Disclosures: John D. Hummel, M.D.

Research Grants: Boston Scientific, Medtronic, EP Medsystems, and

St Jude Medical

Speakers Bureau/Honoraria: Boston Scientific,

Medtronic, and St Jude Medical

Advisory Boards: Boston Scientific, Medtronic, and

St Jude Medical

Personal Investment: None

Prevention of Sudden Cardiac Death: Prevention of Sudden Cardiac Death: Increasing Awareness In 2006Increasing Awareness In 2006

John D. Hummel, M.D.

Mid-Ohio Cardiology and Vascular

Consultants

Riverside Methodist Hospital

Columbus, Ohio

Why We Talking About This Today?Why We Talking About This Today?

• There are patients currently in cardiology and primary care clinics who are at risk for Sudden Cardiac Arrest (SCA)

• For those who have an arrest, 95% of them will die (without an ICD).

• There is a simple indicator to assess who is at risk for SCA: Ejection Fraction (EF)

Leading Causes of Death in the USLeading Causes of Death in the US

1 National Vital Statistics Report, Vol 49 (11), Oct. 12, 20012 MMWR. State-specific mortality from sudden cardiac death – US 1999.Feb 15, 2002;51:123-126.

Sudden cardiac arrest (SCA)

0% 5% 10% 15% 20% 25%

Septicemia

Nephritis

Alzheimer’s Disease

Influenza/pneumonia

Diabetes

Accidents/injuries

Chronic lower respiratory diseases

Cerebrovascular disease

Other cardiac causes

All cancers

Only after the deaths from ALL cancers are combined does

anything cause more deaths each year than sudden cardiac arrest .

- ~450,000 per year1

1200 per day• 50 every hour

• 1 every 80 seconds

- Although SCA is the first presentation of cardiac disease in 20-25% of patients, most cases occur in patients with clinically recognized heart disease.2

Magnitude of SCA in the USMagnitude of SCA in the US

1Circulation. 2001;104:2158-2163.

2 Myerburg RJ, Castellanos A. Cardiac Arrest and Sudden Cardiac Death, in Braunwald E, Zipes DP, Libby P, Heart Disease, A textbook of Cardiovascular Medicine. 6th ed. 2001. W.B. Saunders, Co.

Treatments to Reduce SCATreatments to Reduce SCA

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

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

Cause of SCACause of SCA

Albert CM. Circulation. 2003;107:2096-2101.

12%Other Cardiac

Cause

88%Arrhythmic

Cause

Bayés de Luna A. Am Heart J. 1989;117:151-159.

Underlying Arrhythmias of Underlying Arrhythmias of Sudden Cardiac ArrestSudden Cardiac Arrest

Bradycardia17%

VT62% Primary VF

8%

Torsades de Pointes13%

Cummins RO. Annals Emerg Med. 1989;18:1269-1275.

SCA Resuscitation Success vs. Time*SCA Resuscitation Success vs. Time*

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9

% Success

*Non-linear DFT

Time (minutes)

Chance of success reduced 7 - 10% each minute

SCA Chain of Survival StatisticsSCA Chain of Survival Statistics

• 5% estimated SCA out-of-hospital survival2,3

• Even in the best EMS/early defibrillation programs it is difficult to have high survival times due to many SCA events not being witnessed and the difficulty of reaching victims within 6-8 minutes.

– 40% SCAs not witnessed or occur in sleep1

– 80% SCAs occur at home1

1 Swagemakers V. J Am Cardiol. 1997;30:1500-15052 Ginsburg W. Am J Emer Med. 1998;16:315-319.3 Cobb LA. Circ. 1992;85:I98-102.

Community Survival Rates Before and After Early Community Survival Rates Before and After Early Defibrillation Programs (AED’s)Defibrillation Programs (AED’s)

Ornato JP. Community experience in treating out-of-hospital cardiac arrest. In: Akhtar M. Sudden Cardiac Death. Baltimore, Md: Williams & Wilkins; 1994:450-462.

0

5

10

15

20

25

30

King County,WA

Iowa SE Minnesota NE Minnesota Wisconsin

Before Early DF

After Early DF

VF

Su

rviv

al

26%

19%17%

10% 11%

7%

3% 4% 3% 4%

What About the High Risk Population?What About the High Risk Population?

