Sudden Cardiac Death:Sudden Cardiac Death: Clinical Practice in EuropeClinical Practice in Europe

Panos E. Vardas Panos E. Vardas Professor of CardiologyProfessor of Cardiology

President of EHRAPresident of EHRA

SUDDEN CARDIAC DEATHSUDDEN CARDIAC DEATH

Sudden cardiac death is defined as the Sudden cardiac death is defined as the unexpectedunexpected death due to a cardiac cause, in patient with or death due to a cardiac cause, in patient with or

without cardiac disease, which occurswithout cardiac disease, which occurs within one within one hour hour from the appearance of the from the appearance of the firstfirst clinical clinical

symptoms.symptoms.

My taskMy task

To briefly highlight the main messages derived To briefly highlight the main messages derived from SCD Guidelines.from SCD Guidelines.

I will focus on primary prevention of SCD and the I will focus on primary prevention of SCD and the use of ICD devices in patients with DCM (of use of ICD devices in patients with DCM (of ischemic and non-ischemic origin). ischemic and non-ischemic origin).

I will also briefly discuss the varying I will also briefly discuss the varying implementation of these guidelines in different implementation of these guidelines in different European countries and ICD cost effectiveness European countries and ICD cost effectiveness issues. issues.

SUDDEN CARDIAC SUDDEN CARDIAC DEATHDEATH

Primary preventionPrimary preventionThe main Clinical TrialsThe main Clinical TrialsThe Guidelines OrdersThe Guidelines Orders

DefibrillatorDefibrillator

ConventionalConventional

P = 0.007P = 0.007

1.01.0

0.90.9

0.80.8

0.70.7

0.60.6

0.00.0

00 11 22 33 44

YearYear

MADITMADIT--I II I

DefibrillatorDefibrillator

ConventionalConventional

P = 0.007P = 0.007

1.01.0

0.90.9

0.80.8

0.70.7

0.60.6

0.00.0

00 11 22 33 44

YearYear

MADITMADIT--I II I

MADIT IMADIT I

No. of patients

Defibrillator 95 80 53 31 173

Conventional 101 67 48 29 170

therapy

Year

1.0

0.8

0.6

0.4

0.2

0.00 1 2 3 4 5

Pro

bab

ilit

y o

f su

rviv

al

Conventionaltherapy

Defibrillator

P-value = 0.009

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

MADIT-IIMADIT-II

DefibrillatorDefibrillator

ConventionalConventional

P = 0.007P = 0.007

1.01.0

0.90.9

0.80.8

0.70.7

0.60.6

0.00.0

Pro

babili

ty o

f Surv

ival

Pro

babili

ty o

f Surv

ival

00 11 22 33 44

YearYearNo. At RiskNo. At Risk

DefibrillatorDefibrillator 742742 502 (0.91)502 (0.91) 274 (0.94)274 (0.94) 110 (0.78)110 (0.78) 99

ConventionalConventional 490 490 329 (0.90)329 (0.90) 170 (0.78)170 (0.78) 65 (0.69) 65 (0.69) 33

Survival curves diverged at 9 months

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

SSudden udden CCardiac ardiac DDeath in eath in HeHeart art FFailure ailure TTrial rial ((SCD-HeFTSCD-HeFT))

ICD reduced mortality by 23%

Bardy GH . N Engl J Med. 2004;352(3):225-37

0

20

40

60

80

MADIT MUSTT MADIT-II SCD-HeFT

Overall Death

Arrhythmic Death

0

20

40

60

80

AVID CASH CIDS

Overall Death

Arrhythmic Death

ICD mortality reductions in primary

prevention trialsare equal to or

greaterthan those in

secondaryprevention trials

13, 4

2

5 76

54%

75%

55%

76%

31%

61%

27 months 39 months 20 months

31%

56%

28%

59%

20%

33%

% M

ort

ali

ty R

ed

uc

tio

n w

/ IC

D R

x%

Mo

rta

lity

Re

du

cti

on

w/

ICD

Rx

3 Years 3 Years 3 Years

23%

45.5 months

MORTALITY RATE REDUCTION WITHMORTALITY RATE REDUCTION WITH ICDsICDs

POST-INFARCTION DILATED CARDIOMYOPATHYPOST-INFARCTION DILATED CARDIOMYOPATHY

Class I, level of evidence AClass I, level of evidence A

ICD therapy is recommended in patients withICD therapy is recommended in patients with: :

Left ventricular dysfunction due to an earlier Left ventricular dysfunction due to an earlier myocardial infarction, 40 days post MImyocardial infarction, 40 days post MI

