Fighting cardiovascular disease – a blueprint for EU action
June 2020
Fighting cardiovascular disease – a blueprint for EU action
1 ForthedefinitionofCVDpleaseseeAppendix12 Inthispaper,theEUcomprises28memberstates
Substantialprogressinthepreventionandtreatmentofcardiovasculardisease(CVD1)hasresultedinthedramaticdeclineinprematuredeathfromCVDoverthelast50years.ThismayhaveledtofalseoptimismthatCVDneednolongerbeapublichealthpriority.
However,thisisnotthecase.
IntheEuropeanUnion(EU)2,theburdenofCVDremainsgreaterthanthatofanyotherdisease.Cardiovascularevents–mainlymyocardialinfarction(heartattack)andstroke–remain,byfar,theleadingcauseofdeathintheEU.Inaddition,millionsofpeoplenowlivewith,andintheaftermathof,CVD.
Anynotionthat“thejobisdone”isclearlyamiss.
Thedevelopmentofinnovativesolutionstoensurepeople’saccesstopreventionandtreatmentofCVDacrossEuropeisanecessaryandurgentpriority.SupportingresearchinCVDbycreatingaEuropean-wideinfrastructuretoenablequalityofcareassessment,harmonisedhigh-qualitydiseaseregistries,andstreamlinedpragmaticrandomisedclinicaltrialswillnotonlyimprovethehealthofpeoplelivinginEurope,butstimulatethepharmaceuticalanddeviceindustrytoinvestinEurope.
ThispaperprovidesablueprintforaddressingthehugeburdenofCVDamongtheEUpopulation,byputtingforwardspecificrecommendationsforanambitiousEUactionplanthataddressescardiovascularhealthtobeimplementedinthecurrentEUmandate.
WecallonEUpolicymakerstosupportthisproposal.
Understanding the burden of cardiovascular disease (CVD)
Morbidity
MostrecentdatafromtheGlobalBurdenofDiseasedatabaseestimatethat,intheEU,morethan60millionpeoplelivewithCVD,andthatcloseto13millionnewcasesofCVDoccureveryyear.
60MILLION
Total of peopleliving with
CardiovascularDisease today
13MILLIONNew cases of CardiovascularDisease each year
LIVING WITH CVD (EU)LIVING WITH CVD (EU)
A blueprint for EU action | 1
Morepatientssurviveheartattackorstroke,andthepatternofCVDhaschanged–inparticular,nowadaysmanypatientswithCVDareco-morbid(thatis,haveco-existingrenalfailure,cognitivedecline,diabetesorotherconditions).ThiscombinationhassignificantadverseeffectsonpatientsandputssubstantialstrainonhealthcaresystemsacrosstheEU.
Mortality
CVD is the number one cause of death in the EU:morethan1.8millionpeople–equaltothepopulationofVienna–dieeveryyearasaresultofCVD,accountingfor36%ofalldeaths—farmorethananyothercondition(asacomparison,canceraccountsfor26%ofalldeathsintheEU).Thisrepresents,onaverage,about5000deathsperdayintheEU.
Moreover,alargeproportionofCVDdeathsispremature.IntheEU,24%ofdeathsamongmenbeforeage65,and17%ofdeathsamongwomenbeforeage65,areduetoCVD.
Notably,therateofdeclineinCVDmortalityappearstobetapering.Indeed,for the first time in 50 years some EU countries have reported an increase in premature CVD death.TheseadversetrendshavebeenattributedtoaninsufficientawarenessofCVD,limitedandgeographicallyvariedinvestmentincardiovascularpreventionandtreatment,andtherisingprevalenceofobesity(andwiththatofdiabetes,hypertension,dyslipidaemiaandatherosclerosis).
The economic cost
TheburdenofCVDisnotonlyahealthissue,butanenormouseconomicchallengetohealthcaresystemsintheEUthatisexpectedtogrowinfutureyears.
ThemostrecentdataestimatethatCVD costs the EU economy approximately €210 billion a year.Ofthatcost,around53%(€111billion)isforhealthcarecosts,26%(€54billion)isduetoproductivitylossesand21%(€45billion)duetoinformalcareofpeoplewithCVD.
