when drugs and devices are not enough - advocate … drugs and devices are not enough: referral for...
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Gregory P. Macaluso MD Associate Director Advanced Heart Failure and Transplant Cardiology Fellowship
Advocate Christ Medical Center Clinical Assistant Professor of Medicine The University of Illinois at Chicago
May 7, 2016
When Drugs and Devices are Not Enough: Referral for Advanced Heart Failure Therapies
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Objectives • Discuss classification schemes for advanced heart failure (HF)
• Identify clinical clues of advanced HF
• Review prognostic markers of advanced HF
• Discuss various clinical risk models to help determine patient
prognosis
• Determine when to refer patients for advanced therapies and why?
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New York Heart Association Class
• Class I: no symptoms with ordinary activity
• Class II: symptoms with moderate activity
• Class III: symptoms with ADLs, very limited
• Class IV: symptoms at rest
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Natural History of Chronic and Acute Heart Failure
Initial phase Last year
Normal heart Chronic heart failure 5 million in the US
10 million in Europe
Death
Initial myocardial
injury
First ADHF episode: Pulmonary edema
ER admission
Later ADHF episodes: Rescue therapy ICU admission
Gheorghiade M. Am J Cardiol. 2005;96(suppl 6A):1-4G.
Hear
t Via
bilit
y >60% mortality within 5 years after diagnosis
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LV dysfunction – Natural History 5-7 Million patients with CHF
AHA Stage A 100
0
% Survival
Risk Factors Asymptomatic Mild Moderate Severe
Time
Annual Mortality
<5% 10% 20-30% 30-80%
Mechanism of death 40% SCD
40% ↑ CHF 20% Other
AHA Classification
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Further Characterization of Advanced Heart Failure
To identify patients for medical, pacing, transplantation or circulatory support:
INTERMACS PROFILES 1-7
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PROFILE-LEVEL PRIMARY LVADs 12-09
Official Shorthand NYHA CLASS
Modifier option
INTERMACS LEVEL 1
633 “Crash and burn” IV
INTERMACS LEVEL 2
841 “Sliding fast” on ino IV
INTERMACS LEVEL 3
284 Stable but Ino-Dependent Can be hosp or home
IV ish
INTERMACS LEVEL 4
185 Resting symptoms on oral therapy at home.
ambul IV
+FF frequent flyer A for arrhythmia
INTERMACS LEVEL 5
“Housebound”, Comfortable at rest, symptoms with minimum activity ADL
ambuI IV
+ FF A
INTERMACS LEVEL 6
“Walking wounded”-ADL possible but meaningful activity limited
IIIB +FF A
INTERMACS LEVEL 7
(5,6,7 = 119)
Advanced Class III III A only
CURRENT VAD INDICATIONS
(after Lynne Stevenson)
ROADMAP TRIAL
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INTERMACS Levels - Outcome
Lietz, Curr Opin Cardiol; 09:246
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Objectives • Discuss classification schemes for advanced heart failure (HF)
• Identify clinical clues of advanced HF
• Review prognostic markers of advanced HF
• Discuss various clinical risk models to help determine patient
prognosis
• Determine when to refer patients for advanced therapies and why?
![Page 11: When Drugs and Devices are Not Enough - Advocate … Drugs and Devices are Not Enough: Referral for Advanced Heart Failure Therapies Objectives • Discuss classification schemes for](https://reader034.vdocuments.net/reader034/viewer/2022051509/5af114057f8b9ac57a8f6f0f/html5/thumbnails/11.jpg)
Clinical Clues • Dyspnea and fatigue
• Weight
– Rapid and recurrent gains – Eventually weight loss (cachexia)
• Signs of hypoperfusion
– Narrow Pulse Pressure
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Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA 1989;261:884-8.
91% sensitivity and 83% specificity
Pulse Pressure and C.I.
a pulse pressure of <25% of the systolic
pressure is associated with a cardiac index of
<2.2 L/min/m2.
