Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic's Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies

Abstract

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. METHODS: A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed. RESULTS: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p < 0.001), sex (p < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications. CONCLUSIONS: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.