Gangjun Zong

An Integrated Pericardial Valved Stent Special for Percutaneous Tricuspid Implantation: An Animal Feasibility Study

BACKGROUND Various percutaneous valve replacement approaches have been reported in animals to replace the aortic and pulmonary valve. To broaden the indications of percutaneous approach to atrioventricular valves replacement, we developed a novel valved stent and evaluated the feasibility and safety of percutaneous implantation of the device in the tricuspid position. MATERIALS AND METHODS A unidirectional semilunar valve of porcine pericardium was sutured to a valvular ring. Then the ring with pericardial valve was mounted on a double-edge nitinol stent to construct the tricuspid valved stent. Transcatheter tricuspid valved stent implantation was performed on 10 healthy sheep. These sheep were followed up shortly after procedure with echocardiography evaluation and 64-slice CT imaging examination during the periodical follow-up at 1 mo and at 6 mo post-implantation. Additionally, two sheep were sacrificed after the procedure for anatomic and histological evaluation one at 1 h and the other at 1 mo, respectively. RESULTS Percutaneous valve implantation was successful in eight of 10 sheep. Two sheep died during the procedure due to migration of stent and fatal arrhythmia. The pressure of right heart did not significantly change after the procedure. Further echocardiography and imaging confirmed the stents were in desired position during the follow-up. The remaining six sheep with normal valvular and cardiac functionality survived for 6 mo after implantation. CONCLUSIONS The tricuspid stent with a valvular ring and pericardial valve can be implanted in tricuspid annulus percutaneous. The double-edge stent could substitute the native tricuspid valve chronically.

Use of a novel valve stent for transcatheter pulmonary valve replacement: An animal study

OBJECTIVE The goal of this study was to evaluate valvular functionality after transcatheter pulmonary valve replacement in sheep using a novel pulmonary valve stent. METHODS Fresh porcine pericardium cross-linked with 0.6% glutaraldehyde was treated with L-glutamine to eliminate glutaraldehyde toxicity and sutured onto a valve ring before mounting on a nitinol stent to construct the pulmonary valve stent. Percutaneous femoral vein transcatheter pulmonary valve replacement was performed with the newly constructed valve stent. Pulmonary valve stents were implanted in 10 healthy sheep (6 males and 4 females) weighing an average of 25.7 +/- 4.1 kg. Color Doppler echocardiography, 64-row computed tomography, and direct catheter examination were used to assess valvular function. RESULTS Implantation was successful in 8 sheep. Shortly after surgery, all artificial valve stents exhibited normal open and close functionality and no stenosis or insufficiency. Heart rate was slightly elevated at this time, while all other hemodynamic parameters were normal. Six-month follow-up revealed no evidence of valve stent dislocation and normal valvular and cardiac functionality. There was no evidence of stent fracture. Repeated valve stent implantation was well tolerated as indicated by good valvular functionality 2 months postdelivery. CONCLUSION The novel pulmonary valve stent described herein can be delivered via percutaneous femoral vein transcatheter implantation and is highly efficacious at 6 months postdelivery. Furthermore, repeated valve stent replacement was successful.

Percutaneous reimplantation of a pulmonary valved stent in sheep: A potential treatment for bioprosthetic valve degeneration

OBJECTIVE Percutaneous pulmonary valve replacement has been recently introduced into clinical practice. Patients with transcatheter pulmonary valve replacement will definitely face the problems of valve degeneration. In addition to surgical re-replacement of the degenerated bioprosthetic valves, we studied the replacement of degenerated bioprosthetic valves with transcatheter reimplantation of stent-mounted pulmonary valves. METHODS Percutaneous pulmonary valve replacement was first performed in 6 sheep used a homemade valved stent. Two months after the initial procedure, the 6 sheep previously implanted with a valved stent underwent the same implantation procedure of a pulmonary valved stent. Hemodynamic assessment of the bioprosthetic pulmonary valve was obtained by echocardiography immediately post-implant and at 2 months follow-up. RESULTS All 6 sheep had successful transcatheter stent-mounted pulmonary valve replacement in the first experiment. After 2 months, reimplantation was successful in 5 sheep but failed in 1 sheep because the first valved stent was pushed to the bifurcation of the pulmonary artery by the delivery sheath. Echocardiography confirmed the stents were in the desired position during the follow-up. The remaining 5 sheep with normal valvular and cardiac functionality survived for 3 months after implantation. CONCLUSION Transcatheter stent-mounted bioprosthetic pulmonary valve reimplantation is feasible in an animal model and more convenient than open chest reimplantation.

Eighteen-month outcome of pulmonary valve stent implantation by direct right ventricle puncture: an animal study.

OBJECTIVE The purpose of this study was to investigate the feasibility and safety of pulmonary valve implantation via direct right ventricle puncture. METHODS A standard thoracotomy and direct right ventricle puncture were performed in 8 healthy sheep to implant the pulmonary valve stents. Animals were followed up for 18 months. RESULTS Three sheep died within the first 4 months after stent placement. The remaining 5 animals survived. After 18 months, examinations by color echocardiography, 64-slice computed tomography scan, and cardiac catheter showed an ideal position of each stent. The function of the pulmonary valves and hearts was not different compared with the preoperative conditions of the sheep. Anatomic examination revealed that the stent was covered by a layer of endothelial tissue with no stent fracture or valvular calcification. The histologic evaluation of the stent and surrounding tissue showed that the surface of the stent was smooth and covered by a complete layer of endothelial cells without obvious infiltration of inflammatory cells. The vascular wall was integrative without tear phenomenon in each layer of tissue. CONCLUSIONS These results show that pulmonary valve stents can be implanted via direct right ventricle puncture. Further studies evaluating xenograft valve material and the effect of implantation in vivo are needed.