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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?
• 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
 Primary Prevention ICD Clinical
 Studies Versus:
    1. Secondary Prevention ICD Clinical
       Studies
    2. Major Drug trials
                                      ICD Mortality Benefits
                                   in Primary Prevention Trials
                                          75%                      73%
 % Mortality Reduction w/ ICD Rx




                                                                                                        61%
                                   54%                    55%



                                                                                             31%




                                           1                           2                                    3, 4


                                    27 Months              39 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
                                        75%                76%
% Mortality Reduction w/ ICD Rx




                                                                                61%
                                  54%                55%


                                                                          31%

                                                                                                           ICD mortality
                                                                                                      reductions in primary
                                                 1                    2                   3, 4
                                                                                                         prevention trials
                                  27 months           39 months            20 months                  are equal to or greater
                                                                                                     than those in secondary
                                                                                                        prevention trials.
% Mortality Reduction w/ ICD Rx




                                                           59%
                                        56%


                                  31%                                            33%
                                                     28%
                                                                          20%
                                                                                                 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
                                                                  6                              4
                                             5                                        7            Moss AJ. Presented before ACC 51st Annual Scientific Sessions,
                                                                                                    Late Breaking Clinical Trials, March 19, 2002.
                                   3 Years            3 Years               3 Years              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.
                           Primary Prevention ICD Trials:
      In Context with Other Landmark Trials

                          30                                       p=0.019
                                                                                                 Non-active Rx
                                                                  24.6                p=0.016
                                                                                                 Active Rx
          Mortality (%)




                                                                         20.4         19.8



                          15                                                              14.2
                                  p<0.01
                                                p=NS
                                 9.8
                                               9.0
                                       7.2           8.0



                          0
                                 BHAT         CASS               SAVE                MADIT II
                                 N=3800        N=780              N=2200             N=1200
                               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 Patients?
                 Who are the Primary
                 Prevention Patients?
Primary prevention patients have low LVEF and high
percentages of Class II/III CHF.
                                          MADIT 1                  MUSTT 3      MADIT II2
                                            (n=196)                   (n=704)    (n=1232)

Age                                           63                        68         64
LVEF                                         0.26                      0.30       0.23
NYHA I                                       37%                       37%        39%
NYHA II or III                               63%                       63%        57%
NYHA IV                                  Excluded                  Excluded       4%
CAD (%)                                      100                       100        100
Previous CABG/PTCA (%)                      73/27                     56/23      60/45
                         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?
                                 AVID1    MADIT-II2
Study Completed                  1997       2001
Study Population                 1016       1232
3-year Mortality (ICD arm)       24.6%4     22%5
3-year Mortality (control arm)   35.9%4     31%5
Patient History
•Age                              65         64
•Male %                           78%       84%            MADIT II patients
•NYHA Class II or III            36%3       59%            had more severe
•EF %                             32%       23%
                                                           structural heart
                                                           disease than
•History of Prior MI %            76%      100%
                                                           AVID patients.
AF at enrollment                  21%        9%
Patient Medical Management                            1AVID investigators. N Engl. J Med.
                                                      1997; 337: 1576-1583.
•Beta Blocker Use                 39%       70%       2.Moss AJ. N Engl J Med. 2002;
•ACE Inhibitor Use                68%       68%       346: 877-83.
                                                      3 Domanski  MJ. Am J Cardiol.
•Digoxin Use                      44%       57%       1997; 80: 299-301.

•Diuretics Use
                                                      4AVID @ 3 years f rom the KM curve:
                                  57%       72%
                                                      36%-25%, NNT=9 N Engl J Med.
•Amiodarone/Sotalol Use           12%       13%       1997;337:1576-1583
                                                      5MADIT-II @ 3 years f rom KM curve:
•Class I AA Use                   10%        3%       31%-22%, NNT=11 N Engl J Med.
                                                      2002;346:877-883
•Statin Use                       23%       67%
What Are the Therapy
  Requirements?
     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

1.   Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274
2.   Moss AJ. J Cardiovasc Electrophysiol, Vol. 14, pp. S96-S98, September 2003, Suppl.
3.   Bayés de Luna A. Am Heart J. 1989;117:151-159.
     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

