Late-term results of tissue-engineered vascular grafts in humans.
OBJECTIVE
The development of a tissue-engineered vascular graft with the ability to grow and remodel holds promise for advancing cardiac surgery. In 2001, we began a human trial evaluating these grafts in patients with single ventricle physiology. We report the late clinical and radiologic surveillance of a patient cohort that underwent implantation of tissue-engineered vascular grafts as extracardiac cavopulmonary conduits.


METHODS
Autologous bone marrow was obtained and the mononuclear cell component was collected. Mononuclear cells were seeded onto a biodegradable scaffold composed of polyglycolic acid and epsilon-caprolactone/L-lactide and implanted as extracardiac cavopulmonary conduits in patients with single ventricle physiology. Patients were followed up by postoperative clinic visits and by telephone. Additionally, ultrasonography, angiography, computed tomography, and magnetic resonance imaging were used for postoperative graft surveillance.


RESULTS
Twenty-five grafts were implanted (median patient age, 5.5 years). There was no graft-related mortality (mean follow-up, 5.8 years). There was no evidence of aneurysm formation, graft rupture, graft infection, or ectopic calcification. One patient had a partial mural thrombosis that was successfully treated with warfarin. Four patients had graft stenosis and underwent successful percutaneous angioplasty.


CONCLUSIONS
Tissue-engineered vascular grafts can be used as conduits in patients with single ventricle physiology. Graft stenosis is the primary mode of graft failure. Further follow-up and investigation for the mechanism of stenosis are warranted.
Hibino
Narutoshi
N
Yale University School of Medicine, Section of Cardiac Surgery, New Haven, Conn 06520, USA. narutoshi.hibino@yale.edu
McGillicuddy
Edward
E
Matsumura
Goki
G
Ichihara
Yuki
Y
Naito
Yuji
Y
Breuer
Christopher
C
Shinoka
Toshiharu
T
D000293:Adolescent; D001807:Blood Vessel Prosthesis; D001854:Bone Marrow Cells; D002648:Child; D002675:Child, Preschool; D005260:Female; D006352:Heart Ventricles / Q000002:abnormalities*; D006801:Humans; D007223:Infant; D019344:Lactic Acid / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D008297:Male; D008567:Membranes, Artificial; D011091:Polyesters; D011108:Polymers / Q000627:therapeutic use; D011651:Pulmonary Artery / Q000601:surgery; D023822:Tissue Engineering / Q000379:methods*; D054457:Tissue Scaffolds; D014654:Vascular Patency; D014684:Venae Cavae / Q000601:surgery
D008567:Membranes, Artificial; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)