Mid-term performance of decellularized equine pericardium in congenital heart surgery.

Objective: The aim was to report mid-term performance of decellularized equine pericardium used for repair of various congenital heart defects in the pediatric population.

Methods: A retrospective review of all patients undergoing patch implantation between 2016 - 2020 was performed. Patch quality, surgical handling, hemostasis and early patch-related complications were studied on all patients. Mid-term performance was observed in patients with ≥12 months follow-up and intact patch at discharge (without reoperation/stent implantation).

Results: A total of 201 patients with median age of 2.5 years [interquartile range (IQR): 0.6-6.5] underwent 207 procedures at 314 implant locations. The patch was used in 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 implantations occurred in 28 locations (8.9%). No patch-related complications were noted except for bleeding from implant site in three locations (1%). Follow-up ≥ 12 months was available for 132 patients/200 locations. During a median follow-up of 29.7 months [IQR: 20.7-38.3], 53 patch-related reoperations/catheter reinterventions occurred (26.5%) with the majority in PA position (88.7%, 47/53). Overall 12- and 24-months freedom from patch-related reoperation/catheter reintervention per location was 91.5% (95% CI: 86.7%-94.6%) and 85.2% (95% CI: 78.9%-89.6%) respectively.

Conclusion: Decellularized equine pericardium used for repair of various congenital heart defects showed acceptable mid-term performance. Reoperation/reintervention rates were in a range as observed with other xenogeneic materials previously reported articles, occurring most frequently after PA augmentation.