Aims: To compare transcatheter aortic valve replacement TAVR with self-expandable first-generation Medtronic CoreValve with new-generation Evolut R devices in patients with aortic stenosis.
Methods: Multiple databases were screened for all available reports directly or indirectly comparing CoreValve vs Evolut R. Primary endpoint was device success. Procedural, functional and clinical outcomes were assessed as well.
Results: Ten retrospective series including 12 294 pts. were found. Overall device success rate was 95.5% and was statistically higher in the Evolut R treated patients as compared with CoreValve: 96.6 vs. 94.8%, respectively; RR (risk ratio) 95%CIs (confidence intervals): 1.02 (1.00-1.04); P = 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 +/- 5.3 vs 7.9 +/- 4.6 with Evolut R and CoreValve. Evolut R valve demonstrated nearly 50% reduction of the risk for moderate-to-severe paravalvilar leak 0.55 (0.39-0.79); P = 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P = 0.002 and numerical reductions in the risk of acute kidney injury, vascular complications and bleeding. Together with significantly reduced risk of permanent pacemaker implantation (0.80 [0.67-0.96]; P = 0.02) the above benefits were associated with 40% reduction in the risk of 30-day all-cause mortality with Evolut R as compared to CoreValve: 0.60 (0.37-1.00); P = 0.05.
Conclusions: The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.