4:20 PM - 5:10 PM
[II-JCKO5-01] New self-expandable percutaneous pulmonary valve implantation using knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve
OBJECTIVE
To report first human cases of new self-expandable percutaneous pulmonary valve implantation (PPVI) using knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve.
METHODS
New valved-stent was made by knitted nitinol-wire backbone and tissue valve using porcine pericardium with multiple steps for tissue preservation including decellularization and alpha-galactosidase treatment. And, a feasibility study was done.
RESULTS
Ten patients underwent total correction of Tetralogy of Fallot previously and showed severe PR (mean PR fraction: 44.6%) and enlarged RV volume (mean indexed RV end-diastolic volume; 184.1 mL/m2). Their median age at PPVI was 21.8 years old (range: 13-36). Five patients were implanted with 28 mm and 5 patients were implanted with 26 mm diameter valved-stent loaded in the 18 French delivery sheath. There were no significant peri-procedural complications in all patients. After procedure, there was no significant pulmonary stenosis or PR from echocardiography in all patients. All patients discharged 4 days after PPVI without any problem. Eight patient completed 6 months follow-up until now. Cardiac MRI showed that mean indexed RV end-diastolic volume decreased from 188.6 to 124.9 mL/m2.
CONCLUSION
A feasibility study about first human implantation of new self-expandable percutaneous pulmonary valve using knitted nitinol wire mounted with a tri-leaflet porcine pericardial valve was completed and short-term follow-up data showed good result and there was no serious adverse effect associated with valve itself.
To report first human cases of new self-expandable percutaneous pulmonary valve implantation (PPVI) using knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve.
METHODS
New valved-stent was made by knitted nitinol-wire backbone and tissue valve using porcine pericardium with multiple steps for tissue preservation including decellularization and alpha-galactosidase treatment. And, a feasibility study was done.
RESULTS
Ten patients underwent total correction of Tetralogy of Fallot previously and showed severe PR (mean PR fraction: 44.6%) and enlarged RV volume (mean indexed RV end-diastolic volume; 184.1 mL/m2). Their median age at PPVI was 21.8 years old (range: 13-36). Five patients were implanted with 28 mm and 5 patients were implanted with 26 mm diameter valved-stent loaded in the 18 French delivery sheath. There were no significant peri-procedural complications in all patients. After procedure, there was no significant pulmonary stenosis or PR from echocardiography in all patients. All patients discharged 4 days after PPVI without any problem. Eight patient completed 6 months follow-up until now. Cardiac MRI showed that mean indexed RV end-diastolic volume decreased from 188.6 to 124.9 mL/m2.
CONCLUSION
A feasibility study about first human implantation of new self-expandable percutaneous pulmonary valve using knitted nitinol wire mounted with a tri-leaflet porcine pericardial valve was completed and short-term follow-up data showed good result and there was no serious adverse effect associated with valve itself.