1.    Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274
2.    Moss A, et al. N Engl J Med. 1996; 335: 1933-40.
3.    Buxton A, et al. N Engl J Med. 1996; 341: 1882-90.
4.    Moss AJ. N Engl J Med. 2002; 346: 877-83.
5.    AVID investigators. N Engl. J Med. 1997; 337: 1576-1583.
6.    Schmitt C, Montero M, Melicherick J. PACE 1994; 17: 295-302.
7.    Medtronic GEM DR clinical data on f ile.
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.
      How Do Devices Today
Meet These Therapy Requirements?
    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
1   Wathen M, Sweeney M, DeGroot P. Circulation. 2001; 104: 796-801.
2   Marquis DR 7274 Reference Manual
                        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
     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 60 th Sessions #1235
2 Himmrich, et al; Abstract, Europace, Vol. 1, Suppl. D, July 2000, pg. 154

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

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

* Ref erences in slide notes.
  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
 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
Positioning: Prophylactic ICD for those patients who have
not demonstrated a need for advanced features.
Size (cc)                                     39cc              VF zone           Yes

Mass                                          78g               Max shocks        ~30

Output                                        30J               Number VF         3
                                                                episodes before
                                                                ERI
Longevity                                     5 years           VT Zone           Yes – Monitor Only

Warranty                                      5 years           ATP for VT        No

Upgrade                                       $5000 (0-24mo)    VT/SVT            Fixed Stability
                                              $2500 (25-60mo)   discrimination
http://www.biotronikusa.com/tachy/cardair/index.cfm
  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

• 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!
     Is Saving Lives
with ICDs Cost Effective?
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



                   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 of ICD Therapy and
                                                 Other Cardiovascular Interventions
Incremental Cost per Life-Year Saved




                                                                                                                                                                                      Economically
                                                                                                                                                                                      Unattractive




                                                                                                                                                                                      Expensive



                                                                                                                                                                             Borderline
                                                                                                                                                                             Cost-effective

                                                                                                                                                                             Cost-Effective

                                                                                                                                                                             Highly
                                                                                                                                                                             Cost-Effective

                                                         CABG                      Primary Hypertension Cardiac                                         PTCA        Lovastatin
                                                      (Chronic CAD,                coronary                                                            (Chronic (chol. = 290 mg/dL,
                                                                                             therapy    Transplant                                     CAD, mild
                                                       mild angina,                                                                                                 50 yrs old,
                                                                                   stenting  (Diastolic    (CHF,                                        angina,
                                                          3 VD)                                                                                                    male, no risk
                                                                                     (CAD,        95-104       transplant                                1 VD)        factors)
                                                                                  Angina, 1 VD,                candidate)
                                                                       ICD-                       mmHg)                       ICD-
                                                                                  Male, age 55)                                                 ICD-
                                                                      MADIT                                                 MADIT II*           AVID
                                                                                                                            estimate


                                       *Moss AJ. Presentation at Satellite Symposium, “Cost-Ef f ectiveness 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
 NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)


                                                          Drug Therapy




                                                                                     amiodarone

             ICD Therapy
                                                                       simvastatin


                                                          Metoprolol
                                                          succinate
                                              captopril




    (5 Yr)     (2.4 Yr)   (3 Yr)     (3 Yr)    (3.5 Yr)    (1 Yr)         (6 Yr)       (2 Yr)
  Cost Effectiveness
   Considerations:

