Case Demonstration by Prof. Pan Ye’s Team: Application of DKutting® High-Pressure Scoring Balloon in Lower Extremity Arterial Occlusive Disease
DK Medtech
Vascular Interventional Balloon Product Developer
With the vigorous development of China's peripheral vascular intervention market, common balloons tend to cause complications such as excessive vascular injury, flow-limiting dissections, and hematomas when dealing with the increasing number of highly resistant stenotic lesions. However, pressure-focused balloons utilize cutting/notching elements positioned between the vessel wall and the balloon’s outer diameter during expansion, enhancing localized pressure for efficient directional dilation. This reduces vascular elastic recoil and represents a new direction in the evolution of vascular intervention balloons.
DK Medtech's Self-Developed DKutting®The high-pressure scoring balloon, with an exclusive patented design (CN201810478242.X), boasts numerous advantages such as excellent deliverability, uniform expansion, and high burst pressure. In terms of overall product performance, it can be called a "hexagonal warrior," marking a significant breakthrough in local enterprises' independent innovation surpassing first-class imported products.
DK Medtech Special Release[Professor Pan Ye's Team: DKutting®Application of High-Pressure Scoring Balloon in Lower Limb Arterial Occlusive Disease: Case Presentation, demonstrating the precise operations of each case and the clinical application of advanced equipment and instruments. From the formulation of treatment strategies for different cases, standardized intraoperative procedures and technical applications, complication prevention, to perioperative management, etc., the aim is to promote the standardization of diagnosis and treatment for vascular stenosis and occlusive diseases, strengthen technical exchanges and experience sharing among doctors, with the hope of providing new ideas and methods for future diagnosis and treatment, benefiting more clinical patients.
DKutting®High-Pressure Scoring Balloon
Application in Lower Limb Arterial Occlusive Disease
Pan Ye, Wu Haisheng from the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Patient Information
Basic Information:Male, 75 years old.
Chief Complaint:Aching pain in both lower limbs for more than 5 years, with the right lower limb being more prominent.
Physical Examination:Both lower limbs are symmetrical, without deformities, and with good skin color. Left dorsalis pedis artery (+). Right dorsalis pedis artery (-).
Admission Diagnosis:
Arteriosclerosis Obliterans of Both Lower Limbs;
Right Iliac Artery Occlusion;
Type ǁ Diabetes.
Preoperative Analysis
Preoperative Analysis:The patient was admitted to the hospital due to right lower limb arterial sclerosis occlusion, right iliac artery occlusion, and type ǁ diabetes. Preoperative examination indicated right iliac artery occlusion with a claudication distance of 100m. The surgical indication was clear, and preoperative examination showed no significant surgical contraindications. The planned procedure is lower limb PTA with stent angioplasty.
Surgical Objective:
Main Objectives:Open the right iliac artery.
Surgical Preparation/Precautions:
Surgical Preparation:Guidewire, Catheter, Balloon, Stent;
Precautions:Careful operation during the procedure, postoperative anticoagulant and antiplatelet therapy, thrombolysis or thrombectomy.
Surgical Procedure
Seldinger Method: Percutaneous puncture of the right femoral artery, placement of a 6F introducer sheath
Angiography via sheath: Proximal segment occlusion of the right common iliac artery branching from the common femoral artery; attempts to pass through the occluded segment to the proximal external iliac artery using a guidewire and catheter were unsuccessful, with repeated attempts failing to return to the true lumen.
The left femoral artery was punctured in the same way, and a 6F introducer sheath was placed. A 0.035 guidewire and crossover catheter were advanced through the sheath to the lower abdominal aorta for angiography. The blood flow in the abdominal aorta and the left common iliac artery was unobstructed; the right common iliac artery, internal iliac artery, and external iliac artery were visualized. There was a long segment occlusion from the right external iliac artery to the common femoral artery, multiple stenoses in the left external iliac artery, and localized occlusion.
The guidewire is paired with a catheter across the abdominal aortic bifurcation to the right internal iliac artery. A 6F long crossover sheath is exchanged to the right common iliac artery. A single-curve catheter is advanced along the long sheath, tracking a 0.035 guidewire through the stenotic lesion to the right deep femoral artery. An Asahi guidewire is then exchanged to pass through the occluded segment and reach the distal portion of the deep femoral artery. The right puncture sheath is subsequently withdrawn, and the puncture site is sutured.
Import Balloon (4mm*150mm High-Pressure Balloon);6mm*80mm DKutting®High-Pressure Scoring Balloon) Dilate the common femoral artery and external iliac artery.
The dilation effect of the stenotic occlusion segment is satisfactory.
Left external iliac artery and common femoral artery.
