Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study.

Objectives: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR).
Background: Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV.
Methods: Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported.
Results: Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported.
Conclusions: This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed.
Competing Interests: Author Relationship With Industry Edwards Lifesciences sponsored this study. Dr. Shahanavaz is a consultant for Medtronic; and is a proctor for Edwards Lifesciences. Dr. Balzer is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr. Babaliaros is a consultant for Edwards Lifesciences; and has equity in TransMural Systems. Dr. Dimas is a consultant for Medtronic and Abbott Laboratories/St. Jude Medical. Dr. Reddy is a consultant for B. Braun Interventional Systems. Dr. Leipsic is a core laboratory consultant for Edwards Lifesciences, Medtronic, and Abbott Laboratories; and is a consultant for Circle CVI. Dr. Blanke is a consultant for Edwards Lifesciences. Dr. Gorelick is an employee of Edwards Lifesciences. Dr. Zahn is a proctor and consultant for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)