““People who’ve had People who’ve had a heart attack have a a heart attack have a

sudden death rate that’s sudden death rate that’s 4-6 times 4-6 times

that of the general population.” that of the general population.”11

1American Heart Association. Heart Disease and Stroke Statistics—2003 Update. Dallas, Tex.: American Heart Association; 2002.

In people diagnosed with CHF, In people diagnosed with CHF, sudden cardiac death occurs at sudden cardiac death occurs at 6-9 6-9

timestimes the rate of the general the rate of the general population.population.11

1 American Heart Association. Heart and Stroke Statistical –2003 Update. Dallas, Tex.: American Heart Association: 2002.

Survival After Acute MISurvival After Acute MI

Bigger JT. Am J Cardiology. 1986;57:12B.

3210

ABCD

0.4

0.6

0.8

1.0S

urv

ivo

rsh

ip

N 5361138037

EF 30

%30

%30

%30

%

VPD 10/hr10/hr< 10/hr 10/hr

0.2

Year

A

BC

D

CAST TRIAL CONCLUSIONSCAST TRIAL CONCLUSIONS

This is your Heart This is your Heart on Drugs

Primary PreventionPrimary PreventionICD Trials ICD Trials

• MUSTT

• MADIT – II

• SCD-HeFT

Post-MI

Ischemic and Non-ischemic

MUSTT Results, Total Mortality: MUSTT Results, Total Mortality: Pts With EF≤40%, NSVT EP (Inducible VT)Pts With EF≤40%, NSVT EP (Inducible VT)

Time after Enrollment (Years)0 1 2 3 4 5

0

0.1

0.2

0.3

0.4

0.5

0.6

Ev

ent

Ra

te

p < 0.001

Best Medical Therapy + AA drugs

Best Medical Therapy

Best Medical Therapy + ICDSurveillance

Reduced left ventricular ejection fraction (LVEF) Reduced left ventricular ejection fraction (LVEF) remainsremains the single most important risk factorthe single most important risk factor for for

overall mortality and sudden cardiac arrest.overall mortality and sudden cardiac arrest.

Patients withoutLV Dysfunction

(LVEF >35%)Patients with

LV Dysfunction

(LVEF < 35%)

No PVBs

1-10 PVBs/h

> 10 PVBs/h

0.86

A

0.88

0.90

0.92

0.94

0.96

0.98

1.00

0 30 60 90 120 150 180

Days

Su

rviv

al

p log-rank 0.002

0.88

0.90

0.92

0.94

0.96

1.00

0 30 60 90 120 150 180

Days

Su

rviv

al

B

p log-rank 0.0001

0.86

Maggioni AP. Circulation. 1993;87:312-322.

Inclusion: Q-wave MI > 4 weeks, LVEF <30%

ICD implant n=742 No-ICD implant n=490

(EPS after implant) (Conventional Post-MI drug Rx)

20 months mean follow- up

• Avoid AAD

• Optimize: B, ACE-I, Diuretics

MADIT II ProtocolMADIT II Protocol

Moss AJ. N Engl J Med. 2002;346:877-83.

MADIT-II Survival ResultsMADIT-II Survival Results31% Relative Reduction in Mortality31% Relative Reduction in Mortality

Study Stopped EarlyStudy Stopped Early

Defibrillator 14% Mortality

Conventional Medical Therapy 20% Mortality

p = 0.007

1.0

0.9

0.8

0.7

0.6

0.0

Pro

babi

lity

of S

urvi

val

0 1 2 3 4

Year

19.8%

14.2%

0.00%

10.00%

20.00%

Conventional Therapy ICD Therapy

Moss AJ. N Engl J Med. 2002;346:877-83.

