Abstract
Objective: The goal was to report the midterm performance of decellularized equine pericardium used for repair of various congenital heart defects in the paediatric population. Methods: A retrospective review of all patients undergoing patch implants between 2016 and 2020 was performed. Patch quality, surgical handling, haemostasis and early patch-related complications were studied in all patients. Midterm performance was observed in patients with ≥12 months follow-up and an intact patch at discharge (without reoperation/stent implant). Results: A total of 201 patients with a median age of 2.5 years [interquartile range: 0.6-6.5] underwent 207 procedures at 314 implant locations. The patch was used in the following numbers/locations: 171 for pulmonary artery (PA) augmentation, 36 for aortic repair, 35 for septal defect closure, 22 for valvular repair and 50 at other locations. Early/30-day mortality was 6.5%. Early patch-related reoperations/stent implants occurred in 28 locations (8.9%). No patch-related complications were noted except for bleeding in 3 locations (1%). Follow-up for ≥ 12 months was available for 132 patients/200 locations. During a median follow-up of 29.7 months [interquartile range: 20.7-38.3], 53 patch-related reoperations/catheter reinterventions occurred (26.5%), with the majority in the PA position (88.7%, 47/53). Overall 12- and 24-months freedom from patch-related reoperation/catheter reintervention per location was 91.5% (95% confidence interval: 86.7%-94.6%) and 85.2% (95% confidence interval: 78.9%-89.6%), respectively. Conclusion: Decellularized equine pericardium used for repair of various congenital heart defects showed acceptable midterm performance. The range of reoperation/reintervention rates was similar to those observed with other xenogeneic materials in previously reported articles, occurring most frequently after PA augmentation.

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