The latest ACE thrombus aspiration system produced by Penumbra is now officially introduced into China by Hua Medtech Medical Devices (Shanghai) Co., Ltd. Hosted by Hua Medtech Medical Devices (Shanghai) Co., Ltd., the conference specially invited Professor Liu Jianmin, Director of Neurosurgery, Cerebrovascular Disease Center, Changhai Hospital, and Professor Miao Zhongrong, Director of the Department of Interventional Neurology, Beijing Tiantan Hospital to serve as co-chairman of the conference.
| Speeches by Guests
Zhang Wei, CEO of Hua Medtech Medical Devices (Shanghai) Co., Ltd., extended thanks to all experts present at the conference and considered it an honor to hold the China Debut Conference of ACE at the foot of the Great Wall. Just as the Great Wall symbolizes wisdom, inheritance, and protection, the ACE system based on continuous technological innovation also safeguards the health of stroke patients. Zhang Wei believes that the aspiration techniques represented by ACE will surely flourish in the field of neurointervention in China in the future.
Li Ge, CEO of Wuxi AppTec, and Arani Bose, Founder of Penumbra, expressed their sincere wishes for ACE aspiration catheter and Hua Medtech, firmly believing that this will be a new opportunity and choice. Mr. Li said that Hua Medtech is expected to take up a share of 70%-80% in the future market of medical devices for cranial neuropathy approved by China’s CFDA (China Food and Drug Administration).
| ACE in China
Liu Jianmin: Solumbra Technique Likely to Be the Mainstream Thrombectomy Technique in Future
Professor Liu Jianmin from Changhai Hospital in Shanghai delivered an academic report entitled “Progress in the Treatment of Acute Intracranial Large Vessel Occlusion through Multimodal Recanalization”. Epidemiological studies have shown that China is the most severely affected area of stroke where deaths caused by stroke account for 29.4% of that of the world. This is primarily attributed to the imperfect emergency medical system for stroke and the uneven emergency response capability in China. With the rapid development of studies on the treatment of acute ischemic stroke (AIS), many clinical studies have finally suggested that revascularization is the core and target of the treatment. In particular, the MR CLEAN study has confirmed that intravenous thrombolysis and/or endovascular thrombectomy are “gold standards” for AIS treatment. More and more studies have verified that the combined use of aspiration system with stent retriever can bring good prognosis and is the most well-documented treatment method at present. Therefore, Solumbra technique is likely to be the mainstream thrombectomy technique in the future.
Professor Liu Jianmin mentioned that the determinants of the prognosis of AIS treatment also include ischemia time, case selection and degree of recanalization in addition to advanced thrombolysis and thrombectomy techniques. When selecting cases that can bring good prognosis, functional imaging is particularly important. If a strategy of one-stop imaging in the cath lab is implemented, transfers between different examination rooms will be avoided. The development and application of devices has catalyzed the progress of clinical research. With regard to whether to apply intravenous thrombolysis, intra-arterial thrombolysis, stent retriever, balloon occlusion, or catheter aspiration in the treatment of stroke patients, a multimodal revascularization therapy has gradually taken shape, that is, fast and reasonable AIS thrombolysis process + convenient and long-lasting multimodal imaging support + perfect combination of thrombectomy and aspiration techniques + selective use of balloon angioplasty + discreet use of stent-retriever thrombectomy.
Miao Zhongrong: ACE Enters China Market After Being Long-awaited
Professor Miao Zhongrong from Beijing Tiantan Hospital said that he has eagerly waited for the introduction of Penumbra’s ACE to China for a decade. A decade ago, he expected that Penumbra’s first-generation product could benefit stroke patients in China, which was not realized due to various reasons. Today, the new-generation product of Penumbra is officially launched in China and is ready to benefit more stroke patients in China. This is a memorable moment. As Professor Liu Jianmin said, the current status indicates that China still has a long way to go in the treatment of stroke. In China, the number of potential population with a demand for thrombectomy is more than 1 million, and due to a different pathogenesis of stroke compared to westerners, 30% to 40% of this population concurrently suffer from intracranial artery stenosis. Consequently, the treatment method of stent retriever for these patients have a poor prognosis in reality, which indicates that these people may be the target population of the aspiration method. Professor Miao believed that the launch of ACE in the China market would bring more clinical benefits to stroke patients in China and improve the stroke treatment rate in China. On August 1, 2018, Beijing Tiantan Hospital established a new Neurointervention Center, which will mainly focus on emergency treatment, including the treatment of acute aneurysm and acute ischemic stroke. The Center is expected to play a significant role of demonstration and training in the promotion and clinical application of ACE aspiration catheter.
| Academic Reports
Blaise W. Baxter: ADAPT Technique Can Be Used as a Front-line Method for Stroke Treatment.
