China's First-Ever HeartLight X3 Laser Ablation Procedure for Paroxysmal Atrial Fibrillation Successfully Completed
Atrial Fibrillation Ablation Ushers in a New Era of Treatment Technology.
Recently, China’s first HeartLight X3 laser ablation procedure for atrial fibrillation was performed at Ruijin Hospital Hainan Branch (Boao Research Hospital), affiliated with Shanghai Jiao Tong University School of Medicine. The surgery was conducted by Professor Wu Liqun, a renowned cardiovascular specialist in China and Director of the Department of Cardiology at Ruijin Hospital, along with his team. In a post-operative interview, Professor Wu stated, “A key therapeutic strategy for atrial fibrillation is pulmonary vein isolation. Using the HeartLight X3 system for pulmonary vein isolation offers simplified operation, as well as efficient and rapid circumferential ablation.” Additionally, the HeartLight X3 system received high praise from multiple experts present.
It is understood that the HeartLight X3 Laser Ablation Platform is one of the outcomes of Grand Pharmaceutical (0512.HK)’s precise strategic layout in implementing internationally leading technologies in the field of precision interventional diagnosis and treatment for cardiovascular and cerebrovascular diseases. This product is also the only atrial fibrillation (AF) therapy worldwide that achieves circumferential ablation using laser energy. The successful completion of the first licensed clinical application surgery of its kind in China at Boao Lecheng marks the advent of a novel therapeutic option for AF treatment in China.
Atrial fibrillation is one of the most common clinical arrhythmias, often leading to severe cardiovascular and cerebrovascular diseases such as heart failure, myocardial infarction, and stroke, thereby necessitating urgent treatment. China currently has nearly 20 million patients with atrial fibrillation, and its prevalence shows a significant positive correlation with age. As the aging population in China intensifies, the number of patients with atrial fibrillation is increasing year by year. In terms of cure rates, earlier treatment for atrial fibrillation leads to a higher likelihood of recovery. However, due to practical factors such as scarce medical resources and insufficient public awareness of the disease, China’s level of prevention and control of atrial fibrillation remains relatively backward compared to the global average.
At present, catheter ablation is one of the important means for the treatment of atrial fibrillation. Both "Atrial Fibrillation: Current Understanding and Treatment Recommendations (2018)" and "European Heart Journal (2020)" list catheter ablation as a first-line treatment option for patients with atrial fibrillation who have poor response to drug control. Currently, in China, radiofrequency ablation is the predominant method for atrial fibrillation ablation procedures, supplemented by cryoablation.
Based on current clinical outcomes and practical implementation, both radiofrequency ablation (RFA) and cryoablation have certain limitations. Traditional RFA not only causes damage to surrounding tissues but also predisposes patients to pulmonary vein stenosis. Furthermore, the point-by-point ablation technique employed in RFA is operationally complex and associated with a steep learning curve for physicians. Although cryoablation offers higher safety, a relatively simpler procedure, and a shorter learning curve, it may result in incomplete ablation and a high postoperative recurrence rate. Therefore, there is a clinical demand for safer, more convenient, and more efficient ablation therapies.
In contrast, laser ablation can precisely and efficiently ablate cardiomyocytes while isolating the surrounding pulmonary veins, significantly reducing dependence on the operator’s experience and technical proficiency, with a short learning curve and ease of operation for physicians.
Professor Liao Dening, Director of the Department of Cardiology at Shanghai Changzheng Hospital, stated: “Laser ablation enables controlled and efficient transmural ablation. With the focal point located subendocardially, it offers a protective effect on the endocardium and reduces the risk of thrombus formation. Furthermore, the ablation depth is controllable, resulting in uniform and irreversible lesion formation.”
In the future, with the expanded application of laser energy in the atrial fibrillation ablation market, it is expected to bring new hope to nearly 20 million atrial fibrillation patients across China.
It is reported that the patient who underwent China’s first HeartLight X3 laser ablation procedure for atrial fibrillation was a 66-year-old woman with a more than three-year history of paroxysmal palpitations and chest tightness. She was admitted with a diagnosis of paroxysmal atrial fibrillation. Preoperative cardiac CT revealed a rare anatomical variation in her left atrial pulmonary veins, characterized by an additional small pulmonary vein branch compared to the typical anatomy, which significantly increased the surgical complexity. After comprehensive evaluation, Dr. Wu Liqun’s team decided to perform China’s first HeartLight X3 laser ablation surgery for paroxysmal atrial fibrillation on this patient.
From a procedural standpoint, the surgery was performed under local anesthesia. Wu Liqun’s team accessed the patient’s femoral and jugular veins via percutaneous puncture, advancing a laser balloon through sheaths only a few millimeters in diameter to the antra of the four pulmonary veins. After precise positioning, the balloon achieved complete occlusion at the antral sites. Subsequently, under endoscopic guidance, the surgical team maneuvered the laser balloon to successfully complete circumferential ablation therapy.
The surgical record indicates that,The total procedure time was approximately 70 minutes, with a total ablation time of about 17 minutes (compared to approximately 40 minutes for conventional point-by-point radiofrequency ablation). The isolation time for each individual pulmonary vein (PVI) was less than 3 minutes, and all pulmonary veins were successfully isolated in a single pass without the need for repeat touch-up ablations.. Moreover, postoperative observations indicated that the patient was in good condition with no adverse reactions. The safety and efficacy of atrial fibrillation ablation surgery have been significantly improved.
