Hillhouse Medical has completed the world's first two cases of surgical pulsed field ablation for atHillhouse Medical has completed the world's first two cases of surgical pulsed field ablation for atrial fibrillation, and will open the global application The market of pulsed electric field ablation therapy has received another big news. At the end of February 2023, the world's first two surgical pulsed field ablation procedures for atrial fibrillation (AF) were performed in Guangdong Provincial People's Hospital by the surgical pulsed field ablation system (PFSA) independently developed by Strategically located Shanghai Medical Equipment Co., LTD. (referred to as "Strategically located Medical"). Two female patients with valvular atrial fibrillation aged 57 years and 48 years were successfully completed by Professor Guo Hui-ming and Professor Liu Jian's team in the Department of Cardiac Surgery, Guangdong Provincial People's Hospital, Guangdong Institute of Heart Surgery. One patient underwent LIMA-LAD coronary artery bypass grafting + mitral valve repair + tricuspid valve repair at the same time, and the other underwent mitral valve replacement and tricuspid valve repair at the same time. Extrapulmonary verification block and endocardial electrophysiological mapping were completed under cardiopulmonary bypass. All procedures were completed as expected. Pulmonary vein and left atrial appendage were successfully isolated immediately after treatment, and the ablation diameter was transmural. The success of this operation not only demonstrated the major breakthrough in the field of the combination of medicine and engineering, but also was the first clinical trial of PFSA reported in the world, which is expected to provide new treatment solutions for more patients with complex atrial fibrillation.
PFSA clinical enrollment site The integration of medicine and engineering has overcome the difficult problem of complex atrial fibrillation treatment. PFSA has better transmural and linear integrity In the treatment of AF, the Cox-Maze III procedure is the most effective method to terminate AF and is also the "gold standard" for surgical treatment of AF. However, its operation is too complex and has rarely been used in clinical practice. At present, Cox-Maze Ⅳ procedure is the most widely used procedure for the treatment of atrial fibrillation. It mainly uses radiofrequency and cryoablation energy to replace the traditional "incision and suture", which greatly simplifies the operation time and reduces the risk of operation, but its disadvantage is that it does not selectively damage myocardial tissue. It may affect the surrounding normal tissues and cause damage to the adjacent esophagus, coronary artery and phrenic nerve during the operation, and there are problems such as treatment cost, recurrence rate, and risk of side injury complications. Pulsed field ablation technology is considered as the third possibility in the field of AF ablation due to its tissue specificity and safety advantages, which will break the "ice" and "fire" dilemma of AF ablation. It destroys the stability of the cell membrane by forming a local high voltage difference by pulsed electric field, forming irreversible nanoscale pores and leaking cell contents. Compared with radiofrequency ablation and cryoablation, it has the advantages of tissue selectivity, non-thermal energy ablation, fast electric field effect, less damage and low recurrence rate. The first two cases of PFSA performed by our hospital successfully completed the electrical isolation of atrial and pulmonary vein tissue, and the resulting ablation has good transmural and linear integrity. It has incomparable advantages in terms of operation convenience, operation time, and ablation integrity compared with catheter ablation and current surgical ablation, and has good efficacy for AF. In particular, AF patients with complex structural heart disease benefit more. The results showed that PFSA had short time, simple operation and significant effect, and did not cause myocardial perforation caused by steam blasting during discharge, which greatly reduced the complexity and risk of surgical operation. PFSA has high tissue selectivity and does not damage phrenic nerve, nerve, coronary artery, etc. At the same time, the system has the function of self-test during each ablation discharge to avoid blind beating and repeated treatment, effectively forming an intelligent closed loop of ablation. Surgery that used to take 30 to 45 minutes can now be completed in only a few minutes, achieving a significant improvement in surgical efficiency. In the process of project research and development, Cunhouse Medical adhered to the "combination of medicine and engineering to meet clinical needs to drive technological innovation". In close cooperation with Professor Guo Huiming and Professor Liu Jian's team from Guangdong Provincial People's Hospital and Guangdong Institute of Cardiology, Cunhouse Medical explored the clinical needs and treatment pain points of doctors in the front line, and specially optimized the energy platform of surgical pulse ablation. Based on the clinical characteristics of atrial fibrillation and the development trend of pulsed electric field technology, combined with the advantages of advanced energy platform and deep active technology precipitation, the team pioneered the use of pulsed electric field to successfully achieve ablation of atrial fibrillation by surgical method. The systems and instruments used in this operation were independently developed by Hillhouse Medical, with completely independent intellectual property rights. Traditional ablation devices may encounter problems such as impermeability of ablation, large energy dissipation, and easy damage to some low-impedance tissues (such as esophagus and coronary artery), which may cause complications. In view of this clinical pain point, based on the cooperation with Professor Guo Huiming and Professor Liu Jian's team, we have designed the curved tip tip ablation forceps and flexible pen to meet the treatment needs of different types of lesions, which has greatly improved the convenience and success rate of surgical procedures for atrial fibrillation.
