Hans Gustav Hørsted Thyregod1, Nikolaj Ihlemann2, Troels Højsgaard Jørgensen3, Henrik Nissen4, Bo Juel Kjeldsen5, Petur Petursson6, Yanping Chang7, Olaf Walter Franzen8, Thomas Engstrøm9, Peter Clemmensen10, Peter Bo Hansen11, Lars Willy Andersen12, Daniel Andreas Steinbrüchel13, Peter Skov Olsen14, Lars Søndergaard15. 1. Cardiothoracic Surgery, Rigshospitalet, Denmark. 2. Cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark. 3. The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark. 4. Cardiology, Odense University Hospital, Denmark. 5. Thoracic Surgery Department, Odense University Hospital, Denmark. 6. Cardiology, Sahlgrenska University Hospital, Sweden. 7. CV CSH, Medtronic, United States. 8. Cardiology, Klinik im Park, Switzerland. 9. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark. 10. University Heart Center Hamburg, Germany. 11. Cardiothoracic anaesthesia, Copenhagen University Hospital, Rigshospitalet., Denmark. 12. Copenhagen University Hospital, Rigshospitalet, Denmark. 13. Thoracic Surgery, Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Denmark. 14. Dept. of Cardiothoracic Surgery RT 2152, Copenhagen University Hospital, Rigshospitalet., Denmark. 15. Cardiology, Rigshospitalet, Denmark.
Abstract
BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. METHODS: Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria. RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% vs. 36.3%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 vs. 1.2 cm2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% vs. 0.0%, p<0.001) and a new pacemaker (43.7% vs. 8.7%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.
RCT Entities:
BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. METHODS:Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria. RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% vs. 36.3%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 vs. 1.2 cm2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% vs. 0.0%, p<0.001) and a new pacemaker (43.7% vs. 8.7%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: 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: Didrik Kjønås; Gry Dahle; Henrik Schirmer; Siri Malm; Jo Eidet; Lars Aaberge; Terje Steigen; Svend Aakhus; Rolf Busund; Assami Rösner Journal: Health Sci Rep Date: 2021-05-06
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