An ejection fraction of An ejection fraction of ≤ 30 – 40 % ≤ 30 – 40 %

NYHA classNYHA class II orII or IIIIII

Receiving optimal pharmaceutical therapyReceiving optimal pharmaceutical therapy

Patients should Patients should have reasonable expectation of have reasonable expectation of survival with a good functional status (> 1 year)survival with a good functional status (> 1 year)

NON ISCHAEMIC CARDIOMYOPATHYNON ISCHAEMIC CARDIOMYOPATHY

Class I, level of evidence Class I, level of evidence BB

ICD Therapy is recommended for primary prevention, to ICD Therapy is recommended for primary prevention, to reduce total mortality by reducing SCD in patients withreduce total mortality by reducing SCD in patients with: :

Non ischaemic dilated cardiomyopathyNon ischaemic dilated cardiomyopathy

LVEF ≤ 30 – 35 %LVEF ≤ 30 – 35 %

NYHA class II – IIINYHA class II – III

Optimal Pharmaceutical TherapyOptimal Pharmaceutical Therapy

Patients should Patients should have reasonable expectation of survival have reasonable expectation of survival with a good functional status (> 1 year)with a good functional status (> 1 year)

Post MI cardiomyopathiesPost MI cardiomyopathies

Class I, level of evidence AClass I, level of evidence A

ICD therapy is indicated in patients with LVEF less ICD therapy is indicated in patients with LVEF less than 35%than 35% due to prior MI who are at least 40 days due to prior MI who are at least 40 days post-MI and are inpost-MI and are in NYHA II or IIINYHA II or III..

ICD therapy is indicated in patients with LV ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than 30%, and days post-MI, have an LVEF less than 30%, and are in NYHA I.are in NYHA I.

NON ISCHAEMIC CARDIOMYOPATHYNON ISCHAEMIC CARDIOMYOPATHY

Class I, level of evidenceClass I, level of evidence AA

ICD therapy is indicated in patients with nonICD therapy is indicated in patients with non--ischemicischemic DCM who have an LVEF less than or equal DCM who have an LVEF less than or equal to 35% andto 35% and who are in NYHA functional Class II or IIIwho are in NYHA functional Class II or III

SUDDEN CARDIAC SUDDEN CARDIAC DEATHDEATH

Primary preventionPrimary preventionClinical practice in EuropeClinical practice in Europe

Introductory commentsIntroductory comments

Clinical decisions that concern the use of ICD, CRT-Clinical decisions that concern the use of ICD, CRT-P and CRT-D devices in the various European P and CRT-D devices in the various European countries are characterized by significant countries are characterized by significant heterogeneity.heterogeneity.

The Guidelines that are followed are usually those The Guidelines that are followed are usually those of the ESC, in their unadulterated form or altered, of the ESC, in their unadulterated form or altered, sometimes national Guidelines (e.g. NICE) and not sometimes national Guidelines (e.g. NICE) and not infrequently, the American Guidelines.infrequently, the American Guidelines.

The patient access to advanced medical technology The patient access to advanced medical technology and especially ICD, CRT-P and CRT-D varies and especially ICD, CRT-P and CRT-D varies significantly in different European countries as a significantly in different European countries as a result of numerous causes and reasons. result of numerous causes and reasons.

ICD use in Europe vs USAICD use in Europe vs USA2004 - 20062004 - 2006

ICD use in EuropeICD use in Europe2005 - 20082005 - 2008

Eucomed 2009

CRT-D use in EuropeCRT-D use in Europe2005 - 20082005 - 2008

Eucomed 2009

Regional differences in ICDs implanation in UK. Regional differences in ICDs implanation in UK. Data from Data from Heart Rhythm Devices: UK National Survey 2007Heart Rhythm Devices: UK National Survey 2007

ICD implantation rate per million population ICD implantation rate per million population in Germany in 2002 - 2005in Germany in 2002 - 2005

2002 2005

We need to recognize that even in Germany there remains a significantWe need to recognize that even in Germany there remains a significant difference in implantation rates in the various regionsdifference in implantation rates in the various regions

One of the One of the main main roles of EHRA, is to roles of EHRA, is to promote equal promote equal

access to therapy for all patients across Europe.access to therapy for all patients across Europe.

TThe first step he first step waswas to compile data on the current to compile data on the current

situation in various ESC membership countries, situation in various ESC membership countries,

compare them, and propose actions to move towards compare them, and propose actions to move towards

harmonization.harmonization.

