**3. The development of TAVI technology in China**

According to incomplete statistics, China has a total population of 1.4 billion, including 44.8 million elderly people over the age of 75 (3.4%), and about 1.5 million patients (3.4%) with severe aortic valve stenosis, including about 0.2 million high-risk patients and 0.3 million moderate-risk patients. A single-center survey led by Gao Runlin showed that among the 139,496 patients examined by echocardiography from January 2010 to December 2015, the detection rate of severe mitral regurgitation was the highest (0.68%). This was followed by mitral stenosis (0.38%), aortic stenosis (0.28%), and aortic regurgitation (0.27%) [32]. From January 2009 to December 2013, Liu et al. investigated 19,428 patients with abnormal valvular structure or function in Guangdong People's Hospital, of which 13,549 (69.7%) were relatively certain to be valvular heart disease through clinical data, patient characteristics, and echocardiography. Among these patients, rheumatic heart disease accounted for 37.0%, and congenital valvular disease accounted for 13.9%. Degenerative valvular disease accounted for 11.5%, ischemic valvular disease accounted for 12.7%, infectious valvular disease accounted for 3.1%, and autoimmune-mediated valvular disease accounted for 0.7%. In 5 years, rheumatic heart disease decreased from 42.8% in 2009 to 32.8% in 2013 (P < 0.001), while degenerative valvular heart disease increased from 8.8% to 14.5% (P < 0.001), ischemic valvular disease increased from 9.2% to 11.3% (P = 0.003), and congenital valvular disease increased from 9.0% to 12.3% (P < 0.001). The prevalence of degenerative valvular disease is dominant in patients over 65 years old much more than rheumatic valvular disease [33]. The level of medical treatment level in different regions of China is uneven, and the evaluation of surgical risks and taboos is different from that of foreign countries. A 20-year review of data from Changhai Hospital affiliated to the Second Military Medical University in Shanghai showed

**87**

*Transcatheter Treatment of Aortic Stenosis and Regurgitation*

that among the 6300 patients who underwent valve replacement of the left heart system, only 2.0% were over 70 years old, and the maximum age was 79 years old [34]. Another study included 521 consecutive valve surgery patients, of whom 53 (10%) were assessed to be at the highest risk before operation, with an average STS

TAVI operation was completed (GE Junbo, Zhongshan Hospital) [36].

began clinical trials; 7 cases were completed nationwide.

eter aortic valve replacement for adult aortic valve stenosis [38].

In 2002, the world's first TAVI operation was completed; in 2010, the first China

In 2012, China's first independent intellectual property valve product Venus A

In 2017, the Venus A valve via the femoral artery and the J-Valve valve via the apical approach were officially approved and put on the market, marking a new era of interventional therapy for valvular heart disease in China. In 2017, the United States issued the consensus of experts on the clinical decision-making path of transcath-

In 2018, more than 1000 TAVI operations were completed nationwide in China.

GE Junbo and Wang Jianan [39] published the Chinese expert consensus on transcatheter aortic valve replacement team construction and operation standard. Wu Yongjian and others issued the clinical pathway of transcatheter aortic valve implantation in China [40]. Zhang Yun and others organized the China expert consensus on perioperative echocardiographic examination of transcatheter aortic valve implantation [41]. Cheng Weiping and Li Lihuan organized the Chinese anesthesia expert consensus on TAVR surgery clinical Ppathway Mmanagement [42]. Wang Chunsheng and others published the Chinese transcatheter aortic valve implantation (TAVI) multidisciplinary expert consensus [43]. Xu Zhiyun and Lu Fanglin started the interventional tricuspid valve clinical trials with LUX valve. Hu Shengshou and Meng Xu led the mitral stitch technique of trans-apical artificial chordae tendineae implantation to begin clinical trials. GE Junbo and Zhou Daxin led the trans-apical mitral valve double-hole valve clamp technique to

