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The Primary Prevention of Sudden Cardiac Death with ICD Therapy: Who Should Get a “Shock Box” ?. Presentation Overview. Review of the clinical evidence supporting ICD therapy for primary prevention Who are the patients? What are the therapy requirements?

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the primary prevention of sudden cardiac death with icd therapy who should get a shock box

The Primary Prevention of Sudden Cardiac Death with ICD Therapy:Who Should Get a “Shock Box” ?

presentation overview
Presentation Overview
  • Review of the clinical evidence supporting ICD therapy for primary prevention
  • Who are the patients?
  • What are the therapy requirements?
  • Is saving lives with ICDs cost effective?
  • Can the U.S. afford expanding device therapy to primary prevention patients?
    • A closer look at the size of the indicated populations
    • Putting it in perspective
  • Conclusions
icd mortality data in context

ICD Mortality Data in Context

Primary Prevention ICD Clinical Studies Versus:

Secondary Prevention ICD Clinical Studies

Major Drug trials

icd mortality benefits in primary prevention trials
ICD Mortality Benefitsin Primary Prevention Trials






% Mortality Reduction w/ ICD Rx




3, 4

39 Months

27 Months

20 Months

1 Moss AJ. N Engl J Med. 1996;335:1933-40.

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

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

4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002.

mortality benefits with icd therapy
Mortality Benefits with ICD Therapy







% Mortality Reduction w/ ICD Rx

ICD mortality reductions in primary prevention trialsare equal to or greaterthan those in secondaryprevention trials.



3, 4

27 months

39 months

20 months




% Mortality Reduction w/ ICD Rx




1 Moss AJ. N Engl J Med. 1996;335:1933-40.

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

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

4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002.

5 The AVID Investigators. N Engl J Med. 1997;337:1576-83.

6 Kuck K. Circ. 2000;102:748-54.

7 Connolly S. Circ. 2000:101:1297-1302.




3 Years

3 Years

3 Years


Primary Prevention ICD Trials:

In Context with Other Landmark Trials

Non-active Rx

Active Rx







Mortality (%)


















HR=0.73 HR=0.89 HR=0.81 HR=0.69

Moss, AJ. MADIT II and its implications. European Heart Journal (2003); 24, 16-18.

who are the primary prevention patients
Who are the Primary Prevention Patients?

Primary prevention patients have low LVEF and high percentages of Class II/III CHF.

1Moss A, et al. N Engl J Med. 1996;335:1933–40.

2Buxton, A, et al; N Engl J Med. 1999;341:1882–90.

3AVID Investigators; N Engl J Med. 1997;337:1576–83.

4Moss, A. et al; N Engl J Med. 2002;346:877–83.

who are the madit ii patients
Who are the MADIT II Patients?

MADIT II patients had more severe structural heart disease than AVID patients.

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

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

3 Domanski MJ. Am J Cardiol. 1997; 80: 299-301.

4AVID @ 3 years from the KM curve: 36%-25%, NNT=9 N Engl J Med. 1997;337:1576-1583

5MADIT-II @ 3 years from KM curve: 31%-22%, NNT=11 N Engl J Med. 2002;346:877-883

what are the therapy requirements11
What Are the Therapy Requirements?
  • Primary prevention patients will need > # of shocks as a secondary-prevention patient.1
    • 40% of MADIT II study patients had a potential life-threatening VT/VF event terminated by their ICD within the first four years after implant. 2
  • Ventricular fibrillation is the cause of SCA in only a small percentage of cases (< 10%). Ventricular tachycardia is the underlying etiology in >75% of SCA events. 3
  • Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274
  • Moss AJ. J Cardiovasc Electrophysiol, Vol. 14, pp. S96-S98, September 2003, Suppl.
  • Bayés de Luna A. Am Heart J. 1989;117:151-159.
what are the therapy requirements12
What Are the Therapy Requirements?

