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

Lars Søndergaard; Josep Rodés-Cabau; Axel Hans-Peter Linke; Stephan Fichtlscherer; Ulrich Schäfer; Karl-Heinz Kuck; Joerg Kempfert; Dabit Arzamendi; Francesco Bedogni; Federico M Asch; Stephen Worthley; Francesco Maisano

doi:10.1016/j.jacc.2018.09.014

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

Lars Søndergaard, Josep Rodés-Cabau, Axel Hans-Peter Linke, Stephan Fichtlscherer, Ulrich Schäfer, Karl-Heinz Kuck, Joerg Kempfert, Dabit Arzamendi, Francesco Bedogni, Federico M Asch, Stephen Worthley, Francesco Maisano

Department of Clinical Medicine

15 Citations (Scopus)

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 cm ² , 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.

Original language	English
Journal	Journal of the American College of Cardiology
Volume	72
Issue number	23, Part A
Pages (from-to)	2859-2867
Number of pages	9
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2018.09.014
Publication status	Published - 11 Dec 2018

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10.1016/j.jacc.2018.09.014

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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, F. M., 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, Part A), 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

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 et al.

In: Journal of the American College of Cardiology, Vol. 72, No. 23, Part A, 11.12.2018, p. 2859-2867.

Research output: Contribution to journal › Journal article › Research › peer-review

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, Part A, pp. 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

@article{b4f5cb1dad5c4f29ac2d620daed32f6a,

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 cm 2 , 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.",

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",

year = "2018",

month = dec,

day = "11",

doi = "10.1016/j.jacc.2018.09.014",

language = "English",

volume = "72",

pages = "2859--2867",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier",

number = "23, Part A",

}

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

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 cm 2 , 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.

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 cm 2 , 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.

U2 - 10.1016/j.jacc.2018.09.014

DO - 10.1016/j.jacc.2018.09.014

M3 - Journal article

C2 - 30261238

SN - 0735-1097

VL - 72

SP - 2859

EP - 2867

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 23, Part A

ER -

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

Abstract

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