up to date management and innovations for heart failure · therapy for heart failure today (ie...
TRANSCRIPT
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Up to Date Management and
Innovations for Heart Failure
Dael Geft, MD
Cardiologist, Advanced Heart Failure/Transplant/MCS
Associate Director Pulmonary Hypertension Research
and Education
Smidt Heart Institute
Cedars-Sinai
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No Disclosures
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Case Presentation
• 55 yo M with no past medical history, soccer referee, p/w increased
fatigue and sob for three weeks.
• Vitals normal
• Cr 1, Bun 17, Na 140, K 4.3
• CXR shows cardiomegaly
• Echo: EF 20%, LV 8 cm
• Cardiac Cath: no obstructive CAD
• Patient is started on optimal medical therapy for HF – Carvedilol,
Lisinopril, Spironolactone, Lasix
• After three months, NYHA II but no improvement in EF ICD placed
• Patient was followed and did well for couple years
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• Over the course of the next year, notices more fatigue with daily
activities
• Patient is admitted twice to hospital for heart failure – diuretics
increased
• Dose of carvedilol and lisinopril lowered due to low blood pressure
• Cr 1.5 (no proteinuria)
• Echo: EF 15%, 8.2 cm, RV dilated 5 cm, PASP 55 mmHg
• What next?
–Continue current treatment plan and pretend you didn’t see the
labs
–Implant Cardiomems device
–Refer to advanced heart failure clinic
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• One day, patient experiences 4 ICD shocks VT storm
• In hospital gets intubated for pulm edema
• Dobutamine and Dopamine started
• RHC: RA 15, PA 60/30, Wedge 28, Cardiac index 1.9
• What now?
–Panic
–Pray
–Panic and Pray
–Pursue advanced heart failure therapies (ie Heart
transplant or MCS)
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Who you gonna call?!
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AHA Heart and Stroke Statistical Update 2018.
The Burden of Congestive Heart Failure
• Nearly 6.5 million Americans
w/ HF (~ 8 million by 2030)
• male to female nearly 1:1
• > 1,000,000 new cases/yr
• #1 DRG -- $32 billion
• 50% readmitted within 6 mos
• 50% dead within 5 yearsClass II1.79 M(35%)
Class IV255 K(5%)
Class III1.28 M(25%)
Class I1.79 M(35%)
“STAGE D”
100K
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Etiologies of Cardiomyopathies
• CAD
• Idiopathic
• Toxin (EtOH,
Cocaine, ChemoTx
• Infectious (Coxsackie,
HIV, Chagas)
• CTD (SLE, RA)
• Endocrine (DM, T4,
Vit B1 def)
• Iron Overload
• Tachy mediated
• Myocarditis (Giant
cell)
• Familial (ARVD,
Muscular dystrophies,
Non-compaction)
• Hypereosinophilic
(Loeffler’s)
• Takotsubo “stress
induced”
• Peripartum
• Radiation
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What can we do
for our patients?
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IMPROVE-HF
Cumulative % Reduction in Odds of Death At 24 Months With
Each Sequentially Applied Guideline Recommended
Fonarow G C et al. J Am Heart Assoc 2012;1:16-26
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The Current Paradigm
NYHA I NYHA II NYHA III NYHA IV
ACEI
ARB if ACEI-intolerant
Beta-blocker
ICD if life-expectancy > 1 year
CRT if LBBB, QRS > 150 msec, sinus rhythm
Spironolactone
Isordil/hydralazine if Afr American
Digoxin if still symptomatic
Transplant/MCS
evaluation
Ivabradine
Sacubitril/Valsartan
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MacDonald PS et al. Clinical Therapeutics 2015; 37: 2199-2205.
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PARADIGM-HF study
•~8400 patients
–EF ≤ 35%
–One HF hosp or ↑ BNP
•Outcomes
–CV deaths: 17% 13%
–HF hosp: 16% 13%
McMurray J et al. NEJM 2014; 371: 993-1004.
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HR in HF … Cause or Effect?
•Higher HR is related to poor prognosis in HF, and
many patients continue to have elevated HR despite
maximally tolerated betablockers
•Ivabradine inhibits the funny (If) channels in the SA
node to reduce heart rate
•Unlike beta-blockers or calcium channel blockers,
ivabradine does NOT affect:
–Myocardial contractility
–Intra-cardiac conduction
–Hemodynamics (e.g. blood pressure)
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SHIFT study
Swedberg K et al. Lancet 2010; 376: 875-885.
