Primary Prevention of Sudden Cardiac Arrest in Heart Failure Patients with LV Dysfunction

1
Primary Prevention of Sudden Cardiac Arrest
in Heart Failure Patients
with LV Dysfunction
2
Presentation Overview

• Magnitude of Sudden Cardiac Arrest
• Heart Failure and Sudden Cardiac Death Risk
• Key Heart Failure Drug Trials Prevention of SCD
• Recent ICD, CRT, CRT-D Trials
• SCD-HeFT
• DEFINITE
• COMPANION
• CARE-HF
• ICD, CRT, CRT-D Cost-Effectiveness
• CMS Coverage for ICD, CRT, CRT-D Devices
• ICD/CRT-D Device Selection Considerations
• Medtronic ICD/CRT-D Therapy, Detection and
  Diagnostics

3
Magnitude of SCA
4
Magnitude of SCA in the US
163,000
Stroke1
SCA claims more lives each year than these other
causes of mortality.
335,000
SCA3
Lung Cancer2
152,200
1 Killer in the US
Breast Cancer2
40,000
18,000
AIDS3
1 American Heart Association. Heart Disease and
Stroke Statistics 2005 Update. 2 Jemel A. CA
Cancer J Clin. 2003535-26. 3 U.S. HIV AIDS
Statistic Summary. Avert.org.
5
Leading Causes of Death in the US
Septicemia
Nephritis
Only after the deaths from ALL cancers are
combined does anything cause more deaths each
year than sudden cardiac arrest.
Alzheimers Disease
Influenza/Pneumonia
Diabetes
Accidents/Injuries
Chronic Lower Respiratory Diseases
Cerebrovascular Disease
Other Cardiac Causes
Sudden Cardiac Arrest (SCA)
All Cancers
0
5
10
15
20
25
National Vital Statistics Report, Vol 49 (11),
Oct. 12, 2001. State-specific mortality from
sudden cardiac death United States 1999. MMWR.
200251123-126.
6
Heart Failure and Sudden Cardiac Death Risk
7
CHF Magnitude in the US

• ? 5 million have CHF (prevalence)1
• ? 550,000 new cases annually (incidence)1
• HF most common cardiovascular discharge in
  elderly patients2
• 25 probability of dying over 2.5 years3
• 50 of these deaths occur suddenly

1 American Heart Association. Heart Disease and
Stroke Statistics 2005 Update. 2 NHLBI, CHF
Data Fact Sheet, September 1996. 3 Sweeney MO.
PACE. 200124871-888.
8
In people diagnosed with CHF, sudden cardiac
death occurs at 6-9 times the rate of the
general population.
American Heart Association. Heart Disease and
Stroke Statistics 2005 Update.
9
CHF Patients Survival Results1
80 of men and 70 of women who have CHF will die
within 8 years.2
Women (N 230)
100
Men (N 237)
90
80
70
60
Probability of Survival ()
50
40
30
20
10
0
0
2
4
6
8
10
Time After CHF Diagnosis (Years)
1 Framingham Heart Study (1948-1988) in Atlas of
Heart Diseases. 2 American Heart Association.
Heart Disease and Stroke Statistics2005 Update.
10
CHF and Sudden Cardiac Death
Overall Mortality
Age-Adjusted Annual Rate/100
Sudden Death
Women
Women
Men
Men
CHF predicts increased sudden death and overall
mortality. During a 39-year follow-up of subjects
in the Framingham Heart Study, the presence of
CHF significantly increased sudden death and
overall mortality in both men and women.1
1 Redrawn from Kannel WB. Am Heart J.
1998136205-212.
11
Severity of Heart FailureModes of Death
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)
1 MERIT-HF Study Group. LANCET.
19993532001-2007.
12
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.
13
LV Dysfunction and Sudden Cardiac Death Risk
14
Relationship of SCD and Left Ventricular
Dysfunction

• Reduced left ventricular ejection fraction (LVEF)
  remains the single most important risk factor
  for overall mortality and sudden cardiac death1
• Increased risk is measurable at ejection
  fractions above 30, but an ejection fraction
  30 is the single most powerful independent
  predictor for SCD2

