Partners in Preventing SCA

1
Partners in Preventing SCA
SCA Myth Busters
Medtronic wishes to acknowledge the work of
Andre J. Gauri, M.D.

in identifying myths and facts
surrounding SCA
2
Goals for the Presentation

• Challenge current perceptions of Sudden Cardiac
  Arrest
• Demonstrate understanding through case studies
• Construct opportunities to identify at-risk
  patients

3

Myth 1

• Not many people die of
• Sudden Cardiac Arrest.

4
SCA- A Public Health Issue

• The Facts
• Significant Killer in America
• 95 fatal without ICD protection5 - 98 survival
  with ICD protection
• Nearly 1000 SCA deaths/day6
• ICDs are Class I indicated for most at-risk Pts7
• New guidelines clearly outline at-risk groups7
• Studies show that ICDs are cost effective8

SCD claims more lives each year than these other
diseases combined
Lung Cancer1
Breast Cancer1
AIDS2
SCD3
5
Urgency of Sudden Cardiac Arrest

• Resuscitation Success vs. Time

Chance of success reduced 7-10 every minute
100
100
100
90
90
90
80
80
80
70
70
70
60
60
60
50
50
50
40
40
40
30
30
30
20
20
20
Adapted from text Cummins RO, 1998. Annals of
Emergency Medicine 18 1269-1275.
10
10
10
0
1
2
3
4
5
6
7
8
9
0
1
2
3
4
5
6
7
8
9
0
1
2
3
4
5
6
7
8
9
Time (minutes)
6
Myth 2

• You cannot predict who will
• experience an SCA event.

7
Clinical Trials Do Define Risk Factors
8
2006 ACC/AHA/ESC Ventricular Arrhythmia SCD
Guidelines
supported by guidelines

• ICD Class I Recommendations
• Secondary prevention for patients with a history
  of SCA, VF, or
• hemodynamically destabilizing VT, unexplained
  syncope
• Prevention of SCD in patients who are at least 40
  days post-MI with an LVEF 30-40 and NYHA
  functional class II or III
• Prevention of SCD in NYHA Class II-III, LVEF
  30-35, non-ischemic cardiomyopathy
• Patients who are at high risk of SCA due to
  genetic disorders such as long QT syndrome,
  Brugada syndrome, hypertrophic cardiomyopathy and
  arrhythmogenic right ventricular dysplagia
  (ARVD).
• ICD Class II Recommendations
• Ischemic and non-ischemic patients with NYHA
  functional class I, LVEF 30-35

9
Myth 3

• Most of my patients had their MI many years ago
  and therefore
• are no longer at risk for SCA.

10
Relation of Time from MI to ICD Benefit in the
MADIT-II Trial
Mortality for Each Time Period
Time from MI
(n 300)
(n 283)
(n 284)
(n 292)
Hazard Ratio
.98 (p 0.92)
0.52 (p 0.07)
0.50 (p 0.02)
0.62 (p 0.09)
Wilber, D. Circulation. 20041091082-1084.
11
Myth 4

• My heart failure patients
• are not dying from
• sudden cardiac arrest.

12
SCA Risk and Severity of Heart Failure
Modes of Death1
NYHA II
NYHA III
CHF
CHF
12
Other
26
Other
Sudden
59
24
64
Sudden
Death
15
Death
(N 103)
(N 103)
NYHA IV
CHF
Other
33
56
Sudden
Death
11
(N 27)
Patients with mild to moderate heart failure are
more likely to die suddenly.
1 MERIT-HF Study Group. LANCET.
19993532001-2007.
13
SCD in Heart Failure

• Despite improvements in medical therapy,
  symptomatic HF still confers a 20-25 risk of
  premature death in the first 2.5 years after
  diagnosis1-4
• ? 50 of these premature deaths are SCD
  (VT/VF)1-4

1 SOLVD Investigators. N Engl J Med
1992327685-691. 2 SOLVD Investigators. N Engl J
Med 1991325293-302. 3 Goldman S. Circulation
199387V124-V131. 4 Sweeney MO. PACE.
200124871-888.
14
Myth 5

• Medications are just as effective
• and less invasive.

15
Residual Risk of SCD in Treatment Arms of CHF
Beta Blocker Trials
Number of Deaths
1
2
3
Sudden Death of Total Death
54
54
31
N 696
No. Pts in Treatment Arm
N 1327
N 1990
16 months
Average Follow-Up
12 months
6.5 months
1 CIBIS-II Investigators. Lancet.
19993539-13. 2 MERIT-HF Study Group. Lancet.
19993532001-2007. 3 Packer M. N Engl J Med.
1996334349-355.
16
SCD-HeFT Overall Mortality Results
ICDs reduce mortality by 23 on top of optimal
medical therapy
Bardy GH. N Engl J Med. 2005352225-237.
17
Myth 6

• ICDs are too expensive to use
• with all indicated patients.

