Lars Søndergaard1, Daniel Andreas Steinbrüchel2, Nikolaj Ihlemann2, Henrik Nissen2, Bo Juel Kjeldsen2, Petur Petursson2, Anh Thuc Ngo2, Niels Thue Olsen2, Yanping Chang2, Olaf Walter Franzen2, Thomas Engstrøm2, Peter Clemmensen2, Peter Skov Olsen2, Hans Gustav Hørsted Thyregod2. 1. From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.). Lars.Soendergaard.01@regionh.dk. 2. From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Abstract
BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. METHODS AND RESULTS:Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). CONCLUSIONS: Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.
RCT Entities:
BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. METHODS AND RESULTS: Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). CONCLUSIONS: Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.
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: Aisha Ahmed; Paul Sorajja; Ross F Garberich; R Saeid Farivar; Kevin M Harris; Mario Gössl Journal: JAMA Cardiol Date: 2017-10-01 Impact factor: 14.676
Authors: Adam Chakos; Ashley Wilson-Smith; Sameer Arora; Tom C Nguyen; Abhijeet Dhoble; Giuseppe Tarantini; Matthias Thielmann; John P Vavalle; Daniel Wendt; Tristan D Yan; David H Tian Journal: Ann Cardiothorac Surg Date: 2017-09