20-year experience with decellularized pulmonary homografts for pulmonary valve replacement

Abstract OBJECTIVES Fresh, non-cryopreserved and non-seeded, decellularized pulmonary homografts (DPH) 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 two institutions. Indication for pulmonary valve replacement according to current clinical guidelines was the key inclusion criterion without age limits; patients with active endocarditis were not included. RESULTS From 1/2005 to 8/2025, 310 patients (188 male) received DPH for PVR. Median patient age at implantation was 14.8 yrs, (IQR 12.7–16.6 yrs., min. 0.1 yrs, max.72.8 yrs, median DPH diameter 22 mm (IQR 19–23 mm, min. 12 mm, max 34 mm). Median follow-up was 8.3 yrs. (IQR 4.5–12.1, max 20.5 years). 7 out of 310 patients died, a freedom from death according Kaplan–Meier of 96.9% (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 pulmonary valve replacement with freedom from explantation that appears favorable compared with published long-term series of cryopreserved homografts. However, our data also indicate a decline in valve function over two decades. We hypothesize that residual immunogenicity is the underlying cause, suggesting that there is potential for further refinement of decellularization methods.