Transcript Too Well, Too Sick, or Just Right” for Advanced Heart

“Too Well, Too Sick, or
Just Right” for Advanced
Heart Failure Therapies
Todd D. Edwards MD FACC FACP FASNC
Too Sick
Too Well
Just Right
Cardiologist
Looking for Mr./Mrs. Right
Disclosures
I have nothing to disclose (unfortunately)
Too well, too sick, or just
right?
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1) 40 female with dilated cardiomyopathy with A blood type, LVEF 20, PVR 1.8,
CPX mv02 18, LVEDD 5.7 cm
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2) 35 male with ischemic cardiomyopathy with LVEF 20, GFR 20, CPX mvO2 8,
LVEDD 7.2, non CRT responder, total bilirubin 3.0, frailty score of 5, 2 prior
CABG operations
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3) 52 male with ischemic cardiomyopathy with LVEF 20, CPX mvO2 14, O
blood type, GFR 45, PVR 2.2 after Flolan challenge, LVEDD 6.5, large anterior
wall scar
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4) 47 female with dilated cardiomyopathy with AB blood type, CPX mvO2 14,
LVEDD 5.6, DOE 1 to 2 blocks, PVR 2.1 without challenge
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5) 65 male with ischemic cardiomyopathy with nephrectomy for renal cell
carcinoma 4 years ago, GFR 35, PVR 3.0 with Flolan Challenge, cvp/paw 0.4,
RVSWI 750
Assumptions
1) This presentation predominantly focused on systolic
CHF with LVEF less than or equal to 25%
Assumptions
2. In this subset , I assume that patients are already treated with:
A. Ace inhibitors and if intolerant an ARB
B. Beta blockers (carvedilol/metoprolol/bisoprolol)
C. appropriate diuretics to control congestive symptoms
D. Aldosterone antagonists (spironolactone/eplerenone) with
Class II to IV symptoms
Assumptions
E. Nitrates/Hydralazine for patient intolerant of ACE and ARB’s
and for African Americans with continued Class II to IV symptoms
despite the above standard therapy
F. Typical heart failure therapy required for elective advance heart
therapies for 45 of the preceding 60 days or IABP for 7 days
Addressing An Unmet Need
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The VAD and Heart Transplant patient population is
approaching 100,000 in the United States alone.
US population1
Target population (35-74 age
Diagnosed CHF
301,000,000
cohort)1
139,100,000
population2
5,520,000
All ages
3,744,000
35-74
IV3
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NYHA Class IIIB and
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Comorbidities estimated in this cohort
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374,400
in 35-74 age cohort
(280,800)
Target VAD and Heart TX patient population (35-74 years)
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93,600
US Census Bureau Statistics (2007)
Heart and Stroke Statistics, American Heart Association
3 Cardiovascular Round Table research and analysis, The Advisory Board company (2009)
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Physical Exam
The most prognostic findings are
A. JVP
B. S3 gallop
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JVP and a S3 gallop in SOLVD (Drazner et al,
NEJM 2001) proved to be the most prognostic
signs for death and CHF hospitalization (RR 1.30
for JVP and RR 1.22 for S3)
Physical Exam
Far less helpful signs include
A. rales (very specific for PAW over 18 if present but not sensitive for
PAW over 18 with one study showing only 9 of 37 (24%) having rales
with known PAW over 18 at RHC
B.peripheral edema (not specific for CHF with many other possible
diagnoses)
Imaging
A. CXR can be very characteristic but also can be nondiagnostic—Intersititial
edema has a sensitivity of 60%/specificity of 73%/PPV 78%/NPV 53% for
elevated PAW
B. ECHO is the most information dense test we have and and is essential to
classify CHF
C. If severe systolic CHF present with LVEF less than 25%, cardiac
catheterization to assess coronary anatomy is preferred to stress imaging
which can be falsely negative or falsely positive in this population.
Lab
1. BNP helps to separate CHF patients from other causes of dyspnea but can be
elevated in other cardiac conditions (afib /pulmonary hypertension) High BNP
levels do not prove a diagnosis of acute heart failure. BNP elevation suggests
CHF when pretest probability likely. A low BNP suggests alternative diagnoses.
The BNP decreases with increasing BMI and decreases with obesity.
2. GFR is a sign of both venous congestion and and inadequate cardiac output.
One needs to look at “minor changes”. There is an increased 1.5 relative risk of
pump failure when comparing patients with Cr less than 1.5 versus Cr 1.5 to 2.0
in multivariate analysis.
3. Total billirubin is marker for hepatic congestion (MELD score and modified
MELD score for those on Warfarin) MELD score can be done with calculator app
with age,creatinine, bilirubin, INR, and yes/no concerning HD twice in past week.
Modified MELD substitutes albumin value for INR on those taking Warfarin.
