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.