In 2019, the VitaFlow valve (via the femoral artery) was approved to be put on the Chinese market. 2000 TAVI operations were performed by cardiologists and surgeons all over the country. Xu et al. led the establishment of the Academic Committee on Interventional Therapy of Cardiac Valvular Disease and published the expert consensus on the responsibilities and requirements of cardiac surgeons in cardiac team Building [44]. Haibo and others developed innovation with J-Valve valve in valve techniques for mitral and tricuspid tissue valve deterioration [45]. Both Edwards SAPIEN valve and domestic Taurus valve have completed clinical trials and are expected to be on the market within 2 years. Runlin et al. released good 5-year follow-up results of Venus A valve and J-Valve valve, which showed that their safety

At present, a total of 150 centers in China have the ability to carry out TAVI surgery, of which there are about 10 units; the cumulative number of TAVI cases is more than 100 cases. Different from Europe and the United States, Chinese patients with bicuspid aortic valve are in the majority, with more severe calcification, more weakness in elderly patients, and more complications when they see a doctor later. And at present, there are obvious differences in TAVI experience and team construction among different centers in China, most of which are in the initial stage of the learning curve, with both opportunities and challenges. With the introduction of a new generation of valves into clinical practice, the success rate of TAVI in various centers in China will continue to improve, and more clinical experience needs to be accumulated. In the aspect of image evaluation, combined with the individual characteristics of the Chinese

and effectiveness had been verified in the medium and long term.

In 2015, GE Junbo, Wang Jianan, and other organizations have reached the consensus of Chinese experts on transcatheter aortic valve replacement [37].

*DOI: http://dx.doi.org/10.5772/intechopen.92997*

score of only 3.25 [35].

begin clinical trials.

### *Transcatheter Treatment of Aortic Stenosis and Regurgitation DOI: http://dx.doi.org/10.5772/intechopen.92997*

*Advances in Complex Valvular Disease*

ACCURATE neo group [27].

reduced [30, 31].

This is similar to the Chinese domestic J-Valve.

**3. The development of TAVI technology in China**

of ACCURATE neo 30 days and SAPIEN 3 did not achieve non-inferiority (24% vs. 16% personality 0.42). Although there was no difference in 30-day mortality (2 vs. 1%) and stroke (2 vs. 3%) between the two groups, the incidence of acute renal injury (3% vs. 1%) and moderate perivalvular leakage (9 vs. 3%) was higher in the

The JenaValve valve is specially designed [28, 29]. The stent valve with three fixed keys is implanted through the apical approach. TF-JenaValve is the new version of JenaValve via the femoral artery. The JenaValve is a short stent with a large mesh hole at the upper end, which is beneficial to the introduction of the coronary artery. The outer edge of the stent contains three anchoring parts, which can prevent the stent from being fixed to the bottom of the three aortic sinuses. The artificial valve is designed for supra-annular valve. The JenaValve deployment first releases the proximal anchoring device, then pushes it to the autologous aortic valve annulus, automatically locates and gets stuck, then releases the proximal stent, and finally releases the distal connecting device. The delivery system of TF-JenaValve is 18F, which has a bending function to ensure the coaxiality of the release valve and the aortic valve annulus. The design of the JenaValve with a fixed key makes it possible to treat aortic regurgitation and patients with low coronary artery openings.

The design of the Engager valve produced by Medtronic is similar to that of the JenaValve valve. It is also a valve implanted through the apical approach. By placing the control arm with anatomical positioning function at the root of the aortic sinus, the valve stent can be positioned accurately, and the complications can be

