Biomimetic transcatheter aortic valve replacement restores ascending aortic flow towards native physiology: a first-in-human prospective imaging study

Abstract Background Abnormal ascending aortic flow can persist after transcatheter aortic valve replacement (TAVR) and may contribute to aortopathy and incomplete left ventricular (LV) mass regression. The DurAVR transcatheter heart valve is designed to reproduce native leaflet shape and restore flow. Aims The main aim of this study was to establish if DurAVR improves and restores aortic flow haemodynamics in patients with severe aortic stenosis. Methods and results In a prospective study, patients with symptomatic severe aortic stenosis underwent transthoracic echocardiography and cardiovascular magnetic resonance (CMR) before TAVR with DurAVR and at 6 months. Post-implant findings were compared with age-, sex-, and haemodynamics-matched controls without aortic valve disease. Ascending aortic flow displacement (FD) and flow reversal ratio (FRR) were quantified using phase-contrast imaging. Haemodynamic correlates of LV mass regression post-DurAVR were explored using multivariable analysis. One hundred and forty-one participants were studied with CMR (aortic stenosis, 60; DurAVR, 46; controls, 35). Thirty-nine patients had paired baseline and 6-month data. Compared with baseline, DurAVR reduced indexed FD (4.0 ± 1.2 to 3.5 ± 0.8%/cm2, P < .005) and indexed FRR (3.9 ± 1.0 to 2.6 ± 0.7%/cm2, P < .0001). Post-DurAVR, indexed FD was comparable to controls (3.5 ± 0.8 vs 3.5 ± 1.3%/cm2, P = .81) and indexed FRR approached control values (2.5 ± 0.7 vs 2.2 ± 0.8%/cm2, P = .06). Left ventricular mass regressed by 18% (P < .0001). In regression (R2 = 0.43), LV mass regression was independently associated with the change in the mean transaortic gradient (relative contribution 68%, P = .005) and change in systolic FRR (relative contribution 26%, P = .03). Conclusion DurAVR transcatheter heart valve implantation restored ascending aortic flow towards native physiology and was accompanied by LV reverse remodelling at 6 months. Larger comparative studies should determine whether normalized post-implant flow translates into improved patient outcomes.