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J Thorac Cardiovasc Surg 2000;120:1158-1167
© 2000 The American Association for Thoracic Surgery

Evolving Technology

Patch augmentation of the pulmonary artery with bioabsorbable polymers and autologous cell seeding

From the Department of Cardiovascular Surgery, Children's Hospital,^a the Department of Surgery, Massachusetts General Hospital,^f the Department of Cardiology, Children's Hospital,^c the Department of Surgery, Children's Hospital,^d and the Department of Pathology, Brigham and Women's Hospital,^e Harvard Medical School, Boston, Mass, and Tepha Inc,^b Cambridge, Mass.

This study was supported by generous grants from the Department of Cardiac Surgery, Children's Hospital, Boston, Deutsche Forschungsgemeinschaft (Sto 359/1-1, U.A.S.), and the National Institutes of Health (NIH HL-97-005, J.E.M.).

Address for reprints: John E. Mayer, Jr, MD, Department of Cardiovascular Surgery, Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115 (E-mail: mayer{at}a1.tch.harvard.edu).

Abstract

Objective: In recent years bioabsorbable synthetic or biologic materials have been used to augment the pulmonary artery or the right ventricular outflow tract. However, each of these polymers has one or more shortcomings. None of these patch materials has been seeded with cells. Thus, we have tested a fast-absorbing biopolymer, poly-4-hydroxybutyric acid, with autologous cell seeding for patch augmentation of the pulmonary artery in a juvenile sheep model.
Methods: Vascular cells were isolated from ovine peripheral veins (n = 6). Bioabsorbable porous poly-4-hydroxybutyric acid patches (porosity > 95%) were seeded on 3 consecutive days with a mixed vascular cell suspension (21.3 ± 1.3 x 10⁶ cells). Forty-five (± 2) days after the vessel harvest, 1 unseeded and 6 autologously seeded control patches were implanted into the proximal pulmonary artery. The animals received no postoperative anticoagulation. Follow-up was performed with echocardiography after 1 week and before explantation after 1, 7, and 24 weeks (2 animals each) for the seeded control patches and after 20 weeks for the nonseeded control patch.
Results: All animals survived the procedure. Postoperative echocardiography of the seeded patches demonstrated a smooth surface without dilatation or stenosis. Macroscopic appearance showed a smooth internal surface with increasing tissue formation. Histology at 169 days demonstrated a near-complete resorption of the polymer and formation of organized and functional tissue. Biochemical assays revealed increasing cellular and extracellular matrix contents. The control patch showed a slight bulging, indicating a beginning dilatation.
Conclusion: This experiment showed that poly-4-hydroxybutyric acid is a feasible patch material in the pulmonary circulation.

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