Key result
Percutaneous transcatheter pulmonary valve replacement using the Sapien S3 valve was technically successful in all 50 patients, though tricuspid valve injury occurred as a serious complication.
Why the study?
Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease and large diameter dysfunctional right ventricular outflow tract, motivating a description of initial multi-center experience.
Does off-label use of the Sapien S3 valve for percutaneous transcatheter pulmonary valve replacement provide procedural success and safety in patients with congenital heart disease and large diameter dysfunctional right ventricular outflow tract?
Observational (n=50)
Yes
Does off-label use of the Sapien S3 valve for percutaneous transcatheter pulmonary valve replacement provide procedural success and safety in patients with congenital heart disease and large diameter dysfunctional right ventricular outflow tract?
Off-label use of the Sapien S3 valve for TPVR in patients with CHD and large dysfunctional RVOTs is technically feasible with excellent short-term valve function, though tricuspid valve injury is a serious potential complication.
No takes yet. Share an insight, caveat, or question.
Short-term feasibility of off-label Sapien S3 TPVR supported in small cohort; leaves open need for prospective safety data before practice change.
Sinha et al. (2018) conducted an observational in Congenital heart disease and large diameter dysfunctional right ventricular outflow tract (n=50). Edwards Sapien S3 Valve was evaluated on Procedural success, complications, and efficacy. Percutaneous transcatheter pulmonary valve replacement using the Sapien S3 valve was technically successful in all 50 patients, though tricuspid valve injury occurred as a serious complication.
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