< 65 YEAR OLDSPremature death from Cardiovascular Disease
17% 24%
DEATHS IN < 65 YEAR OLDSDEATHS IN < 65 YEAR OLDS
2 | Fighting cardiovascular disease
Inequalities in CVD in the EU
RobustactiononCVDhasthepotentialtosignificantlyreducehealthinequalitiesintheEU.InequalitiesinmortalityfromCVD account for almost half of the excess mortality in lower socio-economic groups in most European countries.
GeographicalinequalitiesaresignificantandpersistentinCVD:
� TheprevalenceofCVDishigherinEasternandCentralEuropeancountriesandlowerinWestern,NorthernandSouthernEuropeancountries.Indeed,in2017,orlatestavailableyear,theage-standardisedCVDprevalencerateintheEUinmenwas50%higherinthecountrywiththehighestrate(Bulgaria)thaninthecountrywiththelowestrate(Cyprus),andinwomentheratewas60%higherinthecountrieswiththehighestrates(BulgariaandtheCzechRepublic)comparedtothecountrieswiththelowestrates(ItalyandSpain).
� CVD is responsible for 27 million disability-adjusted life years (DALYs) in the EU(18%).TheratesofDALYslostduetoCVDareagainhigherinCentralandEasternEuropethaninNorthern,SouthernandWesternEurope.
� Inlinewiththeprevalencedata,death rates from both heart disease and stroke are higher in Central and Eastern Europe thaninNorthern,SouthernandWesternEurope.Forexample,theage-standardiseddeathrateforheartdiseasein2017,orlatestavailableyear,is13-foldhigherinwomeninLithuaniathaninFrance,and9-foldhigherinmen.Forstroke,theage-standardiseddeathrateis7-foldhigherinwomeninBulgariathaninFrance,and8-foldhigherinmen.
ThesinglemostimportantcontributortoexcessmortalityinEasternEuropeancountriesisCVD.While among men less than 50% of the excess mortality is due to CVD, in women this percentage is 80%.
A man in Bulgaria is
8xmore likely to die from stroke than a man in France
A woman in Lithuania is
13xmore likely to die from
heart disease than a woman in France
DISPARITIES IN MORTALITY (EU)
A blueprint for EU action | 3
An action plan for cardiovascular disease
3 SeeAppendix2forCVDriskfactors
WhiletheorganisationanddeliveryofhealthcareareMemberStates’competences,the EU can play a crucial role in tackling the burden of CVD through policy and regulation, as well as supporting research and innovation into CVD prevention and management.
TakingintoconsiderationthecompetencesoftheEU,weproposeanactionplanonCVDinthefollowingareas:
� TheneedforprioritisingpreventionofavoidableCVD
� Theneedforpromotinginnovationandmodernisingresearchregulationstoimproveaccess
� Betterpatientcarethroughimproveddiagnosis,treatmentandmanagement
1 The Need for Prioritising Prevention of Avoidable CVD
CVDisoftenreferredtoasalifestylediseasebecauseofitscausallinkwithbehaviouralriskfactors(lifestyledeterminants).However,asforcancer,CVDiscausedbyseveralotherfactors3and,giventhescaleofthedisease,itwouldbemoreappropriatetorefertoCVDasasocietaldisease.
Manypeoplearealreadydisabledbyill-healthbeforetheyreachretirementage.Greaterreductionofexposuretothemainbehaviouralriskfactors–tobacco,unhealthydiet,physicalinactivityandharmfuluseofalcohol–wouldincreasethenumberofyearslivedingoodhealth.
Effective population-wide interventions to prevent CVD have the potential to provide both human and economic benefits with considerable returns on investment. GiventhatthemajorityofcasescomefromindividualsatlowormoderateriskofCVD,smallreductionsinCVDriskfactorsacrossthepopulationwillproducelargesocietalgain.
Cardiovascular Disease is the biggest killer
in the EU and the world
CARDIOVASCULAR DISEASE
4 | Fighting cardiovascular disease
1.1 Food and nutrition
IntheEU,unhealthydietsareassociatedwithover800000deathsfromCVDeachyear,accountingforover40%ofallCVDdeaths–417000inmenandalmost400000inwomen.Dietaryrisksareresponsibleforalmost45%ofalltheyearslosttoCVDdeathordisabilityintheEU.
