Journal article
Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
- Søndergaard L Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: Lars.Soendergaard.01@regionh.dk.
- Rodés-Cabau J Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
- Hans-Peter Linke A Technical University Dresden, Heart Center Dresden, Dresden, Germany.
- Fichtlscherer S Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt, Germany.
- Schäfer U UKE Hamburg (Universitatsklinik Eppendorf), Hamburg, Germany.
- Kuck KH Asklepios Klinik St. Georg, Lohmuehlenstrasse, Hamburg, Germany.
- Kempfert J Deutsches Herzzentrum Berlin, Berlin, Germany.
- Arzamendi D Hospital de la Santa Creu I Sant Pau, Sant Antoni Maria Claret, Barcelona, Spain.
- Bedogni F IRCCS Policlinico San Donato, Piazza E. Malan, San Donato Milanese, Italy.
- Asch FM Cardiovascular Core Laboratories, MedStar Health Research Institute at Washington Hospital Center, Washington, DC.
- Worthley S Royal Adelaide Hospital, Adelaide, South Australia, Australia.
- Maisano F Clinic for Heart and Vascular Surgery, University Hospital Zurich, Zurich, Switzerland.
- 2018-09-28
Published in:
- Journal of the American College of Cardiology. - 2018
TAVR
aortic stenosis
clinical research
degenerative valve
Aged
Aged, 80 and over
Aortic Valve Stenosis
Female
Follow-Up Studies
Heart Valve Prosthesis
Humans
Internationality
Male
Mortality
Prosthesis Design
Self Expandable Metallic Stents
Transcatheter Aortic Valve Replacement
Treatment Outcome
English
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).
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2018.09.014
- PMID 30261238
- Persistent URL
- https://sonar.ch/global/documents/30040
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