Chinese Expert Consensus on Transcatheter Aortic Valve Replacement (2020 Update)

Introduction Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation, refers to the installation of an artificial stented valve into a catheter and its delivery into the aortic valve position to replace the function of the aortic valve. Since the first successful case in 2002,[1] TAVR has become the first-line treatment option for aortic stenosis (AS) in the elderly. European and American countries have published and updated TAVR guiding documents.[2-6] The development of TAVR in China is relatively slow, and the first case of TAVR[7] was performed on October 3, 2010. However, TAVR has entered a stage of rapid and comprehensive development in China since the 2017 approval of two domestic valves. The Structural Heart Disease Professional Committee, Cardiovascular Branch, Chinese Physicians' Association issued the first TAVR guiding document, “Chinese expert consensus on transcatheter aortic valve replacement” at the end of 2015.[8] The document has played a positive role in guiding the early promotion of TAVR in China. Since the publication of the document, significant progress has been made in the devices, clinical research, and application experiences in TAVR. Therefore, this expert consensus needs to be updated to update the knowledge on TAVR and promote the healthy, standardized, and rapid development of TAVR in China. Epidemiological Characteristics of Aortic Valve Disease In Western countries, AS is a common heart disease in the elderly, and its incidence increases with age. About 2% of the population over 65 years and 4% over 85 years have been reported to suffer from AS.[9,10] There are no exact epidemiological data on AS in China. A single-center echocardiography database analysis indicated that the incidence of AS in China may be lower than that in Western countries.[11] TAVR candidates in China have a higher proportion of bicuspid aortic valve (BAV), more severe calcification, more aortic regurgitation (AR), a higher proportion of rheumatic etiology, and a smaller femoral artery diameter than those in Western countries.[11-15] In addition, in the constitution of the anatomical subtypes of patients with BAV undergoing TAVR, the Type 0 (non-ridge type) in Chinese patients is higher than that in patients from Western countries.[12] Although the proportion of BAV in TAVR candidates in China is relatively higher, a single-center study showed that the proportion in Chinese patients with severe AS might be similar to that in patients from Western countries (about 50% in patients aged 60-80 years and about 20% in those over 80 years).[16] Another large sample population analysis based on an echocardiography database showed that the incidence and complication rate of BAV in China were similar to those in the Western population.[14] Current Status of Transcatheter Aortic Valve Replacement Based on the results of the Partner 2[4] and SURTAVI trials,[5] the European and American guidelines have recommended patients at extremely high, high, and intermediate risk for surgery as an indication for TAVR. Recently, the PARTNER 3 (using balloon-expanding valve Sapien 3)[17] and Evolut Low-Risk Trial (using self-expanding valve Evolut R) studies[18] showed that in patients at low risk for surgery, TAVR was superior to or not inferior to surgery. Based on these two trials, in 2019, the US and European governments approved the Sapien 3 and Evolut R transcatheter heart valves for use in low-risk patients. Until 2019, more than a dozen types of TAVR valves were approved for clinical application outside China. Over 400000 cases of TAVR have been performed globally. In May 2017, two domestic valves (Venus-A and J-Valve) were approved in China. In July 2019, another domestic valve (VitaFlow) was approved. Venus-A and VitaFlow are self-expanding valves implanted through the peripheral artery. The J-Valve is a transapical self-expanding valve that can be used to treat AS and AR. The approval of domestic valves promoted the rapid development of TAVR in China. By the end of 2019, >20 provinces or municipalities and 200 hospitals in China had completed over 4000 TAVR procedures, including >2600 completed in 2019. China has accumulated its own experience in TAVR. The experience of several major centers in China reveals that there is no significant difference in the efficacy of TAVR between the BAV and tricuspid aortic valve (TAV).[19-22] The J-Valve transcatheter aortic valves have anchoring equipment and are suitable for treating AR patients.[23] China has gained much experience in the area of TAVR for patients with AR. There are a small number of centers that can independently perform the TAVR procedure in China; however, there is still a large gap in TAVR experience between China and European or American countries. Clinical characteristics of Chinese patients are also different from those of patients in other countries. Therefore, overseas guiding documents cannot be completely applicable for the clinical practices in China. Thus, it is necessary to formulate guiding documents that are suitable for China's national conditions. Transcatheter Aortic Valve Replacement Indications TAVR indications listed in the 2017 European valvular heart disease management guidelines are as follows:[4] patients with symptomatic severe AS who are not suitable for surgery (I, B); patients with a high surgical risk, defined as the Society of Thoracic Surgery (STS) score or the European Cardiac Surgery score second version (EuroSCORE II) >4%; and patients having other risk factors, such as weakness, porcelain aorta, and prior chest radiotherapy, especially elderly patients who are suitable for femoral artery access. TAVR indications listed in the American valvular heart disease management guidelines of 2017 are as follows:[5] AS patients with contraindications or high risk for surgery, who are expected to survive for >12 months (I, A); and severe AS patients at intermediate risk for surgery (IIa, B-R). Although the relevant government departments in the United States and Europe have approved the Sapien 3 and Evolut R transcatheter aortic valves for low surgical risk patients, the European and American guidelines do not recommend TAVR for these patients. The medical development levels in different regions of China are unbalanced. There is a difference in the knowledge of high-risk and contraindications for surgery. Compared with European or American countries, both patients and doctors are more inclined to select conservative treatment rather than surgery in China.