Journal
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
Volume 92, Issue 7, Pages 1374-1379Publisher
WILEY
DOI: 10.1002/ccd.27588
Keywords
AVDP-aortic value disease; IDI-interventional devices/innovation; percutaneous intervention; TVI-transcatheter valve implantation
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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.
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