Performance of the Evolut-R 34 mm versus Sapien-3 29 mm in Transcatheter aortic valve replacement patients with larger annuli: Early outcome results of Evolut-R 34 mm as compared with Sapien-3 29 mm in patients with Annuli ≥26 mm.

Background: Evolut-R 34 mm (received CE mark in January 2017) and Sapien-3 29 mm are the only options for transcatheter aortic valve replacement (TAVR) in patients with annulus ≥26 mm. We compared the short-term outcomes of these valves in these patients.

Methods: Data was collected prospectively from consecutive patients with severe aortic stenosis and annulus diameter larger than 26 mm treated by femoral approach TAVR.

Results: Between February 1, 2014 to August 19, 2017 Sapien-3 29 mm was implanted in 55 and Evolut-R 34 mm in 37 consecutive patients. Device success rate was 98.2% and 97.3% (P = 1.0) and the composite peri-procedural complication rate was 7.3% and 2.7% (P = .645) in Sapin-3 29 mm and Evolut-R 34 mm, respectively. Composite endpoint of early safety in-hospital did not differ significantly [5(9.2%) vs 3(8.1%), P = 1.00], respectively. Prosthetic valve Gradients were significantly lower with Evolut-R 34 mm [maximal (18.0 ± 5.8 vs 11.2 ± 4.8 mmHg, P < .001) and mean (10.0 ± 3.3 vs 6.3 ± 2.7 mmHg, P < .001)]. Pacemaker implantation rate was high in both groups, and numerically but not statistically significant higher with Evolut-R [10/50 (20.0%) vs 8/28 (28.6%), P = .389].

Conclusions: As compared to Sapien-3 29 mm the Evolut-R 34 mm is a real alternative for TAVR in patients with a large annulus with a comparable peri-procedural complication rate, better hemodynamic results but a trend for higher pacemaker rate.