Author + information
- Received August 21, 2018
- Revision received September 13, 2018
- Accepted September 14, 2018
- Published online September 25, 2018.
- Lars Søndergaard, MD1,∗ (, )
- Josep Rodés-Cabau, MD2,
- Axel Hans-Peter Linke, MD3,
- Stephan Fichtlscherer, MD4,
- Ulrich Schäfer, MD5,
- Karl-Heinz Kuck, MD6,
- Joerg Kempfert, MD7,
- Dabit Arzamendi, MD8,
- Francesco Bedogni, MD9,
- Federico M. Asch, MD10,
- Stephen Worthley, MD11 and
- Francesco Maisano, MD12
- 1Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- 2Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
- 3Technical University Dresden, Heart Center Dresden, Dresden, Germany
- 4Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt, Germany
- 5UKE Hamburg (Universitatsklinik Eppendorf), Hamburg, Germany
- 6Asklepios Klinik St. Georg, Lohmuehlenstrasse, Hamburg, Germany
- 7Deutsches Herzzentrum Berlin, Berlin, Germany
- 8Hospital de la Santa Creu I Sant Pau, Sant Antoni Maria Claret, Barcelona, Spain
- 9IRCCS Policlinico San Donato, Piazza E.Malan, San Donato Milanese, Italy
- 10Cardiovascular Core Laboratories, MedStar Health Research Institute at Washington Hospital Center, Washington, DC
- 11Royal Adelaide Hospital, Adelaide, Australia
- 12Clinic for Heart and Vascular Surgery. University Hospital Zurich, Zurich, Switzerland
- ↵∗Corresponding author: Lars Søndergaard, MD Department of Cardiology, Rigshospitalet Rigshospitalet - University of Copenhagen Blegdamsvej 9, 2100 Copenhagen, Denmark Telephone: +45 35458693 Fax: +45 35452705 Twitter: @uni_copenhagen | @Rigshospitalet.
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 To report 1-year outcomes of transcatheter aortic valve replacement (TAVR) with 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, STS 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 are 12.1%, 6.6%, 2.2% and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66mmHg and 1.75cm2 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.
Conclusion Transcatheter aortic valve replacement with the new THV in patients 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 PVL.
Sponsor: Abbott funded this study.
Conflict of interest: Lars Søndergaard, MD received consultant fee and institutional research grant from Abbott (formerly SJM). Ulrich Schäfer, MD, Stephan Fichtlscherer, MD, and Francesco Maisano, MD are proctors for Abbott Vascular and received travel/speaker’s honoraria and grant support. Josep Rodés-Cabau, MD received institutional research grants from Abbott. Axel Linke, MD received speaker honoraria as consultant and received grant support from Abbott. Stephen Worthley, MD received consultancy fees. Federico M Asch, MD, Director of MedStar Health with institutional contracts from Abbott, Dabit Arzamendi, MD and Joerg Kempfert are proctors for Abbott, Francesco Bedogni, MD is proctor and consultant for Abbott and Karl-Heinz Kuck, MD receive research grants and is consultant for Abbott.
Clinical Trial Registration Number: NCT01802788
- Received August 21, 2018.
- Revision received September 13, 2018.
- Accepted September 14, 2018.
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