[8] Combining the national conditions and research progress in China and other countries, we suggest the following TAVR indications and contraindications: Absolute indications (1) Severe AS. Echocardiography shows that the blood flow velocity across the aortic valve is >4 m/s, the mean transvalvular pressure gradient is >40 mmHg (1 mmHg = 0.133 KPa), the aortic valve orifice area is <1 cm2, or the effective aortic valve orifice area index is <0.5 cm2/m2. Patients with low blood flow and output were assessed using the dobutamine stress test, Doppler echocardiography, or other imaging methods and identified as severe AS. (2) Having symptoms such as shortness of breath, chest pain, and syncope. The New York Heart Association (NYHA) cardiac function class is above two grades, and the symptoms were definitely caused by AS. (3) Suitable anatomy for TAVR, including calcification severity of the native valve, aortic annulus diameter, aortic sinus diameter and height, coronary ostia, and peripheral artery diameter. (4) The life expectancy expected to be >12 months after rectifying AS. (5) TAV. (6) Extremely high-risk for surgery (without age requirement), or intermediate- or high-risk for surgery and over 70 years of age. Surgical risk assessment is based on the 2014 American valvular heart disease management guidelines.[3] Those who meet all the above conditions are considered to have absolute indications for TAVR. Furthermore, surgical bioprosthetic valve degeneration is also an absolute indication for TAVR.[24] Relative indications (1) Meeting terms 1-5 above, surgical low-risk (STS score <4%), and over 70 years. (2) Meeting terms 1, 2, 3, 4, and 6 above, and BAV, or meeting the above terms, BAV 1, low surgical risk, and over 70 years. TAVR can be performed under these two conditions in experienced centers (defined as completing >20 cases of TAVR per year) or with the help of an experienced team (defined as completing more than 20 cases of TAVR per year). (3) For patients meeting terms 1, 2, 3, and 4 above and aged 60-70 years (BAV or TAV), the heart team judges suitability for TAVR based on the surgical risk and patient's wish. The J-Valve valve is effective for pure AR through the transapical approach. This consensus is mainly focused on TAVR with vascular access. Therefore, related content about transapical TAVR using the J-valve are not mentioned. Currently, some centers in China and other countries use self-expanding valves to perform TAVR for the treatment of pure AR,[25] but there is still insufficient clinical evidence. Contraindications Contraindications to TAVR include left ventricular thrombus, left ventricular outflow tract obstruction, unsuitable access, or aortic root anatomy for TAVR (such as the high risk of coronary artery occlusion), and short life expectancy after AS correction (<12 months). Preoperative Screening Preoperative screening for TAVR includes clinical assessment and imaging evaluation. Clinical assessment includes determining (1) whether valve replacement is needed, including the expected benefit of TAVR; (2) whether there is a surgical risk; and (3) whether there is a contraindication of TAVR. Imaging evaluation is the focus of preoperative evaluation for TAVR suitability, including the native aortic valve, aortic annulus, aorta, coronary and peripheral artery anatomy, and the size of the stented valve and includes the following techniques: (1) Transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE). Cardiac morphology and function, valvular function and anatomy, and aortic root anatomy can be assessed by TTE or TEE. Echocardiography can be used as the main method of preoperative anatomical evaluation of the aortic root for patients who cannot tolerate computed tomography (CT) examination. Most patients have an elliptically shaped aortic annulus, and routine two-dimensional echocardiography is not accurate enough to measure the annulus from a single section. Three-dimensional echocardiography can make up for this defect. (2) Multislice computed tomography (MSCT). MSCT is currently one of the most important methods of TAVR imaging evaluation and is the main basis for judging patient suitability for TAVR and artificial valve size choice. We can observe the valve shape and evaluate the thickness of the valve, severity of calcification, and valve volume at the aortic root. We can measure the circumference and area of the annulus in the annulus plane and then calculate the inner diameter of the annulus to provide a basis for the selection of valve types and sizes and to assess the risk of postoperative paravalvular leakage (PVL). Further, MSCT can be used to assess the height of the coronary Ostia, predict the risk of coronary artery occlusion, and evaluate the degree of coronary artery disease. Furthermore, MSCT can also be used to assess the diameter of the peripheral artery. (3) Angiography. Aortic root angiography is not accurate enough for the measurement of the aortic annulus, aortic diameter, and coronary Ostia height. It is rarely used before TAVR. The abdominal aorta angiography can be used to assess the diameter of approaching vessels. Coronary angiography can be used to accurately assess the degree of coronary artery stenosis. Operative Specifications and