Approaches to the prevention of sudden death how well do icds work
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APPROACHES TO THE PREVENTION OF SUDDEN DEATH How Well Do ICDs Work ?. Gianluca Botto, MD, FESC Sant’ Anna Hospital, Como. ICD Rx in Primary & Secondary Prevention Effect on Total Mortality. Relative Reduction = 25% Absolute Reduction = 7% Number Need to Treat = 15. Lee DS

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APPROACHES TO THE PREVENTION OF SUDDEN DEATH How Well Do ICDs Work ?

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Approaches to the prevention of sudden death how well do icds work

APPROACHES TO THE PREVENTION OF SUDDEN DEATHHow Well Do ICDs Work ?

Gianluca Botto,

MD, FESC

Sant’ Anna Hospital, Como


Icd rx in primary secondary prevention effect on total mortality

ICD Rx in Primary & Secondary PreventionEffect on Total Mortality

Relative Reduction = 25% Absolute Reduction = 7%

Number Need to Treat = 15

Lee DS

JACC 2003; 41: 1573

Relative Reduction = 25

Absolute Reduction = 8%

Number Need to Treat = 12

Nanthakumar K.

JACC 2004; 44: 2166-72


Approaches to the prevention of sudden death how well do icds work

62%

Non-ICD

49%

MADIT II Long-Term8-Year All-Cause Mortality

FU 20 ms

0,17 LYS

AR = 6%

NNT = 17

Efficacy Analysis HR 0.66 (0.56-0.78)

FU 8 ys

0,52 LYS

AR = 13%

NNT = 8

The long-term benefit was also evident in an ITT analysis. P= 0.017


Number needed to treat to save one life

Number Needed to Treat to Save One Life

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

Drug Therapy

ICD Therapy

(5 Yr) (3 Yr) (3.8 Yr) (3 Yr) (3 Yr) (4 Yr) (1 Yr) (2 Yr) (1 Yr) (6 Yr) (5 Yr) (30 dy)

Botto GL It Heart J 2005; 6: 210-215 modif.


Incremental cost effectiveness of icd therapy and other cardiovascular interventions

Incremental Cost-Effectiveness of ICD Therapy and Other Cardiovascular Interventions

Economically

Unattractive

Incremental Cost per Life-Year Saved

Expensive

Borderline

Cost-effective

Cost-Effective

HighlyCost-Effective

PTCA(ChronicCAD, mildangina,1 VD)

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

male, no riskfactors)

CABG(Chronic CAD,mild angina,3 VD)

Pre

Prticipation

Screening

(Young Athlets)

Primarycoronarystenting

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

Hypertensiontherapy(Diastolic95-104mmHg)

ICD

AVID

ICD-

MADIT II

ICD-

MADIT

(Transvenous)

Various Articles 2010


Approaches to the prevention of sudden death how well do icds work

Drugs

ICD

ICD In Severe LV Disfunction

Giant stadium NY

“…the game was stopped at the 5th inning because of obvious superiority of the antagonist (i.e. ICD)


U s hf device market adoption 2008

U.S. HF Device Market Adoption - 2008

Courtesy of E. Pristowsky


Real world example of inadequate access to rx for patients

Real World Example of Inadequate Access to Rx for Patients

Eligible ICD candidate

hospitalized for HF

N=13.034

Overall percent of eligible pts receiving an ICD was 35,4 %- white man 43,6%- black men 33,4%- white women 29,8%- black women 29,8

Less than 40% of potentially eligible pts hospitalized for HF received ICD Rx.

Rate of use were lower among women and black patients

Hernandez JAMA 2007; 298: 1525-32


Approaches to the prevention of sudden death how well do icds work

Merkely B. EUROPACE 2010


Approaches to the prevention of sudden death how well do icds work

EF is NOT The Ideal Risk Stratification Test For Deciding Whether to Implant an ICD for Preventing SCD


Oregon cardiac arrest registry

48% of

Known EF

ICD Indicated

30%

Oregon Cardiac Arrest Registry

N° of SCA Patients

Daubert JP. HRS Late Breacking Trials 2008


Total mortality arrhythmic death ca relation with ef

Total Mortality, Arrhythmic Death / CARelation with EF

Buxton AE. Circulation 2002; 102: 2466-2472


Cost effectiveness of icd therapy role of mortality rate and mode of death

Cost-Effectiveness of ICD TherapyRole of Mortality Rate and Mode of Death

Cowie RM. Europace 2009; 11: 716-726


Approaches to the prevention of sudden death how well do icds work

15.9%

36.8%

11.5%

Mortality

45.5 months (3.8 years)

Patients (%)

Poole JE. N Engl J Med 2008; 359: 1009


I m sure you ll hear all the virtues of methods to further risk stratify patients at risk for scd

Reduced EF is single

most important RF for

overall mortality and SD

MTWA

17,8 3,8

I’m sure you’ll hear all the virtues of methods to further risk stratify patients at risk for SCD

Bailey JJ. J Am Coll Cardiol 2001; 38: 1902-11 modif.


