Self-Expanding Valve vs. Balloon-Expandable Valve, Randomized, Head to Head

The “arms race”among transcatheter valves has been vertiginous. By the time we received the mid- or long-term outcomes of studies focused on a given valve, we were already using its next generation in clinical practice.

As a result, there is little information addressing which valve is the best.

Nowadays, this “arms race” has reached a plateau. There is a third generation for the two most frequent commercially available valves, including design changes to solve the same problems (access profile, rate of pacemaker implantation, paravalvular leak, proper implantation).

SOLVE-TAVI is a multicenter trial that included 447 patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement who were randomized to self-expanding valve (Evolut R, Medtronic Inc., Minneapolis, MN, USA) or balloon-expandable valve (Sapien 3, Edwards Lifesciences, Irvine, CA, USA).

Read also: In Search of the Optimal Depth for Self-Expandable Valves.

The primary efficacy endpoint was a composite of all-cause mortality, stroke, moderate or severe paravalvular regurgitation, and permanent pacemaker implantation at 30 days.

The composite endpoint occurred in 28.4% of patients who received Evolut R vs. 26.1% of patients who received Sapien 3 (Pequivalence = 0.04)

The individual components also met the equivalence criteria, with the following rates: all-cause mortality, 3.2% vs. 2.3%; stroke, 0.5% vs. 4.7%; moderate/severe paravalvular regurgitation, 3.4% vs. 1.5%; and permanent pacemaker implantation, 23% vs. 19.2%.

Conclusion

The newer generations of the two most used commercially available valves were equivalent as regards the efficacy and safety endpoints in patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement.

These findings support the equal use of both valves in most patients, with some specific preferences based on individual valve anatomy.

Original Title: Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.

Reference: Holger Thiele et al. European Heart Journal (2020) 41, 1890–1899 doi:10.1093/eurheartj/ehaa036.

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