Lab
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Sodium-increase risk of mortality with levels less
than 135 and greater than 145 (Optimize HF
registry)
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Hematocrit-increase risk of mortality with levels
less than 12.8 and greater than 15.8
EKG
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Assess cardiac rhythm and conduction
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Detect LVH
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Evaluate QRS duration for candidates for
biventricular pacing/resynchronization
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Detect evidence of myocardial ischemia
Severity Assessment
Although many scoring models exist (Forrester HF class,
Framingham CHF criteria, Killip Class, Stevenson HF
class, and Valiant HF risk score), 4 scoring models are
used in advance CHF
1. NYHA Functional CLASS
2. Seattle Heart Failure Model
3.Heart Failure Survival Score
Severity Assessment
4. INTERMACS Class
NYHA Functional
Class
Class I no limitation with activity
Class II mild limitation of activity
Class III marked limitation of activity
Class IV rest symptoms or with minimal activity
Seattle Heart Failure
Model
Can be done quickly with computer model algorithm on largely
well known and easily retrieved data. Caveats for use are that
SHFM tends to underestimate risk/overestimate survival and
based on an outpatient broad (less sick) population. SHFM
incorporates treatment data in contrast to HFSS
Seattle Heart Failure
Model
Variables required for score include age, LVEF, SBP,
weight, gender, NYHA Class, etiology, diuretic type and
dose, allopurinol use, statin use, ACE use, beta blocker
use, ARB use, K sparing diuretic, devices, sodium level,
total cholesterol, hemoglobin, lymphocytes,and uric acid.
Uric acid is felt to be a sign of oxidative stress.
Seattle Heart Failure
Model
This calculation yields an anticipated 1 year, 2
year, and 5 year survival. Calculation with the
proper app take less than 2 minutes.
Heart Failure Survival
Score
This score developed for more sick patients with Class III
and IV CHF to help with transplant listing but only has 7
variables to plug into an online risk calculator. Caveats
are that this score tends to overestimate risk and requires
a MVO2 from a CPX treadmill
Heart Failure Survival
Score
The variables include presence/absence of CAD,
resting heart rate, LVEF, mean arterial BP,
presence absence of IVCD on EKG, serum
sodium, and peak VO2
Heart Failure Survival
Score
The calculation give you a result of risk in three groups
1. low risk HFSS greater than 8.10 (88% 1 yr survival)
2.Moderate risk HFSS 7.20 to 8.09 (60% 1 yr survival)
3.High risk HFSS less then 7.20 (35% 1 yr survival)
Intermacs Profiles
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Seven different profiles developed to allow
optimal selection of patients for medical/pacing
therapies, transplant and MCS (Stevenson et al,
ISHLT 2009)
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Intermacs profiles are divided into 3 Class IV
profiles, 3 ambulatory Class IV profiles and 1
advanced Class III categories.
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Assessment of the
Advanced Heart Failure
Patient
1. Are they sick enough to benefit?
2. How far along are they in their disease?
3. Do we have time to wait or do they need workup now?
4. What are the non cardiac issues?
5. Do they have adequate social, psychologic and
financial support?
Assessment of the
Advance Heart Failure
Patient
6. Are the “well enough” not to die?
Patient Referral Criteria
 Patient with more than 1 of the following factors and
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Class III/IV with LVEF less than or equal to 25%
Inability to walk one block without dyspnea
Intolerant or refractory to ACE/ARB/B-Blockers
One or more CHF admissions in the past 6 months
CRT nonresponder
High diuretic dose (furosemide > 120 mg/day)
Na < 135
BUN > 40 or Cr > 1.5
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Starting Points
1. ABO blood type/body size
2. Recent ECHO
3. CPX treadmill
4. Right heart catheterization (addition of
left heart cath if not recently done)
ABO blood type and body
size
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Since O blood type is the universal donor, finding
hearts for O blood type is the most difficult. AB
recipients are the easiest to find donors as the
universal recipient and are among the the few that can
be transplanted from home as Status 2.
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Donors should be roughy no more than 20% over ideal
body weight and no less then 40% under the ideal body
weight of the recipient.
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Therefore, the “big O recipient ” is the most difficult to
transplant and often use LVAD as bridge to transplant
ECHO
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2D and Doppler/Color flow is the single most
useful test in the evaluation of heart failure
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In addition to a full exam, attention to LV
dilatation is important. Those patients with larger
LV’s have increased wall tension (Law of
Laplace) and more likely to “fall” off the Frank
Starling Curve. The LV compensation of dilatation
is deleterious.
