Focus of the Report: This Health Technology Assessment focuses on percutaneous pulmonary valve implantation (PPVI) with Edwards Sapien 3 or Sapien XT valves for the treatment of right ventricular outflow tract (RVOT) defects.
Technology Description: The goal of PPVI is to improve hemodynamics, cardiopulmonary function, and survival while delaying the need for open surgical repair of a dysfunctional RVOT. PPVI, also referred to as transcatheter pulmonary valve implantation or replacement, is a minimally invasive surgical approach used to replace a failing pulmonary valve in patients who have congenital heart defects (CHDs). The procedure involves the percutaneous catheter-based deployment and placement of a pulmonary valve prosthesis.
Controversy: Pulmonary valves usually last 10 to 15 years after replacement via open-heart surgery; valves implanted via PPVI may be less durable and more difficult to replace.
Is percutaneous pulmonary valve implantation (PPVI) using Sapien 3 and Sapien XT valves effective for treatment of right ventricular outflow tract (RVOT) defects?
How does PPVI using Sapien 3 and Sapien XT valves compare with open surgery or other percutaneous pulmonary valve systems in patients who have RVOT defects?
What is the safety profile of PPVI using Sapien 3 and Sapien XT valves in patients who have RVOT defects?
Have definitive patient selection criteria been established for PPVI using Sapien 3 and Sapien XT valves for RVOT defects?
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