According to incomplete statistics, China has a total population of 1.4 billion, including 44.8 million elderly people over the age of 75 (3.4%), and about 1.5 million patients (3.4%) with severe aortic valve stenosis, including about 0.2 million high-risk patients and 0.3 million moderate-risk patients. A single-center survey led by Gao Runlin showed that among the 139,496 patients examined by echocardiography from January 2010 to December 2015, the detection rate of severe mitral regurgitation was the highest (0.68%). This was followed by mitral stenosis (0.38%), aortic stenosis (0.28%), and aortic regurgitation (0.27%) [32]. From January 2009 to December 2013, Liu et al. investigated 19,428 patients with abnormal valvular structure or function in Guangdong People's Hospital, of which 13,549 (69.7%) were relatively certain to be valvular heart disease through clinical data, patient characteristics, and echocardiography. Among these patients, rheumatic heart disease accounted for 37.0%, and congenital valvular disease accounted for 13.9%. Degenerative valvular disease accounted for 11.5%, ischemic valvular disease accounted for 12.7%, infectious valvular disease accounted for 3.1%, and autoimmune-mediated valvular disease accounted for 0.7%. In 5 years, rheumatic heart disease decreased from 42.8% in 2009 to 32.8% in 2013 (P < 0.001), while degenerative valvular heart disease increased from 8.8% to 14.5% (P < 0.001), ischemic valvular disease increased from 9.2% to 11.3% (P = 0.003), and congenital valvular disease increased from 9.0% to 12.3% (P < 0.001). The prevalence of degenerative valvular disease is dominant in patients over 65 years old much more than rheumatic valvular disease [33]. The level of medical treatment level in different regions of China is uneven, and the evaluation of surgical risks and taboos is different from that of foreign countries. A 20-year review of data from Changhai Hospital affiliated to the Second Military Medical University in Shanghai showed

**86**

that among the 6300 patients who underwent valve replacement of the left heart system, only 2.0% were over 70 years old, and the maximum age was 79 years old [34]. Another study included 521 consecutive valve surgery patients, of whom 53 (10%) were assessed to be at the highest risk before operation, with an average STS score of only 3.25 [35].

In 2002, the world's first TAVI operation was completed; in 2010, the first China TAVI operation was completed (GE Junbo, Zhongshan Hospital) [36].

In 2012, China's first independent intellectual property valve product Venus A began clinical trials; 7 cases were completed nationwide.

In 2015, GE Junbo, Wang Jianan, and other organizations have reached the consensus of Chinese experts on transcatheter aortic valve replacement [37].

In 2017, the Venus A valve via the femoral artery and the J-Valve valve via the apical approach were officially approved and put on the market, marking a new era of interventional therapy for valvular heart disease in China. In 2017, the United States issued the consensus of experts on the clinical decision-making path of transcatheter aortic valve replacement for adult aortic valve stenosis [38].

In 2018, more than 1000 TAVI operations were completed nationwide in China. GE Junbo and Wang Jianan [39] published the Chinese expert consensus on transcatheter aortic valve replacement team construction and operation standard. Wu Yongjian and others issued the clinical pathway of transcatheter aortic valve implantation in China [40]. Zhang Yun and others organized the China expert consensus on perioperative echocardiographic examination of transcatheter aortic valve implantation [41]. Cheng Weiping and Li Lihuan organized the Chinese anesthesia expert consensus on TAVR surgery clinical Ppathway Mmanagement [42]. Wang Chunsheng and others published the Chinese transcatheter aortic valve implantation (TAVI) multidisciplinary expert consensus [43]. Xu Zhiyun and Lu Fanglin started the interventional tricuspid valve clinical trials with LUX valve. Hu Shengshou and Meng Xu led the mitral stitch technique of trans-apical artificial chordae tendineae implantation to begin clinical trials. GE Junbo and Zhou Daxin led the trans-apical mitral valve double-hole valve clamp technique to begin clinical trials.

In 2019, the VitaFlow valve (via the femoral artery) was approved to be put on the Chinese market. 2000 TAVI operations were performed by cardiologists and surgeons all over the country. Xu et al. led the establishment of the Academic Committee on Interventional Therapy of Cardiac Valvular Disease and published the expert consensus on the responsibilities and requirements of cardiac surgeons in cardiac team Building [44]. Haibo and others developed innovation with J-Valve valve in valve techniques for mitral and tricuspid tissue valve deterioration [45]. Both Edwards SAPIEN valve and domestic Taurus valve have completed clinical trials and are expected to be on the market within 2 years. Runlin et al. released good 5-year follow-up results of Venus A valve and J-Valve valve, which showed that their safety and effectiveness had been verified in the medium and long term.

