5/23/16 1 Liviu Klein MD, MS Associate Professor Director, Mechanical Circulatory Support and Heart Failure Device Programs [email protected]Recent Advances in Heart Failure • Only CVD with stagnant/ increasing incidence, prevalence, morbidity (hospitalizations), mortality • 20+ mil patients worldwide (6 mil in US) – One and 5 years survival: 90% and 50% – One year hospitalization rate 20-25% • HF reduced EF (HFrEF) – EF < 40% – Lots of medications, devices • HF preserved EF (HFpEF) – EF > 50% – No medications, devices • HF borderline or improved EF – EF 40-50% • Remote management needed to decrease costs and serve an increasing number of patients Heart Failure in 2016 Current Management of HFrEF Diuretics Treat Clinical Congestion: Slow Disease Progression: Treat Residual Symptoms: ACE-I/ ARB BB MRB CRT Sudden Death: ICD BB MRB Digoxin, ARB, Hy-ISDN CRT Advanced Disease: Heart transplant LVAD ACE-I: an g io ten sin co n ver tin g en zym e in h ib ito r s; ARB: an g io ten sin 2 r ecep to r b lo cker s; BB: b eta-b lo cker s; MRB: m in er alo co r tico id r ecep to r b lo cker s; Hy-ISDN: h yd r alazin e/ iso so r b id e d in itr ate; ICD: im p lan tab le car d io ver ter d efib r illato r ; CRT: car d iac r esyn ch r o n izatio n th er ap y; L VAD: left ven tr icu lar assist d evices Drugs Associated with Improved Survival in HFrEF Beta blocker Mineralocorticoid receptor antagonist (MRB) ACE inhibitor Angiotensin receptor blocker (ARB) Drugs that inhibit the renin-angiotensin system (RAS) have modest effects on survival 10% 20% 30% 40% 0% % Decrease in mortality
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Liviu Klein MD, MSAssociate Professor Director, Mechanical
Discontinuation for adverse event 449 516 0.02Discontinuation for hypotension 36 29 NSDiscontinuation for hyperkalemia 11 15 NSDiscontinuation for renal impairment 29 59 0.001
Angioedema (adjudicated)Medications, no hospitalization 16 9 NSHospitalized; no airway compromise 3 1 NS
PARADIGM-HF Summary:
McMurray JJ et al. N Engl J Med. 2014; 371: 993-1004.
In HFrEF, compared to high doses of enalapril:LCZ696 was more effective than enalapril in . . .• Reducing the risk of CV death, sudden death and HF death
by incremental 20%• Reducing the risk of HF hospitalization by incremental 21%• Reducing all-cause death by incremental 16%• Incrementally improving symptoms and physical limitationsLCZ696 was better tolerated than enalapril . . .• Less likely to cause cough, hyper K or renal impairment• Less likely to be discontinued due to an adverse event• Not more likely to cause serious angioedema• More hypotension, but no increase in drug discontinuation
ARNI Doubles Survival in HFrEFCompared to ACE-I/ ARBs
10%
20%
30%
40%
ACEInhibitors (ACE-I)
AngiotensinReceptor
Blockers (ARB)0%
% De
crea
se in
Mor
tality 18%
20%
Angiotensin ReceptorNeprilysin
Inhibitor (ARNI)
15%
• Stop ACE-I for 48 hrs. prior• Make sure patient is not “dry” (adjust diuretics)• Start with low dose (24/26 mg BID) and increase
dose slowly (every 7-10 days) as tolerated if patients’ baseline BP < 120 mmHg• If BP > 120 mmHg, one can start at higher dose (49/
51 mg BID) and titrate up faster• For patients that cannot achieve target dose (98/102
mg BID), check NT-pro BNP and echocardiogram (LV size, LVEF) after 3 months on therapy to assess benefit
Caveats of Using ARNI
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Future Management of HFrEFDiureticsTreat Congestion:
Slow Disease Progression:
Treat Residual Symptoms:
ARNI BB MRB CRT
Sudden Death:
ICDARNI BB MRB
Digoxin, ARB, Hy-ISDN
CRT
Advanced Disease: Heart transplant LVADACE-I: angiotensin converting enzyme inhib itors; ARB: angiotensin 2 receptor b lockers; ARNI: angiotensin receptor b locker and neprilysin inhib itor; BB: beta-b lockers; MRB: mineralocorticoid receptor b lockers; Hy-ISDN: hydralazine/ isosorbide d in itrate; ICD: implantable cardioverter defibrillator; CRT: cardiac resynchronization therapy; LVAD: left ventricular assist devices
ARNI in HFpEF: PARAMOUNTand PARAGON
Solomon SD et al. Lancet. 2012; 380: 1387-1395.
