Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Randomized studies have shown the benefits of TAVR in patients at prohibitive surgical risk, as well as high and intermediate risk.
The NOTION trial (Nordic Aortic Valve Intervention Trial) randomized patients with low risk severe AS to TAVR and surgical aortic valve replacement (SAVR). Outcomes showed no significant differences in mortality, stroke, acute MI 8 years after the intervention.
Two other studies on low risk patients, the PARTNER 3 and EVOLUTE Low Risk, with 5 and 4 year follow-ups respectively, also found no significant differences between TAVR and SAVR in terms of all-cause mortality and disabling stroke.
The aim of this multicenter randomized study was to look at clinical and prosthesis outcomes at 10 years.
Primary end point was a combination of all cause death, stroke or AMI. Other clinical variables included transient ischemic attack, (TIA), atrial fibrillation (FA) de novo, new pacemaker implantation and endocarditis. Bio prosthesis durability was classified as bio prosthetic valve failure (BVF), defined as valve related death, severe structural hemodynamic deterioration or reintervention, and bio prosthetic valve dysfunction (BVD), classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis or endocarditis.
Read also: Third Generation Balloon-Expandable and Self-Expanding Valves: TAVR Meta- Analysis.
280 patients were enrolled, 145 were randomized to TAVR and 135 to SAVR. Mean age was 79.1 ± 4.8 years and 47% were women. Mean STS score was 3.0 ± 1.7%. After 10 years, the risk of primary end point was 65.5% for both groups (HR 1.0; CI 95% 0.7-1.3; p=0.9), with no significant differences in individual components of primary end point.
Severe SVD (mean trans prosthetic gradient ≥30 mmHg, or ≥ 20 mmHg increase in 3 months, or new severe prosthesis leak) occurred in 1.5% of TAVR patients and 10% of SAVR patients (HR 0.2; CI 95% 0.04-0.7; P=0.02). Accumulated incidence of severe NSVD was 20.5% and 43.0% (P < .001), while endocarditis was 7.2% and 7.4% (P=1.0) after TAVR and SAVR, respectively.
There were no valve thrombosis events. BVF occurred in 9.7% of TAVR patients vs. 13.8% of SAVR patients (HR 0.7; IC 95% 0.4-1.5; P=0.4). Patients in the SAVR group presented a higher rate of de novo AF (p<0.01), while TAVR patients presented higher need for pacemaker implantation (p<0.01).
Conclusion
After 10 years, the NOTION trial showed no significant differences between TAVR and SAVR in primary end point. Severe SVD risk was lower after TAVR vs SAVR, while BVF resulted similar between the groups.
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.
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