Percutek Therapeutics
Developer of Minimally Invasive Cardiovascular Treatment Devices
Today's sharing is byProfessor Wu Zhiyong's Team from Renmin Hospital of Wuhan UniversityA Completed Case of High-Difficulty TEVAR Surgery. The patient had Stanford Type B aortic dissection with complex conditions: the dissection entry was close to the origin of the left subclavian artery (LSA), and the false lumen had already involved the root of the LSA, while the left common carotid artery (LCCA) was adjacent to the LSA, leaving an insufficient proximal anchoring zone; the LSA formed an acute angle with the aortic arch, and its involved ostium was narrowed; the dissection had an extensive range, with a small true lumen and a large false lumen, imposing high requirements on the sealing performance of the stent as well as the deliverability, and flexibility of the delivery system.
In response to these challenges, Professor Wu Zhiyong's team innovatively utilized the Percutek Therapeutics Thoracic Aortic Stent Graft System, successfully completing the in-situ reconstruction of the LSA by instantaneously penetrating the stent graft with a 250T guidewire. This approach precisely overcame technical difficulties such as in-situ fenestration angle control and establishing access through tortuous vessels, ensuring complete closure of the lesion while efficiently restoring blood supply to the LSA. Postoperatively, the patient recovered well, with significant occlusion of the lesion, fully demonstrating the technical advantages of this procedure and the team’s exceptional skill.
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Gender:Male
Age:56 years old
Chief Complaint:Chest and back swelling pain for 6 hours.
History of Present Illness:The patient experienced sudden chest and back swelling pain, chest tightness, and profuse sweating all over the body 6 hours after lifting heavy objects. The patient visited our hospital's emergency department, and a CTA examination revealed an aortic dissection.
Past Medical History:Hypertension for 3 years.
Detailed Explanation of CTA:Stanford Type B Aortic Dissection, with the tear close to the LSA ostium and the false lumen already involving the root of the LSA; the LCCA is adjacent to the LSA, with a distance of only 2mm; the root of the LSA is involved, and the ostium is narrowed. The true lumen of the dissection is small, measuring only 28.5*11mm, while the false lumen is large, with a maximum size of 38.8*28.5mm. The lesion range is extensive, involving the right common iliac artery and the right internal iliac artery distally; the celiac trunk, superior mesenteric artery, and inferior mesenteric artery are supplied by both true and false lumens, and the bilateral renal arteries are supplied by the true lumen.
Preoperative Three-dimensional Reconstruction
Preoperative CTA Cross-Section
Condition of the Aortic Arch
Stanford Type B aortic dissection, with the tear close to the LSA opening, has already involved the root of the LSA. The proximal anchoring zone is significantly insufficient, and the LCCA is adjacent to the LSA. It is necessary to extend the anchoring zone proximally and reconstruct the LSA.
The lesion range of aortic dissection is large, with a small true lumen and a large false lumen. High demands are placed on the sealing, compliance, and adhesion of thoracic aortic stent grafts, as well as the stability, trackability, and flexibility of the delivery system.
LSA forms an acute angle with the aortic arch, and its root is narrow, which creates difficulties in controlling the fenestration angle during the operation. Additionally, common covered stents on the market are more challenging to fenestrate.
Severe thrombosis at the root of the LSA false lumen requires careful and gentle manipulation.
Surgical Plan Strategy
Endovascular Repair of Thoracic Aortic Stent Graft Directly Covering the Left Subclavian Artery: The procedure is simple and effective, but covering the left subclavian artery may lead to clinical manifestations of posterior circulation ischemia and upper limb ischemia in patients.
Thoracic Aortic Stent-Graft Endovascular Repair + Left Subclavian Artery Chimney Technique: The surgical procedure is relatively simple, but the left subclavian artery is tortuous and narrow, with a higher risk of endoleaks and occlusion, and the mid-to-long-term outcomes are suboptimal.
Endovascular Repair of Thoracic Aortic Stent Grafts with In Vitro Fenestration: Excellent sealing of lesions, preservation of original hemodynamic characteristics, but complex operation. Preoperative modification of the stent is required based on measurement results, which is time-consuming; intraoperative precise alignment and ultra-selective window positioning are required, posing higher risks.
Endovascular Repair of Thoracic Aortic Stent Graft + In-situ Fenestration: Effective sealing of the lesion, no preoperative stent modification required. However, traditional in-situ fenestration of aortic stent grafts demands advanced interventional devices, such as in-situ fenestration needles, lasers, biopsy needles, and other specialized membrane-puncturing instruments.
The Hua Mai thoracic aortic stent graft can perform in-situ fenestration using the soft tip of a CTO guidewire. Considering the mid-to-long term treatment outcomes and the simplicity of intraoperative manipulation, after comprehensive evaluation, Professor Wu Zhiyong's team chose Hua Mai • Tianyi.®Endovascular repair of the thoracic aorta with a covered stent graft and reconstruction of the left subclavian artery using in-situ fenestration technology.
