Ten years of clinical results with a tissue-engineered pulmonary valve.

Abstract

This study was performed to collect prospective safety and effectiveness data from a tissue-engineered heart valve implanted for reconstruction of the right ventricular outflow tract during the Ross operation. From May 2000 until June 2002, 11 consecutive patients, mean age 39.6 ± 10.3 years, received a tissue-engineered heart valve (additive and logistic European System for Cardiac Operative Risk Evaluation, respectively, 3.3 ± 1.3 and 2.8% ± 1.4%). Two to four weeks prior to the Ross operation a piece of forearm vein or saphenous vein was harvested to isolate, characterize, and expand endothelial cells. A cryopreserved pulmonary allograft was decellularized, coated, and seeded with autologous vascular endothelial cells, using a specially developed bioreactor. Cell seeding density was 1.1 × 10(5) ± 0.5 × 10(5) cells/cm(2) with a viability of 93.2% ± 2.1%. All patients survived surgery. Postoperatively no fever of unknown origin was evident. Currently all patients are in New York Heart Association class I. Evaluation of the tissue-engineered heart valve by transthoracic echocardiography showed a mean pressure gradient of 5.4 ± 2.0 mm Hg at 10 years. Multislice computed tomography showed no calcification up to 10 years. Tissue-engineered heart valves showed excellent hemodynamic performance and may prevent degeneration during long-term follow-up.