Figure note: The PFSA ablation system developed by Hillhouse Medical Innovation and self-research The global declaration is about to open, Advance to the "frontier" of atrial fibrillation Atrial fibrillation (AF) is the most common arrhythmia. In atrial fibrillation, the systolic function of the atrium is poor, which is easy to cause blood stasis in the atrium and thrombosis. Thrombosis with blood flow to the whole body, leading to multiple organ embolism, cerebral embolism, pulmonary embolism, coronary artery embolism, renal artery embolism, limb artery embolism and other diseases. In addition, the incidence of stroke in patients with atrial fibrillation is more than five times that of the general population, and stroke caused by atrial fibrillation has the characteristics of high disability rate, high mortality rate and high recurrence rate. According to The "Prevalence and risk of atrial" published by Professor Zheng Qiangsun and other experts from the Second Affiliated Hospital of Xi 'an Jiaotong University in The Lancet Regional Health - Western Pacific in April 2022 fibrillation in China: Anational cross-sectional epidemiological study showed that the overall prevalence of atrial fibrillation in Chinese adults was 1.6%, and it is estimated that there are 22 million patients with atrial fibrillation in China. In addition, the prevalence of AF was positively correlated with age, with the prevalence increasing with age. With the improvement of China's economic level and the extension of life expectancy, the number of atrial fibrillation electrophysiological surgery will continue to grow, and the market size of atrial fibrillation ablation will continue to expand. The PFSA products developed by Hillhouse Medical, as an innovative treatment plan with lower risk and fewer complications, will also benefit more AF patients. Founded in 2021, Strategically Located Medical is an innovative medical device enterprise driven by research and development. It is committed to providing high-quality medical devices to patients in China and the world for the treatment of cardio-cerebral system, respiratory system and other life-threatening major diseases. The company's technical team to the United States and Germany returned research and development personnel as the core, in the field of medical equipment has decades of development, research experience, technical level in the leading position in China. Hillhouse Medical has a standardized GMP plant with a total of about 1000 square meters, which can ensure that a number of product lines have sufficient production capacity. We have well-equipped physical and active laboratories and modern office environment to meet the strategic needs of sustainable development of the company. PFA's clinical experience on a global scale has proved the great attraction of this market, and Chinese and American companies are also standing on the same starting line. Hillhouse Medical completed the world's first two cases of surgical pulsed electric field ablation for atrial fibrillation, which is undoubtedly a charge of science and technology and opens up a new idea for the treatment of atrial fibrillation. It is reported that Hillhouse Medical will soon carry out multi-center registration clinical trial, and will simultaneously carry out CE and FDA application. With the continuous accumulation of clinical and real-world data, it is believed that the advantages of Hillhouse Medical innovative ablation system will further emerge and provide more safe and effective Chinese solutions for the dilemma of AF treatment. Expert Introduction
 广东省人民医院 郭惠明 Guo Huiming of Guangdong Provincial People's Hospital Chief physician, professor, doctoral supervisor. He is the deputy director of Cardiac Surgery at Guangdong Provincial People's Hospital and Guangdong Cardiovascular Institute, and the leader of minimally invasive surgery group, coronary heart disease surgery and atrial fibrillation surgery. Member of the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), member of the American Society for Thoracic Surgery (AATS), member of the Standing Committee of the Chinese Branch of the Asian Valvular Heart Association, Vice Chairman of the Special Committee of Minimally Invasive Cardiovascular Surgery of the National Committee of Cardiovascular Experts, member of the Standing Committee of the Chinese Society of Cardiovascular Surgery and Vice Chairman of the minimally invasive Group, Chinese Medical Doctor Association. He is also a member of the Thoracic and Cardiovascular Surgery Society of the Chinese Medical Association, the vice chairman of the Atrial Fibrillation Special Committee of the Chinese Research Hospital Association, and the vice chairman of the Cardiovascular Surgery Society of the Guangdong Medical Association.  广东省人民医院 刘健 Jian Liu, Guangdong Provincial People's Hospital Deputy chief physician, Doctor of medicine, postgraduate tutor, Team leader of cardiac surgery of Guangdong Provincial People's Hospital, Deputy director of atrial Fibrillation Center Expert Committee of Guangdong Provincial People's Hospital. Visiting Scholar, Deutsches Herzzentrum Berlin (DHZB), Heart Center, Linkoping University Hospital,Sweden. Member of Youth Committee of Chinese Society of Thoracic and Cardiovascular Surgery, Chinese Medical Doctor Association, member of Youth Committee of Chinese Society of Cardiovascular Surgeons, member of Atrial Fibrillation Prevention and Treatment Committee of Chinese Research Hospital Association, member of Academic Committee of Interventional Therapy Technology of Chinese Branch of Asian Valvular Association, member of Minimally Invasive Cardiovascular Surgery Committee of National Cardiovascular Experts Committee. Member of International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), Vice Chairman of the Expert Committee of Atrial Fibrillation Center of Guangdong General Hospital, Member of the Arrhythmia Committee of Chinese Society of Cardiovascular Surgeons, Member of the minimally Invasive Committee of Chinese Society of Cardiovascular Surgeons, He is a young member of the First Committee of Immunotherapy Engineering Branch of Chinese Biomedical Engineering Society, a young and middle-aged editorial member of Chinese Journal of Biomedical Engineering, and a reviewer of Chinese Journal of Biomedical Engineering and Chinese Journal of Clinical Thoracic and Cardiovascular Surgery |