A Device IS NOT a Drug
            Device/Drug Distinctions
               (Chronic Disease)
Device                           Drug (Oral)
• Direct mechanism of action     • Indirect mechanism of
   – Readily apparent response     action
                                    – Metabolites, liver inactivation
• Site/organ-specific therapy    • Systemic treatment
• Uniform patient response to    • Variable patient response
  treatment                         – Dosing
                                    – Side-effects
• High initial cost              • Costs spread over
                                   treatment
• Automatic therapy              • Requires patient
                                   compliance
                                 • Cost-effectiveness remains
• Successive generations           relatively constant
  generally improve cost-
  effectiveness
    Intrinsic and Extrinsic Factors Affect
   Therapeutic Device Cost-Effectiveness
Device-Intrinsic              Extrinsic Factors
• Achieved performance life   • Implantation procedure
   – Battery longevity
   – Reliability                 – Learning curve
   – Durability                  – Implantation facility
• Size                           – Length of stay
• Electronic sophistication   • Indications for use
   – Functionality            • Patient selection
   – Software/algorithms
                                 – Co-morbidities
• Complications
• Deployment requirements     • Complications
• Follow-up requirements
 Intrinsic and extrinsic device advances
progressively increase cost-effectiveness
                   Representative Device Cost-Effectiveness Trends

                     1st generation




                                                                     Increasing Cost Effectiveness
Financial Metric




                                                Nth generation


                                                            Time, yrs.
                                          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)




                                                                                          Increasing Cost Effectiveness
Energy Consumption Per
Pacing Stimulus (µJ)

                                                 Major increase in functionality




                             1970         1975        1980       1985      1990    1995

   Adapted f rom Ohm, Pace, Vol 20 1997
         Intrinsic Example: Implantable
                Defibrillator (ICD)
Influence of ICD technology advance on cost-effectiveness: Power Source
                               Longevity
  $/LYS (000)                       Cost-Effectiveness




                                    Power Source Longevity


 Mushlin AI, et al. Circulation. 1998; 97: 2129-2135.
                              Extrinsic Example
  Influence of ICD patient selection criteria on
cost-effectiveness: Pre-implant Ejection Fraction

 $/LYS (000)
                                        Cost -Effectiveness




                                          Ejection Fraction
  Kupersmith J, et al. Am H J 1995; 130: 507-15.
              Failure to consider therapy duration can
            incorrectly color cost-effectiveness findings
                                                                     $/LYS
          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.




1. Antiarrhythmics Versus Implantable Def ibrillator (AVID)                    MADIT 2        AVID1
2. Multicenter Automatic Def ibrillator Implantation Trial (MADIT)
                                                                             > 4 yr battery
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
                                                  • 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 inf ormation in slide notes.
                            Cost of ICD Therapy
                             Down 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.


                                              Major increase in functionality




                                                                                Increasing Cost Effectiveness
Calculations and references in slide notes.
 Can the U.S. Afford The
Primary Prevention of SCA
    with ICD Therapy?
            Can the US afford Expanding
            Indications For ICD therapy?
PERCEPTION:                               REALITY:
•   Sudden cardiac arrest is not a        •   SCA is the #1 cause of death in the
    major problem.                            U.S.



•   ICDs are a last resort for patients   •   Clinical evidence supports ICD as
    who survive a sudden cardiac              first-line therapy for prevention of
    arrest.                                   SCA.


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

•   ICDs are being over-utilized.         •   Very few indicated patients are
                                              actually receiving therapy today.


•   The current health care system        •   The current health care system can
    cannot support treating all these         afford to treat these patients.
    patients.
  A Closer Look at the
Indicated Populations …
Millions of Primary Prevention Patients?
           Analysis of Gross Prevalence Groups
                                                             Diagrams not to scale
                                                          References in Slide ―Notes‖
                       Post- MI1
                       ~ 7,500k


                        EF<40%2
                        ~1,350k

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

                      EF<35%, NSVT,     EF<40%, NSVT,
    EF<40%, NSVT=     inducible, non   Inducible VT/VF=
        400k10        suppressible12       140k11

   (MUSTT Registry)      (MADIT)         (MUSTT)



                                                                     Portion of
                                                                  MUSTT Not Part of
                                                                   MADIT II = 95k
         Millions of Primary Prevention Patients?
                                         Analysis of Prevalence Groups

