NOTION Trial: 10 Year Outcomes, TAVR vs. SAVR in Low Risk Patients

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Randomized studies have shown the benefits of TAVR for treating inoperable patients, as well as high and intermediate risk patients. 

Anillos aórticos pequeños, ¿Qué válvula deberíamos elegir?

The NOTION (Nordic Aortic Valve Intervention Trial) randomized patients with low risk severe AS to TAVR or SAVR (surgical valve replacement). Outcomes have shown no significant differences in terms of mortality, stroke or acute MI at 8 year followup. Other two studies on low risk patients, the PARTNER 3 and EVOLUTE Low Risk, at 5 and 4 years respectively, also found no significant differences between TAVR and SAVR as regards all-cause mortality and disabling stroke. 

The aim of this multicenter, randomized study was to look at clinical outcomes and prosthesis performance at 10 years. 

Primary end point was a composite of all cause death, stroke, or AMI. Other clinical variables they looked at included transient ischemic attack, de novo atrial fibrillation, need for new pacemaker implantation and endocarditis. Bioprosthesis duration was classified as bioprosthesis failure (BVF), defined as valve related death, severe structural hemodynamic deterioration or reintervention and bioprosthesis dysfunction (BVD), classified as structural deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis or endocarditis. 

Read also: ISCHEMIA Outcomes: Does Sex Have Any Impact?

280 patients were included; 145 were assigned to TAVR and 135 to SAVR. Mean age was 79.1 ± 4.8 years, with 47% women. Mean STS was 3.0 ± 1.7%. After 10 years, the risk of primary end point was 65.5% for TAVR patients and 65.5% for SAVR (HR 1.0; CI 95%: 0.7-1.3; p=0.9), with no significant differences when looking at primary end point individual components. The incidence of severe SVD (mean transprosthetic gradient ≥30 mmHg, or ≥ 20 mmHg increase in 3 months or new severe prosthetic regurgitation) was 1.5% for TAVR patients and 10% for SAVR (HR 0.2; CI 95%: 0.04–0.7; p = 0.02). The accumulated incidence of severe NSVD was 20.5% and 43.0% (p < 0.001) for TAVR and SAVR respectively, while endocarditis incidence was 7.2% and 7.4% (p = 1.0) for TAVR and SAVR respectively. There were no valve thrombosis events. BVF occurred in 9.7% of patients undergoing TAVR and 13.8% of patients undergoing SAVR (HR 0.7; CI 95%: 0.4–1.5; p = 0.4). SAVR patients presented higher rates of de novo atrial fibrillation (p < 0.01), while TAVR patients showed higher need for pacemaker implantation (p < 0.01).

Conclusion

After a 10 year followup of the NOTION study, no significant differences were seen between TAVR and SAVR in primary outcome. Severe SVD risk was lower after TAVR vs. SAVR, while BVF risk resulted similar.

Dr. Andrés Rodríguez

Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.

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

Reference: Hans Gustav Hørsted Thyregod et al European Heart Journal (2024) 00, 1–9.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

TAVR and Surgical Bailout: Temporal Trends and Clinical Implications

The evolution of transcatheter aortic valve replacement (TAVR), both regarding its planning and execution, has resulted in minimally invasive interventions with high safety levels....

Edge-to-Edge Repair in Atrial Secondary Tricuspid Regurgitation

Tricuspid regurgitation (TR) has been associated with higher morbimortality and a negative impact on quality of life.  In most cases, its main cause is a...

Percutaneous Treatment of Tricuspid Regurgitation with K-CLIP

Roughly 4% of the adult population presents tricuspid regurgitation (TR), a condition that might progress to severe or worse end-organ function, associated to hospitalizations...

PULSE Registry Subanalysis: Radial vs. Femoral Secondary Access

In view of its lower complications rate, the transfemoral approach is the most used in transcatheter aortic valve replacement (TAVR), vs. alternative access sites....

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

RODIN-CUT: Successive Cutting Balloon Technique in Calcified Lesions

Moderate or severe coronary calcification can be a marker of poor prognosis in coronary artery disease, as it significantly increases the risk of failure...

Acute Coronary Syndrome with Multivessel Disease: Best Revascularization Strategy

The gold standard treatment for acute coronary syndrome (ACS), especially acute myocardial infarction (AMI) is primary angioplasty (PCI). However, 40 to 70% of ACS...

Improved Ejection Fraction in Chronic Total Occlusion?

Chronic total occlusions (CTO) represent a significant challenge in the current clinical practice, seeing as CTO percutaneous coronary intervention (PCI) is complex and involves...