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Heart Failure TherapiesState of the Art 2017
Andrew J. Sauer, MDAssistant ProfessorDirector, Center for Heart FailureMedical Director, Heart TransplantationUNOS Primary Transplant [email protected]
DisclosuresNovartis: Speaker HonorariumMedtronic: Speaker/Consultant Honorarium
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Learning Objectives• Understand the heart failure epidemiology trends• Review the 2017 Stage C HF Guidelines Update• Identify Stage D “Advanced” Heart Failure• Appreciate Contemporary LVAD Therapy• Recognize some temporary mechanical support
technologies in the critically ill patient
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Heart Failure Burden
1.JACCHF.2013;1:1-20.2. RoseEA,etal.Long-termmechanicalleftventricularassistanceforend-stageheartfailure.
NEngl JMed.Nov.2001;5;345(20):1435-43.4. Rogers,Butler,Lansman,etal.JAmColl Cardiol.2007;50:741-47.5. Hershberger,Nauman,Walker,etal.JCardFail.2003;22:616-24.6. Gorodeski,Chu,Reese,etal.Circ HeartFail.2009;2:320-24.7. Dataonfile.Pleasanton,Calif:Thoratec Corp.
Heart Failure Natural History
2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure
CitationThisslidesetwasadaptedfromthe2017ACC/AHA/HFSAFocusedUpdateofthe2013ACCF/AHAGuidelinefortheManagementofHeartFailure(JournaloftheAmericanCollegeofCardiology). PublishedonApril28,2017,availableat: Yancy,et.al.ACC/AHA/HFSA2017HeartFailureFocusedUpdate
Thefull-textguidelinesarealsoavailableonthefollowingWebsites:• AmericanCollegeofCardiology(www.acc.org)• AmericanHeartAssociation(professional.heart.org)• HeartFailureSocietyofAmerica(www.hfsa.org)
Stage C
Treatment of HF Stages A Through D
Treatment of HFrEF Stage C and D
†Hydral-Nitratesgreenbox:ThecombinationofISDN/HYDwithARNIhasnotbeenrobustlytested.BPresponseshouldbecarefullymonitored.‡See2013HFguideline.§ParticipationininvestigationalstudiesisalsoappropriateforstageC,NYHAclassIIandIIIHF.ACEIindicatesangiotensin-convertingenzymeinhibitor;ARB,angiotensinreceptor-blocker;ARNI,angiotensinreceptor-neprilysin inhibitor;BP,bloodpressure;bpm,beatsperminute;C/I,contraindication;COR,ClassofRecommendation;CrCl,creatinineclearance;CRT-D,cardiacresynchronizationtherapy–device;Dx,diagnosis;GDMT,guideline-directedmanagementandtherapy;HF,heartfailure;HFrEF,heartfailurewithreducedejectionfraction;ICD,implantablecardioverter-defibrillator;ISDN/HYD,isosorbidedinitratehydral-nitrates;K+,potassium;LBBB,leftbundle-branchblock;LVAD,leftventricularassistdevice;LVEF,leftventricularejectionfraction;MI,myocardialinfarction;NSR,normalsinusrhythm;andNYHA,NewYorkHeartAssociation.
Neprilysin Inhibition (ARNI: LCZ696)sacubatril-valsartan
Simplifiedschematicoftherenin–angiotensin–aldosteronesystem.
vonLueder TGetal.Circ HeartFail.2013;6:594-605
Simplifiedschematicofthenatriureticpeptidesystem(NPS).
vonLueder TGetal.Circ HeartFail.2013;6:594-605
PARADIGM HF
Kaplan–MeierCurvesforKeyStudyOutcomes,AccordingtoStudyGroup.
McMurray JJ et al. N Engl J Med 2014. DOI: 10.1056/NEJMoa1409077
PrimaryandSecondaryOutcomes.
