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Approaches to the Prevention of Sudden Death

This article discusses the effectiveness of ICD therapy in the prevention of sudden death and provides data on the relative reduction in mortality, number needed to treat, and long-term benefits. It also explores the cost-effectiveness of ICD therapy and identifies predictors of mortality in patients receiving ICD treatment.

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Approaches to the Prevention of Sudden Death

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  1. APPROACHES TO THE PREVENTION OF SUDDEN DEATHHow Well Do ICDs Work ? Gianluca Botto, MD, FESC Sant’ Anna Hospital, Como

  2. ICD Rx in Primary & Secondary PreventionEffect on Total Mortality Relative Reduction = 25% Absolute Reduction = 7% Number Need to Treat = 15 Lee DS JACC 2003; 41: 1573 Relative Reduction = 25 Absolute Reduction = 8% Number Need to Treat = 12 Nanthakumar K. JACC 2004; 44: 2166-72

  3. 62% Non-ICD 49% MADIT II Long-Term8-Year All-Cause Mortality FU 20 ms 0,17 LYS AR = 6% NNT = 17 Efficacy Analysis HR 0.66 (0.56-0.78) FU 8 ys 0,52 LYS AR = 13% NNT = 8 The long-term benefit was also evident in an ITT analysis. P= 0.017

  4. Number Needed to Treat to Save One Life NNTx years = 100 /(%Mortality in Control Group – %Mortality in Treatment Group) Drug Therapy ICD Therapy (5 Yr) (3 Yr) (3.8 Yr) (3 Yr) (3 Yr) (4 Yr) (1 Yr) (2 Yr) (1 Yr) (6 Yr) (5 Yr) (30 dy) Botto GL It Heart J 2005; 6: 210-215 modif.

  5. 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) Lovastatin(chol. = 290 mg/dL,50 yrs old, male, no riskfactors) CABG(Chronic CAD,mild angina,3 VD) Pre Prticipation Screening (Young Athlets) Primarycoronarystenting (CAD,Angina, 1 VD,Male, age 55) Hypertensiontherapy(Diastolic95-104mmHg) ICD AVID ICD- MADIT II ICD- MADIT (Transvenous) Various Articles 2010

  6. Drugs ICD ICD In Severe LV Disfunction Giant stadium NY “…the game was stopped at the 5th inning because of obvious superiority of the antagonist (i.e. ICD)

  7. U.S. HF Device Market Adoption - 2008 Courtesy of E. Pristowsky

  8. Real World Example of Inadequate Access to Rx for Patients Eligible ICD candidate hospitalized for HF N=13.034 Overall percent of eligible pts receiving an ICD was 35,4 %- white man 43,6%- black men 33,4%- white women 29,8%- black women 29,8 Less than 40% of potentially eligible pts hospitalized for HF received ICD Rx. Rate of use were lower among women and black patients Hernandez JAMA 2007; 298: 1525-32

  9. Merkely B. EUROPACE 2010

  10. EF is NOT The Ideal Risk Stratification Test For Deciding Whether to Implant an ICD for Preventing SCD

  11. 48% of Known EF ICD Indicated 30% Oregon Cardiac Arrest Registry N° of SCA Patients Daubert JP. HRS Late Breacking Trials 2008

  12. Total Mortality, Arrhythmic Death / CARelation with EF Buxton AE. Circulation 2002; 102: 2466-2472

  13. Cost-Effectiveness of ICD TherapyRole of Mortality Rate and Mode of Death Cowie RM. Europace 2009; 11: 716-726

  14. 15.9% 36.8% 11.5% Mortality 45.5 months (3.8 years) Patients (%) Poole JE. N Engl J Med 2008; 359: 1009

  15. Reduced EF is single most important RF for overall mortality and SD MTWA 17,8 3,8 I’m sure you’ll hear all the virtues of methods to further risk stratify patients at risk for SCD Bailey JJ. J Am Coll Cardiol 2001; 38: 1902-11 modif.

