Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis The PORTICO-I Trial 1-Year Outcomes
Por:
Sondergaard, L, Rodes-Cabau, J, Linke, AHP, Fichtlscherer, S, Schafer, U, Kuck, KH, Kempfert, J, Arzamendi, D, Bedogni, F, Asch, FM, Worthley, S, Maisano, F
Publicada:
11 dic 2018
Resumen:
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 naive 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) (c) 2018 the American College of Cardiology Foundation. Published by Elsevier. All rights reserved.
Filiaciones:
Sondergaard, L:
Univ Copenhagen, Dept Cardiol, Rigshosp, Blegdamsvej 9, DK-2100 Copenhagen, Denmark
Rodes-Cabau, J:
Univ Laval, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Linke, AHP:
Tech Univ Dresden, Heart Ctr Dresden, Dresden, Germany
Fichtlscherer, S:
Klinikum Johann Wolfgang Goethe Univ Frankfurt, Frankfurt, Germany
Schafer, U:
UKE Hamburg Univ Klin Eppendorf, Hamburg, Germany
Kuck, KH:
Asklepios Klin St Georg, Lohmuehlenstr, Hamburg, Germany
Kempfert, J:
Deutsch Herzzentrum Berlin, Berlin, Germany
Arzamendi, D:
Sant Antoni Maria Claret, Hosp Santa Creu & St Pau, Barcelona, Spain
Bedogni, F:
IRCCS Policlin San Donato, Piazza E Malan, San Donato Milanese, Italy
Asch, FM:
Washington Hosp Ctr, Cardiovasc Core Labs, MedStar Hlth Res Inst, Washington, DC 20010 USA
Worthley, S:
Royal Adelaide Hosp, Adelaide, SA, Australia
Maisano, F:
Univ Hosp Zurich, Clin Heart & Vasc Surg, Zurich, Switzerland
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