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.

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.

Objective To explore the predictive value of CXC chemokine receptor 2(CXCR2)and Zonula occluden-1(ZO-1)for postoperative cerebral vasospasm in subarachnoid hemorrhage(SAH)patients with ruptured intracranial aneurysm.Methods A total of 215 SAH patients with ruptured intracranial aneurysm admitted to our hospital between May 2020 and October 2023 were recruited,and according to occurrence of postoperative cerebral vasospasm or not,they were separated into a spasm group(70 cases)and a non-spasm group(145 cases).The spasm group was further divided into mild,moderate and severe subgroups(14,38 and 18 cases,respectively).ELISA was applied to detect the serum levels of CXCR2 and ZO-1;Spearman and Pearson corre-lation analyses,multivariate logistic regression analysis,and ROC curve analysis were applied to test the correlation,influencing factors,and predictive value of indicators,and their AUC values were calculated.Results The spasm group had significantly higher CXCR2 and ZO-1 levels,inci-dence of intracranial hemorrhage,and larger proportions of Glasgow coma scale(GCS)score of 3-8 at admission,Hunt-Hess grade Ⅲ,and Fisher grades m and Ⅳ than the non-spasm group(P＜0.01).Intracranial hemorrhage volume,Hunt-Hess grade and Fisher grade were positively correlated with CXCR2 and ZO-1 levels,and the GCS score at admission was negatively correlated with the levels of the two indicators in the SAH patients with ruptured intracranial aneurysm(P＜0.01).CXCR2 and ZO-1 were independent risk factors for postoperative cerebral vasospasm in these patients(P＜0.01).The AUC value of CXCR2,ZO-1 and their combination in predicting postoperative cerebral vasospasm was 0.839(95％CI:0.780-0.898),0.813(95％CI:0.750-0.876),and 0.910(95％CI:0.869-0.951),with the combination showing better predictive per-formance(Z=2.391,Z=3.266,P＜0.05).The serum levels of CXCR2 and ZO-1 in the severe subgroup were significantly higher than those in the moderate subgroup and then followed by the mild subgroup in order,with statistical differences(P＜0.01).Conclusion Serum CXCR2 and ZO-1 levels are associated with postoperative cerebral vasospasm in SAH patients with ruptured intracranial aneurysm,and can be used as potential biomarkers for prognosis prediction.