5-Year Results from the Prospective European Multicenter Study on Decellularized Homografts for Pulmonary Valve Replacement

Background: Early results of the prospective ESPOIR Trial have indicated excellent results for pulmonary valve replacement (PVR) when using decellularized pulmonary homografts (DPH).

Method: Five-year analysis of the ESPOIR Trial patients and matched comparison of ESPOIR Registry patients to bovine jugular vein conduits (BJV) and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures.

Results: A total of 121 patients (59 female) were prospectively enrolled (8/2014–12/2016), with age of 21.3 years (SD: 14.4) and DPH diameter of 24.4 mm (2.8). One death (73 year-old) occurred during a mean follow-up of 5.3 years (0.9), in addition to two perioperative deaths resulting overall mortality of 2.5%. One endocarditis in 637 patient-years, incidence of 0.15% per patient-year. At 5 years, mean peak gradient of 19.9 mm Hg (9.9), mean regurgitation of 0.9 (0.6, Grade 0–3), and freedom from explantation/any reintervention of 97.5% (1.5).

The combined DPH cohort, n = 319, comprising both Trial and Registry data showed significantly better freedom from explantation, DPH 95.5% (SD 1.7), CH 83.0% (2.8), p < 0.001, and BJV 81.7% (2.9), p = 0.001 and less structural valve degeneration at 10 years when matched to CH, n = 319, and BJV, n = 319, DPH 65.5% (SD 4.4), CH 47.3% (3.7), p = 0.11, BJV 39.6% (3.9), p < 001.

Conclusion: Five-year data of the prospective ESPOIR Trial showed excellent performance of DPH and low rates of adverse events. ESPOIR Registry data up to 15 years, including matched comparison to CH and BJV, showed statistically significant better freedom from explantation or functional explantation and proof of DPH as the current gold standard for PVR.

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Artikel online veröffentlicht:
03. Februar 2022