McMurray JJ et al. N Engl J Med 2014. DOI: 10.1056/NEJMoa1409077
Pharmacological Treatment for Stage C HF With Reduced EF
Renin-Angiotensin System Inhibition With ACE-Inhibitor or ARB or ARNI
I
ACE-I:ATheclinicalstrategyofinhibitionoftherenin-angiotensinsystemwithACEinhibitors(LevelofEvidence:A), ORARBs(LevelofEvidence:A), OR ARNI(LevelofEvidence:B-R)inconjunctionwithevidence-basedbetablockers,andaldosteroneantagonistsinselectedpatients,isrecommendedforpatientswithchronicHFrEF toreducemorbidityandmortality.
NEW: Newclinicaltrialdatapromptedclarificationandimportantupdates.ARB:A
ARNI:B-R
COR LOE Recommendations Comment/Rationale
Pharmacological Treatment for Stage C HF With Reduced EF
Renin-Angiotensin System Inhibition With ACE-Inhibitor or ARB or ARNI
COR LOE Recommendations Comment/Rationale
I ARNI:B-R
InpatientswithchronicsymptomaticHFrEF NYHAclassIIorIIIwhotolerateanACEinhibitororARB,replacementbyanARNIisrecommendedtofurtherreducemorbidityandmortality.
NEW:Newclinicaltrialdatanecessitatedthisrecommendation.
Pharmacological Treatment for Stage C HF With Reduced EF
Renin-Angiotensin System Inhibition With ACE-Inhibitor or ARB or ARNI
COR LOE Recommendations Comment/Rationale
III:Harm B-R
ARNIshouldnotbeadministeredconcomitantlywithACE inhibitorsorwithin36hoursofthelastdoseofanACEinhibitor.
NEW:AvailableevidencedemonstratesapotentialsignalofharmforaconcomitantuseofACEinhibitorsandARNI.
III:Harm C-EO
ARNIshouldnotbeadministeredtopatientswithahistoryofangioedema.
NEW:Newclinicaltrialdata.
Pharmacological Treatment for Stage C HF With Reduced EF
Ivabradine
COR LOE Recommendations Comment/Rationale
IIa B-R
IvabradinecanbebeneficialtoreduceHFhospitalizationforpatientswithsymptomatic(NYHAclassII-III)stablechronicHFrEF(LVEF≤35%)whoarereceivingGDEM*,includingabetablockeratmaximumtolerateddose,andwhoareinsinusrhythmwithaheartrateof70bpmorgreateratrest.
NEW:Newclinicaltrialdata.
*Inotherpartsofthedocument,theterm“GDMT”hasbeenusedtodenoteguideline-directedmanagementandtherapy.Inthisrecommendation,however,theterm“GDEM”hasbeenusedtodenotethissameconceptinordertoreflecttheoriginalwordingoftherecommendationthatinitiallyappearedinthe“2016ACC/AHA/HFSAFocusedUpdateonNewPharmacologicalTherapyforHeartFailure:AnUpdateofthe2013ACCF/AHAGuidelinefortheManagementofHeartFailure”.
HFpEF Trends in Heart Failure
NEngl JMed2006;355:251-9.
NEngl JMed2006;355:251-9.
Trends in HF
Barry A. Borlaug, and Margaret M. Redfield Circulation. 2011;123:2006-2014
Response to treatment HFrEF vs HFpEF
Shah,A.M.&Pfeffer,M.A.(2012) ThemanyfacesofheartfailurewithpreservedejectionfractionNat.Rev.Cardiol.doi:10.1038/nrcardio.2012.123
*ElectricalandMechanicalRepolarizationHeterogeneity
Pharmacological Treatment for Stage C HF With Preserved EF
I B
SystolicanddiastolicbloodpressureshouldbecontrolledinpatientswithHFpEF inaccordancewithpublishedclinicalpracticeguidelinestopreventmorbidity
2013recommendationremainscurrent.
I C
DiureticsshouldbeusedforreliefofsymptomsduetovolumeoverloadinpatientswithHFpEF.
2013recommendationremainscurrent.
COR LOE Recommendations Comment/Rationale
IIb B-R
InappropriatelyselectedpatientswithHFpEF(withEF≥45%,elevatedBNPlevelsorHFadmissionwithin1year,estimatedglomerularfiltrationrate>30mL/min, creatinine<2.5mg/dL,potassium<5.0mEq/L),aldosteronereceptorantagonistsmightbeconsideredtodecreasehospitalizations.
