The 8th China Vascular Congress (CVC 2023) was grand opened in Xi'an, the ancient capital of the millennium, from September 21 to September 24. Adhering to the concept of "Innovation, Transformation and Cooperation" and with the theme of "Smooth Blood Vessels and Long River of Life", this conference aims to promote the development of medical cause of vascular diseases in China, break disciplinary barriers and expand international vision. This conference has once again received extensive attention from industry experts and colleagues in the industry!
Opening speech
During the main venue from 13:30 to 14:30 on September 22, the pre-marketing clinical study data release meeting of RescSeal thoracic aortic covered stent specially invited Professor Shu Chang from Fuwai Hospital, Chinese Academy of Medical Sciences, Professor Huanglian Jun from Shanghai Deda Hospital, Professor Li Zhen from the First Affiliated Hospital of Zhengzhou University and Professor Zuo Jian from Xijing Hospital of Air Force Military Medical University as the moderators, Professor Li Gonghui from Zhujiang Hospital of Southern Medical University, Professor Wu Wenhui from Beijing Anzhen Hospital, Capital Medical University, Professor Wang Qiang from Renji Hospital, Shanghai Jiao Tong University School of Medicine, Professor Wang Hai from the First Affiliated Hospital of Guangzhou Medical University, Professor Zhou Weimin from the Second Affiliated Hospital of Nanchang University and Professor Zhao Hui from Beijing Luhe Hospital, Capital Medical University as the discussion guests. In addition to Professor Shuchang and Professor Wang Hai, Professor Li Jiehua from the Second Xiangya Hospital of Central South University was also invited as the sharing guests to share the pre-marketing clinical trial results and clinical cases of RescSeal thoracic aortic covered stent.
At the beginning of the meeting, under the solemn opening speech of Professor Shu Chang, the academic conference was officially
Academic link
1. Publication of the results of premarket clinical trials of RescSeal thoracic aortic stent graft
Speaker: Dr.Chang SHU
Organization: Fuwai Hospital, CAMS & PUMC
With the increasing incidence of AD and the deepening of TBAD research in China, TEVAR has become the first choice for TBAD treatment because it can effectively reduce the incidence of long-term adverse events. At present, TEVAR surgery still faces many problems, whether from the patient population, or stent performance, these problems give higher requirements to the existing stents.
RescSeal thoracic aortic stent system characteristics:
The stent features a Low Profile (15F-19F) which is able to complete stent selection between 40 and 46 mm in proximal graft diameter. RescSeal Thoracic Stent System reduces vascular access diameter requirement by up to 5F compared to other similar stents. In addition, the stent uses an ultrathin membrane, which, by unique fabrication techniques, produces neither endoleaks nor favors intimal coverage. The special bare stent is designed in horn shape and concave arc at tip, which is beneficial to avoid "bird 's beak" and reduce vascular injury.
Premarket Clinical Data for RescSeal Thoracic Stent System:
a、Of the 150 patients enrolled in the thoracic aortic endograft system, 110 (73.33%) were acute cases (time to onset ≤ 14 days) and 40 (26.67%) were subacute and chronic cases (time to onset > 14 days).
b、The 12-month clinical success rate was 100.00% (138/138), and patients who died were carried forward with 12-month clinical failure, and the 12-month clinical success rate was 92.00% (138/150). Acute success was 100% (150/150).
c、The complete thrombosis rate of stent segment false lumen at 12 months after operation was 92%. At 12 months after surgery, the minimum diameter of the true lumen of aortic dissection was 154% preoperatively and the maximum diameter of the false lumen vessels was 18% preoperatively.
Summary: RescSeal thoracic aortic stent system is effective and safe in the treatment of type B dissection; Low profile is more helpful in the treatment of patients with tortuous and calcified approach; material progress: long-term follow-up results demonstrate that the paper-thin membrane is safe and effective; engineering progress: the main stent is specially designed to ensure the efficacy while reducing complications.
2. RescSeal Thoracic Stent Graft Clinical Example Sharing —— The Pernicious Approach to Patients with Ultrafine Common Iliac Approach Dissection
Speaker: Dr.Haiyang WANG
Organization: The First Affiliated Hospital of Guangzhou Medical University
TEVAR usually requires a sufficient caliber iliofemoral artery to complete stent implantation, so the establishment of approach remains one of the factors affecting the success of surgery. The ultra-small delivery outer diameter of RescSeal thoracic aortic stent system realizes the Low Profile while ensuring the excellent delivery performance of the stent system.