Stay tuned: fall 2019
• Only CVD with stagnant/ increasing incidence, prevalence, morbidity (hospitalizations), mortality• 20+ mil patients worldwide (6 mil in US)
– One and 5 years survival: 90% and 50%– One year hospitalization rate 20-25%
• HF reduced EF (HFrEF) – EF < 40%– Lots of medications, devices
• HF preserved EF (HFpEF) – EF > 50%– No medications, devices
• HF borderline or improved EF – EF 40-50%• Remote management needed to decrease costs and
serve an increasing number of patients
Heart Failure in 2016 Heart Failure Hospitalizations: 1 Million and Counting….
Go AS et al. Circulation. 2014; 129: e28-e292.
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Dharmarajan K et al. JAMA. 2013; 309: 355-363.
Timing of Heart Failure Re-Hospitalizations:
Heart Failure Hospitalizations: All Roads Lead to Rome
Dharmarajan K et al. JAMA. 2013; 309: 355-363.
High Mortality Post Discharge for Heart Failure Hospitalization
Solomon SD et al. Circulation. 2007; 116: 1482-1487.
Heart Failure Signs/ Symptoms in Hospitalized Patients
Admission DischargeSymptoms (%)Dyspnea on exertion 79 58Dyspnea at rest 42 5Orthopnea 50 12PND 33 4Fatigue 53 57
Congestion Precedes Most Heart Failure Hospitalizations
Zile MR et al. Circulation. 2008; 118: 1433-1441.
Congestion Precedes Most Heart Failure Hospitalizations
Zile MR et al. Circulation. 2008; 118: 1433-1441.
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CardioMEMS HF System
PA Sensor and Delivery System
120 cm4.5 c m
Patient Electronics System
PA Pressure Database
Physic ian Access Via Secure Website
Heart Failure Pressure Sensor
Abraham WT et al. Lancet. 2011; 377: 658-666.
CHAMPION Trial: Baseline Char.
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Abraham WT et al. Lancet. 2011; 377: 658-666.
CHAMPION Trial: Results
Abraham WT et al. Lancet. 2016; 387: 453-461.
CHAMPION Trial – Long Term Results
Success of a CHAMPION: Treatment Algorithm
Costanzo MR et al. J Am Coll Cardiol HF. 2016; 4: 333-344. Costanzo MR et al. J Am Coll Cardiol HF. 2016; 4: 333-344.
CHAMPION Trial: Medications Changes
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Costanzo MR et al. J Am Coll Cardiol HF. 2016; 4: 333-344.
CHAMPION Trial: Diuretic Changes by PA Pressures
Costanzo MR et al. J Am Coll Cardiol HF. 2016; 4: 333-344.
CHAMPION Trial: Vasodilator Changes by PA Pressures
• Congestion is the lead cause of HF hospitalizations• Congestion contributes to progression of HF• Patients leave hospital with congestion, resulting in
high rehospitalization rate• Congestion is often subclinical and difficult to assess
when present• Significant dissociation between hemodynamic and
clinical congestion, even when hemodynamics are very abnormal• Need for better monitoring of degree and changes in
congestion (more accurate and sensitive)
Congestion in Heart Failure Hemodynamic vs. ClinicalCongestion in Heart Failure
He artRate Variab il ity
Re stingheart rate
Activity le ve l
Re sp iration rate
In trathoracic fluid
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Conclusions• Monitoring PAP/ PWP can provide early
warning of condition worsening/ decompensation much better than body weight and before symptoms
• Most changes occur over a few days - weeks
• Having a treatment algorithm based on PAP/PWP values is key to successful treatment and preventing heart failure readmissions
• Always treat to max: drive pressures down to patient’s normal
Future Management of HFrEFDiureticsTreat Congestion:
Slow Disease Progression:
Treat Residual Symptoms:
ARNI BB MRB CRT
Sudden Death:
ICDARNI BB MRB
Digoxin, ARB, Hy-ISDN
CRT
Advanced Disease: Heart transplant LVADACE-I: angiotensin converting enzyme inhib itors; ARB: angiotensin 2 receptor b lockers; ARNI: angiotensin receptor b locker and neprilysin inhib itor; BB: beta-b lockers; MRB: mineralocorticoid receptor b lockers; Hy-ISDN: hydralazine/ isosorbide d in itrate; ICD: implantable cardioverter defibrillator; CRT: cardiac resynchronization therapy; LVAD: left ventricular assist devices