MADIT II: All-Cause MortalityMADIT II: All-Cause Mortality

Hazard Ratio=

0.69

(p= 0.016)

31% Relative Reduction

N= 490 N= 742

Risk of Sudden Death in HF TrialsRisk of Sudden Death in HF TrialsStudy HF

ClassControl

(n)

Treat-ment

(n)

Total Mortality Reduction

w/Treatment

Sudden Death as % of Total Death in

Control Arm

Sudden Death- as a % of Total Death in Treatment Arm

MERIT-HF1

(Metroprolol)

2-4 2001 1990 34% (60%)

132/217

(54%)

79/145

BEST2

(Bucindolol)

3,4 1354 1354 10% (45%)

203/449

(44%)

182/411

CIBIS-II3

(Bisoprolol)

3,4 1320 1327 34% (36%)

83/228

(31%)

48/156

CARVEDILOL- (U.S.)4

2-4 398 696 65% (48%)

15/31

(54%)

12/22

RALES5 3, 4 841 882 30% (28%)

110/386

(29%)

162/478

EPHESUS6 2-4 3313 3319 15% (36%)

201/554

(34%)

162/478

References in slide notes.

SCD-HeFT: SCD-HeFT: The Sudden Cardiac Death in Heart The Sudden Cardiac Death in Heart

Failure TrialFailure Trial

• Gust Bardy, MD et al, NEJM January 27, 2005

• Largest and longest follow-up ICD trial ever conducted

– 2521 patients

– 148 centers

– 41 month median follow-up

– Vital status known on 100% of patients

• Sponsored by NIH

• 70% of Patients were Class II NYHA (Typically less sick than in previous ICD trials)

• 48% of Patients were non-ischemic

SCD-HeFT: Primary ConclusionsSCD-HeFT: Primary Conclusions

1. In class II or III CHF patients with EF < 35% on good background drug therapy, the mortality rate for placebo-controlled patients is 7.2% per year over 5 years

2. Simple, single lead, shock-only ICDs decrease mortality by 23%

3. Amiodarone, when used as a primary preventative agent, does not improve survival

Bardy G et al.NEJM 2005; 352:3

Mortality Benefit: Time Dependent

Current RecommendationsCurrent Recommendations

• ICD Implantation for

– Ischemic Cardiomyopathy > 4 post-MI with LVEF ≤30%

– Chronic Ischemic or Non-ischemic cardiomyopathy with CHF and LVEF ≤ 35%

• Further EP evaluation

– Chronic Ischemic or Non-ischemic cardiomyopathy with LVEF > 35% and ≤ 45%

Indication/

Patient Groups

Estimated

Net Prevalence

Estimated % Penetration of Net

Prevalence

Class I(AVID, MADIT, MUSTT,

MADIT-II, SCD-Heft)670,000 ~20% 1,2

1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43.2 Medtronic internal estimate.

How Effective Are We In Getting How Effective Are We In Getting ICD Therapy to Eligible Patients?ICD Therapy to Eligible Patients?

Why Aren’t These Patients Getting ICD’s To Why Aren’t These Patients Getting ICD’s To Protect Them From Sudden Cardiac Arrest?:Protect Them From Sudden Cardiac Arrest?:

Can We Afford This?

The US Pharmaceutical industry spends $10B on CV Drug marketing

The predicted cost of 80% application of ICD therapy to eligible patients is 8.8 billion dollars

Are Doctors and Patients Paying Attention To This Issue

In the typical CHF clinic (Cardiology Run) 25-35% of eligible patients have no ICD.

Many patients will never use their ICD

Direct Medical Expenditures on DiseasesDirect Medical Expenditures on Diseases with High Mortality (2001 $US) with High Mortality (2001 $US)

1 Bozzette et al., 1998 2 http://www.cdc.gov/hiv/stats.htm: Accessed 2/04/20033 http://www.cancer.org/docroot/mit/content/mit_3_2x_costs_of_cancer.asp: Accessed 12/07/20024 Healthcare Financing Review, Medicare and Medicaid Statistical Supplement, 2000

19.5

5 68.2

3.7

0

5

10

15

20

AIDS Breast Cancer Lung Cancer Stroke CardiacDysrhythmia

Do

llar

s (B

illi

on

s)

1, 2 3 3 4

4

Despite the higher number of SCD Despite the higher number of SCD deaths, spending is lower than for deaths, spending is lower than for diseases with fewer annual deaths.diseases with fewer annual deaths.

