TY - JOUR
T1 - Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation
AU - Dimas, V. Vivian
AU - Babaliaros, Vasilis
AU - Kim, Dennis
AU - Lim, D. Scott
AU - Morgan, Gareth
AU - Jones, Thomas K.
AU - Armstrong, Aimee K.
AU - Berman, Darren
AU - Aboulhosn, Jamil
AU - Mahadevan, Vaikom S.
AU - Gillespie, Matthew J.
AU - Balzer, David
AU - Zellers, Thomas
AU - Yu, Xiao
AU - Shirali, Girish
AU - Parthiban, Anitha
AU - Leipsic, Jonathan
AU - Blanke, Philipp
AU - Zahn, Evan
AU - Shahanavaz, Shabana
N1 - Publisher Copyright:
© 2024 American College of Cardiology Foundation
PY - 2024/10/14
Y1 - 2024/10/14
N2 - 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.
AB - 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.
KW - Alterra Adaptive Prestent
KW - pulmonary regurgitation
KW - right ventricular outflow tract/pulmonary valve dysfunction
KW - SAPIEN 3 THV
KW - transcatheter pulmonary valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85205554684&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2024.07.036
DO - 10.1016/j.jcin.2024.07.036
M3 - Article
C2 - 39415386
AN - SCOPUS:85205554684
SN - 1936-8798
VL - 17
SP - 2287
EP - 2297
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 19
ER -