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A domestically produced self-expanding transcatheter aortic valve controllable bending delivery system(VitaFlow? Ⅲcontrollable bending retrievable delivery system)was first used to perform transcatheter aortic valve replacement(TAVR)in a symptomatic severe aortic valve stenosis patient with severe heart failure and high risk of surgery in China on September 22,2023.The patient successfully completed TAVR under general anesthesia,with good valve position and function after the operation.Before discharge and at one month of follow-up,the patient's symptoms and degree of heart failure were significantly improved.The follow-up results of this case showed that the VitaFlow? Ⅲ controllable bending retrievable delivery system for TAVR is safe and feasible,and future prospective,multicenter clinical trials are expected to evaluate its efficacy.
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Objective@#To investigate the impact of aortic root morphology on the implantation depth of aortic valve prosthesis during trans-catheter aortic valve replacement (TAVR) in bicuspid aortic valve patients.@*Methods@#Clinical data of 40 patients with native bicuspid aortic valve stenosis who underwent TAVR using the self-expandable prosthesis (the Venus A-valve) from 2014 to 2017 in Fuwai Hospital was retrospectively analyzed. The patients were divided into non-deep implantation group (implant depth ≤10 mm by instant angiogram after implantation,29 cases) and deep implantation group (implant depth> 10 mm by instant angiogram after implantation,11 cases).Pre-procedural aortic root characteristics (e.g. calcification, angle and dimensions) were assessed by CT. The impact of aortic root morphology on the implantation depth and clinical outcomes were also evaluated.@*Results@#The age was (75.1±5.9) years with equal representation from the raphe-type and non-raphe type (52.5%(21/40) and 47.5%(19/40)).The bigger aorta angle ((56.5±4.5)° vs. (47.4±9.4)°, P=0.004),more frequent mild-calcification (HU850, <200 mm3) or severe-calcification(HU850, >1 000 mm3) of aortic leaflets (7/11 vs. 4/29, P=0.006), as well as higher ratio of left ventricular outflow tract perimeter to annulus perimeter ((109.2±7.5)% vs. (101.5±6.5)%, P=0.004) were found in the deep implantation group compared to the non-deep implantation group. The new in-hospital onset of bundle-branchheart-block or atrioventricular block conduction disturbance rate was higher in the deep implantation group than in the non-deep implantation group (6/11 vs. 2/29, P=0.030).Left ventricular ejection fraction was similar between deep implantation group and non-deep implantation group at baseline((49.9±8.9)% vs. (55.8±10.4)%, P=0.117), and was significantly lower in the deep implantation group than in the non-deep implantation group at 30 days after implantation ((51.6±12.8)% vs. (60.9±8.1)%, P=0.020).@*Conclusion@#Aortic root morphology of bicuspid aortic valve patients is associated with implantation depth of the prosthesis during TAVR, which affects the conduction system and left ventricular function during and post TAVR.
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Objective@#To compare the outcome of surgical high-risk elderly patients with severe aortic stenosis(SAS) treated by different therapy procedures, including transcatheter aortic valve implantation(TAVI), surgical aortic valve replacement(SAVR), and drug therapy.@*Methods@#We retrospectively analyzed the clinical data of 242 surgical high-risk elderly (age ≥65 years old) SAS patients hospitalized in Fuwai Hospital between September 2012 and June 2015. According to the treatment method, patients were divided into TAVI group (81 cases), SAVR group (59 cases) and drug therapy group (102 cases). The primary end point was all-cause mortality at 1 year post procedure, and secondary end point included cardiac function class(NYHA), vascular complication, valvular function, non-fatal myocardial infarction, new atrial fibrillation, stroke, bleeding, pacemaker implantation, acute renal failure, and readmission. We used the Kaplan-Meier method to estimate survival function based on follow up data and survival was compared between groups with the use of the log-rank test.@*Results@#(1) In the baseline data, there were statistically significant difference among 3 groups for the age, left ventricular ejection fraction, cardiac function class Ⅲ and Ⅳ, rates of combined diabetes, chronic renal failure, mild and moderate mitral regurgitation (P<0.01 or 0.05). The risk score of the Society of Thoracic Surgeons(STS) was 7.28±4.98 in the TAVI group, and 5.67±3.49 in the SAVR group(P=0.036). (2) The perioperative rates of pacemaker implantation(11.3%(9/81) vs. 0, P=0.025) and mild paravalvular regurgitation(29.6%(24/81) vs.1.7%(1/59), P<0.001) were significantly higher in TAVI group than in SAVR group.(3)The rate of rehospitalization was significantly lower in TAVI group than in SAVR group(3.0%(2/67) vs. 22.7%(10/44) P=0.005) and the rate of pacemaker implantation was significantly higher in TAVI group than in SAVR group(17.5 (12/67) vs. 0, P=0.008) after 1 year. The rates of death from any cause in the TAVI (5.8%(4/67)) and SAVR group (11.4%(5/44)) were significantly lower than that in the drug therapy group (54.9%(50/91), both P<0.05) after 1 year and was similar between TAVI group and SAVR group(P=0.622). (4) The rates of cardiac function classⅠandⅡ increased and Ⅲ and Ⅳ decreased in TAVI and SAVR group after 1 year when compared with base line(P<0.001). The rates of cardiac function class Ⅱ, and Ⅲ increased , class Ⅰ and Ⅳ decreased in drug therapy group after 1 year compared with base line (P=0.020). (5)The survival rates after 1 year were significantly higher in the TAVI group and SAVR group than in the drug therapy group(log-rank test, P<0.001), and the difference was similar between TAVI group and SAVR group (log-rank test, P=0.062).@*Conclusion@#In surgical high-risk elderly patients with SAS, the prognosis of drug therapy was poor, and TAVI and SAVR were associated with similarly improved rates of survival after 1 year, although there were significant differences in periprocedural complications between TAVI and SAVR groups.
