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The Primary Prevention of Sudden Cardiac Death with ICD Therapy: Who Should Get a “Shock Box” ?

The Primary Prevention of Sudden Cardiac Death with ICD Therapy: Who Should Get a “Shock Box” ?. Presentation Overview. Review of the clinical evidence supporting ICD therapy for primary prevention Who are the patients? What are the therapy requirements?

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The Primary Prevention of Sudden Cardiac Death with ICD Therapy: Who Should Get a “Shock Box” ?

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  1. The Primary Prevention of Sudden Cardiac Death with ICD Therapy:Who Should Get a “Shock Box” ?

  2. Presentation Overview • Review of the clinical evidence supporting ICD therapy for primary prevention • Who are the patients? • What are the therapy requirements? • Is saving lives with ICDs cost effective? • Can the U.S. afford expanding device therapy to primary prevention patients? • A closer look at the size of the indicated populations • Putting it in perspective • Conclusions

  3. ICD Mortality Data in Context Primary Prevention ICD Clinical Studies Versus: Secondary Prevention ICD Clinical Studies Major Drug trials

  4. ICD Mortality Benefitsin Primary Prevention Trials 75% 73% 61% 55% 54% % Mortality Reduction w/ ICD Rx 31% 1 2 3, 4 39 Months 27 Months 20 Months 1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AF. N Engl J Med. 2002;346:877-83. 4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002.

  5. Mortality Benefits with ICD Therapy 75% 76% 61% 55% 54% 31% % Mortality Reduction w/ ICD Rx ICD mortality reductions in primary prevention trialsare equal to or greaterthan those in secondaryprevention trials. 1 2 3, 4 27 months 39 months 20 months 59% 56% 33% % Mortality Reduction w/ ICD Rx 31% 28% 20% 1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AJ. N Engl J Med. 2002;346:877-83 4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002. 5 The AVID Investigators. N Engl J Med. 1997;337:1576-83. 6 Kuck K. Circ. 2000;102:748-54. 7 Connolly S. Circ. 2000:101:1297-1302. 6 7 5 3 Years 3 Years 3 Years

  6. Primary Prevention ICD Trials: In Context with Other Landmark Trials Non-active Rx Active Rx 30 p=0.019 24.6 p=0.016 20.4 19.8 Mortality (%) 15 14.2 p<0.01 p=NS 9.0 9.8 7.2 8.0 0 BHAT CASS SAVE MADITII N=3800 N=780 N=1200 N=2200 HR=0.73 HR=0.89 HR=0.81 HR=0.69 Moss, AJ. MADIT II and its implications. European Heart Journal (2003); 24, 16-18.

  7. Who are the Patients?

  8. Who are the Primary Prevention Patients? Primary prevention patients have low LVEF and high percentages of Class II/III CHF. 1Moss A, et al. N Engl J Med. 1996;335:1933–40. 2Buxton, A, et al; N Engl J Med. 1999;341:1882–90. 3AVID Investigators; N Engl J Med. 1997;337:1576–83. 4Moss, A. et al; N Engl J Med. 2002;346:877–83.

  9. Who are the MADIT II Patients? MADIT II patients had more severe structural heart disease than AVID patients. 1AVID investigators. N Engl. J Med. 1997; 337: 1576-1583. 2. Moss AJ. N Engl J Med. 2002; 346: 877-83. 3 Domanski MJ. Am J Cardiol. 1997; 80: 299-301. 4AVID @ 3 years from the KM curve: 36%-25%, NNT=9 N Engl J Med. 1997;337:1576-1583 5MADIT-II @ 3 years from KM curve: 31%-22%, NNT=11 N Engl J Med. 2002;346:877-883

  10. What Are the Therapy Requirements?

  11. What Are the Therapy Requirements? • Primary prevention patients will need > # of shocks as a secondary-prevention patient.1 • 40% of MADIT II study patients had a potential life-threatening VT/VF event terminated by their ICD within the first four years after implant. 2 • Ventricular fibrillation is the cause of SCA in only a small percentage of cases (< 10%). Ventricular tachycardia is the underlying etiology in >75% of SCA events. 3 • Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274 • Moss AJ. J Cardiovasc Electrophysiol, Vol. 14, pp. S96-S98, September 2003, Suppl. • Bayés de Luna A. Am Heart J. 1989;117:151-159.

