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

Standard

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

In: J AM COLL CARDIOL, Vol. 72, No. 23 Pt A, 11.12.2018, p. 2859-2867.

Research output: SCORING: Contribution to journalSCORING: Journal articlesResearchpeer-review

Harvard

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', J AM COLL CARDIOL, vol. 72, no. 23 Pt A, pp. 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

APA

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

Vancouver

Søndergaard L, Rodés-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schäfer U, Kuck K-H et al. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. J AM COLL CARDIOL. 2018 Dec 11;72(23 Pt A):2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

Bibtex

@article{b43c928f90824c42a097d39b3343a4e9,
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).",
keywords = "Journal Article",
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 {\textcopyright} 2018 American College of Cardiology Foundation. All rights reserved.",
year = "2018",
month = dec,
day = "11",
doi = "10.1016/j.jacc.2018.09.014",
language = "English",
volume = "72",
pages = "2859--2867",
journal = "J AM COLL CARDIOL",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "23 Pt A",

}

RIS

TY - JOUR

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

KW - Journal Article

U2 - 10.1016/j.jacc.2018.09.014

DO - 10.1016/j.jacc.2018.09.014

M3 - SCORING: Journal articles

C2 - 30261238

VL - 72

SP - 2859

EP - 2867

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 23 Pt A

ER -