the profile of the heart failure patient who doesn’t benefit from an icd giosuè mascioli, md,...

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THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

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Page 1: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT

FROM AN ICD

Giosuè Mascioli, MD, FESCHumanitas Gavazzeni - Bergamo

Page 2: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Death in Heart Failure

ICDPossible role

of ICD

ICD ?

Modified from: Henkel DM, Circ Heart Fail, Jul 2008

Page 3: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

ICD benefit is not homogeneous

Risk FactorRisk Factor HRHR 95% CI95% CI p valuep value

NYHA > 2 1.87 1.23 - 2.86 0.004

AF 1.87 1.05 - 3.22 0.034

QRS > 120 msec 1.65 1.08 - 2.51 0.020

Age > 70 yrs 1.57 1.02 - 2.41 0.042

BUN>26 mg/dl (and < 50)

1.56 1.00 - 2.42 0.048

VHR: BUN ≥ 50 mg/dl and serum creatinine ≥ 2.5 mg/dl

Goldenberg I, JACC Jan 2008

Page 4: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Greater or lesser benefit

Burden of cardiovascular illness

Mag

nit

ud

e o

f b

en

efi

t (l

ow

er

nu

mb

er

need

ed

to t

reat)

Cost-efficacythreshold

Low risk of SDLow overall risk of death

High risk of SDIntermediate overall

risk of death

Intermediate risk of SDHigh overall risk of death

Page 5: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

The deadly duo

Goldenberg I, Circulation Jun 2006

Page 6: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

ICD therapy and Competing Death

First appropriate ICD therapyDeath before first appropriate ICD therapy

Koller MT, Circulation Apr 2008

Page 7: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

ICD and Comorbidities

Bruch C, Europace Sep. 2007

Page 8: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

THE SICKEST THE WORST ? - 1

Analysis of MADIT 2 patients:

Mutivariate analysis of predictor of mortality:

Age > 65 yrs

NYHA class III - IV

AF

Increased level of BUNCygankiewicz I, Heart Rhythm Apr 2009

Page 9: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

THE SICKEST THE WORST ? - 2

BMI < 26

Schernthaner C, Croat Med Journ 2007

Page 10: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Reverse epidemiology and acute HF

Burger AJ, Int J Cardiol Mar 2008

Page 11: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

BMI and unadjusted all-cause mortality

Curtis JP, Arch Intern Med 2005

Page 12: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Importance of number of HF episodes

Setoguchi S, CMAJ Mar 2009

Page 13: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Badly treated,worst prognosis- 1

In MADIT 2, use of ICD was associated with a significant 39% increase in risk of HF

Risk can be reduced used the corrected therapy:

With B-blockers + ACE-inhibitors HR 0.36

With B-blockers only HR 0.51 (metoprolol 0.49, carvedilol 0.48)

With ACE-inhibitors only HR 0.64 (p NS)

Pietrasik G, JCE Apr. 2009

Page 14: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Badly treated,worst prognosis- 2

Gardiwal A, Europace Oct 2008

Page 15: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Predictors of early mortality in ICD patients

ParameterParameter p value in univ. anal.p value in univ. anal. p value in multiv. anal.p value in multiv. anal.

History of AFHistory of AF < 0.0001 p < 0.001

DiabetesDiabetes = 0.0001 = 0.004

Failure to use statinsFailure to use statins < 0.001 NS

Use of digitalisUse of digitalis < 0.0001 NS

Use of diureticsUse of diuretics < 0.0001 NS

Low BMILow BMI < 0.0001 = 0.001

Increasing AGEIncreasing AGE < 0.0001 NS

Low EFLow EF < 0.0001 NS

Low activity hoursLow activity hours < 0.0001 NS

Elevated resting HRElevated resting HR = 0.014 NS

Low MAPLow MAP = 0.007 = 0.04

Poor NYHA classPoor NYHA class < 0.0001 = 0.006

Stein KM, Europace Mar 2009

Page 16: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Predictors of late mortality in ICD patients

FactorFactor Hazard RatioHazard Ratio(95% CI)(95% CI) p valuep value

DigoxinDigoxin1.86

(1.12 - 2.86)= 0.0046

Loops diureticsLoops diuretics1.59

(1.06 - 2.38)= 0.024

ACE-inhibitors or ACE-inhibitors or Aldosterone Aldosterone

receptor blockersreceptor blockers

0.50(0.31 - 0.80)

= 0.0038

Thibodeau JB, Am J Cardiol Mar 2008

Page 17: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

ICD and kidney disease

Stage/

Age

Stage 1

Stage 2

Stage 3

Stage 4

Stage 5

< 65 yrs

< 75 yrs

< 80 yrs

Favo

red

Unf

avor

ed

* At standard procedural mortality. At procedural mortality rates increased,age thresholds for ICD implant decrease.

Amin MS, JCE Dec. 2008

Page 18: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

ICD and eGRF

Goldenberg I, Am J Cardiol Aug 2006

Page 19: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Cause-specific mortality in ICD patients: evadef study - 1

Marijon E, Am Heart J Feb 2009

Page 20: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Cause-specific mortality in ICD patients: evadef study - 2

Among characteristics at implantation:

EF < 30% and history of AF related to SCD

Age, NYHA class, systemic HT, QRS duration, EF < 30% and lack of B-blockers related to HF death

An EF < 30% at implant appears to be the most important predictor of ICD-unresponsive SCD

Marijon E, Am Heart J Feb 2009

Page 21: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Age and ICDs- 1

Healey JS, Eur Heart J Feb 2007

Page 22: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Age and ICDs- 2

Cause - specific mortality ratesAge < 75 yrsAge < 75 yrs

(1614 pts)(1614 pts)Age ≥ 75 yrsAge ≥ 75 yrs

(252 pts)(252 pts) p valuep value

Arrhythmic deathArrhythmic death 3,84 6,73 0,03

Heart Failure DeathHeart Failure Death 3,96 8,74 0,001

Non-cardiac deathNon-cardiac death 1,51 4,72 0,001

Non-arrhythmic deathNon-arrhythmic death 5,47 13,46 0,001

All-cause deathAll-cause death 9,31 20,19 0,001

Arrhythmic/All-cause Arrhythmic/All-cause death ratiodeath ratio

0,41 0,33

Healey JS, Eur Heart J Feb 2007

Page 23: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Conclusions - 1

We MUST keep in mind that we do not use ICD to reduce sudden death, but to reduce TOTAL mortality

If we cannot reach this goal, to implant an ICD is absolutely USELESS (if not negative for the patient)

The problem is: how I identify patients whose greater risk is to die of non cardiac cause of of HF ?

Page 24: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Conclusions - 2

Predictors od adverse prognosis in HF can be used to identify patients whose prognosis do not deserve an ICD

Among this factor we can recognize: non optimal drug therapy, too low EF, comorbidities, AF, low BMI and - particularly - kidney function

Score tables can be of some help in taking the right decision, together with good clinical sense

Page 25: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

Extending Life, Defibrillators Can Prolong Misery

By Gina KolataMarch 25, 2002

Out of the Blue, a Lightning Bolt to the Heart

By Sandeep Jahuar Febrary 10, 2004

Page 26: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

The final answer ...

Page 27: THE PROFILE OF THE HEART FAILURE PATIENT WHO DOESN’T BENEFIT FROM AN ICD Giosuè Mascioli, MD, FESC Humanitas Gavazzeni - Bergamo

... and the final comment

I’ve stopped smoking. My life will be one week longer.And that week will rain all the time!

Woody Allen