Example:
BP 90/70…PP is 20
25% of 90 is
23 mmHg
20 < 23 and therefore
correlates with CI <2.2
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Clinical Clues • Dyspnea and fatigue
• Weight loss • Signs of hypoperfusion
– Narrow Pulse Pressure – Sleepy/obtunded – Cool extremeties – Renal dysfunction
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Rapid Assessment of Hemodynamic Status Congestion at Rest
Low Perfusion at Rest
C
NO
NO YES
YES L
A B Warm &
Dry Warm &
Wet
Cold & Wet Cold & Dry
(Complex) (Low Profile)
Signs/Symptoms of Congestion:
Orthopnea / PND JV Distension Hepatomegaly Edema Rales (rare in chronic heart
failure) Elevated est. PA systolic
Possible Evidence of Low Perfusion: Narrow pulse pressure Cool extremities Sleepy / obtunded Hypotension with ACE inhibitor Low serum sodium Renal Dysfunction (one cause)
R. Bourge, UAB (adpt from L. Stevenson)Stevenson LW. Eur J Heart Failure 1999
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End Organ Dysfunction
• Pulmonary hypertension – Pulmonary venous congestion – PAH: Arterial remodeling elevated TPG (MPA-PCWP)
• RV enlargement/dysfunction • Hepatic or bowel congestion
– Early satiety, nausea – Diuretic resistance
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Objectives • Discuss classification schemes for advanced heart failure (HF)
• Identify clinical clues of advanced HF
• Review prognostic markers of advanced HF
• Discuss various clinical risk models to help determine patient
prognosis
• Determine when to refer patients for advanced therapies and why?
![Page 17: When Drugs and Devices are Not Enough - Advocate … Drugs and Devices are Not Enough: Referral for Advanced Heart Failure Therapies Objectives • Discuss classification schemes for](https://reader034.vdocuments.net/reader034/viewer/2022051509/5af114057f8b9ac57a8f6f0f/html5/thumbnails/17.jpg)
Prognostic Markers • General
– Age, diabetes, sex, weight (BMI), etiology of HF, comorbidities (COPD, cirrhosis)
• Laboratory markers – Na, creatinine (and eGFR), urea, BUN, – Hgb, % lymphocytes, – uric acid – Low HDL – Insulin resistance
• Urine – Abluminuria – NGAL - neutrophil gelatinase associated
lipocalin • Biomarkers
– BNP, NT pro BNP, troponin, CRP, cystatin C, GDF-15 (growth differentiation factor), serum cortisol, TNF, ET, NE, midregional-pro-adrenomedullin (MR-proADM), pro-apoptotic protein apoptosis-stimulating fragment (FAS)
• Medication – Intolerance to ACEI, diuretic dose
• FC IV – Especially if sustained > 90 days – 6 minute walk
• Cardiopulmonary markers – Peak VO2, % predicted, VE/VCO2, AT,
workload, systolic BP < 130, HR recovery • Clinical Exam markers
– BP (admission and discharge), heart rate, JVP, +S3, cachexia
– Depression – Obstructive sleep apnea
• Echo parameters – EF, chamber size (LV, LA, RA), sphericity, DT
• RNA – RVEF, LVEF
• Recurrent hospitalizations • ECG
– IVCD • Hemodynamic markers
– PA pressures, CO, CI, MVO2 • Endomyocardial biopsies
– Microarrays transcriptomic biomarkers • Marital status
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Hemodynamic Status and Prognosis
Congestion at Rest
Low Perfusion at Rest
C
NO
NO YES
YES L
A B Warm &
Dry Warm &
Wet
Cold & Wet Cold & Dry
(Complex) (Low Profile)
Signs/Symptoms of Congestion:
Orthopnea / PND JV Distension Hepatomegaly Edema Rales (rare in chronic heart
failure) Elevated est. PA systolic
Possible Evidence of Low Perfusion: Narrow pulse pressure Cool extremities Sleepy / obtunded Hypotension with ACE inhibitor Low serum sodium Renal Dysfunction (one cause)
Adapted From Starling. 2009 CCBR
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Copyright restrictions may apply.
Gheorghiade, M. et al. JAMA 2006;296:2217-2226.
In-Hospital Mortality Rates by Admission Systolic Blood Pressure Deciles (n = 48,567)
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Klein, L. et al. Circulation 2005;111:2454-2460
Kaplan-Meier survival curves to 60 days by admission serum sodium quartiles
(unadjusted analysis) – OPTIME CHF
Na 134
Na 138, 140, 142
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Prognosis - NYHA FC
SOLVD NEJM 1991
SOLVD - Treatment
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Prognosis - EF
Adapted from Cohn et al Circ 1993
Ann
ual M
orta
lity
(%)
Ejection Fraction
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LV Chamber Size
2 Year Survival
(%)
Lee et al, AJC 1993
>7.5 <7.5 >4 < 4
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PHTN in HFrEF Hemodynamic Data is Vital
Miller, et al JACC HF 2013
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© 2010 American Heart Association, Inc. Published by American Heart Association.