01. The patient was placed in the supine position, followed by routine disinfection and draping. After general anesthesia, the Seldinger technique was used to puncture the left brachial artery and left femoral artery, and sheaths were inserted. Aortography revealed a Stanford Type B aortic dissection, with the primary tear near the ostium of the left subclavian artery (LSA), a small true lumen, and a large false lumen.
Abdominal Aortic Angiography
Ascending Aortography
02. Through the left brachial artery, an 8.5F steerable sheath was exchanged, and a pigtail catheter was advanced into the ascending aorta. Through the left femoral artery, a yellow-marked pigtail catheter was introduced into the ascending aorta, and its position was adjusted to be located on the anterior wall.
03. A Percutek Therapeutics thoracic aortic stent graft PTBS3026180 was implanted in the left femoral artery. The proximal end of the stent graft was positioned distal to the LCCA opening, covering the LSA. After controlling blood pressure, the stent was released with good morphology.
Implantation of Percutek Thoracic Stent
Release of Percutek Therapeutics' Thoracic Stent
04. A 250T guidewire was inserted into the left brachial artery and successfully punctured the membrane with the assistance of a steerable sheath and a steerable catheter.
250T Guidewire Successfully Penetrates Membrane
05. Sequentially dilate the fenestration using 3*30mm, 5*30mm, 6*20mm Sterling balloons and 5*40mm, 8*40mm Mustang balloons.
3*30mm Balloon Dilation Window
5*30mm Balloon Expandable Window
6*20mm Balloon Dilatation Window
5*40mm Balloon Dilation Window
8*40mm Balloon Dilation Window
06. Through the balloon-sheath technique via the aortic fenestration site, a self-expanding covered stent 10*40mm was implanted in the LSA. After fluoroscopic positioning, the stent was released. Angiography showed that blood flow in the thoracic aorta and its branches was unobstructed.
LSA Branch Stent Implantation
07.Postoperative angiography showed that the blood flow of the branches above the aortic arch was unobstructed, and the main stent and branch stents were in good position. No opacification was observed in the thoracic aortic dissection, with no significant endoleak. The blood flow in the abdominal aorta and its branches remained unobstructed.
Postoperative Thoracic Angiography
Postoperative Abdominal Aortic Angiography
08.Withdraw all guidewires, catheters, and sheaths. Apply pressure dressing to each puncture site. Procedure completed.
Summary of Case Experience
This case study involves a patient with Stanford Type B aortic dissection, where the tear is close to the left subclavian artery (LSA). The false lumen is large and has already extended to the root of the LSA, with an insufficient proximal anchoring zone. The true lumen is small and tortuous, posing extremely high demands on the stability, deliverability, and flexibility of the stent delivery system, as well as the sealing capability, conformability, apposition, and minimal elastic recoil of the covered stent. Therefore, the primary challenge of the surgery lies in effectively sealing the lesion while ensuring the patient's long-term prognosis.
In response to these challenges, Professor Wu Zhiyong's team implemented targeted measures and chose Percutek Therapeutics.®The thoracic aortic stent graft system was used for treatment. During the procedure, the fenestration of the thoracic aortic stent graft was easily completed using only a 250T guidewire. The stent graft covering at the fenestration site was easy to penetrate and expand, and the balloon dilation process was simple, safe, and reliable, efficiently and safely achieving supra-arch reconstruction of the LSA. Postoperatively, the stent showed good morphology with significant lesion sealing, and the patient had a favorable prognosis. The supra-arch reconstruction outcome met preoperative planning expectations, fully demonstrating the team's excellent technical skills and extensive clinical experience.
Expert Introduction
Professor Zhiyong Wu
Doctor of Medicine, Chief Physician, Master's Graduate Supervisor. Director of the Cardiovascular Surgery Center, Director of Cardiovascular Surgery Department 1, and Director of the Cardiac Intensive Care Unit at Renmin Hospital of Wuhan University.
Proficient in various types of heart valve surgeries, open and minimally invasive hybrid surgeries for aortic diseases, coronary artery bypass grafting (CABG), surgical radiofrequency ablation for atrial fibrillation, and minimally invasive treatments for congenital heart disease. Performs over 40 heart transplants and more than 400 aortic surgeries annually, ranking among the top single-center volumes in China. Particularly experienced in non-surgical valve replacement (TAVI), valve repair (TEER), and non-surgical interventional closure for congenital heart diseases (such as patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and pulmonary arteriovenous fistula). Also has extensive clinical experience in complex congenital heart diseases, hypertrophic obstructive cardiomyopathy, cardiac tumors, and peripheral vascular diseases such as arterial occlusion and varicose veins.