At present, a total of 150 centers in China have the ability to carry out TAVI surgery, of which there are about 10 units; the cumulative number of TAVI cases is more than 100 cases. Different from Europe and the United States, Chinese patients with bicuspid aortic valve are in the majority, with more severe calcification, more weakness in elderly patients, and more complications when they see a doctor later. And at present, there are obvious differences in TAVI experience and team construction among different centers in China, most of which are in the initial stage of the learning curve, with both opportunities and challenges. With the introduction of a new generation of valves into clinical practice, the success rate of TAVI in various centers in China will continue to improve, and more clinical experience needs to be accumulated. In the aspect of image evaluation, combined with the individual characteristics of the Chinese

population, the multiplane valvular three dimentional measurement technique proposed by Wu Yongjian of Fuwai Hospital, the small balloon measurement method put forward by the Zhongshan Hospital affiliated to Fudan University, and the sequential balloon measurement strategy put forward by Wang Jianan of the Second Affiliated Hospital of Zhejiang University Medical College. The optimized measurement technology of optimal reshaping put forward by Chen Mao of West China Hospital of Sichuan University and the concept of effective annular diameter and effective valve area of TAVI surgery put forward by Meng Xu and Zhang Haibo of Beijing Anzhen Hospital have made substantial contributions to the development of TAVI technology in China. The new generation of interventional valve represented by SAPIEN 3, Evolut R, and Centera has mainly improved the defects of early interventional valve, which is characterized by lower incidence of perivalvular leakage, retrievable, small delivery system, and automatic localization. At present, it is considered that the new interventional valve with the above two characteristics can be classified as the secondgeneration valve. In the research and development of the second-generation valve, China has gradually caught up with the pace of the world, and new-generation valves such as J-Valve developed by Suzhou Jiecheng Company, VitaFlow II valve developed by Shanghai Minimally Invasive Medical Devices Co., Ltd., and Venus A plus valve developed by Hangzhou Qiming Company have been implanted in the first patient one after another.

Venus A valve is the first TAVI valve on the market in China, which was implanted through the femoral artery. Up to October 2019, a total of more than 2000 Venus A TAVI operations have been performed in 142 centers in China. Among them, there were 19 centers with more than 20 TAVI cases, 16 centers with 10 cases, and 16 centers with less than 10 cases. The prospective multicenter observational study, which began in 2012 to evaluate the safety and efficacy of Venus A valve in the treatment of severe aortic valve stenosis, followed up patients with TAVI for 5 years. The results showed that the 5-year all-cause mortality rate was 20.8% and the cardiovascular mortality rate was 15.8%. The risk ratio of age > 85 years old was 1.47 [95%CI (1.12 ~ 2.00), P = 0.007], and the risk ratio of STS > 8 was 1.56 [95%CI (1.21–2.01), 0.033]. On March 29, 2019, at the China Interventional Cardiology Conference (CIT2019) in Beijing, Gao Runlin reported the results of a 5-year follow-up study with severe Venus A valve stenosis or severe regurgitation of 0 and moderate velocity increase or moderate regurgitation of less than 10%. The second generation interventional aortic valve system developed by Venus A plus has a retrievable function. Structurally, the valve release recyclable function is realized through innovative sheath design. The conveying system uses a 19F guide sheath. On the basis of the retrievable function, the Venus A pilot adds an adjustable bending function to ensure the coaxiality of the valve release. Qiming Venibri Valve is the world's first preinstalled TAVI valve, so that the valve can be used in the catheterization room, saving valuable time for critically ill patients to save lives [46].

VitaFlow II is a second-generation interventional aortic valve system developed by Shanghai Minimally Invasive Medical Devices Co., Ltd., which has the function of retrievable and anti-perivalvular leakage and belongs to the second-generation interventional aortic valve. VitaFlow II valve stent is the same generation of VitaFlow. Structurally, the valve release retrievable function is realized through innovative sheath design, that is, repositioning and rerelease. The design of the inner and outer tubes of the transportation system has an enhanced structure, which not only ensures the stability and accuracy of the release but also realizes the multidirectional bending function, so as to reduce the damage to blood vessels and reduce the probability of vascular complications. According to the characteristics of thinner femoral artery in Chinese elderly patients, the internal catheter sheath was