2
Kaplan-Meier plots by RVEF categories for A All-cause mortality (A) B HF hospitalization (B) Conclusions—Baseline RVEF 20% is a significant independent predictor of mortality and HF hospitalization in systolic HF.
Meyer et al, Circulation.2010 121(2):252-258
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Relationship Between BNP and Mortality in Patients with Advanced HF
Months
BNP > 485 pg/ml
BNP < 485 pg/ml
RR 3.7, 95% CI 2.0-6.9
p<0.0001
BNP cut point by ROC
Horwich TB wt al Circ 2003;108:833.
N=238 Referred for HTx
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ADHERE – troponin/hospital days N=67,924
Peacock et al, NEJM 2008; 358:2117-26.
Odds ratio for death (+) troponin 2.55
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Oxidative Stress: Uric Acid
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Hillege, H. L. et al. Circulation 2006;113:671-678
Death or unplanned admission By quintile of eGFR N=2680
Renal Dysfunction and HF outcomes
CHARM study
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ANCHOR study – Hemoglobin and death
Mortality Rates based on Hgb Go et al, Circ 2006;113:2713
N=59,772 Northern California community Mean age 72 46% women
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Prognosis - VO2
Adapted from Cohn et al Circ 1993
Ann
ual M
orta
lity
(%)
Peak Oxygen Consumption (ml/kg/min)
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6MWT and Prognosis SOLVD
% Risk of death
242 days
Bitner JAMA 1993
<300 m highest risk of hospitalization 41% vs 20%
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Objectives • Discuss classification schemes for advanced heart failure (HF)
• Identify clinical clues of advanced HF
• Review prognostic markers of advanced HF
• Discuss various clinical risk models to help determine patient
prognosis
• Determine when to refer patients for advanced therapies
• What is advanced therapy and why do it?
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Prognostic Models
• Inpatient – ADHERE – EFFECT – ESCAPE
• Ambulatory – HFSS – SHFS – MUSIC risk score
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Fonarow, G. C. et al. JAMA 2005;293:572-580.
Predictors of In-Hospital Mortality
ADHERE
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Fonarow, G. C. et al. JAMA 2005;293:572-580.
Predictors of In-Hospital Mortality OPTIMIZE-HF
Abraham et al, JACC 2008;52:347-56
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Prognostic Models
• Inpatient – ADHERE – EFFECT – ESCAPE
• Ambulatory – HFSS – SHFS – MUSIC risk score
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Seattle HF Model
http://depts.washington.edu/shfm/
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First Visit
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Added BB and Statin
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Benefit of Aldosterone
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Benefit of BiV ICD
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Risk Prediction in Heart Failure
Rahimi, K. JACC HF Oct 2014
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Prognostic Models
• Inpatient – ADHERE – EFFECT – ESCAPE
• Ambulatory – HFSS – SHFS – MUSIC risk score
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Objectives • Discuss classification schemes for advanced heart failure (HF)
• Identify clinical clues of advanced HF
• Review prognostic markers of advanced HF
• Discuss various clinical risk models to help determine patient
prognosis
• Determine when to refer patients for advanced therapies and why?
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49
Patients With Refractory End-Stage Heart Failure (Stage D)
Referral for cardiac transplantation in potentially eligible patients is recommended for patients with refractory end-stage HF. NO CHANGE
Referral of patients with refractory end-stage HF to an HF program with expertise in the management of refractory HF is useful.
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
NO CHANGE
Referral of Patients with Refractory End-Stage HF
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
ACC/AHA Guidelines Heart Failure. 2009.
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50
Patients with refractory end-stage HF and implantable defibrillators should receive information about the option to inactivate defibrillation.
Patients With Refractory End-Stage Heart Failure (Stage D)
Options for end-of-life care should be discussed with the patient and family when severe symptoms in patients with refractory end-stage HF persist despite application of all recommended therapies.
NO CHANGE
NO CHANGE
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Severe Symptoms in Patients With Refractory End-Stage HF
Consideration of an left ventricular assist device as permanent or “destination” therapy is reasonable in highly selected patients with refractory end-stage HF and an estimated 1-year mortality over 50% with medical therapy.
