What question did this study set out to answer?

Assess 10-year clinical and bioprosthetic valve durability outcomes comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at lower surgical risk.

February 7, 2024European Heart JournalOpen Access

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

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Why the study?

NOTION was the first trial to randomize lower-surgical-risk patients with severe aortic valve stenosis to TAVI or SAVR, motivating this report of clinical and bioprosthesis outcomes at 10 years.

Does transcatheter aortic valve implantation compared to surgical aortic valve replacement improve clinical outcomes and bioprosthesis durability at 10 years in lower surgical risk patients with severe aortic stenosis?

Population

280 patients with severe aortic valve stenosis at lower surgical risk

Comparison

TAVI with a self-expanding bioprosthesis vs SAVR with a bioprosthesis

Design

Randomized trial

Follow-up

10 years

Authors

HTHans Gustav Hørsted ThyregodCross-Cutting Cardiology TJTroels Højsgaard Jørgensen NINikolaj IhlemannInterventional Cardiology

Discussion

Member takes

Implication

TAVI and SAVR yield equivalent 10-year hard outcomes in lower-risk aortic stenosis; extends randomized evidence to a decade of follow-up.

Key Points

Assess 10-year clinical and bioprosthetic valve durability outcomes comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at lower surgical risk.
Randomized clinical trial (NOTION trial) enrolling 280 lower-risk severe aortic stenosis patients assigned to self-expanding TAVI (n = 145) or SAVR (n = 135) with 10-year follow-up.
Evaluated primary composite endpoint of all-cause mortality, stroke, or myocardial infarction, along with bioprosthetic valve dysfunction and failure defined by VARC-3 criteria.
The 10-year composite outcome of all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR (HR 1.0; 95% CI 0.7–1.3; P = .9).
Severe structural valve deterioration occurred in 1.5% of TAVI and 10.0% of SAVR patients (HR 0.2; 95% CI 0.04–0.7; P = .02), while severe non-structural dysfunction occurred in 20.5% vs 43.0% (P < .001).
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), with comparable endocarditis rates (7.2% vs 7.4%; P = 1.0).

Structured PICO

Population

280 patients with severe aortic valve stenosis at lower surgical risk (STS score < 4% in ~80%), mean age ~79 years, ~53% male.

Intervention

Transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis (n=145)

Comparator

Surgical aortic valve replacement (SAVR) with a bioprosthesis (n=135)

Outcome

Composite of all-cause mortality, stroke, or myocardial infarction at 10 yearscomposite

In lower surgical risk patients with severe aortic stenosis, TAVI and SAVR demonstrated similar rates of major clinical outcomes at 10 years, with TAVI showing a significantly lower risk of severe structural valve deterioration.

Coverage & sources

Journal, society, and media accounts. Useful signal, not independent expert judgment.

Cite This Study

Thyregod et al. (2024) studied this question.

synapsesocial.com/papers/6995afa083d686757580cce7 https://doi.org/10.1093/eurheartj/ehae043

Topics

TAVR in low-risk patients Transcatheter aortic valve replacement Infective endocarditis

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Coverage & sources

Cite This Study

Topics

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Coverage & sources

Cite This Study

Also Consider

Topics

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