AchievingaCVDhealth-promotingdietrequiresmovingawayfromananimal-baseddiettoamoreplant-baseddiet.CVD-specificnutrients,wheretargetgoalsatapopulationlevelshouldbereached,aresaturatedfats(lessthan10%ofcalories),salt(lessthan5gofsaltperday)andfibre(atleast12.6gofdietaryfibreper1000kcal=3gperMJenergy).
RECOMMENDED EU PRIORITY ACTIONS
� Set nutrient profiles to underpin nutrition and health claims as required by the EC regulation on nutrition and health claims (EC) No 1924/2006
� Adopt rules on simplified front-of-pack nutritional labelling
� Adopt regulations restricting all marketing to children, including digital, of food and drinks high in fat, salt and sugar
1.2 Smoking
SmokingisthesecondlargestcauseofCVDafterhighbloodpressure.Itisassociatedwith13%ofallCVDdeathsintheEU,whichtranslatestoalmost250000CVDdeathseveryyear(around165000maleand82000femaledeaths).
Theaverageprevalenceofsmoking(dailyandoccasionalsmokers;peopleolderthan15)intheEUis24%.However,prevalencevarieshugely,fromjustunder17%inSwedentoalmost35%inBulgaria.
Recentstudiesincreasinglyhighlighttherisksofelectroniccigaretteusetothecardiovascularsystem.
RECOMMENDED EU PRIORITY ACTIONS
� Raise minimum tobacco excise duties to the highest possible level
� Bring excise duties on “roll your own” tobacco up to the same level as manufactured cigarettes
� Strengthen regulation on e-cigarettes
A blueprint for EU action | 5
1.3 Physical inactivity
Lowphysicalactivityisestimatedtoberesponsiblefor140000cardiovasculardeathsintheEUeveryyear.Itcausesmoredeathsamongthefemalepopulation(77000)thanamongthemalepopulation(63000).
Participationinregularphysicalactivityand/oraerobicexercisetrainingisassociatedwithareductionintheprevalenceofandmortalityfromCVD,whileasedentarylifestyleincreasestheriskofCVDbyincreasingtheriskofhypertension,hightriglycerides,lowHDL(‘good’)cholesterol,diabetesandobesity.
RECOMMENDED EU PRIORITY ACTION
� Encourage the development and approval of EU funded projects (in particular projects supported by EU Structural Funds) that have a positive impact on active living
1.4 Alcohol
Harmfulalcoholconsumptionisestimatedtoberesponsibleforcloseto50000CVDdeathsintheEU.
Highalcoholconsumption,particularlybingedrinking,increasestheriskofCVDbyraisingbloodpressureandbloodlevelsoftriglycerides.ConsumptionofthreeormorealcoholicdrinksperdayisassociatedwithincreasedCVDrisk.
RECOMMENDED EU PRIORITY ACTIONS
� Raise minimum excise duties on alcoholic beverages to the highest possible level
� Introduce mandatory, front-of-pack energy labelling on alcohol
� Introduce mandatory ingredients list on alcoholic beverages
1.5 Air pollution
Airpollutionhasbeenassociatedwitharound115000cardiovasculardeathsperyear(6%ofallcardiovasculardeaths)intheEU,accountingformorethan60000maledeathsandmorethan53000femaledeaths.
Exposuretoairpollutionaffectseverybody,butitisanamplifyingfactorforhealthinequalities,aspeoplelivinginlessaffluentareasareoftenmoreexposedtoit.
RECOMMENDED EU PRIORITY ACTION
� Revise the ambient air quality directive adopting the WHO Air Quality Guideline values as limit values
6 | Fighting cardiovascular disease
2 The need for promoting innovation and modernising research regulations to improve access
DespitetheburdenofCVDbeinggreaterthananyotherdisease,researchandinnovationinCVDislagging,comparedwithotherdiseasedomains.OnlyoneCVDmedicinewasapprovedbytheEuropeanMedicinesAgencyin2018.
Thecomplexityandcostsofclinicaltrialsandanunfavourableregulatoryframeworkforfosteringinnovationarekeycontributorstothisdecline.
