ICDs have been available since the 80s for the prevention of sudden cardiac death. The advancements are quite amazing, with a reduction in size from >250cc to less than 40cc, ease of implantation, safety and longevity.
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
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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)
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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
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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
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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
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8. Antiarrhythmic drugs may worsen survival.
Amiodarone may slightly improve
mortality.
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9. Dr. Michel Mirowski
◦ Friend died of SCD
Concept:
◦ could a defibrillator be
implanted in the body?
Technological
challenges
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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
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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
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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
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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
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
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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