Dr.Haiyang WANG confirmed the clinical utility of the Low Profile in a case of acute standford type B thoracic aortic dissection with a difficult approach. Imaging data showed that the proximal end of the dissection exceeded 1 cm beyond the posterior edge of the left subclavian artery, the dissection extended to the right common iliac artery and was completely covered by a false lumen, and the left common iliac artery was occluded. After the guide wire was successfully introduced into the true lumen during surgery, the RescSeal thoracic aortic stent graft had a smaller delivery profile, conforming to the guide wire delivery to the thoracic aorta, and completing stent delivery and release. Angiography performed after stent withdrawal showed no endoleak, good blood supply to the visceral artery, and the left iliac artery was opened after successful stent release with smooth blood flow. The post-operative results showed that the dissection, the false lumen was reduced and the true lumen was enlarged, and the 3-year follow-up results showed no abnormalities, which fully confirmed the reshapeability of the RescSeal Thoracic Stent System Low Profile for difficult access patients.
Finally, Dr.Haiyang WANG concluded that the RescSeal Thoracic Stent System Low Profile can easily cope with patients with ultra-fine common iliac artery and can also benefit patients with calcification and distortion. It is also easy to deal with in special emergency patients, giving us more confidence when faced with challenging access patients.
三、RescSeal Thoracic Stent Graft Clinical Example Sharing 2 —— Slim and Easy Handling
Lecturer: Dr.Jiehua LI
Institution: The Second Xiangya Hospital of Central South University
At present, the long-term effectiveness of stent graft placement remains the focus of social concern. At present, there are many stent grafts with different materials, development and support on the market, but the main purpose of their design is to successfully release the stent and maintain the long-term safety and effectiveness after surgery. While the RescSeal thoracic aortic stent system ensures the Low Profile, its long-term effectiveness can also be seen from Professor Li Jiehua 's sharing of one case of acute and one case of chronic aortic dissection.
Case 1：
RescSeal thoracic aortic stent system was released precisely, the closure of the first intimal cleft of aortic dissection was complete, the true lumen was dilated, the false lumen disappeared, and the left subclavian artery blood flow was normal. At the same time, the maximum diameter of ± false lumen was significantly reduced at 30 days after surgery, from 33.6 mm preoperatively to 7.1 mm, and at 6 months after surgery ± the maximum diameter of false lumen was 0 mm. Follow-up was 4 years and was unremarkable.
Case 2：
Preoperative examination showed true and false lumen blood supply in the celiac trunk, SMA and true lumen blood supply in both renal arteries
During the operation, rapid superselective access to the true lumen, successful stent placement, complete closure of the first intimal cleft of aortic dissection, dilatation of the true lumen, disappearance of the false lumen, and normal blood flow in the left subclavian artery. Distal angiography showed normal blood flow in both renal arteries, mesenteric arteries, and celiac trunk arteries coexisting with SMA. The follow-up results showed that the maximum diameter of the false lumen was 0 mm at 6 months after operation, no endoleak occurred at 12 months after operation, and the false lumen was completely thrombosed.
The RescSeal thoracic aortic stent system Low profile is designed to facilitate stent access to the vessel, reduce procedural difficulty, have a thinner graft design, ensure a thinner delivery sheath, but still maintain a good seal, while having a taper size to better meet clinical treatment needs.
Discussion session
Experts have expressed their views and should share the clinical use feelings of each center, and look forward to the marketing of RescSeal thoracic aortic stent system in the future.
Meeting Summary
After a wonderful speech sharing and discussion, at the end of the meeting, this data press conference gradually introduced the clinical benefits of RescSeal thoracic aortic stent system from the total data of pre-marketing clinical trials, starting with the stent characteristics to difficult cases to verify the clinical advantages of Low profile, to the final long-term safety and effectiveness verification.
It is expected that in the future, the long-term safety and effectiveness of RescSeal thoracic aortic stent system can be verified by longer-term data and follow-up. Ept Medical will continue to refine and optimize the products, serve the patients and promote the development of vascular innovation together with the clinical operators.