Device Longevity Requirements:

  • Same age and life expectancy as secondary prevention patient.1
  • Patient survival is ~75% at 5 years. 2,3

Discrimination Technology Requirements:

  • AF/SVT even more an issue in MADIT II patients (more severe heart disease than AVID patients)4,5
    • 20-30% of ICD patients have atrial fibrillation at implant; 45% will have AF within 17 months post-implant 6,7
  • Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274
  • Moss A, et al. N Engl J Med. 1996; 335: 1933-40.
  • Buxton A, et al. N Engl J Med. 1996; 341: 1882-90.
  • Moss AJ. N Engl J Med. 2002; 346: 877-83.
  • AVID investigators. N Engl. J Med. 1997; 337: 1576-1583.
  • Schmitt C, Montero M, Melicherick J. PACE 1994; 17: 295-302.
  • Medtronic GEM DR clinical data on file.
what are the therapy requirements13
What Are the Therapy Requirements?
  • Conclusions:
  • The clinical profile and needs of the primary prevention patients are similar to the “classic” or secondary-prevention patients.
  • There is no single type of device that will meet the needs for the entire primary prevention population.
reducing shocks atp programming
ICD patients can be spared the majority (77%) of painful shocks if ATP is programmed as the first therapy for FVT1

Improved patient quality of life

Shock therapy is painful and remains a barrier to patient acceptance of ICD therapy

Reduction in potential hospitalizations associated with shocks

Minimize “problem” calls to physician and staff

Improved ICD longevity

Each shock reduces battery life by ~ 24 days2

Reducing Shocks – ATP Programming

1 Wathen M, Sweeney M, DeGroot P. Circulation. 2001; 104: 796-801.

2 Marquis DR 7274 Reference Manual

reducing shocks sophisticated detection
Reducing Shocks – Sophisticated Detection

ICD patients can be spared the painful inappropriate shocks with advanced detection and SVT discrimination

  • PR Logic clinically proven to reduce inappropriate shocks.

- 100% Sensitivity, 92.8% PPV 1

  • Wavelet2 clinically proven to reduce inappropriate shocks.

- 100% Sensitivity, 78% Specificity 2

1 Wilkoff, et al. Circulation, 2001; 103: 381-386.

2 Merrill, JJ etc al. NASPE Abstract, 2003

therapy success fast charge times
Therapy Success – Fast Charge Times

Short and consistent charge times are important to minimize the risk of syncope and potential for DFTs to rise over time

  • DFTs increase with VF duration1
  • Pre-shock syncope is a clinically relevant problem with ICD patients2
  • Limiting the time in VF to <10 seconds may reduce the risk of syncope3

1 Platia, et al;, Abstract, AHA 60th Sessions #12352Himmrich, et al; Abstract, Europace, Vol. 1, Suppl. D, July 2000, pg. 154

3Windecker, et al; JACC.1999;33:33-38.

fewer replacements optimal longevity
Fewer Replacements – Optimal Longevity

Younger patients will live with their implantable devices longer

  • Patient survival is approximately 75% at 5 years1,2
  • Minimize replacement procedures
  • Increase cost-effectiveness

1 Moss A, et al. N Engl J Med. 1996;335:1933–40. 2 Buxton A, et al. N Engl J Med 1999; 341:1882–90

therapy success high output
Therapy Success – High Output

We don’t know in advance which patients may have a problem at implant and which patients may have a problem with DFTs over time, 35J device provide a safety net for all.

  • A patient’s clinical status is always changing.
  • DFTs rise over time in specific patients.1-4
  • Both acute and chronic conditions may affect DFT values.5-20

* References in slide notes.

device monitoring patient alert
Device Monitoring – Patient Alert

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.
patient monitoring cardiac compass
Patient Monitoring – Cardiac Compass

ICD diagnostics should provide clinically relevant information to assist with patient and device management

  • Provides trended diagnostic data to help you assess your patient's responses to therapeutic choices.
  • Provides a chronological picture of patient response to validate that current medical treatments are working.
  • Allows for drug, diet, and programming optimization.
current lifeboat biotronik airbag
Current Lifeboat - Biotronik Airbag

Positioning: Prophylactic ICD for those patients who have not demonstrated a need for advanced features.

