Abstract 19224: Ten Years of Clinical Results With a Tissue Engineered Pulmonary Valve in Eleven Consecutive Patients to Replace the Pulmonary Valve During Ross Operation.
Background: The Ross procedure is limited by the durability of the valve prostheses used to reconstruct the right ventricular outflow tract.
Objective: This study was performed to collect prospective safety and effectiveness data of a tissue engineered heart valve to reconstruct the right ventricular outflow tract during Ross procedure.
Methods: From May 2000 till June 2002, eleven consecutive patients received a tissue engineered heart valve. Two to four weeks prior to the Ross operation a piece of forearm or saphenous vein was harvested, to isolate, characterize and expand autologous vascular endothelial cells. A cryopreserved pulmonary allograft was decellularized, coated and seeded with endothelial cells, using a specially developed bioreactor. Follow-up was performed by clinical evaluation, transthoracic echocardiography, and multi-slice computed tomography.
Results: Patients mean age was 39.6 ± 10.3 years. Cell seeding density was 110.000 ± 50.000 cells/cm2 with a viability of 93.2 ± 2.1 %. All patients survived surgery. No fever of unknown origin was seen postoperatively and leucocyte count did not increase. Currently all patients are in NYHA class I. Transthoracic echocardiography evaluation of the tissue engineered heart valve showed a mean flow velocity at discharge of 0.8 ± 0.1 m/s and at latest follow-up of 1.0 ± 0.3 m/s. Multi-slice computed tomography showed absence of calcification.
Conclusions: Tissue engineered heart valves showed excellent hemodynamic performance during 10 years of follow-up. Decellularization of heart valves and seeding with autologous vascular endothelial cells may prevent degeneration of tissue valves.
- © 2010 by American Heart Association, Inc.