Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system: evidence on the benefit of a meta-analytical approach

Abstract

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.

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

“…The abovementioned improvements seen in next-generation devices seem not to be the case with ACURATE neo; in the meta-analysis, we found 11.7% incidence of moderate-to-severe PVL in the ACURATE neo arm, nearly fourfold higher than in SAPIEN 3 and mild PVL in 45.5% cases, translating into 60% increased risk. Unlike the current findings, SAVI TF registry showed 4.1% of >mild PVL in 1000 patients treated with ACURATE neo which is within ranges observable for other devices [33][34][35][36][37][38]. Postdilatation was performed in 44.8% of the patients in that series, and this percentage is also comparable to 40.4%-51.9% in the current analysis, and therefore, theoretically, should not influence the outcome; on the other hand, Barth et al [15] reports lower >mild PVL rates in one of participating centers (C) that used "zero tolerance of more than mild paravalvular leak" policy and postdilated more frequently than other centers (52.7% as compared to 12.3% and 33.3%), which translated to 3.4% rate of >mild PVL (as compared to 6.0% and 34.1% in the remaining centers).…”

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

“…While the Evolut R is equipped with a longer porcine pericardial sealing skirt, the Sapien 3 consists of an outer polyethylene terephthalate cuff to reduce paravalvular regurgitation (9,26). Researchers have reported up to a 50% reduction in moderate to severe paravalvular leak with Evolut R, as compared to its predecessor, the CoreValve (27). Moderate to severe para-valvular leak has reduced from 6.9% with SAPIEN XT to 1.6% with Sapien 3 (28).…”