Animal study results of a novel designed transcatheter mitral valve replacement system
10.3760/cma.j.cn112148-20250126-00069
- VernacularTitle:TruDelta TM经导管二尖瓣介入置换系统动物试验评价结果
- Author:
Da ZHU
1
;
Shouzheng WANG
;
Jianbin GAO
;
Zhiling LUO
;
Ke YANG
;
Chunmei XIE
;
Pengxu KONG
;
Shuyi FENG
;
Hong JIANG
;
Xiangbin PAN
Author Information
1. 云南省阜外心血管病医院 昆明医科大学附属心血管医院结构性心脏病中心，昆明 650102
- Publication Type:Journal Article
- Keywords:
Mitral valve;
Mitral valve insufficiency;
Animal experiment
- From:
Chinese Journal of Cardiology
2025;53(3):287-292
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To preliminarily assess the biocompatibility and durability of the TruDelta TM transcatheter mitral valve replacement (TMVR) system. Method:Six adult sheep were divided into 3 groups based on the duration of follow-up: 30 days ( n=1), 90 days ( n=3) and 180 days ( n=2). The TruDelta TM TMVR system was implanted through a transapical approach under transesophageal echocardiographic guidance. The operability of the TMVR system was evaluated using an instrument performance evaluation scale (consisting of 39 items), with scores ranging from 1 (worst) to 10 (best) assigned by the operator. Echocardiography was conducted preoperatively, immediately after surgery, and at 30, 90, and 180 days post-implantation. At the last follow-up time point, the intervention mitral valve membrane and major organs were dissected for observation. The artificial valves were taken for hematoxylin eosin (HE) staining and observed under a scanning electron microscope. Result:All six procedures were successfully completed using 29S size TruDelta TM TMVR device. At the final follow-up, echocardiogram demonstrated good valve function without obvious paravalvular leakage, with a transvalvular gradient of (7.8±3.2) mmHg (1 mmHg=0.133 kPa) and a mitral valve orifice area of (1.8±0.2) cm 2. Autopsy findings revealed no structural valve failure and almost complete endothelialization (>75%) with 90 to 180 days. Both HE staining and scanning electron microscopy confirmed optimal endothelialization of the valve stent. Conclusion:The preclinical animal study indicates that the TruDelta TM device exhibits favorable biocompatibility and durability.
