TY - JOUR
T1 - Transcatheter Treatment of Native Aortic Valve Regurgitation
T2 - The North American Experience With a Novel Device
AU - Garcia, Santiago
AU - Ye, Jian
AU - Webb, John
AU - Reardon, Michael
AU - Kleiman, Neal
AU - Goel, Sachin
AU - Hatab, Taha
AU - Fam, Neil
AU - Peterson, Mark
AU - Liauw, Samantha
AU - Frisoli, Tiberio M.
AU - Bashir, Hanad
AU - Paige, Debra
AU - Rock, Darlene
AU - Schmidt, Christian
AU - Jollis, James G.
AU - Kereiakes, Dean J.
N1 - Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2023/8/28
Y1 - 2023/8/28
N2 - Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR. Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve). Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm). Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days. Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.
AB - Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR. Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve). Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm). Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days. Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.
KW - aortic regurgitation
KW - compassionate use
KW - transcatheter aortic valve replacement
KW - Humans
KW - Risk Factors
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
KW - Prosthesis Design
KW - Heart Valve Prosthesis/adverse effects
KW - Animals
KW - Cattle
KW - Aged, 80 and over
KW - Aortic Valve Stenosis/surgery
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Insufficiency/diagnostic imaging
UR - http://www.scopus.com/inward/record.url?scp=85163362487&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85163362487&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2023.05.018
DO - 10.1016/j.jcin.2023.05.018
M3 - Article
C2 - 37212431
AN - SCOPUS:85163362487
SN - 1936-8798
VL - 16
SP - 1953
EP - 1960
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 16
ER -