Background: In the randomized SOLVE-TAVI trial comparing newer generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as conscious sedation (CS) and general anesthesia (GA), clinical outcomes were similar both for valve and anesthesia comparison at 30 days and 1 year. Prosthesis durability may affect clinical outcomes during long-term follow-up. Moreover, the impact of the anesthesia strategy on long-term clinical outcomes is unknown so far.
Objectives: To compare clinical outcomes during 5-year follow-up in the randomized SOLVE-TAVI trial.
Methods: In the randomized, multicenter, 2x2 factorial, open-label SOLVE-TAVI trial, 447 intermediate-to-high risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral transcatheter aortic valve replacement (TAVR) using either SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or BEV (Sapien 3, Edwards Lifesciences, Irvine, California) and also to CS versus GA. Patients were followed-up for 5 years.
Results: During 5 years of follow-up, the combined predefined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation was similar in the SEV and BEV group (67.7% vs. 63.4%, hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.70-1.13, p=0.34). Stroke rates at 5 years were lower in the SEV group (2.2% vs. 9.6%, HR 4.84, 95% CI 1.65-14.18, p=0.002). Regarding the anesthesia comparison, the primary endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred in 51.4% in the CS group and 61.3% in the GA group (HR 0.80, 95% CI 0.62-1.04, p=0.09). All-cause mortality at 5 years was lower for CS (41.5% vs. 54.3%, HR 0.70, 95% CI 0.53-0.94, p=0.02).
Conclusions: Transfemoral TAVR using either SEV and BEV as well as CS and GA showed similar clinical outcomes at 5-years using a combined clinical endpoint.
Editors
Editor-in-Chief
Harlan M. Krumholz, MD, SM, FACC
CME Editor
Ragavendra R. Baliga, MD
Author
Meg Ospina, MD
Valerian Fernandes, MD
Important Dates
Date of Release: January 6, 2025
Term of Approval/Date of CME/MOC Expiration: January 5, 2026