Heart Failure Therapies State of the Art 2017...Heart Failure (Journal of the American College of...
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Heart Failure Therapies State of the Art 2017 Andrew J. Sauer, MD Assistant Professor Director, Center for Heart Failure Medical Director, Heart Transplantation UNOS Primary Transplant Physician [email protected]
Transcript of Heart Failure Therapies State of the Art 2017...Heart Failure (Journal of the American College of...
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]
