Aortic Valve Neocuspidization Using Xenologous Pericardium Versus Bioprosthetic Valve Replacement.

Abstract

Surgical aortic valve replacement (SAVR) for patients with aortic valve stenosis (AS) with small aortic root is associated with a higher rate of prosthesis-patient mismatch and suboptimal clinical outcomes. Aortic valve neocuspidization using xenologous pericardium (xAVNeo) has shown a favorable hemodynamic performance. The aim was to compare 6-year clinical outcomes of xAVNeo with SAVR. Between 2003 and 2018, 412 patients with severe AS and small aortic root received either xAVNeo (n = 114) or bioprosthesis (n = 298). After propensity matching the cohort included 222 patients. The primary endpoints were early mortality, 6-year mortality, and freedom from reoperation. Mean follow-up averaged 3.4 ± 3.1 years and was 95% complete. Early mortality was 8.1% for the SAVR group versus 9.9% for the xAVNeo group (odds ratio, 1.25; 95% confidence interval, 0.51-2.89). The estimated survival probabilities at 6 years for the SAVR and xAVNeo cohorts were 89.9% and 88.8%, respectively (odds ratio, 1.07; 95% confidence interval, 0.49-2.34). Progressive degeneration of the neocusps resulted in a mean gradient increase from 6.1 ± 2.3 mm Hg to 22.7 ± 11.5 mm Hg (P < .0001); cusp sclerosis was the most common indication for reoperation in the xAVNeo group with a linearized rate of 1.92% versus 0.26% per patient-year (rate ratio, 7.41; 95% confidence interval, 0.95-333.7). The freedom from reoperation was 84.8% at 6 years, inferior to that of the SAVR group (100%). Early clinical outcomes and 6-year survival rates after xAVNeo and SAVR were comparable. However xAVNeo using bovine pericardium was associated with a higher rate of structural valve deterioration and inferior freedom from reoperation when compared with SAVR.