2.1 The need for promoting research & innovation in CVD
ResearchfundingforCVDisdisproportionallylowatEUlevel,comparedwithotherdiseases.CVDanditsriskfactorsfeatureverylittleinthecalldescriptionsforHorizon2020,andthenumberofEU-fundedprojectsrelatedtoCVDisfarfewerthanthoseinotherclinicalareas.
TheStrategicResearchAgendaforCVD,whichwasproducedbytheERA-CVDNetworkincooperationwiththeEuropeanHeartNetworkandtheEuropeanSocietyofCardiology,identifieskeyareasforwhichclinicalresearchisneededifwewanttosucceedinreducingCVDmortalityandmorbidity.Thetopfiveresearchprioritiesidentifiedare:
1. Earlierrecognitionofcardiovasculardisease
2. Repairoftheheartandbloodvessels
3. TheinteractionbetweenCVDandotherdisorders
4. Treatmentofchronicheartfailureandatrialfibrillation
5. Personalisedtreatmentandmanagementofcardiovasculardisease
RECOMMENDED EU PRIORITY ACTION
� Recognise key areas of CVD research as priorities in the Horizon Europe programme
36% CardiovascularDisease
26% Cancer
8% Respiratory
2% Diabetes
1.8MILLION Cardiovascular Disease deaths per year
=
5000 Cardiovascular Disease deaths per day
DYING FROM CARDIOVASCULAR DISEASE (EU)DYING FROM CARDIOVASCULAR DISEASE (EU)
A blueprint for EU action | 7
2.2 Modernise the regulatory framework for the assessment of the efficacy and safety of new treatments
Cardiologyhasoneofthestrongestevidencebases,yetonlyabout14%ofESCClinicalPracticeGuidelinerecommendationsarebasedonrandomisedclinicaltrialevidence,demonstratingtheprohibitivecostandcomplexityofclinicaltrialsinCVD.
Currently,thecostofrandomisedcontrolledtrialsandthereluctanceofpayerstoreimbursetherapiesthatproduceeffectsonmoderatesizeinverylargenumbersofeligiblepatientsareamajorthreattothedevelopmentofnewtreatmentsinCVD,andthereasonwhyseveralpharmaceuticalcompanieshavemovedoutofthecardiovasculararea.
To mitigate these worrying trends, innovative approaches are urgently needed.
Theseincludearegulatoryframeworkadaptedtothechallengesofdevelopingnewtherapies,betterandmoreflexiblerulesfortheconductofrandomisedclinicaltrials,andthe development of a European-wide infrastructureeitherbasedonpatients’ electronic health records or continuous patient registriesthatwouldallowrandomisationatthepointofcareandlow-costlong-termautomatedcaptureofefficacyandsafetysignalswithinhealthcaresystemsorregistriesforreliableassessmentofnewtherapiesanddevices.
Fewinterventionscouldhavesuchamajorimpactonthecosteffectivenessofregulatorystudies,ultimatelyleadingtobetterdataandpotentiallymuchlessexpensivetreatments,notonlyforCVDbutforallcommonconditions.
Together,suchdevelopmentswouldnotonlyimprovepatientaccesstobettertreatments,butalsobe instrumental in bringing investment to and promoting innovation in Europeandwouldbenefitallareasofmedicalresearch.
RECOMMENDED EU PRIORITY ACTIONS
� Promote and support the development of harmonised and comprehensive continuous patient registries in CVD, as well as the digital capability to enable the evidence generated within health systems to improve the speed and efficiency of randomised controlled trials
� Establish a structured collaboration between academic clinical trialists, patients, regulators and industry, to modernise the International Council of Harmonisation (ICH) Good Clinical Practice (GCP) standards and make them fit for the digital era
8 | Fighting cardiovascular disease
2.3 Unlocking the full potential of digital technologies for cardiovascular health
Digitaltechnologiesmayhavegreatpotentialintransformingprevention,earlydetectionandmanagementofcardiovasculardisease.Inprimarypreventionforexample,mobileapplications,textmessagingandmonitoringsensorsforself-tracking,aswellasonlinecounselling,havethepotentialtoidentifypeoplewithhighcardiovascularrisk,andimprovelifestylemanagementinterventiontoreducecardiovascularrisk.