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
NO CHANGE
ACC/AHA Guidelines Heart Failure. 2009.
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Indications for Advanced HF Therapy
• NYHA Class IIIb/IV • Worsening renal function • Intolerance to ACE I and Beta
blockers due to hypotension and CKD
• 1 hospitalization in last 6 months • 2 or more hospitalizations 1 yr • Inability to walk one block
without dyspnea • Diuretic dose > 1.5 mg/kg/day
• Refractory ventricular arrhythmias
• LVEF < 25% • Severe refractory angina • Severe restrictive cardiomyopathy • CRT nonresponder • Measured peak VO2 < 14
ml/kg/min or < 50% age-gender predicted on treadmill
• 6MWT < 300 meters
Peura, et al. Circulation Nov 2012;126:00-00 Russell SD, Miller LW, Pagani FD. Congest Heart Fail. 2008;14:316-321
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Patient Selection – Pearls
• Don’t wait for progressive renal dysfunction and recurrent ascites
• Don’t wait till multiple pressors are required
• Don’t wait for cardiac cachexia
• ICD shocks as persistent elevation of LVEDP – not just scar mediated VT/VF
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Patient Selection – Pearls
• Patients who require inotrope therapy to reverse/manage renal dysfunction or pulmonary hypertension are VERY high risk patients despite symptoms (inotrope dependence)
• Patients with significant secondary pulmonary hypertension – Pre-operative pulmonary hypertension contraindication to
OHT – a good sign RV can pump effectively (protective with VAD) – Worry about the dilated RV, low PA pressures and high CVP
• Hospital admission – 34% risk of death at 1 year
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Establish Risk and Schedule Referral Advanced CHF Risk Tool
• 2 admits in the last year for CHF • LVEF < 25% • BNP > 485 • Serum Na < 134 mmol/L • BUN > 50 • Serum Cr > 2 mg/dL or GFR < 40 • Use of any intravenous inotrope:
– milrinone, dobutamine, dopamine
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Clinical Course is Variable:
Peura, et al. Circulation Nov 2012;126:00-00
Refer Early
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The Advanced Heart Failure Team: Therapeutic Decision Tree
Ongoing Medical Therapy
Other surgery
VAD
Transplant
Palliative Care Hospice
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Transplant Survival is the Gold Standard Candidacy is tricky…
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Transplants Are Limited • 5-7 million patients with CHF (50% HFpEF)
• 200, 000 CHF patients Stage D (5%)
• Approximately 4,000 transplants worldwide
each year – Numbers have plateaued
• Many Stage D patients are not transplant candidates
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Orthotopic Heart Transplantation
• Dying mostly of heart failure – Absence of other non-cardiac conditions that would limit
life expectancy
• Multidisciplinary evaluation
• Acceptable characteristics on continuous intravenous high dose inotropes with inability to wean
• Recovery of end organs and pulmonary vascular resistance/reversible pulmonary HTN
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Destination Therapy survival improvement over time1
60 1. Jorde UP, Khushwaha SS, Tatooles AJ, et al. Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry. Presented at the ISHLT annual meeting, April 25, 2013.
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Importance of Quality of Life
Most patients weighted quality of life as having similar importance as survival post implantation and many noted that quality of life was even more important than survival.
Stewart GS, Brooks K, Pratibhu, et.al., JHLT, Sept. 2009.
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*p < 0.0001
Baseline 90 Days 180 Days 365 Days
NYHA Class
3.7 1.4* 1.2* 1.2*
6 Minute Walk
122.7 414.3* 487.4* 478.4*
MLHF total score
76.5 32.0* 26.4* 28.2*
MLHF Physical Score
34.7 13.4* 11.3* 10.6*
MLHF Emotional Score
15.0 5.9* 5.2* 6.1*
Courtesy of Coyle, L. ACMC. ISHLT 2009.
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“Unlearn” Advanced Heart Failure • There are patients in our community with subtle clues of a
very sick heart
• Patients are at greater risk of treatment failure, complications, or absolute contraindications for advanced therapies when they are critically ill
• Patients should be evaluated by multidisciplinary advanced heart failure team early in the course of the disease to determine optimal timing of advanced therapies
• MCS or Transplantation is superior to medical therapy in patients with advanced heart failure and can provide excellent improvements in both quantity and quality of life