Postoperative Antithrombotic Therapy Facilities and staff It is suggested that TAVR be performed in a modified cardiac catheterization room or a hybrid operation room, and a multidisciplinary heart team be The are in the guidelines for the Chinese expert consensus on the and operation of a TAVR of procedure TAVR is recommended under and using angiography in the in the a TAVR is not to be and the risk of surgery for the patient is not high, it is also to TAVR under with and the of patients in China currently use self-expanding the of the procedure are as of vascular The femoral artery in the of the valvular is and an artery is A catheter is to the root of the aorta through its for pressure measurement and A catheter is through a to the ventricular is performed to the abdominal aorta or its main artery through the femoral artery of the femoral artery is performed by The be in the of the femoral artery and the femoral artery the successful artery are can also be by the and then and the femoral artery. A is to the abdominal artery under the and of an the femoral cannot be used as the diameter of the aorta, other such as the common artery and be of the into the left A or a is used for the aortic valve. The catheter is a 6 left coronary artery angiography the valve, the guiding catheter is also into the left and for the The left ventricular pressure is is then into the left through the The of the end be into a to the area with the left and to the and the valve delivery be performed under ventricular The of be that blood pressure is mmHg (1 mmHg = 0.133 and pressure is is the blood pressure the blood pressure after the be and and then be and be and the be to caused by Preoperative is performed to the of the delivery through the aortic valve and to It can also in the selection of valve and predict the risk of of the coronary artery. centers have different experiences in diameter, but the diameter of the not that of the native aortic Valve the valve is the catheter by the be at the of the as a The of is to the of the aortic in the Preoperative MSCT can provide an for The after valve is the valve in most cases the the is higher than the the the of the valve be to the of the valves and can be to the position of the calcification of the native valve, or The of the valve can be by the or the delivery or The of the valve be The valve is from the to the anchoring can be by rapid of the of valve the valve is used and the valve position or valve size is not the valve can be and following implantation, echocardiography or and valve valve transvalvular coronary artery occlusion, and also be Severe paravalvular regurgitation and under of the may to postoperative management For access, angiography of the femoral artery through the femoral artery is recommended before to Surgical or vascular with and be The of the procedure with balloon-expanding valves Sapien are similar to those of the procedure with self-expanding for the in TAVR with balloon-expanding valves a for procedure to short valve can be by angiography and TEE. A catheter is in the coronary The an to the in the of the left coronary and the position is the balloon-expanding valve is under rapid ventricular by a in pressure to mmHg and a pressure Postoperative In be The after TAVR is for months with to Patients with or other indications for treatment and of The Valve consensus was published in with the of consensus for for single and clinical and in clinical of patients who have and left and are common The incidence of other with the of devices, for The incidence of with the valve was about valves were with a higher rate of than the balloon-expanding valves The incidence of after TAVR was The incidence of after the of the self-expanding valve was higher than that after the of the balloon-expanding valve Most of the after TAVR. However, of over after TAVR. some patients a in months after of were the self-expanding valve, valve large size of the of the and calcification volume of the A position of the large valve self-expanding valve, and are with a risk of the other small aortic the for after TAVR. For patients and can be after the and is in after the For patients with or the be in for and evaluation is is recommended for patients with the high or in after the leakage leakage is a common complication after TAVR with the valves. The of were for the valve and for the valve in terms of lower is with the use of a than is with a higher is caused by the small size of the severe calcification or a large and a for the and (using the AR can all with the severity of It is to perform of the or a valve low or high or a in case of more than A surgical procedure may be for the area and and may to more and Coronary artery Coronary is a relatively but complication of Patients with low coronary were not for TAVR. In these patients, in those with aortic the coronary artery are by the native after TAVR. the of the also coronary artery the valve is Preoperative evaluation be valvular anatomy of the aortic and characteristics are in It is necessary to select be performed with a size similar to the expected TAVR valve size root to assess the of the with to the coronary artery be for high-risk patients with coronary artery (1) a small size valve and but the incidence of may (2) coronary artery including the of or in the coronary and (3) coronary artery or coronary artery may be an for coronary artery after transcatheter aortic valve The of to be the of as a of to the valve The incidence of symptomatic is The incidence of using imaging was patients with may be at an risk of risk include caused by delivery rapid and of the the risk of has been with The of has been and is currently under from a may also be in select vascular mainly include occlusion, and of the such as the femoral and and the abdominal The incidence rate used to be up to However, with the application of the and the delivery the incidence of has been to patients, especially