  12. What Are the Therapy Requirements? Device Longevity Requirements: • Same age and life expectancy as secondary prevention patient.1 • Patient survival is ~75% at 5 years. 2,3 Discrimination Technology Requirements: • AF/SVT even more an issue in MADIT II patients (more severe heart disease than AVID patients)4,5 • 20-30% of ICD patients have atrial fibrillation at implant; 45% will have AF within 17 months post-implant 6,7 • Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274 • Moss A, et al. N Engl J Med. 1996; 335: 1933-40. • Buxton A, et al. N Engl J Med. 1996; 341: 1882-90. • Moss AJ. N Engl J Med. 2002; 346: 877-83. • AVID investigators. N Engl. J Med. 1997; 337: 1576-1583. • Schmitt C, Montero M, Melicherick J. PACE 1994; 17: 295-302. • Medtronic GEM DR clinical data on file.

  13. What Are the Therapy Requirements? • Conclusions: • The clinical profile and needs of the primary prevention patients are similar to the “classic” or secondary-prevention patients. • There is no single type of device that will meet the needs for the entire primary prevention population.

  14. How Do Devices TodayMeet These Therapy Requirements?

  15. ICD patients can be spared the majority (77%) of painful shocks if ATP is programmed as the first therapy for FVT1 Improved patient quality of life Shock therapy is painful and remains a barrier to patient acceptance of ICD therapy Reduction in potential hospitalizations associated with shocks Minimize “problem” calls to physician and staff Improved ICD longevity Each shock reduces battery life by ~ 24 days2 Reducing Shocks – ATP Programming 1 Wathen M, Sweeney M, DeGroot P. Circulation. 2001; 104: 796-801. 2 Marquis DR 7274 Reference Manual

  16. Reducing Shocks – Sophisticated Detection ICD patients can be spared the painful inappropriate shocks with advanced detection and SVT discrimination • PR Logic clinically proven to reduce inappropriate shocks. - 100% Sensitivity, 92.8% PPV 1 • Wavelet2 clinically proven to reduce inappropriate shocks. - 100% Sensitivity, 78% Specificity 2 1 Wilkoff, et al. Circulation, 2001; 103: 381-386. 2 Merrill, JJ etc al. NASPE Abstract, 2003

  17. Therapy Success – Fast Charge Times Short and consistent charge times are important to minimize the risk of syncope and potential for DFTs to rise over time • DFTs increase with VF duration1 • Pre-shock syncope is a clinically relevant problem with ICD patients2 • Limiting the time in VF to <10 seconds may reduce the risk of syncope3 1 Platia, et al;, Abstract, AHA 60th Sessions #12352Himmrich, et al; Abstract, Europace, Vol. 1, Suppl. D, July 2000, pg. 154 3Windecker, et al; JACC.1999;33:33-38.

  18. Fewer Replacements – Optimal Longevity Younger patients will live with their implantable devices longer • Patient survival is approximately 75% at 5 years1,2 • Minimize replacement procedures • Increase cost-effectiveness 1 Moss A, et al. N Engl J Med. 1996;335:1933–40. 2 Buxton A, et al. N Engl J Med 1999; 341:1882–90

  19. Therapy Success – High Output We don’t know in advance which patients may have a problem at implant and which patients may have a problem with DFTs over time, 35J device provide a safety net for all. • A patient’s clinical status is always changing. • DFTs rise over time in specific patients.1-4 • Both acute and chronic conditions may affect DFT values.5-20 * References in slide notes.

  20. Device Monitoring – Patient Alert Patient Alert self-monitoring of lead impedance, battery voltage, charge times, therapies delivered, and therapy success. • Simple notification of device parameters that might require attention. • Minimize potential for adverse outcomes. • Patient peace of mind that device is operational.

  21. Patient Monitoring – Cardiac Compass ICD diagnostics should provide clinically relevant information to assist with patient and device management • Provides trended diagnostic data to help you assess your patient's responses to therapeutic choices. • Provides a chronological picture of patient response to validate that current medical treatments are working. • Allows for drug, diet, and programming optimization.

  22. Current Lifeboat - Biotronik Airbag Positioning: Prophylactic ICD for those patients who have not demonstrated a need for advanced features. http://www.biotronikusa.com/tachy/cardair/index.cfm

  23. Do Physicians really want Airbag? • Limited number of shocks • Risk of electrical storms 1 • No PainFREE therapies (no ATP) • 77% reduction in shocks for fast VT episodes 2 • Basic SVT discrimination • Risk of inappropriate device therapies 3-8 • Limited Diagnostics • Adequately manage advanced HF patients? • Upgrade to a full-featured device once the patient receives a shock • Cost efficient?

