Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves.

Abstract

Introduction: Indications for transcatheter aortic valve implantation (TAVI) continue to expand. Very often TAVI must be done in large annuli. Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes.

Aim: To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29.

Material and methods: We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves. Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%) patients who received an Evolut 34 valve.

Results: EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02). The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001). The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01). Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04). There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05). Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%) (p = 0.56). 30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16).

Conclusions: TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves. Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.