"Hot Article" Yu Bo: Half a Century China intervened to achieve from scratch, from backwardness to catching up

In 1929, nearly 100 years from now in Germany, Dr. Werner Forssmann performed the first surgery on himself to insert it into the heart. In 1953, Seldinger invented percutaneous vascular puncture and quickly applied it to the left and right ventricular catheters, ending the history of cardiac catheterization requiring incision of the skin and laying the foundation for the clinical application of left cardiac catheterization. In 1977, German physician Grüentzig applied balloon catheters for the first time to perform balloon dilation (PTCA) for a 38-year-old male patient with angina, announcing the beginning of the era of PTCA in the field of intervention.

The first stage: technological "zero" breakthrough

　　In Contemporary China, Chen Haozhu of Zhongshan Hospital affiliated to Fudan University and Wang Hengrun of Shanghai Sixth People's Hospital successfully performed the first case of percutaneous puncture of femoral selective coronary angiography in Mainland China in 1973. In 1985, Zheng Xiaolian of Xijing Hospital of the Fourth Military Medical University carried out the first case of PTCA in China, and zhu Guoying of the First Hospital of Peking University completed 100 cases of PTCA in China in 1991.

The second stage: intervene to promote the whole country

　　In the 1990s, after the mainland was able to independently carry out coronary angiography technology, intracoronal stenting began to be carried out nationwide. In 1994, Gao Runlin's team and others first reported cases of coronary artery stenting for the prevention of PTCA restenosis or acute occlusion of intraoperative vascular occlusion, and in 1996, Han Yaling's team of the General Hospital of the Northern Theater of Operations successfully inserted 16 patients with coronary heart disease into bare metal stents (BMS), and around 1996, PTCA and stent placement were successively carried out in the Second Hospital of Boeto Harbin Medical University. At this stage, bare metal stenting was rapidly promoted nationwide, and at the same time, in order to standardize interventional operations, the mainland formulated the "Guidelines for Percutaneous Coronary Interventional Therapy", which promoted the comprehensive and standardized development of interventional therapy in Mainland China.

　　With the continuous development of interventional technology, in order to overcome the expansion of simple balloons and the narrowing of blood vessels in bare metal stents, the world has entered the era of drug-coated stents. China is almost in sync with the international community at this time. In 2007, Gao Runlin presided over and carried out the "Cypher SELECT" study on the safety and efficacy of the new generation of sirolimus drug-eluting stents in Chinese populations, and the results found that the incidence of major cardiovascular adverse events, target vascular revascularization rate and restenosis rate were similar to previous studies. Han Yaling et al. studied the safety and efficacy of zotamus drug-eluting stents in Chinese populations, and the results found that the incidence of major cardiovascular adverse events and the incidence of intrastental thrombosis in 1 year were low, laying the evidence for the clinical application of drug-eluting stents in mainland China. At the same time, domestic stents also began to sprout, innovate and develop at this stage. Such as the TARGET series of firehawk stents, the first domestic degradable coated stent EXCEL DES pre-marketing study, and Han Yaling presided over the EXCEL stent multi-centerCREATE registration study. Of course, not only the doctors and research mentioned above, at this stage, the national interventional experts are carrying out interventional diagnosis and treatment in their respective centers and regions, and with the development of clinical applications and research, the proportion of drug-eluting stent implantation was close to 95.7% in 2009, and the total number of interventions in mainland China was 408,000 in 2011. As of last year, the number of interventional surgeries in mainland China has reached 1.2241 million cases, an increase of 2 times in ten years.

The third stage: intervention technology and concept to achieve catch-up

　　First, the construction of chest pain centers in line with the national conditions of the mainland

　　In 1989, Gao Runlin of Fuwai Hospital took the lead in domestically to remediate PTCA after the failure of acute ST-segment elevation myocardial infarction (STEMI), and carried out direct PTCA in STEMI patients in the same year. This is the prototype of the treatment of patients with acute myocardial infarction in mainland China, and the reality before us is that China has a huge population of patients with coronary heart disease, the level of interventional technology varies greatly from region to region, and the distribution of medical resources is uneven. Compared with foreign developed countries, it is more difficult to overcome.

　　In 2010, in order to solve the problem of acute myocardial infarction in the mainland, the mainland first issued the "Consensus of Chinese Experts on the Construction of Chest Pain Centers", and the following year, the first regional collaborative treatment chest pain center was officially established in the General Hospital of the Guangzhou Military Region of the Chinese People's Liberation Army. From 2011 to 2012, the first China Chest Pain Center Summit Forum and the construction of the National Standardized Chest Pain Center and the ON-site demonstration and experience exchange meeting of STEMI Regional Collaborative Treatment were held. From 2011 to 2013, more than ten chest pain centers were established nationwide. As of July 2019, there were 1,063 chest pain centers in Mainland China. The establishment of the chest pain center has improved the early diagnosis and treatment ability of cardiovascular critical diseases manifested by "chest pain", improved and standardized the examination process, reduced misdiagnosis and missed diagnosis, and greatly shortened the treatment time of patients for acute events of coronary heart disease.

