Mid-Term Results of New Heart Valve Tissue Bioprosthesis for Pulmonary Valve Replacement

Background To evaluate hemodynamic performance and midterm durability of the Inspiris Resilia Valve (IRV) in pulmonary position in patients with different cardiac anomalies. Methods We retrospectively reviewed the medical records of 45 patients who underwent pulmonary valve implantation with IRV between January 2018 and August 2023. Demographic data included primary diagnosis, age at surgery, intraoperative data, and follow-up (FU). Primary outcomes are bioprosthesis dysfunction (BD) and prosthesis-related reintervention. BD was defined as moderate or severe bio-prosthesis insufficiency or trans-prosthesis peak gradient >50 mmHg. Results Most common primary diagnosis was Tetralogy of Fallot (28 patients). Indication for surgery was severe pulmonary regurgitation with significant right ventricle (RV) dilatation, with median RV end-diastolic volume of 164 (151–174) ml/m 2 . Median age and weight at surgery were 18 years (interquartile range [IQR] 15–30) and 62 kg (IQR 47–72). Most common IRV size implanted was 25 mm (31 patients), followed by 27 mm (11 patients). After a median FU time of 33 months (IQR 18–45), 6 patients (13.3%) developed BD and 1 required trans-catheter reintervention. All patients who developed BD had a 25 mm IRV implanted. Our statistical analysis showed that higher peak gradient and higher RV systolic pressure were associated with increased BD occurrence ( p value < 0.001); moreover, bioprosthesis regurgitation was a more significant cause of BD than stenosis ( p value < 0.001). Conclusions Despite short–medium-term FU, our results suggest that IRV durability in the pulmonary position is concerning. Further discussion and collaboration are needed to evaluate this prosthesis for pulmonary valve replacement on a larger scale and with a longer FU.