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. Issue 7 (9th March 2018)

• Record Type: Journal Article
• Authors: Eitan, Amnon; Witt, Julian; Stripling, Jan; Haselbach, Timo; Rieß, Friedrich‐Christian; Schofer, Joachim
• Is Part Of: Catheterization and cardiovascular interventions. Volume 92:Issue 7(2018)
• Page Start: 1374
• Page End: 1379
• Publication Date: 2018-03-09
• Subjects: AVDP—aortic value disease -- IDI—interventional devices/innovation -- percutaneous intervention -- TVI—transcatheter valve implantation; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.27588
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: 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.