Hemodynamics of self-expanding versus balloon-expandable transcatheter heart valves in relation to native aortic annulus anatomy

Abstract

Objectives This study aimed to compare hemodynamic characteristics of different self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THV) in relation to native aortic annulus anatomy. Background A patient centered THV selection becomes increasingly important as indications for transcatheter aortic valve replacement (TAVR) are extended towards lower risk populations. Methods Hemodynamic parameters including mean gradient (MG), effective orifice area (EOA), Doppler velocity index (DVI), degree of paravalvular regurgitation (PVR) and patient-prosthesis mismatch (PPM) were compared by valve type, label size and in relation to quintiles of native aortic annulus area. Results 2609 patients were treated at 3 centers in Germany with SAPIEN 3 (n = 1146), ACURATE Neo (n = 649), Evolut R (n = 546) or Evolut Pro (n = 268) THV. SE THVs provided superior hemodynamics in terms of larger EOA, higher DVI and lower MG compared to BE THV, especially in patients with small aortic annuli. Severe PPM was less frequent in SE treated patients. The rate of PVR ≥ moderate was comparable for SE and BE devices in smaller annular dimensions, but remarkably lower for BE TAVR in large aortic annular dimensions (> 547.64 mm2) (2% BE THV vs. > 10% for SE THV; p < 0.001). Conclusions Patients with small aortic annular dimensions may benefit hemodynamically from SE THV. With increasing annulus size, BE THV may have advantages since PVR ≥ moderate occurs less frequently. Graphical abstract

Soft robotic patient-specific hydrodynamic model of aortic stenosis and ventricular remodeling

“…5H) resulting from simulating intervention in our model. We found that changes measured in this study are consistent with the literature of large-population studies of TAVR outcome ( 41 – 43 ).…”

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

“…Of these, 751 were excluded because they were not pertinent to the design of the meta-analysis or did not meet the explicit inclusion criteria. Eleven observational studies [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ] (among them seven multi-center registries), including N = 12,363 patients, were eventually included in the analysis. Potential sources of study bias were analyzed with the use of the components recommended by the ROBINS-I tool, and the results are shown in Supplementary Table S2 .…”

“… Risk Ratios (RRs) and corresponding 95% Confidence Intervals (CIs) for the comparison of Evolut PRO and Evolut R devices [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ]; ( A ) moderate-to-severe paravalvular leak; ( B ) mild paravalvular leak. Each square represents study point estimate; diamonds reflect the overall effect.…”

Predictors of bioprosthetic valve dysfunction after transcatheter aortic valve implantation

“…Recently, the Valve Academic Research Consortium (VARC)-3 proposed an updated endpoint definition of aortic valve clinical research including bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) 7 . In the previous data, supra-annular prostheses demonstrated an excellent haemodynamic performance as compared to intra-annular prostheses in surgical and transcatheter aortic valve replacement 8,9 . Moreover, the data from the UK-TAVI registry demonstrated that TAVI with predilatation was associated with a decrease in valve dysfunction, although it was not confirmed after multiple tests in the short-term follow-up data 10 .…”