Novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves

Abstract Background The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the apparatus without accounting annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, exerted by expanding is determined diameter balloon pressure (Laplace's Law). Objective We proposed tested a novel aimed at controlling resulting allow prosthesis-annulus apposition while preventing significant tissue injury. Methods 330 consecutive with severe native aortic stenosis who underwent between 2015–2020 were included. 106 considered high-risk rupture. THVs deployed until reaching pre-determined pressure; 4–4.5atm in earlier cases establish experience safety, later increasing 5–6.5atm most cases. Post-dilatation was performed reduce >mild angiographic regurgitation (PVR). Using biomechanical model, stress (tension) estimated each case assessed against recorded rates post-dilatation, ≥mild paravalvular (PVR) TTE, new PPM or LBBB Results Patients >3MPa (n=184) had reduced post-dilatation rate (p<0.001) final PVR (≥mild, p=0.014). Annular rupture occurred 2/3 >3.5MPa; no 102 ≤3.5MPa. Based these results, we defined target levels (3–3.5MPa) associated per size. within this range (n=136) 8.1% PPM, 12.5% LBBB, 12.7% mild ≥moderate PVR. Importantly, there an relationship volume stress. Conclusion Pressure-regulated simple, easily reproducible, safe effective method, regardless anatomical complexities. FUNDunding Acknowledgement Type funding sources: None. Model, vs strategy