Gi Beom Kim1, Hong-Gook Lim2, Yong Jin Kim3, Eun Young Choi4, Bo Sang Kwon1, Saeromi Jeong5. 1. Department of Pediatrics, Seoul National University Children's Hospital, Seoul, Republic of Korea; Xenotransplantation Research Center, Seoul National University Hospital, Seoul, Republic of Korea. 2. Department of Thoracic and Cardiovascular Surgery, Seoul National University Children's Hospital, Seoul, Republic of Korea; Xenotransplantation Research Center, Seoul National University Hospital, Seoul, Republic of Korea. 3. Department of Thoracic and Cardiovascular Surgery, Seoul National University Children's Hospital, Seoul, Republic of Korea; Xenotransplantation Research Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: kyj@plaza.snu.ac.kr. 4. Department of Pediatrics, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea; Xenotransplantation Research Center, Seoul National University Hospital, Seoul, Republic of Korea. 5. Xenotransplantation Research Center, Seoul National University Hospital, Seoul, Republic of Korea.
Abstract
BACKGROUND: Because transcatheter implantation of pulmonary valve is indicated for limited-size dysfunctional right ventricular outflow tract only as a balloon-expandable stent, we investigated the feasibility of a large-diameter self-expandable valved stent and the durability of the valve after >6 months. METHODS: We made a nitinol-wire-based, self-expandable valved stent with leaflets made from porcine pericardium. The porcine pericardium was treated with α-galactosidase, glutaraldehyde, and glycine after decellularization. After cutting the inguinal or cervical area, we implanted a valved stent in 12 sheep through the femoral or jugular vein by using an 18-Fr delivery catheter, controlling the catheter handles and hook block under fluoroscopic and echocardiographic guidance. RESULTS: The mean body weight of sheep was 43.9 kg. We successfully implanted valved stents (diameter: 24 mm in 7 sheep, 26 mm in 5 sheep) in good position in 8 sheep, in the main pulmonary artery (PA) in 2 sheep, and in the right ventricular outlet tract (RVOT) in 2 sheep. We sacrificed 8 sheep (6 sheep in good position, 1 sheep in the main PA, and 1 sheep in the RVOT) after >6 months. Five of the 6 sheep implanted in good position showed well-preserved valve morphology at the time of sacrifice. Histologic findings after routine sacrifice showed well-maintained collagen wave structure and no visible calcification in all explanted valve leaflets. CONCLUSIONS: Transcatheter implantation of a nitinol-wire-based, self-expandable valved stent in the pulmonic valve was feasible, and stents implanted in good position showed well-preserved valve leaflets with functional competence in the mid-term results.
BACKGROUND: Because transcatheter implantation of pulmonary valve is indicated for limited-size dysfunctional right ventricular outflow tract only as a balloon-expandable stent, we investigated the feasibility of a large-diameter self-expandable valved stent and the durability of the valve after >6 months. METHODS: We made a nitinol-wire-based, self-expandable valved stent with leaflets made from porcine pericardium. The porcine pericardium was treated with α-galactosidase, glutaraldehyde, and glycine after decellularization. After cutting the inguinal or cervical area, we implanted a valved stent in 12 sheep through the femoral or jugular vein by using an 18-Fr delivery catheter, controlling the catheter handles and hook block under fluoroscopic and echocardiographic guidance. RESULTS: The mean body weight of sheep was 43.9 kg. We successfully implanted valved stents (diameter: 24 mm in 7 sheep, 26 mm in 5 sheep) in good position in 8 sheep, in the main pulmonary artery (PA) in 2 sheep, and in the right ventricular outlet tract (RVOT) in 2 sheep. We sacrificed 8 sheep (6 sheep in good position, 1 sheep in the main PA, and 1 sheep in the RVOT) after >6 months. Five of the 6 sheep implanted in good position showed well-preserved valve morphology at the time of sacrifice. Histologic findings after routine sacrifice showed well-maintained collagen wave structure and no visible calcification in all explanted valve leaflets. CONCLUSIONS: Transcatheter implantation of a nitinol-wire-based, self-expandable valved stent in the pulmonic valve was feasible, and stents implanted in good position showed well-preserved valve leaflets with functional competence in the mid-term results.