Effectivity And Safety Of Transcatheter Aortic Valve Implantation In Patients With Servere Aortic Stenosis

BackgroudAortic valve stenosis (AS) is a disease of the heart valves in which the opening of the aortic valve is narrowed, and it is often due to rheumatic valve disease, congenitally abnormal valve and calcific disease.When the aortic valve becomes stenotic, resistance to systolic ejection occurs and a systolic pressure gradient develops between the left ventricle and the aorta, and contributes to symptom onset.In surgical pathologic cases in the United States, calcific AS is most commonly encountered, accounting for51%of cases, with bicuspid and rheumatic etiologies accounting for36%and9%of cases, respectively.As reported in people over65years old, morbidity is2%-7%.The patient with AS is asymptomatic for a prolonged period despite the obstruction and increased pressure load on the left ventricle. Once definite symptoms of aortic stenosis are present, outcome is very poor without intervention. Studies indicate survival rates with severe symptomatic aortic stenosis of only15%to50%at5years.Surgical aortic valve replacement (SAVR) is the main traetment of symptomatic AS, but there are still30%to40%patients deemed to have excessive risk for traditional surgery.In last10years, many registries indicate that transcatheter aortic valve implantation(TAVI) is effect and safe, and is an alternative treatment of SAVR. Nowadays, more than130thousand TAVI have been performed. Bicuspidaortic valve (BAV) is the most common congenital heart disease and may lead to aortic stenosis (AS), its morbidity is0.5%to2%. Because of its specific anatomic characteristics, BAV was considered a contraindication to TAVI, but now with the development of technology, there have been some reports that indicate TAVI is also effect and safe in BAV patients.Part1Outcomes of transcatheter aortic valve implantation in patients with servere aortic stenosisObjectiveThis study is to evaluate the efficacy and safety of TAVI in high-risk patients with severe aortic stenosis.MethodInclude from March2013to April2014, high-risk patients with severe aortic stenosis, whose age≥65years old and NYHA class≥Ⅱ. Preprocedural assessment includes heart function, aortic annular size and shape, distance between annulus and coronary ostia, aortic valve, dimensions and atherosclerosis of aorta and iliofemoral vessels using dual-source computed tomography (DSCT), transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). TAVI was performed by experienced interventional cardiologists according to standard operating procedures. During perioperative period, patients were monitored closely. At1month-,3month-and12-month follow-up, pro-BNP test, echocardiography and NYHA class were performed. The main efficacy points of this study were aortic valve area, mean aortic gradient, and combined end points were parameters of heart function including left ventricular ejection fraction (LVEF), pro-BNP and NYHA class. Secondary end points included the rate of death from any cause at1year, repeat hospitalization because of heart failure and device success. A safety composite end point included periprocedural all-cause mortality,major stroke, life-threatening bleeding, periprocedural myocardial infarction, acute kidney injury (including stage3and renal replacement therapy), major vascular complications, valve dysfunction and pacemaker implantation.The data were analyzed using SPSS statistics20.0. Normality test and homoscedasticity test were performed. Quantitative variables are expressed as mean±tandard deviation. Comparison of quantitative variables was performed with a paired Student t test. Qualitative variables are expressed as numbers and percentages, chi-square test or the Fisher exact test was used to compare qualitative variables depending on variable distribution.ResultEighteen servere AS patients were diagnosed by echocardiography, including14males and4females. Patients’ age was75±5years old, STS was5.80±4.25%, and Logistic EuroSCORE was18.54±6.76%. Device success was100%, and mortality at1years was5.6%, which was caused by servere pulmonary infection during1month. At1-month follow up, rate of NYHA class≥Ⅲ was6%, compared to baseline, the NYHA class was significantly improved (NYHA class≥Ⅲ6%vs.83.3%, P<0.001). There was significant difference in aortic valve area (1.48±0.17cm2vs.0.53±0.14cm2, P<0.001), mean pressure gradient (10.94±4.17mmHg vs.55.56±16.84mmHg, P<0.001), LVEF (55.29±6.90%vs.49.04±12.10%, P=0.005) and pro-BNP (3206±3525pg/ml vs.11394±11613pf/ml, P=0.003) in1-month follow up compared with baseline, and there was no moderate or above parabasilar leak. Complications included minor stroke in1patient, severe atrioventricular block needing permanent pacemaker implantation in3patients, no major stroke, major bleeding, myocardial infarction, acute kidney injury including stage3and renal replacement therapy and major vascular complications. Part2Efficacy