1 Task Force on Sudden Cardiac Death of the
European Society of Cardiology. Eur Heart J,
2001221374-1450. 2
Myerburg RJ, In Braunwald E, Zipes DP, Libby P,
Heart Disease, A textbook of Cardiovascular
Medicine. 6th ed. Philadelphia W.B. Saunders,
Co. 2001 895.
15
Risk of Sudden Death Data from GISSI-2 Trial
1.00
1.00
0.98
0.98
p log-rank 0.002
0.96
0.96
0.94
0.94
Survival
Survival
0.92
0.92
p log-rank 0.0001
0.90
0.90
0.88
0.88
A
B
0.86
0.86
0
30
60
90
120
150
180
0
30
60
90
120
150
180
Days
Days

• Patients withoutLV Dysfunction(LVEF 35)

Patients withLV Dysfunction(LVEF
No PVBs1-10 PVBs/h 10 PVBs/h
Maggioni AP. Circulation. 199387312-322.
16
LVEF and SCA Incidence
7.5
5.1
SCA Victims
2.8
1.4
LVEF
Gorgels PMA. European Heart Journal.
2003241204-1209.
17
Type of Death and LVEF
23.1
17.5
Death
10.6
9.4
7.7
6.8
6.3
3.2
2.2
LVEF
Patients 193 881 1432
Yap. Heart. 20008385.
18
SCD Rates in CHF Patients with LV Dysfunction
Control Group Mortality
12 months
16 months
41.4 months
27 months
13 months
45 months
6 months
Total mortality 15-40 SCD accounts for 50 of
the total deaths.
References in notes.
19
Drug Trials in Heart Failure PatientsOverall
Mortality and SCD Results
20
Effect of ACE Inhibitors on Mortality Reduction
Patients with LVD or Heart Failure
Mortality
Trial
ACE-I
Controls
RR (95 CI)
Chronic CHF
CONSENSUS I
39
54
0.56 (0.34 - 0.91)
SOLVD (Treatment)
40
35
0.82 (0.70 - 0.97)
SOLVD (Prevention)
15
16
0.92 (0.79 - 1.08)
Post- MI
SAVE
25
20
0.81 (0.68 - 0.97)
AIRE
17
23
0.73 (0.60 - 0.89)
TRACE
0.78 (0.67 - 0.91)
35
42
SMILE
6.5
8.3
0.78 (0.52 - 1.12)
Mean
21
25
Garg R. JAMA. 199527314501456.
21
Effect of Beta Blockade on Outcome Heart Failure
and Post-MI LVD Patients
Target HF Dosage Study Drug Severity
(mg/day) Outcome US Carvedilol1 Carvedilol
Mild/ 6.25 to ? 48 disease progression Moderat
e 25 bid (P .001) CIBIS-II2 Bisoprolol
Moderate/ 10 qd ? 34 mortality Severe (P .0001) MERIT-HF3 Metoprolol Mild/ 200 qd ?
34 mortality Succinate Moderate (P
.0062) COPERNICUS4 Carvedilol Severe 25
bid ? 35 mortality (P .0014) CAPRICORN5 Ca
rvedilol Post-MI LVD 25 bid ? 23 mortality
(P .031)
1 Colucci WS. Circulation. 19969428002806. 2
CIBIS-II Investigators. Lancet.1999353913. 3
MERIT-HF Study Group. Lancet. 199935320012007.
4 Packer M. N Engl J Med. 200134416511658. 5
The CAPRICORN Investigators. Lancet.
200135713851390.
22
Risk of Sudden Death in HF Trials
1 MERIT-HF Investigators. Lancet.
19993532001-2007. 4
Packer M. N Engl J Med. 19963341349-1355. 2
BEST Investigators. N Engl J Med.
20013441659-1667. 5 Pitt
B. N Engl J Med. 1999341709-717.
3 CIBIS-II Investigators. Lancet.
19993539-13.
23
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.
24
ACE Inhibitor and Beta Blocker TrialsHeart
Failure Patient Conclusions

• Beta blocker drugs were found to be effective in
  reducing overall mortality
• Some beta blocker drugs were found to be
  effective in reducing sudden cardiac death (42)
  and reducing hospitalizations due to heart
  failure
• ACE inhibitors reduced overall mortality, but
  had no apparent effect on SCD
• ACE inhibitors reduced overall mortality or HF
  hospitalizations by 26

25
Recent ICD, CRT-D, CRT Clinical Trials Heart
Failure Patients

• SCD-HeFT
• Sudden Cardiac Death in Heart Failure Trial
  
• Bardy GH. N Engl J Med. 2005352225-237.
• DEFINITE
• Defibrillators in Non-Ischemic Cardiomyopathy
  Treatment Evaluation
• Kadish A. N Engl J Med. 20043502151-218.
• COMPANION
• Comparison of Medical Therapy, Pacing and
  Defibrillation in Heart Failure Trial
• Bristow M. N Engl J Med. 20043502140-2150.
• CARE-HF
• Cardiac Resynchronization Heart Failure Study
• Cleland JGF. N Engl J Med. 20053521539-1549.

