Myocardial Perfusion Imaging in the Pediatric Population

Peter Gardiner, MB ChB, MRCP

Vice President, Medical Sciences

Bristol-Myers Squibb Medical Imaging

Bristol-Myers Squibb Medical Imaging• A worldwide leader in cardiovascular imaging

research• Product line includes:

– Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

– Definity® (Vial for Perflutren Lipid Microsphere Injectable Suspension)

• Committed to appropriate evaluation of imaging drugs and cardiac imaging procedures in children

• Focus on nuclear myocardial perfusion imaging (MPI)

Nuclear Myocardial Perfusion Imaging

• Only modality approved by FDA for assessment of myocardial perfusion and function

• >13 years experience with Tc99m agents• Indications: Perfusion; function; exercise and

pharmacologic stress• Extensive literature documenting use in diagnosis,

prognosis and risk stratification• Safe and well tolerated• Continued growth in usage

Cardiolite®(Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

• Launched in US in 1991• Indications: myocardial perfusion and function;

exercise and pharmacologic stress; developing information for use in patient management decisions

• Leadership position:– Clinical use

– Continued significant investment in Clinical Research and Education

Nuclear Myocardial Perfusion Imaging in Children

• Lack of substantial, well-controlled clinical studies to define dosing and efficacy

• Usage - ~ 2-3,000 studies in 2002• Patient populations:

– Kawasaki’s Disease

– Cardiac transplant vasculopathy

– Cardiomyopathies (including hypertrophic and drug-induced)

– Congenital heart disease, including anomalous LCA

Nuclear Myocardial Perfusion Imaging in Children

• Advantages– Extensive experience and FDA approved for use in

adults

– Operator independent

– Reduced dose and duration of imaging with Tc99m based agents

• Disadvantages– Radiation exposure

– Limited information on dosing (only weight-based)

– Lack of substantial efficacy data

Nuclear Myocardial Perfusion Imaging in Children

Summary

• Nuclear imaging is the only modality approved by FDA for assessment of myocardial perfusion and function in adults

• Extensive experience in adults• Limited and variable experience in children• Bristol-Myers Squibb Medical Imaging (BMS MI)

supports FDA’s initiatives to evaluate nuclear cardiac imaging in children