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Prevention of Sudden Cardiac Death

Prevention of Sudden Cardiac Death. Mark Greenberg, MD. Magnitude of Sudden Cardiac Arrest in the U.S. 167,366. Stroke 3. 450,000. Sudden cardiac arrest claims more lives each year than these other diseases combined. Sudden Cardiac Arrests 4. Lung Cancer 2. 157,400. #1 Killer in the U.S.

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Prevention of Sudden Cardiac Death

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  1. Prevention of Sudden Cardiac Death Mark Greenberg, MD

  2. Magnitude of Sudden Cardiac Arrest in the U.S. 167,366 Stroke3 450,000 Sudden cardiac arrest claims more lives each year than these other diseases combined Sudden Cardiac Arrests4 Lung Cancer2 157,400 #1 Killer in the U.S. 40,600 Breast Cancer2 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 Zheng Z. Circulation. 2001;104:2158-2163.

  3. 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 Sudden Cardiac Death Zipes DP. Circulation. 1998;98:2334-2351. Pitt B. N Engl J Med. 2003;348:1309-1321.

  4. Secondary Prevention of SCD--Conclusions from Three RCT’s • The ICD is first-line therapy for patients with hemodynamically-compromising primary ventricular tachyarrhythmias (relative mortality reduction of 27% compared to medication). • Benefit of ICD mainly with EF<35%, and is independent of beta blocker use. • Further study is required to assess the cost-efficacy of the ICD in other patient subsets (EF>35%, well-tolerated VT, secondary VT/VF).

  5. 2000 • CardiacResynchro-nization* • 1980 • First HumanImplant • 1985 • FDA Approvalof ICDs • 1993 • SmallerDevices • 1996 • SteroidLeads • MADIT 100,000 • 1999 • MUSTT 90,000 • 1989 • TransvenousLeads • BiphasicWaveform 80,000 70,000 60,000 50,000 • 1988 • TieredTherapy • 1997/98 • DC ICDs • AT Therapies • AVID • CASH • CIDS 40,000 30,000 20,000 10,000 0 Number of Worldwide ICD Implants Per Year* Under clinical investigation in the US Evolution of ICD Therapy: 1980 to Present 1980 1985 1990 1995 2000 E

  6. Implantable Cardioverter Defibrillator First-line therapy for patients at risk for VT/VF • Small devices, pectoral implant site • Transvenous, single incision • Local anesthesia; conscious sedation • Short hospital stays • Few acute complications • Perioperative mortality < 1% • Programmable therapy options • Single- or dual-chamber therapy • Battery longevity up to 9 years • 80,000 implants/year (2000 E)1 1Morgan Stanley Dean Witter. Investors Guide to ICDs. 2000.

  7. Syncope with structural heart disease is a risk factor for sudden cardiac death.

  8. “Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factorfor overall mortality and sudden cardiac death.”1 1Prior SG, Aliot E, Blonstrom-Lundqvist C, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology. Eur Heart J, Vol. 22; 16; August 2001.

  9. MULTICENTER AUTOMATIC DEFIBRILLATOR IMPLANTATION TRIAL-II (MADIT-II) 1997-2001A trial designed to evaluate the effect of prophylactic ICD therapy on survival in patients with prior MI and LV dysfunction. Supported by a research grant from Guidant Corp.

  10. MADIT-II: Eligibility • Chronic CAD with prior MI • EF<0.30 • No requirement for NSVT or EPS • No upper age limitation

  11. MADIT-II: MEDS at Last Follow-Up CONV DEFIB (n=490) (n=742) percent • ACE inhibitors 72 68 • Amiodarone 10 13 • Antiarrhythmics 2 3 • Beta-blockers 70 70 • Digitalis 57 57 *No significant differences between CONV and DEFIB groups.

  12. MADIT-II: CONCLUSION • In coronary patients with LVEF <0.30, prophylactic ICD therapy is associated with 31% reduction in mortality. • This improved survival is on top of optimal medical Rx.

  13. ICD Cost-Effectiveness Results for High Risk Post-MI Patients $100,000 • MUSTT patients are similar to MADIT patients. • ICD therapy is cost-effective for high risk post MI patients. Other Therapies Conclusions Expensive $80,000 $60,000 $57,300 Borderline Cost-Effective $LYS $44,300 $40,000 $28,400 Cost-Effective $22,800 $16,900 $20,000 Highly Cost-Effective $0 8 yr ICD Transvenous ICD Captopril Post MI EF < .402 Cardiac Transplant CHF Transplant Candidate2 Peritoneal Dialysis3 MADIT Patient1 1 Mushlin A. Circulation. 1998;97:2129-35. 2 Kupersmith J. Progress in Cardiovascular Diseases. 1995;37:307-46. 3 Kupperman M. Circulation. 1990;81:91-100.

  14. 60% 54% 31% 31% 20% NS AVID13 years CIDS23 years MADIT32 years MUSTT42 years MADIT II52 years ICD Trials Summary 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Connolly SJ. Circulation. 2000; 101; 1297-1302. 3 Moss AJ. N Engl J Med. 1996;335;1933-1940. 4 Buxton AE. N Engl J Med. 1999; 341:1882-90. 5 Moss AJ. N Engl J Med. 2002;346:877-83.

  15. MADIT II Milestones 2002-2003 NEJM publication FDA approval ACC/AHA/NASPE Guidelines updated BCBS, Aetna, Kaiser recommend coverage Modified CMS approval

  16. CMS double bind “You need an ICD, but it may not be reimbursed.”

  17. SCD-HeFT Hypothesis In patients with moderately symptomatic CHF and LVEF <=35%, amiodarone and/or ICD added to standard medical Rx will be associated with reduced mortality compared with standard medical Rx alone.

  18. SCD-HeFT Patient Characteristics • Patients enrolled: 2521 • NYHA Class: 70% NYHA II, 30% NYHA III • Median follow-up: 45.5 months • Median age: 60 years • % female: 23% • Median EF: 25% • Concomitant Rx: ACE 72%, beta blocker 78%

  19. Mechanism Linking MTWA toVentricularArrhythmias Long APD Region Short APD Region Long APD Short APD Long APD Short APD Spatially Discordant Alternans Leads to Dispersion of Recovery, Wave Front Fractionation, and Reentry Action Potential Alternans Leads to T-Wave Alternans

  20. Patient MS:Modified Bruce Protocol

  21. TWA + TWA + Equivalency Between TWA and EPS + 10 % EPS + - 10 % EventRate 1 year Time

  22. “Ultimately, risk stratification will be important only if it can be coupled with a therapeutic intervention that reduces the risk of dying.” Zipes and Wellens. Sudden Cardiac Death. Circulation. 1998;98:2334-51.

  23. Population Size SCD Percent / Year Total SCD / Year High Coronary Risk Post MI Heart Failure/ E F < 35%) Syncope / Heart Disease Previous VF / VT 0 50 100 200 300 20 0 1 2 5 10 0 1 2 5 10 20 50 (thousands) (percent) (millions) High Risk Groups for SCD Adapted from Myerburg

  24. Sudden Cardiac Death: Management Strategies • Salvage and treat (too few are salvaged). • Predict and prevent (pathophysiology complex, positive predictive value of risk stratifiers relatively low).

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