Abstract
OBJECTIVES: Fresh, non-cryopreserved and non-seeded, decellularized pulmonary homografts (DPHs) were translated in 2005 into clinical practice. The aim of this current study is to summarize our 20-year clinical experience with DPH for pulmonary valve replacement (PVR) in congenital heart disease. METHODS: Prospective follow-up of all DPH implanted within 2 institutions. Indication for PVR according to current clinical guidelines was the key inclusion criterion without age limits; patients with active endocarditis were not included. RESULTS: From January 2005 to August 2025, 310 patients (188 male) received DPH for PVR. Median patient age at implantation was 14.8 years, (interquartile range [IQR] 12.7-16.6 years, min. 0.1 years, max.72.8 years), and the median DPH diameter was 22 mm (IQR 19-23 mm, min. 12 mm, max 34 mm). Median follow-up was 8.3 years (IQR 4.5-12.1, max 20.5 years). Seven out of 310 patients died, a freedom from death according Kaplan-Meier of 96.9% (confidence interval [CI] 93.1%-98.6%) at 20 years. Freedom from DPH explantation was 85.2% (CI 75.1%-91.4%), and freedom from endocarditis was 91.0% (CI 77.1%-96.6%) at 20 years. Valve function showed a steady decline over the study period. At 15 years, freedom from stenosis, as defined as a maximum gradient of ≥ 50 mmHg, was 68.3% (CI 52.4%-79.8%) and 0 at 20 years. Freedom from ≥ moderate pulmonary regurgitation was 65.1% (CI 48.1%-77.7%) at 15 years and 0 at 20 years. The number of patients at risk beyond 15 years was limited. CONCLUSIONS: Decellularized pulmonary homografts show good long-term results for PVR with freedom from explantation that appears favourable compared with published long-term series of cryopreserved homografts. However, our data also indicate a decline in valve function over 2 decades. We hypothesize that residual immunogenicity is the underlying cause, suggesting that there is potential for further refinement of decellularization methods.