Transcript Quality of care

BNP for CHF
Dr James Young
Head, Section of Heart Failure and
Cardiac Transplant Medicine
Cleveland Clinic Foundation
Cleveland, OH
BNP for CHF
B-type natriuretic peptide
nesiritide (B-type natriuretic peptide)
Hormone produced by the left ventricle in
response to increase in volume and pressure
in the left ventricle.
A potent vasodilator, acts to counteract other
hormones that are associated with heart
failure.
BNP for CHF
VMAC trial
Vasodilation in the Management of Acute CHF
498 patients in a multicenter (55 US sites) trial
Randomization stratified by use of right heart catheter
Placebo- and nitroglycerin-controlled
BNP for CHF
VMAC: design
3-hour
placebo-controlled period
Active-controlled
treatment period
randomization
stratification
catheterized
(n=246)
eligible
patient
(n=489)
noncatheterized
(n=243)
nitroglycerin (n=60)
nitroglycerin (n=92)
placebo (n=62)
nesiritide fixed-dose (n=62)
nesiritide fixed-dose (n=92)
nesiritide adjustable-dose (n=62)
nesiritide adjustable-dose (n=62)
nitroglycerin (n=83)
nitroglycerin (n=124)
placebo (n=80)
nesiritide fixed-dose (n=80)
nesiritide fixed-dose (n=119)
3 hours
time zero
Time
end of
study
drug
6
months
BNP for CHF
VMAC: findings
Primary endpoint: PCWP through 3 hours
NTG
Nesiritide
30
29
28
27
26
25
24
23
22
21
20
19
18
#
Placebo
*
#
*
#
*
#
#
*
Time
*p <0.05 versus placebo
BNP for CHF
Mortality
VMAC not designed to answer mortality question
No statistically significant difference at 30 day,
90 day, 150 day marks.
BNP for CHF
Costs
Yet to be approved for general use as treatment
by the FDA.
Pharmacoeconomic studies have not been done.
Hope to see it competitively priced with some of
the inotropic agents used today.
Added value possible if it aids treatment by
keeping people out of ICU or out of hospital.
BNP for CHF
FDA approval
Cardio-renal advisory panel of FDA voted 54 in January 1999 for the drug.
VMAC was designed to answer some
additional questions the FDA had.
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BNP for CHF
Specificity and sensitivity
100 patients presenting to the ER with signs or
symptoms of congestive heart failure (eg, dyspnea,
edema, weight gain)
Specificity Sensitivity
Jugular venous pressure
92%
34%
Third heart sound
90%
26%
Rales
81%
57%
BNP (cutoff value of 100 pg/mL)
98%
100%
Dao and colleagues, 49th Annual Scientific Session of
the American College of Cardiology
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BNP for CHF
Marker for CHF
BNP levels identified individuals with:
normal heart function
(BNP = 38  4 pg/mL)
normal ejection fraction but wall motion
abnormalities
(BNP = 177  20 pg/mL)
impaired ejection fraction
(BNP = 523  50 pg/mL, p<0.001)
Koon and colleagues, 49th Annual Scientific Session of
the American College of Cardiology
BNP for CHF
The future?
“I think it’s going to be an elegant way
of being able to track patients with heart
failure and seeing where exactly they are. It
may become, if my hunch is right […] the
complete blood count measurement to see
where a patient is at with this heart failure
syndrome at any given time.”
Dr James Young
Head, Section of Heart Failure and
Cardiac Transplant Medicine
Cleveland Clinic Foundation
Cleveland, OH