Cardiac Device Therapy Cardiac Electrophysiology
Abrar H. Shah M.D.
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Disclosures Speaker declared research support from: Biotronik Medtronic Speakers bureau: Boehringer Ingelheim
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Cardiac Device Therapy
Pacemaker
Implantable Cardioverter Defibrillator
Bi-Ventricular Pacemaker
Implantable Loop Recorder
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Permanent Pacemaker
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Indication for Pacemaker
Symptomatic Bradycardia.
Sinus Node Dysfunction – Sinus Node Pauses (> 3 sec) – Chronotropic Incompetance – Bradycardia as a result of needed medical therapy
AV Block – Mobitz II – Complete Heart Block – Pause of > 5 sec in patient with atrial fibrillation.
Alternating bundle-branch block
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Lyme Disease
A-V Block resolves spontaneously.
Lyme Disease is Borrelia Burgdorderi
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A-V Block
Sarcoid
Amyloid
Neuromuscular Disorder – Myotonic muscular dystrophy – Kearns-Sayre Syndrome – Erb dystrophy
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Bifascicular Block
-Syncope -HV > 100 msec -Intermittent Type II or third degree AV Block “Helping You to a Healthy Heart”
Third International Study on Syncope of Uncertain Etiology (ISSUE-3):
77 patients were at least 40 years old and had a clinical history that suggested NMS
ILR monitoring, demonstrated at least three seconds of asystole associated with clinical syncope or an asystolic nonsyncopal episode of at least six seconds.
The pacemaker-on group showed a 57% reduction in relative risk of fainting within two years of randomization (p=0.039).
Circulation. 2012;125:2566-2571 “Helping You to a Healthy Heart”
Implantable Cardioverter Defibrillator For Primary and Secondary Prevention of Sudden Cardiac Death
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Magnitude of SCA in the US
Stroke3
Lung Cancer2
SCA claims more lives each year than these other diseases combined
SCA 4
Breast Cancer2 AIDS1
1 2 3 4
U.S. Census Bureau, Statistical Abstract of the United States: 2001. American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001. 2002 Heart and Stroke Statistical Update, American Heart Association. Circulation. 2001;104:2158-2163. “Helping You to a Healthy Heart”
Underlying Arrhythmia of Sudden Cardiac Arrest Primary VF 8% Torsades de Pointes 13%
VT 62%
Adapted from Bayés de Luna A. Am Heart J. 1989;117:151-159. “Helping You to a Healthy Heart”
Bradycardia 17%
Etiology of SCA
5% Other*
15% Cardiomyopathy
80% Coronary Artery Disease
Adapted from Heikki et al. N Engl J Med, Vol. 345, No. 20, 2001. * ion-channel abnormalities, valvular or congenital heart disease, other causes
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Evolution of ICD Therapy: 1980 to Present 1980
1985
1993
1996
2002-4
• First Human Implant
• FDA Approval of ICDs
• Smaller Devices
MADIT
• MADIT II • SCD-HeFT • COMPANION 100,000
1999
1989
90,000
• MUSTT
• Transvenous Leads
80,000 70,000 60,000 50,000
1997/98 • DC ICDs • AT Therapies • AVID • CASH • CIDS
40,000 30,000 20,000 10,000 0
1980
1985
1990
Number of Worldwide ICD Implants Per Year * Under clinical investigation in the US
1995
2000 E “Helping You to a Healthy Heart”
Therapies Provided By ICDs
Ventricle
Atrium & Ventricle
Antitachycardia pacing
Bradycardia sensing
Cardioversion
Bradycardia pacing
Defibrillation
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Primary Prevention Trials
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Primary Prevention Trials: Benefit of ICD therapy. MADIT
MADIT II Moss et al, NEJM 1996
Moss et al, NEJM 2002
MUSTT
Buxton et al, NEJM 1999
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SCD HeFT Sudden Cardiac DeathHeart Failure Trial
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Indication for ICD for Primary Prevention in Patients With Cardiomyopathy Nonischemic
Ischemic
Ischemic
Ischemic
CMP (9 months)
CMP
CMP
CMP & NSVT
EF < 35%
EF < 30% *
EF 31-35% *
EF < 40%
Class I
Yes
If + EPS
Class II
Yes
Yes
Yes
If + EPS
Class III
Yes
Yes
Yes
If + EPS
Only if CRT
Only if CRT
Class IV Only if CRT SCD-HeFT + COMPANION
MADIT II + COMPANION
SCD-HeFT + COMPANION
Contraindication: Life expectancy < 1 yr. * No MI in 40 days or revascularization in 3 months for ischemic CMP.
MUSTT: NSVT at least 4 days after Cardiac event “Helping You to a Healthy Heart”
Continuum of Risk of Sudden Cardiac Death
Myerburg R et al. Circulation 1998, 97:1514-1521 “Helping You to a Healthy Heart”
Secondary Prevention Trials
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Reductions in Mortality with ICDs Secondary Prevention Trials
% Mortality Reduction
60% 50% 37%
40% 31% 30%
20% 20 % 10% 0%
AVID1
CASH2
CIDS3
3 years
2 years
3 years
1
The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Kuck K. ACC98 News Online. April, 1998. Press release.
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3
Connolly S. ACC98 News Online. April, 1998. Press release.
ICD in Hereditary Arrhythmia Patients
Long QT syndrome
ARVD
Brugada Syndrome
Hypertrophic Cardiomyopathy
Short QT syndrome
Catecholenergic Polymorphic Ventricular Tachycardia
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Number Needed to Treat To Save A Life NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)
50
Drug Therapy
45 40 35
26
30
ICD Therapy
25
20
28
simvastatin
20 11
15 10
3
metoprolol
9
captopril
4
5 0 MUSTT (5 Yr)
MADIT (2.4 Yr)
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MADIT II (3 Yr)
AVID (3 Yr)
SAVE (3.5 Yr)
Merit-HF (1 Yr)
4S (6 Yr)
Cardiac Resynchronization on Morbidity and Mortality in Heart Failure: Care-HF trial
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Death and Hospitalization for Major Cardiovascular Event
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Reduction in all cause Mortality with BiV Pacemaker
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MADIT CRT
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A. Moss: N Engl J Med 2009; 361:1329-1338
Conclusions
“Calculations based on hazard ratios suggest that, for every nine devices implanted, one death and three hospitalizations for major cardiovascular events are prevented.”
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Indication for Biventricular Pacemaker
Class I-IV heart failure despite medical therapy.
QRS > 120 msec (LBBB)
LV ejection fraction < 35%
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Implantable Loop Recorder
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Early application of an ILR allows effective specific therapy in patients with recurrent suspected NMS
Eur Heart J (2006) 27 (9): 1085-1092. “Helping You to a Healthy Heart”
Syncopal recurrence of the total population undergoing ILR implantation (Phase I) and of the two subgroups of patients who received ILR-based specific therapy
Brignole M et al. Eur Heart J 2006;27:1085-1092
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