Use of the Inspiris valve in the native right ventricular outflow tract is associated with early prosthetic regurgitation

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 166; no. 4; pp. 1210 - 1221.e8
• Main Authors: Nguyen, Stephanie N., Vinogradsky, Alice V., Sevensky, Riley, Crystal, Matthew A., Bacha, Emile A., Goldstone, Andrew B.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-10-2023
• Subjects: bioprosthetic valves; pulmonary valve replacement; right ventricular outflow tract; transcatheter pulmonary valve implantation; RV-PA; PR; PS; TTE; bioprosthetic valves; transcatheter pulmonary valve implantation; IQR; pulmonary valve replacement; PVR; right ventricular outflow tract; RVOT
• ISSN: 0022-5223; 1097-685X; 1097-685X
• DOI: 10.1016/j.jtcvs.2023.04.018

The Inspiris Resilia prosthesis (Edwards Lifesciences) has been increasingly used in the pulmonic position with limited performance data. We sought to investigate its durability as a surgical pulmonary valve replacement (PVR).
We retrospectively reviewed patients who underwent PVR or conduit replacement with an Inspiris or non-Inspiris valve/conduit from 2018 to 2022. The primary end point was freedom from a composite of at least moderate pulmonary regurgitation, pulmonary stenosis, or valve/conduit reintervention. Secondary end points were individual components of the composite outcome. To account for baseline differences, propensity matching identified 70 patient pairs.
A total of 227 patients (median age: 19.3 years [interquartile range, 11.8-34.4]) underwent PVR or conduit replacement (Inspiris: n = 120 [52.9%], non-Inspiris: n = 107 [47.1%]). Median follow-up was 26.6 months [interquartile range, 12.4-41.1]. Among matched patients, 2-year freedom from valve failure was lower in the Inspiris group (53.5 ± 9.3% vs 78.5 ± 5.9%, P = .03), as was freedom from at least moderate pulmonary regurgitation (54.2 ± 9.6% vs 86.4 ± 4.9%, P < .01). There was no difference in 2-year freedom from at least moderate pulmonary stenosis (P = .61) or reintervention (P = .92). Inspiris durability was poorer when implanted in the native right ventricular outflow tract compared with as a conduit, with 18-month freedom from valve failure of 59.0 ± 9.5% versus 85.9 ± 9.5% (P = .03).
Early durability of the Inspiris valve is poor when implanted in the native right ventricular outflow tract; its unique design may be incompatible with the compliant pulmonary root. Modified implantation techniques or alternative prostheses should be considered.
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