Lars Søndergaard1, Nikolaj Ihlemann2, Davide Capodanno3, Troels H Jørgensen2, Henrik Nissen4, Bo Juel Kjeldsen5, Yanping Chang6, Daniel Andreas Steinbrüchel7, Peter Skov Olsen7, Anna Sonia Petronio8, Hans Gustav Hørsted Thyregod7. 1. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: Lars.Soendergaard.01@regionh.dk. 2. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 3. Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele," University of Catania, Catania, Italy. 4. Department of Cardiology, Odense University Hospital, Odense, Denmark. 5. Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark. 6. Coronary and Structural Heart Disease Management, Medtronic, Mounds View, Minnesota. 7. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 8. Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Abstract
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).
RCT Entities:
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).
Authors: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
Authors: Gudrun Lamm; Matthias Hammerer; Uta C Hoppe; Martin Andreas; Rudolf Berger; Ronald K Binder; Nikolaos Bonaros; Georg Delle-Karth; Matthias Frick; Michael Grund; Bernhard Metzler; Thomas Neunteufl; Philipp Pichler; Albrecht Schmidt; Wilfried Wisser; Andreas Zierer; Rainald Seitelberger; Michael Grimm; Alexander Geppert Journal: Wien Klin Wochenschr Date: 2021-03-23 Impact factor: 1.704
Authors: Sameer A Hirji; Edward D Percy; Cheryl K Zogg; Alexandra Malarczyk; Morgan T Harloff; Farhang Yazdchi; Tsuyoshi Kaneko Journal: Eur Heart J Date: 2020-08-01 Impact factor: 29.983
Authors: Ahmed A Kolkailah; Rami Doukky; Marc P Pelletier; Annabelle S Volgman; Tsuyoshi Kaneko; Ashraf F Nabhan Journal: Cochrane Database Syst Rev Date: 2019-12-20