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- Gi-Beom Kim1
Severe pulmonary regurgitation (PR) and associated right ventricular (RV) dilatation in native right ventricular outflow tract (RVOT) is challenging and still on clinical trial. We report first human cases of new self-expandable percutaneous pulmonary valve implantation (PPVI) using newly made knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve developed in South Korea.
We reviewed 10 cases of new self-expandable PPVI at the Seoul National University Children’s Hospital. This self-expandable valved-stent was newly developed by our research team with the cooperation of the TaeWoong medical company in South Korea. This valved-stent was made by knitted nitinol-wire backbone with tissue valve using porcine pericardium with multiple steps for tissue preservation including decellularization and alpha-galactosidase treatment.
Ten patients underwent total correction of Tetralogy of Fallot previously and showed severe PR (mean PR fraction: 44.6%, range: 35.4-56) and enlarged RV volume (mean indexed RV end-diastolic volume; 184.1 mL/m2, range: 161–209.8). Their median age at PPVI was 21.8 years old (range: 13-36). At the targeted RVOT area, 5 patients were implanted with 28 mm diameter valved-stent and 5 patients were implanted with 26 mm diameter valved-stent loaded in the 18 French delivery cable. There were no significant peri-procedural complications in all patients. After the procedure, there was no significant pulmonary stenosis or PR from cine-angiography and echocardiography in all patients. Chest X-ray showed good valved-stent position at targeted RVOT area. All patients discharged 4 days after PPVI without any problem. Two patient completed 6 months follow-up after PPVI and showed decreased indexed RV end-diastolic volume from 181.7 to 126.7 mL/m2 and 167.5 to 112.6 mL/m2, respectively from cardiac MRI.
First human implantation of the new self-expandable percutaneous pulmonary valve using knitted nitinol wire mounted with a tri-leaflet porcine pericardial valve developed in South Korea was feasible and effective at short-term follow-up. A clinical trial for feasibility to evaluate the safety and short-term effectiveness of this self-expandable valved-stent for 10 patients is complete for the congenital heart disease with pulmonary valve disease in South Korea.