OBJECTIVE To compare the outcomes of transapical transcatheter aortic valve replacement(TA-TAVR)and surgical aortic valve replacement(SAVR)using a large US population sample.METHODS The U.S.National Inpatient Sample w...OBJECTIVE To compare the outcomes of transapical transcatheter aortic valve replacement(TA-TAVR)and surgical aortic valve replacement(SAVR)using a large US population sample.METHODS The U.S.National Inpatient Sample was queried for all patients who underwent TA-TAVR or SAVR during the years2016-2017.The primary outcome was all-cause in-hospital mortality.Secondary outcomes were in-hospital stroke,pericardiocentesis,pacemaker insertion,mechanical ventilation,vascular complications,major bleeding,acute kidney injury,length of stay,and cost of hospitalization.Outcomes were modeled using multi-variable logistic regression for binary outcomes and generalized linear models for continuous outcomes.RESULTS A total of 1560 TA-TAVR and 44,280 SAVR patients were included.Patients who underwent TA-TAVR were older and frailer.Compared to SAVR,TA-TAVR correlated with a higher mortality(4.5%vs.2.7%,effect size(SMD)=0.1)and higher periprocedural complications.Following multivariable analysis,both TA-TAVR and SAVR had a similar adjusted risk for in-hospital mortality.TA-TAVR correlated with lower odds of bleeding with(adjusted OR(aOR)=0.26;95%CI:0.18-0.38;P<0.001),and a shorter length of stay(adjusted mean ratio(aMR)=0.77;95%CI:0.69-0.84;P<0.001),but higher cost(aMR=1.18;95%CI:1.10-1.28;P<0.001).No significant differences in other study outcomes.In subgroup analysis,TA-TAVR in patients with chronic lung disease had higher odds for mortality(aOR=3.11;95%CI:1.37-7.08;P=0.007).CONCLUSION The risk-adjusted analysis showed that TA-TAVR has no advantage over SAVR except for patients with chronic lung disease where TA-TAVR has higher mortality.展开更多
Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardia...Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardial tissue bioprosthesis.Methods The valve was implanted in 26 sheep using a transapical approach for short-and long-term evaluation.The technical feasibility,safety,durability,and valve function were evaluated during and 6 months after the procedure using intracardiac and transthoracic echocardiography,multisliced computed tomography,histological analysis,and electron microscopy.Results The success rate of valve implantation was 100%,and the immediate survival rate after surgery was 84%.Five animals died within 90 min after the development of the prosthetic valve due to an acute left ventricular outflow tract obstruction(n=2)and sudden intraoperative ventricular fibrillation(n=3).Twelve animals died within 1 month due to acute left heart dysfunction.Mild(n=5)and moderate(n=2)paravalvular leakage occurred in seven animals,and two moderate PVL animals died of chronic heart failure within three months.Multimodality imaging studies of the remaining seven animals showed excellent function and alignment of the valves,with no coronary artery obstruction,no left ventricular outflow tract obstruction,no severe transvalvular gradients and no paravalvular leakage.Macroscopic evaluation demonstrated stable,secure positioning of the valve,with full endothelialization of the valve leaflets without injury to the ventricular or atrial walls.Histological and electron microscopic examinations at six months showed no obvious macro-or microcalcification in the leaflets.Conclusions Preclinical studies indicate that transcatheter implantation of the Mi-thos valve is technically safe and feasible.The durability,functionality,and lack of leaflet calcification were all verified in animal experiments.The information from these preclinical studies will be applied to patient selection criteria and the first-in-human studies.展开更多
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 compare the outcomes of transapical transcatheter aortic valve replacement(TA-TAVR)and surgical aortic valve replacement(SAVR)using a large US population sample.METHODS The U.S.National Inpatient Sample was queried for all patients who underwent TA-TAVR or SAVR during the years2016-2017.The primary outcome was all-cause in-hospital mortality.Secondary outcomes were in-hospital stroke,pericardiocentesis,pacemaker insertion,mechanical ventilation,vascular complications,major bleeding,acute kidney injury,length of stay,and cost of hospitalization.Outcomes were modeled using multi-variable logistic regression for binary outcomes and generalized linear models for continuous outcomes.RESULTS A total of 1560 TA-TAVR and 44,280 SAVR patients were included.Patients who underwent TA-TAVR were older and frailer.Compared to SAVR,TA-TAVR correlated with a higher mortality(4.5%vs.2.7%,effect size(SMD)=0.1)and higher periprocedural complications.Following multivariable analysis,both TA-TAVR and SAVR had a similar adjusted risk for in-hospital mortality.TA-TAVR correlated with lower odds of bleeding with(adjusted OR(aOR)=0.26;95%CI:0.18-0.38;P<0.001),and a shorter length of stay(adjusted mean ratio(aMR)=0.77;95%CI:0.69-0.84;P<0.001),but higher cost(aMR=1.18;95%CI:1.10-1.28;P<0.001).No significant differences in other study outcomes.In subgroup analysis,TA-TAVR in patients with chronic lung disease had higher odds for mortality(aOR=3.11;95%CI:1.37-7.08;P=0.007).CONCLUSION The risk-adjusted analysis showed that TA-TAVR has no advantage over SAVR except for patients with chronic lung disease where TA-TAVR has higher mortality.
基金This paper was supported by the National Key Research and Development Plan(2016YFC1101000)National Natural Science Foundation of China(81600240 and 81470500)The Distinguished Young Scholar Cultivation Project of Xijing Hospital(XJZT14J03,XJZT15ZL01,and 13QNP129)。
文摘Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardial tissue bioprosthesis.Methods The valve was implanted in 26 sheep using a transapical approach for short-and long-term evaluation.The technical feasibility,safety,durability,and valve function were evaluated during and 6 months after the procedure using intracardiac and transthoracic echocardiography,multisliced computed tomography,histological analysis,and electron microscopy.Results The success rate of valve implantation was 100%,and the immediate survival rate after surgery was 84%.Five animals died within 90 min after the development of the prosthetic valve due to an acute left ventricular outflow tract obstruction(n=2)and sudden intraoperative ventricular fibrillation(n=3).Twelve animals died within 1 month due to acute left heart dysfunction.Mild(n=5)and moderate(n=2)paravalvular leakage occurred in seven animals,and two moderate PVL animals died of chronic heart failure within three months.Multimodality imaging studies of the remaining seven animals showed excellent function and alignment of the valves,with no coronary artery obstruction,no left ventricular outflow tract obstruction,no severe transvalvular gradients and no paravalvular leakage.Macroscopic evaluation demonstrated stable,secure positioning of the valve,with full endothelialization of the valve leaflets without injury to the ventricular or atrial walls.Histological and electron microscopic examinations at six months showed no obvious macro-or microcalcification in the leaflets.Conclusions Preclinical studies indicate that transcatheter implantation of the Mi-thos valve is technically safe and feasible.The durability,functionality,and lack of leaflet calcification were all verified in animal experiments.The information from these preclinical studies will be applied to patient selection criteria and the first-in-human studies.
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.
