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J Thorac Cardiovasc Surg 2010;139:431-436
© 2010 The American Association for Thoracic Surgery

Evolving Technology/Basic Science

Late-term results of tissue-engineered vascular grafts in humans

^a Yale University School of Medicine, Section of Cardiac Surgery, New Haven, Conn
^b Tokyo Women's Medical University, Tokyo, Japan

Received for publication April 30, 2009; revisions received September 14, 2009; accepted for publication September 29, 2009.

^_* Address for reprints: Narutoshi Hibino, MD, PhD, Yale School of Medicine, Section of Cardiac Surgery, 333 Cedar St, Boardman 204, PO Box 208039, New Haven, CT 06520. (Email: narutoshi.hibino{at}yale.edu).

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 -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.

Conclusion: 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.

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