Author + information
- Received August 20, 2018
- Revision received October 26, 2018
- Accepted October 30, 2018
- Published online February 4, 2019.
- Lars Søndergaard, MD, DMSca,∗ (, )@Rigshospitalet,
- Nikolaj Ihlemann, MD, PhDa,
- Davide Capodanno, MD, PhDb,
- Troels H. Jørgensen, MDa,
- Henrik Nissen, MD, PhDc,
- Bo Juel Kjeldsen, MD, PhDd,
- Yanping Chang, MSe,
- Daniel Andreas Steinbrüchel, MD, DMScf,
- Peter Skov Olsen, MD, DMScf,
- Anna Sonia Petronio, MDg and
- Hans Gustav Hørsted Thyregod, MD, PhDf
- aDepartment of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
- bCardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria “Policlinico-Vittorio Emanuele,” University of Catania, Catania, Italy
- cDepartment of Cardiology, Odense University Hospital, Odense, Denmark
- dDepartment of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark
- eCoronary and Structural Heart Disease Management, Medtronic, Mounds View, Minnesota
- fDepartment of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
- gCardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- ↵∗Address for correspondence:
Dr. Lars Søndergaard, Department of Cardiology, Section 2011, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Background Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.
Objectives The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria.
Methods In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD.
Results At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89).
Conclusions In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)
This work was supported by the Danish Heart Foundation (grant numbers: 09-10-AR76-A2733-25400, 12-04-R90-A3879-22733, and 13-04-R94-A4473-22762) and Medtronic. Dr. Søndergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Ihlemann has received educational compensation from Medtronic. Dr. Jørgensen has received a research grant from Edwards Lifesciences. Dr. Kjeldsen has served as a proctor for Edwards Lifesciences. Ms. Chang is an employee and shareholder of Medtronic. Dr. Steinbrüchel has received research contracts from Medtronic and St. Jude Medical. Dr. Petronio is a consultant for Medtronic, Abbott, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received August 20, 2018.
- Revision received October 26, 2018.
- Accepted October 30, 2018.
- 2019 American College of Cardiology Foundation
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