Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation.
Document Type
Article
Publication Date
10-14-2024
Identifier
DOI: 10.1016/j.jcin.2024.07.036
Abstract
BACKGROUND: A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs.
OBJECTIVES: The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement.
METHODS: The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis.
RESULTS: Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years.
CONCLUSIONS: The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort.
Journal Title
JACC Cardiovasc Interv
Volume
17
Issue
19
First Page
2287
Last Page
2297
MeSH Keywords
Humans; Pulmonary Valve Insufficiency; Treatment Outcome; Male; Heart Valve Prosthesis; Female; Heart Valve Prosthesis Implantation; Time Factors; Pulmonary Valve; Cardiac Catheterization; Prosthesis Design; Recovery of Function; Adult; United States; Young Adult; Hemodynamics; Adolescent; Prospective Studies; Middle Aged; Balloon Valvuloplasty; Risk Factors; Europe
Keywords
Alterra Adaptive Prestent; SAPIEN 3 THV; pulmonary regurgitation; right ventricular outflow tract/pulmonary valve dysfunction; transcatheter pulmonary valve replacement
Recommended Citation
Dimas VV, Babaliaros V, Kim D, et al. Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation. JACC Cardiovasc Interv. 2024;17(19):2287-2297. doi:10.1016/j.jcin.2024.07.036
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