LV dilatation
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LV wall stress =LV pressure X radius divided by
2x LV wall thickness
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French astronomer and mathematician Pierre
Simone Laplace
LV dilatation
Law of Laplace
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Increase wall stress and neurohormonal
activation drive the remodeling process favoring
LV dilatation and deterioration in function until a
new equilibrium is reached between forces
exerted by the extracellular matrix and distending
forces that promote LV dilatation
CPX
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CPX gives objective determination of functional
capacity impairment
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For systolic CHF patients, the key variables are
work effort, maximal oxygen capacity, and
ventilatory equivalent for CO2
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Work effort grouped as maximal, submaximal, and
poor. 1)maximal (RER greater than 1.1 WR max)
2) submaximal (RER less than 1.1 and greater than
0.9 WR max.) 3) poor (RER less than 0.9 WRmax)
CPX
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Respiratory exchange ratio (RER) —-related to but not
equivalent to its cellular counterpart, the respiratory
quotient, and is defined as the ratio of CO2 to O2
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Maximal oxygen capacity (Vo2max)—value achieved
with O2 remains stable despite a progressive increase
in the intensity of exercise —synonymous with peak
aerobic capacity. The anaerobic threshold is the
highest oxygen uptake without a sustained incase in
blood lactate concentration and lactate/pyruvate ratio
CPX
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Ventilation/carbon dioxide production ratio
(Ve/VCO2 slope)-also known as the ventilatory
equivalent for CO2 and represents a respiratory
control function that reflects chemoreceptor,
sensitivity, acid-bace balance, and ventilatory
efficiency
CPX
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Assuming maximal effort, a MVO2 less than 14
ml/kg/min will call for advance CHF therapies. A
MVO2 less than 10 ml/kg/min is a higher risk
group.
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A VE/VCO2 slope over 30 has a decreased
survival. In general, a VE/VCO2 slope over 35
qualifies for advance CHF therapies. A VE/VCO2
over 40 is high risk
CPX
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Suggest CPX in those patients with LV
dysfunction with a LVEF less or equal to 25% to
be sure adequate treatment. If MVO2 over 14
ml/kg/min and VE/VC02 slope less than 35, it is
proper to continue optimal pharmacologic therapy
including the proper EP directed therapies for
prevention of sudden death and biventricular
pacing.
Right Heart Cath
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Pulmonary hypertension—defined as mean PAP of
25 or greater—can be venous, arterial, or both
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Transpulmonary gradient —PA mean minus the PAW
mean. Normal TPG 10 or less. If TPG greater than
10, then at least some pulmonary arterial component
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Pulmonary vascular resistance (PVR) —expressed in
Wood units—acceptable is 2.3 Wood units or less
here—if TPG 10 or less, then accept up to 2.7 Wood
units.
Right Heart Cath
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Can use IV Nipride, inhaled Flolan, IV Flolan, or
IV adenosine for vasodilator challenge if initial
PVR over these levels
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RA pressure—-want less than 10 pre LVADincrease risk of venous hepatic and renal
congestion
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CVP/PAW ratio —want less than 0.63—sign of
significant RV dysfunction if higher than 0.63
Right Heart Cath
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RV stroke work index (RVSWI)—RV stroke
volume (cardiac index in ml/heart rate) multiplied
times the difference between the PA mean and
RA mean. RVSWI greater than 600 suggests
adequate RV 2) RVSWI greater than 900
suggests excellent RV 3) RVSWI less than 400
suggests failing RV and high risk for RV failure
with LVAD alone.
Multidisciplinary approach to selection
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cardiologist-symptoms, echo, cath data, cpx,
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CV surgeon-operative risk, vascular issues
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pulmonologist- operative risk for pulmonary complication
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nephrologist- acceptable preop renal function
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infectious disease -infectious risks
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hematologist- anemia and hypercoagulability issues
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PharmD- compliance with obtaining and taking med correctly
Multidisciplinary approach to selection
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coordinators- risk score tabulations, survival statistics, compliance
assessment
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social worker- personal responsibility, family support, financial ability
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psychologist-psychiatric disease, compliance assessment,
educational level assessment
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supportive care- expectations and life/death issues
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dietician-obesity, diet, diabetes control
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physical therapist-fraility, ability to rehab
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financial administrator- insurance approval and ongoing coverage
Too well, too sick, or just
right?
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1) 40 female with dilated cardiomyopathy with A
blood type, LVEF 20, PVR 1.8, CPX mv02 18,
LVEDD 5.7 cm
Responses
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1) Too well
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2) Too sick
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3) Just right
Too well, too sick, or just
right?
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2) 35 male with ischemic cardiomyopathy with
LVEF 20, GFR 20, CPX mvO2 8, LVEDD 7.2,
non CRT responder, total bilirubin 3.0, frailty
score of 5, 2 prior CABG operations
Responses
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1) Too well
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2) Too sick
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3) Just right
Too well, too sick, or just
right?
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3) 52 male with ischemic cardiomyopathy with
LVEF 20, CPX mvO2 14, O blood type, GFR 45,
PVR 2.2 after Flolan challenge, LVEDD 6.5, large
anterior wall scar
Responses
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1) Too well
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2) Too sick
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3) Just right
Too well, too sick, or just
right?
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4) 47 female with dilated cardiomyopathy with AB
blood type, CPX mvO2 14, LVEDD 5.6, DOE 1 to
2 blocks, PVR 2.1 without challenge
Responses
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1) Too well
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2) Too sick
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3) Just right
Too well, too sick, or just
right?
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5) 65 male with ischemic cardiomyopathy with
nephrectomy for renal cell carcinoma 4 years
ago, GFR 35, PVR 3.0 with Flolan Challenge,
cvp/paw 0.4, RVSWI 750
Responses
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1) Too well
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2) Too sick
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3) Just right
I would like to thank my tech support.