those with such as and are to vascular calcification, and may to vascular Preoperative MSCT be used to and evaluate to the selection of small or and vascular a peripheral vascular and peripheral can be and vascular surgery be performed Cardiac incidence is the of this the end of be into a and the be and of delivery the using the to the left be to aortic sinus or left ventricular Aortic or is a complication of TAVR. This complication can be by accurate measurement of the size of the aortic annulus and of aortic valve There are methods for the The more used method is of BAV into 1, and The most common heart is BAV Type is Type 1, and is Type the BAV stenosis has not been in the TAVR indication in Europe and However, more and more shows that the efficacy of TAVR in BAV patients is not inferior to that in Compared with patients, the of TAVR in BAV patients include the (1) the annulus is the valve not to may (2) the native valve is not to a and the valve is to the by the native valve, in the of the and the higher incidence of (3) valve not and different are to and (4) the aorta may be at risk of in the to the domestic valve selection for BAV patients more on the The diameter, and area of the annulus are for is to the circumference of the is and the valve size can be on the basis of the diameter of The self-expanding valve is from a higher position Surgical aortic bioprosthetic valve degeneration There is a higher risk of surgical valvular replacement surgical bioprosthetic valve degeneration The of TAVR an option for such patients. The operation and are as (1) the and size of the surgical valve before surgery, with the MSCT and select the (2) the imaging characteristics of the valve as a for the of the valve that some of the annulus on are not the of the valve (3) the types of valvular disease (such as or is not suggested with mainly AR to the of (4) some patients have a smaller inner diameter of the surgical bioprosthetic valve annulus (such as Aortic valvular pressure gradient may be high to left ventricular outflow tract or rather than valve stenosis. We observe the of the and the inner diameter of the bioprosthetic annulus is be calcification or calcification Current have that TAVR is and effective for AS with no calcification and is the most common of AS. of no calcification or calcification, the valve is to after Therefore, a valve size to be and or is The of is vascular the femoral artery valve delivery in China is or above and the femoral diameter to be femoral artery is with severe stenosis or calcification the can be used to the of diameter of the blood to the is not or there is still a risk, other such as the aorta, and of the heart can be to the of aorta there is a large between the aorta and the annulus it is for the valves to The delivery is not with the aorta at the the valve is the lower is not to the annulus plane under it to the valve it is The valve can be after it is to the of and valve The and are as (1) it is to the delivery through the aortic a can be used to especially a second valve is to severe (2) the valve with function can be the valve position to be it is not and (3) the of delivery can help this coronary artery Preoperative and evaluation be and some can be on coronary artery Aortic stenosis with calcification of the valve patients have extremely valves and large can to such as in the valve through the delivery the valve cannot be leakage and is to the results of we a smaller valve, and the position is higher the self-expanding valve is The use of and TAVR can to may patient However, have that function is more common in patients with TAVR of Therefore, is not a contraindication for TAVR patients. be used to may be performed after the operation Coronary heart disease About of patients undergoing TAVR have coronary heart and the higher the the higher the However, the study not the of coronary for patients with coronary heart disease. guidelines and clinical still recommend before TAVR in patients with coronary artery stenosis of A number of have that before or with TAVR is and has similar However, risk is for patients with a left ventricular or score It is recommended to with TAVR and aortic valve be to before transcatheter aortic valve replacement patients in a with severe heart or to TAVR and TAVR. patients are to tolerate MSCT such that preoperative evaluation is mainly on echocardiography, especially angiography is used to evaluate the and is to assess the size of the annulus and risk of coronary artery patients with a low or may preoperative and such as In the of TAVR valves in the catheterization room, especially patients may single aortic valve first and then MSCT and evaluation the is relatively by TAVR. In with the Chinese expert consensus of TAVR, the Chinese expert consensus version of TAVR has been updated as The epidemiological was and it was that the proportion of rheumatic in Chinese patients with aortic valve disease was relatively the of anatomical of the BAV patients, Type 0 type) for a higher proportion in Chinese patients than in Western countries. The indications were to the clinical elderly age years and low surgical risk were in the There was no age for high-risk TAVR, and TAVR was the indication for patients with risk and aged years. Patients aged 60-70 years were to be suitable for TAVR by the cardiac team to the risk of surgery and patient The valve procedure was that can be used to in the selection of the artificial valve and to predict the risk of valve of the coronary artery. It was that the valve be by rapid to the of valve Postoperative were In after months of single was Patients with valve and some with other indications be with The and treatment of important including cardiac coronary artery occlusion, and were and updated in In case common clinical including coronary heart and TAVR, were Chinese of Chinese of of the expert by to China of of of to of of Heart of of to of of and of There are no of