Import Balloon (5mm*150mm High-Pressure Balloon,6mm*80mm DKutting®High-Pressure Scoring Balloon, Scoring Balloon Pressure 20ATM, Duration 2 Minutes) Dilate the left external iliac artery and common femoral artery.
Follow-up
Discharge Status:Postoperative patient with bilateral dorsalis pedis artery (+), good skin temperature of both lower limbs, significant relief of intermittent claudication symptoms on the right side, no soreness, discharged with Rivaroxaban 10mg + Clopidogrel 50mg qd, and Kaina 2 tablets bid orally. The patient is currently in good condition.
Case Summary
Case Characteristics:
Arteriosclerosis Obliterans of Both Lower Limbs;
Occlusion of the right iliac artery, stenosis of the left iliac artery.
Preoperative Assessment Key Points:Multiple severe calcified plaques in both iliac arteries with occlusion, requiring extra care during passage; balloon dilation is prone to creating dissections.
Features/Usage Tips of the Device:
The pressure increases slowly, pausing for two or three seconds with each increase of one atmosphere;
Effective use of scored balloons successfully prevented the occurrence of flow-limiting dissections.
Introduction of Experts
Professor Pan Ye
Surgeon of This Case
Ph.D. in Surgery, Associate Chief Physician;Director of the Department of Vascular Surgery at Shanghai Sixth People's Hospital, affiliated with Shanghai Jiao Tong University;Member of the Vascular Surgery Specialty Committee of the Shanghai Medical Association;Member of the Lower Extremity Artery Group, Vascular Surgery Specialty Committee, Shanghai Medical Association;Member of the Peripheral Vascular Disease Professional Committee of the Chinese Society for Microcirculation;Secretary and Member of the National Varicose Veins of the Lower Extremities Group, Peripheral Vascular Professional Committee, Chinese Society of Microcirculation;Member of the Multidisciplinary Team for Diabetic Foot at the Shanghai Diabetes Clinical Medical Center.
With over 10 years of clinical experience in vascular surgery, proficient in the diagnosis and treatment of vascular diseases, especially skilled in limb salvage treatment for severe diabetic foot, minimally invasive treatment of vascular surgical diseases such as lower extremity arterial occlusive diseases (e.g., arteriosclerosis obliterans, thromboangiitis obliterans), varicose veins of the lower extremities, and deep vein thrombosis.
Hosted and participated in multiple provincial and ministerial-level research projects, published over 20 academic papers in domestic and international professional journals, authored several SCI papers as the first author, and co-authored two monographs.
Professor Haisheng Wu
Surgeon of This Case
Attending Physician, Department of Vascular Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University;Member of the Expert Committee of the Pressure Group of the Peripheral Vascular Disease Professional Committee of the Chinese Society of Microcirculation;Youth Committee Member of the Expert Committee on Varicose Vein Diseases of the Lower Limbs, Peripheral Vascular Disease Professional Committee, Chinese Association of Integrative Medicine;Member of the China Primary Health Care Foundation's China Children's Hemangioma and Vascular Malformation Alliance.
Department Introduction
The Vascular Surgery Department of Shanghai Sixth People's Hospital boasts a long history. As early as the 1950s, the renowned vascular surgery expert Professor Qian Yunqing, the founder of the department, collaborated with Professor Chen Zhongwei from the Orthopedics Department to perform the world's first successful replantation of an amputated finger. This achievement earned them the First Prize of the National Science and Technology Progress Award and an audience with Premier Zhou Enlai. The pioneering "vascular cuff anastomosis" technique ensured the survival of the replanted finger. Entering the new century, with rapid advancements in endovascular interventional technology, the Vascular Surgery Department at the Sixth People’s Hospital has carried forward the innovative spirit of its predecessors by integrating minimally invasive endovascular techniques with traditional open surgeries. With a focus on minimally invasive treatments for varicose veins of the lower extremities as a breakthrough point, the hospital was among the first in China to introduce minimally invasive surgeries such as endovenous laser and radiofrequency ablation, forming one of the key treatment characteristics of the department. Additionally, in collaboration with leading departments like Orthopedics and Endocrinology, the Vascular Surgery Department has developed its own unique approaches to comprehensive limb salvage treatments for diabetic foot, minimally invasive treatments for lower extremity arterial occlusive diseases, prevention and early intervention of VTE related to bone trauma. Combined with traditional open surgical techniques, the department also performs minimally invasive and hybrid surgeries for conditions such as carotid artery disease, abdominal aortic aneurysms, and aortic dissections. Currently, the Vascular Surgery Department has 20 open beds, four senior title holders, two intermediate title holders, and performs over 1,500 surgeries annually.