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Objective@#To evaluate the effect of transcatheter aortic valve replacement(TAVR) using Venus-A valve for treating patients with severe aortic stenosis.@*Methods@#In this prospective study, 101 consecutive severe aortic stenosis patients with high surgical risk(Society of Thoracic Surgeon(STS) score ≥4%) or at prohibitive surgical risk were enrolled from 5 academic cardiovascular centers in China(Fuwai hospital, the second affiliated hospital of Zhejiang university school of medicine, West China hospital of Sichuan university, the first affiliated hospital of Nanjing medical university, Ruijin hospital of Shanghai Jiaotong university school of medicine) from September 2012 to January 2015, and Venus-A valves were used in TAVR for these patients. The primary endpoints were death from any cause and major stroke in 1 year. The secondary endpoints included efficacy and safety of TAVR in 1 year.@*Results@#TAVR success rate was 97.9%(98/101), and 3 patients were transferred to receive surgical AVR. There were 85 patients using 1 Venus-A valve, and 13 patients underwent valve-in-valve implantation using 2 Venus-A valves. There were 1 case(1.0%) of stroke, 2 cases(2.0%)of acute myocardial infarction, 5 cases(5.0%) of pericardial effusion, 6 cases(5.9%) of severe vascular complication, and 2 cases(2.0%) of death after 7 days of TAVR. Meanwhile, aortic pressure gradient derived from echocardiography was significantly reduced when compared with pre-procedure level(11(8, 15) mmHg (1 mmHg=0.133 kPa) vs. 59(45, 71)mmHg, P<0.01), and there was no aortic root rupture or leaflets thrombosis. Rate of NYHA functional class ≤Ⅱ improvements were observed at 6 months follow-up when compared with pre-procedure(94.4%(84/89)vs. 21.3%(21/89), P<0.01). The primary endpoint was 7.9%(8/11), and the incidence of all cause death and stroke was 5.9%(6/101) and 2.0%(2/101) respectively at 1 year after the procedure. Kaplan-Meier survival analysis showed that cumulative survival rate was 94.1% at 1 year after the procedure.@*Conclusion@#TAVR using Venus-A valve for treating patients with severe aortic stenosis is effective and safe in the early and medium term post procedure.
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Objective: To analyze the risk factors affecting prognosis of calciifc aortic stenosis in patients elder than 75 years of age and to compare the safety among different treatments. Methods: A total of 421 consecutive aortic stenosispatients treated in our hospital from 2008-01-01 to 2015-01-01 were retrospectively studied. The patients were at the age of (79.1 ± 3.5) years and with 243 (57.7%) of male gender. According to echocardiography data, the patients were divided into 3 groups: Mild stenosis group,n=112, Moderate stenosis group,n=83 and Severe stenosis group,n=226. All patients were followed-up for 1 year to observe the end point of all cause and cardiac death. In Severe stenosis group, mortalities by different treatments were compared; the risk factors related to death were calculated by Logistic regression analysis. Results: The overall 1 year all cause and cardiac mortalities were 22.3% (94/421) and 19.7% (83/421) respectively, both all cause and cardiac mortalities were similar among 3 groups,P>0.05. Multivariate Logistic regression analysis indicated that peripheral vascular disease (OR=2.31, 95% CI 1.215-4.392), LVEF (OR=0.966, 95% CI 0.942-0.991) and NT-proBNP (OR=2.022, 95% CI 1.140-3.586) were the independent risk factors for 1 year all cause death; diabetes (OR=2.157, 95% CI 1.213-3.836), LVEF (OR=0.975, 95% CI 0.950-1.000), NT-proBNP (OR=2.786, 95% CI 1.449-5.356) and blood levels of phosphorus (OR=5.755, 95% CI 1.462-22.657) were the independent risk factors for 1 year cardiac death. In Severe stenosis group, the all cause mortalities by medication, PBAV, TAVR and SAVR were 43.6%, 57.1%, 7.3% and 6.45% respectively, the patients with TAVR, SAVR had the lower mortality than those with medication, P0.05. Conclusion: All cause and cardiac mortalities within 1 year were increasing with the age accordingly, while aortic stenosis grade was not related to mortality in elder patients with calcific aortic stenosis. Peripheral vascular disease and blood levels of phosphorus were the risk factors affecting prognosis. TAVR and SAVR had better effect for treating the patients with severe aortic stenosis.
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Objective: To study the aortic root imaging and clinical application in 15 patients with transcatheter aortic valve implantation (TAVI). Methods: A total of 15 patients with severe aortic valve stenosis received TAVI in our hospital from 2011-03 to 2013-11 were studied. The CT scan and transthoracic echocardiography were conducted to measure the aortic root anatomy and the differences of annulus size between CT and echocardiography were calculated. The prosthetic valves were selected based on CT measurement. The pre-operative accuracy of measurement was evaluated by the follow-up study at 6 months after operation. Results: The CT measured pre-operative aortic annulus short diameter was (21.5 ± 2.4) mm, long diameter was (27.3 ± 2.7) mm, the average inner diameter was (24.4 ± 2.4) mm, left ventricular out lfow (LVOF) tract long diameter was (28.3 ± 4.5) mm, the average inner diameter of LVOF was (24 ± 3.5), ascending aorta diameter was (35.3 ± 4.4) mm. The Venus Medtech A-Valve implanted in 8 patients with #26 and in 7 patients with #29. The average inner diameter of aortic annulus measured by CT was larger than transthoracic echocardiography, P Conclusion: There is a difference for aortic annulus size by CT and transthoracic echocardiography measurements. CT may presisely assess the aortic root morphology and provide strong support for TAVI.