Key result
Self-expanding valves and conscious sedation show no 5-year TAVR benefit over balloon-expandable valves and general anesthesia.
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Why the study?
Prosthesis durability may affect clinical outcomes during long-term follow-up after TAVR, and the impact of the anesthesia strategy on long-term outcomes was unknown.
RCT (n=447)
Open-label
2 × 2 factorial
Yes
Randomized trial finds comparable five-year composite outcomes across valve types and anesthesia approaches during transfemoral TAVR, indicating durable efficacy for both strategies.
BACKGROUND In the randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) 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 The authors sought to compare clinical outcomes during 5-year follow-up in the randomized SOLVE-TAVI trial. METHODS In the randomized, multicenter, 2 × 2 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) or BEV (SAPIEN 3, Edwards Lifesciences) and also to CS vs 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 groups (67.7% vs 63.4%; HR: 0.89; 95% 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.
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Feistritzer et al. (2024) conducted an RCT in severe, symptomatic aortic stenosis (n=447). Self-expanding valves (SEV) vs. Balloon-expandable valves (BEV) was evaluated on all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation (HR 0.89, 95% CI 0.70-1.13, p=0.34). Transfemoral TAVR using self-expanding vs balloon-expandable valves (HR 0.89; P=0.34) and conscious sedation vs general anesthesia (HR 0.80; P=0.09) showed similar composite outcomes at 5 years.
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