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History of ICDs (Internal Cardiac Defibrillators)
- 2. SCD is the most common cause of death in the U.S. Incidence: 300,000 to 400,000 each year (U.S.) Only 2% – 15% reach the hospital Half of these early survivors die before discharge www.theafcenter.com
- 3. Overall Incidence in Adult Population High Coronary Risk Sub-Group Any Prior Coronary Event EF < 30% Heart Failure Out-of-Hospital Cardiac Arrest Survivors Convalescent Phase VT/VF After MI Source: Myerburg RJ. Circulation. 1992;85(suppl I):I-2 – I-10. 3020105210 3002001000 (%) (x 1000) Incidence (%/Year) Total Events (#/Year) www.theafcenter.com
- 4. Antiarrhythmic Drug Trials “Prevention” Of SCD www.theafcenter.com
- 5. CAST I – Cardiac Arrhythmia Suppression Trial (1991) CHF STAT – Congestive Heart Failure: Survival Trial of Antirarrhythmic Therapy (1992) ESVEM – Electrophysiologic Study versus Electrocardiographic Monitoring (1993) GESICA – Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (1994) SWORD – Survival with Oral d-Sotalol (1996) CAMIAT – Canadian Amiodarone Myocardial Infarction Arrhythmia Trial (1997) EMIAT – European Myocardial Infarction Amiodarone Trial (1997) SCD Prevention Trials: Antiarrhythmic Drugs www.theafcenter.com
- 6. Echt DS. N Engl J Med. 1991;324:781-788. 80 85 90 95 100 0 91 182 273 364 455 Days After Randomization PatientsWithoutEvent(%) Placebo (n = 743) Encainide or Flecainide (n = 755) P = 0.001 CAST I – Prognosis of Post-MI Patients www.theafcenter.com
- 7. Waldo AL. Lancet. 1996;348:7-12. 1.00 0.98 0.94 0.92 0.90 0.88 60 240 300 Time from randomization (days) Proportionevent-free Placebo d-sotalol P = 0.006 1801200 0.96 SWORD – Survival with d-sotalol vs. Placebo www.theafcenter.com
- 8. Antiarrhythmic drugs may worsen survival. Amiodarone may slightly improve mortality. www.theafcenter.com
- 9. Dr. Michel Mirowski ◦ Friend died of SCD Concept: ◦ could a defibrillator be implanted in the body? Technological challenges www.theafcenter.com
- 13. Primary Prevention Antiarrhythmic Drug and ICD Trials www.theafcenter.com
- 14. CASH – Cardiac Arrest Study Hamburg (1994) AVID – Amiodarone versus Implantable Defibrillator (1995) MADIT – Multicenter Automatic Defibrillator Implantation Trial (1996) CABG-Patch – Coronary Artery Bypass Graft Patch Trial (1997) MUSTT – Multicenter Unsustained Tachycardia Trial (1999) CIDS – Canadian Implantable Defibrillator Study (2000) MADIT II – Multicenter Automatic Defibrillator Implantation Trial (2002) www.theafcenter.com
- 15. Hypothesis Prophylactic implantation of an ICD in high arrhythmic risk patients with: • MI 3 weeks prior • LVEF 35% • Inducible/nonsuppressible sustained VT and • Asymptomatic NSVT (3–30 beats) … significantly reduces all-cause mortality compared to conventional medical management (AA Rx therapy). Moss, et al. New Engl J Med. 1996; 335:1933-40. www.theafcenter.com
- 16. 1.0 0.8 0.6 0.4 0.2 0.0 0 1 2 3 4 5 Year Probabilityofsurvival Conventional therapy Defibrillator No. of patients Defibrillator 95 80 53 31 17 3 Conventional 101 67 48 29 17 0 therapy Moss, et al. New Engl J Med. 1996; 335:1933-40. www.theafcenter.com
- 17. Hypothesis ICD therapy will improve overall survival in patients with: • Prior infarct • EF < 30% Moss Ann Noninvasive Electrocardiol 1999, 4:83-91. www.theafcenter.com
- 18. Moss et al. N Engl J Med 2002;346:877-83. ICD Conventional P = 0.007 1.0 0.9 0.8 0.7 0.6 0.0 Probabilityof Survival 0 1 2 3 4 YearNo. At Risk Defibrillator 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3 Reduction in death rate with ICD Rx: 12% at 1 yr, 28% at 2 yrs, 28% at 3 yrs www.theafcenter.com
- 19. 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. % Reduction in Mortality with ICD 0 20 40 60 80 MADIT MUSTT MADIT II 2 3 54% 75% 55% 73% 31% 61% 27 Months 39 Months 20 Months 1 Risk Reduction – All-Cause Death Risk Reduction – Arrhythmic Death www.theafcenter.com
- 23. Large devices – Abdominal site First human implants Thoracotomy, multiple incisions 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 www.theafcenter.com
- 24. Small devices – Pectoral site First-line therapy for VT/VF patients Transvenous, single incision Local anesthesia; conscious sedation Short hospital stays Few complications Perioperative mortality < 1% Programmable therapy options Single- or dual-chamber therapy Battery longevity up to 9 years ~100,000 implants/year www.theafcenter.com
- 25. Implanting Physician Cardiac surgeon EP Device size >200cc < 40 cc Procedure Median sternotomy Skin incision Lateral thoracotomy Procedure time 2 - 4 hours 1 hour Perioperative 2.5% < 0.5% mortality Post-implant 3 - 5 days 1 day hospitalization Battery longevity 18 months Up to 9 years Thoracotomy Transvenous/ Pectoral www.theafcenter.com
- 26. Number of Worldwide ICD Implants Per Year 1980 • First Human Implant 1985 • FDA Approval of ICDs 1989 • Transvenous Leads • Biphasic Waveform 1993 • Smaller Devices 1996 • Steroid Leads • MADIT 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000 100,000 1980 1985 1990 1995 2000 E 1999 • MUSTT • AT Therapies 1997/98 • DC ICDs • Size Reduction • AVID • CASH • CIDS 1988 • Tiered Therapy
- 27. $56,679 $44,128 $99,081 0 20,000 40,000 60,000 80,000 100,000 Postoperative Hospitalization 11.6 days 3.8 days 2.9 days Source: Cardinal DS. Am J Cardiol. 1996;78:1255-1259. Charges(U.S.$) Epicardial Implantation Abdominal Implantation w/o Thoracotomy Pectoral Implantation www.theafcenter.com
- 28. Medtronic Implantable Defibrillators (1989-2001) 209 cc 113 cc 80 cc 80 cc 72 cc 54 cc 62 cc 49 cc 39.5 cc 39 cc 39.5 cc39.5 cc 39 cc 36 cc www.theafcenter.com
- 31. Procedural Risks Leads – the weakest link ◦ Infections ◦ Lead degradation/Fracture ◦ Venous occlusion ◦ Explantation Risks Patients with no pacing indications 33www.theafcenter.com
- 32. Proven therapy for SCD ◦ Patients at high risk Prolong Survival ◦ Cost-effectiveness Significant advancements Lead ◦ Weakest link 34www.theafcenter.com