  24. Low Cost vs Patient Considerations • Optimize outcome for primary prevention patients: • Fast, effective SCA protection to reduce mortality • 35J available • Fast charge time • Patient and device monitoring to better manage patients and reduce potential hospitalizations • Cardiac Compass • Patient Alert • Minimal replacement procedures • Longevity • Minimal Shocks for patient acceptance and quality of life • Painless ATP therapy for FVT • Sophisticated Detection Algorithms • Do not sub-optimize your patient’s treatment!

  25. Is Saving Liveswith ICDs Cost Effective?

  26. Cost-Effectiveness Analysis 1 Compare total cost of therapy with its benefit or effectiveness Average Cost-Effectiveness: total cost of therapy divided by years of life lived after receiving therapy:cost per life year($/LY) Incremental Cost-Effectiveness: compare differences in total therapy cost and effectiveness between two competing therapies: cost per life year saved($/LYS) 1 European Heart Journal (2000) 21, 712-719.

  27. Incremental Cost Effectiveness Analysis Therapy A versus Therapy B Total Cost A – Total Cost B Life Expectancy A – Life Expectancy B = Cost Per Life Year Saved($/LYS) 1 European Heart Journal (2000) 21, 712-719.

  28. Cost Per Life Year Saved ($LYS): Effectiveness $0 or Less Cost Saving $1 - $20,000 Highly Cost-Effective $20,001- $40,000 Cost-Effective $40,001 - $60,000 Borderline Cost-Effective $60,001 - $100,000 Expensive > $100,000 Unattractive Source: Goldman. Cir 85. 1992 Incremental Cost-Effectiveness Results

  29. Incremental Cost-Effectiveness of ICD Therapy and Other Cardiovascular Interventions Economically Unattractive Incremental Cost per Life-Year Saved Expensive Borderline Cost-effective Cost-Effective HighlyCost-Effective PTCA(ChronicCAD, mildangina,1 VD) CABG(Chronic CAD,mild angina,3 VD) Primarycoronarystenting (CAD,Angina, 1 VD,Male, age 55) Lovastatin(chol. = 290 mg/dL,50 yrs old, male, no riskfactors) CardiacTransplant(CHF,transplantcandidate) Hypertensiontherapy(Diastolic95-104mmHg) ICD- MADIT ICD- MADIT II* estimate ICD- AVID *Moss AJ. Presentation at Satellite Symposium, “Cost-Effectiveness of Device Therapy in the Heart Failure Population”, Heart Failure Society of America Annual Meeting September 23, 2003.

  30. Number Needed to Treat To Save A Life NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) Drug Therapy amiodarone ICD Therapy simvastatin Metoprolol succinate captopril (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr)

  31. Cost Effectiveness Considerations:A Device IS NOT a Drug

  32. Device/Drug Distinctions (Chronic Disease) Device • Direct mechanism of action • Readily apparent response • Site/organ-specific therapy • Uniform patient response to treatment • High initial cost • Automatic therapy • Successive generations generally improve cost-effectiveness Drug (Oral) • Indirect mechanism of action • Metabolites, liver inactivation • Systemic treatment • Variable patient response • Dosing • Side-effects • Costs spread over treatment • Requires patient compliance • Cost-effectiveness remains relatively constant

  33. Intrinsic and Extrinsic Factors Affect Therapeutic Device Cost-Effectiveness Device-Intrinsic • Achieved performance life • Battery longevity • Reliability • Durability • Size • Electronic sophistication • Functionality • Software/algorithms • Complications • Deployment requirements • Follow-up requirements Extrinsic Factors • Implantation procedure • Learning curve • Implantation facility • Length of stay • Indications for use • Patient selection • Co-morbidities • Complications

  34. Intrinsic and extrinsic device advances progressively increase cost-effectiveness Representative Device Cost-Effectiveness Trends 1st generation Financial Metric IncreasingCost Effectiveness Nth generation Time, yrs.

  35. Major increase in functionality IncreasingCost Effectiveness Case Example: Advances in Leads/electrodes and Pacemaker Current Drain(Composite effect of improved lead/electrode efficiency, stimulation patterns, increased understanding of stimulation physiology, and physician practice) Energy Consumption Per Pacing Stimulus (µJ) 1970 1975 1980 1985 1990 1995 Adapted from Ohm, Pace, Vol 20 1997

  36. $/LYS (000) Cost-Effectiveness Power Source Longevity Intrinsic Example: Implantable Defibrillator (ICD)Influence of ICD technology advance on cost-effectiveness: Power Source Longevity Mushlin AI, et al. Circulation. 1998; 97: 2129-2135.