and safety of transcatheter aortic valve implantation in high-risk patients with servere stenotic bicuspid aortic valvesObjectiveThis study is to evaluate the efficacy and safety of TAVI in high-risk patients with servere stenotic bicuspid aortic valvesMethodInclude from March2013to April2014, high-risk patients with severe aortic stenosis, whose age≥65years old and NYHA class≥Ⅱ. According to etiology, patients were divided into BAV group [BAV was diagnosed by dual-source computed tomography (DSCT) and echocardiography] and non-BAV group.Preprocedural assessment includes heart function, aortic annular size and shape, distance between annulus and coronary ostia, aortic valve, dimensions and atherosclerosis of aorta and iliofemoral vessels using dual-source computed tomography (DSCT), transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). TAVI was perfn. ned by experienced interventional cardiologists according to standard operating procedures. During perioperative period, patients were monitored closely. At1month-,3month-and12-month follow-up, pro-BNP test, echocardiography and NYHA class were performed. The main efficacy points of this study were aortic valve area, mean aortic gradient, and combined end points were parameters of heart function including left ventricular ejection fraction (LVEF), pro-BNP and NYHA class. Secondary end points included the rate of death from any cause at1year, repeat hospitalization because of heart failure and device success. A safety composite end point included periprocedural all-cause mortality, major stroke, life-threatening bleeding, periprocedural myocardial infarction, acute kidney injury (including stage3and renal replacement therapy), major vascular complications, valve dysfunction and pacemaker implantation. The data were analyzed using SPSS statistics20.0. Normality test and homoscedasticity test were performed. Quantitative variables are expressed as mean±tandard deviation. Comparison of quantitative variables was performed with an unpaired Student t test or Mann-Whitney U test, depending on variable distribution. Qualitative variables are expressed as numbers and percentages, chi-square test or the Fisher exact test was used to compare qualitative variables depending on variable distribution.ResultEighteen servere AS patients were diagnosed were diagnosed by echocardiography, including8BAV patients and10non-BAV patients. In BAV group, there were6males and2females, and patients’ age was74±3years old, STS was4.43±1.80%, Logistic EuroSCORE was18.05±5.07%; in non-BAV group, there were8males and2females, and patients’ age was76±7years old, STS was6.89±5.34%, Logistic EuroSCORE was18.93±8.12%. There was no significant difference in age, sex, body mass index (BMI), creatinine, STS, Logistic EuroSCOR, concomitant diseases and pacemaker implantation at baseline between BAV group and non-BAV group. The BAV group had no significant difference in mean aortic gradient, LVEF, pro-BNP level and NYHA class compared to non-BAV group except for aortic valve area (0.44±0.06cm2vs.0.61±0.14cm2, P=0.005).There was no significant difference in device success (100%vs.100%, P=1.00), risk of valve-in-valve (12.5%vs.10%, P=1.00), or coronary occlusion (0%vs.0%, P=1.00), or valve migration (0%vs.0%, P=1.00), or conversion to open heart surgery (0%vs.0%, P=1.00) in BAV patients compared with non-BAV patients.1-month aortic valve area (1.50±0.12cm2vs.1.47±0.21cm2, P=0.68), mean pressure gradient (9.86±3.39mmHg vs.11.78±4.71mmHg, P=0.38), moderate or above aortic regurgitation (0%vs.0%, P=1.00) were also similar in both groups. Compared to non-BAV group, there were significant differences in change of aortic valve area (variable1.07±0.09cm2vs.0.82±0.14cm2, P=0.001; variability249±38%vs.143±44%, P<0.001) and NYHA class (variable-2.00±0.58vs.-1.22±0.67, P=0.003; variability63±14%vs.38±19%, P=0.01). The mortality (0%vs.10%, P=1.00), major stroke (0%vs.0%, P=1.00), major bleeding (0%vs.0%, P=1.00), myocardial infarction (0%vs.0%, P=1.00), acute kidney injury including stage3and renal replacement therapy (0%vs.0%, P=1.00) and major vascular complication (0%vs.0%, P=1.00) were similar in both groups.ConclusionThis study is to evaluate the efficacy and safety of TAVI in high-risk old patients with severe aortic stenosis. The result indicates that TAVI can effectively increase aortic valve area, decrease mean aortic gradient, decrease pro-BNP level, improve LVEF and NYHA class. So TAVI is an effective and safe interventional therapy that has good application prospects. Compared to non-BAVpatients, TAVI can more effectively increase aortic valve area and improve NYHA class in BAV patients, but it dosen’t increase periprocedural all-cause mortality and morbidity of major stroke, life-threatening bleeding, periprocedural myocardial infarction, acute kidney injury, major vascular compli(?)ons, valve dysfunction and pacemaker implantation.So TAVI has some advantage in these patients.