Second, the innovation and development of new technologies and concepts in the field of intervention

　　Mainland experts and scholars have also innovated and applied interventional technologies and treatment strategies. In 2003, Han Yaling proposed the new surgical "micro-squeeze stent technology" of left trunk intervention, which reduced the risk of thrombosis and re-stenosis after double stent surgery; her team proposed the "multi-guide wire plaque extrusion" chronic occlusive lesion opening technology (CTO) opening technology and completed the first reverse opening CTO lesion PCI in China in 2004. In 2005, Ge Junbo of Zhongshan Hospital affiliated to Fudan University performed the first surgical demonstration of reverse technology to open CTO lesions at the American Transcatheter Cardiovascular Therapy Conference (TCT). In 2005, Chen Shaoliang of Nanjing First Hospital invented the double-pair kissing extrusion stent technology (DK-Crush technology) and presided over a series of in-depth randomized controlled studies to confirm its safety and efficacy against left trunk terminal bifurcation lesions and complex bifurcation lesions. In 2013, Yu Bo proposed the etiology classification of acute coronary syndrome (ACS), so that interventional therapy opened the starting point from "whole" to "individual" treatment, in 2016, Yu Bo led the team to suggest the concept of "antithrombotic therapy for plaque erosion" based on the previous research results, and carried out EROSION research, which adopted a conservative treatment strategy of drug antithrombotic for 60 cases of ACS patients with ACS caused by plaque erosion after thrombotic aspiration of less than 70% of patients with ACS caused by plaque erosion. The results showed that the volume of thrombosis decreased by 94.2% and the diameter of the lumen increased by 13.6% at 1 month; there were only 3 cases of revascularization treatment at 1 year of follow-up, and there was no sudden death and myocardial infarction; and 80% of patients with non-obstructive plaque erosion had no significant progress in luminal stenosis at 4 years of follow-up. The findings suggest that acS conservative antithrombotic therapy due to plaque erosion is safe and feasible. The study was named one of the top ten clinical studies in the world in 2016 by the Annual Meeting of the European Society of Cardiology.

　　In terms of interventional devices, we have been monopolized by foreign products, the price of products is expensive, and many patients cannot afford it because of economic conditions, which greatly affects the health of mainland citizens. While successively mastering intervention techniques, mainland experts are also seeking to lift technical barriers. Among them, in the field of absorbable stents (BRS), the independent research and development of Xinsorb BRS led by Ge Junbo of the mainland and the NeoVas BRS research led by Han Yaling. In addition, there are a number of domestic stents such as Firesorb stents, IBS stents, AMsorb stents and so on are in clinical trials. At present, the BRS research and development in mainland China is developing rapidly and has entered the international advanced list. In the field of drug balloons (DCB), in 2021, Han Yaling presided over the bioRise Clinical Study (BIO-RISE CHINA) of the fourth generation of muscular drugs carried in mainland China, and the results of the study were released in TCT in 2021, confirming its safety and efficacy in primary lesions of small blood vessels.

　　Third, intraluminal imaging and functional science have emerged on the international stage

　　As early as the 1990s, the mainland began to apply intravascular ultrasound (IVUS) to guide clinical interventional therapy. Until 2002, optical coherence tomography (OCT) technology emerged and was applied in the coronary arteries. In 2005, the Second Affiliated Hospital of Harbin Medical University took the lead in introducing the first coronary OCT in mainland China, and after more than ten years of efforts, carried out a lot of pioneering work, and became the founder of the oct cause in mainland China. In 2010, his team first reported the OCT findings of neonatal atherosclerotic plaques in stents internationally, and proposed that neonatal atherosclerotic plaques may be another new mechanism for thrombosis in very advanced stents. In 2013, the three pathophysiological mechanisms of acute coronary syndrome (ACS) were first elucidated in vitro - plaque rupture, plaque erosion and calcified nodules, and the results were written into the cardiology textbook Braunwald's Heart Disease. In 2018, Yu Bo and Jia Haibo of the Second Hospital of Harbin Medical University participated in the compilation of the first "Expert Consensus on the Clinical Application of Intracoronal Imaging in Europe" with 20 experts from 15 countries around the world as invited units in China, which is a full recognition of the development of intracamore imaging in the mainland by international peers, indicating that the mainland is at the international leading level in this field.

　　In recent years, the mainland has also made rapid development in the fields of fusion imaging, multimodal imaging, and artificial intelligence. The global OCT-IVUS in vivo, forward-looking and multi-center clinical study led by Yu Bo of the Second Hospital of Harbin Medical University is underway, and the study has evaluated the safety and efficacy of clear stent acquisition rate by comparing oct and IVUS imaging catheters that are currently on the market for clinical application, and all patients have been selected. This will be a breakthrough in the mainland's cardiovascular interventional imaging technology, and achieve the goal of getting rid of foreign technology blockades and independent innovation in this field. In addition, the mainland is also in an international leading position in the evaluation of vascular function based on contrast and intraluminal imaging. The team of Tu Shengxian of Shanghai Jiao Tong University has independently developed QFR, OFR, UFR and other computational functional technologies, which have the advantages of safety, economy and convenience compared with the invasive FFR based on pressure guide wire. OFR based on OCT, a retraction imaging can obtain both coronary plaque morphology and functional accurate evaluation, compared with the difference between QFR and FFR, found that ofr accuracy is as high as 97%, similar to FFR accuracy, significantly better than QFR. The 2021 FAVOR III study led by Xu Bo, Qiao Shubin and others in Fuwai Hospital is a global large-scale coronary physiology-guided blood circulation reconstruction clinical trial, comparing QFR with contrast-guided interventional treatment, and the 1-year follow-up has proved the superiority, effectiveness and safety of QFR, which has been highly praised by international peers and is expected to be further popularized worldwide.

　　It has been nearly fifty years since the first case of intracorrangular angiography in mainland China. The predecessors planted trees, the posterity cooled off, and the older generation of cardiovascular experts laid a solid foundation for the development of the motherland's medical cause. In the past half century, China's cardiovascular field has also lived up to expectations, and the whole industry has adhered to the professional attitude of benevolence of doctors in overcoming challenges and difficulties, taking patients as the center, treating diseases and saving people as the core, and constantly seeking breakthroughs. I believe that in the future, we will respond to challenges from all over the world with a stronger and more powerful attitude and go to China to intervene in the second fifty years together.