NEW: CurrentrecommendationreflectsnewRCTdata.
Pharmacological Treatment for Stage C HF With Preserved EF
COR LOE Recommendations Comment/Rationale
IIb B
TheuseofARBsmightbeconsideredtodecreasehospitalizationsforpatientswithHFpEF.
2013recommendationremainscurrent.
Anemia
Important Comorbidities in HF
Anemia
COR LOE Recommendations Comment/Rationale
IIb B-R
InpatientswithNYHAclassIIandIIIHFandirondeficiency(ferritin<100ng/mLor100to300ng/mLiftransferrinsaturationis<20%),intravenousironreplacementmightbereasonabletoimprovefunctionalstatusandQoL.
NEW: Newevidenceconsistentwiththerapeuticbenefit.
III:NoBenefit B-R
InpatientswithHFandanemia,erythropoietin-stimulatingagentsshouldnotbeusedtoimprovemorbidityandmortality.
NEW: Currentrecommendationreflectsnewevidencedemonstratingabsenceoftherapeuticbenefit.
What About Heart Failure Complicated by Shock?
Who is a Stage D HF Patient?
Cardiogenic Shock
Intra-Aortic Balloon Pump: 2015
IABP post AMI: SHOCK-II Trial
Temporary Support Devices
We Can’t Transplant Everybody
1. Currentestimatesofadultpatientswithadvancedheartfailure(HF)intheUnitedStates,withprojectedleftventricularassistdevice(LVAD)candidates.U.S.populationestimateisderivedfromU.S.Censusdata.EstimateofHFprevalenceisderivedfromlatestAmericanHeartAssociation(AHA)statistics.
2. UNOSWebsite:http://optn.transplant.hrsa.gov3. O’Connell.AdvancedHeartFailureTherapiesForum,Atlanta.2013.
Ventricular Assist Device: State of the Art 2017
MCS vs Medical Therapy
MCS vs Medical Therapy
Evolution of Devices
10 Main Points on LVAD 20171. LVAD: The Big Picture2. LVAD: Hemodynamic Optimization3. LVAD Device Trends 2006-20164. LVAD Trial Data Summary & New Devices5. Adverse Event Rate Trends6. Quality of Life7. Cost of Device Implantation8. Cost Effectiveness9. LVAD and Electrophysiology10.The Future10/23/17 38
1. LVAD: THE BIG PICTURE
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2. LVAD: HEMODYNAMICOPTIMIZATION
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3. LVAD IMPLANTTRENDS: 2006-2016
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4. LANDMARK TRIALS& NEW TECHNOLOGY
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5. ADVERSE EVENT RATES
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6. QUALITY OF LIFE
Quality of Life Data: INTERMACS
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7. COST: WHAT DRIVES COST?
What Drives the VAD Implant Cost?
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Post Implant Length of Stay of Patients Discharged Alive
0
5
10
15
20
25
30
Days Intermacs
TUKH
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8. COST-EFFECTIVENESS
DT LVAD: Costs, QALYs, ICER
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Pulsatile to CF – LVAD Transition
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Beyond the Index Admission: Costs
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9. LVAD & Electrophysiology
LVAD: EP Topics• ICD Implantation Post-LVAD• Tachy-therapies settings• LV lead ON vs OFF• Atrial fibrillation treatments• VT Ablation
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10. THE FUTURE
Future Developments & Challenges• Driveline removal (totally internal LVAD)• Minimally invasive implantation• Continuous hemodynamic monitoring
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10 Main Points on LVAD 20171. Heart failure epidemic: large and growing2. Novel pharma and device therapies
-ARNI to replace ARB/ACE-I-HCN blockers-ambulatory PA pressure monitoring devices
3. Lacking data / guidelines on HFpEF4. System innovations are key5. Refer early for Stage D HF patients
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Andrew J. Sauer, MDAssistant ProfessorDirector, Center for Heart FailureMedical Director, Heart TransplantationUNOS Primary Transplant [email protected]
