May 19, 2003European Journal of Cardio-Thoracic Surgery
Early failure of the tissue engineered porcine heart valve SYNERGRAFT™ in pediatric patients
Why the study?
Is the Synergraft tissue engineered decellularized porcine heart valve safe and durable for right ventricular outflow tract reconstruction in pediatric patients?
Population
4 male children undergoing right ventricular outflow tract root replacement.
Design
Case_series
Follow-up
Up to 1 year
Authors
Discussion
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Member takes
Implication
Rapid failure and mortality in this pediatric series warrant caution; hypothesis-generating for decellularized xenograft durability.
Structured PICO
Is the Synergraft tissue engineered decellularized porcine heart valve safe and durable for right ventricular outflow tract reconstruction in pediatric patients?
P
Population
4 male children (age 2.5-11 years) undergoing right ventricular outflow tract (RVOT) root replacement (2 Ross operation, 2 homograft replacement).
I
Intervention
Tissue engineered decellularized porcine heart valve (Synergraft, model 500 and 700) implanted in the RVOT.
O
Outcome
Valve failure, graft degeneration, and mortalitysafety
The Synergraft decellularized porcine heart valve elicits a severe inflammatory response leading to rapid structural failure and high mortality in pediatric patients, prompting immediate cessation of its use.
Cite This Study
Paul Simon (2003) studied this question.