Comparison of Healthcare CostsComparison of Healthcare Costs

ICD* PTCA† CABG+ Statins‡

*Medtronic estimations (total number of implants x $30,000)†Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data.+AHA 2002 / Cowper, et al; American Heart Journal. 143:(1):130–9.

2.30

8.358.97 9.04

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0A

nn

ual

Co

st in

Bill

ion

s

ICD* CABG+ Statins‡

Economic impact of over-

prescribing antibiotics^

Lost dollars from health care fraud,

abuse and waste^^

2 8 930

100

294

90.0

50.0

100.0

150.0

200.0

250.0

300.0

350.0A

nn

ual

Co

st in

Bill

ion

s

PTCA†

*Medtronic estimations (total number of implants x $30,000).†Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data.+AHA 2002 / Cowper, et al; American Heart Journal. 143;(1):130–9.‡ Pharmacy Times, “Top 200 drugs of 2000”; 2001.^ National Institute of Health, Antimicrobial Resistance, NIAID Fact Sheet.^^ U.S. General Accounting Office 2001.1 Woolhandler S, et al. Costs of Healthcare Administration in the United States and Canada. N Engl J Med 344, 2003; 349: 768-75.

Comparison of Healthcare CostsComparison of Healthcare Costs

$11.6 B—estimated amount due to

miscoding, insufficient documentation, etc. in

Medicare

(HCFA 2000 Financial Report)

Healthcare

Administration1

Societal Spending on Other Societal Spending on Other Life-Saving Interventions Life-Saving Interventions 11

Intervention

Cost/Life-Year

Flashing lights at railroad crossings $42,000

Flammability standard for upholstered furniture $68,000

Airbags (vs. manual lap belts) in cars $120,000

Annual mammography for women age 40-49 $190,000

Smoke detectors in homes $210,000

Front disk (vs. drum) brakes in cars $240,000

Strengthen buildings in earthquake-prone areas $18,000,000

Ground fault circuit interrupters $1,200,000

1. Tengs TO, et al. Five-Hundred Life-Saving Interventions and Their Cost-Effectivenss. Risk Analysis, Vol. 15, No. 3, 1995.

We need to educate about EFWe need to educate about EF

• EF is very easy for patients to understand • “Sudden Cardiac Arrest” is a scary message

• “EF” is easy to understand and rally behind

• EF crosses between two “at risk” patient groups• Heart Failure and Post-MI

• Research shows low patient awareness of EF• 86% of Post-Mi and HF patients are aware of Echos & have had one

• 14% of Post-Mi and HF patients are aware of EF

• Only 5% of patients know their EF

• Conclusions:

» Getting an echo is not a key barrier

» Clinicians aren’t talking EF numbers to patients

» Patients don’t know to ask about it

EF Program to Help educate and prepare EF Program to Help educate and prepare patientspatients

Main Heart Patient Message:Main Heart Patient Message:“Get to know your EF number”“Get to know your EF number”

• Continue preventive care

• Follow-up echo and clinic visit in 6 months

• Appointment to see an electrophysiologist

Implantable Cardioverter Defibrillators in the Implantable Cardioverter Defibrillators in the Early DaysEarly Days

Are All Defibrillators Created Equal?Are All Defibrillators Created Equal?

• Single Chamber

• Dual Chamber

• Three Chamber (Bi-Ventricular, CRT)

● ● The pathophysiology of a wide The pathophysiology of a wide QRS is dyssynchronyQRS is dyssynchrony

●● The therapy provided by BiV The therapy provided by BiV pacing is to resynchronize pacing is to resynchronize activation of the heart walls activation of the heart walls so so they contract in a nearly they contract in a nearly simultaneous mannersimultaneous manner

BiVentricular PacingBiVentricular PacingCorrects DyssynchronyCorrects Dyssynchrony

CRT – Device UtilizationCRT – Device UtilizationRiverside HospitalRiverside Hospital

Device 2001 2002 2003 2004

Pacer 60 48 42 40

BiV P 2 2 2 2

ICD 34 42 40 35

BiV ICD 4 8 16 23

Numbers Represent % of Volume

CARE HFCARE HF

• 813 pts with NYHA Class III CHF

• Randomized to Medical Treatment vs. CRT (BiV Pacemaker without Defib capability)

• Primary Endpoint: Time to death or Unplanned Hospitalization for Cardiovascular Event

• Primary Endpoint Reached:

39% CRT vs. 55% Med Rx at 30 mo’s (p<0.001)

• Mortality:

20% CRT vs. 30% Med Rx (p<0.002)

• Echo Parameters of LV Fxn, CHF Class, QOL:

– Better with CRT (p<0.01)

CRT – Who’s a candidateCRT – Who’s a candidate

Standard criteria: NYHA > III, EF < 35%, QRS > 120ms.

