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Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes

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Søndergaard, L, Rodés-Cabau, J, Hans-Peter Linke, A, Fichtlscherer, S, Schäfer, U, Kuck, K-H, Kempfert, J, Arzamendi, D, Bedogni, F, Asch, FM, Worthley, S & Maisano, F 2018, 'Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes' Journal of the American College of Cardiology, vol. 72, no. 23 Pt A, pp. 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

APA

CBE

Søndergaard L, Rodés-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schäfer U, Kuck K-H, Kempfert J, Arzamendi D, Bedogni F, Asch FM, Worthley S, Maisano F. 2018. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. Journal of the American College of Cardiology. 72(23 Pt A):2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

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Author

Søndergaard, Lars ; Rodés-Cabau, Josep ; Hans-Peter Linke, Axel ; Fichtlscherer, Stephan ; Schäfer, Ulrich ; Kuck, Karl-Heinz ; Kempfert, Joerg ; Arzamendi, Dabit ; Bedogni, Francesco ; Asch, Federico M ; Worthley, Stephen ; Maisano, Francesco. / Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis : The PORTICO-I Trial 1-Year Outcomes. In: Journal of the American College of Cardiology. 2018 ; Vol. 72, No. 23 Pt A. pp. 2859-2867.

Bibtex

@article{ec1ab3f4396242a8af15538c63c66aac,
title = "Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes",
abstract = "BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7{\%} female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8{\%}) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1{\%}, 6.6{\%}, 2.2{\%}, and 2.5{\%}, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6{\%} of patients with no severe leakage. New pacemaker rates were 18.7{\%} and 21.3{\%} for pacemaker na{\"i}ve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).",
author = "Lars S{\o}ndergaard and Josep Rod{\'e}s-Cabau and {Hans-Peter Linke}, Axel and Stephan Fichtlscherer and Ulrich Sch{\"a}fer and Karl-Heinz Kuck and Joerg Kempfert and Dabit Arzamendi and Francesco Bedogni and Asch, {Federico M} and Stephen Worthley and Francesco Maisano",
note = "Copyright {\circledC} 2018 American College of Cardiology Foundation. All rights reserved.",
year = "2018",
month = "12",
day = "11",
doi = "10.1016/j.jacc.2018.09.014",
language = "English",
volume = "72",
pages = "2859--2867",
journal = "American College of Cardiology. Journal",
issn = "0735-1097",
publisher = "Elsevier Inc",
number = "23 Pt A",

}

RIS

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis

T2 - The PORTICO-I Trial 1-Year Outcomes

AU - Søndergaard, Lars

AU - Rodés-Cabau, Josep

AU - Hans-Peter Linke, Axel

AU - Fichtlscherer, Stephan

AU - Schäfer, Ulrich

AU - Kuck, Karl-Heinz

AU - Kempfert, Joerg

AU - Arzamendi, Dabit

AU - Bedogni, Francesco

AU - Asch, Federico M

AU - Worthley, Stephen

AU - Maisano, Francesco

N1 - Copyright © 2018 American College of Cardiology Foundation. All rights reserved.

PY - 2018/12/11

Y1 - 2018/12/11

N2 - BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

AB - BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

U2 - 10.1016/j.jacc.2018.09.014

DO - 10.1016/j.jacc.2018.09.014

M3 - Journal article

VL - 72

SP - 2859

EP - 2867

JO - American College of Cardiology. Journal

JF - American College of Cardiology. Journal

SN - 0735-1097

IS - 23 Pt A

ER -

ID: 56524192