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
Background::Acute type A aortic dissection(ATAAD)and acute type A intramural hematoma(ATAIMH)are life-threatening diseases with high mortality.To better understand their clinical features in the Chinese population,we ...Background::Acute type A aortic dissection(ATAAD)and acute type A intramural hematoma(ATAIMH)are life-threatening diseases with high mortality.To better understand their clinical features in the Chinese population,we analyzed the data from the first Registry of Aortic Dissection in China(Sino-RAD)to promote the understanding and management of the diseases.Methods::All patients with ATAAD and ATAIMH enrolled in Sino-RAD from January 1,2012 to December 31,2016 were involved.The data of patients’selection,history,symptoms,management,outcomes,and postoperation complications were analyzed in the study.The continuous variables were compared using the Student’s t test for normal distributions and the Mann-Whitney U test for non-normal distributions.Categorical variables were compared using the Chi-square test or Fisher exact test.Results::A total of 1582 patients with ATAAD and 130 patients with ATAIMH were included.The mean age of all patients was 48.4 years.Patients with ATAAD were significantly younger than patients with ATAIMH(48.9 years vs.55.6 years,P<0.001).For the total cohort,males were dominant,but the male ratio of patients with ATAAD was significantly higher compared to those with ATAIMH(P=0.01).The time range from the onset of symptom to hospitalization was 2.0 days.More patients of ATAIMH had hypertension than that of ATAAD(82.3%vs.67.6%,P<0.05).Chest and back pain were the most common clinical symptoms.Computerized tomography(CT)was the most common initial diagnostic imaging modality.84.7%received surgical treatment and in-hospital mortality was 5.3%.Patients with ATAAD mainly received surgical treatment(89.6%),while most patients with ATAIMH received medical treatment(39.2%)or endovascular repair(35.4%).Conclusions::Our study suggests that doctors should comprehensively use clinical examination and genetic background screening for patients with ATAAD and ATAIMH and further shorten the time range from symptoms onset to intervention,achieving early diagnosis and treatment,thereby reducing the mortality rate of patients with aortic dissection in China.We should standardize the procedures of aortic dissection treatment and improve people’s understanding.Meanwhile,the curing and transferring efficiency should also be improved.展开更多
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.
基金the National Key Research and Development Program of China(2016YFC1301900)the National Natural Science Foundation of China(81970213,81870218,and 81770373)the Subject Booster Program from Xijing Hospital,the Fourth Military Medical University(XJZT18M L13).
文摘Background::Acute type A aortic dissection(ATAAD)and acute type A intramural hematoma(ATAIMH)are life-threatening diseases with high mortality.To better understand their clinical features in the Chinese population,we analyzed the data from the first Registry of Aortic Dissection in China(Sino-RAD)to promote the understanding and management of the diseases.Methods::All patients with ATAAD and ATAIMH enrolled in Sino-RAD from January 1,2012 to December 31,2016 were involved.The data of patients’selection,history,symptoms,management,outcomes,and postoperation complications were analyzed in the study.The continuous variables were compared using the Student’s t test for normal distributions and the Mann-Whitney U test for non-normal distributions.Categorical variables were compared using the Chi-square test or Fisher exact test.Results::A total of 1582 patients with ATAAD and 130 patients with ATAIMH were included.The mean age of all patients was 48.4 years.Patients with ATAAD were significantly younger than patients with ATAIMH(48.9 years vs.55.6 years,P<0.001).For the total cohort,males were dominant,but the male ratio of patients with ATAAD was significantly higher compared to those with ATAIMH(P=0.01).The time range from the onset of symptom to hospitalization was 2.0 days.More patients of ATAIMH had hypertension than that of ATAAD(82.3%vs.67.6%,P<0.05).Chest and back pain were the most common clinical symptoms.Computerized tomography(CT)was the most common initial diagnostic imaging modality.84.7%received surgical treatment and in-hospital mortality was 5.3%.Patients with ATAAD mainly received surgical treatment(89.6%),while most patients with ATAIMH received medical treatment(39.2%)or endovascular repair(35.4%).Conclusions::Our study suggests that doctors should comprehensively use clinical examination and genetic background screening for patients with ATAAD and ATAIMH and further shorten the time range from symptoms onset to intervention,achieving early diagnosis and treatment,thereby reducing the mortality rate of patients with aortic dissection in China.We should standardize the procedures of aortic dissection treatment and improve people’s understanding.Meanwhile,the curing and transferring efficiency should also be improved.