Approaches to the prevention of sudden death how well do icds work

How Strong a RF is Necessary to Discriminate Pts @ Risk for SCD ?Probability Distibutions of a Marker

Pepe MS. Am J Epidemiology 2004; 159: 882-890


Deliver icd therapy to those who need it

Deliver ICD Therapy to Those Who Need It

“Trade-off” B/ween Therapeutic Efficiency and Risk

Costantini O. The ABCD Trial

JACC 2009; 53: 471-9 (modif.)


Risk stratification in madit ii probability of survival in intermediate risk pts

Risk Stratification in MADIT-IIProbability of Survival in Intermediate Risk Pts

  • EF ≤ 25%

  • Age ≥ 72 ys

  • Atrial fibrillation

  • NYHA III-IV

  • Creatinine ≥ 1.4 mg/dl

  • QRS > 0.13

1 Risk Factors

2 Risk Factors

Goldenberg I. JACC 2008; 51: 288-96


Risk stratification in madit ii probability of survival in very low and high risk patients

Risk Stratification in MADIT-IIProbability of Survival in Very Low and High Risk Patients

  • EF ≤ 25%

  • Age ≥ 72 ys

  • Atrial fibrillation

  • NYHA III-IV

  • Creatinine ≥ 1.4 mg/dl

  • QRS > 0.13

≥ 0 Risk Factors

≥ 3 Risk Factors

Goldenberg I. JACC 2008; 51: 288-96


U shaped curve for icd efficacy

U-Shaped Curve for ICD Efficacy

Goldenberg I, et al. J Am Coll Cardiol 2008; 51: 288


Risk stratification in madit ii predictors of long term mortality 655 pts 9 year follow up

Risk Stratification in MADIT-IIPredictors of Long-Term Mortality(655 pts – 9-year follow-up)

Cygankiewicz I. Heart Rhythm 2009: 6: 468-473


Atrial fibrillation in icds recipients effects on mortality

Atrial Fibrillation in ICDs RecipientsEffects on Mortality

Deneke T. Europace 2004; 6: 151-158


Cost effectiveness of icd rx by age

Cost-Effectiveness of ICD Rx by Age

Chan PS. Circ Cardiovasc Qual Outcomes 2009; 2: 16-24


Mortality in pts with ckd and icd tx serum creatinine estimated gfr

Mortality in Pts with CKD and ICD TxSerum Creatinine / Estimated GFR

Korantzopoulos P. Europace 2009; 11: 1469-1475


Bai r natale a j cardiovasc electrophysiol 2008 19 1259 1265

Bai R. – Natale A. J Cardiovasc Electrophysiol 2008; 19: 1259-1265

After CRT implant, chronic renal failure, diabetes mellitus, and history of AF are strong independent predictors of death

Mortality in HF Pts After CRT

Identification of Predictors


Acute device complications among 17 804 patients

Acute Device ComplicationsAmong 17.804 Patients

Swindle JP. Arch Intern Med 2010: 170: 631-637


Unresolved issues in icd rx

Unresolved Issues in ICD Rx

  • Cardiologist and Electrophysiologist are dealing with pts who have multiple concomitant diseases

  • GLs based on RCT should not be employed w/out first carefully considering all the factors that might influence the treatment decision in an individual pt

  • Comorbid conditions will limit any potential benefit from an ICD implant (avoid risks and costs)

  • This principle should also apply to decision regarding elective ICD generator replacements for battery depletion


Potential barriers ti the dissemination of icd rx

Potential Barriers ti the Dissemination of ICD Rx

  • HCP / Institutional level

  • Difficulty identifieng pts

  • Limited stuff capacity

  • Lack of funding for ICD Rx

  • Lack of applicability of RCT

  • Concern over the relative benefit at an individual pts level

  • Concern over the safety of ICD and leads

  • Dissatisfaction with the high rate of inappropriate shock

  • Need for better tools to stratify pts for SCD

  • HCP biases and cultural influences

Patient level

  • Difficulty understanding risks

  • Concern over the safety of ICD

  • Concern over the impact on QOL

  • Skepticism about the benefit of ICD expecially in the absence of symptoms

  • Personal biases and cultural influences

  • Purchaser / Payer level

  • The cost of ICD Rx

  • The very high numbers of eligible pts fpr primary prevention ICDs


How well do icds work conclusion

How Well Do ICDs Work ?Conclusion

  • ICDs Rx has proved effective in preventing SD

  • Significant barriers to implementation remain with respect to:- identification of pts @ risk- cost of the Rx- acceptance of ICDs by pts and providers

  • Effort should focused to facilitate dissemination of ICD Rx- better tools to risk-stratify pts for SCD- educating pts and HCPs about SCD and ICDs- improving ICD technology to enhance safety and reduce the risk of inappropriate shocks


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