OptiVol Fluid TrendsOptiVol Fluid Trends

Sep 29: Crossed OptiVol Threshold.

Oct 7: Regular follow-up. LV Lead dislodgement & OptiVol Threshold crossing observed. No symptoms reported. Decision made to reposition lead in November.

Oct 28: Hospitalization for heart failure decompensation. Patient admitted with orthopnea, peripheral edema, crackles in lower lungs. BNP: 1960 pg/ml. Weight: 96 kg. Treated with IV diuretics.

Nov 5: Lead replacement. Aldactone® initiated. Impedance stabilizes several days after procedure. BNP: 786 pg/ml. Weight: 80 kg.

Effects of Concurrent Structural Heart Disease and Rate Control Before Ablation on LV Effects of Concurrent Structural Heart Disease and Rate Control Before Ablation on LV Function after Ablation Among Patients with CHFFunction after Ablation Among Patients with CHF

40

0 12Month

LV

Fu

ncti

on

al

Sh

ort

en

ing

(%

)

No concurrentheart disease

Concurrentheart disease

P<0.001

P<0.001

35

30

25

20

15

10

0

70656055504540353025

00 12

Month

LV

Eje

cti

on

Fra

cti

on

(%

)

No concurrentheart disease

Concurrentheart disease

P<0.001

P<0.001

A B

40

0 12Month

LV

Fu

ncti

on

al

Sh

ort

en

ing

(%

)

Inadequaterate control

Adequaterate control

P<0.001

P<0.001

35

30

25

20

15

10

0

70656055504540353025

0 12Month

LV

Eje

cti

on

Fra

cti

on

(%

)

Inadequaterate control

Adequaterate control

P<0.001

P<0.001

C D

Heart Disease DCM

Chronic AF CHF

Improvement of CHF by Curative Ablation of Improvement of CHF by Curative Ablation of Atrial FibrillationAtrial Fibrillation

•58 consecutive patients with CHF and LVEF≤45%

•Control group of 58 pts. without Hx/o CHF undergoing AF ablation,

matched for age, sex, classification of AF

Results:

•NSR: 78% of CHF, 84% non-CHF pts (p=0.38)

•Increase in LVEF: 21% in CHF pts. (p<0.001 vs. non-CHF pts)

•Improvements in LVEF occurred regardless of whether there was

adequate rate control pre-procedure

Pulmonary Venous AnatomyPulmonary Venous Anatomy

74 yo medically refractory AF, Echo – Normal AA Rx - Verapamil, Rythmol, Betapace, Norpace

I

II

III

V1

RSPV

dist

RSPV

prox

LIPV

RA

*

Lasso CatheterLasso Catheter

Circular Mapping & Ablation Catheter inCircular Mapping & Ablation Catheter inRight Superior Pulmonary VeinRight Superior Pulmonary Vein

Pulmonary Veins Pulmonary

Veins

Left Atrium

70 y/o Male with PAF – Progression of Fractionated70 y/o Male with PAF – Progression of FractionatedEgm to Organized Egm to Termination of Egm to Organized Egm to Termination of

Arrhythmia – Anteroseptal LineArrhythmia – Anteroseptal Line

I

II

V1

ABL prox

ABL dist

CS prox

CS dist

5 6 3 4

The Bottom Line

Bottom LineBottom Line

• If LVEF ≤ 35% Consider Implantable Defibrillator

• If Your Patient Has CHF and a Bundle Branch Block: Consider BiVentricular Implant or Upgrade

• If Your Patient Has CHF and AFib: Consider restoration of NSR

Quality of LifeQuality of Life