CONTRAST AGENTS AND RADIOPHARMACEUTICALS IN CHILDREN WITH ...
CONTRAST AGENTS AND
CHILDREN WITH CARDIAC DISEASE:
SHOULD THEIR USE BE STUDIED?
John C. Ring, MD, FAAP, FACC
Associate Professor of Pediatrics
(Cardiology and Critical Care Medicine)
University of Tennessee Health Science Center
College of Medicine
Member: American Academy of Pediatrics Committee on Drugs
United States Food and Drug Administration
Center for Drug Evaluation and Research
Pediatric Advisory Subcommittee Meeting
February 3 & 4, 2004
WHAT WE KNOW ABOUT
• Congenital and acquired heart disease is common in
children and of considerable clinical importance.
• Accurate diagnosis is central to effect a good outcome.
• The diagnostic use of intravascular contrast agents and
radiopharmaceuticals is likely to increase in this patient
• Current use is guided by good intentions rather than
WHAT DOES THE
• Key words utilized
– intravascular contrast agents and radiopharmaceuticals
– cardiac disease
• Pertinent databases were exhaustively searched
– PubMed Medline 1950-Present
– BIOSIS Preview 1969-Present
– EMBASE Drugs and Pharmacology 1980-Present
– CINAHL 1982-Present
• Minimal information was found
WHAT DOES THE AAP SAY?
“Knowledge is good!”
“Children are not little adults.”
CARDIAC DISEASE IMPACTS CHILDREN OF
BOTH SEXES AND EVERY ETHNICITY
REGARDLESS OF AGE
• Reported frequency of CHD = 2.03-8.56/1000 (median = 5.93) live births
Confirmed cases = 2.03-4.30/1000 (median = 3.99)
• ACHD: 8,500 children with operated CHD reach adulthood annually
(Am.J.Cardiol. 1982; 50: 560-568.)
• Inflammatory cardiac disease
Kawasaki syndrome: 3-3.5 x 103 new cases/year in the U.S.
acute rheumatic fever: incidence (U.S.) = 0.5-3.1/100,000 population
myocarditis: histopathology in 16-21% of children dying suddenly
(JAMA. 1985; 254: 13211325.)
THE ULTIMATE COST IS THE
CHILD’S POTENTIAL LOST
• The AAP is “committed to the attainment of optimal
physical, mental, and social health and well-being for all
infants, children, adolescents, and young adults”.
Mission Statement: American Academy of Pediatrics
• Congenital anomalies are the 5th ranked cause of years of
premature mortality in the U.S.
(MMWR 1988; 37: 47-48.)
structural CHD account for 6/15 most lethal
DEPEND ON GOOD IMAGING
• Applies to both surgical and catheter-
• Higher risk interventions reduce the
“acceptable margin of diagnostic error”
• Different imaging modalities are
complimentary rather than competitive
USE OF THESE AGENTS IS
LIKELY TO INCREASE
• The volume of interventional cardiac procedures performed in children
is increasing rapidly.
35-60% of catheterizations include an intervention
interventional procedures require more/different
• The number of adult patients with congenital heart disease is
burgeoning; thus, the assessment of myocardial function and blood-
flow becomes more important.
• Interventional radiology is increasingly applied to non-cardiac areas of
pediatric practice, e.g. embolization of AVM in the CNS and catheter-
CARDIOLOGISTS WANT TO
• Are non-ionic contrast agents really that safe (or have I just been
• Is there a maximum volume of contrast I can inject safely? Does that
– program of injections?
• Is there an agent that will give me adequate opacification at lower
volumes in large patients?
• (How can I earn as much as the internists do?)
WHY WOULDN’T YOU STUDY
• Philosophical considerations
• Practical considerations
• “Fruits of FDAMA”
As of December
• The FDA should exercise its authority to require that
studies be performed regarding the use of intravascular
contrast agents and radiopharmaceuticals in children
with cardiac disease.
• Contrast studies should focus on dosing considerations,
balancing safety concerns with imaging effectiveness.
• A different regulatory posture may need to be
considered in order to study these agents.
TO LEARN MORE
John C. Ring, MD, FAAP, FACC
Physician Office Building, Suite P-215
777 Washington Ave. Memphis, TN 38105
901.572.3292 (voice) 901.572.5107 (FAX)