Digitaltechnologiesinhealthcaredeliveryprovidetheopportunitytoredesignandimprovepatients’careafterdiagnosisanddischarge,thankstoinnovationsintelecommunicationtechnologies(i.e.cardiactelerehabilitation).
Furthermore,supportingthedigitisationofhealthsystemsthroughthedevelopmentofelectronichealthrecordsanddatarepositories,aswellasexploitingthepotentialofartificialintelligence,wouldplayakeyroleinimprovingdiagnosisandtreatmentofCVD.
RECOMMENDED EU PRIORITY ACTION
� Support research and deployment of digital health technologies in cardiovascular disease prevention and management
2.4 Better understand the interaction between CVD and cancer
Advancesinoncologicaltreatmenthaveledtotheimprovedsurvivalofpatientswithcancerbuthavealsoincreasedmorbidityandmortalityduetothecardiotoxicityofcancertreatment.
Researchershavefoundthatwithinfiveyearsofacancerdiagnosis,theriskofheartfailurewasthreetimeshigherinpeopletreatedforbreastcancerorlymphomathaninpeoplewithoutcancer.Equally,anincreasedincidenceofcancerinpatientswithheartfailurehasbeenidentified,withsomestudiesestimatingthisincidencetobeintherangeof19–33%per1000person-years.
WebelieveitisofgreatimportancetoconductresearchintheareaofCVDandcancerco-morbiditiesandcomplications,aswewitnessanincreasingnumberofpatientswithbothdiseasesorrecoveringcompletelyfromcancerbutendingupdyingorsufferingfromcardiovasculardiseaseasaresultoftheircancertreatment.
RECOMMENDED EU PRIORITY ACTION
� Include a focus on cancer and CVD co-morbidities and research on the short-term and long-term cardiovascular effects of cancer treatment in the new Europe’s Beating Cancer Plan and Cancer Mission within Horizon Europe
A blueprint for EU action | 9
3 Better patient care through improved diagnosis, treatment and management
ItisessentialtoenablepeoplewhoareathighriskofdevelopingCVD,orwhohavealreadycontractedCVD,toactivelymanagetheircondition,sothattheycanlivetoanoldagewithagoodqualityoflife.
EUMemberStatesareresponsiblefororganising,fundingandprovidinghealthcaretotheirpeople.EUpolicymakerscanpromotecoordination,sharebestpracticeandguidelines,aswellascarryoutnon-bindinginitiatives.
3.1 Identification of people at high risk of developing CVD
Around20–40%ofheartattacksoccurinpeoplepreviouslyundiagnosedwithCVD.Inordertoassistthesepeopletoreducetheirrisks,andtoavoidtheonsetofdisease,itiscrucialtoidentifythemandprovidethemwiththeappropriateadviceandpreventativetreatment.
Targetedhigh-quality,risk-assessmentprogrammesmayhelpidentifypeopleatriskanddeterminethemostappropriatepreventivemeasures.Indeprivedcommunities,therateofhigh-riskindividualsisknowntobesignificantlyhigherthaninotherareas.Itisthereforecriticaltodevelopapproachesthatenabletheinclusionofhard-to-reachgroups.
RECOMMENDED EU PRIORITY ACTION
� Establish a joint action/network of Member States, supported by experts, to identify the most effective policies and measures for reaching out to and managing individuals at high risk of developing CVD
3.2 Improving treatment
Substantialdifferencesexistbetweencountriesintermsofaccesstotechnologiesandproceduresfortreatingpatientswithcardiovasculardisease.Whileaccesstoinnovativetreatmentscorrelateswithhealthexpenditurepercapitainacountry,budgetallocationexplainsonlysomeofthevariationinprovision.
Highstandardsfortheevaluationandmonitoringofhealthtechnologiesalongtheirwholelife-cycle–frommarketauthorisationtopost-marketingsurveillance–areanessentialelementofensuringthatsafe,effectiveandinnovativetechnologiesareavailabletopatientsinatimelymanner.
