Key result
RESILIA pulmonary valve replacement is linked to peak gradients rising ~0.16 mmHg per month.
Why the study?
Pulmonary valve replacement is challenged by structural valve deterioration and reinterventions; the RESILIA bioprosthesis aims to improve tissue durability but early hemodynamic performance data are limited.
Does surgical pulmonary valve replacement with the RESILIA bioprosthesis maintain acceptable early hemodynamic performance in patients with RVOT dysfunction?
Cohort (n=28)
No
Does surgical pulmonary valve replacement with the RESILIA bioprosthesis maintain acceptable early hemodynamic performance in patients with RVOT dysfunction?
Effect estimate: +0.155 mmHg/month (95% CI 0.059-0.251)
p-value: p=0.002
Surgical pulmonary valve replacement with the RESILIA bioprosthesis is feasible and demonstrates acceptable short-term hemodynamics, though a modest rise in gradients highlights the need for continued surveillance.
Short-term RESILIA pulmonary valve replacement shows low regurgitation without reintervention; leaves open long-term durability amid rising gradients.
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.
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Wehbeh et al. (2026) conducted a cohort in Right ventricular outflow tract (RVOT) dysfunction requiring pulmonary valve replacement (n=28). INSPIRIS RESILIA bioprosthesis was evaluated on Early hemodynamic performance (sequential change in peak transvalvular gradient over time) (+0.155 mmHg/month, 95% CI 0.059-0.251, p=0.002). The RESILIA bioprosthesis for pulmonary valve replacement had no early reinterventions and none-to-mild regurgitation, but peak transvalvular gradients increased by +0.155 mmHg/month (p=0.002).
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