Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

Helge Möllmann; Axel Linke; David M Holzhey; Thomas Walther; Ganesh Manoharan; Ulrich Schäfer; Karl Heinz-Kuck; Ad J Van Boven; Simon R Redwood; Jan Kovac; Christian Butter; Lars Søndergaard; Alexander Lauten; Gerhard Schymik; Stephen G Worthley

doi:10.1016/j.jcin.2017.05.021

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

Helge Möllmann, Axel Linke, David M Holzhey, Thomas Walther, Ganesh Manoharan, Ulrich Schäfer, Karl Heinz-Kuck, Ad J Van Boven, Simon R Redwood, Jan Kovac, Christian Butter, Lars Søndergaard, Alexander Lauten, Gerhard Schymik, Stephen G Worthley

51 Citationer (Scopus)

Abstract

OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.

BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.

METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.

RESULTS: A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).

CONCLUSIONS: Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

Originalsprog	Engelsk
Tidsskrift	JACC: Cardiovascular Interventions
Vol/bind	10
Udgave nummer	15
Sider (fra-til)	1538-1547
Antal sider	10
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2017.05.021
Status	Udgivet - 14 aug. 2017

Adgang til dokumentet

10.1016/j.jcin.2017.05.021

Citationsformater

Möllmann, H., Linke, A., Holzhey, D. M., Walther, T., Manoharan, G., Schäfer, U., Heinz-Kuck, K., Van Boven, A. J., Redwood, S. R., Kovac, J., Butter, C., Søndergaard, L., Lauten, A., Schymik, G., & Worthley, S. G. (2017). Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family. JACC: Cardiovascular Interventions, 10(15), 1538-1547. https://doi.org/10.1016/j.jcin.2017.05.021

Möllmann, H, Linke, A, Holzhey, DM, Walther, T, Manoharan, G, Schäfer, U, Heinz-Kuck, K, Van Boven, AJ, Redwood, SR, Kovac, J, Butter, C, Søndergaard, L, Lauten, A, Schymik, G & Worthley, SG 2017, 'Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family', JACC: Cardiovascular Interventions, bind 10, nr. 15, s. 1538-1547. https://doi.org/10.1016/j.jcin.2017.05.021

@article{199e98aecea24335a0d589b40a3bb383,

title = "Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family",

abstract = "OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.RESULTS: A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).CONCLUSIONS: Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.",

keywords = "Journal Article",

author = "Helge M{\"o}llmann and Axel Linke and Holzhey, {David M} and Thomas Walther and Ganesh Manoharan and Ulrich Sch{\"a}fer and Karl Heinz-Kuck and {Van Boven}, {Ad J} and Redwood, {Simon R} and Jan Kovac and Christian Butter and Lars S{\o}ndergaard and Alexander Lauten and Gerhard Schymik and Worthley, {Stephen G}",

note = "Copyright {\textcopyright} 2017. Published by Elsevier Inc.",

year = "2017",

month = aug,

day = "14",

doi = "10.1016/j.jcin.2017.05.021",

language = "English",

volume = "10",

pages = "1538--1547",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "15",

}

TY - JOUR

T1 - Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

AU - Möllmann, Helge

AU - Linke, Axel

AU - Holzhey, David M

AU - Walther, Thomas

AU - Manoharan, Ganesh

AU - Schäfer, Ulrich

AU - Heinz-Kuck, Karl

AU - Van Boven, Ad J

AU - Redwood, Simon R

AU - Kovac, Jan

AU - Butter, Christian

AU - Søndergaard, Lars

AU - Lauten, Alexander

AU - Schymik, Gerhard

AU - Worthley, Stephen G

PY - 2017/8/14

Y1 - 2017/8/14

N2 - OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.RESULTS: A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).CONCLUSIONS: Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

AB - OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.RESULTS: A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).CONCLUSIONS: Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

KW - Journal Article

U2 - 10.1016/j.jcin.2017.05.021

DO - 10.1016/j.jcin.2017.05.021

M3 - Journal article

C2 - 28797431

SN - 1936-8798

VL - 10

SP - 1538

EP - 1547

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 15

ER -

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

Abstract

Adgang til dokumentet

Fingeraftryk

Citationsformater