contrast agents and radiopharmaceuticals in children with cardiac disease: should their use be...
TRANSCRIPT
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CONTRAST AGENTS AND RADIOPHARMACEUTICALS IN
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 CenterCollege of Medicine
Member: American Academy of Pediatrics Committee on Drugs
United States Food and Drug AdministrationCenter for Drug Evaluation and ResearchPediatric Advisory Subcommittee Meeting
February 3 & 4, 2004Rockville, Maryland
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WHAT WE KNOW ABOUT THIS QUESTION
• 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 population.
• Current use is guided by good intentions rather than data.
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WHAT DOES THE LITERATURE SAY?
• Key words utilized – intravascular contrast agents and radiopharmaceuticals – children – cardiac disease– complications
• 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
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WHAT DOES THE AAP SAY?
“Knowledge is good!”
and
“Children are not little adults.”
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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.)
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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 congenital malformations
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OPTIMAL INTERVENTIONS DEPEND ON GOOD IMAGING
• Applies to both surgical and catheter-directed procedures
• Higher risk interventions reduce the “acceptable margin of diagnostic error”
• Different imaging modalities are complimentary rather than competitive
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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 interventioninterventional procedures require more/different
angiography
• 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-directed thrombolysis.
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WHAT PEDIATRIC CARDIOLOGISTS WANT TO
KNOW• Are non-ionic contrast agents really that safe (or have I just been
lucky…or good)?
• Is there a maximum volume of contrast I can inject safely? Does that change with…– age– lesion/co-morbidities– 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?)
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WHY WOULDN’T YOU STUDY THESE AGENTS?
• Philosophical considerations
• Practical considerations
• “Fruits of FDAMA”
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Pediatric Exclusivity Statistics
As of December 31, 2003
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RECOMMENDATIONS
• 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.
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TO LEARN MORE
CONTACT INFORMATION
John C. Ring, MD, FAAP, FACC
Physician Office Building, Suite P-215777 Washington Ave. Memphis, TN 38105
901.572.3292 (voice) 901.572.5107 (FAX)