As the world’s only product that achieves circumferential ablation for atrial fibrillation treatment using laser technology, the HeartLight X3 Laser Ablation Platform’sThe Rapid continuous ablation mode eliminates the need for manual point-by-point operation in radiofrequency ablation, enabling automated continuous circumferential pulmonary vein ablation. It combines the adjustable energy delivery and precision of radiofrequency ablation with the operational simplicity, safety, and shorter procedure time characteristic of cryoablation.。
Notably,The HeartLight X3 system features an integrated endoscope, enabling physicians to directly visualize target tissues and adjust laser delivery positions during clinical procedures, thereby eliminating the need for repeated contrast agent administration throughout the surgery.. At the same time, it also provides better treatment options for patients with atrial fibrillation.
In 2020, a total of 81,900 atrial fibrillation (AF) ablation procedures were performed in China, including 9,800 cryoablation cases and 72,100 radiofrequency ablation cases. Given the population of tens of millions of AF patients, the penetration rate of AF ablation in China remains significantly insufficient, primarily due to factors such as procedural complexity, therapeutic efficacy, recurrence rates, surgical costs, and the availability of medical resources.
Given the backdrop of scarce medical resources and a healthcare system predominantly funded by basic medical insurance in China, issues such as surgical expenditures and physician training must be addressed under government leadership. In this context, enterprises can contribute by shortening physicians’ learning curves, enhancing treatment outcomes, and reducing recurrence rates, thereby improving the diagnosis and treatment rate of atrial fibrillation.
Overseas studies have shown that HeartLight X3 requires only about 3 minutes to isolate a single pulmonary vein, with a total procedure time of approximately 73.7 minutes. Meanwhile, under the operation of HeartLight X3, clinicians' total radiation exposure time is around 4 minutes. HeartLight X3 received FDA approval for market launch in May 2020, and its first- and second-generation systems have completed over 15,000 clinical treatments worldwide. Currently,The product has submitted a marketing registration application in China.。
Further studies have shown that, compared with radiofrequency ablation, laser ablation is not only comparable in terms of therapeutic efficacy and safety, but also yields similar one-year atrial fibrillation (AF)-free recurrence rates across both high-volume and low-volume centers (approximately 70%). In contrast, the one-year AF-free recurrence rate in the radiofrequency ablation group is significantly influenced by operator experience (approximately 71% in high-volume centers versus approximately 58% in low-volume centers), suggesting that the laser ablation system may have a lower learning curve than radiofrequency ablation. Long-term data indicate that the four-year success rate of pulmonary vein isolation (PVI) remains as high as approximately 75% in patients treated with the laser ablation system.
The advent of the HeartLight X3 laser ablation platform is poised to promote the adoption of atrial fibrillation (AF) ablation procedures at primary healthcare institutions, enabling patients in these areas to receive treatment locally. This will not only alleviate the patient burden on tertiary hospitals but also enhance the therapeutic capabilities of primary care facilities. Furthermore, experts present at the event noted that physicians can master the laser ablation technique after performing approximately ten procedures, which significantly shortens the training cycle for clinicians.
As noted by Director Wu Liqun in his postoperative assessment, the HeartLight X3 balloon-based laser ablation technology safely and effectively performed atrial fibrillation ablation. The advent of this technology is poised to usher in a new era in atrial fibrillation ablation therapy, offering a novel treatment option for the vast number of atrial fibrillation patients in China.
The pioneering application of this world-first technology in China was driven by Grand Pharmaceutical. In 2021, Grand Pharmaceutical entered into a collaboration and exclusive product licensing agreement with CardioFocus, formally introducing the HeartLight X3 Laser Ablation Platform to China. This marked Grand Pharmaceutical’s first product in the electrophysiology field.
Professor Zhang Shu, Director of the Center for Arrhythmia at Fuwai Hospital, stated: “The localization of electrophysiology products is a major trend; however, the current rate of domestic production remains low. This is partly because China’s electrophysiology market started relatively late, and partly due to insufficient investment and attention from manufacturers’ production departments. Compared with the coronary stent market, which sees over one million procedures annually, the electrophysiology device segment has a limited market size.”
Currently, the technical barriers in electrophysiology are extremely high, with international giants holding a monopolistic position. However, driven by the growing patient population, technological advancements, and the strengthening of China’s economic power, the electrophysiology sector is gradually “breaking the ice.” Grand Pharmaceutical (China) Co., Ltd. is also scaling the heights of electrophysiology.
It is worth noting that Grand Pharmaceutical has long positioned precision interventional diagnosis and treatment of cardiovascular and cerebrovascular diseases as one of its core strategic areas, not only in the field of electrophysiology. The company has established a comprehensive layout across three key directions: vascular access management, structural heart disease, and electrophysiology and heart failure. Currently,The company has a pipeline of 16 innovative products in this field, four of which have received marketing approval in China for vascular intervention.。
Chen Xiaojie, Vice President of Grand Pharmaceutical, stated, “Grand Pharmaceutical adheres to the therapeutic philosophy of ‘intervention without implantation’ and pursues a dual-pronged strategy. First, we acquire full rights, including innovative technologies and subsequent localization in China, continuously improving our products during their application in the domestic market. Second, we strengthen our in-house R&D capabilities. Currently, the company has fully established an innovative medical device platform integrating both passive and active devices, forming a R&D and manufacturing layout with two centers in China and multiple bases overseas.”
The advantages of localizing international innovative products lie in reducing production costs, lowering prices for patients, and improving product accessibility. In the future, Grand Pharmaceutical will continue to increase its investment in global innovative products and advanced technologies, fully leverage its industrial advantages and R&D capabilities, and accelerate the commercialization of technologically innovative products. Meanwhile, it will persist in independent research and technological innovation, striving to build a leading precision interventional diagnosis and treatment platform for cardiovascular and cerebrovascular diseases in China and globally.