•~6500 pts
–EF ≤ 35%
–HR ≥ 70
–One HF hospitalization
–Max tolerated BB
•Outcomes
–HF deaths 5% 3%
–HF hosp 21% 16%
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Development of Acute Decompensation
-30 -20 - 10 Days0
Hospitalization
Filling pressuresIncrease
Autonomic Adaptation
Intrathoracic Impedance
Changes
Weight ChangesSymptoms
Adamson PB Current HF Reports 2009;6:287-292
Decompensation
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Zile MR, et al. Circulation, 2008.
Intracardiac Pressures Rise Early Preceding HF Events
Depressed EF Heart Failure (N=122 events)
Preserved EF Heart Failure (N=41 events)
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CardioMEMS™ HF System
Merlin.net
PA Pressure Integrated Website
Patient Electronics Unit
PA Pressure Sensor on
Catheter Delivery System
120cm4.5cm
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CHAMPION TRIAL: PA pressure monitoring to reduce
heart failure admissions
Abraham WT, et al, Lancet 2011
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CardiomemsChampion trial SUB-analysis:
• HFpEF or diastolic HF patients represent ~50% of all HF patients.
• The effect in HFpEF patients demonstrates an estimated NNT = 2.
50% Reduction
p<0.0001 vs. control
PA pressure-guided therapy
SIGNIFICANTLY REDUCED HF HOSPITALIZATIONS in HFpEF patients in the treatment group, demonstrating that the CardioMEMS™ HF
System is the first effective treatment strategy to manage 50% of patients
hospitalized with HF.
Adamson PB, et al. Circ Heart Fail, 2014.
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Changes in thoracic impedance are a more
accurate predictor of worsening HF than weights
Device-Based Monitoring –Fluid Index Impedance
Optivol
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This article was published on
September
23, 2018, at NEJM.org.
DOI: 10.1056/NEJMoa1806640
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COAPT Trial
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When all else fails…Stage D Heart Failure
Yancy CW, et al. ACCF/AHA guideline for the management of heart failure. J Am Coll
Cardiol 2013; 62:e147-239
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Who Needs a Heart Transplant?
Advanced heart disease with unacceptable quality of life
or risk of sudden death despite maximal medical therapy
No other appropriate surgical options such as high risk
CABG or valve replacement
No other medical illnesses (such as a metastatic malignancy)
which would be expected to limit the patient’s 5 year
survival
**Indications are similar for mechanical support though
more options may be available as destination therapy – ie
older patients, more recent malignancy
28
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Durable Management Options for ESHD
370,000Class IIIb/IV
~70,000 potentialVAD candidates
for DT
~100,000Heart Tx
candidates
2,300 Heart
transplants/yr
~97,000 waiting medical Rx
~3-4,000 MCS*2,800 LVADs
200 TAHs
~200,000Non-Tx/VAD
Palliative
Care
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Heart Transplantation
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Louis Washansky
South Africa - 1967
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Global Adult and Pediatric Heart TransplantsNumber of Transplants by Year and Location
JHLT. 2015 Oct; 34(10): 1244-1254
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Smidt Heart InstituteNumber of Heart Transplants per Year
2025
3427
76
8995
103*
*
** Ht Tx program moved from UCLA to CSMC
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Adult and Pediatric Heart Transplants
Kaplan-Meier Survival(Transplants: January 1982 – June 2013)
N = 112,521
N at risk at 30 years = 16
JHLT. 2015 Oct; 34(10): 1244-1254
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Not a walk in the park…
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OHT Challenges…
•Early
–Rejection
–Infection
•Late
–Cardiac allograft
vasculopathy
–Malignancy
•Common
–HTN
–Renal Insufficiency
–Hyperlipidemia
–Diabetes
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“Heart in a Box”
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But what if you can’t wait…
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Mechanical
Circulatory Support
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Patient Selection for MCS
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Strategies for MCS
CardiogenicShock
Recovery
Heart Transplant
Destination
Decision or Long
term Device
BTR
BTT
DT
BTD
Temp MCS
Short-term / temporary
MCS
Long-term /
durable MCS
Inotropes / IABP
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Temporary MCS devices
•Left ventricular support
–IABP
–Impella
•Right ventricular