€ 111 BILLIONHealthcare costs
€ 54 BILLION
€ 45 BILLIONInformal care costs
€210BILLIONper year
53%
26%
21%
COSTS OF CVD (EU)COSTS OF CVD (EU)
10 | Fighting cardiovascular disease
TheEUmustensureadequatecapacityforafullyoperationalregulatorysystemforpharmaceuticalsandmedicaldevicesalike.CooperationinHealthTechnologyAssessment(HTA)atEUlevelisequallyimportantforreducinginequalitiesinCVDtreatmentandwastefulspending,allowingdecision-makerstotakeinformeddecisionsbasedontheclinicaleffectivenessoftechnologies.Inthisrespect,patientsandhealthcareprofessionalsmustbeinvolvedinregulatoryprocessessothattheymaymeaningfullycontributetoasafe,effectiveandequitablesystem.
RECOMMENDED EU PRIORITY ACTIONS
� Ensure the necessary human and financial resources are available to the European Commission services responsible for the implementation of the Medical Devices Regulation
� Secure a positive outcome for the EU legislative proposal on Health Technology Assessment, covering the assessment of both medicines and medical devices
3.3 Cardiac and stroke rehabilitation and secondary prevention
AcrucialpartoftreatmentforCVDisrehabilitationafteranevent,includingcounselling,medicaltreatment,exerciseandpsychologicalsupport.Theseprogrammeshelppreventrecurrence,andimprovefunctionalcapacity,recoveryandpsychologicalwell-being.Theyhelppatientsregainasnormalalifeaspossible,optimisetheirqualityoflife,andreducetheburdenonhealthservicesbyreducinghospitalre-admissions.
Althoughtheconsiderablebenefitsofcardiacandstrokerehabilitationforpatientsaswellasthewidersocietyarewell-documented,accesstoanduptakeofqualityrehabilitationispatchyinmostEuropeancountriesandisconsideredanunderutilisedresource.
RECOMMENDED EU PRIORITY ACTIONS
� Adopt a European definition of cardiac and stroke rehabilitation
� Establish a joint action/network of Member States to identify barriers for uptake of cardiac and stroke rehabilitation and secondary prevention programmes and how to address them
A blueprint for EU action | 11
OVERALL AIM
Reduce premature disease and death from CVD and inequalities in cardiovascular death rates in the EU
Conclusions and recommendations
DeathratesfromCVDhavefallensteadilyoverthepasthalfcentury.Thishasbeenduetosuccessfulinterventions,includingpopulation-basedpreventionandimprovedtreatmentoptions.Nonetheless,CVDremainsthemostcommoncauseofdeathintheEU,claimingmorethan1.8millionliveseachyear.Recentdataestimatethatmorethan60millionpeopleintheEUlivewithCVD.
RecenttrendsshowaslowdownintherateofdeclineinCVDdeathrates–atrendwhichismorepronouncedinyoungeragegroups.Thesetrendsarealarmingandsuggestthatifthestatusquoprevails,therecouldbeanincreaseindeathsfromCVDoverandabovewhatwouldbeexpectedfromagrowingandageingpopulation.Moreover,thereisevidencefromEUcountriesforanincreaseinthedeterminantsofCVD,includingdiabetesandobesity.Shouldthistrendcontinue,thenthelatenteffectswouldsetthesceneforatremendoussetbackinCVDmorbidityandmortality.
Wemustnotbecomplacent:fightingCVDisfarfromover,andactionatEUlevelisurgentlyneeded.ThisCVDActionPlanprovidesablueprintforthe2019–24EUmandate.
