Objective To preliminarily assess the biocompatibility and durability of the TruDelta TM transcatheter mitral valve replacement(TMVR)system.Methods Six adult sheep were divided into 3 groups based on the duration of f...Objective To preliminarily assess the biocompatibility and durability of the TruDelta TM transcatheter mitral valve replacement(TMVR)system.Methods 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 implanteddthrougah 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 followup 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.Results 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 TruDeltarm device exhibits favorable biocompatibility and durability.展开更多
文摘Objective To preliminarily assess the biocompatibility and durability of the TruDelta TM transcatheter mitral valve replacement(TMVR)system.Methods 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 implanteddthrougah 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 followup 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.Results 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 TruDeltarm device exhibits favorable biocompatibility and durability.