Repeatedly awarded the Outstanding Core Talent Award and the Medical Expert title by Renmin Hospital of Wuhan University, holding several important positions in the academic field of cardiovascular surgery. Member of the Cardiac Transplantation Group under the Organ Transplantation Branch of the Chinese Medical Association; Member of the Organ Regeneration and Engineering Group under the Organ Transplantation Branch of the Chinese Medical Association; Vice Chairman of the Cardiovascular Surgery Branch of Wuhan Medical Association; Standing Committee Member of the Cardiovascular Surgery Branch of Hubei Province Physicians Association; Member of the Thoracic and Cardiovascular Surgery Branch of Hubei Province Medical Association; Vice Chairman of the Aortic Surgery Professional Group of Hubei Province Cardiovascular Surgery Quality Control Center; Member of the Medical Appraisal Expert Database of the Chinese Medical Association; Member of the National Science and Technology Expert Database; Member of the Appraisal Expert Database of Hubei Province Medical Association; Member of the Expert Guidance Group for Screening and Treatment of Neonatal Congenital Heart Disease in Hubei Province; Youth Committee Member of the Mechanical Circulatory Support Branch of the Chinese Society of Biomedical Engineering.
Hosted and participated in more than 10 national and provincial-level scientific research projects, published over 50 academic papers in authoritative journals such as "Critical Care" both in China and internationally, including more than 10 SCI papers. Authored or co-authored 5 monographs, received 5 provincial-level awards, and obtained 1 patent.
Professor Ren Wei
M.D., Associate Chief Physician at Renmin Hospital of Wuhan University, Visiting Scholar at HUMA University Hospital in Milan, Italy.
Specializes in the surgical diagnosis and treatment of congenital heart disease, valvular heart disease, aortic diseases, coronary artery disease, and cardiomyopathy. Has undergone systematic training at Fuwai Hospital of the National Center for Cardiovascular Diseases and HUMA University Hospital in Milan, Italy. Possesses unique expertise in minimally invasive cardiac surgery, particularly in interventional and hybrid treatments for cardiac and aortic diseases, such as minimally invasive multi-branched fenestrated surgery for complex aortic dissections or aneurysms, minimally invasive non-thoracotomy surgeries for congenital and valvular heart diseases, and was the first to perform "radiation-free, non-general anesthesia, incision-free" transthoracic echocardiography-guided closure surgeries for pregnant women with congenital heart disease within the province. In the field of aortic diseases, has received one First Prize for Science and Technology Progress from Hubei Province, one First Prize for Science and Technology Progress from Wuhan City, and holds one invention patent. Leads projects funded by the National Natural Science Foundation of China, Hubei Provincial Natural Science Foundation, Hubei Provincial Health Commission Fund, and Central Universities Research Fund, and has published over 20 papers in authoritative domestic and international journals, including SCI and Chinese Journal series.
Department Introduction
Department of Cardiovascular Surgery, Renmin Hospital of Wuhan University
Cardiovascular Surgery Department of Renmin Hospital, Wuhan University was established in the 1960s. It is one of the first master's and doctoral degree granting points, postdoctoral research stations, and key disciplines in Hubei Province as rated by the Academic Degrees Committee of the State Council. Currently, it serves as the Hubei branch of the Cardiovascular Technology Collaboration and Training Center of the Chinese Academy of Medical Sciences, the Central-South Regional Cardiovascular Disease Technical Collaboration Center, the Hubei Provincial Clinical Research Center for Cardiovascular Diseases, and a clinical trial base of the National Medical Products Administration. The department has established the Hubei Key Laboratory of Cardiovascular Diseases and the Cardiovascular Disease Research Institute of Wuhan University. It is also a key specialty under construction as part of Wuhan’s initiative to build itself into a central medical service hub in China. After over fifty years of meticulous development, the cardiovascular surgery department has become a professional institution integrating medical treatment, teaching, and research, with an annual surgical volume ranking among the top in the Central-South region.
In 2023, the Cardiovascular Hospital of Renmin Hospital of Wuhan University was established based on the original departments of cardiovascular surgery and cardiovascular medicine. The surgical division comprises the Adult Cardiac Surgery Center, Pediatric Cardiac Surgery Center, Great Vessel Surgery Center, Transplantation Center, Cardiovascular Surgery Intensive Care Unit, and Extracorporeal Circulation and Life Support Center. With its strong foundation in cardiovascular surgery, the hospital is poised for rapid advancement, steadily progressing toward becoming a leading cardiac critical care treatment base in China.