OVERARCHING RECOMMENDATION
Ensure that TFEU Article 168 is properly operationalised, by establishing a world-class health impact assessment methodology that considers potential impact on CVD as well as differential impact in regions (East/West) of the EU by 2024
12 | Fighting cardiovascular disease
Specific priority recommendations to be achieved by 2024
� Set nutrient profiles to underpin nutrition and health claims as required by the EC regulation on nutrition and health claims (EC) No 1924/2006
� Adopt rules on simplified front-of-pack nutritional labelling
� Adopt regulations restricting all marketing to children, including digital, of food and drinks high in fat, salt and sugar
� Raise minimum tobacco excise duties to the highest possible level
� Bring excise duties on “roll your own” tobacco up to the same level as manufactured cigarettes
� Strengthen regulation on e-cigarettes
� Encourage the development and approval of EU funded projects (in particular projects supported by EU Structural Funds) that have a positive impact on active living
� Raise minimum excise duties on alcoholic beverages to the highest possible level
� Introduce mandatory, front-of-pack energy labelling on alcohol
� Introduce mandatory ingredients list on alcoholic beverages
� Revise the ambient air quality directive adopting the WHO Air Quality Guideline values as limit values
� Recognise key areas of CVD research as priorities in the Horizon Europe programme
A blueprint for EU action | 13
� Promote and support the development of harmonised and comprehensive continuous patient registries in CVD, as well as the digital capability to enable the evidence generated within health systems to improve the speed and efficiency of randomised controlled trials
� Establish a structured collaboration between academic clinical trialists, patients, regulators and industry to modernise the International Council of Harmonisation (ICH) Good Clinical Practice (GCP) standards and make them fit for the digital era
� Support research and deployment of digital health technologies in cardiovascular disease prevention and management
� Include a focus on cancer and CVD co-morbidities and research on the short-term and long-term cardiovascular effects of cancer treatment in the new Europe’s Beating Cancer Plan and Cancer Mission within Horizon Europe
� Establish a joint action/network of Member States, supported by experts, to identify the most effective policies and measures for reaching out to and managing individuals at high risk of developing CVD
� Ensure the necessary human and financial resources are available to the European Commission services responsible for the implementation of the Medical Devices Regulation
� Secure a positive outcome for the EU legislative proposal on Health Technology Assessment, covering the assessment of both medicines and medical devices
� Adopt a European definition of cardiac and stroke rehabilitation
� Establish a joint action/network of Member States to identify barriers to uptake of cardiac and stroke rehabilitation and secondary prevention programmes, and how to address them
14 | Fighting cardiovascular disease
This blueprint has been developed by:
TheEuropeanHeartNetworkandtheEuropeanSocietyofCardiology.
About the EHN
TheEuropeanHeartNetwork(EHN)isaBrussels-basedallianceoffoundationsandassociationsdedicatedtofightingheartdiseaseandstrokeandsupportingpatientsthroughoutEurope.
TheEHNplaysaleadingroleinthepreventionandreductionofcardiovasculardiseases,inparticularheartdiseaseandstroke,throughadvocacy,networking,capacity-building,patientsupport,andresearchsothattheyarenolongeramajorcauseofprematuredeathanddisabilitythroughoutEurope.www.ehnheart.org
About the ESC
TheEuropeanSocietyofCardiology(ESC)bringstogetherhealthcareprofessionalsfrommorethan150countries,workingtoadvancecardiovascularmedicineandhelppeopleleadlonger,healthierlives. www.escardio.org
A blueprint for EU action | 15
Appendix 1What is CVD?
CVDaffectsmenandwomenofallages,inallEUcountries.CVDhasmanyforms,allrelatedtotheheartandthecirculatorysystem.
Theyinclude:
� Ischaemic heart disease (IHD),alsoknownascoronary artery disease (CAD),whichiscausedbyatherosclerosisinwhichfattyplaquedepositscauseanarrowingofthearterywallsleadingthehearttoreducebloodflow,theprimarycauseofheartattacks.Chronicstableanginaischestpainthatoccurswhentheheartisworkinghardandneedsmoreoxygen.Itisoftenduetophysicalexertionandindicatesdamagedheartfunction.
� Stroke,whichoccurswhenanarterythatcarriesoxygenandnutrientstothebrainisaffectedbyatherosclerosis,blockedbyaclot,orbursts.
� Peripheral artery disease,inwhichnarrowedarteriesreducebloodflowtothelimbs.Commonindiabetes,andthemajorcauseoflowerlimbamputations.
� Heart rhythm disturbances: sudden cardiac deathisoftenthefirstandfinalpresentationofotherunderlyingCVDandisofongoingconcerninmostpatientswithCVD.Atrial fibrillation (AF or AFIB)isanarrhythmiawithirregularheartratethatmaycausestroke,heartfailure,palpitations,fatigueandshortnessofbreath.
� Heart failure (HF)occurswhendamagetotheheartmuscleissevereenoughtopreventitfromfunctioningproperly;morbidityandmortalityinsevereheartfailureisworsethaninmanycancersandtheonlycurrentcureistransplantation.
� Congenital heart diseaseisageneraltermforarangeofbirthdefectsthataffectthenormalwaytheheartworks.Theterm“congenital”meanstheconditionispresentfrombirth.Congenitalheartdiseaseisoneofthemostcommontypesofbirthdefect,affectingupto8inevery1,000babiesborninEurope.