  37. Extrinsic ExampleInfluence of ICD patient selection criteria on cost-effectiveness: Pre-implant Ejection Fraction Cost -Effectiveness $/LYS (000) Ejection Fraction Kupersmith J, et al. Am H J 1995; 130: 507-15.

  38. Failure to consider therapy duration can incorrectly color cost-effectiveness findings $/LYS The AVID1 Trial concluded implantable cardioverter-defibrillator therapy reduces mortality compared with antiarrhythmic drugs in defined populations. However, by confining its length of follow-up to only 1.5 years, rather than patient life-expectancy or device longevity, cost/LYS was found to be in the “very expensive” range. MADIT reached a different conclusion. MADIT2 > 4 yr battery AVID1 1. Antiarrhythmics Versus Implantable Defibrillator (AVID) 2. Multicenter Automatic Defibrillator Implantation Trial (MADIT)

  39. 1980:Large Devices, Limited Battery Life, Abdominal Implant, Epicardial Leads • First human implants • Thoracotomy, multiple incisions • Primary implanter= cardiac surgeon • General anesthesia • Long hospital stays • Complications from major surgery • Perioperative mortality up to 9% • Nonprogrammable therapy • High-energy shock only • Device longevity  1.5 years • Fewer than 1,000 implants/year

  40. TodaySmall devices - Pectoral site • First-line therapy for VT/VF patients • Treatment of atrial arrhythmias • Cardiac resynchronization therapy for Heart Failure • Transvenous, single incision • Local anesthesia; conscious sedation • Short hospital stays and few complications • Perioperative mortality < 1% • Programmable therapy options • Single- or dual-chamber therapy • Battery longevity up to 9 years • More than 100,000 world-wide implants/year *Battery longevity information in slide notes.

  41. Major increase in functionality IncreasingCost Effectiveness Cost of ICD TherapyDown by 85% Since 1990 The cost/day of ICD therapy has dropped dramatically due to reduced procedure costs, reduced LOS (less invasive implant procedure due to pectoral implants/endocardial leads, ) and increased battery life. Calculations and references in slide notes.

  42. Can the U.S. Afford The Primary Prevention of SCA with ICD Therapy?

  43. PERCEPTION: Sudden cardiac arrest is not a major problem. ICDs are a last resort for patients who survive a sudden cardiac arrest. Millions of patients meet MADIT II criteria. ICDs are being over-utilized. The current health care system cannot support treating all these patients. REALITY: SCA is the #1 cause of death in the U.S. Clinical evidence supports ICD as first-line therapy for prevention of SCA. Only a small fraction of post-MI survivors qualify for an ICD under MADIT II criteria (approximately 280,000). Very few indicated patients are actually receiving therapy today. The current health care system can afford to treat these patients. Can the US afford Expanding Indications For ICD therapy?

  44. A Closer Look at the Indicated Populations …

  45. Millions of Primary Prevention Patients?Analysis of Gross Prevalence Groups Diagrams not to scale References in Slide “Notes” Post- MI1~ 7,500k EF<40%2~1,350k EF<30%=405k 3-9 (MADIT II) EF<40%, NSVT=400k10 (MUSTT Registry) EF<40%, NSVT, Inducible VT/VF=140k11 (MUSTT) EF<35%, NSVT, inducible, non suppressible12 (MADIT) Portion of MUSTT Not Part of MADIT II = 95k

  46. Millions of Primary Prevention Patients?Analysis of Prevalence Groups The incidence (annual new cases) of total high-risk post-MI patients is estimated to be 70,000.* • 15% of the U.S. Population does not have access to healthcare. Health Insurance Coverage in the United States; 2002; U.S. Census Bureau, Current Population Survey, 2002 and 2003 Annual Social and Economic Supplements. • Of the remaining 85% who have access to health coverage, approximately 20% would not be considered for ICD therapy due to clinical exclusions (e.g., comorbidities, age, patient refusal, etc.) Source: physician interviews. • Not overlapping with MADIT II. • * Calculations in slide notes.

  47. Number of Potential ICD Therapy Candidates in the US 1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43. 2 Medtronic internal estimate. * Weighted average of Class I and Class IIa penetration estimates.

  48. Putting it in Perspective…

  49. Magnitude of SCA in the US SCA claims more lives each year than these other diseases combined 167,366 Stroke3 450,000 SCA 4 Lung Cancer2 157,400 Breast Cancer2 40,600 #1 Killer in the U.S. 42,156 AIDS1 1 U.S. Census Bureau, Statistical Abstract of the United States: 2001. 2 American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures2001. 3 2002Heart and Stroke Statistical Update, American Heart Association. 4 Circulation. 2001;104:2158-2163.

  50. 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

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