26
SCD-HeFTSudden Cardiac Death in Heart Failure
Trial
Bardy GH. N Engl J Med. 2005352225-237.
27
SCD-HeFT Hypothesis

• Determine if amiodarone or ICD will decrease the
  risk of death from any cause in patients with
  mild-to-moderate heart failure

Bardy GH. N Engl J Med. 2005352225-237. SCD-HeF
T study conducted by the NIH with funding
provided by Medtronic, using Medtronic devices
28
SCD-HeFT Inclusion Criteria

• Symptomatic CHF (NYHA Class II and III) due to
  ischemic or non-ischemic dilated cardiomyopathy
• LVEF 35
• 18 years of age no upper age limitation
• CHF 3 months
• On optimal medical therapy for 3 months
• Appropriate dose of ACE-I
• Beta blocker, if tolerated

Bardy GH. N Engl J Med. 2005352225-237.
29
SCD-HeFT Endpoints

• Primary
• Overall Mortality
• Secondary
• Mortality ischemic vs. non-ischemic
• Mortality NYHA Class II vs. III
• Mortality by Sub Groups age, gender, LVEF, MI
  Hx, time of MI, QRS width
• Cause-Specific Death
• HF Morbidity and Mortality
• Quality of Life
• Cost of Care and Cost-Effectiveness

Bardy GH. N Engl J Med. 2005352225-237.
30
SCD-HeFT Protocol

• Prospective, randomized study
• Double blind, placebo controlled
• 2521 patients
• 847 placebo
• 845 amiodarone
• 829 ICD
• All patients on optimal medical therapy
• 45 months mean follow-up

Bardy GH. N Engl J Med. 2005352225-237.
31
SCD-HeFT Mortality Rate Overall Results
Hazard Ratio (97.5 Cl) P-Value Amiodarone vs.
Placebo 1.06 (0.86-1.30) 0.53 ICD vs.
Placebo 0.77 (0.62-0.96) 0.007
0.4
0.3
Mortality Rate
0.2
0.1
Amiodarone
Placebo
ICD
0.0
48
36
24
12
0
60
Months of Follow-Up
No. at Risk Amiodarone 845 772 715 484 280 97 Plac
ebo 847 797 724 505 304 89 ICD 829 778 733 501 30
4 103
Bardy GH. N Engl J Med. 2005352225-237.
32
SCD-HeFT 5-Year Mortality RateOverall Results
36.1
34
28.9
Mortality Rate
Bardy GH. N Engl J Med. 2005352225-237.
33
SCD-HeFT Overall Mortality Results
ICDs reduce mortality by 23
Bardy GH. N Engl J Med. 2005352225-237.
34
SCD-HeFT Conclusions

• In NYHA Class II-III patients with EF 35 on
  optimal drug therapy
• ICDs decreased mortality by 23
• Amiodarone did not improve survival

Bardy GH. N Engl J Med. 2005352225-237.
35
DEFINITEDefibrillators in Non-Ischemic
Cardiomyopathy Treatment Evaluation

• Kadish A. N Engl J Med. 20043502151-2158.

36
DEFINITE Objective and Endpoints

• Objective
• Evaluate the effectiveness of ICD therapy
  compared to optimal medical therapy in
  non-ischemic cardiomyopathy patients
• Primary Endpoint
• Death from any cause
• Secondary Endpoint
• Sudden death from arrhythmia

Kadish A. N Engl J Med. 20043502151-2158. DEFIN
ITE study conducted by St. Jude using St. Jude
devices
37
DEFINITE Study Design

• Prospective, two arm randomized trial
• 458 patients
• 229 Optimal Medical Therapy (OMT)
• 229 ICD OMT
• 29 months mean follow-up

