Performance of the Evolut-R 34mm Versus Sapien-3 29mm in TAVR Patients with Larger Annuli

Background:

The Sapien-3 29mm prosthesis (Edwards lifesciences) was the only option for large annuli until recently. In January 2017 Evolut-R 34mm (Medtronic) received CE mark. Because it is unknown how the Evolut-R 34mm performs in patients with large annuli we compared it`s short term outcome with the Sapien 29mm prosthesis.

Methods:

Data was collected prospectively from consecutive patients treated with TAVR. We compared Evolut-R 34mm to Sapien-3 in TAVR-patients with annulus diameter larger than 26mm, which is indicated for both valves.

Results:

Between 1/2/2014-31/12/2016 Sapien-3 29mm was implanted in 59 consecutive patients and between 1/1-17/8/2017 Evolut-R 34mm in 33 consecutive patients.

Device success was 100% and 97% (p=0.359) in Sapien-3 and Evolut-R, respectively. Peri-procedural complication rate was numerically but not significantly higher with Sapien-3, (13.6% vs. 3%, p=0.15, Table).

Composite endpoint of early safety in-hospital did not differ [3(5.2%) vs. 1(3.6%), p=1.0] between Sapien3 (2-strokes, 1-major bleeding) and Evolut-R (1-stroke), respectively.

Gradients over the prosthetic valve were significantly lower with Evolut-R 34mm [maximal (18.4±5.9 vs. 11.8±5, p<0.001) and mean (10.1±3.3 vs. 6.6±2.8, p<0.001)]. Pacemaker implantation rate was numerically but not significantly higher with Evolut-R [11(19%) vs. 10(34.5%), p=0.111].

Conclussions:

As compared with Sapien-3 29mm the Evolut-R 34mm was safe with trend for lower peri-procedural complications rate, had better hemodynamic results but was associated with a trend for a higher pacemaker rate.