18
Number Needed to Treat To Save A Life
NNTx years 100 / ( Mortality in Control Group
Mortality in Treatment Group)
Drug Therapy
ICD Therapy
amiodarone
simvastatin
Metoprolol succinate
captopril
(5 Yr) (2.4 Yr) (3 Yr)
(5 Yr) (3 Yr) (3.5 Yr) (1 Yr)
(6 Yr) (2 Yr)
19
More Spent on Leading Pharmaceuticals than ICDs

• Total United States Sales, 2004E

Implantable defibrillator sales estimates
include initial implants and replacements
1 IMS Health, IMS National Sales PerspectivesTM,
2005. Leading 20 Therapeutic Classes by U.S.
Sales, 2004. http//www.imshealth.com/ims/portal/f
ront/articleC/0,2777,6599_49695983_69891394,00.htm
l. Accessed March 7, 2005. 2 JP Morgan Annual
Market Model for Implantable Cardioverter
Defibrillators. The MedTech Monitor. JP Morgan
New York January 6, 2004.
20
Societal Spending on Other Life-Saving
Interventions 1
1. Tengs TO, et al. Five-Hundred Life-Saving
Interventions and Their Cost-Effectivenss. Risk
Analysis, Vol. 15, No. 3, 1995.
21
Myth 7

• SCA is too big of a problem our clinic is not
  resourced to
• identify at-risk patients.

22
Does patient have history of cardiac arrest, VF,
or symptomatic VT?
The Ohio Heart Vascular Center in Cincinnati
Patient Care Pathway Note Pathway only begins
after optimal medical therapy coronary
evaluation / intervention as appropriate
PATIENT
NYHA Class II or III CHF
Is patient on optimal medical therapy?
NYHA Class I CHF
Optimize therapies or consult CHF specialist
NO
40 days post MI with EF 30
YES
Consult EP
Consult EP or Cardiologist
YES
Determine EF
Note This is an example of a pathway that has
been used.
EF 35
EF gt 35
Non-Ischemic
Ischemic
1. Consider referral to HF Specialist or HF
Program. 2. Repeat diagnostics with change of
symptoms AND consider annual testing.
Class III or IV CHF and QRS gt 120 ms
40 days post MI OR 3 months post
revascularization
Consult EP for possible CRT-D
3-9 months Post diagnosis
Consult EP for possible ICD
Consult EP for possible ICD
23
Summary

• SCA a leading cause of death in the U.S. with
  335,000 deaths annually
• Certain high risk patients can be identified
  those at high risk include
• Low EF
• Post-MI
• Heart Failure
• Family History
• Prior SCA Event
• Mortality risk in post- MI pts with EF lt 30
  tends to increase as a function of time from last
  MI
• The major cause of death in HF Class II/III
  patients in SCA
• Recent trials show that ICDs are the most
  effective treatment option to prevent death from
  SCA
• ICDs are a cost-effective treatment strategy
• Pathways do exist for identifying at-risk patients

24
Case Studies

• 52 year old woman
• Heavy Smoker for past 20 years, has stopped since
  MI
• Lives alone in rural community
• PMHX MI 1 year ago, echo on discharge was 35
• Medications BB, ACE-I, lipid-lowering agent,
  clopidorgrel, omega-3
• What is the appropriate follow-up?
• How do you ensure she gets follow-up?
• Is she at risk for SCA?
• If so, how do you manage her risk?

25
Case Studies

• 78 year old man
• Wheelchair bound due to automobile accident
• Plays bridge competitively
• Lives in assisted-living
• PMHX NIDCM, HF class II, sinus node dysfunction
  treated with a pacemaker, EF measured in 2000 was
  30
• Medications ACE-I, BB, Diuretic
• Is he at risk for SCA?
• What are the appropriate next steps in care?

26
Conclusion

• The key to SCA prevention is to identify high
  risk patients BEFORE they have a SCA event. The
  majority of cases are in patients with
• Coronary artery disease, previous MI
• Low left ventricular ejection fraction
• Dilated cardiomyopathy and heart failure
• Final Question
• How can we increase survival rates?

27

• Brief Statement
• Medtronic ICDs
• Indications
• Medtronic implantable cardioverter defibrillators
  (ICDs) are indicated for ventricular
  antitachycardia pacing and ventricular
  defibrillation for
• automated treatment of life-threatening
  ventricular arrhythmias.
• Contraindications
• Medtronic ICDs are contraindicated in patients
  whose ventricular tachyarrhythmias may have
  transient or reversible causes, patients with
• incessant VT or VF, patients who have a unipolar
  pacemaker, and patients whose primary disorder is
  bradyarrhythmia.
• Warnings/Precautions
• Changes in a patient¹s disease and/or medications
  may alter the efficacy of the device¹s programmed
  parameters. Patients should avoid
• sources of magnetic and electromagnetic radiation
  to avoid possible underdetection, inappropriate
  sensing and/or therapy delivery, tissue
• damage, induction of an arrhythmia, device
  electrical reset, or device damage. Do not place
  transthoracic defibrillation paddles directly
  over the
• device.
• Potential Complications
• Potential complications include, but are not
  limited to, rejection phenomena, erosion through
  the skin, muscle or nerve stimulation,
  oversensing,