do physicians really want airbag
Do Physicians really want Airbag?
  • Limited number of shocks
    • Risk of electrical storms 1
  • No PainFREE therapies (no ATP)
    • 77% reduction in shocks for fast VT episodes 2
  • Basic SVT discrimination
    • Risk of inappropriate device therapies 3-8
  • Limited Diagnostics
    • Adequately manage advanced HF patients?
  • Upgrade to a full-featured device once the patient receives a shock
    • Cost efficient?
low cost vs patient considerations
Low Cost vs Patient Considerations
  • Optimize outcome for primary prevention patients:
    • Fast, effective SCA protection to reduce mortality
      • 35J available
      • Fast charge time
    • Patient and device monitoring to better manage patients and reduce potential hospitalizations
      • Cardiac Compass
      • Patient Alert
    • Minimal replacement procedures
      • Longevity
    • Minimal Shocks for patient acceptance and quality of life
      • Painless ATP therapy for FVT
      • Sophisticated Detection Algorithms
  • Do not sub-optimize your patient’s treatment!
cost effectiveness analysis 1
Cost-Effectiveness Analysis 1

Compare total cost of therapy with its benefit or effectiveness

Average Cost-Effectiveness:

total cost of therapy divided by years of life lived after receiving therapy:cost per life year($/LY)

Incremental Cost-Effectiveness:

compare differences in total therapy cost and effectiveness between two competing therapies: cost per life year saved($/LYS)

1 European Heart Journal (2000) 21, 712-719.

incremental cost effectiveness analysis
Incremental Cost Effectiveness Analysis

Therapy A versus Therapy B

Total Cost A – Total Cost B

Life Expectancy A – Life Expectancy B

= Cost Per Life Year Saved($/LYS)

1 European Heart Journal (2000) 21, 712-719.

incremental cost effectiveness results
Cost Per Life Year

Saved ($LYS): Effectiveness

$0 or Less Cost Saving

$1 - $20,000 Highly Cost-Effective

$20,001- $40,000 Cost-Effective

$40,001 - $60,000 Borderline Cost-Effective

$60,001 - $100,000 Expensive

> $100,000 Unattractive

Source: Goldman. Cir 85. 1992

Incremental Cost-Effectiveness Results
incremental cost effectiveness of icd therapy and other cardiovascular interventions
Incremental Cost-Effectiveness of ICD Therapy and Other Cardiovascular Interventions



Incremental Cost per Life-Year Saved






PTCA(ChronicCAD, mildangina,1 VD)

CABG(Chronic CAD,mild angina,3 VD)


(CAD,Angina, 1 VD,Male, age 55)

Lovastatin(chol. = 290 mg/dL,50 yrs old,

male, no riskfactors)










*Moss AJ. Presentation at Satellite Symposium, “Cost-Effectiveness of Device Therapy in the Heart Failure Population”, Heart Failure Society of America Annual Meeting September 23, 2003.

number needed to treat to save a life
Number Needed to Treat To Save A Life

NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)

Drug Therapy


ICD Therapy





(5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr)


Device/Drug Distinctions (Chronic Disease)


  • Direct mechanism of action
    • Readily apparent response
  • Site/organ-specific therapy
  • Uniform patient response to treatment
  • High initial cost
  • Automatic therapy
  • Successive generations generally improve cost-effectiveness

Drug (Oral)

  • Indirect mechanism of action
    • Metabolites, liver inactivation
  • Systemic treatment
  • Variable patient response
    • Dosing
    • Side-effects
  • Costs spread over treatment
  • Requires patient compliance
  • Cost-effectiveness remains relatively constant

Intrinsic and Extrinsic Factors Affect Therapeutic Device Cost-Effectiveness


  • Achieved performance life
    • Battery longevity
    • Reliability
    • Durability
  • Size
  • Electronic sophistication
    • Functionality
    • Software/algorithms
  • Complications
  • Deployment requirements
  • Follow-up requirements

Extrinsic Factors

  • Implantation procedure
    • Learning curve
    • Implantation facility
    • Length of stay
  • Indications for use
  • Patient selection
    • Co-morbidities
  • Complications

Intrinsic and extrinsic device advances progressively increase cost-effectiveness

Representative Device Cost-Effectiveness Trends

1st generation

Financial Metric

IncreasingCost Effectiveness

Nth generation

Time, yrs.


