A new coated nitinol occluder for transcatheter closure of ventricular septal defects in a canine model.
OBJECTIVE
This study evaluated feasibility and safety of implanting the polyester-coated nitinol ventricular septal defect occluder (pcVSDO) in the canine model.


RESULTS
VSD models were successfully established by transseptal ventricular septal puncture via the right jugular vein in 15 out of 18 canines. Two types of VSDOs were implanted, either with pcVSDOs (n = 8) as the new type occluder group or with the commercial ventricular septal defect occluders (VSDOs, n = 7, Shanghai Sharp Memory Alloy Co. Ltd.) as the control group. Sheath size was 10 French (10 Fr) in two groups. Then the general state of the canines was observed after implantation. ECG and TTE were performed, respectively, at 7, 30, 90 days of follow-up. The canines were sacrificed at these time points for pathological and scanning electron microscopy examination. The devices were successfully implanted in all 15 canines and were retrievable and repositionable. There was no thrombus formation on the device or occurrence of complete heart block. The pcVSDO surface implanted at day 7 was already covered with neotissue by gross examination, and it completed endothelialization at day 30, while the commercial VSDO was covered with the neotissue in 30th day and the complete endothelialization in 90th day.


CONCLUSIONS
The study shows that pcVSDO is feasible and safe to close canine VSD model and has good biocompatibility and shorter time of endothelialization.
Department of Cardiology, The No. 411 Hospital of People's Liberation Army, Shanghai 200081, China ; Department of Cardiology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China.
Yong
Y
Zhou
Feng
F
Chen
Xinmiao
X
Huang
Xianxian
X
Zhao
Hong
H
Wu
Yuan
Y
Bai
Yongwen
Y
Qin
D000497:Alloys / Q000009:adverse effects / Q000737:chemistry* / Q000627:therapeutic use; D000818:Animals; D057785:Catheters / Q000009:adverse effects*; D020099:Coated Materials, Biocompatible / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D004195:Disease Models, Animal; D004285:Dogs; D006345:Heart Septal Defects, Ventricular / Q000473:pathology / Q000628:therapy*; D006801:Humans; D011091:Polyesters / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D055989:Septal Occluder Device / Q000009:adverse effects*
D000497:Alloys; D020099:Coated Materials, Biocompatible; D011091:Polyesters; C013616:nitinol