January 1, 2019EuroIntervention
Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system
Why the study?
Multiple surgical revisions are often necessary for congenital heart defects affecting the RVOT or pulmonary valve, but multicentre data on the feasibility and safety of PPVI using the SAPIEN 3 transcatheter heart valve were lacking.
Does percutaneous pulmonary valve implantation using the SAPIEN 3 transcatheter heart valve improve haemodynamic outcomes and safety in patients with congenital heart defects affecting the RVOT?
Population
82 patients undergoing PPVI across centres in Europe and Canada
Comparison
PPVI using the SAPIEN 3 transcatheter heart valve
Design
Multicentre observational registry
Follow-up
Within two years
Authors
Discussion
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Member takes
Implication
Supports short-term RVOT relief with SAPIEN 3 PPVI; hypothesis-generating pending durability and randomized data.
Structured PICO
Does percutaneous pulmonary valve implantation using the SAPIEN 3 transcatheter heart valve improve haemodynamic outcomes and safety in patients with congenital heart defects affecting the RVOT?
P
Population
82 patients with congenital heart defects affecting the RVOT or pulmonary valve (most commonly Tetralogy of Fallot, 58.5%), mean age 27.3 years, across centres in Europe and Canada.
I
Intervention
Percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve (90.2% received pre-stenting).
O
Outcome
Short-term safety, feasibility, and haemodynamic outcomes (peak systolic gradient over the RVOT, pulmonary regurgitation, and NYHA class).safety
Percutaneous pulmonary valve implantation using the SAPIEN 3 valve is feasible and safe in patients with congenital heart defects, providing significant short-term improvements in hemodynamics and functional status.
Cite This Study
Hascoët et al. (2019) studied this question.