sudden cardiac death: clinical practice in europe panos e. vardas professor of cardiology president...
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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 €€