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

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: Aortic valve stenosis; Bioprosthetic aortic valve durability; Surgical aortic valve replacement; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement.

Structured Graphical Abstract

Clinical and bioprosthesis 10-year outcomes after transcatheter or surgical aortic valve implantation. TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement. Hazard ratio (HR); 95% confidence interval (CI); the P-value was based on Cox regression.

Figure 1

NOTION—clinical outcomes up to 10 years of follow-up: all-cause mortality and all-cause mortality, stroke, or myocardial infarction (MI). TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement; MI, myocardial infarction. Hazard ratio (HR); 95% confidence interval (CI); P-value was based on Cox regression

Figure 2

NOTION—aortic valve haemodynamics up to 10 years of follow-up: transprosthetic gradient and effective orifice area (EOA). EOA, effective orifice area; TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement. *P < .05 for inter-group comparison

Figure 3

Structural valve deterioration (SVD)—haemodynamic VARC-3 definition: ≥moderate SVD and severe SVD. SVD, structural valve deterioration; AR, aortic valve regurgitation; TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement; VARC-3, Valve Academic Research Consortium third definition. Table and curve are cumulative incidences after 10 years of follow-up compared with Gray’s test. Hazard ratio (HR); 95% confidence interval (CI); P-value was based on Cox regression

Figure 4

Bioprosthetic valve dysfunction (BVD) and failure (BVF)—haemodynamic VARC-3 definition: severe BVD and BVF. BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement. VARC-3, Valve Academic Research Consortium third definition. Table and curve are cumulative incidences after 10 years of follow-up compared with Gray’s test. Hazard ratio (HR); 95% confidence interval (CI); P-value was based on Cox regression