Professor Blaise W. Baxter, Chief of the Department of Radiology, College of Medicine, University of Tennessee, Chattanooga, first conducted an in-depth interpretation of the ADAPT technique based on the SNIS guidelines and related research data.
In 2013, a study published in JNIS demonstrated that the ADAPT thrombosis aspiration technique can enable 75% of stoke patients to reach a revascularization level of TICI 2b/3, and enable 65% of stoke patients to reach TICI 3. In 2014, the MR CLEAN study indicated that, for patients with acute ischemic stroke caused by proximal intracranial occlusion of the anterior circulation, it is safe and effective to adopt endovascular interventional treatment within 6 hours after stroke, and there is a marked improvement in the clinical functional independence of patients after 3 months of follow-up. According to the ASTER study published in JAMA in 2017, for patients with ischemic stroke whose anterior circulation is suitable for thrombectomy, the ADAPT technique does not produce a higher rate of recanalization compared to the stent retriever procedure, but it at the same time confirmed that the ADAPT technique can be used as a front-line method for stroke treatment.
The COMPASS study presented at ISC 2018 also showed that the effects of ADAPT technique and stent retriever procedure in the treatment of stroke are similar, with no statistical difference. If the two are combined in the treatment, the TICI 2b/3 revascularization level will reach 85% immediately. Based on studies such as COMPASS, the ADAPT technique was officially included into the AHA / ASA guidelines in 2018, which started a new chapter for the technique.
Blaise W. Baxter: Standardized Diagnosis and Treatment Procedures, Case Selection, and Advanced Thrombectomy Are Equally Important
The second topic of Professor Baxter was an introduction to the relevant application experience of ACE from the perspective of the treatment process of stroke patients. To reduce the time for patients to receive multimodal imaging examinations to less than 10 minutes, the time from imaging examinations to arterial puncture to less than 60 minutes, and the time for revascularization to less than 90 minutes, multidisciplinary integration is needed to build a streamlined in-hospital treatment channel. Professor Baxter mentioned an intelligent stroke care model developed by Viz. Ai. The model uses deep learning algorithms to automatically analyze CT neural images to detect indicators related to stroke and is thus able to notify the experts in advance, thereby shortening the treatment time and minimizing the scope or progress of stroke. Fast, accurate, easy, and repeatable, the intelligent stroke care model of Viz. Ai can reduce the door-to-puncture time to 41 minutes in the treatment of stroke.
In addition to a standardized intelligent stroke diagnosis and treatment process, the selection of stroke patients is also important for the improvement of treatment rate. Professor Baxter introduced the treatment assessment factors of patients 0-6 hours and 6-24 hours after stroke onset, respectively. He emphasized that apart from the above two key factors, advanced thrombectomy is equally important. He introduced the Neuron MAX & ACE triaxial catheter aspiration system in detail at the conference, as well as the details in clinical use.
Holly Sit: Evolution of Mechanical Thrombectomy Devices
—From a Perspective of Engineering
Holly Sit, an engineer from Penumbra, began her speech with a question: What kind of device is the best for thrombectomy? First, it must be able to open the artery quickly; second, it must be able to completely remove the thrombus; third, it must be safe and easy to operate; fourth, it must be economical. From an engineer’s perspective, Ms. Sit introduced the design of each catheter and compared ACE catheter with its prototype. These thrombectomy devices have been upgraded and perfected: first, the device must be safe, being able to reduce new cerebral infarction and interaction with blood vessels; second, the device must be simple and easy, with clear locus marking and same operating procedures for them; third, the device must be fast enough to reduce the number of passes. The latest generation of ACE catheter will surely bring a newer and better treatment experience.
