II NYHA (Typically less sick than in previous ICD trials) • 48% of Patients were non-ischemic SCD-HeFT: Primary Conclusions 1. In class II or III CHF patients with EF < 35% on good background drug therapy, the mortality rate for placebocontrolled patients is 7.2% per year over 5 years 2. Simple, single lead, shock-only ICDs decrease mortality by 23% 3. Amiodarone, when used as a primary preventative agent, does not improve survival Bardy G et al. NEJM 2005; 352:3 Mortality Benefit: Time Dependent Current Recommendations • ICD Implantation for – Ischemic Cardiomyopathy > 4 post-MI with LVEF ≤30% – Chronic Ischemic or Non-ischemic cardiomyopathy with CHF and LVEF ≤ 35% • Further EP evaluation – Chronic Ischemic or Non-ischemic cardiomyopathy with LVEF > 35% and ≤ 45% How Effective Are We In Getting ICD Therapy to Eligible Patients? Indication/ Estimated Patient Groups Net Prevalence Estimated % Penetration of Net Prevalence Class I (AVID, MADIT, MUSTT, MADIT-II, SCD-Heft) 1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43. 2 Medtronic internal estimate. 670,000 ~20% 1,2 Why Aren’t These Patients Getting ICD’s To Protect Them From Sudden Cardiac Arrest?: Can We Afford This? The US Pharmaceutical industry spends $10B on CV Drug marketing The predicted cost of 80% application of ICD therapy to eligible patients is 8.8 billion dollars Are Doctors and Patients Paying Attention To This Issue In the typical CHF clinic (Cardiology Run) 25-35% of eligible patients have no ICD. Many patients will never use their ICD Direct Medical Expenditures on Diseases with High Mortality (2001 $US) Dollars (Billions) 20 Despite the higher number of SCD deaths, spending is lower than for diseases with fewer annual deaths. 19.5 15 10 8.2 5 5 6 3.7 0 AIDS 1, 2 1 Breast Cancer 3 Lung Cancer 3 Stroke 4 Cardiac Dysrhythmia 4 Bozzette et al., 1998 http://www.cdc.gov/hiv/stats.htm: Accessed 2/04/2003 3 http://www.cancer.org/docroot/mit/content/mit_3_2x_costs_of_cancer.asp: Accessed 12/07/2002 4 Healthcare Financing Review, Medicare and Medicaid Statistical Supplement, 2000 2 Comparison of Healthcare Costs 10.0 8.35 Annual Cost in Billions 9.0 8.97 9.04 8.0 7.0 6.0 5.0 4.0 3.0 2.30 2.0 1.0 0.0 ICD* PTCA† *Medtronic estimations (total number of implants x $30,000) †Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data. +AHA 2002 / Cowper, et al; American Heart Journal. 143:(1):130–9. CABG+ Statins‡ Comparison of Healthcare Costs 350.0 294 Annual Cost in Billions 300.0 $11.6 B—estimated amount due to miscoding, insufficient documentation, etc. in Medicare 250.0 200.0 Healthcare Administration1 (HCFA 2000 Financial Report) 150.0 100 100.0 50.0 2 0.0 ICD* 8 9 9 30 PTCA† CABG+ Statins‡ Economic impact of overprescribing antibiotics^ *Medtronic estimations (total number of implants x $30,000). †Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data. +AHA 2002 / Cowper, et al; American Heart Journal. 143;(1):130–9. ‡ Pharmacy Times, “Top 200 drugs of 2000”; 2001. ^ National Institute of Health, Antimicrobial Resistance, NIAID Fact Sheet. ^^ U.S. General Accounting Office 2001. 1 Woolhandler S, et al. Costs of Healthcare Administration in the United States and Canada. N Engl J Med 344, 2003; 349: 768-75. Lost dollars from health care fraud, abuse and waste^^ Societal Spending on Other Life-Saving Interventions 1 Cost/Life-Year Intervention Flashing lights at railroad crossings $42,000 Flammability standard for upholstered furniture $68,000 Airbags (vs. manual lap belts) in cars $120,000 Annual mammography for women age 40-49 $190,000 Smoke detectors in homes $210,000 Front disk (vs. drum) brakes in cars $240,000 Strengthen buildings in earthquake-prone areas $18,000,000 Ground fault circuit interrupters $1,200,000 1. Tengs TO, et al. Five-Hundred Life-Saving Interventions and Their Cost-Effectivenss. Risk Analysis, Vol. 15, No. 3, 1995. We need to educate about EF • • EF is very easy for patients to understand • “Sudden Cardiac Arrest” is a scary message • “EF” is easy to understand and rally behind EF