European Heart Rhythm AssociationEuropean Heart Rhythm AssociationMain ActionsMain Actions

European Heart Rhythm AssociationEuropean Heart Rhythm AssociationMain ActionsMain Actions

The European White Book of Electrophysiology:The European White Book of Electrophysiology:The first necessary step towards equal access to therapy The first necessary step towards equal access to therapy

in Europein Europe

Significant diversity exists among European Significant diversity exists among European countriescountries in:in:

The age distribution of the populationThe age distribution of the population

Gross Domestic Product (GDP)Gross Domestic Product (GDP)

The percentage of the GDP devoted to health The percentage of the GDP devoted to health expenditureexpenditure

Health systems (Private vs Public)Health systems (Private vs Public)

Medical education and EP training Medical education and EP training

The Value of the White BookThe Value of the White Book ObservationsObservations

The Value of the White BookThe Value of the White Book ObservationsObservations

Significant diversity exists among European countries Significant diversity exists among European countries in:in:

Healthcare dataHealthcare data Hospitals (per 100.000 population)

Beds (per 100.000 population)

Density of physicians (per 1.000 population)

Density of nurses (per 1.000 population)

Pacemaker –ICD-CRT implantation ratesPacemaker –ICD-CRT implantation rates

Number of Ablations performed Number of Ablations performed

The Value of the White BookThe Value of the White Book ObservationsObservations

The Value of the White BookThe Value of the White Book ObservationsObservations

CRT-D use in EuropeCRT-D use in Europe in 2007 in 2007

The highest CRT-D The highest CRT-D implantation rate per implantation rate per

million (upper quartile)million (upper quartile)

The lowest CRT-D The lowest CRT-D implantation per millionimplantation per million

(lower quartile)(lower quartile)

Italy 93,47 Georgia 1,08

Netherlands 85,63 Slovenia 1,00

Germany 84,13 Tunisia 0,96

Israel 68,33Russian

Federation 0,43

Czech Republic 58,57 Estonia 0,37

Austria 57,44 Lithuania 0,28

Denmark 50,11

France 46,34

United Kingdom 38,83

EHRA White Book

CountryCountry

Total expenditure on health as % of

GDPGDP/head GDP/head

($)($)

AustriaAustria 10.310.3 45,18145,181

CroatiaCroatia 7.77.7 14,41414,414

FranceFrance 10.510.5 41,51141,511

GermanyGermany 10.610.6 40,41540,415

GreeceGreece 9.99.9 33,43333,433

NorwayNorway 9.79.7 83,92283,922

RussiaRussia 66 9,0759,075

SpainSpain 8.18.1 32,06632,066

TurkeyTurkey 7.77.7 9,6299,629

EuropeEuropeGDP/Health expenditure %GDP/Health expenditure %

EuropeEuropeGDP/Health expenditure %GDP/Health expenditure %

EHRA White Book

SUDDEN CARDIAC SUDDEN CARDIAC DEATHDEATH

Primary preventionPrimary preventionCost-Effectiveness IssuesCost-Effectiveness Issues

IMPLANTABLE CARDIOVERTER DEFIBRILLATORSIMPLANTABLE CARDIOVERTER DEFIBRILLATORSCost - Effectiveness IssuesCost - Effectiveness Issues

ICD therapy generally costs more than ICD therapy generally costs more than conventional management of cardiac arrhythmias conventional management of cardiac arrhythmias but is more effective as compared to the therapy but is more effective as compared to the therapy with amiodaronewith amiodarone

The cost-effectiveness ratio of ICD therapy and The cost-effectiveness ratio of ICD therapy and Annual All Cause Cardiac Mortality has a U shapeAnnual All Cause Cardiac Mortality has a U shape

The cause-effectiveness ratio becomes non-The cause-effectiveness ratio becomes non-profitable at either low or very high percentages profitable at either low or very high percentages of Annual All Cause Cardiac Mortalityof Annual All Cause Cardiac Mortality

PRIMARY PREVENTION OF SCD AND ICDsPRIMARY PREVENTION OF SCD AND ICDsIs the Is the ΝΝΤ ΝΝΤ too high?too high?

Camm J. et al, European Heart Journal (2007) 28, 392–397

PRIMARY PREVENTION OF SCD AND ICD COSTPRIMARY PREVENTION OF SCD AND ICD COSTWhat is the relationship between drug therapy and ICDs?What is the relationship between drug therapy and ICDs?

