TY - JOUR
T1 - Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis
T2 - the prospective, multicentre, global PORTICO NG Study
AU - Sondergaard, Lars
AU - Walton, Antony S.
AU - Worthley, Stephen G.
AU - Smith, Dave
AU - Chehab, Bassem
AU - Manoharan, Ganesh
AU - Yong, Gerald
AU - Bedogni, Francesco
AU - Bates, Nicholas
AU - Reardon, Michael J.
N1 - Publisher Copyright:
© Europa Digital & Publishing 2023. All rights reserved.
PY - 2023/6/19
Y1 - 2023/6/19
N2 - Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow- up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.
AB - Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow- up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.
KW - Navitor
KW - aortic stenosis
KW - paravalvular leak
KW - transcatheter aortic valve implantation
KW - transcatheter aortic valve replacement
KW - Prospective Studies
KW - Humans
KW - Heart Valve Prosthesis
KW - Male
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
KW - Stroke/etiology
KW - Prosthesis Design
KW - Aged, 80 and over
KW - Aortic Valve Stenosis/surgery
KW - Female
KW - Aged
KW - Aortic Valve/diagnostic imaging
UR - http://www.scopus.com/inward/record.url?scp=85152150510&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85152150510&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-22-01108
DO - 10.4244/EIJ-D-22-01108
M3 - Article
C2 - 36895190
AN - SCOPUS:85152150510
SN - 1774-024X
VL - 19
SP - 248
EP - 255
JO - EuroIntervention
JF - EuroIntervention
IS - 3
ER -