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*Transcatheter Treatment of Aortic Stenosis and Regurgitation*

**4. Indications of TAVI in low-risk patients**

the observed death rate trend may be related to TAVI.

set up to realize the integrated puncture function and reduce the vascular damage

J-Valve is a self-expanding Ni-Ti stent, and there are three flexible fixed bond steel rings around the stent. Different from JenaValve in which fixed bond and Ni-Ti stent are welded, the J-Valve fixed bond and Ni-Ti stent are connected by string, which is beneficial for the movement of the fixed bond at the bottom of the sinus during release and better fit to the aortic sinus bottom. The conveying system is 18–22Fr with adjustable bending function. The valve release procedure is similar to that of JenaValve [47]. TF-J-Valve is the femoral artery version of J-Valve, and the valve design is basically the same as J-Valve. TF-J-Valve exploratory clinical trials are mainly conducted in Canada and have confirmed the

Multiple death reasons analysis maintained by the National Center for Statistics from 2008 to 2017 [49] showed that the mortality rate due to aortic stenosis in the elderly in the United States has declined since 2013, while the number of TAVI hands has increased from 4627 in 2012 to nearly 35,000 in 2016. It is speculated that

On March 17, 2019, in the American College of Cardiology (ACC) annual meeting, the low-risk patients TAVI studies PARTNER III and EVOLUT results were released, marking the comprehensive arrival of the TAVI era of severe aortic valve stenosis. Martin Leon of Columbia University Medical Center in New York officially released the results of PARTNER III study at the conference [17]. For low-risk patients with severe aortic stenosis, the incidence of 1-year death, infarction, and rehospitalization in patients with Edwards balloon-expandable TAVI valve implantation was significantly lower than that in patients undergoing open heart surgery. The study included 1000 patients from 71 centers, with an average age of 73 years and an average STS score of 1.9%. The main end point of the study was the compound end points, including 1-year death, infarction, and rehospitalization event rate. The results showed that the event rate of the main end point in the TAVI group was significantly lower than that in the surgical operation group (8.5% vs. 15.1%). The 30-day infarction rate (0.6 vs. 2.4%), infarction or death event rate (1.0% vs. 3.3%), and new atrial fibrillation rate (5.0% vs. 39.5%) in the TAVI group were significantly lower than those in the operation group. In addition, patients in the TAVI group had a shorter average hospital stay (3 days vs. 7 days) and a lower risk of a 30-day poor prognosis (death or low KCCQ score) (3.9% vs. 30.6%). There was no difference in the incidence of major vascular complications, permanent pacemaker implantation, and moderate or severe perivalvular leakage between the two groups. The Evolut study included 1468 patients who underwent Medtronic selfexpanding TAVI valves, of which 1403 underwent TAVI or surgery [18]. The average age of these patients was 74 years, and the main end point of the study was a 24-month complex event of death or crippling infarction. The incidence of major end point events at 24 months in the TAVI group was 5.3%, while that in the surgical group was 6.7%. The incidences of 30-day disabled infarction (0.5 vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute renal injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) in the TAVI group were significantly lower than those in the surgical group. However, moderate or severe perivalvular leakage (3.5 vs. 0.5%) and permanent pacemaker implantation rate (17.4% vs. 6.1%) were higher than those in the surgical group. At 1 year, the mortality rate in the TAVI group was 0.4%, while that in the surgical group was 1.2% (no significant).

caused by the transportation system (equivalent to 16–18F sheath).

*DOI: http://dx.doi.org/10.5772/intechopen.92997*

technical feasibility [48].

