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European Heart Journal
Article . 2024 . Peer-reviewed
License: CC BY
Data sources: Crossref
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Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial

10-year outcomes of the NOTION trial
Authors: Hans Gustav Hørsted Thyregod; Troels Højsgaard Jørgensen; Nikolaj Ihlemann; Daniel Andreas Steinbrüchel; Henrik Nissen; Bo Juel Kjeldsen; Petur Petursson; +3 Authors

Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial

Abstract

Abstract Background and Aims Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. Methods The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. Results Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7–1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04–0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4–1.5; P = .4). Conclusions In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.

Keywords

Male, Bioprosthetic aortic valve durability, Myocardial Infarction, Fast Track Clinical Research, Aortic valve stenosis, Stroke/epidemiology, Transcatheter Aortic Valve Replacement, Risk Factors, Myocardial Infarction/etiology, 80 and over, Humans, Aortic Valve/surgery, Aged, Aged, 80 and over, Heart Valve Prosthesis Implantation, Transcatheter aortic valve implantation, Endocarditis, Surgical aortic valve replacement, Endocarditis/surgery, Thrombosis, Aortic Valve Stenosis, Transcatheter aortic valve replacement, Stroke, Treatment Outcome, Transcatheter Aortic Valve Replacement/adverse effects, Aortic Valve, Heart Valve Prosthesis, Thrombosis/etiology, Heart Valve Prosthesis Implantation/adverse effects

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
193
Top 0.1%
Top 1%
Top 0.1%
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hybrid