Kadish A. N Engl J Med. 20043502151-2158.
38
DEFINITE Inclusion Criteria

• Non-ischemic cardiomyopathy
• LVEF 35
• Asymptomatic NSVT
• NYHA Class I, II, or III
• Hx of symptomatic HF

Kadish A. N Engl J Med. 20043502151-2158.
39
DEFINITE Death from Any Cause Results
ICD
OMT
1.0
0.9
0.8
Probability of Survival
0.7
P 0.08
0.0
6
5
4
3
2
1
0
Survival (Year)
No. at Risk OMT 229 210 131 67 32 ICD
229 218 140 77 41
Kadish A. N Engl J Med. 20043502151-2158.
40
DEFINITE Death from Any Cause Results NYHA Class
III Patients
1.0
ICD
OMT
0.9
0.8
Probability of Survival
0.7
0.6
P 0.02
0.0
6
5
4
3
2
1
0
Survival (Year)
No. at Risk OMT 49 38 22 9 5 ICD
47 45 25 17 10
Kadish A. N Engl J Med. 20043502151-2158.
41
DEFINITE Sudden Death from Arrhythmic Results
1.0
0.9
Probability of Survival
0.8
0.7
ICD
P 0.006
OMT
0.0
6
5
4
3
2
1
0
Survival (Year)
No. at Risk OMT 229 210 131 67 32 ICD
229 218 140 77 41
Kadish A. N Engl J Med. 20043502151-2158.
42
DEFINITE Results
Kadish A. N Engl J Med. 20043502151-2158.
43
DEFINITE Conclusions

• In patients with non-ischemic dilated
  cardiomyopathy treated with optimal medical
  therapy and ICD therapy
• Risk of sudden death from arrhythmia was
  significantly reduced by 80
• Was associated with a nonsignificant reduction
  in the risk of death from any cause (35, P
  0.08)

Kadish A. N Engl J Med. 20043502151-2158.
44
COMPANIONComparison of Medical Therapy, Pacing
and Defibrillation in Heart Failure Trial
Bristow M. N Engl J Med. 20043502140-2150.
45
COMPANION Objective and Endpoints

• Objective
• Evaluate the effectiveness of CRT with or
  without an ICD in reducing the risk of death and
  hospitalizations in patients with advanced heart
  failure and intraventricular conduction delays
• Primary Endpoint
• Composite of death from any cause or
  hospitalization for any cause
• Secondary Endpoint
• Death from any cause

Bristow M. N Engl J Med. 20043502140-2150. COMP
ANION study conducted by Guidant using Guidant
devices
46
COMPANION Inclusion Criteria

• NYHA Class III or IV (ischemic or non-ischemic)
• LVEF 35, LVEDD 60 mm
• QRS 120 ms, PR interval 150 ms
• Hx of HF hospitalization 1 month
  prior to enrollment

Bristow M. N Engl J Med. 20043502140-2150.
47
COMPANION Study Design

• Prospective randomized study
• 1520 patients randomized 122 to three arms
• 308 Optimal Pharmacological Therapy (OPT) alone
• 617 OPT CRT
• 595 OPT CRT-D
• Median follow-up 11.9 - 16.2 months

Bristow M. N Engl J Med. 20043502140-2150.
48
COMPANION Composite of Death or Hospitalization
for Any Cause Results
100
OPT
CRT
CRT-D
80
(CRT vs. OPT) P 0.014 (CRT-D vs. OPT) P
0.010
60
Event-Free Survival ()
40
20
0
1080
960
840
720
600
480
360
240
120
0
Days after Randomization
No. at Risk OPT 308 176 115 72 46 24 16 6 1 CRT 61
7 384 294 228 146 73 36 14 3 CRT-D
595 385 283 217 128 61 24 8 0
Bristow M. N Engl J Med. 20043502140-2150.
49
COMPANION All-Cause Death Results
100
OPT
CRT
CRT-D
90
(CRT vs. OPT) P 0.059 (CRT-D vs. OPT) P
0.003
80
Event-Free Survival ()
70
60
50
90
900
810
720
630
540
360
270
180
0
990
1080
450
Days from Randomization
No. at Risk OPT 308 284 255 217 186 141 94 57 45 2
5 4 2 CRT 617 579 520 488 439 355 251 164 104 60 2
5 5 CRT-D 595 555 517 470 420 331 219 148 95 47 2
1 1
Bristow M. N Engl J Med. 20043502140-2150.
50
COMPANION Death or Hospitalization (Any Cause)
Bristow M. N Engl J Med. 20043502140-2150.
51
COMPANION Death (Any Cause)
Bristow M. N Engl J Med. 20043502140-2150.
52
COMPANION Conclusions