Major increase in functionality

IncreasingCost Effectiveness

Case Example: Advances in Leads/electrodes and Pacemaker Current Drain(Composite effect of improved lead/electrode efficiency, stimulation patterns, increased understanding of stimulation physiology, and physician practice)

Energy Consumption Per Pacing Stimulus (µJ)







Adapted from Ohm, Pace, Vol 20 1997


$/LYS (000)


Power Source Longevity

Intrinsic Example: Implantable Defibrillator (ICD)Influence of ICD technology advance on cost-effectiveness: Power Source Longevity

Mushlin AI, et al. Circulation. 1998; 97: 2129-2135.


Extrinsic ExampleInfluence of ICD patient selection criteria on cost-effectiveness: Pre-implant Ejection Fraction

Cost -Effectiveness

$/LYS (000)

Ejection Fraction

Kupersmith J, et al. Am H J 1995; 130: 507-15.


Failure to consider therapy duration can incorrectly color cost-effectiveness findings


The AVID1 Trial concluded implantable cardioverter-defibrillator therapy reduces mortality compared with antiarrhythmic drugs in defined populations. However, by confining its length of follow-up to only 1.5 years, rather than patient life-expectancy or device longevity, cost/LYS was found to be in the “very expensive” range. MADIT reached a different conclusion.


> 4 yr battery


1. Antiarrhythmics Versus Implantable Defibrillator (AVID)

2. Multicenter Automatic Defibrillator Implantation Trial (MADIT)

1980 large devices limited battery life abdominal implant epicardial leads
1980:Large Devices, Limited Battery Life, Abdominal Implant, Epicardial Leads
  • First human implants
  • Thoracotomy, multiple incisions
  • Primary implanter= cardiac surgeon
  • General anesthesia
  • Long hospital stays
  • Complications from major surgery
  • Perioperative mortality up to 9%
  • Nonprogrammable therapy
  • High-energy shock only
  • Device longevity  1.5 years
  • Fewer than 1,000 implants/year
today small devices pectoral site
TodaySmall devices - Pectoral site
  • First-line therapy for VT/VF patients
  • Treatment of atrial arrhythmias
  • Cardiac resynchronization therapy for Heart Failure
  • Transvenous, single incision
  • Local anesthesia; conscious sedation
  • Short hospital stays and few complications
  • Perioperative mortality < 1%
  • Programmable therapy options
  • Single- or dual-chamber therapy
  • Battery longevity up to 9 years
  • More than 100,000 world-wide implants/year

*Battery longevity information in slide notes.

cost of icd therapy down by 85 since 1990

Major increase in functionality

IncreasingCost Effectiveness

Cost of ICD TherapyDown by 85% Since 1990

The cost/day of ICD therapy has dropped dramatically due to reduced procedure costs, reduced LOS (less invasive implant procedure due to pectoral implants/endocardial leads, ) and increased battery life.

Calculations and references in slide notes.

can the us afford expanding indications for icd therapy

Sudden cardiac arrest is not a major problem.

ICDs are a last resort for patients who survive a sudden cardiac arrest.

Millions of patients meet MADIT II criteria.

ICDs are being over-utilized.

The current health care system cannot support treating all these patients.


SCA is the #1 cause of death in the U.S.

Clinical evidence supports ICD as first-line therapy for prevention of SCA.

Only a small fraction of post-MI survivors qualify for an ICD under MADIT II criteria (approximately 280,000).

Very few indicated patients are actually receiving therapy today.

The current health care system can afford to treat these patients.

Can the US afford Expanding Indications For ICD therapy?

Millions of Primary Prevention Patients?Analysis of Gross Prevalence Groups

Diagrams not to scale

References in Slide “Notes”

Post- MI1~ 7,500k


EF<30%=405k 3-9 (MADIT II)

EF<40%, NSVT=400k10

(MUSTT Registry)

EF<40%, NSVT, Inducible VT/VF=140k11


EF<35%, NSVT, inducible, non suppressible12


Portion of MUSTT Not Part of MADIT II = 95k

millions of primary prevention patients analysis of prevalence groups
Millions of Primary Prevention Patients?Analysis of Prevalence Groups

The incidence (annual new cases) of total high-risk post-MI patients is estimated to be 70,000.*

  • 15% of the U.S. Population does not have access to healthcare. Health Insurance Coverage in the United States; 2002; U.S. Census Bureau, Current Population Survey, 2002 and 2003 Annual Social and Economic Supplements.
  • Of the remaining 85% who have access to health coverage, approximately 20% would not be considered for ICD therapy due to clinical exclusions (e.g., comorbidities, age, patient refusal, etc.) Source: physician interviews.
  • Not overlapping with MADIT II.
  • * Calculations in slide notes.
number of potential icd therapy candidates in the us
Number of Potential ICD Therapy Candidates in the US

1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43.

