Stelios Ioannou, Yahya Wehbeh, George Shiakos, Ioannis Tzanavaros
In this early single-center experience, surgical pulmonary valve replacement with the RESILIA bioprosthesis was feasible, with predominantly none-to-mild regurgitation and no reinterventions during short-term follow-up. The modest increase in gradients over time supports continued surveillance and highlights the need for longer-term, multicenter studies with standardized right ventricular outflow tract prosthesis assessment to define durability.
BACKGROUND: Pulmonary valve replacement remains challenged by structural valve deterioration and the need for reinterventions. The RESILIA bioprosthesis incorporates anti-calcification technology designed to improve tissue durability. This study assessed early hemodynamic performance of the RESILIA valve in the pulmonary position.
METHODS: This retrospective study included 28 patients who underwent Resilia-based PVR at a single center between 2021 and 2024. Demographics, surgical details, and echocardiographic data were retrieved, focusing on peak transvalvular gradient and severity of pulmonary regurgitation (PR). Linear mixed-effects modeling was applied to account for repeated measurements at variable follow-up intervals.
RESULTS: A total of 28 patients underwent pulmonary valve replacement with the RESILIA valve, with no procedural deaths. Median follow-up was 18 months (interquartile range 11-27; range 0-38). A total of 86 postoperative echocardiograms were analyzed. The median peak gradient was 13.0 mmHg (interquartile range 10.2-19.4; range 4.0-31.4). Patient-level worst pulmonary regurgitation during follow-up was none in 18 patients (64.3%), mild in 9 (32.1%), and moderate in 1 (3.6%); no severe regurgitation occurred. No valve-related reinterventions, valve thrombosis, or endocarditis were observed during follow-up. Peak gradient increased modestly over time (+0.155 mmHg/month; 95% confidence interval 0.059-0.251; p = 0.002).
CONCLUSIONS: In this early single-center experience, surgical pulmonary valve replacement with the RESILIA bioprosthesis was feasible, with predominantly none-to-mild regurgitation and no reinterventions during short-term follow-up. The modest increase in gradients over time supports continued surveillance and highlights the need for longer-term, multicenter studies with standardized right ventricular outflow tract prosthesis assessment to define durability.