5-Year Follow-Up of Transcatheter Aortic Valve Replacement With Self-Expanding Intra-Annular Versus Commercially Available Valves.

In 30 seconds

This multicenter randomized controlled trial compared 5-year outcomes after TAVR with a self-expanding intra-annular Portico valve versus commercially available valves in patients with severe symptomatic aortic stenosis at high or extreme surgical risk. Among 750 randomized patients, all-cause mortality or stroke was similar between groups (55.6% vs 51.3%, P = 0.42). The Portico group had more permanent pacemaker implantation, while its mean transvalvular gradient was lower; valve area was similar. The findings indicate broadly comparable long-term clinical outcomes, with differences in pacemaker use and gradient.

Key findings

• Five-year all-cause mortality or stroke was 55.6% with the study valve and 51.3% with commercially available valves (P = 0.42).
• Permanent pacemaker implantation at 5 years was higher with the study valve: 36.6% vs 20.3% (P < 0.0001).
• Mean transvalvular gradient was lower with the study valve (7.2 ± 3.0 vs 9.5 ± 6.5 mm Hg, P = 0.008), while valve area was similar.

Why it matters

These randomized long-term data help characterize trade-offs between valve platforms in patients at high or extreme surgical risk. Similar rates of the combined outcome of death or stroke and comparable valve area are reassuring, while the higher pacemaker implantation rate is an important difference to consider when interpreting device outcomes.

What to keep in mind

The population was limited to patients at high or extreme surgical risk, so the findings may not apply to lower-risk patients.