20-Year Experience With Decellularized Pulmonary Homografts for Pulmonary Valve Replacement

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.

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.

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.

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.