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Percutaneous pulmonary polyurethane valved stent implantation: 6-month follow-up
Anja Metzner1, Judith Pohanke1, Jessica Boldt1, Gunther Fischer2, Ulrich Steinseifer3, Jochen Cremer1, Georg Lutter1.
1Department of Cardiovascular Surgery, University hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, 2Department of Pediatric Cardiology, University hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, 3Department of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, Aachen, Germany.
OBJECTIVE:
Transfemoral application of pulmonary heart valves has been recently introduced clinically. Nevertheless, size restriction of percutaneous heart valved stent are still immanent.
METHODS:
In this study we implanted percutaneously a novel low-profile polyurethane valved stent. Percutaneous valved stent implantation in pulmonary position was evaluated in 3 sheep. This valved stent fits into a 14-French delivery device. The self-expanding nitinol stent was produced by a dip coating technique and a modified commercially-available endovascular stent-graft system served as a delivery device. The valved stents were deployed directly over the native pulmonary valve under fluoroscopic control. Thransthoracic echocardiography was done after implantation, 4 weeks, three and six months. At the time of explantation the animals were reanalyzed and sacrificed. Angiography was performed at implantation and at the end of the study. Explanted constructs were analyzed macro- and microscopically.
RESULTS:
Angio- and echocardiography in all animals demonstrated orthotopic position of the stents at the time of implantation and after 6 months. During the deployment procedure, rhythm disturbances occurred in all animals. The peak-to-peak transvalvular gradient was 2.5±2.0 mmHg initially, and 4.0±2.8 mmHg at 6 months follow-up. Six-month follow-up confirmed competent valves without any leakages. Post-mortem investigation demonstrated good opening and closure characteristics. No signs of calcification and inflammation were seen macroscopically and microscopically in the surrounding tissue. The leaflets were analyzed by scanning electron microscopy. There was found the development of cell clusters.
CONCLUSIONS:
In the present study we demonstrated successful the percutaneous implantation of polyurethane valved stent over a period of 6 months.
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