### *Transcatheter Treatment of Aortic Stenosis and Regurgitation DOI: http://dx.doi.org/10.5772/intechopen.92997*

*Advances in Complex Valvular Disease*

after another.

save lives [46].

population, the multiplane valvular three dimentional measurement technique proposed by Wu Yongjian of Fuwai Hospital, the small balloon measurement method put forward by the Zhongshan Hospital affiliated to Fudan University, and the sequential balloon measurement strategy put forward by Wang Jianan of the Second Affiliated Hospital of Zhejiang University Medical College. The optimized measurement technology of optimal reshaping put forward by Chen Mao of West China Hospital of Sichuan University and the concept of effective annular diameter and effective valve area of TAVI surgery put forward by Meng Xu and Zhang Haibo of Beijing Anzhen Hospital have made substantial contributions to the development of TAVI technology in China. The new generation of interventional valve represented by SAPIEN 3, Evolut R, and Centera has mainly improved the defects of early interventional valve, which is characterized by lower incidence of perivalvular leakage, retrievable, small delivery system, and automatic localization. At present, it is considered that the new interventional valve with the above two characteristics can be classified as the secondgeneration valve. In the research and development of the second-generation valve, China has gradually caught up with the pace of the world, and new-generation valves such as J-Valve developed by Suzhou Jiecheng Company, VitaFlow II valve developed by Shanghai Minimally Invasive Medical Devices Co., Ltd., and Venus A plus valve developed by Hangzhou Qiming Company have been implanted in the first patient one

Venus A valve is the first TAVI valve on the market in China, which was implanted through the femoral artery. Up to October 2019, a total of more than 2000 Venus A TAVI operations have been performed in 142 centers in China. Among them, there were 19 centers with more than 20 TAVI cases, 16 centers with 10 cases, and 16 centers with less than 10 cases. The prospective multicenter observational study, which began in 2012 to evaluate the safety and efficacy of Venus A valve in the treatment of severe aortic valve stenosis, followed up patients with TAVI for 5 years. The results showed that the 5-year all-cause mortality rate was 20.8% and the cardiovascular mortality rate was 15.8%. The risk ratio of age > 85 years old was 1.47 [95%CI (1.12 ~ 2.00), P = 0.007], and the risk ratio of STS > 8 was 1.56 [95%CI (1.21–2.01), 0.033]. On March 29, 2019, at the China Interventional Cardiology Conference (CIT2019) in Beijing, Gao Runlin reported the results of a 5-year follow-up study with severe Venus A valve stenosis or severe regurgitation of 0 and moderate velocity increase or moderate regurgitation of less than 10%. The second generation interventional aortic valve system developed by Venus A plus has a retrievable function. Structurally, the valve release recyclable function is realized through innovative sheath design. The conveying system uses a 19F guide sheath. On the basis of the retrievable function, the Venus A pilot adds an adjustable bending function to ensure the coaxiality of the valve release. Qiming Venibri Valve is the world's first preinstalled TAVI valve, so that the valve can be used in the catheterization room, saving valuable time for critically ill patients to

VitaFlow II is a second-generation interventional aortic valve system developed by Shanghai Minimally Invasive Medical Devices Co., Ltd., which has the function of retrievable and anti-perivalvular leakage and belongs to the second-generation interventional aortic valve. VitaFlow II valve stent is the same generation of VitaFlow. Structurally, the valve release retrievable function is realized through innovative sheath design, that is, repositioning and rerelease. The design of the inner and outer tubes of the transportation system has an enhanced structure, which not only ensures the stability and accuracy of the release but also realizes the multidirectional bending function, so as to reduce the damage to blood vessels and reduce the probability of vascular complications. According to the characteristics of thinner femoral artery in Chinese elderly patients, the internal catheter sheath was

**88**

set up to realize the integrated puncture function and reduce the vascular damage caused by the transportation system (equivalent to 16–18F sheath).

J-Valve is a self-expanding Ni-Ti stent, and there are three flexible fixed bond steel rings around the stent. Different from JenaValve in which fixed bond and Ni-Ti stent are welded, the J-Valve fixed bond and Ni-Ti stent are connected by string, which is beneficial for the movement of the fixed bond at the bottom of the sinus during release and better fit to the aortic sinus bottom. The conveying system is 18–22Fr with adjustable bending function. The valve release procedure is similar to that of JenaValve [47]. TF-J-Valve is the femoral artery version of J-Valve, and the valve design is basically the same as J-Valve. TF-J-Valve exploratory clinical trials are mainly conducted in Canada and have confirmed the technical feasibility [48].
