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Disclosures: John D. Hummel, M.D.

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

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Disclosures: John D. Hummel, M.D.

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  1. 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

  2. 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

  3. 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)

  4. 0% 5% 10% 15% 20% 25% Leading Causes of Death in the US Septicemia Nephritis Only after the deaths from ALL cancers are combined does anything cause more deaths each year than sudden cardiac arrest . Alzheimer’s Disease Influenza/pneumonia Diabetes Accidents/injuries Chronic lower respiratory diseases Cerebrovascular disease Other cardiac causes Sudden cardiac arrest (SCA) All cancers 1 National Vital Statistics Report, Vol 49 (11), Oct. 12, 2001 2MMWR. State-specific mortality from sudden cardiac death – US 1999.Feb 15, 2002;51:123-126.

  5. 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. 2001;104:2158-2163. 2 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.

  6. Correcting Ischemia Revascularization Beta-blocker Preventing Plaque Rupture Statin ACE inhibitor Aspirin Stabilizing Autonomic Balance Beta-blocker ACE inhibitor Improving Pump Function ACE inhibitor Beta-blocker Prevention of Arrhythmias Beta-blocker Amiodarone Terminating Arrhythmias ICDs AEDs Prevent Ventricular Remodeling and Collagen Formation Aldosterone receptor blockade Treatments to Reduce SCA Zipes DP. Circulation. 1998;98:2334-2351. Pitt B. N Engl J Med. 2003;348:1309-1321.

  7. Cause of SCA 12%Other CardiacCause 88%ArrhythmicCause Albert CM. Circulation. 2003;107:2096-2101.

  8. Underlying Arrhythmias of Sudden Cardiac Arrest Torsades de Pointes13% Bradycardia17% VT62% Primary VF8% Bayés de Luna A. Am Heart J. 1989;117:151-159.

  9. 100 90 80 70 60 50 40 30 20 10 0 1 2 3 4 5 6 7 8 9 SCA Resuscitation Success vs. Time* Chance of success reduced 7 - 10% each minute % Success *Non-linear DFT Time (minutes) Cummins RO. Annals Emerg Med. 1989;18:1269-1275.

  10. 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.

  11. Community Survival Rates Before and After Early Defibrillation Programs (AED’s) 26% 19% 17% VF Survival 11% 10% 7% 4% 4% 3% 3% Ornato JP. Community experience in treating out-of-hospital cardiac arrest. In: Akhtar M. Sudden Cardiac Death. Baltimore, Md: Williams & Wilkins; 1994:450-462.

  12. What About the High Risk Population?

  13. “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.

  14. In people diagnosed with CHF, sudden cardiac death occurs at 6-9 times the rate of the general population.1 1 American Heart Association. Heart and Stroke Statistical –2003 Update. Dallas, Tex.: American Heart Association: 2002.

  15. Survival After Acute MI 1.0 A 0.8 B C 0.6 Survivorship D 0.4 N 536 113 80 37 EF 30% 30% 30% 30% VPD 10/hr 10/hr < 10/hr  10/hr A B C D 0.2 0 1 2 3 Year Bigger JT. Am J Cardiology. 1986;57:12B.

  16. CAST TRIAL CONCLUSIONS This is your Heart This is your Heart on Drugs

  17. Primary PreventionICD Trials • MUSTT • MADIT – II • SCD-HeFT Post-MI Ischemic and Non-ischemic

  18. MUSTT Results, Total Mortality: Pts With EF≤40%, NSVT EP (Inducible VT) 0.6 Best Medical Therapy Best Medical Therapy + AA drugs 0.5 Best Medical Therapy + ICD Surveillance 0.4 Event Rate 0.3 p < 0.001 0.2 0.1 0 0 1 2 3 4 5 Time after Enrollment (Years)

  19. Reduced left ventricular ejection fraction (LVEF) remainsthe single most important risk factor for overall mortality and sudden cardiac arrest. 1.00 1.00 0.98 p log-rank0.002 0.96 0.96 0.94 0.94 Survival Survival 0.92 0.92 p log-rank 0.0001 Patients withoutLV Dysfunction (LVEF >35%) 0.90 0.90 0.88 0.88 A B 0.86 0.86 0 30 60 90 120 150 180 0 30 60 90 120 150 180 Days Days Patients withLV Dysfunction (LVEF < 35%) No PVBs1-10 PVBs/h> 10 PVBs/h Maggioni AP. Circulation. 1993;87:312-322.