2 Medtronic internal estimate.

* Weighted average of Class I and Class IIa penetration estimates.

magnitude of sca in the us
Magnitude of SCA in the US

SCA claims more lives each year than these other diseases combined





Lung Cancer2


Breast Cancer2


#1 Killer in the U.S.



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 Circulation. 2001;104:2158-2163.

direct medical expenditures on diseases with high mortality 2001 us




1, 2


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

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

1 Bozzette et al., 1998

2 Accessed 2/04/2003

3 Accessed 12/07/2002

4 Healthcare Financing Review, Medicare and Medicaid Statistical Supplement, 2000

2001 us expenditures 1 2 selected cv drugs and icd therapy
2001 US Expenditures 1,2 Selected CV Drugs and ICD Therapy


$ Billions/Yearly




1 Medtronic ICD industry sales analysis.

2 IMS America 2001 Pharmaceutical sales figures.

comparison of healthcare costs
Comparison of Healthcare Costs









Annual Cost in Billions












*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.

comparison of healthcare costs53
Comparison of Healthcare Costs




$11.6 B—estimated amount due to miscoding, insufficient documentation, etc. in Medicare

(HCFA 2000 Financial Report)





Annual Cost in Billions















Economic impact of over- prescribing antibiotics^

Lost dollars from health care fraud, abuse and waste^^

*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.

2000 us total health expenditures 1 3 trillion 1
2000 US Total Health Expenditures:$1.3 Trillion1

ICD Therapy

$2.2 Billion

  • $2.2 Billion spent on ICD Therapy2 - 0.17% of total US healthcare expenditures
  • If ICD implants double, total ICD costs will remain a fraction of US healthcare costs


2 ICD industry sales, implant, and follow-up cost analysis. Medtronic data on file.

societal spending on other life saving interventions 1
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.


Medical Device Cost-EffectivenessConclusions

  • In practice, medical devices present sharp distinctions to other medical therapies. These distinctions must be considered when determining costs.
  • Cost-effectiveness studies conducted in the nascent period of device evolution are likely to present a worst-case scenario and can produce misleading conclusions.
  • High “front end” costs of implants require that economic analyses consider the life-time benefits of the therapy.
  • Cost-effectiveness metrics generally indicate medical devices compare favorably to other accepted treatments.
conclusions the us can afford icd therapy
Conclusions :The US Can Afford ICD Therapy
  • In the US, SCA is the #1 cause of death.
  • ICD therapy is an accepted first line therapy to prevent SCA.
  • Clinical evidence supports the benefit of ICD therapy for both primary and secondary prevention of SCA.
  • ICD therapy’s cost effectiveness is in line with other widely accepted cardiovascular therapies.
  • ICD therapy represents only a small fraction of US healthcare system expenditures.

“Clinicians and health economists need to be aware that the cost efficacy analysis should be used to guide the development of sensible clinical practice but it can easily be corrupted to a tool for crude rationing. Purchasers of health care should remember that, historically, technological advance has been the solution, not the problem.”

P. R. Roberts T. R. Betts J. M. Morgan

Wessex Cardiothoracic Center Southampton General Hospital, Southampton, U.K.

Eur Heart J, Vol. 21,issue 9, May 2000


DISCLOSUREIndicationsMedtronic implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. ContraindicationsMedtronic ICDs are contraindicated in: Patients with transient or reversible ventricular tachyarrhythmia or as the sole treatment of atrial arrhythmia.Warnings/PrecautionsChanges in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters.Patients should stay away from sources of magnetic and electromagnetic radiation, including MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy delivery, and/or electrical reset of the device.Do not place transthoracic defibrillation paddles directly over the device.See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.