| Case Sharing
Peng Ya: Essentials of Rapid Recanalization of Large Vessel Intracranial Occlusion with ADAPT Technique
Professor Peng Ya from The First People’s Hospital of Changzhou delivered a wonderful lecture on the “Rapid Recanalization of Large Vessel Intracranial Occlusion with ADAPT Technique”. For patients with both posterior circulation basal artery occlusion and anterior circulation occlusion, the ADAPT aspiration technique (Penumbra 4.1F) can be applied to recanalize basilar artery. The catheter can also enter the posterior cerebral artery for aspiration, thereby realizing the recanalization of the basilar artery and the posterior cerebral artery.
An ACE aspiration catheter is a triaxial system with an ACE catheter, a 3MAX long sheath, and a 0.014 micro guidewire. For patients with middle cerebral artery thrombosis and proximal stenosis, the ACE catheter and balloon can be used to first open proximal blood vessel to allow the ACE catheter to enter the middle cerebral artery for aspiration. In this case, the time from puncture to recanalization is 60 minutes. The ACE catheter can also play a great role in the posterior circulation. Thanks to an outstanding delivery performance of the ACE catheter, it can be used in combination with stent retriever and the catheter aspiration technique to produce desired prognosis.
Gao Feng: Preliminary Experience in the Clinical Application of ADAPT Technique
Professor Gao Feng from Beijing Tiantan Hospital shared the “Preliminary Experience in the Clinical Application of ADAPT Technique”. ADAPT technique, which is actually a direct thrombus aspiration technique using negative pressure, has been evolving in clinical use. The conventional method is to use a long sheath or a guide catheter, which can be used in combination with a balloon for distal aspiration, or with a balloon at the proximal end, 5MAX or ACE at the middle end and 3MAX at the distal end for simultaneous aspiration at the distal, middle and proximal end. This may be the development direction of thrombus aspiration system in the future. ADAPT technique has the characteristic of rapidness and does not need direct operation on the thrombus during the thrombectomy process, which greatly increases safety.
Chen Wenhuo: Single-center Experience with ADAPT Technique
Professor Chen Wenhuo from Zhangzhou Municipal Hospital of Fujian Province gave a lecture entitled “Single-center Experience with ADAPT Technique”. Professor Chen introduced the ADAPT technique based on the case of a patient with sudden unconsciousness for 4 hours and a sign of dense basilar artery. According to the patient’s situation at the time, the left vertebral artery access was finally selected. After balloon dilatation, the guide catheter was used for thrombectomy, and then the stent was implanted. During the procedure, the ACE catheter was successfully guided to the basilar artery for aspiration. CT scan 28 hours after the surgery found the swelling of the right supratentorial brain tissue, according to which the postoperative treatment plan was timely adjusted. Professor Chen finally summarized the experience and lessons of this case and had a lively discussion with the participating experts.
Li Zifu: Changhai Experience in Gaining Access with ADAPT Technique
Dr. Li Zifu of Changhai Hospital in Shanghai delivered a report on the “Changhai Experience in Gaining Access with ADAPT Technique”. Numerous epidemiological studies have confirmed that the earlier the vascular recanalization is, the better the clinical prognosis will be. In the wake of the development of stent retriever technique and the catheter aspiration technique, the time from arterial puncture to recanalization of blood vessels is getting shorter and shorter. In the treatment of a patient with left internal carotid artery occlusion, the time from arterial puncture to recanalization of blood vessels spans only 9 minutes using the catheter aspiration technique, while the combined use of stent retriever technique and the catheter aspiration technique can achieve a fastest vascular recanalization of 5 minutes.
The application of the ACE intracranial thrombus aspiration system can extend the time window for the recanalization of occluded artery to 8 hours after stroke onset, and can bring shorter time of pain after puncture, faster revascularization rate, and better prognostic quality of life. Many clinical studies have confirmed the effectiveness and safety of this aspiration technique. The ACE intracranial thrombus aspiration system, as the only device for the treatment of ischemic stroke in China approved by CFDA, is bound to bring a new hope for the diagnosis and treatment of ischemic stroke in China.
Hua Medtech hopes to join hands with physicians in China to create a new future in neurointervention therapy and move towards a new stage of the academic development in this field.