This figure compares various therapy costs for 2004 in four major European countries

Camm J. et al, European Heart Journal (2007) 28, 392–397

SUDDEN CARDIAC SUDDEN CARDIAC DEATHDEATH

Implementation of Implementation of ESC ESC SCD SCD GuidelinesGuidelines

Is it PrimarilyIs it Primarilya Scientific, Political, a Scientific, Political, or Financial Matter?or Financial Matter?

Implementation of ESC Implementation of ESC SCD SCD Guidelines Guidelines A lack of education?A lack of education?

A large number of cardiologists, perhapsA large number of cardiologists, perhaps even the even the majority, in various European countriesmajority, in various European countries are are unaware of significant parts of the guidelines.unaware of significant parts of the guidelines.

It must become more widelyIt must become more widely known that the known that the guidelines have been proved toguidelines have been proved to contribute to contribute to improvement in patients’ quality of lifeimprovement in patients’ quality of life and life and life expectancy. expectancy.

WWe must overcome thee must overcome the reservations of those who reservations of those who question or reject the guidelinesquestion or reject the guidelines without without providing clear justification, simplyproviding clear justification, simply expressing expressing their flat disbelief, for this or that reason.their flat disbelief, for this or that reason.

Implementation of ESC Implementation of ESC SCD SCD Guidelines Guidelines A political matter?A political matter?

MMost governments in ESC countries give priority ost governments in ESC countries give priority to limitingto limiting health care expenditure and are health care expenditure and are aggrieved whenaggrieved when faced with the increased faced with the increased expenses that the guidelinesexpenses that the guidelines often entail.often entail.

It must be admitted here that the cost of It must be admitted here that the cost of implementingimplementing guidelines is indeed often guidelines is indeed often insupportable for ainsupportable for a significant number of significant number of countries in the European Union.countries in the European Union.

VVery often the policiesery often the policies of some governments of some governments disregard and diverge widelydisregard and diverge widely from the from the recommendations issued by their own nationalrecommendations issued by their own national cardiological societies with regard to such topics.cardiological societies with regard to such topics.

Implementation of ESC Implementation of ESC SCD SCD Guidelines Guidelines A financial problem?A financial problem?

TThe cost of complete implementationhe cost of complete implementation of the of the guidelines often stands as an insurmountableguidelines often stands as an insurmountable obstacle for the economies of many countries of obstacle for the economies of many countries of thethe European Union. European Union.

The map of European economiesThe map of European economies shows material shows material differences, where countries with adifferences, where countries with a per capita per capita income of €70,000 coexist besides thoseincome of €70,000 coexist besides those with a with a per capita income of €4,000. per capita income of €4,000.

I I personally believe that forpersonally believe that for countries with a per countries with a per capita income below €25,000capita income below €25,000 the cost is the main the cost is the main reason for non-implementationreason for non-implementation of the guidelines. of the guidelines.

CONCLUSIONSCONCLUSIONS

Clinical effectiveness of ICD for the primary Clinical effectiveness of ICD for the primary prevention of SCD is proven. prevention of SCD is proven.

Therapy cost effectiveness continues to be a Therapy cost effectiveness continues to be a thorny issue.thorny issue.

CONCLUSIONSCONCLUSIONS

The implementation of the current guidelines is The implementation of the current guidelines is expensive.expensive.

The MADIT II criteria can only be universally The MADIT II criteria can only be universally implemented in a limited number of countries.implemented in a limited number of countries.

This life saving, but relatively expensive This life saving, but relatively expensive treatment with ICDs, needs to be implemented treatment with ICDs, needs to be implemented with caution, thoroughness and knowledge.with caution, thoroughness and knowledge.

CONCLUSIONSCONCLUSIONS

The ESC has as a strategic priority,The ESC has as a strategic priority, not only the not only the production of high-quality guidelines,production of high-quality guidelines, but also but also their correct implementation. their correct implementation.

The nationalThe national societies have shown interest and societies have shown interest and understanding withunderstanding with regard to the need for regard to the need for implementation.implementation.

What is needed is systematic and organised What is needed is systematic and organised collaborationcollaboration between national societies and the between national societies and the ESCESC and an assessment of the results on an and an assessment of the results on an annual basis.annual basis.

Government dilemmaGovernment dilemmaSpending the taxpayers’ moneySpending the taxpayers’ moneyGovernment dilemmaGovernment dilemmaSpending the taxpayers’ moneySpending the taxpayers’ money

4.5 4.5 million € million €

14 million € 14 million € annual front annual front cost for UK cost for UK

14-18 million 14-18 million €€