  20. 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.

  21. 1.0 0.9 Defibrillator 14% Mortality 0.8 Probability of Survival 0.7 Conventional Medical Therapy 20% Mortality p = 0.007 0.6 0.0 0 1 2 3 4 Year MADIT-II Survival Results31% Relative Reduction in MortalityStudy Stopped Early

  22. MADIT II: All-Cause Mortality 31% Relative Reduction Hazard Ratio= 0.69 (p= 0.016) N= 742 N= 490 Moss AJ. N Engl J Med. 2002;346:877-83.

  23. Risk of Sudden Death in HF Trials References in slide notes.

  24. 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

  25. SCD-HeFT: Primary Conclusions • In class II or III CHF patients with EF < 35% on good background drug therapy, the mortality rate for placebo-controlled patients is 7.2% per year over 5 years • Simple, single lead, shock-only ICDs decrease mortality by 23% • Amiodarone, when used as a primary preventative agent, does not improve survival Bardy G et al. NEJM 2005; 352:3

  26. Mortality Benefit: Time Dependent

  27. 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%

  28. How Effective Are We In Getting ICD Therapy to Eligible Patients? 1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43. 2 Medtronic internal estimate.

  29. 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

  30. 4 3 3 1, 2 4 Direct Medical Expenditures on Diseases with High Mortality (2001 $US) Despite the higher number of SCD deaths, spending is lower than for diseases with fewer annual deaths. 1 Bozzette et al., 1998 2http://www.cdc.gov/hiv/stats.htm: Accessed 2/04/2003 3http://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

  31. Comparison of Healthcare Costs 10.0 9.04 8.97 8.35 9.0 8.0 7.0 6.0 Annual Cost in Billions 5.0 4.0 2.30 3.0 2.0 1.0 0.0 ICD* PTCA† CABG+ Statins‡ *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.

  32. Comparison of Healthcare Costs 350.0 294 300.0 $11.6 B—estimated amount due to miscoding, insufficient documentation, etc. in Medicare (HCFA 2000 Financial Report) 250.0 Healthcare Administration1 200.0 Annual Cost in Billions 150.0 100 100.0 30 50.0 9 9 8 2 0.0 ICD* PTCA† CABG+ Statins‡ Economic impact of over- prescribing antibiotics^ Lost dollars from health care fraud, abuse and waste^^ *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.

  33. Societal Spending on Other Life-Saving Interventions 1 1. Tengs TO, et al. Five-Hundred Life-Saving Interventions and Their Cost-Effectivenss. Risk Analysis, Vol. 15, No. 3, 1995.

  34. 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

  35. EF Program to Help educate and prepare patients

  36. Main Heart Patient Message:“Get to know your EF number” • Continue preventive care • Follow-up echo and clinic visit in 6 months • Appointment to see an electrophysiologist

  37. Implantable Cardioverter Defibrillators in the Early Days

  38. Are All Defibrillators Created Equal? • Single Chamber • Dual Chamber • Three Chamber (Bi-Ventricular, CRT)

  39. BiVentricular PacingCorrects 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

  40. CRT – Device UtilizationRiverside Hospital Device2001200220032004 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

  41. 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)

  42. CRT – Who’s a candidate Standard criteria: NYHA > III, EF < 35%, QRS > 120ms.

  43. 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.

  44. DCM Heart Disease B A 40 70 P<0.001 65 No concurrentheart disease No concurrentheart disease 35 P<0.001 60 55 30 50 25 LV Functional Shortening (%) LV Ejection Fraction (%) 45 P<0.001 20 40 P<0.001 Concurrentheart disease Concurrent heart disease 35 15 30 10 25 0 0 0 12 0 12 Month Month D C CHF Chronic AF 40 70 P<0.001 P<0.001 65 Inadequaterate control 35 Inadequaterate control 60 30 55 50 25 LV Functional Shortening (%) LV Ejection Fraction (%) P<0.001 45 P<0.001 20 40 Adequaterate control Adequaterate control 35 15 30 10 25 0 0 12 0 12 Month Month Effects of Concurrent Structural Heart Disease and Rate Control Before Ablation on LV Function after Ablation Among Patients with CHF

  45. 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

  46. Pulmonary Venous Anatomy

  47. I II III V1 * RSPV dist RSPV prox LIPV RA 74 yo medically refractory AF, Echo – Normal AA Rx - Verapamil, Rythmol, Betapace, Norpace

  48. Lasso Catheter

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