support
–RP Impella
–Tandom Heart
cannula
–Centrimag
•Biventricular support
–ECMO
–“Tandella”
–Centrimags (LV/RV)
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The Impella Catheters
• Femoral / axillary artery cut-down –21F• Actively unloads the LV• Provides up to 5.0 liters/min of flow• Rapid insertion in cath lab or CVOR
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ECMOShort-term bridge to decision(BTD) or (BTB)
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Durable MCS Devices
LVAD TAH
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HeartMate II LVAD (axial flow)
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Mehra MR, Naka Y, et al. Published Nov 16, 2016 at NEJM.org
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HeartMate III LVAD
• Wide blood-flow passages to reduce shear stress
• Frictionless with absence of mechanical bearings
• Intrinsic Pulse designed to reduce stasis and avert thrombosis
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NYHA Functional Class Retreat:
Impact of LVAD’s on Class IIIb/IV HF
Estep JD, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical
Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am Coll Cardiol. 2015
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The Journal of Heart and Lung Transplantation 2015 34, 1495-1504DOI: (10.1016/j.healun.2015.10.003)
Copyright © 2015 International Society for Heart and Lung Transplantation Terms and Conditions
Overall Survival of CF-VADs
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Key Adverse Events:
Pump Thrombosis, Neurological Events, Bleeding
HeartMate 3
(n=151)
HeartMate II
(n=138)
n (%)no. of
Eventsn (%)
no. of
EventsRR
95% CI for
RRP Value
Suspected or Confirmed Pump
Thrombosis0 (0) 0 14 (10) 18 N/A N/A < 0.0001
All Stroke 12 (7) 12 15 (10) 17 0.73 0.35-1.51 0.39
Hemorrhagic Stroke 4 (2) 4 8 (5) 8 0.46 0.14-1.48 0.18
Ischemic Stroke 8 (5) 8 9 (6) 9 0.81 0.32-2.05 0.66
Disabling Stroke 9(6) 9 5(3) 5 1.65 0.57-4.79 0.36
Other Neurologic Events* 9 (6) 9 8 (5) 8 1.03 0.41-2.59 0.95
Bleeding 50 (33) 100 54 (39) 98 0.85 0.62-1.15 0.29
Bleeding Requiring Surgery 15 (9) 15 19 (13) 21 0.72 0.38-1.36 0.31
Gastrointestinal Bleeding 24 (15) 47 21 (15) 36 1.04 0.61-1.79 0.87
No Pump Thrombosis in the HeartMate 3 LVAS group
Similar Stroke and Bleeding rates in both groups
RR, denotes Relative Risk and CI, confidence interval
*Includes transient ischemic attacks and neurologic events other than stroke
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HK: Destination Therapy Patient (7 yrs+)
Implant: 2/4/10
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M.L. (s/p HM II p-p CMY)
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Candidates for Total Artificial Heart
(TAH)
•Irreversible severe biventricular failure
•Hypertrophic, amyloid, giant cell CMY
•Heart tx w/ severe CAV or refractory reject
•Incessant VT/VF
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Syncardia t-TAH
Indications:
– bridge to OHT (FDA approved)
– severe irrev. bivent failure
– Intractable VT/VF
79% successfully transplanted
Nearly 1,600 implanted WW
50 - 70 cc per each ventricle
Freedom driver
*Copeland J, Arabia F et al; NEJM 351: 859-867 2004
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June 9, 2014
6’ 7”
5’ 2”
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2 months post- implant w/ Yasiel Puig of LA Dodgers
July 2013
Total Artificial Heart Patient at a Baseball Game
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Climbing the Matterhorn Kona Ironman Triathalon
Cardiac Transplantation
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Cedars-Sinai Heart Institute
• Multitude of trials for new medications including oral inotropes, amyloid CMY therapy, HCM
• Stem cell therapy
• Genetic markers for rejection
• Wireless (cordless) total artificial hearts or LVADS
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• Educate and update medical professionals and patients about optimal medical
therapy for heart failure today (ie Entresto, Ivabradine)
• Consider structural interventions ( ie mitraclip) or invasive monitoring
(cardiomems)
• Know when to refer to an advanced heart failure clinic (its never too early!)
• Know that there are still great options when patients are beyond medical
therapy (Heart Transplant and MCS)
Pearls
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“In AdvAnced heArt fAIlure, it is always better to refer a
Patient a year too early than a mInute too lAte!”
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Heart Failure Management Requires Team Approach
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Thank You! Questions?
Transplant Selection Committee