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.
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.
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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.
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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