TY - JOUR
T1 - Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve
T2 - A Propensity-Matched Analysis From the United States
AU - Nazif, Tamim M.
AU - Cahill, Thomas J.
AU - Daniels, David
AU - Mccabe, James M.
AU - Reisman, Mark
AU - Chakravarty, Tarun
AU - Makkar, Raj
AU - Krishnaswamy, Amar
AU - Kapadia, Samir
AU - Chehab, Bassem M.
AU - Wang, John
AU - Spies, Christian
AU - Rodriguez, Evelio
AU - Kaneko, Tsuyoshi
AU - Hahn, Rebecca T.
AU - Leon, Martin B.
AU - George, Isaac
N1 - Funding Information:
Statistical analyses were performed by employees of Edwards Lifesciences. The views or opinions presented here do not represent those of The Society of Thoracic Surgeons, the American College of Cardiology (STS/ACC) or the STS/ACC TVT Registry. Dr Nazif discloses consulting or honoraria for Edwards LifeSciences, Medtronic, and Boston Scientific, and consulting and equity for Venus Medtech. Dr McCabe discloses honoraria from Edwards LifeSciences. Dr Rodriguez discloses clinical research and consulting for Edwards LifeSciences. Dr Kaneko discloses consulting or honoraria from Edwards Lifesciences, Medtronic, Abbott, Cook Medical, Baylis, 4C Medical, and CardioMech. Dr Hahn reports speaker fees from Edwards Lifesciences and Philips Healthcare; consulting fees for Abbott Structural, Edwards Lifesciences, Medtronic, Navigate; nonfinancial support from 3mensio; equity with Navigate; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Leon reports institutional grants for clinical research from Abbott, Boston Scientific, Edwards LifeSciences, and Medtronic, and advisory board participation (nonpaid) for Abbott, Boston Scientific, Edwards LifeSciences, Gore, and Medtronic. The other authors report no conflicts.
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score-matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P=0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P<0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P=0.10), major vascular complications (1.1% versus 1.0%, P=0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P=0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.
AB - Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score-matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P=0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P<0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P=0.10), major vascular complications (1.1% versus 1.0%, P=0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P=0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.
KW - United States
KW - heart valve
KW - paravalvular regurgitation
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85116206372&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.121.010543
DO - 10.1161/CIRCINTERVENTIONS.121.010543
M3 - Article
C2 - 34433290
AN - SCOPUS:85116206372
SN - 1941-7640
VL - 14
SP - E010543
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 9
ER -