This discipline consists of the following units: Cardiovascular Surgery I, Cardiovascular Surgery II, Cardiovascular Surgical Intensive Care Unit (ICU), Outpatient Department of Cardiovascular Surgery, and Extracorporeal Circulation Research Laboratory. The department handles an annual outpatient volume of nearly 20,000 visits, admits over 2,000 inpatients, and performs more than 1,500 surgeries annually. Its medical services extend across 18 provinces, municipalities, and autonomous regions throughout China. The scope of diagnosis and treatment includes all cardiac and major vascular surgical diseases, with a particular focus on aortic dissection and heart transplantation surgeries as its core strengths. Heart transplant surgeries have ranked fourth nationwide for three consecutive years. The department currently serves as the main committee unit of the Hubei Province Medical Association's Cardiovascular Surgery Physician Branch. Additionally, several members hold key positions in important academic institutions such as the Thoracic and Cardiovascular Surgery Branch of the Chinese Medical Association, the Cardiac Transplantation Group of the Organ Transplantation Branch of the Chinese Medical Association, the Hubei Medical Association, the Cardiovascular Surgery Physician Branch of the Hubei Medical Association, and the Vascular Surgery Branch of the Hubei Medical Association.
The department currently has 55 staff members, including 4 with senior professional titles and 7 with associate senior professional titles; 1 expert with outstanding contributions recognized by the National Health Commission, 3 experts receiving special government allowances from the State Council, 3 doctoral supervisors, and 9 master's supervisors; hundreds of master's and doctoral students have been trained.
This discipline has successively undertaken major scientific research projects, including the "12th Five-Year Plan" and "13th Five-Year Plan" Science and Technology Support Programs of the Ministry of Science and Technology, the Health Industry Research Special Project of the Ministry of Health, the National Natural Science Foundation of China, the Hubei Provincial Natural Science Foundation, the Hubei Provincial Health Commission's Scientific Research Key Projects, and the Major Projects in the Social Development Field of Hubei Province. It has received more than ten Hubei Provincial Science and Technology Progress Awards, including three first prizes.
Professor Wang Zhiwei, the academic leader and chief expert, is a first-class director physician, a national second-class professor, and a doctoral supervisor. He is an expert who enjoys special allowances from the State Council, a middle-aged and young expert with outstanding contributions from the National Health Commission, and a recipient of the Chinese Medical Doctor Association's "Good Cardiovascular Surgeon in China (Golden Scalpel Award)." He serves as the inaugural chairman of the Cardiovascular Surgery Physicians Branch of the Hubei Province Medical Association and as a council member of the Hubei Medical Association. Additionally, he holds concurrent positions as a committee member of the Thoracic and Cardiovascular Surgery Branch of the Chinese Medical Association, the Cardiovascular Surgery Physicians Branch of the Chinese Medical Doctor Association, the Heart Transplantation Group of the Organ Transplantation Branch of the Chinese Medical Association, the deputy chairman of the Hubei Thoracic and Cardiovascular Surgery Society, the deputy chairman of the Wuhan Thoracic and Cardiovascular Surgery Society, and as a reputable doctor in Jiangcheng. He is also a specially invited reviewer and editorial board member for authoritative domestic and international journals such as *Ann Transplant*, *Molecular Therapy*, *Chinese Journal of Thoracic and Cardiovascular Surgery*, and *Chinese Journal of Organ Transplantation*. He has led 10 major national and Hubei provincial scientific research projects; received eight provincial and municipal science and technology progress awards, including the First Prize for Science and Technology Progress in Hubei Province, the Second Prize for Science and Technology Promotion in Hubei Province, and the First Prize for Outstanding Scientific Research Achievements of Universities by the Ministry of Education; published over 100 papers, including more than 60 SCI-indexed articles; obtained two national authorized patents; and trained nearly 100 master’s and doctoral graduate students.
Chief Physician Wu Zhiyong, the lead leader of the discipline, is a master's graduate supervisor, a member of the Cardiac Transplantation Group of the Organ Transplantation Branch of the Chinese Medical Association, a standing committee member of the Cardiovascular Surgery Branch of the Hubei Province Physicians Association, and a member of the Thoracic and Cardiovascular Surgery Branch of the Hubei Province Medical Association. He has been committed to the minimally invasive approach in cardiovascular surgery and the surgical diagnosis and treatment of end-stage heart disease. In particular, he has conducted extensive clinical research and exploration in the fields of comprehensive and individualized minimally invasive treatments for aortic diseases and structural heart diseases, as well as heart transplantation. Leading his team to be the first in the province to carry out interventional occlusion for congenital heart disease and "knifeless" valve replacement, significantly reducing patient trauma, he was awarded the title of Surgical Elite by Renmin Hospital of Wuhan University. He has presided over and participated in multiple national and provincial-level scientific research projects, published more than 10 SCI papers in the past five years, and received 5 provincial-level science and technology progress awards and 1 patent.
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