                                            MADIT II                            MUSTT 3                          Total High-
                                                                                                                Risk Post-MI
       Gross                                 405,000                               95,000                         500,000
     Prevalence
     Exclusions                              125,000 1,2                          25,000 1,2                         150,000 1,2
        (clinical and
         economic)
        Net           280,000          70,000       350,000
     Prevalence
      The incidence (annual new cases) of total high-risk
      post-MI patients is estimated to be 70,000.*
1.      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.
2.      Of the remaining 85% who have access to health coverage, approximately 20% would not be considered f or ICD therapy due to cli nical
        exclusions (e.g., comorbidities, age, patient ref usal, etc.) Source: physician interviews.
3.      Not overlapping with MADIT II.
* Calculations in slide notes.
       Number of Potential ICD Therapy
           Candidates in the US
           Indication/                                   Estimated        Estimated %
         Patient Groups                                Net Prevalence    Penetration of
                                                                         Net Prevalence
      Class I
      (AVID, MADIT, MUSTT)
                                                               390,000      ~34% 1
      Class IIa
      (MADIT II)                                               280,000      <10% 2


      Total                                                    670,000      ~20%*

1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43.
2 Medtronic internal estimate.
* Weighted average of Class I and Class IIa penetration estimates.
Putting it in Perspective…
       Magnitude of SCA in the US

                              167,366                                      SCA claims
       Stroke3
                                                                           more lives
                                                                            each year
                                                                           than these      450,000
                                                                              other
        Lung                                                                diseases        SCA 4
      Cancer2                 157,400                                      combined

       Breast
      Cancer2                 40,600                                                        #1 Killer
          AIDS1               42,156                                                       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 Figures 2001.
3   2002 Heart and Stroke Statistical Update, American Heart Association.
4   Circulation. 2001;104:2158-2163.
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, 2                      3                  3             4

                                                                                                  4

  1 Bozzette   et al., 1998
  2 http://www.cdc.gov/hiv/stats.htm:   Accessed 2/04/2003
  3 http://www.cancer.org/docroot/mit/content/mit_3_2x_costs_of_cancer.asp: 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

                             Billion
      $ Billions/Yearly




                                                     Billion

                                                               Billion

                                                                         Billion




1 Medtronic ICD  industry sales analysis.
2   IMS America 2001 Pharmaceutical sales figures.
                   Comparison of Healthcare Costs
                                           10.0
                                                                              8.97    9.04
                                            9.0                   8.35
                                            8.0
                 Annual Cost in Billions



                                            7.0
                                            6.0
                                            5.0
                                            4.0
                                            3.0          2.30
                                            2.0
                                            1.0
                                            0.0
                                                          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.
                      Comparison of Healthcare Costs
                                                 350.0
                                                                                                                                            294
                                                 300.0
                                                                           $11.6 B—estimated
                                                                              amount due to
                       Annual Cost in Billions



                                                 250.0                    miscoding, insufficient                                        Healthcare
                                                                          documentation, etc. in                                     Administration1
                                                 200.0                          Medicare
                                                                           (HCFA 2000 Financial Report)
                                                 150.0
                                                                                                                                   100
                                                 100.0

                                                  50.0                                                              30
                                                             2             8             9             9
                                                   0.0
                                                         ICD*        PTCA† CABG+ Statins‡
                                                                                                           Economic impact                Lost dollars from
                                                                                                               of over-                   health care fraud,
                                                                                                             prescribing                 abuse and waste^^
*Medtronic estimations (total number of implants x $30,000).
†Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data.                                  antibiotics^
+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 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
1 www.cms.hhs.gov/statistics/nhe/historical/t2.asp
2 ICD   industry sales, implant, and follow-up cost analysis. Medtronic data on file.
                      Societal Spending on Other
                      Life-Saving Interventions 1
                                                                                                                  Cost/Life-Year
                                         Intervention                                                             Saved in 1993
  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 Lif e-Saving Interventions and Their Cost-Ef f ectivenss. Risk Analysis, Vol. 15, No. 3, 1995.
Conclusions
    Medical Device Cost-Effectiveness
              Conclusions

• 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
• 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
DISCLOSURE

Indications
Medtronic implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening
ventricular arrhythmias.

Contraindications
Medtronic ICDs are contraindicated in:
Patients with transient or reversible ventricular tachyarrhythmia or as the sole treatment of atrial
arrhythmia.

Warnings/Precautions
Changes 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.