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Prevention of Sudden Cardiac Death. Mark Greenberg, MD. Magnitude of Sudden Cardiac Arrest in the U.S. 167,366. Stroke 3. 450,000. Sudden cardiac arrest claims more lives each year than these other diseases combined. Sudden Cardiac Arrests 4. Lung Cancer 2. 157,400. #1 Killer in the U.S.

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magnitude of sudden cardiac arrest in the u s
Magnitude of Sudden Cardiac Arrest in the U.S.

167,366

Stroke3

450,000

Sudden cardiac arrest claims more lives each year than these other diseases combined

Sudden Cardiac Arrests4

Lung Cancer2

157,400

#1 Killer in the U.S.

40,600

Breast Cancer2

42,156

AIDS1

1 U.S. Census Bureau, Statistical Abstract of the United States: 2001.

2 American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures2001.

3 2002Heart and Stroke Statistical Update, American Heart Association.

4 Zheng Z. Circulation. 2001;104:2158-2163.

treatments to reduce sudden cardiac death
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

Treatments to Reduce Sudden Cardiac Death

Zipes DP. Circulation. 1998;98:2334-2351.

Pitt B. N Engl J Med. 2003;348:1309-1321.

secondary prevention of scd conclusions from three rct s
Secondary Prevention of SCD--Conclusions from Three RCT’s
  • The ICD is first-line therapy for patients with hemodynamically-compromising primary ventricular tachyarrhythmias (relative mortality reduction of 27% compared to medication).
  • Benefit of ICD mainly with EF<35%, and is independent of beta blocker use.
  • Further study is required to assess the cost-efficacy of the ICD in other patient subsets (EF>35%, well-tolerated VT, secondary VT/VF).
evolution of icd therapy 1980 to present

2000

  • CardiacResynchro-nization*
  • 1980
  • First HumanImplant
  • 1985
  • FDA Approvalof ICDs
  • 1993
  • SmallerDevices
  • 1996
  • SteroidLeads
  • MADIT

100,000

  • 1999
  • MUSTT

90,000

  • 1989
  • TransvenousLeads
  • BiphasicWaveform

80,000

70,000

60,000

50,000

  • 1988
  • TieredTherapy
  • 1997/98
  • DC ICDs
  • AT Therapies
  • AVID
  • CASH
  • CIDS

40,000

30,000

20,000

10,000

0

Number of Worldwide ICD Implants Per Year* Under clinical investigation in the US

Evolution of ICD Therapy: 1980 to Present

1980

1985

1990

1995

2000 E

implantable cardioverter defibrillator
Implantable Cardioverter Defibrillator

First-line therapy for patients at risk for VT/VF

  • Small devices, pectoral implant site
  • Transvenous, single incision
  • Local anesthesia; conscious sedation
  • Short hospital stays
  • Few acute complications
  • Perioperative mortality < 1%
  • Programmable therapy options
  • Single- or dual-chamber therapy
  • Battery longevity up to 9 years
  • 80,000 implants/year (2000 E)1

1Morgan Stanley Dean Witter. Investors Guide to ICDs. 2000.

slide9

“Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factorfor overall mortality and sudden cardiac death.”1

1Prior SG, Aliot E, Blonstrom-Lundqvist C, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology. Eur Heart J, Vol. 22; 16; August 2001.

slide10

MULTICENTER AUTOMATIC DEFIBRILLATOR IMPLANTATION TRIAL-II (MADIT-II) 1997-2001A trial designed to evaluate the effect of prophylactic ICD therapy on survival in patients with prior MI and LV dysfunction. Supported by a research grant from Guidant Corp.

madit ii eligibility
MADIT-II: Eligibility
  • Chronic CAD with prior MI
  • EF<0.30
  • No requirement for NSVT or EPS
  • No upper age limitation
madit ii meds at last follow up
MADIT-II: MEDS at Last Follow-Up

CONV DEFIB

(n=490) (n=742)

percent

  • ACE inhibitors 72 68
  • Amiodarone 10 13
  • Antiarrhythmics 2 3
  • Beta-blockers 70 70
  • Digitalis 57 57

*No significant differences between CONV and DEFIB groups.

madit ii conclusion
MADIT-II: CONCLUSION
  • In coronary patients with LVEF <0.30, prophylactic ICD therapy is associated with 31% reduction in mortality.
  • This improved survival is on top of optimal medical Rx.
icd cost effectiveness results for high risk post mi patients
ICD Cost-Effectiveness Results for High Risk Post-MI Patients

$100,000

  • MUSTT patients are similar to MADIT patients.
  • ICD therapy is cost-effective for high risk post MI patients.

