Paediatric aortic valve replacement using decellularized allografts: a multi-Centre update following 143 implantations and 5-year mean follow-up.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced in 2008 as a further option for paediatric aortic valve replacement (AVR).

METHODS: Prospective, multicentre follow-up of all paediatric patients receiving DAH for AVR in 8 European centres.

RESULTS: 143 DAH were implanted between 2/2008 and 2/2023 in 137 children (106 male, 74%) with a median age of 10.8 years (IQR 6.6-14.6). 84 (59%) had undergone previous cardiac operations, 24 (17%) had undergone previous AVR.The median implanted DAH diameter was 21 mm (IQR 19-23). The median operation duration was 348 min (227-439) with a median CPB time of 212 min (171-257) and a median cross-clamp time of 135 min (113-164).After a median follow-up of 5.3 yrs. (3.3-7.2, max. 15.2 yrs.) the primary efficacy end-points peak gradient (median 14 mmHg, 9-28) and regurgitation (median 0.5, IQR 0-1, grade 0-3,) showed good results but an increase over time.Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 5 years were 97.8 ± 1.2/88.7 ± 3.3/99.1 ± 0.9/100 and 99.2 ± 0.8% respectively.Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 10 years were 96.3 ± 1.9/67.1 ± 8.0/93.6 ± 3.9/98.6 ± 1.4 and 86.9 ± 11.6% respectively.In total, 11 DAH were explanted. Five were replaced by mechanical AVR and DAH were implanted in 6 patients with no re-do mortality.The calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.4 yrs.), and in the same range as for Ross patients (9.2 yrs) and mechanical AVR (13.0 yrs.).

CONCLUSIONS: This large-scale prospective analysis demonstrates excellent mid-term survival using DAH with adverse event rates comparable to paediatric Ross procedures.