  16. How Strong a RF is Necessary to Discriminate Pts @ Risk for SCD ?Probability Distibutions of a Marker Pepe MS. Am J Epidemiology 2004; 159: 882-890

  17. Deliver ICD Therapy to Those Who Need It “Trade-off” B/ween Therapeutic Efficiency and Risk Costantini O. The ABCD Trial JACC 2009; 53: 471-9 (modif.)

  18. Risk Stratification in MADIT-IIProbability of Survival in Intermediate Risk Pts • EF ≤ 25% • Age ≥ 72 ys • Atrial fibrillation • NYHA III-IV • Creatinine ≥ 1.4 mg/dl • QRS > 0.13 1 Risk Factors 2 Risk Factors Goldenberg I. JACC 2008; 51: 288-96

  19. Risk Stratification in MADIT-IIProbability of Survival in Very Low and High Risk Patients • EF ≤ 25% • Age ≥ 72 ys • Atrial fibrillation • NYHA III-IV • Creatinine ≥ 1.4 mg/dl • QRS > 0.13 ≥ 0 Risk Factors ≥ 3 Risk Factors Goldenberg I. JACC 2008; 51: 288-96

  20. U-Shaped Curve for ICD Efficacy Goldenberg I, et al. J Am Coll Cardiol 2008; 51: 288

  21. Risk Stratification in MADIT-IIPredictors of Long-Term Mortality(655 pts – 9-year follow-up) Cygankiewicz I. Heart Rhythm 2009: 6: 468-473

  22. Atrial Fibrillation in ICDs RecipientsEffects on Mortality Deneke T. Europace 2004; 6: 151-158

  23. Cost-Effectiveness of ICD Rx by Age Chan PS. Circ Cardiovasc Qual Outcomes 2009; 2: 16-24

  24. Mortality in Pts with CKD and ICD TxSerum Creatinine / Estimated GFR Korantzopoulos P. Europace 2009; 11: 1469-1475

  25. Bai R. – Natale A. J Cardiovasc Electrophysiol 2008; 19: 1259-1265 After CRT implant, chronic renal failure, diabetes mellitus, and history of AF are strong independent predictors of death Mortality in HF Pts After CRT Identification of Predictors

  26. Acute Device ComplicationsAmong 17.804 Patients Swindle JP. Arch Intern Med 2010: 170: 631-637

  27. Unresolved Issues in ICD Rx • Cardiologist and Electrophysiologist are dealing with pts who have multiple concomitant diseases • GLs based on RCT should not be employed w/out first carefully considering all the factors that might influence the treatment decision in an individual pt • Comorbid conditions will limit any potential benefit from an ICD implant (avoid risks and costs) • This principle should also apply to decision regarding elective ICD generator replacements for battery depletion

  28. Potential Barriers ti the Dissemination of ICD Rx • HCP / Institutional level • Difficulty identifieng pts • Limited stuff capacity • Lack of funding for ICD Rx • Lack of applicability of RCT • Concern over the relative benefit at an individual pts level • Concern over the safety of ICD and leads • Dissatisfaction with the high rate of inappropriate shock • Need for better tools to stratify pts for SCD • HCP biases and cultural influences Patient level • Difficulty understanding risks • Concern over the safety of ICD • Concern over the impact on QOL • Skepticism about the benefit of ICD expecially in the absence of symptoms • Personal biases and cultural influences • Purchaser / Payer level • The cost of ICD Rx • The very high numbers of eligible pts fpr primary prevention ICDs

  29. How Well Do ICDs Work ?Conclusion • ICDs Rx has proved effective in preventing SD • Significant barriers to implementation remain with respect to:- identification of pts @ risk - cost of the Rx - acceptance of ICDs by pts and providers • Effort should focused to facilitate dissemination of ICD Rx- better tools to risk-stratify pts for SCD - educating pts and HCPs about SCD and ICDs - improving ICD technology to enhance safety and reduce the risk of inappropriate shocks

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