Other Therapies

Conclusions

Expensive

$80,000

$60,000

$57,300

Borderline

Cost-Effective

$LYS

$44,300

$40,000

$28,400

Cost-Effective

$22,800

$16,900

$20,000

Highly

Cost-Effective

$0

8 yr

ICD

Transvenous

ICD

Captopril

Post MI

EF < .402

Cardiac

Transplant

CHF

Transplant

Candidate2

Peritoneal

Dialysis3

MADIT Patient1

1 Mushlin A. Circulation. 1998;97:2129-35.

2 Kupersmith J. Progress in Cardiovascular Diseases. 1995;37:307-46.

3 Kupperman M. Circulation. 1990;81:91-100.

icd trials summary

60%

54%

31%

31%

20% NS

AVID13 years

CIDS23 years

MADIT32 years

MUSTT42 years

MADIT II52 years

ICD Trials Summary

1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583.

2 Connolly SJ. Circulation. 2000; 101; 1297-1302.

3 Moss AJ. N Engl J Med. 1996;335;1933-1940.

4 Buxton AE. N Engl J Med. 1999; 341:1882-90.

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

madit ii milestones
MADIT II Milestones

2002-2003

NEJM publication

FDA approval

ACC/AHA/NASPE Guidelines updated

BCBS, Aetna, Kaiser recommend coverage

Modified CMS approval

cms double bind
CMS double bind

“You need an ICD, but it may not be reimbursed.”

scd heft hypothesis
SCD-HeFT Hypothesis

In patients with moderately symptomatic CHF and LVEF <=35%, amiodarone and/or ICD added to standard medical Rx will be associated with reduced mortality compared with standard medical Rx alone.

scd heft patient characteristics
SCD-HeFT Patient Characteristics
  • Patients enrolled: 2521
  • NYHA Class: 70% NYHA II, 30% NYHA III
  • Median follow-up: 45.5 months
  • Median age: 60 years
  • % female: 23%
  • Median EF: 25%
  • Concomitant Rx: ACE 72%, beta blocker 78%
mechanism linking mtwa to ventricular arrhythmias
Mechanism Linking MTWA toVentricularArrhythmias

Long APD Region

Short APD Region

Long APD Short APD Long APD Short APD

Spatially Discordant Alternans Leads to

Dispersion of Recovery,

Wave Front Fractionation, and Reentry

Action Potential Alternans Leads

to T-Wave Alternans

equivalency between twa and eps

TWA +

TWA +

Equivalency Between TWA and EPS

+ 10 %

EPS +

- 10 %

EventRate

1 year

Time

slide28

“Ultimately, risk stratification will be important only if it can be coupled with a therapeutic intervention that reduces the risk of dying.”

Zipes and Wellens. Sudden Cardiac Death. Circulation. 1998;98:2334-51.

high risk groups for scd

Population Size

SCD Percent / Year

Total SCD / Year

High Coronary Risk

Post MI

Heart Failure/

E F < 35%)

Syncope /

Heart Disease

Previous

VF / VT

0

50

100

200

300

20

0

1

2

5

10

0

1

2

5

10

20

50

(thousands)

(percent)

(millions)

High Risk Groups for SCD

Adapted from Myerburg

sudden cardiac death management strategies
Sudden Cardiac Death: Management Strategies
  • Salvage and treat (too few are salvaged).
  • Predict and prevent (pathophysiology complex, positive predictive value of risk stratifiers relatively low).