Key result
Balloon-expandable and self-expanding TAVR platforms show distinct clinical trade-offs without clear superiority.
Why the study?
Comparative clinical outcomes of newer-generation self-expanding versus balloon-expandable valves and anesthesia strategies after transfemoral TAVR remain uncertain beyond 30 days.
Does transcatheter heart valve type (balloon-expandable versus self-expanding) impact clinical, procedural, and anatomical outcomes in patients undergoing TAVR?
Systematic Review
Does transcatheter heart valve type (balloon-expandable versus self-expanding) impact clinical, procedural, and anatomical outcomes in patients undergoing TAVR?
The choice between balloon-expandable and self-expanding TAVR platforms should be individualized based on anatomical characteristics and outcome trade-offs, rather than assuming a universal superiority of one valve class.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Similarly, stroke rates in the SOLVE-TAVI trial were substantially higher for BEVs than for SEVs even during early follow-up. This is also a curious finding, as most single-platform studies that randomized TAVR vs surgical aortic valve replacement consistently show either similar or lower stroke rates for the BEV than the SEV.”
“One of the major points made by the study investigators was that there was no difference in permanent pacemaker implantation (PPI) rates between BEVs and SEVs, which was 20% versus 24.5%, respectively, higher than that expected for both groups. These data were somewhat surprising, because many previous studies showed a higher rate of PPI with the SEV platforms, and PPI for BEVs in the current study was almost twice that noted in previous analyses, including real-world registries, and higher even than that in early trials of the S3 valve.”
Valve choice in TAVR should be individualized by anatomy and trade-offs; extends randomized evidence of equivalent 1-year composites between platforms.
BACKGROUND 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 compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. OBJECTIVES The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. METHODS Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. RESULTS In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). CONCLUSIONS In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150).
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Feistritzer et al. (2021) conducted a systematic review in Aortic stenosis requiring transcatheter aortic valve replacement. Balloon-expandable vs. self-expanding TAVR systems vs. Each other (direct and indirect comparisons) was evaluated. Balloon-expandable and self-expanding transcatheter valve platforms demonstrated clinically relevant trade-offs in conduction outcomes, paravalvular leak, and hemodynamics rather than consistent superiority of either mechanism.
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