• In patients with advanced heart failure and
  prolonged QRS
• CRT and CRT-D reduce all-cause death and all
  cause hospitalizations by 19-20
• CRT reduces all-cause mortality by 24
• CRT-D reduces all-cause mortality by 36

Bristow M. N Engl J Med. 20043502140-2150.
53
CARE-HF Study Cardiac Resynchronization Heart
Failure Study
Cleland JGF. N Engl J Med. 20053521539-1549.
54
CARE-HF Objective and Endpoints

• Objective
• Evaluate the effectiveness of CRT on morbidity
  and mortality in HF patients with ventricular
  systolic dysfunction and cardiac dyssynchrony
• Primary Endpoint
• Combined death for any cause or unplanned
  hospitalization for major CV event
• Principal Secondary Endpoints
• Death from any cause
• Death from any cause or unplanned hospitalization
  with worsening heart failure
• Unplanned hospitalization for worsening heart
  failure

Cleland JGF. N Engl J Med. 20053521539-1549. CA
RE-HF study conducted by Medtronic using
Medtronic devices
55
CARE-HF Study Design

• Prospective randomized trial
• 818 patients randomized to
• 409 medical therapy
• 409 medical therapy Medtronic CRT
• 29.4 months mean follow-up

Cleland JGF. N Engl J Med. 20053521539-1549.
56
CARE-HF Inclusion Criteria

• Heart failure 6 weeks
• NYHA Class III, IV
• LVEF 0.35
• Left ventricular end-diastolic dimension 30 mm
• QRS 120 ms

Cleland JGF. N Engl J Med. 20053521539-1549.
57
ICD, CRT, CRT-D Recent StudiesSummary
58
Study Background Comparison
1 Bardy GH. N Engl J Med. 2005352225-237.

2 Kadish A. N Engl J
Med. 20043502151-2158.

3 Bristow M. N Engl J Med.
20043502140-2150. 4
Cleland JGF. N Engl J Med. 20053521539-1549.
59
Study Background Comparison
All studies required optimal medical management
of patients in all study arms
1 Bardy GH. N Engl J Med. 2005352225-237.

2 Kadish A. N Engl J
Med. 20043502151-2158.

3 Bristow M. N Engl J Med.
20043502140-2150. 4
Cleland JGF. N Engl J Med. 20053521539-1549.
60
Study Background and Mortality Results
1 Bardy GH. N Engl J Med. 2005352225-237.

2 Kadish A. N Engl J
Med. 20043502151-2158.

3 Bristow M. N Engl J Med.
20043502140-2150. 4
Cleland JGF. N Engl J Med. 20053521539-1549.
61
ICD, CRT, CRT-D Cost-Effectiveness
62
Incremental Cost-Effectiveness Analysis
Total Cost A Total Cost B
Life Expectancy A Life Expectancy B

Per Life-Year Saved LYS
Roberts PR. European Heart Journal.
200121712-719.
63
Incremental Cost-EffectivenessCardiovascular
Interventions
200,000
Economically Unattractive
150,000
135,000
120,000
Incremental Cost per Life-Year Saved
Expensive
67,000
Borderline Cost-Effective
40,750
Cost-Effective
17,701
8,461
HighlyCost-Effective
HypertensionTherapy(diastolic95 - 104mmHg)
Lovastatin(chol. 290 mg/dL,50 yrs old,
male, no riskfactors)
PTCA (chronic CAD,severe angina1 VD)
CABG (chronic CADmild angina,3 VD)
End Stage Renal Disease Treatment
Exercise SPECT (atypical angina who can walk on
treadmill)
RoutineCoronaryAngiography (35 - 84 yrs old,
low risk MI,has CHF)
Carotid Disease Screening (65 yrs old, male,
no symptoms)
References in notes.
64
Incremental Cost-Effectiveness ICD, CRT, and
CRT-D Therapies
Economically Unattractive
Incremental Cost per Life-Year Saved
Expensive
67,000
50,000
Borderline Cost-Effective
28,000
38,200
33,000
Cost-Effective
HighlyCost-Effective
COMPANIONCRT-D1
COMPANIONCRT1
MADIT-IIICD3
AVIDICD4
SCD-HeFTICD2
1 Feldman AM. www.theheart.org. ACC News. March
16, 2005. 2 Mark DB. www.theheart.org. AHA News.
November 11, 2004. 3 Ak-Khatib S. Ann Intern Med.
2005142593-600. 4 Larsen G. Circulation.
20021052049-2057.
65
CMS Coverage Reference Guide ICD, CRT, CRT-D
Therapies