crosses between two “at risk” patient groups • • Heart Failure and Post-MI Research shows low patient awareness of EF • 86% of Post-Mi and HF patients are aware of Echos & have had one • 14% of Post-Mi and HF patients are aware of EF • Only 5% of patients know their EF • Conclusions: » Getting an echo is not a key barrier » Clinicians aren’t talking EF numbers to patients » Patients don’t know to ask about it EF Program to Help educate and prepare patients Main Heart Patient Message: “Get to know your EF number” • Continue preventive • Follow-up echo and care clinic visit in 6 months • Appointment to see an electrophysiologist Implantable Cardioverter Defibrillators in the Early Days Are All Defibrillators Created Equal? • Single Chamber • Dual Chamber • Three Chamber (Bi-Ventricular, CRT) BiVentricular Pacing Corrects Dyssynchrony The pathophysiology of a wide QRS is dyssynchrony ● The therapy provided by BiV pacing is to resynchronize activation of the heart walls so they contract in a nearly simultaneous manner ● CRT – Device Utilization Riverside Hospital Device 2001 2002 2003 2004 Pacer 60 48 42 40 BiV P 2 2 2 2 ICD 34 42 40 35 BiV ICD 4 8 16 23 Numbers Represent % of Volume CARE HF • 813 pts with NYHA Class III CHF • Randomized to Medical Treatment vs. CRT (BiV Pacemaker without Defib capability) • Primary Endpoint: Time to death or Unplanned Hospitalization for Cardiovascular Event • Primary Endpoint Reached: 39% CRT vs. 55% Med Rx at 30 mo’s (p<0.001) • Mortality: 20% CRT vs. 30% Med Rx (p<0.002) • Echo Parameters of LV Fxn, CHF Class, QOL: – Better with CRT (p<0.01) CRT – Who’s a candidate Standard criteria: NYHA > III, EF < 35%, QRS > 120ms. OptiVol Fluid Trends Sep 29: Crossed OptiVol Threshold. Oct 7: Regular follow-up. LV Lead dislodgement & OptiVol Threshold crossing observed. No symptoms reported. Decision made to reposition lead in November. Oct 28: Hospitalization for heart failure decompensation. Patient admitted with orthopnea, peripheral edema, crackles in lower lungs. BNP: 1960 pg/ml. Weight: 96 kg. Treated with IV diuretics. Nov 5: Lead replacement. Aldactone® initiated. Impedance stabilizes several days after procedure. BNP: 786 pg/ml. Weight: 80 kg. Heart Disease 70 65 60 55 50 45 40 35 30 25 0 B P<0.001 No concurrent heart disease P<0.001 Concurrent heart disease 0 Month 12 Chronic AF LV Ejection Fraction (%) C 70 65 60 55 50 45 40 35 30 25 D P<0.001 Inadequate rate control P<0.001 Adequate rate control 0 Month 12 LV Functional Shortening (%) LV Ejection Fraction (%) A LV Functional Shortening (%) Effects of Concurrent Structural Heart Disease and Rate Control Before Ablation on LV Function after Ablation Among Patients with CHF DCM 40 35 30 No concurrent heart disease P<0.001 25 20 Concurrent heart disease 15 P<0.001 10 0 0 Month 12 CHF 40 P<0.001 Inadequate rate control 35 30 25 P<0.001 20 Adequate rate control 15 10 0 0 Month 12 Improvement of CHF by Curative Ablation of Atrial Fibrillation •58 consecutive patients with CHF and LVEF≤45% •Control group of 58 pts. without Hx/o CHF undergoing AF ablation, matched for age, sex, classification of AF Results: •NSR: 78% of CHF, 84% non-CHF pts (p=0.38) •Increase in LVEF: 21% in CHF pts. (p<0.001 vs. non-CHF pts) •Improvements in LVEF occurred regardless of whether there was adequate rate control pre-procedure Pulmonary Venous Anatomy 74 yo medically refractory AF, Echo – Normal AA Rx - Verapamil, Rythmol, Betapace, Norpace I II III V1 RSPV dist RSPV prox LIPV RA * Lasso Catheter Circular Mapping & Ablation Catheter in Right Superior Pulmonary Vein Pulmonary Veins Left Atrium Pulmonary Veins 70 y/o Male with PAF – Progression of Fractionated Egm to Organized Egm to Termination of Arrhythmia – Anteroseptal Line 5 I II V1 ABL prox ABL dist CS prox CS dist 6 3 4 The Bottom Line Bottom Line • If LVEF ≤ 35% Consider Implantable Defibrillator • If Your Patient Has CHF and a Bundle Branch Block: Consider BiVentricular Implant or Upgrade • If Your Patient Has CHF and AFib: Consider restoration of NSR Quality of Life