� Inherited heart conditions,alsoknownasgenetic heart conditions,astheyarepassedonthroughfamilies.Theycanaffectpeopleofanyageandcanbelife-threatening.Ifleftundetectedanduntreated,aninheritedheartconditionmayleadtoheartfailureorevensuddendeathfromcardiacarrest.Formanyfamilies,thefirstsignthereisaproblemiswhensomeonediessuddenlywithnoobviouscauseorexplanation.
� Vascular dementia,inwhichmentalproblemssuchasconfusion,slowthought,memoryissues,moodandpersonalitychangesoccurincombinationwithreducedbloodflowtothebrain;itisincreasinginincidencewiththeageingpopulation.
� Valvular heart disease,ofwhichaorticstenosisandmitralvalveinsufficiencyarethemostfrequent.
16 | Fighting cardiovascular disease
Appendix 2What are CVD risk factors?
Riskfactorsassociatedwithcardiovasculardiseasecanbedividedintodifferentcategories:
Possessingoneormoreriskfactorsincreasesaperson’sriskofdevelopingcardiovasculardisease.WhilesomeriskfactorsofCVDhavebeenwellreported,notablyelevatedbloodpressureandcholesterolandlifestylefactors,othersareemerging.Theseinclude:
Genetics
Manycardiacdisorderscanbeinherited,includingarrhythmias,congenitalheartdiseaseandcardiomyopathies.ChildrenofparentswhohavebothsufferedfromCVDbeforetheageof55,havea50%greaterriskofdevelopingCVDthanthegeneralpopulation.Individualswithaparentorasiblingwhohassufferedastrokeareatanincreasedriskofstroke.
Cancer treatments
Certaincancertreatments,includingchemotherapyandradiation,maycauseheartproblems.Researchershavefoundthatwithinfiveyearsofacancerdiagnosis,peopletreatedwithchemotherapyandanthracyclineswerethreetimesaslikelytodevelopheartfailurethanpeoplewhohadneverhadcancer.
Biological determinants Lifestyle determinants
Elevatedbloodpressure Unhealthydiet
Raisedbloodsugar Tobaccouse
Elevatedbloodcholesterol Physicalinactivity
Overweight/obesity Alcoholabuse
Broader determinants
Fixed Modifiable
Age Income
Sex Education
Genetics Livingconditions(includingairpollution)
Ethnicity Workingconditions
A blueprint for EU action | 17
Kidney disease
Kidneysareimportantorgansinregulatingbloodpressure.Elevatedbloodpressure,ontheotherhand,oftencauseskidneyinsufficiency.Theheartandkidneysoperatecloselytogether,andchronickidneydisease(CKD)andheartdiseasequiteoftenco-exist,withCKDbeingthemostcommonco-morbidityofheartfailurepatients(50%).DatafromtheUShasshownthattheprevalenceofCVDamongpeopleaged66andolderwhohavekidneydiseaseis69.6%.
Diabetes
Over60millionpeopleinEuropearelivingwithdiabetes.Themajorityofcasesaretype2.AmongEuropeans,theprevalenceofdiabeteshasbeenskyrocketing.Asurveyof17Europeancountriesshowedadoublingofthepercentagefrom1995to2014.InRomania,ittripled,whileadramaticfour-foldincreasewasobservedinLatvia.Peoplewithdiabeteshaveanincreasedriskofcardiovasculardisease,whichistheleadingcauseofdeathinpeoplewithtype2diabetes.
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20 | Fighting cardiovascular disease
TheEuropeanHeartNetworkhasreceivedco-fundingunderanoperatinggrantfromtheEuropeanUnion’sHealthProgramme(2014–2020).ThecontentofthisreportrepresentstheviewsoftheEHNonlyandisitssoleresponsibility;itcannotbeconsideredtoreflecttheviewsoftheEuropeanCommissionand/ortheConsumers,Health,AgricultureandFoodExecutiveAgencyoranyotherbodyoftheEuropeanUnion.TheEuropeanCommissionandtheAgencydonotacceptanyresponsibilityforusethatmaybemadeoftheinformationitcontains