• Updated 1/27/05

66
CMS ICD Coverage Reference GuideExpanded
Coverage for ICDs Effective Jan. 27, 2005

• New Coverage for SCD-HeFT Patients
• Patients with ischemic dilated cardiomyopathy,
  documented prior MI, NYHA Class II or III, and
  LVEF
• Patients with non-ischemic dilated cardiomyopathy
  9 months, NYHA Class II or III and LVEF
  

67
CMS ICD Coverage Reference GuideExpanded
Coverage for ICDs Effective Jan. 27, 2005

• New Coverage for COMPANION NYHA Class IV
  Patients
• Patients who meet all current CMS requirements
  for cardiac resynchronization therapy and have
  NYHA Class IV heart failure
• Full Coverage for MADIT-II Patients
• Patients with a documented prior-MI and LVEF
  30, regardless of QRS width duration

68
CMS ICD Coverage Reference Guide
No
Yes
No
LVEF 30(MADIT-II)
History of MI
LVEF 35
No
Yes
Yes
NIDCM 9 monthsNYHA Class II or IIIheart
failure andLVEF NYHA Class II or IIIheart
failure andLVEF 35(SCD-HeFTnon-ischemic)
NYHA Class II or III heart failure(SCD-HeFT
ischemic)
Not eligible fordefibrillator
Yes
No
Yes
No
CAD, induciblesustained VT or VFat EPS (MADIT)
Yes
Yes
No
History ofinherited conditionswith high risk of
VT
No
Yes
History of cardiac arrest due to VF

• NYHA Class IV
• Cardiogenic shock or hypotension
• CABG or PTCA within past 3 months
• MI within past 40 days
• Candidate for coronary revascularization
• Irreversible brain damage from preexisting
  cerebral disease
• Other disease with survival

Yes
No
No
Yes
Sustained VT,spontaneous orinduced by EPS
No
Eligible for defibrillator
Not eligible for defibrillator
69
CMS CRT/CRT-D Coverage Reference Guide
Yes
Symptomatic heart failure despite stable,
optimal medical therapy
No
Prolonged QRS and LVEF 35
Yes
Yes
NYHA Class IVheart failure
No
No
NYHA Class IIIheart failure
Yes
Meets coveragecriteria for theimplantationof
an ICD
Yes
No
Eligible forCRT defibrillator(CRT-D)
Not eligible forCRT device
Eligible forCRT pacemaker(CRT-P)
Reference CMS Local Coverage Decision and
Bulletins for any specific coverage requirements
specific to your region or state. Some local
policies require a QRS duration 130 ms.
70
ICD/CRT-D Device Selection For patients who meet
current CMS requirements for ICD/CRT-D therapy
Patient Characteristics
Therapy Requirements
Device Selection

• NYHA Class III or IV HF
• Prolonged QRS

Cardiac Resynchronization Therapy (CRT)

• CRT-D
• InSync Sentry
• InSync Maximo

• History of AF or
• Risk of developing AF
• COPD
• Poorly controlled hypertension
• Valvular disease
• Ventricular hypertrophy

Reduce Inappropriate Therapies with PR Logic

• Dual Chamber ICD
• EnTrust DR
• Intrinsic
• Maximo DR

Reduce Inappropriate Pacing with MVP
and/or Promote A/V synchrony with atrial based
pacing

• Beta blocker therapy
• Advanced heart block
• Intermittent SA or AV node dysfunction

• Single Chamber ICD
• EnTrust VR
• Maximo VR

• Chronic AF
• No HF symptoms
• No co morbidities (Paroxysmal AF, bradycardia)

Reduce Inappropriate Therapies with Wavelet
PainFree Therapy Comprehensive Diagnostics High
Output Patient Alert
All Indicated Patients
MVP not available on Maximo devices
71
Medtronic ICD/CRT-D Therapy Features

