Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes
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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.
I: Journal of the American College of Cardiology, Bind 72, Nr. 23, Part A, 2018, s. 2859-2867.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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
Y1 - 2018
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
C2 - 30261238
VL - 72
SP - 2859
EP - 2867
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 23, Part A
ER -
ID: 217558048