1. ICD Indications T he Guidelines and Beyond University of Minnesota Medical Center Fei Lü, M.D., Ph.D., F.A.C.C., F.H.R.S. Associate Professor of Medicine Director of Clinical Cardiac EP Laboratories

2.  Zoll PM et al (1956) external cardiac defibrillation  Mirowski M (1970) standby automatic defibrillator  FDA approved the clinical investigation of AID (2/4/1980):  The pts had to have survived at least 2 episodes of cardiac arrest not associated with an acute infarction, and VF had to be documented at least once  The first ICD was implanted in a patient with prior MI and recurrent episodes of drug-resistant VT requiring resuscitation Cardiac Defibrillation History

3. CAST Prognosis of Post-MI Patients Treated with Placebo vs. Encainide/Flecainide 80 85 90 95 100 091182273364455 Follow-up (Days) Survival (%) Placebo (n = 743) Encainide or Flecainide (n = 755) P = 0.001 10-month F/U Total mortality Placebo: 3.0% Class Ic: 7.7%

4.  Post MI, Amio reduces arrhythmias but not overall mortality (EMIAT & CAMIAT)  In CHF, a trend toward improved survival but a neutral overall survival (GESICA & CHF-STAT)  Empiric Amio is better than other AADs (CASCADE)  Primary: ICD is better than Amio (MADIT)  Secondary: ICD is better than Amio (AVID, CIDS, & CASH)  Is summary, Amio is safe to use in post-MI and CHF patients that need antiarrhythmic therapy. However, ICD should be considered as the first-choice therapy for high- risk patients. Amiodarone for Prevention of SCD Naccarelli GV et al, Curr Opin Cardiol 2000

5. Zipes DP et al; 2006

6. JACC 2008; 51(21):2085-105, May 27, 2008

7. What is New in 2008 Guidelines 1. 1.1 st prevention in NI-DCM are mainly based on SCD-HeFT data. 2. 2.ICD indications in inherited arrhythmia syndromes & selected NI-DCM are listed. 3. 3.MADIT II indication is now Class I (elevated from Class IIa). 4. 4.EF criteria for 1 st prevention are based on entry criteria for trials. 5. 5.Emphasized optimal medical Tx & reasonable expectation of survival for 1 st prevention 6. 6.Independent risk assessment is emphasized (i.e., pt preference). 7. 7.Encouraged to minimize unneeded RV pacing. 8. 8.Discouraged pm for asymptomatic brady, particularly at night. 9. 9.Discussion on ICD and pacemaker programming at end of life.

8. PACING PROTOCOL: 1 – site: RVB = RV Base LVB = LV Base RVA = RV Apex LVA = LV Apex 2 – site: LRVA = LVA+RVA LRVB = LVB+RVB RVAB = RVA+RVB LVAB = LVA+LVB 4 – site: LRVAB = LVA+RVA + RVA+RVB Lü Fei & Zipes DP, 1996 Normal vs CHF With & without AVB Positive Dp/dt max (mmHg/sec) RVB RVA LVB LVA HRA P < 0.001

9. All primary SCD prevention ICD should apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year. The 2008 Guidelines emphasize that:

10. Primary Electrical Disease Idiopathic Ventricular Fibrillation Short QT Syndrome Brugada Syndrome Catecholaminergic Polymorphic VT Primary VF Complete coronary revascularization Significant LV dysfunction Modest rise in cardiac troponin and CPK levels: Evaluation for ischemia ; Do not assume that a new MI was the cause of the VF. without other clinical data to support the occurrence of a new MI, it is reasonable to consider to be at risk for recurrent sustained VT/VF.

11.  Cardiac arrest due to VF or unstable VT  R/o any completely reversible causes  Spontaneous sustained VT with structural heart dz  Stable or unstable  Syncope of unknown etiology  With relevant inducible VT/VF  MI > 40 days,  NYHA FC II/III: LVEF < 40%,  NYHA FC I:LVEF < 30%  NSVT, prior MI, LV < 40%, inducible VT/VF  Non-ischemic DCM, LVEF ≤35%, NYHA FC II/III Class I Indications for ICD AHA/ACC Guidelines, May 27, 2008

12.  NIDCM, unexplained syncope, significant LV dysfunction  Sustained VT, normal/ near-normal ventricular function  HCM: 1 or more major risk factor for SCD  ARVD/C: 1 or more risk factor for SCD  Long-QT syndrome: syncope and/or VT while on ß-B  Brugada syndrome  syncope  documented VT  Syncope and/or documented sustained VT while on ß-B  Catecholaminergic polymorphic VT  Nonhospitalized patients awaiting transplantation  Cardiac sarcoidosis, giant cell myocarditis, Chagas dz Class IIa (Reasonable) Indications for ICD

13.  Nonischemic DCM, LVEF ≤35%,  NYHA Class I  Long QT syndrome  Risk factors for SCD  Unexplained syncope  Advanced structural heart disease  A familial cardiomyopathy  Associated with sudden death  LV noncompaction Class IIb Indications for ICD (may be considered)

14. –Expected survival < 1 year –Incessant VT or VF –Significant psychiatric illnesses –NYHA Class IV CHF: drug-refractory, not candidates for OHT or CRT-D –Syncope of undetermined cause No inducible ventricular tachyarrhythmias and No structural heart disease. –VF/VT is amenable to surgical or catheter ablation –Ventricular tachyarrhythmias A completely reversible disorder and No structural heart disease Class III Indications for ICD

15. Cost-Effectiveness of ICD  Cost per (quality adjusted) life-year saved:  MADIT I:$27,000  MADIT II: $235,000 (≥$66,700 at 12 yrs)  SCD-HeFT:$38,389 (41,530)  CIDS:$139,000  Cost per implant ($32,578 MADIT II data)  Hospital & MD cost: ~ $50,000 (SCD-HeFT data)  ICD  Single chamber system:$17,500  Dual chamber system: $21,760  Renal dialysis (standard benchmark): $30,000-50,000

16. US Expenditures for ICDs (2002) TherapyCost ($billions)% NHE ICD 2.3 0.2 Viagra 2.3 0.2

17. Myerburg RJ et al, 1992

18. Positive Predictive Value Lü Fei, Malik M, & Camm AJ, 1994   Ongoing residual ischemia   Ventricular arrhythmias   Depressed LV function   Others