Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.
Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.
- 2020
Available online through MWHC library: 2008 - present
BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter >=5 mm. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days. Copyright (c) 2020. Published by Elsevier Inc. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 +/- 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with >=1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 +/- 3.2 mm Hg, mean valve area of 1.77 +/- 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days.
English
1936-8798
10.1016/j.jcin.2020.06.041 [doi] S1936-8798(20)31399-6 [pii]
*Aortic Valve Stenosis
*Heart Valve Prosthesis
*Transcatheter Aortic Valve Replacement
Aged
Aged, 80 and over
Aortic Valve Stenosis/su [Surgery]
Aortic Valve/su [Surgery]
Australia
Europe
Female
Humans
Male
Prospective Studies
Prosthesis Design
Severity of Illness Index
Time Factors
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article
Available online through MWHC library: 2008 - present
BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter >=5 mm. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days. Copyright (c) 2020. Published by Elsevier Inc. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 +/- 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with >=1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 +/- 3.2 mm Hg, mean valve area of 1.77 +/- 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days.
English
1936-8798
10.1016/j.jcin.2020.06.041 [doi] S1936-8798(20)31399-6 [pii]
*Aortic Valve Stenosis
*Heart Valve Prosthesis
*Transcatheter Aortic Valve Replacement
Aged
Aged, 80 and over
Aortic Valve Stenosis/su [Surgery]
Aortic Valve/su [Surgery]
Australia
Europe
Female
Humans
Male
Prospective Studies
Prosthesis Design
Severity of Illness Index
Time Factors
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article