Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis

Abstract

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis

“…Overall: A total of twenty-one studies 7 – 16 , 18 , 19 , 21 – 23 , 25 – 29 , 31 , 32 were included that assessed mortality. Our analysis found that the results were significant for BEV compared to SEV for overall mortality.…”

“…30 days: Fourteen studies 9 – 11 , 13 – 15 , 21 , 22 , 25 – 29 , 31 reported 30-day mortality as one of their outcomes. A significant statistical relationship was found, and our analysis revealed favorability towards the BEV arm (OR = 0.780; 95% CI: 0.673–0.905; P = 0.001).…”

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis

“…19 A recent comparison of SE EVOLUT Pro and BE SAPIEN 3 demonstrated safety and high efficacy of both THVs in patients with severe AV calcification, with lower complication rates and higher PPM rates with BE SAPIEN 3. 20 Data are scarce, however, regarding a direct comparison of third-generation prosthesis systems in this specific anatomy.…”

“…4,9,24,32,33 Numerous studies have described an association between severe AV calcification and detrimental hemodynamic properties such as the occurrence of relevant postinterventional PVL for SE devices. 7,15,19,20 The higher rate of relevant PVL…”

Personalised Treatment in Aortic Stenosis: A Patient-Tailored Transcatheter Aortic Valve Implantation Approach

“…PPM occurs when the EOA of the prosthesis is too small according to the patient's body size [54,58]. SEV with the supra-annular valve position allows for a larger EOA, lower transvalvular gradients and, consequently less PPM, as compared with BEV, which is characterized by intra-annular position and thereby reduced EOA [59][60][61].…”