• Cardiac Resynchronization Therapy
• CRT optimized under wide range of clinical
  conditions
• Conducted AF Response In the presence of rapidly
  conducted AF
• Ventricular Sense Response (VSR) In the presence
  of ventricular sensed events
• Atrial Tracking Recovery (ATR) In the presence
  of atrial refractory sensed events
• Sequential Biventricular Pacing increases CRT
  responder rate
• Managed Ventricular Pacing (MVP)
• Ventricular pace only when necessary in the
  presence of intrinsic conduction
• Promote intrinsic AV conduction and preserve
  normal interventricular synchrony
• Promote AV synchrony with atrial-based pacing
• Potential improved clinical outcomes
• Reduce the risk of CHF worsening, AF, and
  mortality due to adverse effects of RV apical
  pacing1-7
• PainFREE Therapy Terminates Fast VT using ATP
• Reduces shocks and improves quality of life8
• High Output -35J

References in notes.
72
Medtronic ICD/CRT-D Detection and Diagnostic
Features

• Enhanced Medtronic Detection Algorithms
• PR Logic
• Delivers up to 96.2 accuracy in delivered
  therapies1
• Minimizes inappropriate therapies
• Wavelet Dynamic Discrimination
• Shown to increase specificity without decreasing
  sensitivity2
• Automatically adapts to changes in EGM2,3
• Comprehensive Medtronic Diagnostics
• Cardiac Compass Trends and Heart Failure
  Management Report - provides 14 months of trended
  data to aid device and drug therapy management
  and manage disease progression
• OptiVol Fluid Status Monitoring helps manage
  patient thoracic fluid status by measuring,
  tracking, and reporting intrathoracic impedance

References in notes.
Available on InSync Sentry only
73
Medtronic ICD/CRT-D Detection and Diagnostic
Features (cont.)

• Patient Alert - self-monitoring of lead
  impedance, battery voltage, charge times,
  therapies delivered, and therapy success
• Simple notification of device parameters that
  might require attention
• Minimize potential for adverse outcomes
• Patient peace of mind that device is operational

74
Conclusions

• Recent device trials have shown ICD and CRT-D
  devices improve survival in targeted heart
  failure patient populations.
• These devices have been found to be
  cost-effective therapies compared to other
  cardiovascular therapies.
• CMS has recently expanded device coverage for
  COMPANION, MADIT II and SCD-HeFT type patients.

COMPANION study conducted by Guidant using
Guidant devices
75
Brief Statement Medtronic CRT-ICDs   Indications
Medtronic Cardiac Resynchronization Therapy
(CRT) Implantable Cardioverter-Defibrillators
(ICDs) are indicated for ventricular
antitachycardia pacing and ventricular
defibrillation for automated treatment of
life-threatening ventricular arrhythmias and for
the reduction of the symptoms of moderate to
severe heart failure (NYHA Functional Class III
or IV) in those patients who remain symptomatic
despite stable, optimal medical therapy and have
a left ventricular ejection fraction less than or
equal to 35 and a prolonged QRS duration.
  Contraindications CRT 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.   Warnings and
Precautions Changes in a patients disease and/or
medications may alter the efficacy of the
devices 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. Certain programming and device
operations may not provide cardiac
resynchronization.   Potential Complications Poten
tial complications include, but are not limited
to, rejection phenomena, erosion through the
skin, muscle or nerve stimulation, oversensing,
failure to detect and/or terminate
tachyarrhythmia episodes, acceleration of
ventricular tachycardia, and surgical
complications such as hematoma, infection,
inflammation, and thrombosis.   See the device
manual for detailed information regarding the
implant procedure, indications,
contraindications, warnings, precautions, and
potential complications/adverse events. For
further information, please call Medtronic at
1-800-328-2518 and/or consult Medtronics website
at www.medtronic.com.   Caution Federal law
(USA) restricts this device to sale by or on the
order of a physician.
76
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 patients disease and/or medications may
alter the efficacy of the devices 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, failure
to detect and/or terminate tachyarrhythmia
episodes, acceleration of ventricular
tachycardia, and surgical complications such as
hematoma, infection, inflammation, and
thrombosis.   See the device manual for detailed
information regarding the implant procedure,
indications, contraindications, warnings,
precautions, and potential complications/adverse
events. For further information, please call
Medtronic at 1-800-328-2518 and/or consult
Medtronics website at www.medtronic.com.   Cautio
n Federal law (USA) restricts this device to
sale by or on the order of a physician.