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

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved..

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.

Errataetall:

CommentIn: JACC Cardiovasc Interv. 2020 Nov 9;13(21):2525-2527. - PMID 33069645

Medienart:

E-Artikel

Erscheinungsjahr:

2020

Erschienen:

2020

Enthalten in:

Zur Gesamtaufnahme - volume:13

Enthalten in:

JACC. Cardiovascular interventions - 13(2020), 21 vom: 09. Nov., Seite 2510-2524

Sprache:

Englisch

Beteiligte Personen:

Shahanavaz, Shabana [VerfasserIn]
Balzer, David [VerfasserIn]
Babaliaros, Vasilis [VerfasserIn]
Kim, Dennis [VerfasserIn]
Dimas, Vivian [VerfasserIn]
Veeram Reddy, Suredranath R [VerfasserIn]
Leipsic, Jonathan [VerfasserIn]
Blanke, Philipp [VerfasserIn]
Shirali, Girish [VerfasserIn]
Parthiban, Anitha [VerfasserIn]
Gorelick, Jeremy [VerfasserIn]
Zahn, Evan M [VerfasserIn]

Links:

Volltext

Themen:

Alterra Adaptive Prestent
Journal Article
Pulmonary regurgitation
Research Support, Non-U.S. Gov't
Right ventricle outflow tract/pulmonary valve dysfunction
SAPIEN 3 THV
Transcatheter pulmonary valve replacement

Anmerkungen:

Date Completed 11.08.2021

Date Revised 11.08.2021

published: Print-Electronic

CommentIn: JACC Cardiovasc Interv. 2020 Nov 9;13(21):2525-2527. - PMID 33069645

Citation Status MEDLINE

doi:

10.1016/j.jcin.2020.06.039

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM316390895