ABSTRACT: In a recent study our group established an acute animal model of percutaneous pulmonary valve replacement using self-expanding nitinol stents. The present study was performed to evaluate these valved stents over a 3-month period.
Bovine jugular xenografts were sutured into nitinol stents. Transfemoral implantation in the pulmonary position using a modified commercially available application device (with a 22-French outer diameter) was evaluated in 9 sheep.
Two sheep died shortly after successful valved stent implantation due to internal venous hemorrhage. Another 1 sheep died 2.5 months after the procedure due to vegetations on the neovalve leading to subtotal stenosis. All other animals survived the 3-month study time (n = 6). An orthotopic pulmonary valved stent position was achieved in 4 animals and a supravalvular position in 1. During the deployment procedure, rhythm disturbances occurred in all animals, and mean arterial blood pressure dropped from 83.9 +/- 26.0 mm Hg to 68.3 +/- 22.3 mm Hg (p = 0.006) (n = 5). The peak-to-peak transvalvular gradient was 5.1 +/- 4.0 mm Hg initially (n = 5), and 3.6 +/- 1.6 mm Hg at follow-up (n = 5). Three-month angiographic and echocardiographic follow-up confirmed competent neovalves without paravalvular leakages.
After 3 months of implantation, percutaneously implanted memory nitinol valved stents demonstrated good function in the sheep.
The Annals of thoracic surgery 09/2006; 82(2):708-13. · 3.74 Impact Factor
ABSTRACT: Percutaneous pulmonary valve implantation is emerging as an alternative and additional option for a successful surgical scheme. To date, these procedures are performed by the balloon-in-balloon technique. The use of self-expanding stents for percutaneous valve replacement is assumed to improve preservation of the valve in its folded condition in the application device and the valve's long-term functioning. Therefore, initial experience with the development of a completely percutaneous transfemoral technique for pulmonary valve implantation using a self-expanding valved stent is described.
Bovine jugular xenografts were sutured into nitinol stents, and functional in vitro tests of valved stents were carried out. Transfemoral implantation in pulmonary position was acutely evaluated in 6 sheep weighing 22 to 29 kg. Radiologic evaluation was performed by angiography and multislice computed tomography (MSCT) scan. In addition, pathoanatomical studies were performed.
Exact implantation in pulmonary valve position was achieved in 5 of 6 sheep, with 1 early stent migration. Another sheep died before stent placement owing to perforation of the right ventricle by the delivery system. Orthotopic pulmonary valved stent position was depicted by MSCT in all other sheep (n = 4). The peak-to-peak transvalvular gradient was 8.2 +/- 3.9 mm Hg (n = 5). Postmortem examination revealed intact stent valves with no adherent clots. No macroscopic damage of the pulmonary artery was noted, whereas minor hematoma of the right atrium and the right ventricular outflow tract were observed in 2 hearts.
This acute study demonstrates that memory nitinol valved stents can be optimally deployed in the pulmonary position through the groin in sheep.
The Annals of thoracic surgery 10/2005; 80(3):969-75. · 3.74 Impact Factor
ABSTRACT: Percutaneous heart valve replacement is an exciting growing field in cardiovascular medicine yet still with some major problems. Only sophisticated improvement of the instruments could make it a real alternative to conventional surgery. Therefore, the aim of this study was to evaluate different delivery devices for percutaneous heart valve replacement in vitro and in vivo.
A catheter prototype designed by our group, and two commercially available devices for the delivery of esophageal stents and aortic endoprostheses, were tested. After in vitro experiments, an ovine animal model of transfemoral pulmonary valve implantation was established using biological valved self-expanding stents. Only the delivery device for aortic endografts (Medtronic, Talent, Santa Rosa, CA, USA) allowed fast in vitro procedures without material fatigue. This device was chosen for the in vivo tests.
Technical success was achieved in 9 of 10 animals (90%). One animal died after perforation of the ventricular wall. Orthotopic pulmonary placement was performed in 6 animals and intentional supravalvular valved stent placement in 3 animals.
An adequate in vitro model for this evolving field of interventional heart valve replacement is presented. Furthermore, the present study pinpoints the key characteristics that are mandatory for a delivery system in percutaneous pulmonary valve implantation. With regard to the delivery device's ductility observed during this "venous" study, an approach to transfemoral aortic valve implantation seems feasible.
CardioVascular and Interventional Radiology 29(3):406-12. · 2.09 Impact Factor